On this page Executive summaryThe current clinical trial regulatory framework has served Canada buy viagra over the counter well by http://myflins.com/how-to-get-viagra-without-prescription/ upholding high standards and patient safety. A modernized clinical trials regulatory framework is needed in buy viagra over the counter light of. Ongoing and accelerated technology advances the development of new types of promising health products the arrival of new clinical trial types and designsBy building on the current framework, we are proposing to introduce flexibilities to support innovation and evolving trial complexity.The modernization of the clinical trials framework is one of 5 pillars under the Regulatory Innovation Agenda for health products. Key aspects of the clinical trial buy viagra over the counter regulatory modernization initiative include. Agile life cycle.
Introduces a single authorization for trials involving multiple buy viagra over the counter product types. It also offers greater agility in the oversight of clinical trials over their life cycle. Risk-based approach buy viagra over the counter. Provides proportional oversight buy viagra over the counter of clinical trials based on the known safety information and relative risk of the product(s) involved in a trial. Terms and conditions.
Give Health Canada the ability to buy viagra over the counter apply (case-by-case) terms and conditions to a clinical trial at any point of the trial to better manage significant risk and uncertainties related to clinical trials. Decentralized trials. Provide opportunities for patients and clinicians who are not connected to major buy viagra over the counter health institutions and/or cannot relocate to a clinical site due to disabilities, family, work, social challenges or other factors, to participate in clinical trials. Service provider oversight. Gives Health Canada direct authority and oversight buy viagra over the counter over service providers (such as contract research organizations).
Transparency. Better informs buy viagra over the counter and educates people on clinical trials by providing them with solid and accurate information.Clinical trials have been at the forefront during the erectile dysfunction treatment viagra. The interim orders adopted as exceptional measures were designed to provide buy viagra over the counter greater flexibility on how to conduct clinical trials during the viagra. This provided us with the opportunity to pilot some of the elements that we were already considering as part of this modernization initiative. It also demonstrated their value and feasibility long-term.As part of this regulatory modernization process, we have consulted and gathered feedback from stakeholders to help us refine the policy and develop regulations.* Stakeholders buy viagra over the counter were invited to comment in writing to a consultation paper through an online questionnaire and email submissions and to participate in 8 interactive webinars.
We received 122 written submissions and close to 1,000 stakeholders participated in the webinars.Overall, respondents agreed with the proposals to modernize the clinical trials framework. Respondents highlighted key benefits for buy viagra over the counter patients and stakeholders in Canada. The proposal would, for example. Help participants to have access to innovative clinical trials and new health technologies while ensuring buy viagra over the counter their safety provide more efficiency in the clinical trials lifecycles without adversely affecting patient safety facilitate the conduct of clinical trial research in Canada better protect participants and the integrity of the data throughout the duration of the clinical trial help clarify expectations between sponsors and service providers involved in a clinical trial better inform and educate people on clinical trials and health productsRespondents also provided suggestions on how to improve the clinical trials framework. These included.
Better harmonization, collaboration and alignment across global regulators (such as the United States (U.S.) and European Union), but also between research ethics boards and Health Canada better buy viagra over the counter defined and articulated risk categories predictable regulations and application requirements reasonable review timelines to reduce burden for sponsors further clarification on technological requirements used to support decentralized trialsSome respondents also emphasized aspects that need to be taken into consideration while designing the clinical trials framework. These included buy viagra over the counter. Needs and issues related to high-risk populations (such as children, people living with rare and/or fatal diseases) patient involvement and engagement when designing studies mechanism for post-trial access to investigational products, allowing patients who benefit from a treatment to continue to receive it after a clinical trial endsThis report summarizes the comments and responses we received during this consultation period, which lasted from May to July 2021.*Please note that a separate consultation on the proposed regulatory framework for clinical trials on foods for a special dietary purpose (FSDP) was held. Read the "what we heard report related to FSDP".IntroductionThere are 5 key pillars of the Government of Canada's Regulatory Innovation Agenda for buy viagra over the counter health products. One of those pillars is the modernization of clinical trial regulations.
This pillar is an important goal for the federal government and will benefit people living buy viagra over the counter in Canada.Technology is advancing quickly and new types of promising health products and foods for a special dietary purpose are being developed. We are also seeing new clinical trial types and designs. In light of such advances, there's buy viagra over the counter a need to modernize Canada's clinical trials regulatory framework.A modernized regulatory framework for clinical trials in Canada should support the adoption of promising novel safe and effective health care therapies. It should also support innovations that can improve people's health. With this initiative, we also want to ensure that people have access to the information they need to make informed decisions buy viagra over the counter about their health.As we stated in the Forward Regulatory Plan for 2021-2023, Health Canada is committed to modernizing the clinical trials framework.
We intend to:⯠introduce a coherent risk-based approach offer greater flexibility in the safe development of innovative therapies authorize clinical trials for non-compliant foods for a special dietary purpose streamline processes to achieve greater efficiency and clarity align with international best practices on matters related buy viagra over the counter to oversight and public access to informationThe interim orders for clinical trials during the erectile dysfunction treatment viagraClinical trials have been at the forefront during the erectile dysfunction treatment viagra, both domestically and internationally. This exceptional crisis has highlighted the need for a revised clinical trials regulatory framework.Canada was quick to respond to the viagra by issuing temporary interim orders (IO). Specifically, the IOs for clinical trials on medical devices and drugs related to erectile dysfunction treatment gave greater flexibility on how to conduct clinical trials buy viagra over the counter during the viagra. The first IO was approved on May 23, 2020, and the second IO on May 3, 2021.The IOs provided the opportunity to pilot and demonstrate the value and feasibility for some elements that Health Canada was already considering under the clinical trials modernization, including. The risk-based approaches for already marketed drugs the ability to add terms and conditions buy viagra over the counter for drug and device clinical trialsThe IOs also made it possible to conduct a broader range of clinical trials and how they are conducted through.
Flexible ways to obtain informed consent for patients at remote sites or who are too ill to sign consent (facilitating decentralized trials) the ability to suspend or cancel part of a trial reducing administrative requirements for assessing new uses of marketed drugs for erectile dysfunction treatment broadening the range of regulated health professionals who can conduct drug trials as qualified investigatorsWhile the scope of the IOs is narrower than what is being proposed, lessons learned from the erectile dysfunction treatment viagra clinical trials have helped us develop the proposed Clinical Trials Regulatory Modernization Initiative. As well, comments received from buy viagra over the counter stakeholders during the consultations were very positive and emphasized the importance of the new measures we implemented as part of the IOs.Consulting with stakeholdersAs part of the modernization initiative, we consulted stakeholders across Canada. Their feedback is being used to inform the development of the proposed policy and regulatory framework.We thank all the stakeholders across Canada who took part in the spring and summer 2021 consultation process. They came from various sectors, including academics and research institutes, industries, patient advocacy groups, health care practitioners and buy viagra over the counter health care organizations.About the consultations and who participatedHealth Canada conducted consultations on the proposed Clinical Trials Regulatory Modernization Initiative between May and July 2021 to gather feedback from stakeholders. As part buy viagra over the counter of this process, we published a consultation paper and invited stakeholders to comment in writing.
We also consulted key stakeholder groups interactively during webinar sessions.Written submissionsFrom May 20 to July 4, 2021, stakeholders were invited to submit their comments and input by filling out an online questionnaire (around 35 questions) or by sending an email. We received 122 buy viagra over the counter written submissions (85 through the online questionnaire). Responses were received as follows. Industry. 43% academics and research institutes.
34% patient advocacy groups. 11% health care practitioners. 4% federal government employees. 3% health care organizations (not including those listed as researchers). 2% research ethics boards.
1% other. 2%Webinar sessionsWe also held 8 interactive webinar sessions in June 2021 to engage stakeholders on the Clinical Trials Regulatory Modernization Initiative. We received many comments and questions at these sessions, which close to 1,000 stakeholders attended. Consultation sessions Number of sessions Number of attendees (approximate) Research institutes, academia and contract research organizations stakeholders 1 350 Medical devices stakeholders 1 205 Pharmaceutical, biologic and over-the-counter medicines industry stakeholders 1 150 Patients and patient groups stakeholders 1 100 Biologic and radiopharmaceutical drugs stakeholders 2 84 National research organizations stakeholders 1 80 Natural Health Products industry stakeholders 1 22 What we heardOverall, most stakeholders supported the modernization initiative. Approximately 75%* of the respondents said the modernization proposals would facilitate and encourage innovative clinical trials in Canada if certain conditions were met.These conditions included, for example.
Regulatory alignment with other major regulators (such as the U.S. And European Union) predictable regulations and application requirements reasonable review timelines to reduce burden for sponsors and attract trials to CanadaMore generally, respondents affirmed that the proposals would improve people's access to health technologies that may help diagnose, prevent, treat or cure physical and mental health conditions.Most respondents favoured international alignment. Others, however, said it's important to learn from other regulators' challenges.Respondents also emphasized that safety is paramount to any innovation. As well, consideration should be given to the needs and issues related to high-risk populations (such as children, people living with rare and/or fatal diseases).Patients and patient groups recommended looking at ways to increase patient involvement and engagement when designing studies (for instance, collaborative research). This would ensure outcomes that matter to patients are included (for example, by setting research priorities and defining research questions).*Note.
We posed the question "Based on your experience and knowledge, would the proposals in the consultation paper meet Health Canada's goal of enabling innovative clinical trials in Canada?. ". About 75% of the stakeholders who gave an answer said "Yes", 18% "Don't know" and 7% "No".The agile life cycle approachMost respondents favoured a more agile life cycle approach to regulating clinical trials (for example, such an approach would create a more favourable environment for conducting master protocols and adaptive trials).The modernized framework would enable and support novel and innovative types of clinical trials in Canada. It would also. Enhance Health Canada's ability to oversee the safe conduct of a trial from start to finish better ensure the health and safety of participants are protected through the application of terms and conditions give Health Canada the ability to suspend a single arm of a trial while allowing the trial to continuePatient safetyRespondents agreed that helping participants to access innovative clinical trials is important while ensuring participant safety.
Some emphasized that the innovative nature of the trial should not supersede the safety of the trial. Others favoured simplifying the regulation of trials involving multiple products (for example, umbrella trials) as long as the expertise needed to review each component is kept.International alignmentIndustry respondents said that the proposed changes are aligned better with international clinical study practice requirements. Harmonization, collaboration and alignment across global regulators are valued, certainly for complex and innovative clinical trials. Biologic and radiopharmaceutical drugs stakeholders suggested that Health Canada accepts or considers foreign clinical trial authorizations to decrease submission burdens.Research ethics boards and Health Canada alignmentIndustry respondents also said it's important to ensure that research ethics boards and Health Canada are better aligned in their processes. Further clarification of their respective roles would also ensure efficiency.Sponsors should be able to submit their trials for review to both a research ethics board and Health Canada at the same time.
Efficiencies are best realized when processes are consistent and predictable.Other suggestions and concernsOther suggestions for Health Canada to consider included the following. Establish an effective and collaborative framework to partner with sponsors to develop innovative trial designs implement a process to seek pre-submission advice from all pertinent review divisions on matters such as study design, statistical methods and novel endpointsSome industry and patient group respondents were concerned the new regulatory framework may create significant administrative barriers (for example, monitoring safety while the trial is ongoing). They felt these proposed requirements should be further clarified. Others viewed those tools and requirements as beneficial to better ensure the safe conduct of trials in Canada.Some respondents said the key to efficient clinical research lies with the integration of clinical research within the health care system rather than novel trial designs. They said that the regulatory framework should not only allow Health Canada to better regulate new research designs, but that it should also cover the type of research infrastructure needed to deliver clinical trials.
It was suggested that Health Canada contribute to developing certain requirements for a permanent research infrastructures across Canadian sites.Other suggestions included introducing a clearly defined mechanism for post-trial access to investigational products. This would allow patients who benefit from a treatment to continue to receive it after a clinical trial ends.Single authorization for multiple productsA modernized regulatory framework would make single authorization possible for clinical trials involving. Combination products (such as a product that combines a drug component and a medical device component) and/or multiple products of different product lines (such as drugs, natural health products and medical devices)Efficiency and reducing burdensA modernized regulatory framework would significantly increase efficiencies for the application, amendment and authorization processes for clinical trials involving multiple health products. This would further streamline Health Canada's interactions with the sponsor throughout the trial.Most respondents said the more streamlined approach would reduce the burden on sponsors for trials that involve multiple products. Currently, these fall under different regulations.
The proposed approach would facilitate the conduct of more complex trial types in Canada.Given the potential complexity associated with the single authorization process, some respondents said a guidance document outlining the administrative and technical requirements and the implementation phase would be helpful.Good clinical practiceTo support the single authorization of a clinical trial involving multiple product lines, it's important to align the clinical trial authorization holder's regulatory good clinical practice (GCP) obligations and requirements across product lines. This would protect participants and the integrity of the data throughout the duration of the clinical trial.Most respondents indicated that they did not anticipate issues adhering to GCP across product lines. Most medical device respondents did not foresee challenges associated with complying with GCP principles in the International Organization for Standardization (ISO) 14155 standard.However, some respondents from the medical devices industry suggested lighter regulatory requirements for trials involving in vitro diagnostic devices. Others recommended allowing sufficient time to adapt to the proposed changes for organizations conducting trials involving natural health products.Risk-based approachThe proposed risk-based approach for clinical trials would stratify different levels of regulatory requirements based on the known safety information and relative risk of the product(s) involved in a trial. Health Canada proposes to establish a coherent risk-based approach in the regulations for clinical trials for all product lines, ensuring the regulations align domestically and internationally where possible.Most respondents said this approach would be more efficient without adversely affecting patient safety.
It would also facilitate the conduct of clinical trial research in Canada by reducing the administrative burden for lower-risk trials.Clearly defining risk categories and processIndustry respondents asked for more clearly defined, detailed and articulated risk categories (for example, in a guidance document). They requested greater evidence as to why certain trials fall under each risk categorization. They also asked for examples of the different trial requirements and criteria used to distinguish between risk categories.Predictable and consistent regulatory requirementsIndustry respondents also said that efficiencies are best realized when regulatory requirements are predictable and consistent. Patient advocacy groups stressed the importance of ensuring timely and appropriate access to innovative health products for patients.Other considerationsHealth care providers said the approach would have the greatest positive impact on investigator-initiated studies that look at repurposing existing therapies for new indications.Academic and research institute respondents noted that this approach would be more feasible with experienced and educated research staff. They also suggested that Health Canada consider putting together expert groups to assess risk levels for high-risk populations (for example, clinical trials involving the pediatric population).Some respondents noted that, for research involving critically ill patients, it would be important to consider the relative risk to these patients and not exclude them from clinical trials.
One patient advocacy group suggested having separate trials and regulatory requirements for lethal and non-lethal diseases.Terms and conditionsThe proposed initiative would give Health Canada the ability to apply terms and conditions to a clinical trial at any point of the trial. This makes the regulations more agile and provides options to protect the health and safety of clinical trial participants better.For the product being tested or the way the trial is being conducted, the intent is to apply terms and conditions on a case-by-case basis to address a significant uncertainty or mitigate a significant risk.Well-defined parametersMost respondents supported this approach. Academics and research institutes, industries and patient advocacy groups emphasized the importance of having well-defined parameters for using terms and conditions to ensure they are applied in a predictable manner. They suggested that Health Canada hold planning meetings with sponsors before a clinical trial starts, to work on terms and conditions together.Research ethics boards and Health Canada alignmentSome industry respondents said the responsibilities of Health Canada and research ethics boards should be clarified. Where possible, they should also be harmonized to avoid redundancies and potential contradictions.Other concernsThere were also concerns that terms and conditions may put more burden on sponsors (for example, asking for information not required in any other jurisdiction).Decentralized clinical trialsMost respondents supported the proposed approach to facilitate the use of decentralized clinical trials (DCTs) in Canada.
This is an important initiative, as over 30% of the population lives outside medium-sized and large urban areas.DCTs are conducted with study participants located outside of clinical research centres. For example, some studies could take place remotely, without a physical visit to a trial site, after the necessary technology has been installed and explained to the patient.DCTs may include the use of videoconferences with investigators, internet-based tools for collecting data, and reporting and mobile technologies such as biosensor devices.As reported by respondents, erectile dysfunction treatment will have a lasting, but positive impact on the use of remote technologies and patient-centricity in clinical trial execution. Video visits have been used in several trials because of erectile dysfunction treatment and results are generally positive.Facilitating participation in clinical trailsRespondents agreed that DCTs are more equitable. They provide an opportunity for patients and clinicians who are not connected to major health institutions and/or cannot relocate to a clinical site due to disabilities, family, work, social challenges or other factors.DCTs may be particularly useful for studying rare diseases, where it can be difficult to get a large enough patient pool together to provide statistically significant trial results. Respondents said DCTs would improve a patient's access to novel therapies.
As stated by an industry respondent, the additional flexibility provided by DCTs during the erectile dysfunction treatment viagra (for example, patients not necessarily needing to go to investigational sites for clinical trial intervention) is a move towards ensuring more patients are able to get treatment faster.It was noted, however, that only patients who are connected to the internet and can afford the technology are able to take advantage of a virtual trial. Other patients would still be left out.More information and clarity needed on DCTsRespondents also said that additional details and clarity are needed to better define DCTs in Canada.Research institutes, academia and contract research organizations stakeholders said that oversight requirements must be clearly outlined in a guidance document to help with implementation and ensure compliance. They also requested more information on how Health Canada will ensure safety for clinical trial participants through adverse events reporting and expanded inspection efforts.Academics and research institute respondents feel that the lack of clarity from regulators on how remotely generated data will be accepted leads to hesitancy to adopt novel technologies.Technologies and DCTsIndustry respondents said that further clarification is needed on the technological requirements for data collection and other types of technologies that may be used to support DCTS (for example, requirements for e-signatures and digital identity). They also said that documented informed consent requires clear interpretation to ensure it incorporates remote and virtual consent formats.National research organizations also favoured an informed consent process through electronic means (for example, electronic signature, video or audio recording) and better use of current communication technologies to enhance communication between participants and researchers.Hybrid approach to DCTsSome industry respondents favoured a hybrid approach for decentralized trials (a combination of site and virtual/remote options). Some assessments could be remote (performed at the patient's home or in their local care community).
Or there could be a mix of partial-remote/partial-traditional (performed on site) within the same study.A hybrid approach would increase options for the participant, which would in turn mean a greater proportion of the population could participate in a trial.Service provider oversightProposed amendments to the regulations would give us direct authority and oversight over service providers (for example, contract research organizations (CROs), site management organizations (SMOs)). This would enable us to address non-compliance or deficiencies in the conduct of clinical trials, which could affect participant safety and data integrity. Essentially, with the proposed amendments, we would have authority over both the sponsor and any service providers to whom the sponsor has outsourced its activities.Most sponsors of clinical trials reported outsourcing a variety of activities to service providers. Outsourced activities could include core laboratory tests, data transfer portals and statistical analysis. Some sponsors noted that it's already common practice to outline legal responsibilities between the sponsor and the service provider in a contract.From the sponsors' perspective, respondents supported the proposal, stating it would help clarify expectations between sponsors and service providers involved in a clinical trial.
It would also increase the quality of outsourced activities since service providers would be accountable for their actions (for instance, improve adherence to regulatory requirements).However, some respondents are concerned that it would likely increase the costs of clinical trials, since service providers would accept more legal risks. Research institutes, academia and contract research organizations requested more information on this proposal (for example, the scope of inspections, selection criteria and verifying compliance of international players).TransparencyMost respondents saw value in a new transparency policy and/or regulations for registering trials and reporting results. Support was strongest from the academic community (73%) compared with industry (54%).There were general statements of support for an updated policy or new regulation and the potential benefits this would have for people living in Canada. One academic says, "Far too often, the outcomes are not known, shared or easy to find."Responses cite benefits for patients. Solid and accurate information is beneficial (and helps) to inform/educate people avoids the risk of duplicating research for drugs and higher-risk medical devicesResponses cite benefits for researchers.
Informs research and development improves understanding of what is expected for certain products in terms of trial design, device approval or expansion of indicationsAbout 13% of total respondents did not see value in a new transparency policy. Reasons given included the following. Information is already available from a number of sources, particularly for multinational drug studies sponsors are already required to register by their institution/funder/another jurisdictionSome pharmaceutical, biologic and over-the-counter medicines industry stakeholders wanted more information on the reasoning behind this regulatory change given that clinical information is disclosed under Vanessa's Law. Some natural health product sponsors indicated that a lack of intellectual property protection may deter some sponsors from doing research in Canada if results reporting were mandated.RegistrationMost respondents from industry and academic research institutes (86%) register their trials with an international registry.Almost all who mentioned a registry use ClinicalTrials.gov. It's the standard or the most widely accepted platform.
Some use the EU Clinical Trials Register and 1 respondent recommends ISRCTN. Device sponsors note that EUDAMED will also be used in the future when it becomes law.Challenges to keep registration information up to dateFeedback indicated that more academic researchers have challenges in keeping their international registration up to date compared with industry researchers. Several industry respondents said they have established practices in place for this.The most common challenge around keeping information up to date in the registries was the burden of being required to use multiple registries in different countries for multinational trials. Other challenges included the dedicated resources needed to maintain up-to-date registry information and registries that are not user-friendly.Public disclosure of resultsMost respondents from industry and academic research institutes (73%) report their results in international registries. Many commented on the value of results reporting.Well-established practiceRespondents explained that reporting their results is an established part of their good clinical practices when conducting research and/or part of a standard operating procedure.
Some explained that reporting is an international or research ethics board requirement, or a requirement for publication.Challenges with reporting resultsOf the 27% of respondents who said they do not report their results in international registries, about half say it's not their role or responsibility. These were contract research organizations (CROs) working with both industry and academic sponsors. Most said this is the sponsor's responsibility.Of those who do not report their results in international registries, 20% (representing both industry and the academic community) said they publish results (for example, anonymized patient level data or result summaries) on their company website.Concerns about burdenBurden plays a large role in compliance for reporting. Some respondents who do not support a new policy or regulation said they support transparency in principle or certain aspects of Health Canada's proposals, particularly for higher-risk products. However, many respondents said they are concerned about certain possible requirements (for example, a new Canadian registry, the need to provide clinical study reports), even though these were not proposed in the consultation.Minimize additional burden by aligning internationallySince they are already required to register, particularly in ClinicalTrials.gov, some respondents indicated that a new policy or regulation on registration in Canada should rely on existing registries.
They said a new registry may add to the burden.Respondents suggested that Health Canada should align the new policy with international regulations. They discouraged Canadian-specific requirements. Suggestions included. Encouraging alignment with other global clinical trial registration requirements ensuring that reporting of results be aligned in terms of timing, location and/or information requirementsClear communicationSome respondents said that Health Canada should clearly communicate its expectations for how to meet a new policy by outlining. Format timelines information where information is to be publishedOnline informationWith enhanced transparency measures, more information about Canadian clinical trials would be available from international registries.
Health Canada proposes to play a role in making this information more accessible on the Government of Canada website.Some respondents indicated that bringing together information about Canadian trials from other sources is useful, including extracting information registered elsewhere or providing links on the Government of Canada website. For example. "Canadians who are interested in clinical trials should be able to access a Health Canada-hosted site to search for clinical trials, find information related to contacting those conducting the clinical trials and learn about the trial results."Biologic and radiopharmaceutical drugs respondents underlined the importance of the peer-review process undertaken by scientific journals to prevent incorrect information from being communicated to the public. They suggested that Health Canada consider this when developing its public registry policy.Research institutes, academia and contract research organizations respondents requested more transparency for the following. Reporting clinical trial inspection results and how Health Canada deals with deficiencies reporting changes to indications and individual arms during multi-arm trialsMedical devicesWith the 2018 Action Plan on Medical Devices, Health Canada committed to reviewing longstanding stakeholder concerns about how the current regulatory framework for medical devices might be unintentionally limiting clinical trials in Canada.
Through the Clinical Trials Regulatory Modernization Initiative, we aim to encourage more clinical research in Canada, while continuing to focus on the protection of patient safety. Respondents who identified themselves as medical device stakeholders were asked questions on the following topics.Off-label use trials of licensed devicesHealth Canada is exploring the possibility of reducing the requirements for clinical trials studying off-label use of medical devices licensed in Canada. Patient safety remains a priority.Most responses supported reduced regulatory requirements for off-label use trials of licensed medical devices, as these products have known safety profiles. However, some stakeholders said there may be cases where a new use could result in significant and/or unexpected new risk that would necessitate proportionate regulatory oversight.Notifications and amendmentsAs part of the regulatory modernization initiative, Health Canada is proposing to allow amendments to clinical trial applications to be made without requiring the sponsor to submit a new application.Most respondents supported the 3 pathways proposed for clinical trial amendments (significant changes, notifiable changes and non-significant changes). Industry stakeholders highlighted the importance of a simple and streamlined online system with predictable timelines that's easy to navigate.
They also requested further guidance on the assessment of changes as significant or non-significant.Investigator-initiated trialsThe current Medical Devices Regulations permit only manufacturers and importers of medical devices to apply for clinical trial authorization. The Clinical Trial Modernization framework would expand who can file an application to include independent investigators in addition to manufacturers and importers.Some stakeholders indicated that these trials may help to generate new clinical data. Others felt that independent researchers may lack the internal resources and experience needed to submit a full application and conduct a clinical study. As well, they may not have adequate access to medical device records from the manufacturer, and thus may not understand fully the risk involved. It was recommended that investigators should coordinate with manufacturers and receive their approval before they apply for an authorization.In all cases, stakeholders emphasized that patient safety and clinical trial integrity should remain priorities.Next stepsHealth Canada appreciates the comments and input from the various stakeholders involved in clinical trials in Canada.The feedback received during the consultation process will help us refine the policy and develop regulations to modernize the clinical trials framework.We will continue to engage stakeholders and subject matter experts as this initiative progresses.
Please continue to consult the Forward Regulatory Plan 2021-2023. Modernization of the Regulation of Clinical Trials for updates and future opportunities to provide your feedback on this important initiative.Disclaimer. This document does not constitute legislation. In the event of any inconsistency or conflict between the legislation and this document, the legislation takes precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the legislation and the applicable administrative policies.Date approved.
February 9, 2022Date implemented. March 2, 2022On this page IntroductionHealth Canada is responsible for helping people in Canada maintain and improve their health. This is done, in part, by helping to ensure that people in Canada have access to the drugs they need when they need them and that these drugs meet an acceptable level of safety.Sections C.01.014.8 and C.10.004 to C.10.011 of the Food and Drug Regulations (FDR) create a framework for the exceptional importation and sale of foreign-authorized drugs. This framework was created to help prevent and mitigate drug shortages.Drugs imported under this framework are labelled for a foreign market, but have been manufactured according to quality standards similar to those required in Canada. These drugs do not receive a Canadian notice of compliance.
They are only permitted to be imported for sale during a limited period of time.Exceptional importation was initially implemented through the following interim orders. Interim Order respecting drugs, medical devices and foods for a special dietary purpose in relation to erectile dysfunction treatment (IO No. 1), effective March 18, 2020, to February 28, 2021 Second Interim Order respecting drugs, medical devices and foods for a special dietary purpose in relation to erectile dysfunction treatment (IO No. 2), effective March 1, 2021, to February 28, 2022 The provisions for the exceptional importation framework from IO No. 2, with some modifications, were made permanent through amendments to the FDR.
The entry into force of these provisions was March 2, 2022, the day after IO No. 2 ceased to have effect.Transitional provisions are included in the regulatory amendments for regulated parties that have imported drugs in accordance with IO No. 2 and must now come into compliance with the regulatory framework.For more information on drug shortages and the roles of various parties in addressing shortage situations, consult the Drug Shortages in Canada page.Purpose and scopePurposeThis guidance document is meant to help drug establishment licence (DEL) holders involved in the exceptional importation and sale of drugs understand how to comply with the regulations. This document is intended to help you understand sections C.01.014.8 and C.10.004 to C.10.011 of the FDR by outlining. What is meant by exceptional importation and sale the circumstances where a foreign-authorized drug may be eligible for exceptional importation and sale in Canada the application process for the exceptional importation and sale of foreign-authorized drugs the regulatory requirements for the exceptional importation and sale of foreign-authorized drugs good manufacturing practices (GMP) requirements for the exceptional importation and sale of foreign-authorized drugs provisions for the transition from the IO No.
2 to FDR requirementsScopeInclusionsSections C.01.014.8 and C.10.004 to C.10.011 of the FDR apply to the following drugs for human use that have a Canadian drug identification number (DIN). Drugs that may be sold without a prescription, but are administered only under a practitionerâs supervision commonly referred to as âethicalâ drugs (for example, hemodialysis solutions, pre-filled syringes with epinephrine for severe allergic reactions, MRI contrast agents) drugs on the Prescription Drug List drugs listed in Schedules C and D of the Food and Drugs Act (the Act) ExclusionsNatural health products, over-the-counter drugs and drugs for veterinary use are excluded from the scope of these provisions.Understanding the regulationsExceptional importationSubject to sections C.01.014.8 and C.10.004 to C10.011 of the FDR, Health Canada may allow the exceptional importation and sale of a foreign-authorized drug by adding it to the List of Drugs for Exceptional Importation and Sale (the list). The list is incorporated by reference into the FDR and is updated as required. In order to have a foreign-authorized drug added to the list, the importer must hold an active DEL that meets the requirements laid out in the DEL information section.Drugs on this list are known as designated drugs. They may be imported and sold to prevent or mitigate a drug shortage.Examples of drugs that may be eligible for exceptional importation and sale (not an exhaustive list) include.
A drug that is identical to a Canadian-authorized drug but has a foreign authorization, and consequently a foreign label (for example, a manufacturing site may make the same drug for many different markets) a drug that has been authorized by a regulatory authority in another country and Health Canada has reasonable grounds to believe the drug can be substituted for the Canadian-authorized drug in shortage or at risk of shortage the drug must also be manufactured to similar quality standards to the Canadian-authorized drug For a drug to be considered eligible for exceptional importation and sale in order to prevent or address a drug shortage, Health Canada has established the following criterion through policy. There is an anticipated or actual critical shortage (Tier 3 or other critical shortage) of the Canadian-authorized version of the drugCritical drug shortages are almost always national in scope and fall into one of 2 categories. Tier 3 drug shortages. The Protocol for the Notification and Communication of Drug Shortages sets out a tiered classification system for drug shortages. Tier 3 shortages are drug shortages that are expected to have the most significant impact on the Canadian drug supply and health care system.
Impact is largely determined based on low availability of alternative supplies, ingredients or therapies. Tier 3 drug shortages are determined by a Tier Assignment Committee (TAC), which is an ad hoc committee of federal and provincial/territorial governments, health care professionals and industry stakeholders. Drugs assessed by the TAC to be in a Tier 3 shortage are posted online in the List of Tier 3 Drug Shortages. All Tier 3 shortages are considered to be critical drug shortages. Shortages with specific patient impacts.
Other shortages not meeting the definition of a Tier 3 shortage may be considered to be critical if certain patient groups (for example, niche drugs that would affect a small number of patients) are likely to experience a serious impact. Health Canada will consider proposals for adding a foreign-authorized drug to the List of Drugs for Exceptional Importation and Sale if the Canadian drug is considered to be in or at risk of a critical shortage.The exceptional importation and sale framework is meant to complement other pathways that exist for accessing drugs under various special circumstances. Examples of such pathways are. The following sections describe the process leading to the exceptional importation and sale and the importation and sale requirements.Submitting a proposal and adding a drug to the List of Drugs for Exceptional Importation and SaleSubmitting a proposalRegulatory requirements outlining when a drug may be added to the List of Drugs for Exceptional Importation and Sale are found in section C.10.005 of the FDR.Health Canada has developed a process by which a DEL holder can submit a proposal to add a drug to the List of Drugs for Exceptional Importation and Sale. We will only consider proposals for foreign-authorized drugs that are considered appropriate substitutes for a drug in or at risk of a critical shortage.Email the completed proposal form to drugshortages.prop.notif-penuriesmedicaments@hc-sc.gc.ca.The details provided in the proposal form allow Health Canada to assess the foreign-authorized drug under consideration to determine if there are reasonable grounds to believe.
The drug is an appropriate substitute for the Canadian drug in actual or anticipated shortage the DEL holder meets regulatory requirements for the applicable licensable activities to ensure safe use of the drug in CanadaThis information, which will be reviewed on a case-by-case basis, includes. Product-specific information DEL informationProduct-specific information. Product labelling (for example, conditions of use, approved indication in the country of authorization) product formulation clinical and quality information (for example, chemistry and manufacturing processes, and specifications of the drug substance and drug product) how this information may differ from a Canadian-authorized productDEL information:To have a drug added to the List of Drugs for Exceptional Importation and Sale. A company must hold an active DEL for the appropriate activity, category (for example, pharmaceutical or biologic) and dosage from (for example, tablet) the DELâs Foreign Building Annex must include the following. all buildings involved in fabricating, packaging/labelling and/or testing the finished dosage form of the drug outside of Canada, including finished dosage form intermediates, for the applicable activity, category of drugs and dosage form the DELâs active pharmaceutical ingredient (API) Foreign Building Annex must include the following.
all buildings fabricating, packaging/labelling and/or testing APIs, including API intermediates, that are being imported by the Canadian building for the applicable activity, category of drugs and API form class all buildings fabricating, packaging/labelling and/or testing APIs, including API intermediates, that are used in the fabrication of the finished drugs, that are being imported by the Canadian building for the applicable activity, category of drugs and API form class For more information on the DEL application process and requirements, consult the. When amending a DEL Foreign Building Annex and API Foreign Building Annex, please consult the Guidance document on how to demonstrate foreign building compliance with drug GMP (GUI-0080) for more information.To address a critical drug shortage, Health Canada may expedite the process to issue or amend a DEL in order to facilitate exceptional importation.Health Canada will follow up with the DEL holder if any additional information is needed to evaluate a proposal. We will communicate the results of the evaluation of the proposal to the DEL holder. In the case where a decision is made to not add the foreign-authorized drug to the List of Drugs for Exceptional Importation and Sale, the DEL holder will be made aware of the reason(s) for the refusal. The DEL holder may address the issues for the initial refusal through the submission of a new proposal form.Adding a drug to the List of Drugs for Exceptional Importation and SaleRegulatory requirements for adding a drug to the List of Drugs for Exceptional Importation and Sale are found in section C.10.005 of the FDR.
Further requirements related to the information required for the list are found in section C.10.006 of the FDR.Once a proposal is accepted, Health Canada will notify the DEL holder in an email and place the designated drug on the List of Drugs for Exceptional Importation and Sale. Designated drugs may be imported once they have been added to this list and the DEL holder has met the notification requirements as outlined in the regulations. Once imported, drugs may be sold until their expiry date, even if further importation is no longer permitted. Guidance on meeting other regulatory requirements before importing and/or selling these drugs is found in the following sections.Designated drugs do not receive full market authorization in Canada and are not assigned a DIN (FDR, section C.10.008(1)(b)).The following information is posted publicly on the List of Drugs for Exceptional Importation and Sale. The DEL holderâs name (âName of Licenced Importerâ on the list) the brand name, medicinal ingredient(s), dosage form, strength, route(s) of administration, identifying code or number (if any) assigned in the country in which it is authorized for sale, a detailed description of its conditions of use and any other information as required the lot number(s) of the drug, if applicable (âSpecified Batch Numberâ on the list) the name of the foreign regulatory authority that authorized the sale of the drug within its jurisdiction responsible regulatory authority in that country the date that the product was added to the list the date after which the importation will no longer be allowed the maximum quantity of the designated drug to be imported or the lot numbers that have been authorized for importation, if applicable information to support the drugâs safe use (such as the DEL holderâs contact information or link to the risk communications plan)Health Canada may modify limitations on dates and importation quantities to address the changing circumstances of a shortage.
We will notify DEL holders in advance of any changes.Companies are encouraged to evaluate the quantities required to support the Canadian market before engaging in the exceptional importation of a drug so that an excess of product is not imported. Health Canada is not responsible for designated drugs that remain unsold in Canada.Health Canada will remove a drug from the List of Drugs for Exceptional Importation and Sale if it is determined that incorrect or misleading information was provided in the proposal or any associated requests for information. We may also remove a drug from the list based on a risk assessment, which may result in a stop sale, recall or other post-market actions. We will notify affected DEL holders as early as possible.The List of Drugs for Exceptional Importation and Sale indicates the most recent date that the list was updated. Health Canada will work with and/or notify the affected DEL holder(s) when a change is being made.
All other DEL holders may consult the list regularly to monitor the status of the various drugs on the list.Notification requirements before importing and selling a designated drugRegulatory provisions for notification requirements are found in section C.10.006 (1)(a) of the FDR.DEL holders must notify Health Canada at least 3 business days before they import a designated drug. This is necessary to help avoid unnecessary processing delays at the border.Please email your notification to drugshortages.prop.notif-penuriesmedicaments@hc-sc.gc.ca. Include the following information in the notification. DEL holderâs name and contact information name and contact information of each fabricator, packager/labeler and tester and the address of each building in which the drug is fabricated, packaged/labelled or tested brand name of the drug to be imported medicinal ingredient(s) dosage form strength route of administration expiry date(s) of drug to be imported identifying code assigned in the country in which it is authorized for sale, if any detailed description of the conditions of use intended port of entry into Canada estimated date of arrival into Canada total quantity of drug to be imported on this dateDEL holders must communicate any changes to this information between the initial notification and importation dates. Changes must be communicated using drugshortages.prop.notif-penuriesmedicaments@hc-sc.gc.ca.Health Canada advises DEL holders to include the customs identification number in the notification.
If a DEL holder does not know the customs identification number at the time of import notification, this should not delay the submission of the import notification. You should clearly indicate if this is the case and that you will provide the number when it is available. Email us at drugshortages.prop.notif-penuriesmedicaments@hc-sc.gc.ca.Information to support the safe use of the drugRegulatory provisions for the detailed description of conditions of use of the drug are found in section C.10.011 of the FDR.DEL holders can import a drug once it has been added to the List of Drugs for Exceptional Importation and Sale. However, the drug product cannot be sold until information is available on the conditions to support the safe use of the drug. Health Canada refers to this information as the risk communication.Health Canada will discuss the requirements for the risk communication plan with DEL holders during the proposal review process.
In most cases, companies are expected to generate letters to health care professionals informing them about the safe use of the designated drug. The letters should also contain information comparing the Canadian-authorized product to the foreign-authorized product.Before a designated drug can be sold in Canada, risk communications to support its safe use must be finalized and available in both English and French.A companyâs risk communication plan should include the following information. The audience for risk communications the method of dissemination a statement that Health Canada has permitted the exceptional, temporary importation and sale of the foreign-authorized product information to support the safe use of the designated drug, such as. name of the foreign product and why it is being imported at this time differences between the foreign and Canadian products that are relevant to users specific recommendations for the foreign product, if any, that are identified in Health Canadaâs assessment, including a statement that clearly tells health care professionals about the appropriate use of the foreign product where to find information about the foreign and Canadian-authorized products online how to report adverse reactions English and/or French translation of the foreign product label(s), if original label does not include both official languages a clear image of the foreign product label(s) and the final foreign product in its primary packaging to help identify the product additional information specified by Health Canada For additional information about risk communication requirements, refer to the risk communication plans page.Good manufacturing practice (GMP) requirements for selling designated drugsRegulatory GMP requirements for selling designated drugs are found in sections C.10.008(1)(b), C.10.009 and C.10.010 of the FDR. Designated drugs must meet all GMP requirements in the FDR (Part C, Division 2 on good manufacturing practices) with the exception of the following:Finished product testing requirements:The requirements in section C.02.019 of the FDR have been modified for designated drugs to.
Remove the requirements for periodic complete confirmatory testing of imported designated drugs require visual examination to be used for identity testing of drugs imported from jurisdictions with which Canada does not have a mutual recognition agreement (non-MRA jurisdictions) if the useful life of the drug is more than 30 days for a list of jurisdictions that have MRAs with Canada, visit Updates on mutual recognition agreements identity testing must include a review of. product labelling dosage form physical measurements (for example, dimensions, volume), if applicable clarify that the term âspecificationsâ refers to the relevant specifications for the designated drug in the foreign jurisdiction where it was authorized Record-keeping requirements:The records specified in section C.02.020 (1) paragraphs a, b and d of the FDR are required to be maintained but need not be maintained on the DEL holderâs premises in Canada. However, this information must be provided electronically in a format specified by or acceptable to Health Canada when requested by Health Canada.These records include. Validation reports executed batch records stability documentation master production documentsOther regulatory requirements and exemptions under the exceptional importation frameworkOther regulatory requirements and exemptions under the exceptional importation framework are found in sections C.10.007 to C.10.009 of the FDR.Designated drugs are exempt from the following FDR provisions. The prohibition on importing drugs in Canada for sale, if the sale of the drug would violate the Act or the FDR (A.01.040) the provision allowing for the opportunity to re-label a drug to make an imported drug sellable in Canada (A.01.044) the requirement to have a person in Canada who is responsible for the sale of the drug, prior to importing a drug in dosage form for sale (C.01.004.1(1)) the prohibition on selling drugs in dosage form imported into Canada unless the following is provided on the label.
the importer's name the principal business address in Canada of the person responsible for the drugsâ sale (C.01.004.1(2)) requirements for labels to be in both official languages (A.01.015) requirements for label format, prominence of information and plain language (A.01.017) the sampling provision that calls for duplicate analysis or examination (A.01.051) DEL holders should note the requirements that remain in effect, including. Obligation to report all adverse drug reactions and issue-related summary reports (C.01.016, C.01.017, C.01.019, C.01.020) obligation for hospitals or other health care institutions to report serious adverse drug reactions (C.01.020.1) existing requirements and controls for prescription drugs (C.01.040.3 to C.01.049) obligation for importers of the drug for sale who commence a recall to report certain information (C.01.051) all DEL requirements in Division 1A of the FDR, including listing foreign buildings on their licence (see the DEL information section) all GMP requirements in Division 2 of the FDR, except for those specifically described in the GMP requirements sectionNote. All other applicable FDR provisions remain in effect. Examples include the following. Security packaging when the drug is intended for sale to the general public (A.01.065) provisions relating to advertising (A.01.067) and sale (A.01.068) Removing drugs from the List of Drugs for Exceptional Importation and SaleCritical drug shortages are considered resolved when the Canadian-authorized drug is available in sufficient quantities to meet demand.
For Tier 3 shortages, decisions to remove a drug from the List of Tier 3 Drug Shortages are made by the TAC, including the same representatives who determined that the drug was in a Tier 3 shortage.Once a critical drug shortage is resolved, Health Canada may amend. This is done so that no further inventory is imported. However, the drug will remain on this list for a time to allow the remaining inventory in Canada to be sold until its expiry date.Once a shortage has been resolved, Health Canada will remove the following from the list. Designated drugs for which there have been no imported shipments drugs for which all imported inventory has been sold drugs that have expired Health Canada will notify DEL holders when the process to remove a designated drug from the List of Drugs for Exceptional Importation and Sale has begun. We may ask for information from the DEL holder to help determine when the drug should be removed from the list.A drug that has been removed from the List of Drugs for Exceptional Importation and Sale can no longer be imported or sold.Coming into force and transition from interim order provisions Coming into force of the RegulationsThe amendments to the FDR come into force on March 2, 2022.Transitional provisionsOn March 2, 2022, all active products that were added to the List of Drugs for Exceptional Importation and Sale under IO No.
2, and whose Canadian substitute is still in or at risk of a critical shortage, will be transitioned to the new list and covered under the new regulations. Transitional provisions are outlined in sections 10 to 15 in the amendments to the FDR.These drugs will be subject to the FDR requirements and guidance stipulated in this document.Health Canada will work with DEL holders for existing products on the List of Drugs for Exceptional Importation and Sale to assign an end of importation date and, if applicable, maximum quantities for importation and sale. This information will be added to the list. Contact usFor more information about drug shortages in Canada, please visit our drug shortages page.For questions about drug shortage and discontinuation regulations, email us at Drug.shortages-Penurie.de.medicament@hc-sc.gc.ca.For questions about submitting a proposal or adding a drug to the List of Drugs for Exceptional Importation and Sale, email us at drugshortages.prop.notif-penuriesmedicaments@hc-sc.gc.ca.At least 3 days before importing designated drugs, submit notifications to drugshortages.prop.notif-penuriesmedicaments@hc-sc.gc.ca.For questions on the DEL application requirements, email us at del.questions-leppp@hc-sc.gc.ca.For questions on the Domestic GMP requirements, email us at drug.gmp.questions-bpf.medicaments@hc-sc.gc.ca.For questions on the Foreign GMP requirements, email us at foreign.site-etranger@hc-sc.gc.ca.DefinitionsActual shortage. A manufacturer's current supply cannot meet current demand in Canada (pénurie réelle) (refer to âShortageâ)Anticipated shortage.
A manufacturer's future supply cannot meet projected demand in Canada (pénurie anticipée) (refer to âShortageâ)Business day. A day other than a. A Saturday or a Sunday or other holiday (jour ouvrable) (FDR, C10.006 (2))Critical drug shortages. Shortages that will have the most impact on the health of people in CanadaCritical drug shortages are almost always national in scope and fall into 2 classes. Tier 3 drug shortages.
The Protocol for the Notification and Communication of Drug Shortages sets out a tiered classification system for drug shortages. Tier 1. Anticipated shortages, of which a manufacturer or importer expects that future supply may not meet projected demand for the drug Tier 2. Actual drug shortages Tier 3. Actual drug shortages with the greatest potential impact on the Canadian drug supply and health care systems by virtue of availability of alternative supplies, ingredients or therapies Tier 3 shortages are determined on a case-by-case basis by a specially convened Tier Assignment Committee (TAC), which includes representatives from federal and provincial/territorial governments and health care professionals.
Drugs assessed by TAC to be in Tier 3 shortage are posted online in the List of Tier 3 Drug Shortages. All Tier 3 shortages are considered critical drug shortages. Shortages with specific patient impacts. Other shortages may also be considered to be critical even if they do not meet the definition of a Tier 3 shortage if it is determined that such shortages will impact the health of specific groups of patients. For example, a shortage of a niche drug that would impact a small number of patients would be considered to be critical without necessarily meeting the definition of a Tier 3 shortage.
Shortages with specific patient impacts are determined by Health Canada. Health Canada looks at the on-label use of the drug to determine if it would impact the health of people in Canada if not available to those who need it. Designated drugs. A drug that is set out in the List of Drugs for Exceptional Importation and Sale (drogue désignée) (FDR, C10.004 (1))Drug. Any of the following drugs for human use.
Drugs included in Schedule I, II, III, IV or V to the Controlled Drugs and Substances Act prescription drugs drugs that are listed in Schedule C or D to the Act and drugs that are permitted to be sold without a prescription but that are to be administered only under the supervision of a practitioner(drogue) (FDR, C.10.004 (1))For clarity. Schedules I, II, III, IV and V to the Controlled Drugs and Substances Act are available online prescription drugs are found on the Prescription Drug List the Act refers to the Food and Drugs Act drugs that are listed in Schedule C or D of the Act are also known as radiopharmaceuticals and biological drugs drugs that may be sold without a prescription but are to be administered only under the supervision of a practitioner are known as âethicalâ drugs (for example, hemodialysis solutions, pre-filled syringes with epinephrine for severe allergic reactions, MRI contrast agents)Drug establishment licence (DEL). A licence issued to a person in Canada pursuant to Division 1A of the FDR to conduct licensable activities in a building that has been inspected and assessed as being in compliance with the requirements of Divisions 2 to 4 of the Food and Drug Regulations (Licence dâétablissement de produits pharmaceutiques (LEPP)) Drug identification number (DIN). An 8-digit numerical code assigned by Health Canada to each drug product marketed under the Food and Drugs Act and RegulationsA DIN uniquely identifies the following product characteristics. Manufacturer, product name, medicinal ingredient(s), strength of medicinal ingredients(s), pharmaceutical form, route of administration (numéro dâidentification dâun médicament)Establishment licence.
Refer to drug establishment licence aboveExpiration date. In the case of a drug in dosage form, the earlier of the following dates, expressed at minimum as a year and month. The date up to and including which the drug maintains its labelled potency, purity and physical characteristics and the date after which the manufacturer recommends that the drug not be used(date limite dâutilisation) (C.01.001 (1))Fabricate. To prepare and preserve a drug for the purposes of sale (manufacturer) (FDR, C.01A.001(1))Foreign regulatory authority. A government agency or other entity outside Canada that has a legal right to control the manufacturing, use or sale of drugs within its jurisdiction (autorité réglementaire étrangère) (FDR, C10.001(1) and C10.004(1))Incorporation by reference.
A term used to describe a mechanism, which allows a document or list that is not in the text of the regulations, in whole or in part, to be made a part of the regulations. Health Canada uses incorporation by reference to achieve policy and regulatory objectives. Incorporation by reference enables Health Canada to leverage existing documents and maintain agile regulatory frameworks that can more quickly adapt to changes in science or technology, or in response to an emerging health or safety risk. Incorporation by reference can also contribute to items such as regulatory alignment with the provinces and territories and to international cooperation on matters of trade, without compromising health and safety (incorporation par renvoi) (Health Canada Incorporation by Reference Policy)List of drugs for exceptional importation and sale. Published and updated by the Government of Canada on its website (FDR, C10.004 (1)).
A drug included on this list is permitted to be imported and sold for the duration and in the quantities specified (if applicable). This list is incorporated by reference in the FDR. (Liste des drogues destinées aux importations et aux ventes exceptionnelles)Manufacturer. A person, including an association or partnership, who under their own name, or under a trade, design or word mark, trade name or other name, word, or mark controlled by them, sells a food or drug (fabricant) (FDR, A.01.010)Market authorization holder (MAH). The legal entity that holds the notice of compliance, the Drug Identification Number (DIN), the medical device licence, the product licence or that has received authorization to import and sell a drug for the purpose of a clinical trial (détenteurs dâune autorisation de mise sur le marché (DAMM))MRA country.
A country that is a participant in a mutual recognition agreement with Canada (pays participant) (FDR, C.01A.001(1))For clarity, this term can also be taken to mean jurisdictions other than countries (for example, the European Union), with which Canada has an MRAPackage/label. To put a drug in its immediate container or to affix the inner or outer label to the drug (emballer-étiqueter) (FDR, C.01A.001(1))Person. An individual or an organization as defined in section 2 of the Criminal Code (personne) (FDA, section 2)Shortage. In respect of a drug, a situation in which the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the Drug Identification Number assigned for the drug is unable to meet the demand for the drug in Canada (pénurie) (FDR, C.01.014.8 (2))Tier 3 drug shortage. Refer to critical drug shortages above (les pénuries de niveau 3)Tier 3 list.
A list published online and maintained by Health Canada that lists the molecules/drugs whose finished dosage form(s) are in shortage on the Canadian market. The molecules/drugs have been determined to meet the definition of a Tier 3 shortage by a Tier Assignment Committee (Liste des pénuries de niveau 3)Tier Assignment Committee (TAC). An ad hoc committee of federal and provincial/territorial governments, health care professionals and industry stakeholders that makes recommendations on the tier assignment of a drug shortage (Comité dâattribution de niveaux (CAN))References and related linksLegislation and regulations Policies and guides Web pages/associated documents.
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How to cite http://www.ec-boucheseche-hoenheim.ac-strasbourg.fr/slideshow/1315/ this article:Singh OP viagra for premature ejaculation. Psychiatry research in India. Closing the research gap viagra for premature ejaculation. Indian J Psychiatry 2020;62:615-6Research is an important aspect of the growth and development of medical science. Research in India in general and medical research in particular is always being criticized for lack of innovation and viagra for premature ejaculation originality required for the delivery of health services suitable to Indian conditions.
Even the Indian Council of Medical Research (ICMR) which is a centrally funded frontier organization for conducting medical research couldn't avert criticism. It has been criticized heavily for not producing quality research papers which are pioneering, ground breaking, or pragmatic solutions for health issues plaguing India. In the words of a leading daily, The ICMR could not even list one practical application of its hundreds of research papers published in various national and international research journals which helped cure any disease, or diagnose it with better accuracy or in less time, or even one viagra for premature ejaculation new basic, applied or clinical research or innovation that opened a new frontier of scientific knowledge.[1]This clearly indicates that the health research output of ICMR is not up to the mark and is not commensurate with the magnitude of the disease burden in India. According to the 12th Plan Report, the country contributes to a fifth of the world's share of diseases. The research conducted elsewhere may not be generalized to the Indian population owing to differences in biology, health-care systems, health practices, viagra for premature ejaculation culture, and socioeconomic standards.
Questions which are pertinent and specific to the Indian context may not be answered and will remain understudied. One of the vital elements in improving this situation is the need for relevant research base that would equip policymakers to take informed health policy decisions.The Parliamentary Standing Committee on Health and Family Welfare in the 100th report on Demand for Grants (2017â2018) of the Department of Health Research observed that âthe biomedical research output needs to be augmented substantially to cater to the health challenges faced by the country.â[1]Among the various reasons, lack of fund, infrastructure, and resources is the prime cause which is glaringly evident from the inadequate budget allocation for biomedical research. While ICMR has a budget of 232 million dollars per year on health research, it is zilch in comparison viagra for premature ejaculation to the annual budget expenditure of the National Institute of Health, USA, on biomedical research which is 32 billion dollars.The lacuna of quality research is not merely due to lack of funds. There are other important issues which need to be considered and sorted out to end the status quo. Some of the factors which need our immediate attention are:Lack of research training and teachingImproper allocation of research facilitiesLack of information about research work happening globallyLack of promotion, motivation, commitment, and passion in the field of researchClinicians being overburdened with patientsLack of collaboration between medical colleges and established research institutesLack of continuity of research in successive batches of postgraduate (PG) students, leading to wastage of previous research and resourcesDifficulty in the application of basic biomedical research into pragmatic intervention solutions due to lack of interdisciplinary technological support/collaboration between viagra for premature ejaculation basic scientists, clinicians, and technological experts.Majority of the biomedical research in India are conducted in medical institutions.
The majority of these are done as thesis submission for fulfillment of the requirement of PG degree. From 2015 onward, publication of papers had been made an obligatory viagra for premature ejaculation requirement for promotion of faculty to higher posts. Although it offered a unique opportunity for training of residents and stimulus for research, it failed to translate into production of quality research work as thesis was limited by time and it had to be done with other clinical and academic duties.While the top four medical colleges, namely AIIMS, New Delhi. PGIMER, Chandigarh. CMC, Vellore viagra for premature ejaculation.
And SGIMS, Lucknow are among the top ten medical institutions in terms of publication in peer-reviewed journals, around 332 (57.3%) medical colleges have no research paper published in a decade between 2004 and 2014.[2]The research in psychiatry is realistically dominated by major research institutes which are doing commendable work, but there is a substantial lack of contemporary research originating from other centers. Dr. Chittaranjan Andrade (NIMHANS, Bengaluru) and Dr. K Jacob (CMC, Vellore) recently figured in the list of top 2% psychiatry researchers in the world from India in psychiatry.[3] Most of the research conducted in the field of psychiatry are limited to caregivers' burden, pathways of care, and other topics which can be done in limited resources available to psychiatry departments. While all these areas of work are important in providing proper care and treatment, there is overabundance of research in these areas.The Government of India is aggressively looking forward to enhancing the quality of research and is embarking on an ambitious project of purchasing all major journals and providing free access to universities across the country.
The India Genome Project started in January, 2020, is a good example of collaboration. While all these actions are laudable, a lot more needs to be done. Following are some measures which will reduce the gap:Research proposals at the level of protocol can be guided and mentored by institutes. Academic committees of different zones and journals can help in this endeavorBreaking the cubicles by establishing a collaboration between medical colleges and various institutes. While there is a lack of resources available in individual departments, there are universities and institutes with excellent infrastructure.
They are not aware of the requirements of the field of psychiatry and research questions. Creation of an alliance will enhance the quality of research work. Some of such institutes include Centre for Neuroscience, Indian Institute of Science, Bengaluru. CSIR-Institute of Genomics and Integrative Biology, New Delhi. And National Institute of Biomedical Genomics, KalyaniInitiation and establishment of interactive and stable relationships between basic scientists and clinical and technological experts will enhance the quality of research work and will lead to translation of basic biomedical research into real-time applications.
For example, work on artificial intelligence for mental health. Development of Apps by IITs. Genome India Project by the Government of India, genomic institutes, and social science and economic institutes working in the field of various aspects of mental healthUtilization of underutilized, well-equipped biotechnological labs of nonmedical colleges for furthering biomedical researchMedical colleges should collaborate with various universities which have labs providing testing facilities such as spectroscopy, fluoroscopy, gamma camera, scintigraphy, positron emission tomography, single photon emission computed tomography, and photoacoustic imagingCreating an interactive, interdepartmental, intradepartmental, and interinstitutional partnershipBy developing a healthy and ethical partnership with industries for research and development of new drugs and interventions.Walking the talk â the psychiatric fraternity needs to be proactive and rather than lamenting about the lack of resource, we should rise to the occasion and come out with innovative and original research proposals. With the implementation of collaborative approach, we can not only enhance and improve the quality of our research but to an extent also mitigate the effects of resource crunch and come up as a leader in the field of biomedical research. References 1.2.Nagoba B, Davane M.
Current status of medical research in India. Where are we?. Walawalkar Int Med J 2017;4:66-71. 3.Ioannidis JP, Boyack KW, Baas J. Updated science-wide author databases of standardized citation indicators.
PLoS Biol 2020;18:e3000918. Correspondence Address:Dr. Om Prakash SinghAA 304, Ashabari Apartments, O/31, Baishnabghata, Patuli Township, Kolkata - 700 094, West Bengal IndiaSource of Support. None, Conflict of Interest. NoneDOI.
10.4103/indianjpsychiatry.indianjpsychiatry_1362_2Abstract Background. The burden of mental illness among the scheduled tribe (ST) population in India is not known clearly.Aim. The aim was to identify and appraise mental health research studies on ST population in India and collate such data to inform future research.Materials and Methods. Studies published between January 1980 and December 2018 on STs by following exclusion and inclusion criteria were selected for analysis. PubMed, PsychINFO, Embase, Sociofile, Cinhal, and Google Scholar were systematically searched to identify relevant studies.
Quality of the included studies was assessed using an appraisal tool to assess the quality of cross-sectional studies and Critical Appraisal Checklist developed by Critical Appraisal Skills Programme. Studies were summarized and reported descriptively.Results. Thirty-two relevant studies were found and included in the review. Studies were categorized into the following three thematic areas. Alcohol and substance use disorders, common mental disorders and sociocultural aspects, and access to mental health-care services.
Sociocultural factors play a major role in understanding and determining mental disorders.Conclusion. This study is the first of its kind to review research on mental health among the STs. Mental health research conducted among STs in India is limited and is mostly of low-to-moderate quality. Determinants of poor mental health and interventions for addressing them need to be studied on an urgent basis.Keywords. India, mental health, scheduled tribesHow to cite this article:Devarapalli S V, Kallakuri S, Salam A, Maulik PK.
Mental health research on scheduled tribes in India. Indian J Psychiatry 2020;62:617-30 Introduction Mental health is a highly neglected area particularly in low and middle-income countries (LMIC). Data from community-based studies showed that about 10% of people suffer from common mental disorders (CMDs) such as depression, anxiety, and somatic complaints.[1] A systematic review of epidemiological studies between 1960 and 2009 in India reported that about 20% of the adult population in the community are affected by psychiatric disorders in the community, ranging from 9.5 to 103/1000 population, with differences in case definitions, and methods of data collection, accounting for most of the variation in estimates.[2]The scheduled tribes (ST) population is a marginalized community and live in relative social isolation with poorer health indices compared to similar nontribal populations.[3] There are an estimated 90 million STs or Adivasis in India.[4] They constitute 8.6% of the total Indian population. The distribution varies across the states and union territories of India, with the highest percentage in Lakshadweep (94.8%) followed by Mizoram (94.4%). In northeastern states, they constitute 65% or more of the total population.[5] The ST communities are identified as culturally or ethnographically unique by the Indian Constitution.
They are populations with poorer health indicators and fewer health-care facilities compared to non-ST rural populations, even when within the same state, and often live in demarcated geographical areas known as ST areas.[4]As per the National Family Health Survey, 2015â2016, the health indicators such as infant mortality rate (IMR) is 44.4, under five mortality rate (U5MR) is 57.2, and anemia in women is 59.8 for STs â one of the most disadvantaged socioeconomic groups in India, which are worse compared to other populations where IMR is 40.7, U5MR is 49.7, and anemia in women among others is 53.0 in the same areas.[6] Little research is available on the health of ST population. Tribal mental health is an ignored and neglected area in the field of health-care services. Further, little data are available about the burden of mental disorders among the tribal communities. Health research on tribal populations is poor, globally.[7] Irrespective of the data available, it is clear that they have worse health indicators and less access to health facilities.[8] Even less is known about the burden of mental disorders in ST population. It is also found that the traditional livelihood system of the STs came into conflict with the forces of modernization, resulting not only in the loss of customary rights over the livelihood resources but also in subordination and further, developing low self-esteem, causing great psychological stress.[4] This community has poor health infrastructure and even less mental health resources, and the situation is worse when compared to other communities living in similar areas.[9],[10]Only 15%â25% of those affected with mental disorders in LMICs receive any treatment for their mental illness,[11] resulting in a large âtreatment gap.â[12] Treatment gaps are more in rural populations,[13] especially in ST communities in India, which have particularly poor infrastructure and resources for health-care delivery in general, and almost no capacity for providing mental health care.[14]The aim of this systematic review was to explore the extent and nature of mental health research on ST population in India and to identify gaps and inform future research.
Materials and Methods Search strategyWe searched major databases (PubMed, PsychINFO, Embase, Sociofile, Cinhal, and Google Scholar) and made hand searches from January 1980 to December 2018 to identify relevant literature. Hand search refers to searching through medical journals which are not indexed in the major electronic databases such as Embase, for instance, searching for Indian journals in IndMed database as most of these journals are not available in major databases. Physical search refers to searching the journals that were not available online or were not available online during the study years. We used relevant Medical Subject Heading and key terms in our search strategy, as follows. ÂMental health,â âMental disorders,â âMental illness,â âPsychiatry,â âScheduled Tribeâ OR âTribeâ OR âTribal Populationâ OR âIndigenous population,â âIndia,â âPsych*â (Psychiatric, psychological, psychosis).Inclusion criteriaStudies published between January 1980 and December 2018 were included.
Studies on mental disorders were included only when they focused on ST population. Both qualitative and quantitative studies on mental disorders of ST population only were included in the analysis.Exclusion criteriaStudies without any primary data and which are merely overviews and commentaries and those not focused on ST population were excluded from the analysis.Data management and analysisTwo researchers (SD and SK) initially screened the title and abstract of each record to identify relevant papers and subsequently screened full text of those relevant papers. Any disagreements between the researchers were resolved by discussion or by consulting with an adjudicator (PKM). From each study, data were extracted on objectives, study design, study population, study duration, interventions (if applicable), outcomes, and results. Quality of the included studies was assessed, independently by three researchers (SD, SK, and AS), using Critical Appraisal Checklist developed by Critical Appraisal Skills Programme (CASP).[15] After a thorough qualitative assessment, all quantitative data were generated and tabulated.
A narrative description of the studies is provided in [Table 1] using some broad categories. Results Search resultsOur search retrieved 2306 records (which included hand-searched articles), of which after removing duplicates, title and abstracts of 2278 records were screened. Of these, 178 studies were deemed as potentially relevant and were reviewed in detail. Finally, we excluded 146 irrelevant studies and 32 studies were included in the review [Figure 1].Quality of the included studiesSummary of quality assessment of the included studies is reported in [Table 2]. Overall, nine studies were of poor quality, twenty were of moderate quality, and three studies were of high quality.
The CASP shows that out of the 32 studies, the sample size of 21 studies was not representative, sample size of 7 studies was not justified, risk factors were not identified in 28 studies, methods used were not sufficiently described to repeat them in 24 studies, and nonresponse reasons were not addressed in 24 studies. The most common reasons for studies to be of poor-quality included sample size not justified. Sample is not representative. Nonresponse not addressed. Risk factors not measured correctly.
And methods used were not sufficiently described to repeat them. Studies under the moderate quality did not have a representative sample. Non-responders categories was not addressed. Risk factors were not measured correctly. And methods used were not sufficiently described to allow the study to be replicated by other researchers.The included studies covered three broad categories.
Alcohol and substance use disorders, CMD (depression, anxiety, stress, and suicide risk), socio-cultural aspects, and access to mental health services.Alcohol and substance use disordersFive studies reviewed the consumption of alcohol and opioid. In an ethnographic study conducted in three western districts in Rajasthan, 200 opium users were interviewed. Opium consumption was common among both younger and older males during nonharvest seasons. The common causes for using opium were relief of anxiety related to crop failure due to drought, stress, to get a high, be part of peers, and for increased sexual performance.[16]In a study conducted in Arunachal Pradesh involving a population of more than 5000 individuals, alcohol use was present in 30% and opium use in about 5% adults.[17] Contrary to that study, in Rajasthan, the prevalence of opium use was more in women and socioeconomic factors such as occupation, education, and marital status were associated with opium use.[16] The prevalence of opium use increased with age in both sexes, decreased with increasing education level, and increased with employment. It was observed that wages were used to buy opium.
In the entire region of Chamlang district of Arunachal Pradesh, female substance users were almost half of the males among ST population.[17] Types of substance used were tobacco, alcohol, and opium. Among tobacco users, oral tobacco use was higher than smoking. The prevalence of tobacco use was higher among males, but the prevalence of alcohol use was higher in females, probably due to increased access to homemade rice brew generally prepared by women. This study is unique in terms of finding a strong association with religion and culture with substance use.[18]Alcohol consumption among Paniyas of Wayanad district in Kerala is perceived as a male activity, with many younger people consuming it than earlier. A study concluded that alcohol consumption among them was less of a âchoiceâ than a result of their conditions operating through different mechanisms.
In the past, drinking was traditionally common among elderly males, however the consumption pattern has changed as a significant number of younger men are now drinking. Drinking was clustered within families as fathers and sons drank together. Alcohol is easily accessible as government itself provides opportunities. Some employers would provide alcohol as an incentive to attract Paniya men to work for them.[19]In a study from Jharkhand, several ST community members cited reasons associated with social enhancement and coping with distressing emotions rather than individual enhancement, as a reason for consuming alcohol. Societal acceptance of drinking alcohol and peer pressure, as well as high emotional problems, appeared to be the major etiology leading to higher prevalence of substance dependence in tribal communities.[20] Another study found high life time alcohol use prevalence, and the reasons mentioned were increased poverty, illiteracy, increased stress, and peer pressure.[21] A household survey from Chamlang district of Arunachal Pradesh revealed that there was a strong association between opium use and age, occupation, marital status, religion, and ethnicity among both the sexes of STs, particularly among Singhpho and Khamti.[15] The average age of onset of tobacco use was found to be 16.4 years for smoked and 17.5 years for smokeless forms in one study.[22]Common mental disorders and socio-cultural aspectsSuicide was more common among Idu Mishmi in Roing and Anini districts of Arunachal Pradesh state (14.2%) compared to the urban population in general (0.4%â4.2%).
Suicides were associated with depression, anxiety, alcoholism, and eating disorders. Of all the factors, depression was significantly high in people who attempted suicide.[24] About 5% out of 5007 people from thirty villages comprising ST suffered from CMDs in a study from West Godavari district in rural Andhra Pradesh. CMDs were defined as moderate/severe depression and/or anxiety, stress, and increased suicidal risk. Women had a higher prevalence of depression, but this may be due to the cultural norms, as men are less likely to express symptoms of depression or anxiety, which leads to underreporting. Marital status, education, and age were prominently associated with CMD.[14] In another study, gender, illiteracy, infant mortality in the household, having <3 adults living in the household, large family size with >four children, morbidity, and having two or more life events in the last year were associated with increased prevalence of CMD.[24] Urban and rural ST from the same community of Bhutias of Sikkim were examined, and it was found that the urban population experienced higher perceived stress compared to their rural counterparts.[25] Age, current use of alcohol, poor educational status, marital status, social groups, and comorbidities were the main determinants of tobacco use and nicotine dependence in a study from the Andaman and Nicobar Islands.[22] A study conducted among adolescents in the schools of rural areas of Ranchi district in Jharkhand revealed that about 5% children from the ST communities had emotional symptoms, 9.6% children had conduct problems, 4.2% had hyperactivity, and 1.4% had significant peer problems.[27] A study conducted among the female school teachers in Jharkhand examined the effects of stress, marital status, and ethnicity upon the mental health of school teachers.
The study found that among the three factors namely stress, marital status, and ethnicity, ethnicity was found to affect mental health of the school teachers most. It found a positive relationship between mental health and socioeconomic status, with an inverse relationship showing that as income increased, the prevalence of depression decreased.[28] A study among Ao-Nagas in Nagaland found that 74.6% of the population attributed mental health problems to psycho-social factors and a considerable proportion chose a psychiatrist or psychologist to overcome the problem. However, 15.4% attributed mental disorders to evil spirits. About 47% preferred to seek treatment with a psychiatrist and 25% preferred prayers. Nearly 10.6% wanted to seek the help of both the psychiatrist and prayer group and 4.4% preferred traditional healers.[28],[29] The prevalence of Down syndrome among the ST in Chikhalia in Barwani district of Madhya Pradesh was higher than that reported in overall India.
Three-fourth of the children were the first-born child. None of the parents of children with Down syndrome had consanguineous marriage or a history of Down syndrome, intellectual disability, or any other neurological disorder such as cerebral palsy and epilepsy in preceding generations. It is known that tribal population is highly impoverished and disadvantaged in several ways and suffer proportionately higher burden of nutritional and genetic disorders, which are potential factors for Down syndrome.[30]Access to mental health-care servicesIn a study in Ranchi district of Jharkhand, it was found that most people consulted faith healers rather than qualified medical practitioners. There are few mental health services in the regions.[31] Among ST population, there was less reliance and belief in modern medicine, and it was also not easily accessible, thus the health-care systems must be more holistic and take care of cultural and local health practices.[32]The Systematic Medical Appraisal, Referral and Treatment (SMART) Mental Health project was implemented in thirty ST villages in West Godavari District of Andhra Pradesh. The key objectives were to use task sharing, training of primary health workers, implementing evidence-based clinical decision support tools on a mobile platform, and providing mental health services to rural population.
The study included 238 adults suffering from CMD. During the intervention period, 12.6% visited the primary health-care doctors compared to only 0.8% who had sought any care for their mental disorders prior to the intervention. The study also found a significant reduction in the depression and anxiety scores at the end of intervention and improvements in stigma perceptions related to mental health.[14] A study in Gudalur and Pandalur Taluks of Nilgiri district from Tamil Nadu used low cost task shifting by providing community education and identifying and referring individuals with psychiatric problems as effective strategies for treating mental disorders in ST communities. Through the program, the health workers established a network within the village, which in turn helped the patients to interact with them freely. Consenting patients volunteered at the educational sessions to discuss their experience about the effectiveness of their treatment.
Community awareness programs altered knowledge and attitudes toward mental illness in the community.[33] A study in Nilgiri district, Tamil Nadu, found that the community had been taking responsibility of the patients with the system by providing treatment closer to home without people having to travel long distances to access care. Expenses were reduced by subsidizing the costs of medicine and ensuring free hospital admissions and referrals to the people.[34] A study on the impact of gender, socioeconomic status, and age on mental health of female factory workers in Jharkhand found that the ST women were more likely to face stress and hardship in life due to diverse economic and household responsibilities, which, in turn, severely affected their mental health.[35] Prevalence of mental health morbidity in a study from the Sunderbans delta found a positive relation with psycho-social stressors and poor quality of life. The health system in that remote area was largely managed by âquack doctorsâ and faith healers. Poverty, illiteracy, and detachment from the larger community helped reinforce superstitious beliefs and made them seek both mental and physical health care from faith healers.[36] In a study among students, it was found that children had difficulties in adjusting to both ethnic and mainstream culture.[27] Low family income, inadequate housing, poor sanitation, and unhealthy and unhygienic living conditions were some environmental factors contributing to poor physical and mental growth of children. It was observed that children who did not have such risk factors maintained more intimate relations with the family members.
Children belonging to the disadvantaged environment expressed their verbal, emotional need, blame, and harm avoidances more freely than their counterparts belonging to less disadvantaged backgrounds. Although disadvantaged children had poor interfamilial interaction, they had better relations with the members outside family, such as peers, friends, and neighbors.[37] Another study in Jharkhand found that epilepsy was higher among ST patients compared to non-ST patients.[31] Most patients among the ST are irregular and dropout rates are higher among them than the non-ST patients. Urbanization per se exerted no adverse influence on the mental health of a tribal community, provided it allowed preservation of ethnic and cultural practices. Women in the ST communities were less vulnerable to mental illness than men. This might be a reflection of their increased responsibilities and enhanced gender roles that are characteristic of women in many ST communities.[38] Data obtained using culturally relevant scales revealed that relocated Sahariya suffer a lot of mental health problems, which are partially explained by livelihood and poverty-related factors.
The loss of homes and displacement compromise mental health, especially the positive emotional well-being related to happiness, life satisfaction, optimism for future, and spiritual contentment. These are often not overcome even with good relocation programs focused on material compensation and livelihood re-establishment.[39] Discussion This systematic review is to our knowledge the first on mental health of ST population in India. Few studies on the mental health of ST were available. All attempts including hand searching were made to recover both published peer-reviewed papers and reports available on the website. Though we searched gray literature, it may be possible that it does not capture all articles.
Given the heterogeneity of the papers, it was not possible to do a meta-analysis, so a narrative review was done.The quality of the studies was assessed by CASP. The assessment shows that the research conducted on mental health of STs needs to be carried out more effectively. The above mentioned gaps need to be filled in future research by considering the resources effectively while conducting the studies. Mental and substance use disorders contribute majorly to the health disparities. To address this, one needs to deliver evidence-based treatments, but it is important to understand how far these interventions for the indigenous populations can incorporate cultural practices, which are essential for the development of mental health services.[30] Evidence has shown a disproportionate burden of suicide among indigenous populations in national and regional studies, and a global and systematic investigation of this topic has not been undertaken to date.
Previous reviews of suicide epidemiology among indigenous populations have tended to be less comprehensive or not systematic, and have often focused on subpopulations such as youth, high-income countries, or regions such as Oceania or the Arctic.[46] The only studies in our review which provided data on suicide were in Idu Mishmi, an isolated tribal population of North-East India, and tribal communities from Sunderban delta.[24],[37] Some reasons for suicide in these populations could be the poor identification of existing mental disorders, increased alcohol use, extreme poverty leading to increased debt and hopelessness, and lack of stable employment opportunities.[24],[37] The traditional consumption pattern of alcohol has changed due to the reasons associated with social enhancement and coping with distressing emotions rather than individual enhancement.[19],[20]Faith healers play a dominant role in treating mental disorders. There is less awareness about mental health and available mental health services and even if such knowledge is available, access is limited due to remoteness of many of these villages, and often it involves high out-of-pocket expenditure.[35] Practitioners of modern medicine can play a vital role in not only increasing awareness about mental health in the community, but also engaging with faith healers and traditional medicine practitioners to help increase their capacity to identify and manage CMDs that do not need medications and can be managed through simple âtalk therapy.â Knowledge on symptoms of severe mental disorders can also help such faith healers and traditional medicine practitioners to refer cases to primary care doctors or mental health professionals.Remote settlements make it difficult for ST communities to seek mental health care. Access needs to be increased by using solutions that use training of primary health workers and nonphysician health workers, task sharing, and technology-enabled clinical decision support tools.[3] The SMART Mental Health project was delivered in the tribal areas of Andhra Pradesh using those principles and was found to be beneficial by all stakeholders.[14]Given the lack of knowledge about mental health problems among these communities, the government and nongovernmental organizations should collect and disseminate data on mental disorders among the ST communities. More research funding needs to be provided and key stakeholders should be involved in creating awareness both in the community and among policy makers to develop more projects for ST communities around mental health. Two recent meetings on tribal mental health â Round Table Meeting on Mental Health of ST Populations organized by the George Institute for Global Health, India, in 2017,[51] and the First National Conference on Tribal Mental Health organized by the Indian Psychiatric Society in Bhubaneswar in 2018 â have identified some key areas of research priority for mental health in ST communities.
A national-level policy on mental health of tribal communities or population is advocated which should be developed in consultation with key stakeholders. The Indian Psychiatric Society can play a role in coordinating research activities with support of the government which can ensure regular monitoring and dissemination of the research impact to the tribal communities. There is a need to understand how mental health symptoms are perceived in different ST communities and investigate the healing practices associated with distress/disaster/death/loss/disease. This could be done in the form of cross-sectional or cohort studies to generate proper evidence which could also include the information on prevalence, mental health morbidity, and any specific patterns associated with a specific disorder. Future research should estimate the prevalence of mental disorders in different age groups and gender, risk factors, and the influence of modernization.
Studies should develop a theoretical model to understand mental disorders and promote positive mental health within ST communities. Studies should also look at different ST communities as cultural differences exist across them, and there are also differences in socioeconomic status which impact on ability to access care.Research has shown that the impact and the benefits are amplified when research is driven by priorities that are identified by indigenous communities and involve their active participation. Their knowledge and perspectives are incorporated in processes and findings. Reporting of findings is meaningful to the communities. And indigenous groups and other key stakeholders are engaged from the outset.[47] Future research in India on ST communities should also adhere to these broad principles to ensure relevant and beneficial research, which have direct impact on the mental health of the ST communities.There is also a need to update literature related to mental health of ST population continuously.
Develop culturally appropriate validated instruments to measure mental morbidity relevant to ST population. And use qualitative research to investigate the perceptions and barriers for help-seeking behavior.[48] Conclusion The current review helps not only to collate the existing literature on the mental health of ST communities but also identify gaps in knowledge and provide some indications about the type of research that should be funded in future.Financial support and sponsorshipNil.Conflicts of interestThere are no conflicts of interest. References 1.Gururaj G, Girish N, Isaac MK. Mental. Neurological and Substance abuse disorders.
Strategies towards a systems approach. In. Burden of Disease in India. Equitable development â Healthy future New Delhi, India. National Commission on Macroeconomics and Health.
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Indian J Psychiatry 2010;52:S95-103. 3.Tewari A, Kallakuri S, Devarapalli S, Jha V, Patel A, Maulik PK. Process evaluation of the systematic medical appraisal, referral and treatment (SMART) mental health project in rural India. BMC Psychiatry 2017;17:385. 4.Ministry of Tribal Affairs, Government of India.
Report of the High Level Committee on Socio-economic, Health and Educational Status of Tribal Communities of India. New Delhi. Government of India. 2014. 5.Office of the Registrar General and Census Commissioner, Census of India.
New Delhi. Office of the Registrar General and Census Commissioner. 2011. 6.International Institute for Population Sciences and ICF. National Family Health Survey (NFHS-4), 2015-16.
India, Mumbai. International Institute for Population Sciences. 2017. 7.World Health Organization. The World Health Report 2001-Mental Health.
New Understanding, New Hope. Geneva, Switzerland. World Health Organization. 2001. 8.Demyttenaere K, Bruffaerts R, Posada-Villa J, Gasquet I, Kovess V, Lepine JP, et al.
Prevalence, severity, and unmet need for treatment of mental disorders in the World Health Organization World Mental Health Surveys. JAMA 2004;291:2581-90. 9.Ministry of Health and Family Welfare, Government of India and Ministry of Tribal Affairs, Report of the Expert Committee on Tribal Health. Tribal Health in India â Bridging the Gap and a Roadmap for the Future. New Delhi.
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Impact on knowledge and attitudes. Int J Ment Health Syst 2011;5:17. 14.Maulik PK, Kallakuri S, Devarapalli S, Vadlamani VS, Jha V, Patel A. Increasing use of mental health services in remote areas using mobile technology. A pre-post evaluation of the SMART Mental Health project in rural India.
J Global Health 2017;7:1-13. 15.16.Ganguly KK, Sharma HK, Krishnamachari KA. An ethnographic account of opium consumers of Rajasthan (India). Socio-medical perspective. Addiction 1995;90:9-12.
17.Chaturvedi HK, Mahanta J. Sociocultural diversity and substance use pattern in Arunachal Pradesh, India. Drug Alcohol Depend 2004;74:97-104. 18.Chaturvedi HK, Mahanta J, Bajpai RC, Pandey A. Correlates of opium use.
Retrospective analysis of a survey of tribal communities in Arunachal Pradesh, India. BMC Public Health 2013;13:325. 19.Mohindra KS, Narayana D, Anushreedha SS, Haddad S. Alcohol use and its consequences in South India. Views from a marginalised tribal population.
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[PUBMED] [Full text] 21.Whiteford HA, Degenhardt L, Rehm J, Baxter AJ, Ferrari AJ, Erskine HE, et al. Global burden of disease attributable to mental and substance use disorders. Findings from the Global Burden of Disease Study 2010. Lancet 2013;382:1575-86. 22.Janakiram C, Joseph J, Vasudevan S, Taha F, DeepanKumar CV, Venkitachalam R.
Prevalence and dependancy of tobacco use in an indigenous population of Kerala, India. Oral Hygiene and Health 2016;4:1 23.Manimunda SP, Benegal V, Sugunan AP, Jeemon P, Balakrishna N, Thennarusu K, et al. Tobacco use and nicotine dependency in a cross-sectional representative sample of 18,018 individuals in Andaman and Nicobar Islands, India. BMC Public Health 2012;12:515. 24.Singh PK, Singh RK, Biswas A, Rao VR.
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2005. 26.Sobhanjan S, Mukhopadhyay B. Perceived psychosocial stress and cardiovascular risk. Observations among the Bhutias of Sikkim, India. Stress Health 2008;24:23-34.
27.Ali A, Eqbal S. Mental Health status of tribal school going adolescents. A study from rural community of Ranchi, Jharkhand. Telangana J Psychiatry 2016;2:38-41. 28.Diwan R.
Stress and mental health of tribal and non tribal female school teachers in Jharkhand, India. Int J Sci Res Publicat 2012;2:2250-3153. 29.Longkumer I, Borooah PI. Knowledge about attitudes toward mental disorders among Nagas in North East India. IOSR J Humanities Soc Sci 2013;15:41-7.
30.Lakhan R, Kishore MT. Down syndrome in tribal population in India. A field observation. J Neurosci Rural Pract 2016;7:40-3. [PUBMED] [Full text] 31.Nizamie HS, Akhtar S, Banerjee S, Goyal N.
Health care delivery model in epilepsy to reduce treatment gap. WHO study from a rural tribal population of India. Epilepsy Res Elsevier 2009;84:146-52. 32.Prabhakar H, Manoharan R. The Tribal Health Initiative model for healthcare delivery.
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Effect of a participatory intervention with women's groups on birth outcomes and maternal depression in Jharkhand and Orissa, India. A cluster-randomised controlled trial. Lancet 2010;375:1182-92. 36.Aparajita C, Anita KM, Arundhati R, Chetana P. Assessing Social-support network among the socio culturally disadvantaged children in India.
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38.Jeffery GS, Chakrapani U. Eco-psychiatry and Environmental Conservation. Study from Sundarban Delta, India. Working Paper- Research Gate.net. September, 2016.
39.Ozer S, Acculturation, adaptation, and mental health among Ladakhi College Students a mixed methods study of an indigenous population. J Cross Cultl Psychol 2015;46:435-53. 40.Giri DK, Chaudhary S, Govinda M, Banerjee A, Mahto AK, Chakravorty PK. Utilization of psychiatric services by tribal population of Jharkhand through community outreach programme of RINPAS. Eastern J Psychiatry 2007;10:25-9.
41.Nandi DN, Banerjee G, Chowdhury AN, Banerjee T, Boral GC, Sen B. Urbanization and mental morbidity in certain tribal communities in West Bengal. Indian J Psychiatry 1992;34:334-9. [PUBMED] [Full text] 42.Hackett RJ, Sagdeo D, Creed FH. The physical and social associations of common mental disorder in a tribal population in South India.
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Identifying risk for dementia across populations. A study on the prevalence of dementia in tribal elderly population of Himalayan region in Northern India. Ann Indian Acad Neurol 2013;16:640-4. [PUBMED] [Full text] 45.Raina SK, Chander V, Raina S, Kumar D. Feasibility of using everyday abilities scale of India as alternative to mental state examination as a screen in two-phase survey estimating the prevalence of dementia in largely illiterate Indian population.
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Correspondence Address:S V. Siddhardh Kumar DevarapalliGeorge Institute for Global Health, Plot No. 57, Second Floor, Corporation Bank Building, Nagarjuna Circle, Punjagutta, Hyderabad - 500 082, Telangana IndiaSource of Support. None, Conflict of Interest. NoneDOI.
10.4103/psychiatry.IndianJPsychiatry_136_19 Figures [Figure 1] Tables [Table 1], [Table 2].
How to cite this buy viagra over the counter article:Singh viagra price per pill OP. Psychiatry research in India. Closing the buy viagra over the counter research gap. Indian J Psychiatry 2020;62:615-6Research is an important aspect of the growth and development of medical science. Research in buy viagra over the counter India in general and medical research in particular is always being criticized for lack of innovation and originality required for the delivery of health services suitable to Indian conditions.
Even the Indian Council of Medical Research (ICMR) which is a centrally funded frontier organization for conducting medical research couldn't avert criticism. It has been criticized heavily for not producing quality research papers which are pioneering, ground breaking, or pragmatic solutions for health issues plaguing India. In the words of a leading daily, The ICMR could not even list one practical application of its hundreds of research papers published in various national and international research journals which helped cure any disease, or diagnose it with better accuracy or in less time, or even one new basic, applied or clinical research or innovation that opened a new frontier of scientific knowledge.[1]This clearly indicates that the health research output of ICMR buy viagra over the counter is not up to the mark and is not commensurate with the magnitude of the disease burden in India. According to the 12th Plan Report, the country contributes to a fifth of the world's share of diseases. The research conducted elsewhere may not be generalized to the Indian population owing to differences in biology, health-care systems, health practices, buy viagra over the counter culture, and socioeconomic standards.
Questions which are pertinent and specific to the Indian context may not be answered and will remain understudied. One of the vital elements in improving this situation is the need for relevant research base that would equip policymakers to take informed health policy decisions.The Parliamentary Standing Committee on Health and Family Welfare in the 100th report on Demand for Grants (2017â2018) of the Department of Health Research observed that âthe biomedical research output needs to be augmented substantially to cater to the health challenges faced by the country.â[1]Among the various reasons, lack of fund, infrastructure, and resources is the prime cause which is glaringly evident from the inadequate budget allocation for biomedical research. While ICMR has a budget of 232 million dollars per year on health research, it is zilch in comparison to the annual budget buy viagra over the counter expenditure of the National Institute of Health, USA, on biomedical research which is 32 billion dollars.The lacuna of quality research is not merely due to lack of funds. There are other important issues which need to be considered and sorted out to end the status quo. Some of the factors which need our immediate attention are:Lack of research training and teachingImproper allocation of research facilitiesLack of information about research work happening globallyLack of promotion, motivation, commitment, and passion in the field of researchClinicians being overburdened with patientsLack of collaboration between medical colleges and established research institutesLack of continuity of research in successive batches of postgraduate (PG) students, leading to wastage of previous research and resourcesDifficulty in the application of basic biomedical research into pragmatic intervention solutions due to buy viagra over the counter lack of interdisciplinary technological support/collaboration between basic scientists, clinicians, and technological experts.Majority of the biomedical research in India are conducted in medical institutions.
The majority of these are done as thesis submission for fulfillment of the requirement of PG degree. From 2015 onward, publication of papers had been made an obligatory requirement buy viagra over the counter for promotion of faculty to higher posts. Although it offered a unique opportunity for training of residents and stimulus for research, it failed to translate into production of quality research work as thesis was limited by time and it had to be done with other clinical and academic duties.While the top four medical colleges, namely AIIMS, New Delhi. PGIMER, Chandigarh. CMC, Vellore buy viagra over the counter.
And SGIMS, Lucknow are among the top ten medical institutions in terms of publication in peer-reviewed journals, around 332 (57.3%) medical colleges have no research paper published in a decade between 2004 and 2014.[2]The research in psychiatry is realistically dominated by major research institutes which are doing commendable work, but there is a substantial lack of contemporary research originating from other centers. Dr. Chittaranjan Andrade (NIMHANS, Bengaluru) and Dr. K Jacob (CMC, Vellore) recently figured in the list of top 2% psychiatry researchers in the world from India in psychiatry.[3] Most of the research conducted in the field of psychiatry are limited to caregivers' burden, pathways of care, and other topics which can be done in limited resources available to psychiatry departments. While all these areas of work are important in providing proper care and treatment, there is overabundance of research in these areas.The Government of India is aggressively looking forward to enhancing the quality of research and is embarking on an ambitious project of purchasing all major journals and providing free access to universities across the country.
The India Genome Project started in January, 2020, is a good example of collaboration. While all these actions are laudable, a lot more needs to be done. Following are some measures which will reduce the gap:Research proposals at the level of protocol can be guided and mentored by institutes. Academic committees of different zones and journals can help in this endeavorBreaking the cubicles by establishing a collaboration between medical colleges and various institutes. While there is a lack of resources available in individual departments, there are universities and institutes with excellent infrastructure.
They are not aware of the requirements of the field of psychiatry and research questions. Creation of an alliance will enhance the quality of research work. Some of such institutes include Centre for Neuroscience, Indian Institute of Science, Bengaluru. CSIR-Institute of Genomics and Integrative Biology, New Delhi. And National Institute of Biomedical Genomics, KalyaniInitiation and establishment of interactive and stable relationships between basic scientists and clinical and technological experts will enhance the quality of research work and will lead to translation of basic biomedical research into real-time applications.
For example, work on artificial intelligence for mental health. Development of Apps by IITs. Genome India Project by the Government of India, genomic institutes, and social science and economic institutes working in the field of various aspects of mental healthUtilization of underutilized, well-equipped biotechnological labs of nonmedical colleges for furthering biomedical researchMedical colleges should collaborate with various universities which have labs providing testing facilities such as spectroscopy, fluoroscopy, gamma camera, scintigraphy, positron emission tomography, single photon emission computed tomography, and photoacoustic imagingCreating an interactive, interdepartmental, intradepartmental, and interinstitutional partnershipBy developing a healthy and ethical partnership with industries for research and development of new drugs and interventions.Walking the talk â the psychiatric fraternity needs to be proactive and rather than lamenting about the lack of resource, we should rise to the occasion and come out with innovative and original research proposals. With the implementation of collaborative approach, we can not only enhance and improve the quality of our research but to an extent also mitigate the effects of resource crunch and come up as a leader in the field of biomedical research. References 1.2.Nagoba B, Davane M.
Current status of medical research in India. Where are we?. Walawalkar Int Med J 2017;4:66-71. 3.Ioannidis JP, Boyack KW, Baas J. Updated science-wide author databases of standardized citation indicators.
PLoS Biol 2020;18:e3000918. Correspondence Address:Dr. Om Prakash SinghAA 304, Ashabari Apartments, O/31, Baishnabghata, Patuli Township, Kolkata - 700 094, West Bengal IndiaSource of Support. None, Conflict of Interest. NoneDOI.
10.4103/indianjpsychiatry.indianjpsychiatry_1362_2Abstract Background. The burden of mental illness among the scheduled tribe (ST) population in India is not known clearly.Aim. The aim was to identify and appraise mental health research studies on ST population in India and collate such data to inform future research.Materials and Methods. Studies published between January 1980 and December 2018 on STs by following exclusion and inclusion criteria were selected for analysis. PubMed, PsychINFO, Embase, Sociofile, Cinhal, and Google Scholar were systematically searched to identify relevant studies.
Quality of the included studies was assessed using an appraisal tool to assess the quality of cross-sectional studies and Critical Appraisal Checklist developed by Critical Appraisal Skills Programme. Studies were summarized and reported descriptively.Results. Thirty-two relevant studies were found and included in the review. Studies were categorized into the following three thematic areas. Alcohol and substance use disorders, common mental disorders and sociocultural aspects, and access to mental health-care services.
Sociocultural factors play a major role in understanding and determining mental disorders.Conclusion. This study is the first of its kind to review research on mental health among the STs. Mental health research conducted among STs in India is limited and is mostly of low-to-moderate quality. Determinants of poor mental health and interventions for addressing them need to be studied on an urgent basis.Keywords. India, mental health, scheduled tribesHow to cite this article:Devarapalli S V, Kallakuri S, Salam A, Maulik PK.
Mental health research on scheduled tribes in India. Indian J Psychiatry 2020;62:617-30 Introduction Mental health is a highly neglected area particularly in low and middle-income countries (LMIC). Data from community-based studies showed that about 10% of people suffer from common mental disorders (CMDs) such as depression, anxiety, and somatic complaints.[1] A systematic review of epidemiological studies between 1960 and 2009 in India reported that about 20% of the adult population in the community are affected by psychiatric disorders in the community, ranging from 9.5 to 103/1000 population, with differences in case definitions, and methods of data collection, accounting for most of the variation in estimates.[2]The scheduled tribes (ST) population is a marginalized community and live in relative social isolation with poorer health indices compared to similar nontribal populations.[3] There are an estimated 90 million STs or Adivasis in India.[4] They constitute 8.6% of the total Indian population. The distribution varies across the states and union territories of India, with the highest percentage in Lakshadweep (94.8%) followed by Mizoram (94.4%). In northeastern states, they constitute 65% or more of the total population.[5] The ST communities are identified as culturally or ethnographically unique by the Indian Constitution.
They are populations with poorer health indicators and fewer health-care facilities compared to non-ST rural populations, even when within the same state, and often live in demarcated geographical areas known as ST areas.[4]As per the National Family Health Survey, 2015â2016, the health indicators such as infant mortality rate (IMR) is 44.4, under five mortality rate (U5MR) is 57.2, and anemia in women is 59.8 for STs â one of the most disadvantaged socioeconomic groups in India, which are worse compared to other populations where IMR is 40.7, U5MR is 49.7, and anemia in women among others is 53.0 in the same areas.[6] Little research is available on the health of ST population. Tribal mental health is an ignored and neglected area in the field of health-care services. Further, little data are available about the burden of mental disorders among the tribal communities. Health research on tribal populations is poor, globally.[7] Irrespective of the data available, it is clear that they have worse health indicators and less access to health facilities.[8] Even less is known about the burden of mental disorders in ST population. It is also found that the traditional livelihood system of the STs came into conflict with the forces of modernization, resulting not only in the loss of customary rights over the livelihood resources but also in subordination and further, developing low self-esteem, causing great psychological stress.[4] This community has poor health infrastructure and even less mental health resources, and the situation is worse when compared to other communities living in similar areas.[9],[10]Only 15%â25% of those affected with mental disorders in LMICs receive any treatment for their mental illness,[11] resulting in a large âtreatment gap.â[12] Treatment gaps are more in rural populations,[13] especially in ST communities in India, which have particularly poor infrastructure and resources for health-care delivery in general, and almost no capacity for providing mental health care.[14]The aim of this systematic review was to explore the extent and nature of mental health research on ST population in India and to identify gaps and inform future research.
Materials and Methods Search strategyWe searched major databases (PubMed, PsychINFO, Embase, Sociofile, Cinhal, and Google Scholar) and made hand searches from January 1980 to December 2018 to identify relevant literature. Hand search refers to searching through medical journals which are not indexed in the major electronic databases such as Embase, for instance, searching for Indian journals in IndMed database as most of these journals are not available in major databases. Physical search refers to searching the journals that were not available online or were not available online during the study years. We used relevant Medical Subject Heading and key terms in our search strategy, as follows. ÂMental health,â âMental disorders,â âMental illness,â âPsychiatry,â âScheduled Tribeâ OR âTribeâ OR âTribal Populationâ OR âIndigenous population,â âIndia,â âPsych*â (Psychiatric, psychological, psychosis).Inclusion criteriaStudies published between January 1980 and December 2018 were included.
Studies on mental disorders were included only when they focused on ST population. Both qualitative and quantitative studies on mental disorders of ST population only were included in the analysis.Exclusion criteriaStudies without any primary data and which are merely overviews and commentaries and those not focused on ST population were excluded from the analysis.Data management and analysisTwo researchers (SD and SK) initially screened the title and abstract of each record to identify relevant papers and subsequently screened full text of those relevant papers. Any disagreements between the researchers were resolved by discussion or by consulting with an adjudicator (PKM). From each study, data were extracted on objectives, study design, study population, study duration, interventions (if applicable), outcomes, and results. Quality of the included studies was assessed, independently by three researchers (SD, SK, and AS), using Critical Appraisal Checklist developed by Critical Appraisal Skills Programme (CASP).[15] After a thorough qualitative assessment, all quantitative data were generated and tabulated.
A narrative description of the studies is provided in [Table 1] using some broad categories. Results Search resultsOur search retrieved 2306 records (which included hand-searched articles), of which after removing duplicates, title and abstracts of 2278 records were screened. Of these, 178 studies were deemed as potentially relevant and were reviewed in detail. Finally, we excluded 146 irrelevant studies and 32 studies were included in the review [Figure 1].Quality of the included studiesSummary of quality assessment of the included studies is reported in [Table 2]. Overall, nine studies were of poor quality, twenty were of moderate quality, and three studies were of high quality.
The CASP shows that out of the 32 studies, the sample size of 21 studies was not representative, sample size of 7 studies was not justified, risk factors were not identified in 28 studies, methods used were not sufficiently described to repeat them in 24 studies, and nonresponse reasons were not addressed in 24 studies. The most common reasons for studies to be of poor-quality included sample size not justified. Sample is not representative. Nonresponse not addressed. Risk factors not measured correctly.
And methods used were not sufficiently described to repeat them. Studies under the moderate quality did not have a representative sample. Non-responders categories was not addressed. Risk factors were not measured correctly. And methods used were not sufficiently described to allow the study to be replicated by other researchers.The included studies covered three broad categories.
Alcohol and substance use disorders, CMD (depression, anxiety, stress, and suicide risk), socio-cultural aspects, and access to mental health services.Alcohol and substance use disordersFive studies reviewed the consumption of alcohol and opioid. In an ethnographic study conducted in three western districts in Rajasthan, 200 opium users were interviewed. Opium consumption was common among both younger and older males during nonharvest seasons. The common causes for using opium were relief of anxiety related to crop failure due to drought, stress, to get a high, be part of peers, and for increased sexual performance.[16]In a study conducted in Arunachal Pradesh involving a population of more than 5000 individuals, alcohol use was present in 30% and opium use in about 5% adults.[17] Contrary to that study, in Rajasthan, the prevalence of opium use was more in women and socioeconomic factors such as occupation, education, and marital status were associated with opium use.[16] The prevalence of opium use increased with age in both sexes, decreased with increasing education level, and increased with employment. It was observed that wages were used to buy opium.
In the entire region of Chamlang district of Arunachal Pradesh, female substance users were almost half of the males among ST population.[17] Types of substance used were tobacco, alcohol, and opium. Among tobacco users, oral tobacco use was higher than smoking. The prevalence of tobacco use was higher among males, but the prevalence of alcohol use was higher in females, probably due to increased access to homemade rice brew generally prepared by women. This study is unique in terms of finding a strong association with religion and culture with substance use.[18]Alcohol consumption among Paniyas of Wayanad district in Kerala is perceived as a male activity, with many younger people consuming it than earlier. A study concluded that alcohol consumption among them was less of a âchoiceâ than a result of their conditions operating through different mechanisms.
In the past, drinking was traditionally common among elderly males, however the consumption pattern has changed as a significant number of younger men are now drinking. Drinking was clustered within families as fathers and sons drank together. Alcohol is easily accessible as government itself provides opportunities. Some employers would provide alcohol as an incentive to attract Paniya men to work for them.[19]In a study from Jharkhand, several ST community members cited reasons associated with social enhancement and coping with distressing emotions rather than individual enhancement, as a reason for consuming alcohol. Societal acceptance of drinking alcohol and peer pressure, as well as high emotional problems, appeared to be the major etiology leading to higher prevalence of substance dependence in tribal communities.[20] Another study found high life time alcohol use prevalence, and the reasons mentioned were increased poverty, illiteracy, increased stress, and peer pressure.[21] A household survey from Chamlang district of Arunachal Pradesh revealed that there was a strong association between opium use and age, occupation, marital status, religion, and ethnicity among both the sexes of STs, particularly among Singhpho and Khamti.[15] The average age of onset of tobacco use was found to be 16.4 years for smoked and 17.5 years for smokeless forms in one study.[22]Common mental disorders and socio-cultural aspectsSuicide was more common among Idu Mishmi in Roing and Anini districts of Arunachal Pradesh state (14.2%) compared to the urban population in general (0.4%â4.2%).
Suicides were associated with depression, anxiety, alcoholism, and eating disorders. Of all the factors, depression was significantly high in people who attempted suicide.[24] About 5% out of 5007 people from thirty villages comprising ST suffered from CMDs in a study from West Godavari district in rural Andhra Pradesh. CMDs were defined as moderate/severe depression and/or anxiety, stress, and increased suicidal risk. Women had a higher prevalence of depression, but this may be due to the cultural norms, as men are less likely to express symptoms of depression or anxiety, which leads to underreporting. Marital status, education, and age were prominently associated with CMD.[14] In another study, gender, illiteracy, infant mortality in the household, having <3 adults living in the household, large family size with >four children, morbidity, and having two or more life events in the last year were associated with increased prevalence of CMD.[24] Urban and rural ST from the same community of Bhutias of Sikkim were examined, and it was found that the urban population experienced higher perceived stress compared to their rural counterparts.[25] Age, current use of alcohol, poor educational status, marital status, social groups, and comorbidities were the main determinants of tobacco use and nicotine dependence in a study from the Andaman and Nicobar Islands.[22] A study conducted among adolescents in the schools of rural areas of Ranchi district in Jharkhand revealed that about 5% children from the ST communities had emotional symptoms, 9.6% children had conduct problems, 4.2% had hyperactivity, and 1.4% had significant peer problems.[27] A study conducted among the female school teachers in Jharkhand examined the effects of stress, marital status, and ethnicity upon the mental health of school teachers.
The study found that among the three factors namely stress, marital status, and ethnicity, ethnicity was found to affect mental health of the school teachers most. It found a positive relationship between mental health and socioeconomic status, with an inverse relationship showing that as income increased, the prevalence of depression decreased.[28] A study among Ao-Nagas in Nagaland found that 74.6% of the population attributed mental health problems to psycho-social factors and a considerable proportion chose a psychiatrist or psychologist to overcome the problem. However, 15.4% attributed mental disorders to evil spirits. About 47% preferred to seek treatment with a psychiatrist and 25% preferred prayers. Nearly 10.6% wanted to seek the help of both the psychiatrist and prayer group and 4.4% preferred traditional healers.[28],[29] The prevalence of Down syndrome among the ST in Chikhalia in Barwani district of Madhya Pradesh was higher than that reported in overall India.
Three-fourth of the children were the first-born child. None of the parents of children with Down syndrome had consanguineous marriage or a history of Down syndrome, intellectual disability, or any other neurological disorder such as cerebral palsy and epilepsy in preceding generations. It is known that tribal population is highly impoverished and disadvantaged in several ways and suffer proportionately higher burden of nutritional and genetic disorders, which are potential factors for Down syndrome.[30]Access to mental health-care servicesIn a study in Ranchi district of Jharkhand, it was found that most people consulted faith healers rather than qualified medical practitioners. There are few mental health services in the regions.[31] Among ST population, there was less reliance and belief in modern medicine, and it was also not easily accessible, thus the health-care systems must be more holistic and take care of cultural and local health practices.[32]The Systematic Medical Appraisal, Referral and Treatment (SMART) Mental Health project was implemented in thirty ST villages in West Godavari District of Andhra Pradesh. The key objectives were to use task sharing, training of primary health workers, implementing evidence-based clinical decision support tools on a mobile platform, and providing mental health services to rural population.
The study included 238 adults suffering from CMD. During the intervention period, 12.6% visited the primary health-care doctors compared to only 0.8% who had sought any care for their mental disorders prior to the intervention. The study also found a significant reduction in the depression and anxiety scores at the end of intervention and improvements in stigma perceptions related to mental health.[14] A study in Gudalur and Pandalur Taluks of Nilgiri district from Tamil Nadu used low cost task shifting by providing community education and identifying and referring individuals with psychiatric problems as effective strategies for treating mental disorders in ST communities. Through the program, the health workers established a network within the village, which in turn helped the patients to interact with them freely. Consenting patients volunteered at the educational sessions to discuss their experience about the effectiveness of their treatment.
Community awareness programs altered knowledge and attitudes toward mental illness in the community.[33] A study in Nilgiri district, Tamil Nadu, found that the community had been taking responsibility of the patients with the system by providing treatment closer to home without people having to travel long distances to access care. Expenses were reduced by subsidizing the costs of medicine and ensuring free hospital admissions and referrals to the people.[34] A study on the impact of gender, socioeconomic status, and age on mental health of female factory workers in Jharkhand found that the ST women were more likely to face stress and hardship in life due to diverse economic and household responsibilities, which, in turn, severely affected their mental health.[35] Prevalence of mental health morbidity in a study from the Sunderbans delta found a positive relation with psycho-social stressors and poor quality of life. The health system in that remote area was largely managed by âquack doctorsâ and faith healers. Poverty, illiteracy, and detachment from the larger community helped reinforce superstitious beliefs and made them seek both mental and physical health care from faith healers.[36] In a study among students, it was found that children had difficulties in adjusting to both ethnic and mainstream culture.[27] Low family income, inadequate housing, poor sanitation, and unhealthy and unhygienic living conditions were some environmental factors contributing to poor physical and mental growth of children. It was observed that children who did not have such risk factors maintained more intimate relations with the family members.
Children belonging to the disadvantaged environment expressed their verbal, emotional need, blame, and harm avoidances more freely than their counterparts belonging to less disadvantaged backgrounds. Although disadvantaged children had poor interfamilial interaction, they had better relations with the members outside family, such as peers, friends, and neighbors.[37] Another study in Jharkhand found that epilepsy was higher among ST patients compared to non-ST patients.[31] Most patients among the ST are irregular and dropout rates are higher among them than the non-ST patients. Urbanization per se exerted no adverse influence on the mental health of a tribal community, provided it allowed preservation of ethnic and cultural practices. Women in the ST communities were less vulnerable to mental illness than men. This might be a reflection of their increased responsibilities and enhanced gender roles that are characteristic of women in many ST communities.[38] Data obtained using culturally relevant scales revealed that relocated Sahariya suffer a lot of mental health problems, which are partially explained by livelihood and poverty-related factors.
The loss of homes and displacement compromise mental health, especially the positive emotional well-being related to happiness, life satisfaction, optimism for future, and spiritual contentment. These are often not overcome even with good relocation programs focused on material compensation and livelihood re-establishment.[39] Discussion This systematic review is to our knowledge the first on mental health of ST population in India. Few studies on the mental health of ST were available. All attempts including hand searching were made to recover both published peer-reviewed papers and reports available on the website. Though we searched gray literature, it may be possible that it does not capture all articles.
Given the heterogeneity of the papers, it was not possible to do a meta-analysis, so a narrative review was done.The quality of the studies was assessed by CASP. The assessment shows that the research conducted on mental health of STs needs to be carried out more effectively. The above mentioned gaps need to be filled in future research by considering the resources effectively while conducting the studies. Mental and substance use disorders contribute majorly to the health disparities. To address this, one needs to deliver evidence-based treatments, but it is important to understand how far these interventions for the indigenous populations can incorporate cultural practices, which are essential for the development of mental health services.[30] Evidence has shown a disproportionate burden of suicide among indigenous populations in national and regional studies, and a global and systematic investigation of this topic has not been undertaken to date.
Previous reviews of suicide epidemiology among indigenous populations have tended to be less comprehensive or not systematic, and have often focused on subpopulations such as youth, high-income countries, or regions such as Oceania or the Arctic.[46] The only studies in our review which provided data on suicide were in Idu Mishmi, an isolated tribal population of North-East India, and tribal communities from Sunderban delta.[24],[37] Some reasons for suicide in these populations could be the poor identification of existing mental disorders, increased alcohol use, extreme poverty leading to increased debt and hopelessness, and lack of stable employment opportunities.[24],[37] The traditional consumption pattern of alcohol has changed due to the reasons associated with social enhancement and coping with distressing emotions rather than individual enhancement.[19],[20]Faith healers play a dominant role in treating mental disorders. There is less awareness about mental health and available mental health services and even if such knowledge is available, access is limited due to remoteness of many of these villages, and often it involves high out-of-pocket expenditure.[35] Practitioners of modern medicine can play a vital role in not only increasing awareness about mental health in the community, but also engaging with faith healers and traditional medicine practitioners to help increase their capacity to identify and manage CMDs that do not need medications and can be managed through simple âtalk therapy.â Knowledge on symptoms of severe mental disorders can also help such faith healers and traditional medicine practitioners to refer cases to primary care doctors or mental health professionals.Remote settlements make it difficult for ST communities to seek mental health care. Access needs to be increased by using solutions that use training of primary health workers and nonphysician health workers, task sharing, and technology-enabled clinical decision support tools.[3] The SMART Mental Health project was delivered in the tribal areas of Andhra Pradesh using those principles and was found to be beneficial by all stakeholders.[14]Given the lack of knowledge about mental health problems among these communities, the government and nongovernmental organizations should collect and disseminate data on mental disorders among the ST communities. More research funding needs to be provided and key stakeholders should be involved in creating awareness both in the community and among policy makers to develop more projects for ST communities around mental health. Two recent meetings on tribal mental health â Round Table Meeting on Mental Health of ST Populations organized by the George Institute for Global Health, India, in 2017,[51] and the First National Conference on Tribal Mental Health organized by the Indian Psychiatric Society in Bhubaneswar in 2018 â have identified some key areas of research priority for mental health in ST communities.
A national-level policy on mental health of tribal communities or population is advocated which should be developed in consultation with key stakeholders. The Indian Psychiatric Society can play a role in coordinating research activities with support of the government which can ensure regular monitoring and dissemination of the research impact to the tribal communities. There is a need to understand how mental health symptoms are perceived in different ST communities and investigate the healing practices associated with distress/disaster/death/loss/disease. This could be done in the form of cross-sectional or cohort studies to generate proper evidence which could also include the information on prevalence, mental health morbidity, and any specific patterns associated with a specific disorder. Future research should estimate the prevalence of mental disorders in different age groups and gender, risk factors, and the influence of modernization.
Studies should develop a theoretical model to understand mental disorders and promote positive mental health within ST communities. Studies should also look at different ST communities as cultural differences exist across them, and there are also differences in socioeconomic status which impact on ability to access care.Research has shown that the impact and the benefits are amplified when research is driven by priorities that are identified by indigenous communities and involve their active participation. Their knowledge and perspectives are incorporated in processes and findings. Reporting of findings is meaningful to the communities. And indigenous groups and other key stakeholders are engaged from the outset.[47] Future research in India on ST communities should also adhere to these broad principles to ensure relevant and beneficial research, which have direct impact on the mental health of the ST communities.There is also a need to update literature related to mental health of ST population continuously.
Develop culturally appropriate validated instruments to measure mental morbidity relevant to ST population. And use qualitative research to investigate the perceptions and barriers for help-seeking behavior.[48] Conclusion The current review helps not only to collate the existing literature on the mental health of ST communities but also identify gaps in knowledge and provide some indications about the type of research that should be funded in future.Financial support and sponsorshipNil.Conflicts of interestThere are no conflicts of interest. References 1.Gururaj G, Girish N, Isaac MK. Mental. Neurological and Substance abuse disorders.
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Correspondence Address:S V. Siddhardh Kumar DevarapalliGeorge Institute for Global Health, Plot No. 57, Second Floor, Corporation Bank Building, Nagarjuna Circle, Punjagutta, Hyderabad - 500 082, Telangana IndiaSource of Support. None, Conflict of Interest. NoneDOI.
10.4103/psychiatry.IndianJPsychiatry_136_19 Figures [Figure 1] Tables [Table 1], [Table 2].
The 54-year-old viagra 100mg online in canada rancher said he has felt the stress of the added that site responsibility of providing meat to customers in a time of food shortages, particularly at the beginning of the viagra. But he feels lucky to have a family that supports him. Because drought has impeded hay production in Colorado, Wheeler has had to have bales shipped in from South Dakota.
Wheeler says the lack of viagra 100mg online in canada rain has been his biggest stressor. (Eli Imadali for KHN) Similar to other Rocky Mountain states, Colorado has one of the highest suicide rates in the country. The rates are often worse in the stateâs rural communities, a factor consistent with rural Americansâ risks nationwide.
A Centers for Disease Control and Prevention report examining viagra 100mg online in canada 2001-15 data found the suicide rate in rural counties was more than 17 per 100,000 people, compared with about 15 per 100,000 in small and medium-sized metro counties and about 12 per 100,000 in large metro counties. Kiowa is in Elbert County, whose 1,850 square miles of mostly dusty, flat plains start where the affluent bedroom communities of Denver end. The county has no urgent care center or hospital like its suburban neighbors, just four clinics to serve a population of 27,000.
A health care center in viagra 100mg online in canada Elizabeth, Colorado, offers counseling, among other services. The few physical and mental health resources available in Elbert County are concentrated in the west, closer to Denver. (Eli Imadali for KHN) Dwayne Smith, Elbert Countyâs public health director, said that to help solve the problem residents need to talk with their health providers as candidly about their mental health challenges as about skin cancer or heart disease.
ÂIn a more conservative community, where historically mental health issues may not have been talked about as openly and as comfortably as in the viagra 100mg online in canada [Denver] area, you have to work diligently to increase peopleâs comfort level,â Smith said. ÂEven saying the words âanxiety,â âdepression,â âmental healthâ â all those things that in prior generations were very much a taboo subject.â Elbert County Public Health Director Dwayne Smith poses outside the Department of Health and Human Services, surrounded by prairie. (Eli Imadali for KHN) The public health crisis is just an added burden to the already high stress on people in the agricultural industry.
ÂFarmers and viagra 100mg online in canada ranchers are absorbing a lot of the shocks to the system for us. Hailstorms, pest outbreaks, drought, markets â theyâre adjusting for all that to keep food production moving,â said Coloradoâs agriculture commissioner, Kate Greenberg. Unpredictable weather, a volatile commodity market and a 700-acre grass fire cost Laura Negley, a rancher in the southeastern town of Eads, a lot of income around 2012.
Negleyâs and her husbandâs families have been in agriculture since the late 1600s and early 1700s, and they are now the third generation viagra 100mg online in canada on the same Colorado land. But she was devastated after those losses, followed by her youngest childâs departure for college. ÂThatâs kind of when the wheels fell off for me.
And then I kind of spiraled down,â Negley viagra 100mg online in canada said. The viagra exacerbated Laura Negleyâs anxiety, isolating her from extended family and causing worry about her elderly parents.(Eli Imadali for KHN) Negley, now 59, said she initially didnât recognize she needed help even though she was deep into her âdark placeâ of depression and anxiety, but her brother encouraged her to see a counselor near him in Greeley. So, when the cattle were done grazing for the season, Negley spent six winter weeks getting counseling 200 miles north.
Those visits eventually transitioned to phone viagra 100mg online in canada counseling and an anti-anxiety medication. ÂI do think you have to have a support group,â said Negley, who said her faith has helped her, too. Over the years, slashed budgets to local health departments have cut to the bone.
In Elbert County, Smith is viagra 100mg online in canada one of just three full-time employees in his department. About 15 years ago, it had at least six nurses. It now has none.
It is viagra 100mg online in canada trying to hire one. ÂWe have a lack of health providersâ in rural America, Negley said. ÂThe ones we do have are doing their best â but theyâre trying to wear multiple hats.â Negley talks with son Jayce as he repairs a sweep plow on their family land in Eads, Colorado.
(Eli Imadali for KHN) Negleyâs and viagra 100mg online in canada her husbandâs families have been in agriculture since the late 1600s and early 1700s, and they are now the third generation on the same Colorado land. (Eli Imadali for KHN) Stressors like severe drought and exhaustion from unrelenting hard work can lead to mental health struggles for farmers and ranchers. Negley will likely not have cattle this year because drought impeded grass growth.(Eli Imadali for KHN) Agencies in Colorado recognize the need to improve mental health services offered to rural residents.
Colorado Crisis Services has a hotline and text-messaging number to refer people to free, confidential viagra 100mg online in canada support. And the state is working on tailored messaging campaigns to help farmers and ranchers understand those numbers are free and confidential to contact. These services can help.
According to the CDC, for every adult death by suicide, about 230 people think viagra 100mg online in canada seriously about suicide. A bill introduced in Coloradoâs legislature would boost funding for rural rehabilitation specialists and help provide vouchers for rural Coloradans to get behavioral health services. ÂWe have to be flexible.
What works in Denver does not viagra 100mg online in canada work in La Juntaâ or the rest of rural Colorado, said Robert Werthwein, director of the stateâs Office of Behavioral Health. But in tightknit small towns, ranchers say, even if the resources are there the stigma remains. ÂThese are normal people with normal problems.
Weâre just viagra 100mg online in canada trying to, perhaps first and foremost, destigmatize mental health needs and resources,â Smith said. ÂTimecards and schedules have had no meaning for the past year,â says Smith, one of three full-time employees in his department. ÂItâs just been never-ending.â (Eli Imadali for KHN) Stigmas are something 26-year-old Jacob Walter and his family want to help tackle.
As Walter was growing up, a friendâs father and another friendâs mother died viagra 100mg online in canada by suicide. Before Walter left the familyâs ranch in southeastern Colorado to start his sophomore year in college, he lost his own father, Rusty, to suicide in 2016. Walter said there were few local resources at the time to help people like his dad, and the nearest town was 45 minutes away.
Rusty was involved in many community service organizations and gave a lot viagra 100mg online in canada of his time to others, Walter said, but he suffered from depression. ÂThe day before he committed suicide, we had been talking at the kitchen table, and he was just talking about [his depression], and he said. ÂYou know, you can always get help and stuff.ââ Thatâs the message agricultural leaders like Ray Atkinson, communications director at the American Farm Bureau Federation, say should be conveyed most.
Itâs OK to acknowledge when you need viagra 100mg online in canada help. ÂIf your tractor needed maintenance ⦠you would stop what youâre doing and youâd get it working right before you go try and go out in the field,â Atkinson said. ÂYou are the most important piece of equipment on your farm.â Cattle eat hay on Rafter W Ranch near Simla, Colorado.
Drought hasnât viagra 100mg online in canada allowed grazing on grassy pastures. (Eli Imadali for KHN) [Editorâs note. If you or someone you know is in a crisis, please call the National Suicide Prevention Lifeline at 1-800-273-TALK (8255), or contact the Crisis Text Line by texting TALK to 741741.
In Colorado, you can also contact Colorado Crisis Services at 1-844-493-TALK (8255) or text TALK to 38255.] Related Topics viagra 100mg online in canada Contact Us Submit a Story TipStart Preamble Department of Veterans Affairs. Announcement for Public Meetings. The Department of Veterans Affairs (VA) will be holding two public virtual listening sessions to seek input on implementing the requirements of section 201 of the Commander John Scott Hannon Veterans Mental Health Care Improvement Act of 2019.
The Act mandates VA to establish the Staff Sergeant Parker Gordon Fox Suicide Prevention Grant Program (SSG Fox SPGP) to reduce Veteran suicide through a 3-year community-based grant program that viagra 100mg online in canada would provide financial Start Printed Page 25939assistance to eligible entities to provide or coordinate providing suicide prevention services to eligible Veterans and their families. VA is required to consult with certain entities related to administering this new grant program. VA previously published a request for information on April 1, 2021, seeking written comments from these entities to help inform VA's development of the SSG Fox SPGP and its implementing regulations.
These public virtual listening sessions viagra 100mg online in canada serve as additional means for VA to consult with these same entities. VA will hold the first public virtual listening session on May 25, 2021, and the second public virtual listening session on May 26, 2021. Each meeting will start at 10:00 a.m.
And conclude viagra 100mg online in canada on or before 5:00 p.m. Eastern Standard Time (EST). There will be limited space for participants to speak at the public virtual listening sessions.
To accommodate as many speakers as possible, viagra 100mg online in canada participants will have no more than 20 minutes to provide oral comments, testimonies and/or technical remarks. More concise contributions are also welcome. The exact time allotted will vary based on the number of participants registered and selected to speak.
The sessions will be held viagra 100mg online in canada virtually as a WebEx Event, and it will be open to the public to listen. Information about the meeting and registration to speak or listen can be obtained by emailing VASSGFoxGrants@va.gov. Virtual attendance will be limited to 1,000 registrants.
Advanced registration for individuals and groups is strongly encouraged viagra 100mg online in canada (see registration instructions below). Individuals or groups who seek to speak must pre-register by May 19, 2021, at 4:00 p.m. EST.
Speakers must virtually check-in between 9:00 viagra 100mg online in canada a.m. And 9:45 a.m. EST to test their WebEx access and resolve any platform issues.
Start Further Info Juliana Hallows, Associate Director for Policy and PlanningâSuicide Prevention viagra 100mg online in canada Program, Office of Mental Health and Suicide Prevention (OMHSP), 11MHSP, 810 Vermont Avenue NW, Washington, DC 20420, 202-266-4653. (This is not a toll-free telephone number.) End Further Info End Preamble Start Supplemental Information Background Section 201 of the Commander John Scott Hannon Veterans Mental Health Care Improvement Act of 2019 (the Act), Public Law 116-171, enacted on October 17, 2020, requires VA to create a new community-based suicide prevention grant program to reduce Veteran suicide. Section 201 authorizes the award of grants for no more than $750,000 per grantee per fiscal year to eligible entities to provide or coordinate providing suicide prevention services to eligible individuals and their families.
An eligible individual is a person at risk of suicide who is a Veteran as viagra 100mg online in canada defined in 38 U.S.C. 101, an individual described in 38 U.S.C. 1720I(b) or an individual described in 38 U.S.C.
1712A(a)(1)(C)(i)-(iv). Consultation With Interested Parties In administering the SSG Fox SPGP, VA is required to consult with certain entities to. 1.
Establish the criteria for selecting eligible entities that have submitted applications. 2. Develop a framework for collecting and sharing information about eligible entities receiving grants.
And 3. Develop the measures and metrics eligible entities receiving grants will use to determine the effectiveness of programming provided to improve mental health status, well-being and reduce suicide risk and deaths by suicide. VA is also required to consult with entities in developing a plan for the design and implementing the provision of grants, including criteria for awarding such grants, and on non-traditional and innovative approaches and treatment practices.
The Act requires VA to specifically consult with the following entities. (1) Veterans Service Organizations. (2) National organizations representing potential community partners in providing supportive services to address the needs of Veterans and their families, including national organizations that advocate for the needs of individuals with or at risk of behavioral health conditions as well as national organizations representing mayors, unions, first responders, chiefs of police and sheriffs, governors, a territory of the United States or representing a Tribal alliance.
(3) National organizations representing members of the Armed Forces. (4) National organizations representing where can you buy viagra counties. (5) Organizations with which VA has a current memorandum of agreement or understanding related to mental health or suicide prevention.
(6) State Departments of Veterans Affairs. (7) National organizations representing members of the Reserve Components of the Armed Forces. (8) National organizations representing members of the Coast Guard.
(9) Organizations, including institutions of higher education, with experience in creating measurement tools for purposes of advising the Secretary on the most appropriate existing measurement tool or protocol for VA to utilize. (10) The National Alliance on Mental Illness. (11) a labor organization (as such term is defined in 5 U.S.C.
7103(a)(4)). (12) The Centers for Disease Control and Prevention (CDC), the Substance Abuse and Mental Health Services Administration and PREVENTS. And (13) Such other organizations as the Secretary deems appropriate.
On April 1, 2021, VA published a request for information in the Federal Register seeking input from these groups and entities. See 86 FR 17268. These public virtual listening sessions serve as an additional means for VA to consult with these entities.
Responses will be used to inform development of the SSG Fox SPGP and its implementing regulations. Oral comment, testimonies and technical remarks are encouraged to be concise and directed toward specific virtual public listening session topics. Please note that VA will not respond to comments or other questions regarding policy plans, decisions or issues regarding this notice.
Comments received in response to this notice will be evaluated and, as appropriate, incorporated into a proposed rulemaking for grants under this law. Registration Individual registration. VA encourages individual registrations for those not affiliated with or representing a group, association or organization.
Group registration. Identification of the name of the group, association or organization should be indicated in your registration request. Due to virtual platform meeting limitations of WebEx and the statutory mandate that VA consult with certain entities, VA may select certain entities to speak or may limit the size of a group's registration to allow receipt of testimonies and/or technical remarks from a broad, diverse group of stakeholders.
Oral comments, testimonies and/or technical remarks may be limited from a group, association or organization to no more than two (2) individuals representing the same group, association or organization. Efforts will be made to accommodate all attendees who wish to participate. However, VA will give priority to representatives of the stakeholders enumerated in the statute who request registration before May 19, 2021, 4:00 p.m.
EST, and wish to provide oral comments, testimonies and/or technical remarks. The length of time allotted for participants to provide oral comments, testimonies and/or technical remarks during the meeting will be no more than 20 minutes and is Start Printed Page 25940subject to the total number of participants speaking, to ensure time is allotted to selected registered speakers. There will be no opportunity for audio-visual presentations during the meeting.
Audio (For listening purposes only). Limited to the first 200 participants, on a first-come, first-served basis. Advanced registration is not required.
Audio attendees will not be allowed to offer oral comments, testimonies and/or technical remarks as the phone line will be muted. Note. Should it be necessary to cancel the meeting due to technical issues or other emergencies, VA will take available measures to notify registered participants.
VA will conduct the public meeting informally, and technical rules of evidence will not apply. VA will arrange for a written transcript of the meeting and keep the official record open for 15 days after the meeting to allow submission of supplemental information. You may make arrangements for copies of the transcript directly with the reporter, and the transcript will also be posted in the docket of the rule as part of the official record when the rule is published.
Each listening session will focus on specific virtual public listening session topics described in this notice and specified in the following Agenda. Listening Session 1 Virtual Public Listening Session 1 Topics (May 25, 2021) A. Distribution and Selection of Grants B.
Administration of Grant Program C. Training and Technical Assistance Agenda 09:00-10:00 Speaker Virtual Check-In 10:00-12:00 Morning Public Meeting Session 12:00-13:00 Break 13:00-17:00 Afternoon Public Meeting Session 17:00 Adjourn Listening Session 2 Virtual Public Listening Session 2 Topics (May 26, 2021) D. Referral for Care E.
Risk of Suicide F. Suicide Prevention Services Agenda 09:00-10:00 Arrival/Check-In 10:00-12:00 Morning Public Meeting Session 12:00-13:00 Break 13:00-17:00 Afternoon Public Meeting Session 17:00 Adjourn Virtual Public Listening Session Topics To design and implement the SSG Fox SPGP consistent with, and pursuant to, section 201 of the Act, the Secretary seeks information on the topics and issues listed below. Commenters do not need to address every question and should focus on those that relate to their expertise or perspectives.
To the extent possible, please clearly indicate which topics and issues you address in your response. Virtual Public Listening Session 1. May 25, 2021 A.
Distribution and Selection of Grants (Section 201(d)(h)(1) of the Act) 1. What criteria should VA establish for the selection of eligible entities that have submitted applications under the SSG Fox SPGP?. 2.
Pursuant to the Act, the Secretary shall give preference to eligible entities that have demonstrated the ability to provide or coordinate suicide prevention services. How should VA weigh evidence of demonstrated ability to provide or coordinate suicide prevention services, in giving preference to eligible entities that have demonstrated such ability?. B.
Administration of Grant Program. Development of Measures and Metrics (Section 201(h)(2) of the Act) 1. How should VA collect and share information about entities in receipt of grants under the SSG Fox SPGP?.
2. How can shared information about entities be used to improve the provision or coordination of suicide prevention services for eligible individuals and families?. 3.
What measures and metrics should eligible entities, who are in receipt of grants under the SSG Fox SPGP, use to determine the effectiveness of the programs they are providing?. 4. What existing measurements, tool or protocols are available to determine program effectiveness?.
Which of these should be used for purposes of measuring effectiveness of programs provided through this grant program?. C. Training and Technical Assistance (Section 201(g) of the Act) Section 201(g) of the Act provides that the Secretary, in coordination with CDC, shall provide training and technical assistance to grant recipients.
The required training and technical assistance will cover suicide risk identification and management, data required to be collected and shared with VA, the means of data collection and sharing, use of tools to be used to measure the effectiveness of the grants and the reporting requirements. The Secretary may provide the training and technical assistance directly or through grants or contracts with appropriate public or nonprofit entities. 1.
What training and technical assistance programs and tools currently exist for the specified subject areas described above that could be utilized by VA?. 2. What data collection tools and training currently exist for the specified subject areas that could be utilized by VA?.
3. What tools and training currently exist for measuring the effectiveness of grants that could be utilized by VA?. 4.
What tools and training currently exist for managing reporting requirements that could be utilized by VA?. 5. Should VA provide training and/or technical assistance directly, through grants or contracts with appropriate public or nonprofit entities, or a combination of both?.
Virtual Public Listening Session 2. May 26, 2021 D. Referral for Care (Section 201(m) of the Act) Section 201(m) of the Act provides that if an eligible entity in receipt of a grant under the SSG Fox SPGP determines that an eligible individual is at risk of suicide or other mental or behavioral health condition pursuant to a baseline mental health screening conducted under subsection (q)(11)(A)(ii) of the Act with respect to the individual, the entity shall refer the eligible individual to VA for additional care under subsection (n) of the Act or any other provision of law.
Section 201(m) of the Act also provides that if an eligible entity in receipt of a grant under the SSG Fox SPGP determines that an eligible individual furnished clinical services for emergency treatment under subsection (q)(11)(A)(iv) of the Act requires ongoing services, the entity shall refer the eligible individual to VA for additional care under subsection (n) of the Act or any other provision of law. 1. When an eligible entity in receipt of a grant under the SSG Fox SPGP determines that an eligible individual is at risk of suicide or other mental or behavioral health condition pursuant to a qualifying baseline mental health screening, by what mechanism should the eligible entity refer the eligible individual to VA for additional care?.
2. When an eligible entity in receipt of a grant under the SSG Fox SPGP determines that an eligible individual furnished clinical services for Start Printed Page 25941emergency treatment requires ongoing services, by what mechanism should the eligible entity refer the eligible individual to VA for additional care?. 3.
How should referrals to VA for additional care be tracked and reported by eligible entities?. E. Risk of Suicide Section 201(q)(8) of the Act directs the Secretary to determine by regulation the degrees of risk of suicide using health, environmental and historical risk factors enumerated in section 201(q)(8)(A)(i)-(iii).
Section 201(q)(8) also provides that the Secretary may, through regulation, establish a process for determining the degrees of risk of suicide for use by grant recipients to focus the delivery of suicide prevention services. 1. What degree(s) of exposure to, or the existence of, the health, environmental and historical risk factors enumerated in section 201(q)(8)(A)(i)-(iii) should VA utilize in determining degrees of risk of suicide?.
2. What process should VA establish for use by grant recipients in determining the degrees of risk of suicide to focus the delivery of services using grant funds?. F.
Suicide Prevention Services Section 201(q)(11)(A)(x) of the Act notes that suicide prevention services includes non-traditional and innovative approaches and treatment practices, as determined appropriate by the Secretary, in consultation with appropriate entities. 1. What non-traditional and innovative approaches and treatment practices should VA determine to be appropriate to be provided under this grant program?.
Signing Authority Denis McDonough, Secretary of Veterans Affairs, approved this document on May 5, 2021, and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Start Signature Jeffrey M.
Treatment for mental health problems buy viagra over the counter special info caused or worsened by the stress and isolation of the viagra has obstacles particular to ranching and farming country. The stigma of acknowledging the need for mental health care can prevent people from seeking it. For those who overcome that obstacle and look for help, they are likely to find underfunded, understaffed and underequipped health providers who often donât have the bandwidth or expertise for sufficient mental health support.
ÂI guess my cows buy viagra over the counter are my therapists,â joked Wheeler. The 54-year-old rancher said he has felt the stress of the added responsibility of providing meat to customers in a time of food shortages, particularly at the beginning of the viagra. But he feels lucky to have a family that supports him.
Because drought has impeded hay production in Colorado, Wheeler has buy viagra over the counter had to have bales shipped in from South Dakota. Wheeler says the lack of rain has been his biggest stressor. (Eli Imadali for KHN) Similar to other Rocky Mountain states, Colorado has one of the highest suicide rates in the country.
The rates are often worse in the stateâs buy viagra over the counter rural communities, a factor consistent with rural Americansâ risks nationwide. A Centers for Disease Control and Prevention report examining 2001-15 data found the suicide rate in rural counties was more than 17 per 100,000 people, compared with about 15 per 100,000 in small and medium-sized metro counties and about 12 per 100,000 in large metro counties. Kiowa is in Elbert County, whose 1,850 square miles of mostly dusty, flat plains start where the affluent bedroom communities of Denver end.
The county has no urgent care center or hospital like its suburban neighbors, buy viagra over the counter just four clinics to serve a population of 27,000. A health care center in Elizabeth, Colorado, offers counseling, among other services. The few physical and mental health resources available in Elbert County are concentrated in the west, closer to Denver.
(Eli Imadali for KHN) Dwayne Smith, Elbert Countyâs public health buy viagra over the counter director, said that to help solve the problem residents need to talk with their health providers as candidly about their mental health challenges as about skin cancer or heart disease. ÂIn a more conservative community, where historically mental health issues may not have been talked about as openly and as comfortably as in the [Denver] area, you have to work diligently to increase peopleâs comfort level,â Smith said. ÂEven saying the words âanxiety,â âdepression,â âmental healthâ â all those things that in prior generations were very much a taboo subject.â Elbert County Public Health Director Dwayne Smith poses outside the Department of Health and Human Services, surrounded by prairie.
(Eli Imadali for KHN) buy viagra over the counter The public health crisis is just an added burden to the already high stress on people in the agricultural industry. ÂFarmers and ranchers are absorbing a lot of the shocks to the system for us. Hailstorms, pest outbreaks, drought, markets â theyâre adjusting for all that to keep food production moving,â said Coloradoâs agriculture commissioner, Kate Greenberg.
Unpredictable weather, a volatile commodity market and a buy viagra over the counter 700-acre grass fire cost Laura Negley, a rancher in the southeastern town of Eads, a lot of income around 2012. Negleyâs and her husbandâs families have been in agriculture since the late 1600s and early 1700s, and they are now the third generation on the same Colorado land. But she was devastated after those losses, followed by her youngest childâs departure for college.
ÂThatâs kind of buy viagra over the counter when the wheels fell off for me. And then I kind of spiraled down,â Negley said. The viagra exacerbated Laura Negleyâs anxiety, isolating her from extended family and causing worry about her elderly parents.(Eli Imadali for KHN) Negley, now 59, said she initially didnât recognize she needed help even though she was deep into her âdark placeâ of depression and anxiety, but her brother encouraged her to see a counselor near him in Greeley.
So, when the cattle were done grazing for buy viagra over the counter the season, Negley spent six winter weeks getting counseling 200 miles north. Those visits eventually transitioned to phone counseling and an anti-anxiety medication. ÂI do think you have to have a support group,â said Negley, who said her faith has helped her, too.
Over the years, slashed buy viagra over the counter budgets to local health departments have cut to the bone. In Elbert County, Smith is one of just three full-time employees in his department. About 15 years ago, it had at least six nurses.
It now buy viagra over the counter has none. It is trying to hire one. ÂWe have a lack of health providersâ in rural America, Negley said.
ÂThe ones we do have are doing their best â but theyâre trying to wear multiple hats.â Negley talks with son Jayce as he repairs a sweep plow on buy viagra over the counter their family land in Eads, Colorado. (Eli Imadali for KHN) Negleyâs and her husbandâs families have been in agriculture since the late 1600s and early 1700s, and they are now the third generation on the same Colorado land. (Eli Imadali for KHN) Stressors like severe drought and exhaustion from unrelenting hard work can lead to mental health struggles for farmers and ranchers.
Negley will likely not have cattle this year because drought impeded grass growth.(Eli Imadali for KHN) Agencies in Colorado recognize the buy viagra over the counter need to improve mental health services offered to rural residents. Colorado Crisis Services has a hotline and text-messaging number to refer people to free, confidential support. And the state is working on tailored messaging campaigns to help farmers and ranchers understand those numbers are free and confidential to contact.
These services buy viagra over the counter can help. According to the CDC, for every adult death by suicide, about 230 people think seriously about suicide. A bill introduced in Coloradoâs legislature would boost funding for rural rehabilitation specialists and help provide vouchers for rural Coloradans to get behavioral health services.
ÂWe have buy viagra over the counter to be flexible. What works in Denver does not work in La Juntaâ or the rest of rural Colorado, said Robert Werthwein, director of the stateâs Office of Behavioral Health. But in tightknit small towns, ranchers say, even if the resources are there the stigma remains.
ÂThese are buy viagra over the counter normal people with normal problems. Weâre just trying to, perhaps first and foremost, destigmatize mental health needs and resources,â Smith said. ÂTimecards and schedules have had no meaning for the past year,â says Smith, one of three full-time employees in his department.
ÂItâs just been never-ending.â (Eli Imadali for KHN) Stigmas are something 26-year-old Jacob Walter and his family want to help tackle buy viagra over the counter. As Walter was growing up, a friendâs father and another friendâs mother died by suicide. Before Walter left the familyâs ranch in southeastern Colorado to start his sophomore year in college, he lost his own father, Rusty, to suicide in 2016.
Walter said there buy viagra over the counter were few local resources at the time to help people like his dad, and the nearest town was 45 minutes away. Rusty was involved in many community service organizations and gave a lot of his time to others, Walter said, but he suffered from depression. ÂThe day before he committed suicide, we had been talking at the kitchen table, and he was just talking about [his depression], and he said.
ÂYou know, you can always get help and stuff.ââ Thatâs the message agricultural leaders like Ray Atkinson, communications director at the American Farm Bureau Federation, say should buy viagra over the counter be conveyed most. Itâs OK to acknowledge when you need help. ÂIf your tractor needed maintenance ⦠you would stop what youâre doing and youâd get it working right before you go try and go out in the field,â Atkinson said.
ÂYou are the most important piece of equipment on your farm.â Cattle eat hay on buy viagra over the counter Rafter W Ranch near Simla, Colorado. Drought hasnât allowed grazing on grassy pastures. (Eli Imadali for KHN) [Editorâs note.
If you or someone you know is in a crisis, please call the National Suicide Prevention Lifeline at 1-800-273-TALK (8255), or contact the Crisis Text Line by texting TALK buy viagra over the counter to 741741. In Colorado, you can also contact Colorado Crisis Services at 1-844-493-TALK (8255) or text TALK to 38255.] Related Topics Contact Us Submit a Story TipStart Preamble Department of Veterans Affairs. Announcement for Public Meetings.
The Department of Veterans Affairs (VA) will be holding two public virtual listening sessions to buy viagra over the counter seek input on implementing the requirements of section 201 of the Commander John Scott Hannon Veterans Mental Health Care Improvement Act of 2019. The Act mandates VA to establish the Staff Sergeant Parker Gordon Fox Suicide Prevention Grant Program (SSG Fox SPGP) to reduce Veteran suicide through a 3-year community-based grant program that would provide financial Start Printed Page 25939assistance to eligible entities to provide or coordinate providing suicide prevention services to eligible Veterans and their families. VA is required to consult with certain entities related to administering this new grant program.
VA previously published a request for information on buy viagra over the counter April 1, 2021, seeking written comments from these entities to help inform VA's development of the SSG Fox SPGP and its implementing regulations. These public virtual listening sessions serve as additional means for VA to consult with these same entities. VA will hold the first public virtual listening session on May 25, 2021, and the second public virtual listening session on May 26, 2021.
Each meeting will buy viagra over the counter start at 10:00 a.m. And conclude on or before 5:00 p.m. Eastern Standard Time (EST).
There will be limited space buy viagra over the counter for participants to speak at the public virtual listening sessions. To accommodate as many speakers as possible, participants will have no more than 20 minutes to provide oral comments, testimonies and/or technical remarks. More concise contributions are also welcome.
The exact time allotted will vary based on the number buy viagra over the counter of participants registered and selected to speak. The sessions will be held virtually as a WebEx Event, and it will be open to the public to listen. Information about the meeting and registration to speak or listen can be obtained by emailing VASSGFoxGrants@va.gov.
Virtual attendance buy viagra over the counter will be limited to 1,000 registrants. Advanced registration for individuals and groups is strongly encouraged (see registration instructions below). Individuals or groups who seek to speak must pre-register by May 19, 2021, at 4:00 p.m.
EST. Speakers must virtually check-in between 9:00 a.m. And 9:45 a.m.
EST to test their WebEx access and resolve any platform issues. Start Further Info Juliana Hallows, Associate Director for Policy and PlanningâSuicide Prevention Program, Office of Mental Health and Suicide Prevention (OMHSP), 11MHSP, 810 Vermont Avenue NW, Washington, DC 20420, 202-266-4653. (This is not a toll-free telephone number.) End Further Info End Preamble Start Supplemental Information Background Section 201 of the Commander John Scott Hannon Veterans Mental Health Care Improvement Act of 2019 (the Act), Public Law 116-171, enacted on October 17, 2020, requires VA to create a new community-based suicide prevention grant program to reduce Veteran suicide.
Section 201 authorizes the award of grants for no more than $750,000 per grantee per fiscal year to eligible entities to provide or coordinate providing suicide prevention services to eligible individuals and their families. An eligible individual is a person at risk of suicide who is a Veteran as defined in 38 U.S.C. 101, an individual described in 38 U.S.C.
1720I(b) or an individual described in 38 U.S.C. 1712A(a)(1)(C)(i)-(iv). Consultation With Interested Parties In administering the SSG Fox SPGP, VA is required to consult with certain entities to.
1. Establish the criteria for selecting eligible entities that have submitted applications. 2.
Develop a framework for collecting and sharing information about eligible entities receiving grants. And 3. Develop the measures and metrics eligible entities receiving grants will use to determine the effectiveness of programming provided to improve mental health status, well-being and reduce suicide risk and deaths by suicide.
VA is also required to consult with entities in developing a plan for the design and implementing the provision of grants, including criteria for awarding such grants, and on non-traditional and innovative approaches and treatment practices. The Act requires VA to specifically consult with the following entities. (1) Veterans Service Organizations.
(2) National organizations representing potential community partners in providing supportive services to address the needs of Veterans and their families, including national organizations that advocate for the needs of individuals with or at risk of behavioral health conditions as well as national organizations representing mayors, unions, first responders, chiefs of police and sheriffs, governors, a territory of the United States or representing a Tribal alliance. (3) National organizations representing members of the Armed Forces. (4) National organizations representing counties.
(5) Organizations with which VA has a current memorandum of agreement or understanding related to mental health or suicide prevention. (6) State Departments of Veterans Affairs. (7) National organizations representing members of the Reserve Components of the Armed Forces.
(8) National organizations representing members of the Coast Guard. (9) Organizations, including institutions of higher education, with experience in creating measurement tools for purposes of advising the Secretary on the most appropriate existing measurement tool or protocol for VA to utilize. (10) The National Alliance on Mental Illness.
(11) a labor organization (as such term is defined in 5 U.S.C. 7103(a)(4)). (12) The Centers for Disease Control and Prevention (CDC), the Substance Abuse and Mental Health Services Administration and PREVENTS.
And (13) Such other organizations as the Secretary deems appropriate. On April 1, 2021, VA published a request for information in the Federal Register seeking input from these groups and entities. See 86 FR 17268.
These public virtual listening sessions serve as an additional means for VA to consult with these entities. Responses will be used to inform development of the SSG Fox SPGP and its implementing regulations. Oral comment, testimonies and technical remarks are encouraged to be concise and directed toward specific virtual public listening session topics.
Please note that VA will not respond to comments or other questions regarding policy plans, decisions or issues regarding this notice. Comments received in response to this notice will be evaluated and, as appropriate, incorporated into a proposed rulemaking for grants under this law. Registration Individual registration.
VA encourages individual registrations for those not affiliated with or representing a group, association or organization. Group registration. Identification of the name of the group, association or organization should be indicated in your registration request.
Due to virtual platform meeting limitations of WebEx and the statutory mandate that VA consult with certain entities, VA may select certain entities to speak or may limit the size of a group's registration to allow receipt of testimonies and/or technical remarks from a broad, diverse group of stakeholders. Oral comments, testimonies and/or technical remarks may be limited from a group, association or organization to no more than two (2) individuals representing the same group, association or organization. Efforts will be made to accommodate all attendees who wish to participate.
However, VA will give priority to representatives of the stakeholders enumerated in the statute who request registration before May 19, 2021, 4:00 p.m. EST, and wish to provide oral comments, testimonies and/or technical remarks. The length of time allotted for participants to provide oral comments, testimonies and/or technical remarks during the meeting will be no more than 20 minutes and is Start Printed Page 25940subject to the total number of participants speaking, to ensure time is allotted to selected registered speakers.
There will be no opportunity for audio-visual presentations during the meeting. Audio (For listening purposes only). Limited to the first 200 participants, on a first-come, first-served basis.
Advanced registration is not required. Audio attendees will not be allowed to offer oral comments, testimonies and/or technical remarks as the phone line will be muted. Note.
Should it be necessary to cancel the meeting due to technical issues or other emergencies, VA will take available measures to notify registered participants. VA will conduct the public meeting informally, and technical rules of evidence will not apply. VA will arrange for a written transcript of the meeting and keep the official record open for 15 days after the meeting to allow submission of supplemental information.
You may make arrangements for copies of the transcript directly with the reporter, and the transcript will also be posted in the docket of the rule as part of the official record when the rule is published. Each listening session will focus on specific virtual public listening session topics described in this notice and specified in the following Agenda. Listening Session 1 Virtual Public Listening Session 1 Topics (May 25, 2021) A.
Distribution and Selection of Grants B. Administration of Grant Program C. Training and Technical Assistance Agenda 09:00-10:00 Speaker Virtual Check-In 10:00-12:00 Morning Public Meeting Session 12:00-13:00 Break 13:00-17:00 Afternoon Public Meeting Session 17:00 Adjourn Listening Session 2 Virtual Public Listening Session 2 Topics (May 26, 2021) D.
Referral for Care E. Risk of Suicide F. Suicide Prevention Services Agenda 09:00-10:00 Arrival/Check-In 10:00-12:00 Morning Public Meeting Session 12:00-13:00 Break 13:00-17:00 Afternoon Public Meeting Session 17:00 Adjourn Virtual Public Listening Session Topics To design and implement the SSG Fox SPGP consistent with, and pursuant to, section 201 of the Act, the Secretary seeks information on the topics and issues listed below.
Commenters do not need to address every question and should focus on those that relate to their expertise or perspectives. To the extent possible, please clearly indicate which topics and issues you address in your response. Virtual Public Listening Session 1.
May 25, 2021 A. Distribution and Selection of Grants (Section 201(d)(h)(1) of the Act) 1. What criteria should VA establish for the selection of eligible entities that have submitted applications under the SSG Fox SPGP?.
2. Pursuant to the Act, the Secretary shall give preference to eligible entities that have demonstrated the ability to provide or coordinate suicide prevention services. How should VA weigh evidence of demonstrated ability to provide or coordinate suicide prevention services, in giving preference to eligible entities that have demonstrated such ability?.
B. Administration of Grant Program. Development of Measures and Metrics (Section 201(h)(2) of the Act) 1.
How should VA collect and share information about entities in receipt of grants under the SSG Fox SPGP?. 2. How can shared information about entities be used to improve the provision or coordination of suicide prevention services for eligible individuals and families?.
3. What measures and metrics should eligible entities, who are in receipt of grants under the SSG Fox SPGP, use to determine the effectiveness of the programs they are providing?. 4.
What existing measurements, tool or protocols are available to determine program effectiveness?. Which of these should be used for purposes of measuring effectiveness of programs provided through this grant program?. C.
Training and Technical Assistance (Section 201(g) of the Act) Section 201(g) of the Act provides that the Secretary, in coordination with CDC, shall provide training and technical assistance to grant recipients. The required training and technical assistance will cover suicide risk identification and management, data required to be collected and shared with VA, the means of data collection and sharing, use of tools to be used to measure the effectiveness of the grants and the reporting requirements. The Secretary may provide the training and technical assistance directly or through grants or contracts with appropriate public or nonprofit entities.
1. What training and technical assistance programs and tools currently exist for the specified subject areas described above that could be utilized by VA?. 2.
What data collection tools and training currently exist for the specified subject areas that could be utilized by VA?. 3. What tools and training currently exist for measuring the effectiveness of grants that could be utilized by VA?.
4. What tools and training currently exist for managing reporting requirements that could be utilized by VA?. 5.
Should VA provide training and/or technical assistance directly, through grants or contracts with appropriate public or nonprofit entities, or a combination of both?. Virtual Public Listening Session 2. May 26, 2021 D.
Referral for Care (Section 201(m) of the Act) Section 201(m) of the Act provides that if an eligible entity in receipt of a grant under the SSG Fox SPGP determines that an eligible individual is at risk of suicide or other mental or behavioral health condition pursuant to a baseline mental health screening conducted under subsection (q)(11)(A)(ii) of the Act with respect to the individual, the entity shall refer the eligible individual to VA for additional care under subsection (n) of the Act or any other provision of law. Section 201(m) of the Act also provides that if an eligible entity in receipt of a grant under the SSG Fox SPGP determines that an eligible individual furnished clinical services for emergency treatment under subsection (q)(11)(A)(iv) of the Act requires ongoing services, the entity shall refer the eligible individual to VA for additional care under subsection (n) of the Act or any other provision of law. 1.
When an eligible entity in receipt of a grant under the SSG Fox SPGP determines that an eligible individual is at risk of suicide or other mental or behavioral health condition pursuant to a qualifying baseline mental health screening, by what mechanism should the eligible entity refer the eligible individual to VA for additional care?. 2. When an eligible entity in receipt of a grant under the SSG Fox SPGP determines that an eligible individual furnished clinical services for Start Printed Page 25941emergency treatment requires ongoing services, by what mechanism should the eligible entity refer the eligible individual to VA for additional care?.
3. How should referrals to VA for additional care be tracked and reported by eligible entities?. E.
Risk of Suicide Section 201(q)(8) of the Act directs the Secretary to determine by regulation the degrees of risk of suicide using health, environmental and historical risk factors enumerated in section 201(q)(8)(A)(i)-(iii). Section 201(q)(8) also provides that the Secretary may, through regulation, establish a process for determining the degrees of risk of suicide for use by grant recipients to focus the delivery of suicide prevention services. 1.
What degree(s) of exposure to, or the existence of, the health, environmental and historical risk factors enumerated in section 201(q)(8)(A)(i)-(iii) should VA utilize in determining degrees of risk of suicide?. 2. What process should VA establish for use by grant recipients in determining the degrees of risk of suicide to focus the delivery of services using grant funds?.
F. Suicide Prevention Services Section 201(q)(11)(A)(x) of the Act notes that suicide prevention services includes non-traditional and innovative approaches and treatment practices, as determined appropriate by the Secretary, in consultation with appropriate entities.
.