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Suggested Citation:"3 Challenge: Inappropriate Selection." Institute of Medicine. 2014. Improving Access to Essential Medicines for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18380.
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Suggested Citation:"3 Challenge: Inappropriate Selection." Institute of Medicine. 2014. Improving Access to Essential Medicines for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18380.
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Suggested Citation:"3 Challenge: Inappropriate Selection." Institute of Medicine. 2014. Improving Access to Essential Medicines for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18380.
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Suggested Citation:"3 Challenge: Inappropriate Selection." Institute of Medicine. 2014. Improving Access to Essential Medicines for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18380.
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Suggested Citation:"3 Challenge: Inappropriate Selection." Institute of Medicine. 2014. Improving Access to Essential Medicines for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18380.
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Page 35
Suggested Citation:"3 Challenge: Inappropriate Selection." Institute of Medicine. 2014. Improving Access to Essential Medicines for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18380.
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Page 36
Suggested Citation:"3 Challenge: Inappropriate Selection." Institute of Medicine. 2014. Improving Access to Essential Medicines for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18380.
×
Page 37
Suggested Citation:"3 Challenge: Inappropriate Selection." Institute of Medicine. 2014. Improving Access to Essential Medicines for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18380.
×
Page 38
Suggested Citation:"3 Challenge: Inappropriate Selection." Institute of Medicine. 2014. Improving Access to Essential Medicines for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18380.
×
Page 39
Suggested Citation:"3 Challenge: Inappropriate Selection." Institute of Medicine. 2014. Improving Access to Essential Medicines for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18380.
×
Page 40
Suggested Citation:"3 Challenge: Inappropriate Selection." Institute of Medicine. 2014. Improving Access to Essential Medicines for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18380.
×
Page 41
Suggested Citation:"3 Challenge: Inappropriate Selection." Institute of Medicine. 2014. Improving Access to Essential Medicines for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18380.
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Page 42

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3 Challenge: Inappropriate Selection Opportunities to Address Inappropriate Selection as Identified by Individual Participants • Development of a coherent and comprehensive national strat- egy, based on the World Health Organization Mental Health Gap Action Programme (mhGAP), for the treatment and care of mental, neurological, and substance use (MNS) disorders that receives widespread support and resources by key stake- holders. • Development of national medicine lists and treatment guide- lines for each level of provider based on agreed-upon task- shifting practices. • Establishment of a learning health system to include review, revision, and periodic updates. • Increased inclusion of medicines that promote adherence and greater accommodation of a reasonable range of provider and patient medication preferences. • Promotion of evidence-based selection of medicines through the development of training programs. NOTE: The items in this list were addressed by individual partici- pants and were identified and summarized for this report by the rapporteurs. This list is not meant to reflect a consensus among workshop participants. For additional attribution information, please refer to the table at the end of this chapter. 31

32 ESSENTIAL MEDICINES FOR MNS DISORDERS IN SSA The appropriate selection of essential medicines for MNS disorders is critical to providing effective and accessible treatment to patients not- ed Hans Hogerzeil. The basic concept of essential medicines is that a limited range of carefully selected essential medicines leads to better health care, better medicine management, and lower costs. According to WHO, essential medicines are selected with regard to disease prevalence, evidence of efficacy and safety, and comparative cost-effectiveness (WHO, 2002b, 2013). It is the responsibility of each country to deter- mine those needs and the list of medicines that are essential for their population; globally, most countries have an essential medicines list (WHO, 2002b, 2011c, 2014). Hogerzeil noted the absence of evidence- based treatment guidelines and said these, too, should be considered as important as the medicines included in a country’s essential medicines list. The development of these guidelines potentially could be financed and supplied in the public sector (e.g., governments). Given the many challenges around access to existing medicines and the fact that 98 percent of the medicines on the WHO Model List of Es- sential Medicines are off-patent, another approach is to consider access to existing medicines that are off-patent and available from multiple sources as an option, rather than access to new, patented medicines that are generally more expensive and from a single source (Abegunde, 2011; Cameron et al., 2011a). In discussing financing and universal access to care, Hogerzeil noted that WHO has defined three dimensions of access to consider: proportion of population covered; proportion of services covered; and proportion of costs reimbursed. Increasing access may in- volve extending coverage, including additional services, and reducing cost sharing and fees (WHO, 2010b). To help identify barriers to access, Hogerzeil detailed the nine diag- nostic indicators or measurable points of assessment of country-level access to essential medicines drafted by WHO (see Box 3-1) (WHO, 2008a). BOX 3-1 Nine Indicators for Measuring Country-Level Assessment of Access to Medicines Proposed by WHO Government commitment • Access to essential medicines/technologies as part of the ful- fillment of the right to health, recognized in the constitution or national legislation.

CHALLENGE: INAPPROPRIATE SELECTION 33 • Existence and year of a published national medicines policy. Rational selection • Existence and year of a published national list of essential medicines. Affordable prices • Legal provisions to allow/encourage generic substitution in pri- vate sector. • Median consumer price ratio of 30 selected essential medi- cines in public and private health facilities. • Percentage mark-up between manufacturer and consumer price. Sustainable financing • Public and private per capita expenditure on medicines. • Percentage of population covered by national health service or health insurance. Reliable systems • Average availability of 30 selected essential medicines in pub- lic and private health facilities. SOURCES: Hogerzeil presentation, January 13, 2014; WHO, 2008a. The selection of essential medicines at the individual country level is a two-step process, Hogerzeil explained. The first step selects from all the medicines in the world to those that are registered for use and al- lowed in the specific country. This step is usually the responsibility of the national regulatory agency and decisions are based on efficacy, safe- ty, and quality. Hogerzeil noted that the number of registered products is likely to be extensive, so the second step is selecting which medicines will be stocked, used, and/or reimbursed. Decisions can be based on which products are the most clinically effective, safe, or cost-effective within therapeutic classes, said Hogerzeil. For example, in an SSA coun- try, a national centralized medicines list may include between 500 and 700 products, and most would be expected to be available at teaching hospitals. A list for a district hospital may include 250 of those medi- cines; for a health clinic, perhaps 100; and for a center staffed by com- munity health workers, maybe 30 products. Hogerzeil noted that al- though many medicines are allowed on the market, most are not actively

34 ESSENTIAL MEDICINES FOR MNS DISORDERS IN SSA supplied or reimbursed by health insurance. High-quality medicines needed in the majority of health facilities and available at low cost are considered essential, said Hogerzeil. APPLYING THE ESSENTIAL MEDICINES CONCEPT TO MNS DISORDERS Hogerzeil highlighted several unique challenges for improving ac- cess to appropriate medicines for MNS disorders. Internationally, he not- ed there has been minimal to no political support for addressing issues related to MNS disorders. For example, MNS disorders are not listed in the MDGs1 or the Alma-Ata Declaration.2 However, a participant noted that WHO has recently developed a Comprehensive Mental Health Ac- tion Plan3 for 2013-2020 endorsed by 194 member states and adopted by the World Health Assembly.4 Focusing on selection, Hogerzeil stated that evidence on the effec- tiveness of medicines to treat MNS disorders is often unavailable, or is perceived to be unavailable. As a result, patient health outcomes are not yet well defined and are difficult to measure. Hogerzeil added that spe- cialists such as psychiatrists oftentimes prefer to have a broad selection of medicines to prescribe for a specific MNS disorder rather than be con- fined to the limits of the country’s essential medicines list. There is a strong preference for “a range of personal choices” as opposed to the concept of essential medicines. Lastly, Hogerzeil stated that MNS disor- ders often require chronic treatment that may lead to catastrophic health expenditures, defined as more than 20 percent of income, and poverty due to unaffordable health care costs. 1 The United Nations Millennium Development Goals are eight goals that all 191 UN Member States have agreed to try to achieve by the year 2015. The United Nations Mil- lennium Declaration, signed in September 2000, commits world leaders to combat pov- erty, hunger, disease, illiteracy, environmental degradation, and discrimination against women. See http://www.who.int/topics/millennium_development_goals/en. 2 International declaration that expresses the need for urgent action by all governments, all health and development workers, and the world community to protect and promote the health of all the people of the world. See http://www.who.int/ publications/almaata_declaration_en.pdf. 3 See http://www.who.int/mental_health/action_plan_2013/en. 4 See http://apps.who.int/gb/ebwha/pdf_files/WHA66/A66_R8-en.pdf.

CHALLENGE: INAPPROPRIATE SELECTION 35 Barriers to Appropriate Selection The WHO Model List of Essential Medicines includes products for MNS disorders in the areas of psychiatric disorders; mood disorders; anxiety, obsessive-compulsive disorders, and substance abuse; and epi- lepsy (WHO, 2013). Hogerzeil reiterated the point that most products on the list are generics because most are off-patent. Availability of generic supply in the public sector can be the most cost-effective way of supply- ing essential medicines, Hogerzeil said. However, low and/or variable availability of generic products in the public sector can drive patients to purchase products from the private sector, with a tendency toward brand- ed products or branded generics that are three to six times the price. One participant noted the importance of further research on the impact of the availability of generic medicines in both the public and private sector on pricing and purchasing patterns. Several participants discussed the “psy- chology” of generic medicines as a barrier because of an inaccurate perception that more expensive medicines are more effective. A few participants noted that in some SSA countries, more than 30 percent of medicines are found to be counterfeit, fostering a negative attitude toward medications that do not carry a brand label (IOM, 2013b; SPS Program, 2011; WHO, 2008b). Hogerzeil added that poor-quality domestic medicines and counterfeits may be linked to “inadequate regu- lation and insufficient penalization” (Hogerzeil et al., 2013; WHO, 2010a). Given the small market value and low prices of medicines in SSA, Hogerzeil suggested there might be a lack of commercial interest in supplying medicines. A central challenge influencing appropriate selection is lack of de- mand, said Hogerzeil. As discussed by Gureje, lack of public procure- ment may be due to the lack of diagnosis and treatment capacity in the public sector, patient demand, and political interest. Hogerzeil noted that patients will not seek care if there is no trust in the system to provide af- fordable and effective health service. Additionally, if health care provid- ers are not trained to request certain medicines to treat MNS disorders, then the medicines will not be available. A participant noted that regula- tory bodies in SSA do not always consult health care providers and ex- perts in the field regarding which medicines are essential. Another partic- ipant added that staff changes within health facilities may impact the medicines procured for a public-sector pharmacy. Prescription practices also impact selection, said Hogerzeil, and in- ternational evidence-based treatment guidelines are important for MNS

36 ESSENTIAL MEDICINES FOR MNS DISORDERS IN SSA disorders. In the private sector, many health care providers prescribe and dispense. This practice may create a conflict of interest due to economic incentives to sell more expensive medicines. In the public sector, patient demand for medicines is weak due to low expectations of this sector (Basu et al., 2012). According to Hogerzeil, the field might benefit from focusing on building up the public sector by training and supporting health care providers to better treat MNS disorders. A participant pointed out that up-to-date national treatment guidelines are needed to reflect current practice and pricing. Revisions to national essential medicines lists and treatment guidelines can be slow and may include medicines that are not relevant, a participant noted. For example, a participant not- ed that amitriptyline—an antidepressant—has a higher degree of toxicity, but widely used throughout SSA because it is relatively inexpensive compared to the alternative safe medication, fluoxetine. A participant suggested that if WHO revised the essential medicine list to put fluoxe- tine ahead of amitriptyline, countries might modify which medication is selected. Several participants suggested considering improving selection of es- sential medicines for a range of neurological disorders. However, one participant noted that for many neurodegenerative diseases, there are few effective or cost-effective medicines. WHO now has a special essential medicines list with appropriate dosages for children5; however, there re- mains a lack of safety data for pediatric use of these medicines. Hogerzeil noted that only one-third of national essential medicines lists include pediatric formulations. The concept of essential medicines is a global concept, Hogerzeil stressed. The selection of essential medicines is closely linked to evidence-based clinical practice guidelines. In summary, Hogerzeil said that universal access to essential care for MNS disorders might be: • Based on the expansion of outpatient care; • Performed by trained paramedical personnel; • Supported by evidence-based treatment guidelines and a national list of essential medicines; • Supplied as generic medicines; and • Reimbursed within social health insurance schemes. 5 See http://apps.who.int/iris/bitstream/10665/93143/1/EMLc_4_eng.pdf?ua=1.

CHALLENGE: INAPPROPRIATE SELECTION 37 LESSONS LEARNED FOR ADDRESSING INAPPROPRIATE SELECTION As previously mentioned, five example programs addressing access to medicines were presented during the workshop to facilitate explora- tion of best practices and lessons learned from other programs. The ex- amples were selected by planning committee members and included two country-level programs, an infectious disease project, and two non- communicable disease programs. Highlights from the presentations of the lessons learned for addressing inappropriate selection are provided in Box 3-2. A full description of the examples as presented can be found in Appendix A. BOX 3-2 Highlights of Lessons Learned from Example Programs: Inappropriate Selection Country Programs National Health Insurance Scheme (NHIS), Ghana • Creation of an essential medicines list and national treatment guidelines for mental, neurological, and substance use (MNS) disorders assisted with the selection of appropriate medicines. The Accredited Drug Dispensing Outlets (ADDO) Program, Tanzania • An essential medicines list that is based on community needs, storage conditions, qualifications of personnel, and public health priorities may help to improve selection, particu- larly for local dispensaries. • Conducting a biannual review of the essential medicines list can help ensure that the list is accurate according to current treatment guidelines. Infectious Disease Program Multidrug-resistant Tuberculosis (MDR-TB) • The release of Guidelines for the Programmatic Management of Drug-Resistant Tuberculosis by the Stop TB Partnership provided health care providers with recommendations to select appropriate quality medicines to treat MDR-TB.

38 ESSENTIAL MEDICINES FOR MNS DISORDERS IN SSA Noncommunicable Disease Programs Diabetes • Training of health care providers to improve knowledge and understanding of diabetes management improved selection of medicines. Schizophrenia • Allowing local experts to select medicines using the WHO es- sential medicines list as a guide may improve the selection of medicines. • A comprehensive treatment guideline with clear algorithms may also help health care providers appropriately treat patients. SOURCE: Presentations by Akpalu, Liana, Zintl, Ilondo, and Bompart. See Appendix A for full discussion and references. CHALLENGES AND OPPORTUNITITES FOR ADDRESSING INAPPROPRIATE SELECTION In preparation for focused discussions on selection, Atul Pande, sen- ior vice president at the Neurosciences Medicines Development Center at GlaxoSmithKline, summarized key challenges that were discussed in the presentations and example programs. In discussing the criteria for select- ing appropriate medicines several participants noted that for many of the medicines used to treat MNS disorders, the evidence on effectiveness is poor. In some cases, the designation of essential medicines are based on health care provider preferences as opposed to health outcome data. Likewise, deficiencies in training and supervision allow inappropriate selection to persist Pande noted. The principles of chronic disease man- agement apply equally to MNS disorders as they do to conditions such as diabetes and hypertension. Following the focused discussion, Pande summarized that three bar- riers were identified by individual participants relative to selection of MNS medicines: (1) lack of mechanisms to clearly define which MNS disorders to treat; (2) lack of evidence-based approaches for developing essential medicine lists and treatment guidelines; and (3) gaps related to training in developing point-of-care prescription lists and continued awareness of evidence to update individual country lists. All constraints and/or barriers and potential opportunities noted by individual partici- pants are included in Table 3-1.

CHALLENGE: INAPPROPRIATE SELECTION 39 The need for a national strategy for the treatment and care of MNS disorders was emphasized by several participants, Pande said, but such a strategy that can drive the appropriate selection of MNS medicines is still lacking or inadequate in some countries. A few participants noted that adequate resources, including specific budget allocations, might be need- ed to promote such a national strategy. Several participants also dis- cussed the value of the WHO essential medicines list and mhGAP treat- ment guidelines as starting points for developing country-specific lists and guidelines. Pande noted that adoption of the WHO list and mhGAP guidelines might result in greater use of evidence-based approaches to treating MNS disorders. A few participants noted that the selection of medicines at the point of care is variable based on prescriber preference, and the consistent application of treatment guidelines could help to achieve some degree of uniformity. Lastly, many participants discussed the role of continuing education and training to ensure provider aware- ness and adherence to evidence-based treatments for MNS disorders.

40 TABLE 3-1 Opportunities to Address Inappropriate Selection of Essential Medicines as Identified by Individual Workshop Participants1 Constraint Potential Relevant Potential Metric(s) Suggested Secondary and/or Barrier Opportunity Outcome(s) of Success Partnership(s) Consideration(s) Lack of Develop a Development of a Economic growth. Ministry of Strategy to be mechanisms to national strategy coherent and Increased interest at Health; Ministry appropriate to the clearly define for the treatment comprehensive multiple levels in of Finance; health resource which MNS and care of MNS national strategy, improving public care providers; constraints found disorders to treat, disorders that based on mhGAP, health.c,d WHO; patients in the country resulting in includes specific supported by the and families.b,c,d and/or region. inappropriate goals.a,b,c government and Countries and/or selection of other agencies regions with medicines.a,f (e.g., private constrained groups, NGOs). resources might Availability of require a more adequate resources limited focus on to promote a fewer MNS national strategy, disorders.a,b,c,d,f including specific budget allocations to implement the national strategy.c,f 1 This table presents challenges and opportunities discussed by one or more workshop participants. During the workshop, individual participants engaged in active discussions. In some cases, participants expressed unique ideas and/or differing opinions. However, because this is a summary of workshop comments and does not provide consensus recommendations, workshop rapporteurs endeavored to include all workshop participant comments. This table and its content should be attributed to the rapporteurs of this summary as informed by the workshop.

Constraint Potential Relevant Potential Metric(s) Suggested Secondary and/or Barrier Opportunity Outcome(s) of Success Partnership(s) Consideration(s) Lack of evidence- Use the WHO Development of Uninterrupted Health care Inclusion of cost- based approaches list of essential national medicines access to essential providers; funders; effective for developing medicines and lists and treatment medicines and Ministry of medicines due to essential medicine mhGAP guidelines for each treatments. Health; Ministry a lack of lists and treatment treatment level of provider Availability of of finance; resources. guidelines.d guidelines as a based on agreed- medicines in the insurers; Leveraging starting point for upon task shifting. public and private nongovernmental successes in the development Establishment of a sectors; absence of organizations; similar countries. of evidence- learning health non-essential patients; National based system to include medicines in the donors.b,c,d,e guidelines for approaches.e a review, revision, public sector. More medicine and periodic than 50 percent of donations updates. Increased patients treated consistent with inclusion of based on new the essential medications that guidelines. Health medicines list. promote adherence institutions and Consideration (e.g., tolerability, providers have that cost- safety, monitoring) access to and effectiveness and greater follow guidelines. might be different accommodation of A national health for acute care a reasonable range system that links versus long-term of provider and reimbursement to care. b,c,d,e,f patient medication desired outcomes.b,c preferences.d,f 41

42 Constraint Potential Relevant Potential Metric(s) Suggested Secondary and/or Barrier Opportunity Outcome(s) of Success Partnership(s) Consideration(s) Gaps related to Overall promotion Providers Increase in Ministry of Effective training in of evidence-based adequately percentage of Health; dissemination of developing point- selection at the trained to patients treated professional information about of-care patient level and recognize, based on associations.c,d,e,f which medications prescription list point of care. diagnose, and use guidelines. Increase are selected and and continued Development of medications for in percentage of why. Desirability awareness of training to provide MNS disorders.e providers having of a Web- evidence to update an evidence base to received continuing based/mobile individual country support selection education each e-learning lists.c of medicines year.c resource. decisions with a Availability for goal of informing telehealth/e-health point-of-care counseling.c,d,e,f decisions. Consideration for the impact of task shifting on the selection of medicines.d,e,f a e Albert Akpalu Atul Pande b f Yonas Baheretibeb Solomon Teferra c Hans Hogerzeil d David Michelson

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In 2011 the Grand Challenges in Global Mental Health initiative identified priorities that have the potential to make a significant impact on the lives of people with mental, neurological, and substance use disorders. Reduction of the cost and improvement of the supply of effective medicines was highlighted as one of the top five challenges. For low- and middle-income countries, improving access to appropriate essential medicines can be a tremendous challenge and a critical barrier to scaling up quality care for mental, neurological, and substance use disorders. Reduction of cost and improvement of the supply of effective medicines has the potential to significantly impact the lives of patients with these disorders.

Improving Access to Essential Medicines for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa is the summary of a workshop convened by the Institute of Medicine Neuroscience Forum in January 2014 in Addis Ababa, Ethiopia to discuss opportunities for achieving long-term affordable access to medicines for these disorders. This report examines challenges and opportunities for improving access to essential medicines in four critical areas: demand, selection, supply chains, and financing and pricing. The report also discusses successful activities that increase access to essential medicines both within Sub-Saharan Africa and in other developing countries, and considers the role of governments, nongovernmental organizations, and private groups in procurement of essential medicines for mental, neurological, and substance use disorders.

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