Associations between essential medicines and health outcomes for cardiovascular disease.

BACKGROUND: National essential medicines lists are used to guide medicine reimbursement and public sector medicine procurement for many countries therefore medicine listings may impact health outcomes. METHODS: Countries' national essential medicines lists were scored on whether they listed proven medicines for ischemic heart disease, cerebrovascular disease and hypertensive heart disease. In this cross sectional study linear regression was used to measure the association between countries' medicine coverage scores and healthcare access and quality scores. RESULTS: There was an association between healthcare access and quality scores and health expenditure for ischemic heart disease (p ≤ 0.001), cerebrovascular disease (p ≤ 0.001) and hypertensive heart disease (p ≤ 0.001). However, there was no association between medicine coverage scores and healthcare access and quality scores for ischemic heart disease (p = 0.252), cerebrovascular disease (p = 0.194) and hypertensive heart disease (p = 0.209) when country characteristics were accounted for. CONCLUSIONS: Listing more medicines on national essential medicines lists may only be one factor in reducing mortality from cardiovascular disease and improving healthcare access and quality scores.

Examining the Ugandan health system's readiness to deliver rheumatic heart disease-related services.

BACKGROUND: In 2018, the World Health Assembly mandated Member States to take action on rheumatic heart disease (RHD), which persists in countries with weak health systems. We conducted an assessment of the current state of RHD-related healthcare in Uganda. METHODOLOGY/PRINCIPAL FINDINGS: This was a mixed-methods, deductive simultaneous design study conducted in four districts of Uganda. Using census sampling, we surveyed health facilities in each district using an RHD survey instrument that was modeled after the WHO SARA tool. We interviewed health workers with experience managing RHD, purposively sampling to ensure a range of qualification and geographic variation. Our final sample included 402 facilities and 36 health workers. We found major gaps in knowledge of clinical guidelines and availability of diagnostic tests. Antibiotics used in RHD prevention were widely available, but cardiovascular medications were scarce. Higher levels of service readiness were found among facilities in the western region (Mbarara district) and private facilities. Level III health centers were the most prepared for delivering secondary prevention. Health worker interviews revealed that limited awareness of RHD at the district level, lack of diagnostic tests and case management registries, and absence of clearly articulated RHD policies and budget prioritization were the main barriers to providing RHD-related healthcare. CONCLUSIONS/SIGNIFICANCE: Uganda's readiness to implement the World Health Assembly RHD Resolution is low. The forthcoming national RHD strategy must focus on decentralizing RHD diagnosis and prevention to the district level, emphasizing specialized training of the primary healthcare workforce and strengthening supply chains of diagnostics and essential medicines.

Access to Cardiovascular Disease and Hypertension Medicines in Developing Countries: An Analysis of Essential Medicine Lists, Price, Availability, and Affordability.

Background Access to medicines is important for long-term care of cardiovascular diseases and hypertension. This study provides a cross-country assessment of availability, prices, and affordability of cardiovascular disease and hypertension medicines to identify areas for improvement in access to medication treatment. Methods and Results We used the World Health Organization online repository of national essential medicines lists (EMLs) for 53 countries to transcribe the information on the inclusion of 12 cardiovascular disease/hypertension medications within each country's essential medicines list. Data on availability, price, and affordability were obtained from 84 surveys in 59 countries that used the World Health Organization's Health Action International survey methodology. We summarized and compared the indicators across lowest-price generic and originator brand medicines in the public and private sectors and by country income groups. The average availability of the select medications was 54% in low- and lower-middle-income countries and 60% in high- and upper-middle-income countries, and was higher for generic (61%) than brand medicines (41%). The average patient median price ratio was 80.3 for brand and 16.7 for generic medicines and was higher for patients in low- and lower-middle-income countries compared with high- and upper-middle-income countries across all medicine categories. The costs of 1 month's antihypertensive medications were, on average, 6.0 days' wage for brand medicine and 1.8 days' wage for generics. Affordability was lower in low- and lower-middle-income countries than high- and upper-middle-income countries for both brand and generic medications. Conclusions The availability and accessibility of pharmaceuticals is an ongoing challenge for health systems. Low availability and high costs are major barriers to the use of and adherence to essential cardiovascular disease and antihypertensive medications worldwide, particularly in low- and lower-middle-income countries.

Relationship between pharmaceutical pricing strategies with price, availability, and affordability of cardiovascular disease medicines: surveys in Qatar and Lebanon.

BACKGROUND: Cardiovascular diseases are the leading cause of death in Lebanon and Qatar. When lifestyle modifications prove insufficient, medication becomes a cornerstone in controlling such diseases and saving lives. Price, availability, and affordability hinder the equitable access to medicines. The study aimed to assess prices, availability, and affordability of essential cardiovascular disease medicines in relation to pricing strategies in Qatar and Lebanon. METHODS: A cross-sectional survey using a variant of the World Health Organization and Health Action International (WHO/HAI) methodology as outlined in "Measuring medicine prices, availability, affordability and price components" (2008), second edition, was adopted. Prices and availability of 27 cardiovascular medicines were collected from public and private dispensing outlets. For international comparison, prices were adjusted to purchasing power parity. Data was analyzed across multiple sectors, within and across countries. RESULTS: A total of 15 public and private outlets were surveyed in each country. Prices were more uniform in Qatar than in Lebanon. In the public sector, medicines were free-of-charge in Lebanon and priced lower than the international reference prices in Qatar. The ratio of medicine unit price to international reference price in the private sectors surveyed are significantly higher than the acceptable threshold of 4. This ratio of originator brands and lowest priced generics in Qatar were up to two and five times those in Lebanon, respectively, even after adjusting for purchasing power parity. However, prices of lowest priced generics in the private sector were at least 35% cheaper in Qatar and 65% cheaper in Lebanon than their comparative originator brands. Medicines were more available in the private sector in Lebanon than in Qatar, but only the originator brand availability in the public sector in Qatar exceeded the WHO target of more than 80%. While affordable in the public sector in Qatar, four out of thirteen medicines exceeded the threshold in all private sectors covered. Hence, only the public sector in Qatar had a satisfying level of availability and affordability. CONCLUSIONS: Except for the Qatari public sector, medicine prices, availability, and affordability are falling short from targets. Key policy decisions should be implemented to improve access to medicines.

Access to essential cardiovascular medicines for children: a pilot study of availability, price and affordability in Nigeria.

Policies to improve access to medicines for children in low- and middle-income countries, such as Nigeria, should consider the growing threat of non-communicable diseases. The aim of this pilot study was to scope availability, price and affordability of essential cardiovascular medicines for children in selected states in Nigeria. The study was a descriptive longitudinal survey conducted in three phases. Availability was determined as percentage of facilities having the medicine on the survey date. Medicines with good availability (>80%) were noted. Prices were cross-referenced against international Reference Prices and the Nigerian National Health Insurance Scheme Prices. Affordability was calculated using the Least-Paid Government Worker method. For medicines compounded to improve availability, a model for calculating affordability was proposed. In Phase I, the availability of all 17 strengths of the cardiovascular medicines or diuretics listed in the Essential Medicines List for Children (2015) were surveyed in two conveniently selected states using the WHO/HAI questionnaire. Data were collected from 17 hospitals and pharmacies. Phases II and III focused on tablet formulations (enalapril, furosemide, hydrochlorothiazide and spironolactone) in three purposively selected state capitals: Lagos, Abuja and Yenagoa. In Phase II, 11 private pharmacies were surveyed in December 2016: Phase III tracked price changes in Abuja and Yenagoa in August 2018. Only furosemide and hydrochlorothiazide tablets had good availability. Oral liquids were unavailable. Prices for four generic oral tablets were 2-16× higher than the International Reference Prices; prices for two of these did not change significantly over the study period. Affordable medicines were generic furosemide and hydrochlorothiazide tablet. Where a fee is charged, compounded medicines were also not affordable. While the small sample sizes limit generalization, this study provides indicative data suggesting that prices for cardiovascular medicines remain high and potentially unaffordable in the private sector in these selected states, and when compounded. Regular systematic access surveys are needed.

Selection of essential medicines for the prevention and treatment of cardiovascular diseases in low and middle income countries.

BACKGROUND: The incidence and mortality of cardiovascular diseases (CVDs) in low and middle income countries (LMICs) have been increasing, while access to CVDs medicines is suboptimal. We assessed selection of essential medicines for the prevention and treatment of CVDs on national essential medicines lists (NEMLs) of LMICs and potential determinants for selection. METHODS: Only operational NEMLs were considered eligible for this study. A selection of medicines listed under "cardiovascular medicines" or "blood products and plasma substitutes" in the NEMLs were included if they were present on international guidelines for the prevention and treatment of CVDs (hyperlipidemia, hypertension, platelet inhibition, ischemic stroke, stable ischemic heart disease, acute coronary syndromes, heart failure, atrial fibrillation, peripheral arterial disease and acute limb ischemia). The number and diversity of essential medicines selected for CVDs were studied. Moreover, determinants of selection of essential medicines for CVDs at a national level were explored. Data analysis was done using univariate linear regression and non-parametric tests. RESULTS: All medicine groups listed by the international guidelines were selected by the majority of the 34 countries studied with the exception of adenosine diphosphate receptor inhibitors which appeared on less than half of the NEMLs studied (41% of countries). The total number of essential medicines for the prevention and treatment of cardiovascular diseases (median 24 (range 16-50)) differed significantly across income levels (median range: 19.5-25, p = 0.014) and across regions (median range: 20-32, p = 0.049). When recommendations of the international guidelines were considered, over 75% of the NEMLs contained essential medicines for the majority of CVDs. CONCLUSION: The main medicine classes for the management of CVDs were represented on NEMLs. Consequently, for the majority of CVDs, evidence-based guideline-recommended treatment is possible as far as selection of essential medicines is concerned. Selection will therefore not be the limiting step in access to medicines for cardiovascular diseases.

Status of cardiac arrhythmia services in Africa in 2018: a PASCAR Sudden Cardiac Death Task Force report.

BACKGROUND: There is limited information on the availability of health services to treat cardiac arrhythmias in Africa. METHODS: The Pan-African Society of Cardiology (PASCAR) Sudden Cardiac Death Task Force conducted a survey of the burden of cardiac arrhythmias and related services over two months (15 October to 15 December) in 2017. An electronic questionnaire was completed by general cardiologists and electrophysiologists working in African countries. The questionnaire focused on availability of human resources, diagnostic tools and treatment modalities in each country. RESULTS: We received responses from physicians in 33 out of 55 (60%) African countries. Limited use of basic cardiovascular drugs such as anti-arrhythmics and anticoagulants prevails. Non-vitamin K-dependent oral anticoagulants (NOACs) are not widely used on the continent, even in North Africa. Six (18%) of the sub-Saharan African (SSA) countries do not have a registered cardiologist and about one-third do not have pacemaker services. The median pacemaker implantation rate was 2.66 per million population per country, which is 200-fold lower than in Europe. The density of pacemaker facilities and operators in Africa is quite low, with a median of 0.14 (0.03-6.36) centres and 0.10 (0.05-9.49) operators per million population. Less than half of the African countries have a functional catheter laboratory with only South Africa providing the full complement of services for cardiac arrhythmia in SSA. Overall, countries in North Africa have better coverage, leaving more than 110 million people in SSA without access to effective basic treatment for cardiac conduction disturbances. CONCLUSION: The lack of diagnostic and treatment services for cardiac arrhythmias is a common scenario in the majority of SSA countries, resulting in sub-optimal care and a subsequent high burden of premature cardiac death. There is a need to improve the standard of care by providing essential services such as cardiac pacemaker implantation.

Exploring the Barriers to and Facilitators of Using Evidence-Based Drugs in the Secondary Prevention of Cardiovascular Diseases: Findings From a Multistakeholder, Qualitative Analysis.

BACKGROUND: Health-system barriers and facilitators associated with cardiovascular medication adherence have seldom been studied, particularly in low- and middle-income countries where uptake rates are poorest. OBJECTIVES: This study sought to explore the major obstacles and facilitators to the use of evidence-supported medications for secondary prevention of cardiovascular disease using qualitative analysis in 2 diverse countries across multiple levels of their health care systems. METHODS: A qualitative descriptive study approach was implemented in Hamilton, Ontario, Canada, and Delhi, India. A purposeful sample (n = 69) of 23 patients, 10 physicians, 2 nurse practitioners, 5 Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homoeopathy physicians, 11 pharmacists, 3 nurses, 4 hospital administrators, 1 social worker, 3 nongovernmental organization workers, 2 pharmaceutical company representatives, and 5 policy makers participated in interviews in Hamilton, Ontario, Canada (n = 21), and Delhi, India (n = 48). All interviews were digitally recorded and transcribed followed by directed content analysis to summarize and categorize the interviews. RESULTS: Themes that emerged across the stakeholder groups included: medication counseling; monitoring adherence; medication availability; medication affordability and drug coverage; time restrictions; and task shifting. The depth of verbal medication counseling provided varied substantially between countries, with prescribers in India unable to convey relevant information about drug treatments due to time constraint and high patient load. Canadian patients reported drug affordability as a common issue and very few patients were familiar with government subsidized drug programs. In India, patients purchased medications out-of-pocket from private, community pharmacies to avoid long commutes, lost wages, and unavailability of medications from hospitals formularies. Task shifting medication-refilling and titration to nonphysician health workers was accepted and supported by physicians in Canada but not in India, where many of the physicians considered a high level of clinical expertise a precondition to carry out these tasks skillfully. CONCLUSIONS: Our findings reveal context-specific, health system factors that affect the patient's choice or ability to initiate and/or continue cardiovascular medication. Strategies to optimize cardiovascular drug use should be targeted and relevant to the health care system.

Capacity for diagnosis and treatment of heart failure in sub-Saharan Africa.

OBJECTIVE: Heart failure is a major cause of disease burden in sub-Saharan Africa (SSA). There is an urgent need for better strategies for heart failure management in this region. However, there is little information on the capacity to diagnose and treat heart failure in SSA. We aim to provide a better understanding of the capacity to diagnose and treat heart failure in Kenya and Uganda to inform policy planning and interventions. METHODS: We analysed data from a nationally representative survey of health facilities in Kenya and Uganda (197 health facilities in Uganda and 143 in Kenya). We report on the availability of cardiac diagnostic technologies and select medications for heart failure (ß-blockers, ACE inhibitors and furosemide). Facility-level data were analysed by country and platform type (hospital vs ambulatory facilities). RESULTS: Functional and staffed radiography, ultrasound and ECG were available in less than half of hospitals in Kenya and Uganda combined. Of the hospitals surveyed, 49% of Kenyan and 77% of Ugandan hospitals reported availability of the heart failure medication package. ACE inhibitors were only available in 51% of Kenyan and 79% of Ugandan hospitals. Almost one-third of the hospitals in each country had a stock-out of at least one of the medication classes in the prior quarter. CONCLUSIONS: Few facilities in Kenya and Uganda were prepared to diagnose and manage heart failure. Medication shortages and stock-outs were common. Our findings call for increased investment in cardiac care to reduce the growing burden of heart failure.

The impact of drug shortages on patients with cardiovascular disease: causes, consequences, and a call to action.

Shortages of cardiovascular drugs have become increasingly common, representing an ongoing public health crisis. Given few therapeutic alternatives to many of the drugs in short supply, these shortages also pose a major challenge for cardiovascular care professionals. Although changes in the regulatory environment have led to some improvements in recent years, problems involving manufacturing processes remain the most common underlying cause. Because of the complex nature of drug shortages, sustainable solutions to prevent and mitigate them will require collaboration between regulatory agencies, drug manufacturers, and other key stakeholder groups. In this report, we describe the scope of the cardiovascular drug shortage crisis in the United States, including its underlying causes and the efforts currently being made to address it. Furthermore, we provide specific recommendations for how cardiovascular care professionals can be involved in efforts to limit the impact of drug shortages on patient care as well as policy changes aimed at preventing and mitigating them.

Availability and affordability of cardiovascular disease medicines and their effect on use in high-income, middle-income, and low-income countries: an analysis of the PURE study data.

BACKGROUND: WHO has targeted that medicines to prevent recurrent cardiovascular disease be available in 80% of communities and used by 50% of eligible individuals by 2025. We have previously reported that use of these medicines is very low, but now aim to assess how such low use relates to their lack of availability or poor affordability. METHODS: We analysed information about availability and costs of cardiovascular disease medicines (aspirin, ß blockers, angiotensin-converting enzyme inhibitors, and statins) in pharmacies gathered from 596 communities in 18 countries participating in the Prospective Urban Rural Epidemiology (PURE) study. Medicines were considered available if present at the pharmacy when surveyed, and affordable if their combined cost was less than 20% of household capacity-to-pay. We compared results from high-income, upper middle-income, lower middle-income, and low-income countries. Data from India were presented separately given its large, generic pharmaceutical industry. FINDINGS: Communities were recruited between Jan 1, 2003, and Dec 31, 2013. All four cardiovascular disease medicines were available in 61 (95%) of 64 urban and 27 (90%) of 30 rural communities in high-income countries, 53 (80%) of 66 urban and 43 (73%) of 59 rural communities in upper middle-income countries, 69 (62%) of 111 urban and 42 (37%) of 114 rural communities in lower middle-income countries, eight (25%) of 32 urban and one (3%) of 30 rural communities in low-income countries (excluding India), and 34 (89%) of 38 urban and 42 (81%) of 52 rural communities in India. The four cardiovascular disease medicines were potentially unaffordable for 0·14% of households in high-income countries (14 of 9934 households), 25% of upper middle-income countries (6299 of 24,776), 33% of lower middle-income countries (13,253 of 40,023), 60% of low-income countries (excluding India; 1976 of 3312), and 59% households in India (9939 of 16,874). In low-income and middle-income countries, patients with previous cardiovascular disease were less likely to use all four medicines if fewer than four were available (odds ratio [OR] 0·16, 95% CI 0·04-0·57). In communities in which all four medicines were available, patients were less likely to use medicines if the household potentially could not afford them (0·16, 0·04-0·55). INTERPRETATION: Secondary prevention medicines are unavailable and unaffordable for a large proportion of communities and households in upper middle-income, lower middle-income, and low-income countries, which have very low use of these medicines. Improvements to the availability and affordability of key medicines is likely to enhance their use and help towards achieving WHO's targets of 50% use of key medicines by 2025. FUNDING: Population Health Research Institute, the Canadian Institutes of Health Research, Heart and Stroke Foundation of Ontario, AstraZeneca (Canada), Sanofi-Aventis (France and Canada), Boehringer Ingelheim (Germany and Canada), Servier, GlaxoSmithKline, Novartis, King Pharma, and national or local organisations in participating countries.

[New Technologies in coronary interventional cardiology: results from the first inter-regional survey promoted by SICI-GISE in four regions of northern Italy ("the GISE TOLOVE" area: Tuscany, Lombardy, Veneto, Emilia-Romagna)]. / Utilizzo di nuove tecnologie in cardiologia interventistica coronarica: risultati della prima survey inter-regionale SICI-GISE in quattro Regioni del Nord Italia (area "GISE TOLOVE": Toscana, Lombardia, Veneto, Emilia-Romagna).

BACKGROUND: The implementation of the latest medical innovations can vary widely within the same geographic area. This study aimed to describe the current status of recent innovations in the field of coronary interventional cardiology in 4 regions of Northern Italy. METHODS: From April to May 2014, 4 regional delegations of the Italian Society of Invasive Cardiology (SICI-GISE) have promoted a multicenter survey. By means of a web-based methodology, a focused questionnaire was administered to head physicians of 97 cath-labs in 4 Italian regions within the "GISE TOLOVE" area (Lombardy, Veneto, Tuscany, Emilia-Romagna). RESULTS: Pharmacological and technological innovations in coronary interventional cardiology appear to be widely used in the area covered by this survey, with uniformity in application and availability of therapeutic devices and drugs within the 4 regions involved. The main limiting factors to the adoption of new technologies and drugs were economic factors or lack of scientific evidence for some specific devices or drugs. CONCLUSIONS: This survey showed widespread and consistent application of the main latest innovations in coronary interventional cardiology across 4 Italian regions of Northern Italy.

Drug treatment and cost of cardiovascular disease in Australia.

Australia's Pharmaceutical Benefits Scheme supports the use of effective drugs for the prevention and control of cardiovascular risk factors. However, there are little data available describing per person costs of medication in primary prevention and secondary prevention in the community. We aim to understand annual expenditure on cardiovascular medicines according to the level and extent of cardiovascular disease, using participants enrolled in the Reduction of Atherothrombosis for Continued Health (REACH) registry. 2873 participants were recruited into the REACH registry through 273 Australian general practices. Cardiovascular medicines review was undertaken at baseline. Average weighted costs of medications were estimated using government-reimbursed prices. Annual costs were stratified by disease extent and location. The annual mean cost of pharmaceuticals per person was 1307 AU dollars. The average reported medicine use per person across all states and participants groups varied significantly. Participants with cerebrovascular or peripheral arterial disease were prescribed less cardiovascular medication than those with coronary artery disease (CAD) (mean number of drugs 3.5 vs. 4.5, P < 0.0001) and (3.6 vs. 4.5, P < 0.0001), while those with risk factor alone had the same medication use as those with CAD (mean number 4.5). Medication use was lower in Western Australia in comparison to eastern States. Participants with existing cerebrovascular disease and peripheral vascular disease receive less preventive therapy than those with CAD or even risk factors alone. This observation is consistent across all mainland states. Given the evidence of the effectiveness and cost-effectiveness of treating all types of vascular diseases, the present study suggests that there is scope to improve the treatment of these high-risk participants in Australia.