Identifying the teaching content on substandard and falsified medical products in global pharmacy education as critical public health issue

Aim: To gain insight into the education about substandard and falsified (SF) medical products. Method: A digital survey was sent to 173 different schools of pharmacy around the world. Results: The response rate was 32% (55 responses, 37 countries). Most schools taught about SF medical products as a stand-alone course or as part of another course or module (67%), whereas 33% did not teach about the subject. The main focus of teaching was on detection (21%) and prevention (21%) of SF medical products, while reporting was taught the least (12%), indicating a knowledge gap in that area. A key barrier to introducing a new course that could close the gaps was insufficient time in pharmacy curriculum (n=33; 60%), while availability of ready-to-adopt course materials was considered as a helpful enabler. Conclusion: These insights can improve the understanding on what is already being taught on SF medical products, where the gaps are and inform the curriculum needed globally

Alignment in the registration, selection, procurement and reimbursement of essential medicines for childhood cancers in South Africa

Introduction The effectiveness of a health system in providing access to medicines is in part determined by the alignment of several core pharmaceutical processes. For South Africa's public health sector, these include the registration of medicines, selection and subsequent procurement through national tenders. Registration, selection and reimbursement are key processes in the private sector. This study assessed the alignment of forementioned processes for essential paediatric oncology medicines in South Africa. Methods A selection of priority chemotherapeutics, antiemetics and analgesics in the treatment of five prevalent childhood cancers in South Africa was compared with those listed in 1) the WHO Essential Medicines List for Children (WHO EMLc) 2021, 2) the registered health products database of South Africa, 3) the relevant South African National Essential Medicines Lists (NEML), 4) bid packs and awarded tenders for oncology medicines for 2020 and 2022 and 5) oncology formularies from the leading Independent Clinical Oncology Network (ICON) and two private sector medical aid schemes. Consistency between these sources was assessed descriptively. Results There was full alignment for 25 priority chemotherapeutics for children between the NEML, the products registered in South Africa and those included on tender. Due to unsuccessful procurement, access to seven chemotherapeutics was potentially constrained. For antiemetics and analgesics, eight of nine active ingredients included on the WHO EMLc were also registered in South Africa and on its NEML. An exploratory assessment of private sector formularies showed many gaps in ICON's formulary and two medical scheme formularies (listing 33% and 24% of the chemotherapeutics, respectively). Conclusion Despite good alignment in public sector pharmaceutical processes, access constraints to essential chemotherapeutics for children may stem from unsuccessful tenders. Private sector formularies show major gaps; however, it is unclear how this translates to access in clinical practice

Longitudinal study of Good Pharmacy Practice roles covered at the annual world pharmacy congresses 2003–2019

Background: Globally accepted roles of pharmacists are described in the Good Pharmacy Practice (GPP) standards, published by the World Health Organization (WHO) and the International Pharmaceutical Federation (FIP) in 2011. These standards provide a wide-ranging description of four main roles pharmacists fulfil. The global platform, where pertinent discussions around excellence and innovation in various pharmacy roles take place, is the annual congress of the pharmacy organisation representing the profession globally, FIP. Objectives: Given the world pharmacy congresses present and reflect on the most topical and contemporary matters, this longitudinal study aimed at creating a historical overview of the frequency of appearance of the different GPP roles in the programmes of the past 17 congresses (2003–2019). This is to distinguish the dominance of different roles over time and thus their relevance for the profession. Methods: The GPP standards served as a framework to create a set of keywords that were analysed for their frequencies of appearance in the programmes through text analysis. Trends in the four overarching GPP roles and at individual keyword level were analysed descriptively over time. Results: The study found that all four GPP roles appeared in the programme each year and none of them was significantly missing, neither in the decade preceding the publication of the GPP standards nor in the decade thereafter. Role 3 “Maintain and improve professional performance” was most frequently represented, also demonstrating an upward trend in appearance, together with Role 4: “Contribute to improve effectiveness of the health-care system and public health”. Trends emerged towards patient-centred clinical focus and positioning pharmacy as an important player in the health-care system—observed also at individual keywords level in areas such as health promotion—away from the more traditional product-centred practice roles such as compounding. Conclusions: GPP roles have been already covered by the FIP annual congresses (long) before 2011, when the GPP roles were formally adopted, and they stayed relevant in the decade after. The more pronounced dominance toward the roles related to improving professional performance and positioning pharmacy are in line with the trend that the rather technical topics in pharmacy are increasingly covered by specialised meetings and that the FIP annual congresses have moved toward more general, scholarly platforms for dialogue and conversation

Monitoring Access to Child Medicines: Introducing a Standardized Set of Age-Appropriate Medicines

Monitoring access to pediatric medicines as part of the Sustainable Development Goal (SDG) agenda for 2030 requires surveying age-appropriate medicines. This study aimed to develop tracer sets of essential age-appropriate medicines for use in SDG indicator 3.b.3 or in conjunction with other methodologies for monitoring access to medicines. Two sets of medicines were developed, one for young children (1 month to 5 years) and one for school-aged children (5–12 years). Priority diseases were selected based on the global burden of disease and linked to active ingredients of first choice according to treatment guidelines and the World Health Organization (WHO) Model List of Essential Medicines for Children (EMLc). To ensure clinical relevance, the Delphi technique was employed to identify areas of (dis)agreement among clinical pediatric experts. During two consultation rounds, experts were invited to indicate (dis)agreement. Five experts per age group were largely in agreement with the initial selections, but various therapeutic alternatives were suggested for addition. A second consultation round with five experts did not lead to major adjustments. The final sets included 26 treatment options for both groups. Specific age-appropriate formulations were selected from the WHO EMLc 2023. These two globally representative tracer sets of medicines consider the particular needs of children and could aid countries in the critical monitoring of accessibility to pediatric medicines

Sustainable Development Goal indicator for measuring availability and affordability of medicines for children: a proof-of-concept study

OBJECTIVES: To complement Sustainable Development Goal (SDG) indicator 3.b.3 that monitors access to medicines for all, a corresponding child-specific methodology was developed tailored to the health needs of children. This methodology could aid countries in monitoring accessibility to paediatric medicines in a validated manner and on a longitudinal basis. We aimed to provide proof of concept of this adapted methodology by applying the method to historical datasets. METHOD: A core set of child-appropriate medicines was selected for two groups of children: children aged 1-59 months and children aged 5-12 years. To enable calculation of affordability of medicines for children, the number of units needed for treatment was created, incorporating the recommended dosage and duration of treatment for the specific age group. The adapted methodology was applied to health facility survey data from Burundi (2013), China (2012) and Haiti (2011) for one age group. SDG indicator 3.b.3 scores and (mean) individual facility scores were calculated per country and sector. RESULTS: We were able to calculate SDG indicator 3.b.3 based on historical data from Burundi, China and Haiti with the adapted methodology. In this case study, all individual facilities failed to reach the 80% benchmark of accessible medicines, resulting in SDG indicator 3.b.3 scores of 0% for all 3 countries. Mean facility scores ranged from 22.2% in Haiti to 40.3% in Burundi for lowest-price generic medicines. Mean facility scores for originator brands were 0%, 16.5% and 9.9% for Burundi, China and Haiti, respectively. The low scores seemed to stem from the low availability of medicines. CONCLUSION: The child-specific methodology was successfully applied to historical data from Burundi, China and Haiti, providing proof of concept of this methodology. The proposed validation steps and sensitivity analyses will help determine its robustness and could lead to further improvements

A critical review of methodologies used in pharmaceutical pricing policy analyses

Robust evidence from health policy research has the potential to inform policy-making, but studies have suggested that methodological shortcomings are abundant. We aimed to identify common methodological weaknesses in pharmaceutical pricing policy analyses. A systematic review (SR) of studies examining pharmaceutical pricing policies served as basis for the present analysis. We selected all studies that were included in the SR (n = 56), and those that were excluded from the SR due to ineligible study designs only (n = 101). Risk of bias was assessed and specific study design issues were recorded to identify recurrent methodological issues. Sixty-one percent of studies with a study design eligible for the SR presented with a high risk of bias in at least one domain. Potential interference of co-interventions was a source of possible bias in 53% of interrupted time series studies. Failing to consider potential confounders was the primary cause for potential bias in difference-in-differences, regression, and panel data analyses. In 101 studies with a study design not eligible for the SR, 32% were uncontrolled before-after studies and 23% were studies without pre-intervention data. Some of the methodological issues encountered may be resolved during the design of a study. Awareness among researchers on methodological issues will help improve the rigor of health policy research in general

The impact of scheduling ketamine as an internationally controlled substance on anaesthesia care in Sub-Saharan Africa: a case study and key informant interviews

Background: Access to anaesthesia and surgical care is a major problem for people living in Sub-Saharan Africa. In this region, ketamine is critical for the provision of anaesthesia care. However, efforts to control ketamine internationally as a controlled substance may significantly impact its accessibility. This research therefore aims to estimate the importance of ketamine for anaesthesia and surgical care in Sub-Saharan Africa and assess the potential impact on access to ketamine if it were to be scheduled. Methods: This research is a mixed-methods study, comprising of a cross-sectional survey at the hospital level in Rwanda, and key informant interviews with experts on anaesthesia care in Sub-Saharan Africa. Data on availability of four anaesthetic agents were collected from hospitals (n = 54) in Rwanda. Semi-structured interviews with 10 key informants were conducted, collecting information on the importance of ketamine, the potential impact of scheduling ketamine internationally, and opinions on misuse of ketamine. Interviews were transcribed verbatim and analysed using a thematic analysis approach. Results: The survey conducted in Rwanda found that availability of ketamine and propofol was comparable at around 80%, while thiopental and inhalational agents were available at only about half of the hospitals. Significant barriers impeding access to anaesthesia care were identified, including a general lack of attention given to the specialty by governments, a shortage of anaesthesiologists and migration of trained anaesthesiologists, and a scarcity of medicines and equipment. Ketamine was described as critical for the provision of anaesthesia care as a consequence of these barriers. Misuse of ketamine was not believed to be an issue by the informants. Conclusion: Ketamine is critical for the provision of anaesthesia care in Sub-Saharan Africa, and its scheduling would have a significantly negative impact on its availability for anaesthesia care

Comparative effectiveness and safety of direct oral anticoagulants versus warfarin in UK patients with atrial fibrillation and type 2 diabetes: a retrospective cohort study

PURPOSE: To estimate the effectiveness and safety of direct oral anticoagulants (DOACs) compared with warfarin in AF patients with type 2 diabetes (T2DM). METHODS: A retrospective cohort study was designed, using the UK Clinical Practice Research Datalink (August 2011 - June 2018). Participants were 1-year naïve users of DOACs or warfarin, followed from the date of first prescription of an oral anticoagulant until the end of the study period, death, discontinuation of treatment, switching to another anticoagulant, or an outcome of interest, whichever came first. Cox regression analysis was performed to estimate the hazard ratio (HR) adjusted for potential confounders. RESULTS: A total of 8,555 patients were identified. No significant differences were found between DOACs and warfarin in the risk of stroke (adjusted HR 1.15; 95% CI 0.82 - 1.60), ischemic and unspecified stroke (adjusted HR 1.23; 95% CI 0.86 - 1.76) or haemorrhagic stroke (adjusted HR 0.75; 95% CI 0.30 - 1.85), and myocardial infarction (adjusted HR 1.39 ;95% CI 0.99 - 1.97). DOAC and warfarin users were comparable with respect to risk of major bleed (adjusted HR 0.83; 95% CI 0.68 - 1.03), intracranial bleeding (HR 0.66; 95% CI 0.34 - 1.30), gastrointestinal bleeding (HR 0.88; 95% CI 0.60 - 1.30), and bleeding on other clinically relevant sites (HR 0.89; 95% CI 0.60 - 1.31). In the subgroup analyses stratified by gender and diabetes severity, the risk for stroke and bleeding remained consistent. CONCLUSION: DOACs are effective and safe alternatives to warfarin for the prevention of stroke in AF patients with T2DM

A systematic review of policies regulating or removing mark-ups in the pharmaceutical supply and distribution chain

The regulation of mark-ups throughout the pharmaceutical supply and distribution chain may be a valuable approach to control prices of medicines and to achieve broader access to medicines. As part of a wider review, we aimed to systematically determine whether policies regulating mark-ups are effective in managing the prices of pharmaceutical products. We searched for studies published between January 1, 2004 and October 10, 2019, comparing policies on regulating mark-ups against other interventions or a counterfactual. Eligible study designs included randomized trials, and non-randomized or quasi-experimental studies such as interrupted time-series (ITS), repeated measures (RM), and controlled before-after studies. Studies were eligible if they included at least one of the following outcomes: price (or expenditure as a proxy for price and volume), volume, availability or affordability of pharmaceutical products. The quality of the evidence was assessed using the GRADE methodology. A total of 32,011 records were retrieved, seven of which were eligible for inclusion for this review. The limited body of evidence cautiously suggests that policies regulating mark-ups may be effective in reducing medicine prices and pharmaceutical expenditures. However, the design of mark-up regulations is a critical factor for their potential success. Additional research is required to confirm the effects of these policies on the availability, affordability or usage patterns of medicines and in low- and middle-income countries

Healthcare workers’ perspectives on access to sexual and reproductive health services in the public, private and private not-for-profit sectors: insights from Kenya, Tanzania, Uganda and Zambia

Background: Access to sexual and reproductive health services remains a challenge for many in Kenya, Tanzania, Uganda and Zambia. Health service delivery in the four countries is decentralised and provided by the public, private and private not-for-profit sectors. When accessing sexual and reproductive health services, clients encounter numerous challenges, which might differ per sector. Healthcare workers have first-hand insight into what impediments to access exist at their health facility. The aim of this study was to identify differences and commonalities in barriers to access to sexual and reproductive health services across the public, private and private not-for-profit sectors. Methods: A cross-sectional survey was conducted among healthcare workers working in health facilities offering sexual and reproductive health services in Kenya (n = 212), Tanzania (n = 371), Uganda (n = 145) and Zambia (n = 243). Data were collected in July 2019. Descriptive statistics were used to describe the data, while binary logistic regression analyses were used to test for significant differences in access barriers and recommendations between sectors. Results: According to healthcare workers, the most common barrier to accessing sexual and reproductive health services was poor patient knowledge (37.1%). Following, issues with supply of commodities (42.5%) and frequent stockouts (36.0%) were most often raised in the public sector; in the other sectors these were also raised as an issue. Patient costs were a more significant barrier in the private (33.3%) and private not-for-profit sectors (21.1%) compared to the public sector (4.6%), and religious beliefs were a significant barrier in the private not-for-profit sector compared to the public sector (odds ratio = 2.46, 95% confidence interval = 1.69–3.56). In all sectors delays in the delivery of supplies (37.4-63.9%) was given as main stockout cause. Healthcare workers further believed that it was common that clients were reluctant to access sexual and reproductive health services, due to fear of stigmatisation, their lack of knowledge, myths/superstitions, religious beliefs, and fear of side effects. Healthcare workers recommended client education to tackle this. Conclusions: Demand and supply side barriers were manifold across the public, private and private not-for-profit sectors, with some sector-specific, but mostly cross-cutting barriers. To improve access to sexual and reproductive health services, a multi-pronged approach is needed, targeting client knowledge, the weak supply chain system, high costs in the private and private not-for-profit sectors, and religious beliefs