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

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

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

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

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

Evidence on the effectiveness of policies promoting price transparency -: A systematic review

Policies promoting price transparency may be an important approach to control medicine prices and achieve better access to medicines. As part of a wider review, we aimed to systematically determine whether policies promoting price transparency are effective in managing the prices of pharmaceutical products. We searched for studies published between January 1, 2004 and October 10, 2019, comparing policies promoting price transparency 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 32011 records were retrieved, two of which were eligible for inclusion. Although based on evidence from a single study, public disclosure of medicine prices may be effective in reducing prices of medicines short-term, with benefits possibly sustained long-term. Evidence on the impact of a cost-feedback approach to prescribers was inconclusive. No evidence was found for impact on the outcomes volume, availability or affordability. The overall lack of evidence on policies promoting price transparency is a clear call for further research

Concurrent use of DOACs and pharmacodynamic interacting drugs is associated with an increased risk of major bleeding compared with patients using DOACs alone: Nested case-control study in UK CPRD

Background: Although many studies on bleeding risk associated with use of direct oral anticoagulants (DOACs) are conducted, the effect of concurrent use of potentially interacting drugs on this risk is not well studied. Objectives: To evaluate the association between concurrent use of DOACs with concurrent use of potential pharmacokinetic or pharmacodynamic interacting drugs on major bleeding. Methods: We used data from the UK Clinical Practice Research Datalink (period 2008-2015) to conduct a nested case-control study in a cohort of new users of DOACs (dabigatran, apixaban, and rivaroxaban). Cases were patients who were hospitalized with a primary discharge diagnosis of major bleeding while taking DOACs. Up to four controls were matched to each case on age, sex, and index date. Controls also had to be a current user of a DOAC on the index date. Conditional logistic regression analysis was used to calculate odds ratios (OR) and 95% confidence intervals (CI) to estimate the risk of major bleeding associated with concurrent use (30 days prior to the index date) of potential pharmacokinetic or pharmacodynamic interacting drugs. The analysis was adjusted for well-known risk factors for bleeding Results: We identified 393 cases from 29 120 new users of DOACs and 1494 controls. Most subjects were current users of rivaroxaban (58.8%). The concurrent use of DOACs and pharmacokinetic interacting drugs did not increase the risk of major bleeding vs use of DOACs alone (45.0% vs 51.2%, adjusted OR 0.90; 95% CI 0.60-1.36). However, concurrent use of pharmacodynamic interacting drugs was associated with an increased risk of major bleeding (21.6% vs 13.5%, adjusted OR, 1.91; 95% CI, 1.39-2.62). This effect was mainly driven by selective serotonin reuptake inhibitors (SSRIs, adjusted OR, 1.73; 95% CI, 1.12-2.65) and antiplatelet drugs (adjusted OR, 1.90; 95% CI, 1.23-2.93), respectively. Conclusions: Among patients taking a DOAC, concurrent use of an SSRIs or antiplatelet drug was associated with increased risk of major bleeding compared with DOAC use without these drugs

Safety of off-label dose reduction of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation

Aim: To investigate the effects of off-label non-vitamin K oral anticoagulant (NOAC) dose reduction compared with on-label standard dosing in atrial fibrillation (AF) patients in routine care. Methods: Population-based cohort study using data from the United Kingdom Clinical Practice Research Datalink, comparing adults with non-valvular AF receiving an off-label reduced NOAC dose to patients receiving an on-label standard dose. Outcomes were ischaemic stroke, major/non-major bleeding and mortality. Inverse probability of treatment weighting and inverse probability of censoring weighting on the propensity score were applied to adjust for confounding and informative censoring. Results: Off-label dose reduction occurred in 2466 patients (8.0%), compared with 18 108 (58.5%) on-label standard-dose users. Median age was 80 years (interquartile range [IQR] 73.0-86.0) versus 72 years (IQR 66-78), respectively. Incidence rates were higher in the off-label dose reduction group compared to the on-label standard dose group, for ischaemic stroke (0.94 vs 0.70 per 100 person years), major bleeding (1.48 vs 0.83), non-major bleeding (6.78 vs 6.16) and mortality (10.12 vs 3.72). Adjusted analyses resulted in a hazard ratio of 0.95 (95% confidence interval [CI] 0.57-1.60) for ischaemic stroke, 0.88 (95% CI 0.57-1.35) for major bleeding, 0.81 (95% CI 0.67-0.98) for non-major bleeding and 1.34 (95% CI 1.12-1.61) for mortality. Conclusion: In this large population-based study, the hazards for ischaemic stroke and major bleeding were low, and similar in AF patients receiving an off-label reduced NOAC dose compared with on-label standard dose users, while non-major bleeding risk appeared to be lower and mortality risk higher. Caution towards prescribing an off-label reduced NOAC dose is therefore required

A comparative human rights analysis of laws and policies for adolescent contraception in Uganda and Kenya

BACKGROUND: Improving access to adolescent contraception information and services is essential to reduce unplanned adolescent pregnancies and maternal mortality in Uganda and Kenya, and attain the SDGs on health and gender equality. This research studies to what degree national laws and policies for adolescent contraception in Uganda and Kenya are consistent with WHO standards and human rights law. METHODS: This is a comparative content analysis of law and policy documents in force between 2010 and 2018 governing adolescent (age 10–19 years) contraception. Between and within country differences were analysed using WHO’s guidelines “Ensuring human rights in the provision of contraceptive information and services”. RESULTS: Of the 93 laws and policies screened, 26 documents were included (13 policies in Uganda, 13 policies in Kenya). Ugandan policies include a median of 1 WHO recommendation for adolescent contraception per policy (range 0–4) that most frequently concerns contraception accessibility. Ugandan policies have 6/9 WHO recommendations (14/24 sub-recommendations) and miss entirely WHO’s recommendations for adolescent contraception availability, quality, and accountability. On the other hand, most Kenyan policies consistently address multiple WHO recommendations (median 2 recommendations/policy, range 0–6), most frequently for contraception availability and accessibility for adolescents. Kenyan policies cover 8/9 WHO recommendations (16/24 sub-recommendations) except for accountability. CONCLUSIONS: The current policy landscapes for adolescent contraception in Uganda and Kenya include important references to human rights and evidence-based practice (in WHO’s recommendations); however, there is still room for improvement. Aligning national laws and policies with WHO’s recommendations on contraceptive information and services for adolescents may support interventions to improve health outcomes, provided these frameworks are effectively implemented. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12978-021-01303-8

Barriers to Accessing Internationally Controlled Essential Medicines in Uganda: A Qualitative Study

Context: Access to internationally controlled essential medicines is a problem worldwide. More than five billion people cannot access opioids for pain and palliative care or do not have access to surgical care or anesthetics, 25 million people living with epilepsy do not have access to their medicines, and 120,000 women die annually owing to postpartum hemorrhage. In Uganda, access to controlled medicines is also problematic, but a lack of data on factors that influence access exists. Objectives: The objective of this study was to identify the social, cultural, and regulatory barriers that influence access to internationally controlled essential medicines in Uganda. Methods: Semistructured interviews with 15 key stakeholders with knowledge on controlled medicines from relevant institutions in Uganda. Interviews were transcribed verbatim and analyzed using the Access to Medicines from a Health System Perspective framework. Results: Barriers in accessing controlled medicines were experienced owing to lack of prioritization, difficulties in finding the balance between access and control, deficiencies in the workings of the estimate and distribution system, lack of knowledge, inadequate human resources, expenses related to use and access, and stigma. It was believed that some abuse of specific controlled medicines occurred. Conclusion: The findings of this research indicate that to improve access to internationally controlled essential medicines in Uganda, health system strengthening is needed on multiple fronts. Active engagement and concerted efforts are needed from all stakeholders to ensure access and prevent abuse