Objectives Ensuring access to essential medicines is central to universal health coverage, yet stockouts at the point of care can undermine formal entitlements. We analysed users' experiences of medicine availability and stockouts in Brazil's Unified Health System and how primary care models manage shortages.Methods We conducted a cross-sectional exit survey of 290 users of primary care pharmacies in Niter & oacute;i, Rio de Janeiro state, Brazil, sampled across three service types: polyclinics, family physician programme units and psychosocial care centres. A semi-structured questionnaire captured self-reported problems obtaining medicines, patterns of medicine-seeking in public pharmacies and guidance received during stockouts. Data were analysed using descriptive statistics and Pearson's chi-square tests with Cram & eacute;r's V to examine associations with type of service.Key findings Overall, 42.4% of users reported unavailability of medicines in public pharmacies, whereas only 1.0% cited financial barriers for not obtaining medicines. Problems obtaining medicines did not differ significantly by service type, but patterns of pharmacy use did: 45.2% sought medicines only at their usual unit, while 33.1% circulated across multiple public pharmacies. Guidance in stockout situations was highly heterogeneous; many users were merely informed of lack of stock, while others were directed to buy privately or use the Farm & aacute;cia Popular programme.Conclusions Medicine stockouts in public primary care pharmacies are common and lead users to circulate across facilities or seek private purchases, despite formal entitlements to free medicines. Strengthening supply systems and improving guidance during stockouts are essential to protect universal access to pharmacotherapy.
Objective Spain's pharmaceutical industry has faced inflation within a closely regulated pricing system. The objective of this study was to quantify the resulting economic pressure at sector level and for three medicines that exemplify different market situations.Methods Covering a 10-year period analysis, the study followed a four-stage framework. First, a narrative review described how inflation, competition, and regulation shape pharmaceutical pricing. Second, three medicines-ustekinumab, nivolumab, and daratumumab-were used to reflect the additional economic impact of distinct competitive mechanisms, including biosimilar entry, therapeutic competition within patented markets, and multi-indication repricing. Third, macro-economic series (consumer-price indexes, wages, electricity, and fuel indices), industry accounts, and price-volume data were consolidated with national tender records. Finally, cost-turnover indices and unit-level price models quantified resulting economic impacts.Key findings Cumulative excess sector costs attributable to inflation totalled & euro;6.5 billion. Purchases of goods and services and staff each accounted for & euro;3.1 billion, while energy added & euro;0.3 billion. At medicine level, the combined economic impact of unadjusted list prices, inflation-driven production costs, and reimbursed-price reductions amounted to & euro;494 million for ustekinumab, reflecting approaching biosimilar competition; & euro;498 million for nivolumab, associated with successive indication-based repricing within a value-alignment framework; and & euro;580 million for daratumumab, in the context of intense competition.Conclusions Inflation, regulated pricing mechanisms, and competitive repricing coincided with a measurable divergence between cost evolution and revenues. Transparent and publicly available metrics would provide a reliable baseline for monitoring Spain's pharmaceutical adaptability within an evolving macro-economic conditions landscape.
Abstract Objective To analyse global sales of misoprostol-containing products in 2016–20 in comparison to 2002–7 to identify changes in availability and access. Methods Using IQVIA MIDAS sales data, we quantified misoprostol availability across 66 countries by calculating the total weight of the active ingredient sold across three categories: misoprostol-only products, misoprostol–non-steroidal anti-inflammatory drug (NSAID) combinations, and mifepristone–misoprostol combipacks. Regional and country-level trends were assessed and compared with trends in 2002–7 data. Combipack sales data were normalized per 1000 women of reproductive age (WRA) using United Nations population estimates. Key findings Between 2002–7 and 2016–20, the availability of misoprostol–NSAID combinations declined substantially, particularly in North America, Western Europe, and Latin America. Misoprostol-only sales remained stable overall, with declines in Western Europe, North America, and Latin America offset by increases in Asia and Eastern Europe. Combipacks, absent in the earlier period, were available in 11 countries by 2020, with the highest sales in India and Bangladesh. Sales of low-strength formulations (25–100 μg), relevant for labour induction, accounted for only 5% of global misoprostol sales. Conclusion The reduced availability of misoprostol–NSAID products likely reflects declining NSAID use for arthritis management and ulcer prevention, whereas the increase in misoprostol-only sales in Asia and Eastern Europe suggests growing gynaecologic use in these regions. Continued support for the commercial viability and quality-assured supply of misoprostol is essential to ensure global access for obstetric and gynaecologic care and reduce preventable maternal mortality.
Although access to medicines is a basic human right, restricted access to highly priced innovative medicines is a global concern. This article explores the various ways that existing legal frameworks, such as the Medicines and Related Substances Act, the Patent Act, and the Competition Act, are used, or not, to access highly priced innovative medicines in South Africa (SA). A narrative review of health and related legislation was undertaken to identify where access to medicines aspects existed, and their strengths and weaknesses in improving such access. No ethics approval was required as this was a review of public records. Various legislative instruments could possibly be used to improve access to highly priced medicines in SA. The existing legal tools have, however, not been used to their full potential to enable improved access to innovative medicines. SA should review its patent examination and patent opposition processes, and make effective use of international trade flexibilities. Individual patient approvals for use of non-registered medicines need to be made transparent, including price information. The potential use of exclusions from the Medicines and Related Substances Act needs to be explored. In particular, the limitations of existing legislation need to be noted as National Health Insurance is implemented.
Objectives To evaluate the impact of a pharmacist-led clinical quality improvement tool and interprofessional education on the management of patients receiving QT-prolonging medications (QTPMs), and to implement a risk assessment and treatment algorithm incorporating alternative therapies to support best-practice prescribing decisions.Methods A pre- and post-intervention design was utilized to evaluate the impact of an interprofessional educational workshop and a clinical quality improvement tool on providers' knowledge and clinical practice regarding QTPM management. A total of 26 providers attended and completed the pre- and post-surveys. The pre-intervention survey assessed provider knowledge and comfort in managing QTPMs. The post-intervention survey evaluated the effect of the tool on providers' comfort and perception. A total of 148 patients under participant care were reviewed, with 115 patients aged >= 18 years and receiving QTPMs included in the analysis.Key findings A total of 26 providers attended. The percentage of providers who felt very comfortable managing patients receiving QTPMs increased (8% vs. 15%), and the percentage of providers who felt very uncomfortable reduced (8% vs. 0%). Most providers (78%) could identify lower-risk QTPMs using the intervention tool. The percentage change in the QT-prolongation mean risk score was statistically significant post-intervention (9.14% decrease; P = .0244). Furthermore, the proportion of electrocardiogram orders for patients receiving QTPMs decreased after the intervention (43% decrease; P = .003).Conclusion Implementing a pharmacist-led risk tool featuring alternative therapeutic recommendations may positively impact providers' knowledge and clinical practice in managing QTPMs.
Objective The current study aims to examine the relationship between supply chain management, operational flexibility (OF), and employee engagement (EE) in community pharmacies in Northern Jordan. Methods This study employed a cross-sectional design. A convenience sample of 300 pharmacists working in community pharmacies located in Northern Jordan was chosen as the participants. The data were collected using self-report instruments and analysed using SPSS statistics Version 25. Key findings The sample included 49.3% women and 50.7% men, with a mean age of 36.2 years (SD +/- 10.1). Respondents demonstrated moderate to high levels of supply chain management (M = 5.1, SD +/- 1.3), EE (M = 4.9, SD +/- 1.4), and OF (M = 4.15, SD +/- 1.2). Simple linear regression analyses indicated significant positive relationships among the study variables. OF had a strong positive effect on SCM (beta = 0.78, P < .001), while EE also positively influenced SCM (beta = 0.36, P < .001). Moreover, OF significantly predicted EE (beta = 0.65, P < .001). Conclusion The findings highlight that both OF and EE are significantly associated with supply chain management practices. These results underscore the importance of fostering flexibility and employee involvement to enhance in supply chain operations.
Objectives The aim of this article is to contribute to a nuanced and empirically grounded understanding of exceptional access as practiced in Quebec from 2016 to 2024. We seek to examine the clinical, social, and political stakes of this program by integrating diverse perspectives, notably those of members of hospital pharmacology committees responsible for decisions regarding "N & eacute;cessit & eacute; M & eacute;dicale Particuli & egrave;re" (NMP), or Particular Medical Necessity in English.Methods A total of 15 semi-structured interviews were conducted across seven healthcare territories and hospital-based establishments. These discussions offered insights into pharmaceutical care practices, the organizational structure and functioning of NMP review committees within the establishments, and the criteria informing their decision-making processes. Interviewees also shared concerns, tensions, and reflections regarding committees' role and the broader healthcare system context.Key findings Our analysis reveals substantial heterogeneity in practices across institutions. This variability has contributed to perceived inequities in medication access. Moreover, the absence of systematic clinical and economic data collection has, according to participants, generated uncertainty discomfort, further exacerbating the perceived inequities in the implementation of this exceptional access program.Conclusion The findings presented in this article document real-world practices related to the management of NMP requests within healthcare establishments and highlight perceived inequities, as well as the ambiguous role institutions are compelled to assume when addressing so-called innovative and promising therapies.
Objectives To evaluate the impact on clinical parameters and maternal-foetal outcomes of serious drug interactions in high-risk hospitalized pregnant women.Methods A prospective cohort study including 571 pregnant women hospitalized between September 2019 and June 2022, with an average age of 30.6 years, mostly diagnosed with hypertensive syndromes (69.7%) and gestational diabetes (57.1%). Drug interactions were characterized daily through Lexicomp (R), with monitoring of clinical parameters linked to their mechanisms of action. We used a multivariable logistic regression model with demographic and treatment variables to identify factors associated with drug interactions. In a second model, we analysed the impact of serious drug interactions on clinical outcomes, including maternal-foetal outcomes such as macrosomia, foetal tachycardia, amniotic fluid abnormalities, and prematurity.Key findings We identified 203 pregnant women with one or more serious drug interactions (35.6%), and the risk factors were gestational age (adjusted odds ratio [AOR]: 0.96; 95% CI: 0.93-0.98), diagnosis of hypertension (AOR: 3.00; 95% CI: 2.49-6.41), number of medications (AOR: 1.09; 95% CI: 1.03-1.15), and length of hospitalization (AOR: 1.18; 95% CI: 1.12-1.26). Dipyrone and acetylsalicylic acid co-administration increased systolic blood pressure (AOR: 2.12; 95% CI: 1.01-4.47), while scopolamine and levomepromazine resulted in greater drowsiness (AOR: 5.38; 95% CI: 1.66-17.40) and a temperature increase (AOR: 5.96; 95% CI: 1.23-28.98).Conclusion High-risk pregnant women of lower gestational age or with hypertensive syndromes are exposed to severe drug interactions, yet these interactions show limited clinical impact and do not significantly affect maternal-foetal outcomes.
Objectives: Ciprofloxacin hydrochloride tablets are widely prescribed for urinary tract and other bacterial infections. Despite well-documented adverse drug reactions (ADRs), emerging safety concerns require continuous post-marketing surveillance. Methods: We retrieved ADR reports related to ciprofloxacin hydrochloride tablets from the FDA Adverse Event Reporting System (FAERS) between January 1, 2014 to June 30, 2024. Disproportionality analyses were conducted using reporting odds ratio (ROR) and Bayesian confidence propagation neural network methods. Adverse events were coded according to MedDRA preferred terms (PTs) and system organ classes (SOCs). Key findings: A total of 27 825 valid reports identified ciprofloxacin hydrochloride tablets as the primary suspect drug. Female patients accounted for 53.7% of cases, and the majority (45.6%) were aged 18-65 years. Forty-eight positive safety signals were detected, with musculoskeletal, immune system, and nervous system disorders being most frequently reported. Notably, 43 potential new ADRs not listed in the product label were identified, including crystalline nephropathy (ROR = 48.44), renal vein compression (ROR = 63.39), urethral pain (ROR = 12.67), and interstitial cystitis (ROR = 10.05). Duration of therapy was significantly associated with urinary system ADR incidence (P < .05). Conclusions: This large-scale FAERS analysis confirmed known ADRs and revealed previously unreported signals for ciprofloxacin hydrochloride tablets, underscoring the need for targeted pharmacovigilance. Findings provide actionable evidence for regulatory updates and clinical risk mitigation.
Objectives To compare country-level spending on glucagon-like peptide-1 (GLP-1) medications as a proportion of overall anti-diabetic drug expenditure across high-income countries.Methods We conducted a repeated cross-sectional study of anti-diabetic drug sales across multiple high-income countries from the fourth quarter of 2022 to the third quarter of 2023.Key findings Norway, the US, and Canada led in GLP-1 spending as a proportion of overall anti-diabetic expenditure. Semaglutide (Ozempic) had the highest anti-diabetic expenditure across these countries.Conclusions There is wide variability in GLP-1 use and spending stemming from country-level differences in drug coverage and patient access, warranting further study in broader healthcare systems.
Health workers are a crucial pillar for strong health systems. The availability of skilled and competent health workers largely determines the quality of care health systems can provide. Health workers’ experiences as corruption and fraud victims can have negative repercussions for health system strengthening. This study identifies different ways national and migrant health workers can be victims of fraud and corruption in the health sector, and the implications for health systems strengthening. A rapid literature review was conducted to identify the different ways corruption and fraud can impact health workers. PubMed, JSTOR, and Google Scholar were searched with terms such as corruption, fraud, and the health workforce. Additionally, relevant grey literature was hand-searched for items. Twenty-eight academic articles and 22 grey literature pieces were included. Health workers’ direct experiences as victims of corruption and fraud happen during recruitment, assignment, transfer, and promotion. For migrant health workers, poor regulatory environments for recruitment agencies increased their vulnerability. Indirectly, corruption and fraud can influence health workers’ experiences in their workplace and during their education. The pharmaceutical industry’s influence affects the quality of education and compromises their prescribing practices. In the workplace, corruption and fraud in health financing and service delivery impact health workers’ ability to work in safe and functional health institutions. Health workers’ vulnerability to fraud and corruption contributes to an overburdened, unprotected, and poorly paid health workforce. For health systems, this translates into higher attrition levels, more systemic corruption, and a more entrenched culture of impunity.
In the French healthcare system, workload units (UO for ‘unités d’œuvre’) are essential for determining public hospital costs. Historically, ‘UO Pharma’ measured pharmacy activity with a single indicator, i.e. dispensed medication and medical devices, which did not reflect the complexity of hospital pharmacy tasks. A new version, introduced in 2021, adds 43 indicators alongside 14 related to specific activity for more accurate measurement. This study evaluates its validity and reliability. A retrospective observational study analysed 2021 and 2022 UO Pharma data from the national hospital cost accounting database. Descriptive analyses evaluated UO Pharma adoption based on hospital characteristics, regions, and activity levels. Validity was assessed through convergent validity (correlation with hospital bed-days) and construct validity (exploratory factor analysis). Reliability was measured using Cronbach’s alpha for internal consistency and test–retest reliability via intraclass correlation coefficients. Approximately 20% of eligible hospitals used UO Pharma, with some regional and hospital-type variations. The tool demonstrated strong internal consistency (Cronbach’s alpha: 0.87 in 2021 and 0.89 in 2022), but some dimensions (e.g. medication dispensing) showed lower consistency (Cronbach’s alpha ≤ 0.6). Test–retest reliability showed excellent reliability (intraclass correlation coefficient > 0.90) for 12 of 35 items, with 13 items showing moderate to good reliability (>0.50). Convergent validity was confirmed with a strong correlation (r = 0.84), improving from 2021 (r = 0.26) to 2022 (r = 0.98). UO Pharma is a reliable and valid tool. To improve user experience and understanding of some items, we recommend clarifications in the user guide for areas with identified confusion.
Objective: To assess whether the development of the pan-Canadian Pharmaceutical Alliance (pCPA) could be a reason for the change in the rate of recommendations to reimburse from Canada's Drug Agency (CDA). Methods: Data on submissions and recommendations were obtained from CDA's reimbursement review reports. Only the first submission for each drug-indication combination between 2009 and 2023 was included. Recommendations to reimburse with or without clinical criteria and/or conditions were combined as positive recommendations, while do not reimburse recommendations were categorized as negative. Rates of positive and negative recommendations for submissions made in 2009 to 2013 (before and during the pCPA's initial development), 2014 to 2018 (when the pCPA was formalized but not a standalone agency), and 2019 to 2023 (when pCPA transitioned into a standalone organization) were calculated for all drugs, oncology drugs, and non-oncology drugs. Key findings: There has been a significant increase in the rate of positive recommendations for non-oncology medicines between 2009 and 2013 when the pCPA was not fully active and the rate in the following 10 years (P < .0001). Oncology drugs had a higher rate of positive recommendations than non-oncology drugs prior to the pCPA becoming fully active and the rate stayed approximately the same. Conclusion: The creation of the pCPA has allowed CDA to step back from its role as price gatekeeper and pass it to the pCPA, permitting CDA to focus on its health technology assessment function. The pCPA's establishment is an alternative reason for the significant increase in positive CDA recommendations.
Objectives Users of prescription medicines often require prescription renewal. However, there is very little research on their expectations for renewal. This study aimed to investigate medicine users' expectations regarding prescription renewal and factors associated with them, as well as channels used to request prescription renewal.Methods The study data were collected through an online survey conducted via Finland's nationwide electronic healthcare services in October 2021. The associations between respondents' background variables and expectations regarding prescription renewal were examined using logistic regression analysis.Key findings Of the respondents (n = 1723), 1695 used prescription medicines and were included in the analysis. Of them, 93.7% had expectations regarding prescription renewal. The most common expectation was that the prescription would be renewed as soon as possible (53.0%). Of all respondents, 80.1% had therapeutic expectations regarding renewal. The most frequently reported therapeutic expectation was that the prescriber would establish the respondent's other medicines and ensure their compatibility before renewal (36.5%). Several factors were associated with therapeutic expectations regarding renewal: gender, certain chronic illnesses, the reported sufficiency of pharmacotherapy monitoring, and experiencing problems with pharmacotherapies. The most frequently used prescription renewal channels were the nationwide patient portal MyKanta (93.6%) and real-time contact with a physician (39.0%).Conclusions Most of the respondents had therapeutic expectations regarding prescription renewal. It is important that these expectations are considered in health care. To meet them, pharmacotherapy monitoring should be an essential part of prescription renewal.
Objective To evaluate the cost-effectiveness of emicizumab compared to recombinant activated factor VII (rFVIIa) in Iraqi patients with hemophilia A and inhibitors.Method A retrospective cost-effectiveness analysis was conducted on 46 male patients with hemophilia A and inhibitors treated at a public children's hospital in Baghdad. Data collection was conducted between November 2024 and March 2025. Clinical and economic data were retrospectively collected for a 12-month follow-up for each of rFVIIa and then emicizumab, including bleeding episodes, emergency visits, treatment costs, and health-related quality of life assessed via EQ-5D-5L (adults) and EQ-5D-Y-3 L proxy (children). Quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios were calculated.Results Emicizumab improved mean utility scores from 0.10 to 1.00 in children and from 0.32 to 0.89 in adults, corresponding to an incremental cost of -$2726.36 and -$4304.78 per QALY, respectively (indicating cost savings). Annual bleeding episodes dropped from 8.70 to 0, saving $282.04 per episode. Hospitalization costs decreased significantly, resulting in a total saving of $286650.41 per hospitalization prevented. Use of emicizumab also reduced overall healthcare resource utilization, eliminating emergency department visits, and minimizing diagnostic procedures.Conclusion Emicizumab delivers substantial clinical and economic benefits over rFVIIa. Its capacity to enhance quality of life while reducing treatment costs positions it as a cost-effective option for adults and children with hemophilia A and inhibitors in resource-constrained settings. Health authorities should prioritize emicizumab over rFVIIa for patients with hemophilia A and inhibitors, due to its superior efficacy and cost-effectiveness.
