Journal of Pharmaceutical Policy and Practice最新文献

Background: Unregistered pharmaceutical products, which have not undergone evaluation by the national regulatory agency, pose significant risks to public health. The continuous influx of these unregistered products into Malaysia highlights the inadequacies within the current regulatory approach. Existing literatures show that there is a gap in knowledge regarding the challenges encountered by enforcement agencies during inspection of imported pharmaceutical products at entry points. Therefore, this study aims to identify the issues and challenges encountered by enforcement officers in curbing the importation of unregistered products and propose recommendations that can be considered to enhance legal enforcement.

Methods: This study employed a qualitative approach by conducting one-to-one interviews with twelve Pharmacy Enforcement Officers and Customs Officers to gather relevant insights.

Results: The key issues and challenges encountered in controlling the importation of unregistered products were categorised into several themes, including (i) organisational constraints; (ii) technical challenges; (iii) modus operandi employed by importer; and (iv) external challenges, such as proliferation of online platforms and persistent market demand for unregistered products.

Conclusion: The findings revealed that the issues and challenges faced by enforcement officers stem from the inadequacies identified in the existing laws and regulatory practices. Multifaceted approaches that encompass legislative reforms, administrative transformation and rigorous enforcement are necessary in fostering more effective control over the importation of unregistered products in Malaysia.

Background: Azithromycin, a widely prescribed macrolide antibiotic, faces emerging safety concerns due to inappropriate use and age-specific adverse drug reactions (ADRs). This study characterises age-stratified safety profiles of azithromycin using pharmacovigilance data.

Methods: Adverse event (AE) reports for azithromycin prescribed in Mycoplasma pneumoniae pneumonia treatment (2004-2024) were extracted from the FDA Adverse Event Reporting System (FAERS). Disproportionality analyses (Reporting Odds Ratio, Proportional Reporting Ratio, Bayesian Confidence Propagation Neural Network, Multi-item Gamma Poisson Shrinker) identified safety signals across four age groups: 0-17, 18-44, 45-64, and ≥65 years.

Results: Among 7,496 AE reports, age-specific risks varied significantly. Paediatric populations (0-17 years) exhibited predominant cutaneous/hypersensitivity reactions (rash, pruritus, Stevens-Johnson syndrome) and unlabelled psychiatric signals (hallucinations). Adults (18-44 years) showed pregnancy-related risks (preterm delivery). Geriatric patients (≥65 years) had heightened cardiac risks (QT prolongation, torsades de pointes), often exacerbated by off-label COVID-19 use. The 45-64-year cohort displayed the highest signal frequency, primarily involving drug hypersensitivity. Off-label prescribing accounted for 65% of geriatric AEs.

Conclusion: Azithromycin safety profiles differ markedly across age groups. Children face dermatologic and neuropsychiatric risks, while elderly patients are vulnerable to cardiac complications. Strict adherence to labelled indications, age-specific monitoring, and avoidance of off-label use - particularly during public health crises - are critical to mitigating ADRs. These findings underscore the need for stratified clinical decision-making and targeted pharmacovigilance.

Background: Pharmaceutical care (PC) is less practised in United Arab Emirates (UAE) community pharmacies. This study assessed community pharmacists' (CPs) perceptions, practices and perceived barriers to providing PC.

Methods: A nationwide cross-sectional survey was conducted from May to October 2024 among CPs through direct visits, email invitations and WhatsApp groups. Customised version of a previously validated 5-point Likert-type questionnaire was used (Cronbach alpha = 0.93). Individual statements were scored 1-5, and Mann Whitney and Kruskal Wallis tests were performed to find the association between total perception, practice and barrier scores with demographic variables. Post hoc analyses and Kendall's correlation were performed wherever applicable, at alpha = 0.05.

Results: A total of 227 CPs, with 70.9% (n = 161) of bachelor in pharmacy degree holders responded. The total median (IQR) scores for perception, practice and barriers were 24 (22-26)/30, 40 (34-45)/50 and 76 (63-86)/125, respectively. Most of the CPs felt that patients' medications should be reviewed by them to prevent medicine-related errors and promote the appropriate medication use [median (IQR) 5 (4-5)]. They also felt that CPs are professionally skilled in providing PC [median (IQR) 5 (4-5)]. The major barrier reported was the lack of support from other health professionals toward PC [median (IQR) 4 (3-5)]. There was a statistically significant association between total perception scores with age (p = 0.023), work experience (0.036) and working hours (p = 0.012), total practice scores with work experience (p = 0.035) and training in PC (p = 0.009) and total barrier scores with the average number of CPs available in the shift (p = 0.002). A significant correlation was noticed within a few perception, practice and barrier constructs and between these constructs and participants' demographic characteristics, p < 0.05.

Conclusion: Specific interventions at academic and regulatory levels targeting specific barriers are urgently needed with the incorporation of patient-centred care and interprofessional collaboration in academic and practice settings as the starting point.

Background: Acute coronary syndromes (ACS) are a spectrum of diseases that diminish blood flow to the heart and are a major cause of global death. They can be prevented with lipid-lowering therapies (LLTs) but these are often sub-optimally managed in practice. A potential solution could include implementing independent prescribing (IP) pharmacists to optimise LLTs within cardiac rehabilitation services. Aim: To explore the impact of a novel pharmacy service within a cardiac rehabilitation centre (CRC) at a local hospital in the West Midlands UK, on post-ACS patients' ability to achieve targets of non-HDL-C.

Methods: A retrospective analysis was undertaken at a rehabilitation centre to evaluate pharmacist interventions in lipid management. Inclusion criteria: Post-ACS patients not attaining target levels of non-HDL-C < 2.5 mmol/L, 3 months after discharge. Non-HDL-C levels were also measured 2 months after the pharmacist interventions.

Results: 169 post-ACS patients were eligible for treatment. 54% of patients achieved their <2.5 mmol/L of non-HDL-C levels. 25% of these were combination therapy of high-intensity statin and ezetimibe. 36% of patients achieved a 40% reduction of baseline non-HDL levels. 38% did not achieve either target.

Conclusion: This innovative pharmacy role in CR could address the suboptimal LLT management that is common in the post-ACS population. It fosters collaborative care across healthcare sectors, improving patient outcomes and augmenting the probability of reducing ACS risk.

Considerable attention has been paid to the utilisation of real-world data throughout the lifecycle of pharmaceuticals, medical devices, and regenerative products. In Japan, regulatory initiatives have been implemented to promote the utilisation of real-world data and evidence for regulatory decision-making, especially focusing on the use of disease registries. In this brief article, we outline regulatory initiatives, summarise the current status of registry utilisation in Japanese regulatory settings, and offer points to consider and perspectives on registry utilisation for stakeholder collaboration.

Background: In response to COVID-19 pandemic, NRAs implemented expedited mechanisms such as EUAs and CMAs, relying on international bodies, to authorize vaccines. Documenting these authorization pathways across countries informs NRAs and strengthens future pandemic responses. Existing studies on COVID-19 vaccine approvals are limited, underscoring the need for a comprehensive review. This study aimed to explore approval pathways, investigate supporting strategies, and review times for COVID-19 vaccines.

Methods: A scoping review was conducted, covering countries with stringent regulatory authorities or countries with significant COVID-19 vaccine manufacturing or rapid rollout. Searches using terms such as 'approval process' and 'COVID-19 vaccine' were performed in electronic databases and on official regulatory authority websites. Countries without authorization information or with language barriers were excluded. Data on vaccine authorization processes including supporting strategies, submission criteria, and approval timelines were extracted and analyzed using content and comparative regulatory analysis.

Results: Twenty-four regulatory pathways from 20 countries were identified, categorized as 'emergency use authorization' (EUA) (n = 10), 'conditional marketing authorization' (CMA) (n = 8), and "temporary authorization' (TA) (n = 6). Twelve new pathways were created by 11 countries, with four countries using two pathways each for different pandemic stages. Common requirements for vaccine approval included good manufacturing practice (GMP) (92%), benefit-risk evaluation (86%), and unmet need (83%). Supporting strategies like 'rolling submission' (85%) and 'pre-submission meeting' (85%) facilitated and fasten the approval process. Non-high-income countries favored the 'reliance' strategy, while high-income countries engaged in regulatory networking. The FDA and EMA were the most referenced agencies. Review times for the first COVID-19 vaccines ranged from 10 to 84 days, significantly faster (3-27 times) than standard review times.

Conclusion: Despite different regulatory pathways, all countries approved the first COVID-19 vaccine quickly. International collaboration was crucial in accelerating approval times. The COVID-19 pandemic positively stimulated global preparedness for serious pandemics.

Background: Medicines are crucial for strengthening health systems and building patient confidence. Yet, there is a global shortage of age-appropriate pediatric formulations, particularly in low- and middle-income countries. Pharmacists are vital in ensuring pediatric medicines' availability and proper use. Research has often overlooked pediatric needs, resulting in significant gaps in understanding the accessibility of medicines for children. This research therefore sought to identify the barriers and facilitators to accessing pediatric medicines from the perspective of community pharmacists in Albania.

Methods: Semi-structured interviews were conducted in March 2024 with 18 members of the Albanian Order of Pharmacists, working in the six most populated cities in Albania. Interviews were transcribed verbatim and analyzed using the Pharmaceutical Value Chain framework.

Results: Barriers to accessing pediatric medicines were evident in almost all domains of the Pharmaceutical Value Chain framework except for health information technology, a domain not referred to by participants. Issues addressed included a limited number of items on the reimbursement list for different child-specific diagnoses and occasional stock-outs of child-appropriate medicines. Open communication channels with other healthcare professionals and patient education were identified as key facilitators in improving access to pediatric medicines.

Conclusion: This is the first study to examine pediatric medicine access in Albania from the viewpoint of community pharmacists. The findings provide context-specific insights that can inform policy reforms and health system strategies to improve the equitable availability of pediatric medicines.

Background: This study analyses public policies concerning access to medicines and pharmaceutical services in Angola from the right to health perspective. Angola, located in the Western Region of Southern Africa, gained independence in 1975, but the regulation of pharmaceutical activity was enacted only in 2010. Despite these policies, health policies alone do not guarantee the right to health.

Methods: This qualitative research involves documentary analysis, participant observation, and interviews, utilising theoretical frameworks on access to medicines, health systems, and sociotechnical systems. The analysis framework is organised into three domains: legal rights and obligations, good governance, and service implementation. Data from documentary analysis and field research were categorised within these domains.

Results: The findings indicate that the regulatory framework acts as a 'letter of intent', as legal guarantees are vague and lack clarity regarding responsibilities and resource allocation. Additional weaknesses include indecipherable financing, centralised management, cultural barriers, lack of transparency, and limited recognition of the right to access medicines among health professionals. These issues are further exacerbated by Angola's political-economic structure, external dependence on medicines, and insufficiently trained human resources.

Conclusion: To enhance access to necessary medicines and services, investment in the education of health professionals and training for community leaders is essential. Public policies regarding access to medicines in Angola are still incipient; therefore, improving drug policy and pharmaceutical services is crucial to ensure access within the framework of the right to comprehensive health care.

Product discolouration is a visually detectable quality defect that can undermine patient trust, often leading to non-adherence due to fears of contamination or chemical degradation. A retrospective study of product recalls due to discolouration, within Kenya, between January 2016 and December 2024 was conducted. Study data was extracted from the Pharmacy and Poisons Board online database, which forms a repository of all product recalls and rapid/safety alerts. All recall entries due to product discolouration were included in the study. A total of 36 products were recalled due to discolouration during the study period, with the number of recalls varying from none to 9 products per year. Tablets constituted 55.6% of the recalled products. A total of 38.9% of the products were anti-infectives. This is a notable concern, as abrupt disruption of anti-infective treatment and/or substandard products can drive drug resistance. Generic formulations comprised 97.2% of recalled products. Twenty-one industries were involved in the manufacture of recalled products, with six industries being affected by multiple recalls. Products locally manufactured in Kenya accounted for 63.9% of the recalls. A comprehensive discussion of the probable causes of the observed discolouration, guided by use of the fishbone (Ishikawa) diagram, revealed three sub-themes namely chemical reactions: microbiological and physical contamination. Product recalls due to discolouration proved to be an emerging concern, affecting up to 70 batches of a product in some cases. The in-depth discussion provides guidance on conducting investigations to identify the root cause of observed defects. The adoption of the fishbone tool alongside development of structured forms for defect reporting and quality assurance workflows is recommended.

Background: In 2015, Indonesia Ministry of Health (MoH) issued a decree to ensure the affordability of medicines by providing transparent prices which obliged all manufacturers to print a maximum retail price (MRP) on medicine primary packaging. We measure the compliance of manufacturers and retailers with the regulation stated in the decree and estimate the retailers' profit.

Methods: Five essential medicines (allopurinol, amlodipine, amoxicillin, cefixime, dexamethasone) were purchased from randomly selected health facilities, retail pharmacies and online outlets in Indonesia. We recorded retailer's selling price and product's MRP. We also sourced product's list price and sales volume from pharmaceutical market data. We conducted an MRP policy implementation analysis by evaluating three indicators (retail price transparency, permitted MRP and permitted sales price). We also estimated the retailers' profit by taking into account the profit margin and sales volume.

Results: Of 1249 sampled medicines, nearly all samples (99.4%) had visible MRP on their packaging indicating high transparency compliance. For unbranded generics, none complied with permitted MRP with a median ratio of printed MRP to permitted MRP being 3.5 (IQR 2.6-7.9), whilst higher compliance (11.2%) was observed for branded generics (IQR 1.1-1.7, median 1.1). 33% of the samples were sold above the printed MRP with the lowest compliance to actual selling price being documented in hospitals. Branded generics accounted for 79% of the product value across the study medicines and generated more profits than the unbranded versions.

Conclusion: The transparency implementation through printed MRP and the compliance with permitted sales price regulation contribute to retailer accountability. Rules restricting permitted MRPs for unbranded generics, irrational since their inception, while they never set any limits at all on the price of branded medicines. This showed not enough evidence that the policy contributed to its objective of ensuring affordability.