Journal of Pharmaceutical Policy and Practice最新文献

Background: Self-medication given by parents or caregivers is a common practice among children. Several frequently used drugs are often administered without professional supervision. This study compares regulatory classifications of common paediatric self-medication drugs across ten countries, aiming to uncover trends based on product type and national policies.

Methods: Data were primarily collected from official drug regulatory agency websites and supplemented from other relevant sources. Twelve widely used drugs were reviewed, by focusing on classification status, approved indications, and paediatric age restrictions. Content and comparative analyses were conducted.

Results: The findings revealed that drugs indicated for fever, pain, mucolytic effects, and non-sedating antihistamines were mostly classified as non-prescription. For drugs with the same active ingredient, but different strengths or dosage forms, compared within the same country, the classification status generally remained unchanged, even across different paediatric age groups. Drugs for asthma and topical corticosteroids were likely to be classified as prescription drugs. In some countries, such as the United Kingdom, Australia, and Singapore, the same drug preparation had different classification statuses which were based on factors such as approved indication and pack size. Additionally, Singapore and Indonesia implement prescription-exemption systems. These allow supply of certain prescription drugs without a prescription under specific conditions.

Conclusion: Commonly used drugs for paediatric self-medication are classified as both non-prescription and prescription. This reflects diverse regulatory approaches across countries. Regulators play a key role in ensuring safe use of self-medication in children. Lack of harmonisation address a critical need for globally consistent paediatric drug classification scheme. They empower consumers through mechanisms such as clear, accessible patient information leaflets and other educational tools.

Background: Pharmacy workforce intelligence (PWI) involves the development, implementation, and evaluation of effective strategies and tools to ensure the availability and quality of pharmacy workforce (PW). Academic capacity (AC) is essential in producing graduates for PW, while quality assurance (QA) in education is crucial in developing competent PW. There is a lack of information about PWI in the Eastern Mediterranean Region (EMR). Based on the available data, there is a notable imbalance in PW distribution in EMR. This study aimed to evaluate the status of AC and QA of pharmacy education in the EMR using the International-Pharmaceutical-Federation (FIP)'s Development-Goals and their associated mechanisms as a framework.

Methods: An explanatory sequential mixed-methods approach was used. The quantitative phase involved distributing a validated questionnaire among pharmacy leaders of all accessible pharmacy schools in the EMR. The qualitative phase involved the conduct of semi-structured interviews with pharmacy leaders, and the data were thematically analysed.

Results: Of 112 identified pharmacy leaders, 61 participated in the survey (response rate, 55%) and 14 participated in the interviews. Most data were consistent among the quantitative and qualitative results. In both phases, most participants reported implementing a student - teacher ratio (70%), periodic accreditation (82%), adoption of global QA standards (67%), and involving key stakeholders in programme development. Enrolment planning based on workforce needs (51%) and capacity-building for teacher-practitioners (47%) were less common and less emphasised in interviews.

Conclusion: Although some AC and QA mechanisms are achieved, many require further improvement. Policymakers could establish a national body representing PW, improve workforce data systems for evidence-based enrolment planning, invest in faculty development, and standardised QA frameworks. Standardising stakeholder engagement and enhancing graduate tracking would further ensure that programmes remain aligned with workforce and health system needs.

Background: Regulatory agencies ensure the safety, efficacy, and quality of pharmaceuticals, influencing patient access to novel therapies. The Saudi Food and Drug Authority (SFDA) oversees drug evaluation in Saudi Arabia. This study evaluates SFDA's drug review times compared to other international agencies and assesses characteristics and approval timelines of novel drugs approved by the SFDA and the U.S. Food and Drug Administration (FDA) in 2019.

Methods: A retrospective observational study analyzed drug evaluation times from the SFDA and six international agencies: FDA, European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), Health Canada, Pharmaceuticals and Medical Devices Agency (PMDA), and Swissmedic. The primary outcome was drug approval timeline, defined as days from submission to registration. Data on 48 novel drugs approved by the FDA in 2019 were collected and tracked for SFDA approval status through 2024. Descriptive statistics compared drug characteristics and evaluation times. A regulatory comparison used publicly available documents and reported timelines.

Results: SFDA and EMA showed shorter median approval times (∼6.5 months), while Swissmedic (14.5 months) and PMDA (10.6 months) had longer timelines. Among 48 FDA-approved novel drugs in 2019, 21 (43.75%) were approved by the SFDA by mid-2024; 23 (47.92%) were not submitted for SFDA review, impacting coverage. Small molecules dominated approvals for both FDA (58.33%) and SFDA (64%). Advanced therapies such as gene therapies and synthetic peptide analogs were absent from SFDA approvals, mainly due to non-submission. Median approval times were comparable (SFDA: 248 days; FDA: 243 days), with greater variability observed in SFDA timelines.

Conclusion: SFDA's review timelines align with major regulatory agencies, supporting timely drug access. Further investigation into submission patterns and regulatory challenges may improve approval rates, especially for advanced therapies.

Background: Competency-based education (CBE) has been implemented across healthcare disciplines, including pharmacy, to address the limitations of the traditional teaching system. While CBE implementation in pharmacy education has been studied globally, research examining its adoption across pharmacy schools in the Eastern Mediterranean Region (EMR) remains limited.

Aim: Explore the nature and extent of CBE incorporation within pharmacy schools' curricula across the EMR and identify barriers and facilitators influencing CBE implementation.

Methods: A sequential explanatory mixed-methods approach was used, combining an online survey followed by semi-structured online interviews. The study was guided by the International Pharmaceutical Federation Global Competency Framework (FIP GbCF).

Results: Out of the 116 schools that received the survey link, 55 responses were received from pharmacy schools in the EMR (any-response rate 47.4%), of which 38 were complete and included in the final analysis (complete-response rate 32.8%). Furthermore, 18 participants participated in the online interview. The majority of the pharmacy schools were accredited (81.6%), and (63.2%) of these implement/incorporate CBE in their curricula. The analysis of the FIP GbCF competencies incorporation revealed that various competencies were prevalent, including communication skills and professional and ethical practice (95.8%), and dispensing and inter-professional collaboration (91.7%). The least incorporated competencies included emergency response (58.3%), followed by workplace management (25%). Inductive thematic analysis identified key challenges for the implementation of CBE in some pharmacy schools, including internal resistance, resource limitations and workload challenges. On the other hand, schools highlighted important facilitators such as leadership support, communication and engagement.

Conclusion: Most accredited pharmacy schools in the EMR adopted CBE, yet considerable gaps remain in implementing many of the FIP GbCF competencies. The study reveals that pharmacy schools face significant challenges in CBE implementation, regardless of their current adoption status, suggesting opportunities for the enhancement of pharmacy education across the region.

Background: Statins are one of the most widely used therapeutic classes and have significantly contributed to health care expenditures with reported variability between countries and regions. We aim to identify the economic implications of different statin prescription patterns in the central region of Portugal.

Methods: A retrospective longitudinal study of statin consumption between 2010 and 2022 in the central region, with data obtained from the national administrative claim database. Prescription and expenditure (retail price) were analysed at the municipality level. A score was created for the quartile position (1 = first to 4 = fourth) of each municipality in the distributions of consumption and expenditure for each year. An overall score was created for the study period by aggregating yearly scores. A four-quadrant analysis with the overall scores of cost/DDD and DDD/1000inhabitants/day (DID) was conducted. Bivariate and multivariate analyses were performed.

Results: Statin consumption increased from 64 DDD/1000inhabitants/day (DID) to 149 DID, while cost/DDD and cost/inhabitant decreased from 0.77 € to 0.26 € and from 17.84 € to 13.99 €, respectively. Prescription pattern of high-intensity statins increased from 26% to 74% of the DDD consumed. A four-quadrant plot revealed discrepancies between the municipalities. These discrepancies were associated with the percentage of pitavastatin in DDD (F = 4.604; p = 0.005), and the percentage of statins monotherapy in DDD (F = 5.201; p = 0.003). Generalising the characteristics of high-level consumption and expenditure municipalities to the entire region would result in a 39.7% increase in expenditure but a 20.8% increase in patients. Prescription of statins per municipality correlated with the prescription of antidepressants (R = 0.643; p < 0.001) in the bivariate analysis, and in the multivariate analysis (p < 0.001; B = 0.580; 95%CI = 0.416:0.744).

Conclusion: Differences in prescribing patterns resulted in very different proportions of patients treated and expenses associated with the consumption of these lipid-lowering agents. Further analysis should be carried out to understand the financial implications of prescribing new (patent-protected) medicines in Portugal.

Background: Improper storage and disposal of unused and expired medicines at home have become a global challenge, creating significant hazards to public health and the environment. This systematic review aimed to explore the prevalence of proper storage and disposal of medicines and to examine factors influencing these proper behaviours.

Method: We searched PubMed, Scopus, Springer Link, Science Direct, and EBSCO for articles published between 1 January 1990, and 31 May 2023. Inclusion criteria included studies conducted about medicines in a household setting, articles written in the English language, and full text that could be retrieved. Exclusion criteria included pilot studies, editorials, or opinions. The QualSyst assessment tool was applied to evaluate the quality of the included studies. This systematic review was conducted and reported in accordance with the PRISMA 2020 (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. The prevalence of proper storage and disposal, determinants of proper and improper storage, and proper disposal of medicines were elaborated using both quantitative and qualitative methods.

Results: The search found 822 articles and included 61 eligible studies from 27 countries. The overall prevalence of proper medicine storage was only 45%. The proper disposal rates were only 13% for unused medicines and 8% for expired medicines. Proper storage was positively associated with knowledge, education, storage counselling, presence of chronic illness, household size, and the number of children in the household; and negatively associated with age and male gender. Proper disposal was positively associated with awareness, peer influence, knowledge, education, and having family members who are incapable of independently managing their medicine.

Conclusion: Proper storage guidance should be included on a medicine label for every medicine dispensed by pharmacists. The take-back programmes campaign and public education related to proper disposal of medicine were recommended to save the environment and public health.

Background: The person-centred care model involves a multidisciplinary team providing individualised health and social care aligned with patient preferences and health goals. Although some evidence supports its use in primary care, it remains under-evaluated. This study aimed to evaluate the effectiveness of a Collaborative Medication Management (CMM) approach in optimising pharmacotherapy plans versus usual care among polymedicated older adults.

Methods: A randomised, open-label, multicentre, parallel clinical trial was conducted across 11 Primary Care Teams in Spain (Sept 2020-Jan 2024), including patients aged ≥75 years taking ≥8 chronic medications with complex or advanced conditions. The intervention group (IG, n = 102) received CMM delivered by a multidisciplinary team, including structured medication review, development of a patient-centred care plan, and follow-up at 6 and 12 months. The control group (CG, n = 106) received usual care. Primary outcomes were number of medications, drug-related prescriptions (DRP), changes to pharmacotherapy plans, and hospital admissions. Secondary outcomes included persistence of changes at 12 months and medication-related safety incidents.

Results: A total of 208 subjects were included (65.4% women; mean age 83.6 ± 6.3 years). IG showed a mean reduction of 1.8 ± 2.1 medications/patient vs. an increase of 0.3 ± 1.4 in CG (p = 0.004); a mean reduction of 2.9 ± 2.5 DRP/patient in IG vs. An increase of 0.2 ± 1.2 in CG (p = 0.004); a mean of 4.3 ± 2.9 changes to pharmacotherapy plans in IG vs. 2.6 ± 3.3 in CG (p = 0.004); a mean of 0.3 ± 0.7 hospital admissions in IG vs. 0.3 ± 0.8 in CG (p = 1.000). Persistence of changes at 12 months was 3.8 ± 2.7 in IG vs. 2.2 ± 2.9 in CG (p < 0.001). In addition, a mean of 0.5 ± 0.7 safety incidents was reported in IG vs. 0.5 ± 1.0 in CG (p = 0.676).

Conclusion: The person-centred care model proved effect in optimising medication use in polymedicated older adults.Trial registration: ClinicalTrials.gov identifier: NCT04188470.

In response to demographic changes, technological innovation, and the increasing complexity of healthcare, Japan revised its Model Core Curriculum (MCC) for pharmacy education in 2022 (hereafter, the 2022 MCC). This reform aims to develop pharmacists with lifelong competencies, the ability to integrate emerging science and technology into practice, and strong interprofessional collaboration competencies. It represents a shift from traditional knowledge-based education to competency- and outcome-based education that addresses evolving societal needs in healthcare and pharmacy. This commentary outlines the key principles and evolution of the 2022 MCC. Faced with challenges such as population aging, declining birth rates, and healthcare system modernisation, Japanese pharmacy education is undergoing significant change. The 2022 MCC enhances practical clinical training, promotes community-oriented healthcare, and encourages scientific inquiry and problem-solving competencies among pharmacists. To support international collaboration and knowledge exchange, an English translation of the 2022 MCC Revised Edition has been published. As many countries face similar demographic and technological challenges, Japan's experience may provide useful insights to support the modernisation of pharmacy education globally.

Background: Despite Nigeria's robust pharmaceutical sector, no local manufacturer there achieved World Health Organization (WHO) prequalification before 2011. This contrasts with countries like South Africa, Morocco, Kenya, and Uganda, which have WHO-prequalified products and can participate in global medicine tenders. This study aimed to analyze successful initiatives supporting good manufacturing practices (GMP) standards in Nigeria, identify challenges hindering WHO prequalification, and proposed recommendations to enhance GMP compliance and facilitate WHO prequalification, aiming to strengthen the Nigerian pharmaceutical industry and improve access to quality medicines.

Methods: A desk review was conducted to examine initiatives supporting adoption of GMP standards in Nigeria. rapid qualitative analysis techniques were used to interview key personnel involved in these initiatives. Interview data were summarized into predefined domains aligned with the interview guide and organized into a matrix, enabling descriptive analysis to highlight key points, narrative synthesis to construct a cohesive account of experiences, and interpretative synthesis to derive implications from the data.

Results: Four major initiatives provided technical support to local pharmaceutical manufacturers, facilitating progress towards GMP compliance and enabling the first Nigerian pharmaceutical manufacturer to obtain World Health Organization prequalification (WHO PQ). Initiatives included: (1) WHO project from 2011 to 2014; (2) the Promoting the Quality of Medicines (PQM) program (2009-2020); (3) the PQM + program (2019-2025), both funded by the United States Agency for International Development (USAID) and implemented by the U.S. Pharmacopeia; and (4) a GMP roadmap project by Nigeria's National Agency for Food and Drug Administration and Control (NAFDAC) and the United Nations Industrial Development Organization (UNIDO) (November 2018 - May 2019).

Conclusion: Collaboration among NAFDAC, local manufacturers, the WHO PQ Team, and other partners enabled successful implementation of these programs, culminating in WHO PQ of Swiss Pharma Nigeria Limited's zinc sulfate dispersible tablets on June 6, 2023 - the first in West Africa. However, significant challenges persist, including insufficient understanding of WHO PQ requirements, inadequate GMP-compliant facilities, and financial constraints. Addressing these issues requires targeted interventions focused on GMP awareness, infrastructure investment, regulatory support, and harnessing Nigeria's potential as a pharmaceutical manufacturing hub.

Background: There remains a gap in understanding lapatinib's real-world safety, particularly in rare adverse events (AEs). Thus, this study aims to evaluate lapatinib's safety by (1) performing data mining of the FDA Adverse Event Reporting System (FAERS); and (2) detecting and analysing safety signals associated with lapatinib that may require monitoring.

Methods: FAERS data from March 2007 to July 2024 were analysed via OpenVigil (version 2.1). AEs were categorised into preferred terms (PTs) and system organ classes (SOCs) using the Medical Dictionary for Regulatory Activities. We used descriptive analysis to analyse report characteristics and four signal detection algorithms to quantify risk signals, including Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Multi-item Gamma Poisson Shrinker (MGPS), and Bayesian Confidence Propagation Neural Network (BCPNN). Top novel strong suspected AEs were further assessed using a case-by-case analysis. The Naranjo algorithm was utilised to determine the potential relation between the suspected AEs and lapatinib.

Results: From 25,506,744 retrieved reports, 18,407 PTs identified lapatinib as the primary suspect, resulting in 10,959 signals analysed. AEs were predominantly females (77.9%) and individuals aged 18-64 (45.38%). Lapatinib-induced AEs affected 16 systems, with 155 lapatinib-related PTs; 115 of these were significantly disproportionate, including 57 new PTs. While gastrointestinal and dermatological disorders were the most common, the latter was more strongly associated with lapatinib, with diarrhoea being the only strong gastrointestinal signal. Notably, cardiac events were less reported, and the top new AEs based on signal strength, such as hypocapnia, lip ulceration, and hepatic infection, were mostly found to be 'possibly' related to lapatinib based on the case-by-case evaluation, warranting further clinical assessments. Initial or prolonged hospitalisation, death, and life-threatening events were the most common AEs outcomes reported, accounting for 28.79%, 13.79%, and 3.06%, respectively.

Conclusion: This study provides valuable insights into lapatinib-induced toxicity in real-world settings.