Journal of Pharmaceutical Policy and Practice最新文献

Bioequivalence studies are required for generic medicines to meet the same quality, safety, and efficacy standards as innovator products before receiving marketing authorisation. These studies compare the in vivo performance of a generic medicine to that of the innovator product. Two products are bioequivalent if they are pharmaceutically equivalent and have similar bioavailabilities (C_max, T_max, and AUC) after the same dose is administered under the same conditions, resulting in essentially the same effects. In Africa, enforcement of bioequivalence requirements varies, and marketing authorisation can be granted based on incomplete data. Some local manufacturers have bioequivalence requirements waived, while regional joint assessments require demonstration of bioequivalence. This article reviewed the bioequivalence landscape in Africa and found that five countries have operational bioequivalence study centres, two aspire to establish them, and one has evidence of previously conducting bioequivalence studies. A major challenge for African manufacturers is limited access to local bioequivalence centres, leading to most studies being conducted in India and the Middle East, which is cost prohibitive. This article also outlines why bioequivalence facilities in Africa are underdeveloped and recommends opportunities to catalyse the growth of bioequivalence facilities across the region. The authors recommend establishing bioequivalence facilities in academic hospitals with proven clinical trial capabilities in key African markets, developing a university-accredited bioequivalence training programme to upskill regulators and pharmaceutical manufacturers, and requiring African national medicines regulatory authorities to mandate demonstration of bioequivalence for generic medicines from all applicants, local or foreign.

Background: Globally, the proportion of aging population is exponentially and rapidly growing. It is estimated that the number of people 65 years or older was 727 million in 2020. This systematic review and meta-analysis aim to assess potentially inappropriate medication use and associated factors among older adults in Ethiopia.

Method: Primary studies were extensively searched from databases such as PubMed, Scopus and HINARI. Observational studies conducted among older adults ≥60 years old and published in English language were included in the review. After screening, Joanna Brigs Institute (JBI) critical appraisal tool was used to assess studies and data were extracted using a checklist. Heterogeneity was assessed using forest plot, Cochran's Q Test and I². The random effects meta-analysis model was employed to pool the prevalence of potentially inappropriate medication use among older adults in Ethiopia. Subgroup analysis and meta-regression were performed to identify the sources of heterogeneity. Publication bias was assessed using funnel plots with Egger's test.

Results: The review was conducted among 15 cross-sectional studies with a total sample size of 4804 older adults ≥60 years old. The pooled estimate of potentially inappropriate medication use among older adults in Ethiopia was 42.11% (95% CI 31.68, 52.54; P < 0.0001) with high heterogeneity (I ² = 98.49%, p < 0.001). The prevalence of PIMs among studies conducted before 2018 was low (24.97% (15.90%, 34.03%)) compared to studies conducted 2018 and above (50.60% (38.14%, 63.05%)). The most common drug used inappropriately among older adults in Ethiopia was Nifedipine 230 (13.6%). Polypharmacy was significantly and positively associated with PIM use among older adults in Ethiopia.

Conclusion: The pooled prevalence of potentially inappropriate medication among older adults in Ethiopia is high indicating two out of five older adults used inappropriate medication. This review is crucial to MOH of Ethiopia, healthcare professionals and researchers.

Background: The COVID-19 pandemic was a stressful time for healthcare workers, including pharmacists. The pandemic brought new challenges compounded by pre-existing ones. As Canadian pharmacists assume greater responsibilities with the expansion of their scope of practice, it is essential to examine their mental health needs to ensure their success in the post-pandemic era. Guided by the Social Ecological Model, this qualitative study explored the mental health needs of pharmacists.

Methods: Registered pharmacists across Canada were involved in one-on-one interviews, dyadic interviews, or focus groups. Data were transcribed and then analyzed using reflexive thematic analysis.

Results: A total of 22 pharmacists across Canada were interviewed for this study. At the individual level, the need to prioritise mental health and maintain boundaries has emerged as a prominent theme. At the organisational level, (1) the need for employee retention strategies and quality staff and (2) the need to improve internal and external communication were two emerging themes. The need to perceive pharmacists' roles beyond dispensing was the central theme at the community level. Finally, the primary theme at the policy level was the need to integrate pharmacies within the broader healthcare system.

Conclusion: With adequate resources, structural support, and targeted investments, pharmacists are well-positioned to alleviate healthcare pressures and expand their roles in meaningful and sustainable ways.

Background: Antibiotics are lifesaving drugs when used appropriately. On the other hand, inappropriate use causes antibiotic-resistant pathogenic bacteria to grow quickly, which has negative health effects such treatment failure, longer hospital stays, greater medical expenses, decreased efficacy, morbidity, and death. The aim of the study is to assess knowledge, attitude, and practice of antibiotic use and resistance among university students.

Methods: A university-based cross-sectional survey study was conducted in Northwest Ethiopia from April 1 to June 30, 2022 among regular undergraduate students at Debre Tabor University. A stratified random sampling technique was used. The Statistical Package for Social Science for Windows version 27 was used to enter and analyze the data. The variables influencing knowledge, attitudes, and practices regarding the usage of antibiotics were evaluated using logistic regression. We used 95% confidence intervals and considered p-values less than 0.05 as significant.

Results: In the end, 316 participants were included in the research. 176 (55.7%) of the participants were male, and 226 (71.5%) were in the 20-25 age range. About half 52.4% of the students showed good knowledge, 48.9% had a positive attitude, and 45.7% used antibiotics appropriately. More than half of the students (54.7%) demonstrated an adequate understanding of antibiotic resistance, while nearly half (45.2%) exhibited a positive attitude toward it. Factors influencing knowledge, attitudes, and practices (KAP) of antibiotic use were identified. Students from rural areas were 48% less likely to be knowledgeable than urban students (AOR = 0.526, 95% CI: 0.159-0.837, p = 0.012). Compared to health related majors, non-health majors had significantly lower knowledge (AOR = 0.660, 95% CI: 0.159-0.987, p = 0.012) and poorer practices (AOR = 0.551, 95% CI: 0.292-0.845, p = 0.013).

Conclusion: The findings indicated insufficient knowledge, unfavourable attitudes, and inappropriate practices concerning antibiotic use and resistance. Targeted interventions may be implemented through structured meetings, educational materials, and comprehensive training programs.

Background: Based on the best available evidence, rapid health technology was used to assess 5 interleukin inhibitors approved for marketing in China. This assessment aims to promote the rational use of drugs in the clinic and provide a reference basis for the selection of drugs by medical institutions in China.

Methods: Depending on the Rapid Guidelines for Drug Evaluation and Selection in Chinese Medical Institutions (the Second Edition), we evaluated the pharmacological properties, efficacy, safety, economy, and other attributes of interleukin inhibitors by assigning scores.

Results: The rankings of composite scores, from highest to lowest, were as follows: ixekizumab with 68.8 points, secukinumab with 65.47 points, ustekinumab with 65.41 points, tildrakizumab with 62.6 points, and guselkumab with 61.64 points, taking into account the results from the 5 dimensions.

Conclusion: Until the guideline recommendations, the National Essential Drug List, clinical studies, and many other dimensions of this assessment are updated, ixekizumab, secukinumab, and ustekinumab, which have the top 3 scores, can be used as a priority recommendation for Chinese medical institutions to select interleukin inhibitors and optimise the use of the drug catalog based on the scoring results of this assessment.

Backgrounds: Worldwide, the opioid crisis is escalating, and pharmacists are well-positioned to address opioid abuse. The objective of the study was to assess pharmacists' knowledge, dispensing behaviours, concerns about physicians prescribing, provision of interventions to patients, and obstacles associated with opioid stewardship interventions.

Methods: We employed a cross-sectional study design utilising a convenience sampling strategy to collect data from pharmacists employed in community and hospital pharmacies. A self-administered questionnaire of 58 items was utilised to gather data about pharmacists' knowledge of opioids, dispensing procedures, and issues related to physicians' prescribing behaviour from five cities of Punjab, Pakistan. Descriptive statistics were used for nominal and continuous variables. The Spearman Rho correlation was used to evaluate the correlation between knowledge, practice, and concern scores, while ANOVA was implemented to analyse the association between scores and demographics.

Results: A total of 496 pharmacists responded, with a response rate of 72%. About 25% pharmacists were aware of using naloxone in opioid poisoning, 88.9% were aware of the potential risks and adverse effects of opioid therapy, and 87.5% explained these risks to patients. Almost half (48.4%) were concerned about physicians prescribing opioids to patients who were suspected of opioid misuse, and 64.5% were concerned that physicians prescribed opioids to patients who did not need them. The highest intervention provided by pharmacists was educating patients on safe and efficacious use of opioids (90.3% provided), and the least was recommendation of Naloxone in case of overdose (29% never provided). Almost 3/5th (58.0%) said lack of access to education or training resources was a high-impact barrier in opioid stewardship intervention provision.

Conclusion: Pharmacists are concerned about physicians prescribing and mostly provide opioid-related training and interventions, but they also mentioned barriers to the provision of interventions. System-wide strategies are needed to improve opioid prescribing and physician-pharmacist communication.

Point-of-care testing (POCT) offers an important opportunity to strengthen primary healthcare in low - and middle-income countries (LMICs), where access to laboratory diagnostics is limited. A pharmacy-led POCT framework has been designed to guide the systematic integration of POCT into community pharmacy practice, aiming to address diagnostic gaps, enhance early detection, and improve healthcare delivery. Drawing on global and regional evidence, the article highlights the growing role of pharmacists in providing POCT for communicable and non-communicable diseases, demonstrating positive impacts on clinical outcomes, patient satisfaction, and health system efficiency. However, barriers such as regulatory constraints, limited training, supply chain challenges, and inadequate reimbursement hinder wider adoption. In this article, we discuss the opportunities and challenges of pharmacy-led POCT in LMICs using the framework and propose key policy and practice recommendations for sustainable implementation. Strengthening pharmacy-led POCT through this structured approach can advance health equity, particularly in underserved areas, and can contribute to more resilient health systems.

Background: The increasing prevalence of antimicrobial resistance (AMR) is a global health issue, and one of the key contributing factors is the inappropriate and excessive use of antibiotics. This problem is particularly relevant to early childhood, where antibiotic administration relies heavily on caregivers. Despite its critical importance, research on the factors influencing rational antibiotic use behaviours among early childhood caregivers remains limited in Thailand. This study, therefore, aims to explore caregivers' behaviours in administering antibiotics to children, as well as personal and health literacy factors that may influence these behaviours.

Method: This cross-sectional descriptive study was conducted in 2024 among 183 caregivers of children under 6 years of age who visited the pediatric outpatient clinics at three tertiary hospitals in Bangkok Metropolitan. Rational antibiotic use was measured using a questionnaire with a 5-point Likert scale. Descriptive statistics (including percentage, mean, and standard deviation) and multiple linear regression analyses were used to explore the relationship between caregivers' characteristics, antibiotic literacy, and rational antibiotic use behaviour.

Results: The overall rational antibiotic use behaviour among caregivers was at a moderate level (mean 3.08, S.D.  0.56). However, inappropriate behaviours were also observed, with 18.6% of caregivers reporting immediate antibiotic administration for fever and 12.6% saving leftover antibiotics. Multiple linear regression analysis revealed that caregivers' household income, knowledge, self-management, and decision-making abilities collectively predicted rational antibiotic use behaviour, accounting for 13.4% of the variance (p < .001).

Conclusions: This study concludes that caregivers' rational antibiotic use needs to be improved. Household income, knowledge, and self-management skills, including decision-making, are key factors influencing this behaviour. The findings have practical implications and can be applied to develop educational programmes and policies that enhance caregivers' antibiotic literacy and promote safe, rational antibiotic use.

In his recent editorial Dr. Hameed Merchant questions why UK adults aged ≥ 80 years of age are not included in the recently introduced national adult RSV immunisation programme. He provides insights suggesting that this age group is at highest risk of hospitalisation following an RSV infection and highlights that efficacy data in those aged ≥80 years from the pivotal clinical trials lacked sufficient precision to support vaccine use in this most elderly age group. He also mentions a need to consider the vaccine for adults aged <75 years in clinical risk groups. We discuss these issues further and summarise those relevant UK data currently available illustrating the annual healthcare burden across the national health service (NHS) attributed to adult RSV infection stratifying by general practitioner (GP) consultations, hospitalisations and accident and emergency (A&E) attendances. These suggest that >630,000 UK adults use NHS services annually due to RSV and shows that a high proportion of adult RSV attributed hospitalisations (∼55%) and A&E attendances (∼48%) occur in those aged ≥75 years. Further UK data now reinforce that the risk of RSV associated hospitalisation increases substantially with increasing age in the most elderly with real-world evidence also now starting to emerge showing the vaccine to be effective in this age group. However, ∼77% of the total annual adult RSV attributed healthcare burden occurs in UK adults aged 18-74 years with ∼14 million adults in this age group estimated to have at least one underlying risk condition for more severe outcomes following a respiratory infection. This supports the need to also consider RSV vaccination for those aged 18-74 years though further research is currently required to optimally identify underlying risk conditions that may specifically be associated with more severe outcomes following an RSV infection. Trial registration: ClinicalTrials.gov identifier: NCT05921903.

Background: Polymyxin-resistant gram-negative bacilli pose a formidable challenge in clinical settings globally and the increasing prevalence of resistance has raised concerns regarding treatment options and patient outcomes. This study aimed to evaluate the risk factors, length of hospital stay and mortality among patients with polymyxin-resistant critical pathogens gram-negative bacilli (PR-CP-GNB) and polymyxin-susceptible (PS-CP-GNB) isolates.

Methods: A one-year case-control study was conducted using retrospective data from patients admitted to Kuala Lumpur Hospital with a positive culture of CP-GNB. CP referred to Carbapenem-Resistant Acinetobacter baumannii and Carbapenem-Resistant Enterobacterales. Patients with PR-CP-GNB isolates were classified as cases, while those with PS-CP-GNB isolates served as controls. Mortality outcomes were assessed using Chi-Square and Fisher's exact tests, while the length of hospital stay was evaluated using the Mann-Whitney U test. Simple and multiple logistic regression analyses were performed to identify risk factors for PR-CP-GNB.

Results: The median age of the 70 patients was 55.5 (IQR 42.6-64.9), with an equal distribution between males and females. Of 70 patients, 50 (71.4%) were identified as PR-CP-GNB and the remaining were PS-CP-GNB. Additionally, 15 isolates were identified as colonisers (12 PR-CP-GNB and 3 PS-CP-GNB). Among the 55 non-coloniser, 38 (69%) were identified as PR-CP-GNB while 17 (31%) had PS-CP-GNB. No significant difference in all-cause mortality (PR-CP-GNB: 60.5%; PS-CP-GNB: 64.7%, p = 0.768) or infection-related mortality (PR-CP-GNB: 65.2%, PS-CP-GNB: 45.5%, p = 0.458) among non-coloniser patients. The median length of hospital stay post-infection was also comparable (PR-CP-GNB: 24 days vs PS-CP-GNB: 25 days, p = 0.791). A previous ICU admission within the last 90 days was associated with approximately six times higher odds of isolating PR-CP-GNB (AOR = 5.90, 95% CI 1.17-29.77, p = 0.032).

Conclusion: Prior ICU admission significantly increased the risk of PR-CP-GNB isolation. Clinicians should consider a history of ICU admission as a major risk factor when evaluating patients for potential polymyxin-resistant infections.