Journal of Pharmaceutical Policy and Practice最新文献

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.

Background: Specific actions to promote the RUD in public and private hospitals are highly needed. The current study aimed to assess RUD based on World Health Organization (WHO) prescribing indicators in selected public and private hospitals in Khartoum state-Sudan.

Methods: A multicenter cross-sectional study was conducted in six public and three private hospitals. After ethics approval, a consecutive random sample of 2880 patient encounter prescriptions was selected. The IRDP indicates adherence to RUD.

Results: The average number of drugs per patient encounter prescription was 1.7 ± 0.2 and 2.5 ± 0.2 (overall 2.1) in public and private hospitals, respectively. Drugs prescribed generically were 61% (index 0.61) in public hospitals and 24% (index 0.24) in private hospitals. The index of injection prescribing was 0.1 for public and 0.85 for private hospitals. Drugs on the EDL accounted for 94% of prescriptions in public hospitals and 70% in private hospitals. The EDL prescribing index was 0.94 for public and 0.7 for private hospitals. The overall mean IRDP for public and private hospitals was 3.11.

Conclusion: Inadequate prescribing patterns in public and private hospitals significantly deviate from WHO standards across most prescribing indicators. Consequently, public and private hospitals should strive to promote the RUD.

Background: Pictograms are widely used in pharmacy practice to enhance patient understanding, especially in contexts where language or health literacy barriers exist. However, limited data are available on the comprehension of United States Pharmacopeia Convention: Drug Information for the Health Care Professional (USP-DI) pictograms among Thai undergraduate students. This study assessed the understanding of USP-DI pictograms and medication-use literacy, and explored factors associated with pictogram comprehension.

Methods: A cross-sectional survey using a structured questionnaire was conducted among 637 university students between August 2023 and April 2024. The Medication Use Literacy Test (MULT) assessed literacy, and the USP-DI pictogram comprehension test evaluated visual understanding. Binary logistic regression was used to identify factors associated with comprehension levels.

Results: Among the 637 participants, the MULT revealed high literacy, with over 90% of questions answered correctly. The mean score for USP-DI pictogram comprehension was 21.82 ± 3.82. Students in health sciences programmes demonstrated the highest proficiency in both tests, followed by those in social sciences and science and technology programmes, with statistically significant differences (P < 0.05). Logistic regression analysis revealed that students aged >20 years had lower pictogram comprehension than younger students (odds ratio [OR] = 0.47; 95% confidence interval [CI]: 0.25-0.88; P = 0.02). Students with a Grade Point Average <3.00/4.00 (OR = 0.55; 95% CI: 0.32-0.96; P = 0.04) and those from non-health science faculties (OR = 0.04; 95% CI: 0.02-0.08; P < 0.001) also showed significantly lower comprehension levels.

Conclusions: This study highlights disparities in pictogram comprehension among Thai undergraduates and affirms the influence of academic discipline, age, and academic performance. The findings support the need for targeted educational strategies to enhance medication-use literacy and pictogram understanding.

Background: To improve medicines management (MM) in health facilities, Nepal piloted a multipronged intervention - the supervision, performance assessment, and recognition strategy (SPARS). This paper describes a pre-post intervention to assess the SPARS intervention effect on improving MM in selected government health facilities at all levels of care.

Methods: Selected health workers were trained as MM supervisors (MMS) to visit health facilities, assess MM performance, and use the findings to provide support in MM practices. MMS assessed performance using an indicator-based tool containing 25 MM indicators covering five domains: dispensing quality, prescribing quality, stock management, storage management, and ordering and reporting, for a maximum score of 25. From mid-2022 to October 2023, 48 MMS visited 347 government health facilities in 12 randomly selected pilot districts in three provinces. We assessed SPARS indicator performance over 3 supervisory visits.

Results: Between the first and third SPARS visit, we found a significant (p ≤ 0.000) improvement of 123% or a 41.4 percentage-point change in the overall SPARS indicator score from an average of 8.5-18.8. improvements were observed in all five domains. Further, MMS with less than 10 years of experience had a higher impact than more experienced MMS - 39.4 and 33.8 points, respectively. At baseline, no facility had adequate SPARS scores of ≥75%, while 184 facilities (53%) were adequate by the third visit. There was no significant difference in impact measured between provinces; remote and residential facilities; high, medium, and low-level care facilities; and resource-based and behavioural indicators.

Conclusion: Following three supervisory visits, the multipronged intervention significantly improved the overall SPARS score and all 25 indicators assessing performance in stock and storage, ordering and reporting, and dispensing and prescribing quality. We recommend SPARS as an effective approach to strengthen MM in health facilities in Nepal and other low-income countries.

Background: An observational retrospective study was conducted in the primary care setting in Qatar to evaluate the prescribing trends and patterns of antihypertensives in hypertensive patients.

Methods: Included patients were adult patients (aged ≥18 years) diagnosed with essential hypertension and attending Primary Health Care Corporation (PHCC) clinics in Qatar between January 2017 and March 2021. A sample of 2185 patients was randomly selected. The data were collected from PHCC's electronic medical records system, Cerner©.

Results: Angiotensin Converting Enzyme inhibitors (ACEIs) prescriptions decreased from 38% in 2017 to 21% in 2021, and that of Angiotensin Receptor Blockers (ARBs) from 37% in 2017 to 31% in 2021. Patients with prescribed Calcium Channel Blockers (CCBs) increased from 31% in 2017 to 40% in 2021. The prescribing of thiazide diuretics declined from 32% in 2017 to 9% in 2021. In 2017, the most prescribed antihypertensive class was ACEIs (38%), while the least prescribed antihypertensive class was loop diuretics (1.4%). In 2018, the most prescribed class of antihypertensives was CCBs (36%) and the least prescribed was vasodilators (0.1%). In 2019, 2020 and 2021, CCBs were the most prescribed.

Conclusion: These findings are consistent with national and international guidelines for hypertension management and with published literature. Yet, there is still room for improvement to optimise antihypertensive prescribing practices. Prescribers need to address potential gaps and explore ways to enhance their hypertension management, so that patients have access to effective and evidence-based treatments.

Background: Hormonal contraceptives are available over the counter in community pharmacies in Qatar, placing significant responsibility on community pharmacists (CPs) to ensure safe use. The current study aimed to develop and validate a contraceptive dispensing protocol for CPs use in Qatar.

Methods: A scoping review identified suitable protocols, with an initial protocol adapted from The United States Medical Eligibility Criteria for Contraceptive Use, developed by the Centers for Disease Control and Prevention. Validation occurred through a three-round online Delphi technique: one qualitative round and two quantitative rounds. A panel of ten licensed obstetricians and gynecologists in Qatar participated. Qualitative data were thematically analysed, and consensus in quantitative rounds was defined as over 80% participant agreement.

Results: Two major themes emerged: (1) challenges in assessing the appropriateness of items related to protected intercourse, recent childbirth, and cultural sensitivity around sexually transmitted disease-related questions, and (2) positive feedback on screening and simplification recommendations. In the first round, the protocol comprised 31 items. In the second round, 25 of these items reached consensus. Five items that received 70% to 80% agreement were carried forward to a third round, along with one newly added item. Of the six items assessed in the third round, consensus was achieved for five. Consequently, the final protocol consisted of 29 items.

Conclusion: A 29-item protocol was developed and validated to assess women's eligibility for contraceptive use by CPs in Qatar. Future research should target translating the protocol into other languages and conducting cultural adaptation studies. It should also explore the development and testing of a collaborative intervention involving pharmacists and other healthcare providers to deliver comprehensive, multidisciplinary contraceptive services to patients.

Background: Amphotericin B (AmB) remains the cornerstone in the treatment of severe fungal infections. However, selecting an appropriate lipid-based formulation for different clinical scenarios remains a challenge for clinicians and clinical pharmacists.

Methods: Adverse event (AE) reports from the FDA Adverse Event Reporting System (FAERS) database (Q1 2004-Q3 2024) were retrospectively analysed to assess the safety profiles of three lipid formulations of AmB: liposomal amphotericin B (L-AmB), amphotericin B lipid complex (ABLC), and amphotericin B colloidal dispersion (ABCD). The baseline patient characteristics, AE distributions, and prognostic outcomes of severe AEs were examined. SPSS software was used to compare AE occurrences among the three groups.

Results: A total of 3284 patient reports were included, comprising 3108 in the L-AmB group, 142 in the ABLC group, and 34 in the ABCD group. Within 30 days, AEs were reported in 666 cases (L-AmB), 72 cases (ABLC), and 13 cases (ABCD) (P < 0.001). AEs were categorised using the System Organ Class (SOC) and Standardized MedDRA Querie (SMQ). Compared with the L-AmB group, the ABLC group had a significantly higher incidence of hypersensitivity and hypertension; whereas hypokalemia was significantly lower (P < 0.001). Compared to the L-AmB and ABLC groups, the ABCD group had a significantly higher incidence of haematopoietic thrombocytopenia (P < 0.001). Prognostic analysis indicated that the incidence of life-threatening events was significantly higher in the ABCD group than in the L-AmB and ABLC groups (P < 0.001).

Conclusion: The safety profiles of L-AmB, ABLC, and ABCD differ among organ systems. These findings highlight the need for individualised treatment strategies based on drug-specific safety characteristics and patient-specific clinical conditions to ensure optimal drug selection and patient safety.

Background: Community pharmacies have an important role to play in green pharmacy practice. As Sweden has been recognised as a driving force in environmental initiatives in the pharmaceutical sector, the aim of this study was to investigate how environmental sustainability is addressed at company and local level in Swedish pharmacies.

Methods: Using a multi-method approach, we reviewed written material from Swedish pharmacy chains and conducted a survey among community pharmacists. The written material consisted of sustainability reports and responses to email inquiries, answered by the companies' sustainability managers in March 2022. A total of 269 pharmacists responded to the survey, divided into two survey rounds, one in April 2021 and one in November/December 2023. The survey was conducted digitally and disseminated via the chains.

Results: The study identified 24 environmental sustainability measures, whereof three were in force across all pharmacy chains. Key measures were prescription reviews to reduce dispensing of unnecessary medications, management of medical waste from households (mandatory), and fossil-free deliveries. A large majority of the participants reported that providing information on proper medicine use and waste management were part of their daily work. There was a significant change in practice regarding the dispensing of only the amount necessary for the customer's dosing regimen and the sale of plastic bags from 2021 to 2023. Notably, Swedish pharmacies implemented a label for over-the-counter medicines in 2021 that indicates whether the manufacturer is transparent about its manufacturing procedures. However, the survey showed that pharmacists had limited knowledge of what this label meant not only when it was introduced, but also two years later.

Conclusion: Swedish pharmacy chains have made significant progress in implementing sustainability measures. However, there is room for improvement in terms of pharmacists' awareness of the sector's own environmental initiatives and better integration of measures outlined at company level into pharmacy practice.