Journal of Pharmaceutical Policy and Practice最新文献

Background: Substandard and falsified medicines (SFMs) continue to pose a significant threat to public health globally. However, there is limited evidence on use of SFMs for both humans and animals particularly in low- and middle-income countries such as Uganda. The study assessed knowledge, attitudes and practices on SFMs for human and animal use in Wakiso District, Uganda.

Methods: A cross-sectional survey that employed a structured questionnaire among 432 community members was conducted in Wakiso District. The questionnaire assessed knowledge, attitudes and practices on SFMs for human and animal use. Data was collected using the KoboCollect mobile application hosted on tablet computers. Univariate data analysis was conducted in Stata Version 14.

Results: The majority of respondents (83%) stated that they had heard about SFMs although only 31% could correctly define them. Only 7% of the respondents accurately identified a falsified medicine despite 24% stating that they believed they could recognise SFMs. Almost two-thirds (62% and 60%) of the respondents disagreed that most human and animal SFMs respectively were as good as genuine medicines. Most of the respondents strongly agreed or agreed that SFMs could be very dangerous for humans (96%) and for animals (95%). Respondents reported having bought products they suspected were SFMs for use in humans (14%) and animals (24%). Seeking health worker advice on the medicine brand (40%) / getting medicine from a trustworthy pharmacy (34%) for humans; and seeking a veterinary officer's advice for choosing the brand (43%) / getting medicine from a trustworthy veterinary pharmacist (29%) for animals were the most common measures respondents reported taking to ensure the medicine bought was genuine. Only 25% of the respondents mentioned informing a health worker and only 4% had reported suspicions of SFMs to the National Drug Authority.

Conclusion: Despite commendable attitudes, there was generally limited knowledge and related poor practices regarding SFMs for both humans and animals. There is a need for key stakeholder engagement involving health and regulatory authorities in both human and animal medicine to increase awareness on SFMs to minimise the potential risks to health among the community.

The healthcare system in Libya faces significant challenges due to political instability, fragmented infrastructure, and inconsistent medical practices. Clinical Practice Guidelines (CPGs) serve as essential tools for standardising care, ensuring evidence-based treatment, and optimising healthcare resources. In Libya, the lack of structured guidelines has contributed to disparities in disease management, affecting patient outcomes and overall healthcare efficiency. This commentary explores the critical need for CPGs in Libya, highlighting their potential to improve healthcare delivery, minimise variability in treatment, and enhance patient safety. While implementation poses challenges, including centralisation, limited research capacity, and resource constraints, integrating CPGs through a phased implementation framework could be a transformative step toward a more resilient and equitable healthcare system. By fostering collaboration among policymakers, healthcare professionals, and international organisations, Libya can lay the foundation for a systematic approach to disease management, ultimately improving the quality of care for its population. Healthcare reform in Libya is urgently needed, and strategic investments in CPG development and dissemination could drive the necessary transformation in Libyan healthcare.

Background: Pharmacogenomics is used to optimise patient drug therapy. The role of community pharmacists in the implementation of pharmacogenomics services is emerging. This study evaluated the knowledge, attitude, perception, and self-reported confidence of community pharmacists towards pharmacogenomics services.

Methods: A cross-sectional study was conducted among community pharmacists in Penang, Malaysia, using a self-administered, validated and pre-tested questionnaire. Data were collected from March 2022 to April 2022, and analysed using both descriptive and inferential analyses.

Results: One hundred and ten questionnaires were included in this study (response rate 65.5%). Only 14.5% had previous pharmacogenomics training, but 56.4% indicated interest to attend future pharmacogenomics training. Overall, respondents have low knowledge of pharmacogenomics, with higher knowledge score observed among those with previous pharmacogenomics training (median score: 10.5 [7-15] vs 9.0 [1-16], p = 0.018) and those with interest in future training (10.0 [4-16] vs 9.0 [1-16], p = 0.001). Median perception score was 32 out 45, indicating a good perception towards pharmacogenomics. Median self-reported confidence score was 23 out of 40, corresponding to a low self-reported confidence. Self-reported confidence was higher among those with previous pharmacogenomics training (28.0 [17-33] vs 22.0 [0-40], p = 0.021) and those with interest in attending future pharmacogenomics training (24.0 [0-40] vs 19.0 [0-39], p = 0.010). Barriers to implementation of pharmacogenomics are lack of knowledge (84.5%), lack of guidelines (83.6%), and lack of reimbursement (75.4%).

Conclusion: Community pharmacists have a low knowledge, and a low self-reported confidence towards pharmacogenomics services. Previous pharmacogenomics training and interest in attending pharmacogenomics training was associated with higher knowledge, attitude, perception, and self-reported confidence scores. Training of community pharmacists, development of local pharmacogenomics guidelines and design of a workable reimbursement plan for pharmacogenomics services are recommended.

Introduction: The United States began drug pricing negotiations in 2024 under the Affordable Care Act. Evaluating the therapeutic benefit of drugs will help guide pricing decisions and are an opportunity to improve healthcare affordability.

Discussion: We conducted a cross-sectional study of the 50 most expensive drugs by dosage unit covered by Medicare Part B, Medicare Part D, and Medicaid in 2022. We reported their level of clinical benefit as evaluated by health technology assessment agencies in France and Germany, their level of innovation as rated by the Food and Drug Administration of the United States, and their safety and effectiveness ratings as measured by Prescrire International, an independent French organisation that evaluates medicines. Our study found that among the 50 most expensive drugs in the U.S. covered by Medicare and Medicaid in 2022, 28 (56%) were rated by French and German HTAs as having low therapeutic benefit and most (n = 20; 40%) were rated by Prescrire International as having poor effectiveness-safety ratings. Almost all (n = 48; 96%) drugs were ineligible under current exclusion criteria for price negotiations.

Conclusion: Many of the most expensive drugs were rated as having low added clinical benefit. As the US begins price negotiations under the Inflation Reduction Act, understanding the clinical value of drugs may help inform debates over drug affordability.

Background: The global proliferation of unregistered and falsified medicinal products poses significant public health risks. In Malaysia, previous studies have shown concerning prevalence rates but are often limited to specific populations and targeted product brands, restricting the generalisability of the findings. This study aimed to determine the prevalence of unregistered and falsified medicinal products in Malaysian community pharmacies, General Practitioner (GP) clinics, and commercial premises, and to identify associated factors.

Methods: A cross-sectional study was conducted in Malaysia from March to November 2023. Medicinal products were sampled from community pharmacies, GP clinics, and commercial premises. Premises were selected using proportionate stratified random sampling and products within premises using convenience sampling. The MAL registration number and hologram on these products were analysed for registration status and authenticity. Data were analysed using descriptive and non-parametric tests (SPSS v.29), with p < 0.05 considered statistically significant.

Results: An examination of 27,137 samples from 1688 premises across Malaysia identified 270 unregistered and 30 falsified products. The prevalence of unregistered products was 0.11% in community pharmacies, 0.18% in GP clinics, and 2.95% in commercial premises. Falsified products were absent in community pharmacies and GP clinics but constituted 0.36% in commercial premises. Logistic regression revealed that region and premise category were significantly associated with the presence of unregistered and falsified products.

Conclusion: Unregistered and/or falsified medicines were present in all premise types, with higher prevalence in commercial premises. Enhanced efforts by enforcement authorities and stakeholders are necessary to improve the quality of medicine in Malaysia.

Background: Drug-related problems (DRPs) are a major health concern, with half being preventable and potentially resolvable through the application of pharmaceutical care (PC). However, performing PC to all hospitalised patients is unfeasible due to staff shortages coupled with an increasing number of patients. Hence, a risk score for identifying patients at high risk of DRPs is needed. This study aimed to develop and validate a DRP risk score for hospitalised patients.

Method: A prospective cohort study was conducted in a tertiary hospital in Northern Thailand. Adult patients (≥ 18 years) admitted to medical wards were included. DRPs were identified by clinical pharmacists specialising in internal medicine. Multivariable logistic regression analysis was used to construct a risk score. The score was validated using bootstrapping, and three risk groups were created based on both probability and severity. Score performance was assessed with the area under the receiver operating characteristic curve (AUROC), calibration plot, sensitivity, and specificity.

Results: Among 1350 eligible admissions, 155 (11.48%) experienced at least one clinically preventable DRP. The DRP risk score included 6 predictors, namely age ≥ 65 years, chronic cardiac disease, number of drugs used prior to admission, parenteral administration (excluding parenteral nutrition), drugs with special instructions, and drugs with a high potential for drug-drug interactions. The AUROC was 0.709 (95% CI 0.672, 0.751), with good calibration (calibration slope of 0.928, intercept 0.004). Patients with a score < 4 were classified as low risk, while score ≥ 8 indicated high risk. A score of 4 yielded a sensitivity of 93.55% and a specificity of 34.48%, whereas a score of 8 demonstrated a sensitivity of 43.87% and a specificity of 83.01%.

Conclusions: The DRP risk score has the potential to identify patients at risk of DRPs. External validation is needed to enhance its generalisability. Integration into automated systems may support timely pharmacist interventions.

Background: As the prevalence of drug shortages has markedly escalated in recent years, this study seeks to investigate the associated clinical implications and burdens in Austria, Germany and Kosovo where healthcare systems differ significantly.

Methods: The research was conducted as a trinational, multiple-methods study utilising questionnaires and in-depth interviews for different stakeholders, including patients, physicians, pharmacists and manufacturers. Descriptive statistics were applied to summarise and analyse the quantitative dataset, providing key insights into central tendencies and overall data distribution, while qualitative data were analysed using the summarising approach based on Mayring's qualitative content analysis.

Results: Manufacturers expressed concerns regarding the intense pressure on pricing amid global inflation. Proposed mitigation strategies were anticipated to incur higher costs, with increased stockpiling in one major country adversely affecting others. Pharmacists across all three nations reported significant disruptions to their clinical practice, with up to fifty per cent of patient encounters being affected by drug shortages, requiring considerable amounts of time to resolve. They expressed feelings of frustration and anger, citing bureaucratic obstacles and excessive regulation as impediments to effective problem-solving. Physicians reported similar challenges in their practice, often resorting to self-initiated solutions and advocating for improved information regarding drug availability. While most patients have been exposed to drug shortages, the majority of these issues were resolved with moderate interruptions to their therapy. The root causes of these problems were primarily attributed to political factors.

Conclusion: The results show that drug shortages have significantly disrupted clinical practice across all three countries, with pharmacists and physicians reporting major impacts on patient care and increased time spent resolving issues. Economic pressures, political factors and regulatory obstacles were identified as key causes exacerbating the crisis and highlighting the need for coordinated mitigation strategies.

Background: Recent regulatory changes in Australia have emphasised system-level approaches to ensure appropriate psychotropic medication use in residential aged care homes. This study explored quality improvement processes related to psychotropic medication use in Australian residential aged care homes.

Methods: This qualitative study used in-depth semi-structured interviews with a maximum variation sample of key stakeholders involved in psychotropic medication use at organisations operating facilities in metropolitan and regional areas in four Australian states. The interviews were transcribed verbatim and thematically analysed using both inductive and deductive approaches by two researchers using a framework developed for learning health systems.

Results: Stakeholders (n = 33) included nurses, occupational therapists, pharmacists, medical practitioners, residents and caregivers. Identified themes were (i) regulation was driving change in organisational policies and procedures, and (ii) aged care organisations were enhancing quality improvement systems for psychotropic medications. Many of the requirements of successful healthcare quality improvement systems were present within the aged care organisations, including alignment of core values and presence of key ethical, legal and policy infrastructure. There are opportunities for better use of clinical data to improve care, especially in terms of learning from the data and implementing tailored change. The challenges identified by participants included navigating the perceived tension between compliance and quality, and aligning the goals and processes of all health professionals.

Conclusions: Recent changes in policies, procedures and infrastructure have provided clearer oversight of psychotropic medication use. Individual and system approaches to psychotropic medication use in aged care have shifted. Key opportunities for improving use of psychotropic medications within aged care organisations include improving the capacity to use local data to improve care and building interdisciplinary teams to facilitate collaborative care.

Background: Epilepsy affects approximately 65 million individuals globally, with medication adherence a critical determinant of seizure control and quality of life (QoL). Community pharmacists, with their accessibility and expertise, are well positioned to support adherence and patient education. However, little is known about the interplay between adherence, readiness for change, and QoL in patients with epilepsy (PWE) in Cyprus. This study is the first comprehensive investigation in Cyprus, addressing this evidence gap and highlighting opportunities for pharmacist-led interventions.

Methods: This cross-sectional study (Sep 2022 - Oct 2023) was conducted at Limassol General Hospital. Greek-speaking adult PWE (N = 85) were assessed via semi-structured telephone interviews using validated tools: Morisky Medication Adherence Scale (MMAS-8), Medication Adherence Report Scale (MARS-5), Readiness for Change Ruler, and Quality of Life in Epilepsy Inventory (QOLIE-31). Ethical approval was obtained from the Cyprus National Bioethics Committee (EEBK EP2019.01.130). Statistical analyses included t-tests, ANOVA, and binary logistic regression using SPSS v28 (p < 0.05).

Results: High adherence was reported by 55.3% (MMAS-8) and 63.5% (MARS-5). Adherence type was significantly associated with QoL (Kruskal-Wallis H = 11.427, p = 0.010), with mixed non-adherence linked to poorer QoL (Bonferroni p = 0.014). The mean QOLIE-31 score was 75.3 (SD = 19.91), significantly higher than Greek (69.6; p = 0.010, Cohen's D = 0.286) and U.S. (62.9, p < 0.001, Cohen's D = 0.623) reference values. Employment (p = 0.009) was positively associated with QoL. Higher MARS-5 scores (≥4.8) and high/medium MMAS-8 scores (≥6) were significant predictors of better QoL (MARS-5: p = 0.003, OR = 4.826, 95% CI 1.738-13.401; MMAS-8: p = 0.004, OR = 7.125, 95% CI 1.899-26.729). Readiness for change was high (mean 9.48/10), largely driven by trust in physicians.

Conclusion: This Cyprus-based study demonstrates strong associations between adherence, sociodemographic factors, and QoL in PWE. The novel adherence sub-classification provides valuable insights for personalised care. Community pharmacists can play a pivotal role in improving adherence, delivering patient-centred education, and enhancing epilepsy management via integrated multidisciplinary care.

Background: Community pharmacists (CPs) are crucial in the healthcare system, particularly in providing culturally sensitive care to diverse populations.

Method: This cross-sectional study assessed the cultural competence and culturally competent behaviours of 360 licensed CPs practicing in Dubai, Sharjah, and Ajman, focusing on the influence of demographic characteristics, training, and workplace support.

Result: Most participants were aged 31-40, mostly non-Arab and bilingual. Although 88.9% had lived abroad for over three years, only 24.4% viewed themselves as culturally competent. The mean cultural awareness score was 44.69, indicating moderate to high awareness. An independent samples t-test revealed that CPs who had received cultural diversity training scored significantly higher on the cultural awareness scale (M = 46.17, SD = 9.84) than those without training (M = 43.82, SD = 10.29), t(358) = 2.121, p = .035. A statistically significant association was found between previous cultural diversity training and self-perceived competence (χ²(4) = 19.933, p < .001). Furthermore, a strong association was observed between perceived adequacy of staffing and workflow and self-perceived competence (χ²(8) = 37.523, p < .001; Cramér's V = 0.228). Additionally, one-way ANOVA tests showed no significant differences in cultural competence behaviour scores observed across demographic and workplace variables.

Conclusion: This study highlights the need for cultural competence training for CPs to improve patient-centred care in diverse healthcare environments in the United Arab Emirates.