Journal of Pharmaceutical Policy and Practice最新文献

Background: Substandard and falsified (SF) medicines are a serious threat to public health in low- and middle-income countries (LMICs). Visual inspection of medicines and screening analysis using the Global Pharma Health Fund (GPHF)-Minilab are important in medicine quality surveillance in low-resource settings.

Methods: Recently, 260 medicine samples from Nigeria had been investigated for assay and dissolution according to the United States Pharmacopeia (USP). In the present study, these results were compared to the results of the investigation of the same samples by visual inspection and by GPHF-Minilab analysis by local personnel in Nigeria.

Results: Visual inspection identified many deficiencies of dosage units and packaging information in SF medicines. All four falsified medicines were readily identifiable, primarily from serious spelling errors in the labelling, and from manufacturer names which could not be verified using internet resources. In GPHF-Minilab disintegration testing, two samples did not disintegrate even after 60 min; both were found to fail USP dissolution testing with extreme deviations. Of the 20 samples which deviated in USP assay analysis by more than 20% from the declared API amount, seven (35%) were detected as non-compliant in TLC analysis. Evaluation by TLC image analysis with a recently developed smartphone application (named TLCyzer) increased sensitivity to 62.5% but led to an unacceptably low specificity (75.2%). Additional training of the local personnel improved the results of both TLC analysis and TLCyzer evaluation. Photographs of the visual deficiencies and of the TLC analysis results of the SF medicines are provided as PowerPoint and PDF slides with this publication, for future training courses of pharmacy staff and health workers in LMICs.

Conclusion: Visual inspection, and screening analysis with simple, rapid and inexpensive methods, are important in the surveillance for SF medicines in LMICs. This study provides data on the potential and the limitations of such screenings.

Background: Non-adherence to lipid-lowering agents poses significant risks to patients and diminishes treatment effectiveness. Current understanding of patients' preferences regarding the characteristics of these agents is limited. This study aims to qualitatively identify the barriers to lipid-lowering medication adherence and the factors considered by patients with hypercholesterolemia when choosing lipid-lowering agents, and to inform the design of a medication preference study.

Methods: Face-to-face focus group interviews were conducted with Cantonese-speaking patients diagnosed with hypercholesterolemia in Hong Kong. Patients were recruited by cardiologists at a university-affiliated hospital using convenience sampling. The interviews consisted of three parts: gathering patients' perceptions of disease and medication, identifying important factors in selecting lipid-lowering agents, and completing the medication preference tasks designed using the Discrete Choice Experiment (DCE) method. Thematic analysis was used to categorise the codes derived from the transcripts into higher-order themes.

Results: Twenty patients completed the focus group interviews on the university campus between January and March 2023. Four main themes emerged: medication management issues, patients' medication preferences, structure, and comprehension of preference tasks. Barriers to medication adherence included lack of knowledge, a high pill burden, poor communication with healthcare providers, minimal treatment decision involvement, limited access to medication information, side effects, and forgetfulness. Factors influencing medication choice were treatment regimen (i.e. the route and frequency of administration), effectiveness, side effects, doctors' opinions, drug interactions, and out-of-pocket costs. Despite suggestions for modifying attributes and levels, the medication preference tasks effectively reflected patients' trade-offs.

Conclusions: The identified barriers to medication adherence and the factors influencing medication choice highlight the importance of considering patients' perspectives. These insights could assist decision-makers in selecting medications that align with patient preferences, thereby promoting medication adherence. A large-scale DCE preference study will be conducted in Hong Kong to quantify the relative importance of the attributes of lipid-lowering agents.

Background: Liraglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, has demonstrated efficacy in improving glycemic control and promoting weight loss in clinical trials. However, real-world data from diverse populations, particularly from South Asia, are limited. The study aims to evaluate the long-term efficacy and safety of liraglutide in a real-world setting among Pakistani patients with type 2 diabetes mellitus (T2DM).

Methodology: A retrospective cohort study of 624 patients initiated on liraglutide was conducted. Data were collected at baseline and 6, 12, 18, and 24 months. Primary outcomes were HbA1c and weight changes. Secondary outcomes included fasting plasma glucose, lipid profile, and blood pressure. Statistical analyses were performed using appropriate methods.

Results: In study population the mean HbA1c reduction of -1.45 ± 0.67% was observed at 24 months, with 30.6% achieving HbA1c ≤ 7.5%. A rapid and sustained weight loss of -7.51 kg was achieved, with 27.2% experiencing ≥5% weight loss. Additionally, liraglutide led to a significant reduction in LDL cholesterol, with 46.7% of patients achieving a ≥ 10% reduction at 24 months. Liraglutide was well-tolerated, with a low discontinuation rate of 4.6%.

Conclusion: Liraglutide demonstrated sustained efficacy and safety in a diverse Pakistani population with T2DM, regardless of baseline characteristics. These findings support the use of liraglutide as an effective treatment option for T2DM in real-world clinical practice.

Introduction: Pharmacogenomics (PG), the study of how genetic variations impact individual responses to drugs, has seen significant advancements globally in recent years. Hospital pharmacists play a crucial role in multi-disciplinary teams and understanding their preparedness to deliver PG services is essential for successful integration into the healthcare systems. This study evaluates their knowledge, training and seeks their views on PG testing implementation.

Methods: A cross-sectional study was conducted on hospital pharmacists practising in Southwest London with the sample size determined as 137. The study was ethically approved. A structured, self-administered questionnaire was initially piloted, then distributed using emails with a link to Microsoft Form over a three-month period. It comprised 31 questions covering training levels, confidence, knowledge, perceptions, barriers to implementation and demographics.

Results: A total of 46 responses were received achieving a response rate of 33.6%. The study revealed that 65% of participants had limited familiarity or understanding of PG. Over 50% indicated not receiving previous undergraduate or postgraduate training relevant to PG and accordingly their responses to the PG knowledge questions were lacking. Pharmacists with postgraduate training demonstrated better awareness and knowledge. An overwhelming number of participants envisaged carving a role for themselves favouring those that would complement their expertise in medicine management such as recommending appropriate treatment and dosages and suggestions based on PG testing results. Barriers identified were mostly concerning financial cost and shortage of trained staff to support PG services.

Conclusions: Most surveyed pharmacists were not prepared to deliver PG services and thus require tailored training; nonetheless, they exhibited a positive attitude towards PG suggesting a willingness to bridge learning gaps. This presents an opportunity for relevant organisations to provide necessary training and for universities to enhance the curriculum enabling pharmacists to be involved in PG implementation.

Background: Chronic kidney disease (CKD) is associated with comorbidities and altered pharmacokinetics, making appropriate prescribing, and monitoring necessary to minimise drug-related problems (DRPs). Therefore, this study aimed to describe the drug-utilisation pattern in hospitalised CKD patients.

Methods: An observational study was conducted in hospitalised adult (≥18 years old) CKD patients in the UK using WHO prescribing indicators, from November 2021 to April 2022 in a large teaching hospital in England from admission until discharge. This study used STATA version 16 for analysis.

Results: The mean number of drugs per prescription was 11.1(±5), the percentage of encounters resulting in the prescription of an antibiotic was 62%, the percentage of drugs prescribed by generic name was 90%, the percentage of encounters resulting in the prescription of an injection was 94%, and the percentage of drugs prescribed from essential drugs list or formulary was 89%. The most frequent drug group prescribed Alimentary Tract and Metabolism was 22%. Longer hospital stays, admission to a renal ward, and the number of comorbidities were independently associated with polypharmacy.

Conclusion: Not all prescribing indicators evaluated in this study were in full compliance with WHO recommendations. Polypharmacy was found in most participants which might require interventions to avoid DRPs. Further research is needed to evaluate factors associated with prescribing in the CKD population and prescriber perspectives on decision-making in the context of available guidelines and patient factors.

Background: The implementation of electronic prescription systems has become a crucial advancement in healthcare, intending to enhance the precision, safety, and effectiveness of the prescription process. Electronic prescription systems provide many solutions to reduce prescribing errors by allowing system modifications that streamline the prescribing process to improve communication between healthcare practitioners. In this study, we aimed to explore the effect of electronic prescription system modification on minimising prescribing errors.

Methods: This retrospective quantitative study assessed the effects of electronic prescribing system modification in a tertiary military centre in Saudi Arabia, specifically focusing on decreasing prescribing errors in different hospital departments. Collected data include all prescribing errors that occurred in the inpatient setting during the study period, while exclude prescribing errors for outpatient settings as they have different e-prescribing system. A total of 29,554 patient admissions were analysed to compare the frequency of prescribing errors before and after the introduction of electronic prescriptions modification.

Results: The findings from this study indicate a total reduction in prescribing errors after electronic prescription modifications from 1.43% to 0.51% (p-value < 0.001) across all departments, which is highly significant. Furthermore, there was a significant reduction of 49.8% in the overall prescribing error rate. The overall reduction in total errors occurrences after implementing e-prescription modifications suggests a systemic improvement, even if individual departments showed mixed results.

Conclusion: This study emphasises the advantages of electronic prescribing system modification in improving patient safety and optimising healthcare operations. However, the variance in results across departments highlights the need for tailored modifications and continuous system optimisation. By addressing the specific needs of each department, hospitals can maximise the benefits of e-prescribing system and achieve more consistent reductions in prescribing errors in clinical practice.

Background: Drug expenditure is an important part of health expenditure. Managed Entry Agreement (MEA) is a common strategy implemented in many countries, such as the United States, the United Kingdom, and the European countries to control drug expenditures, especially for new and high-cost drugs. This study aims to explore the appropriate MEA technique for reaching the lowest cost of drug procurement under specified uncertainty of the high-cost drug.

Methods: The cost of drug procurement varied by the MEA techniques will be investigated in the quantitative analysis based on MEA taxonomies and uncertainty in terms of price, use, and effectiveness. Then, the content analysis will be employed to the qualitative analytical part to summarise the matching of appropriate MEA technique with the characteristics of high-cost drug to lower the cost of drug procurement and increase access to high-cost drugs.

Discussion: The rationales for each MEA technique selection are similar across their objectives. MEA can help reduce drug expenditures. Therefore, the budget in health care system could be sustainable and the patient access to high-cost drug could be increased. However, it might not be suitable for some circumstances and should not be implemented to determine drug price or used as regular reimbursement.

Background: An explosion in a Chinese factory in 2016 caused a global shortage of essential broad-spectrum antibiotic piperacillin-tazobactam. Hitherto, no detailed, policy-relevant analysis has been conducted on this major shortage event. Thus, we aimed to (1) investigate causes; (2) describe supply chain challenges; and (3) uncover policy gaps to support possible mitigation actions.

Methods: Applying an analytical framework for security of medical supply chains, we investigated the changing roles of Pfizer-led and Chinese API suppliers. We identified demand surge, capacity reduction and co-ordination failures. Triangulating between scientific literature, corporate, and regulatory documents, we analysed the impact of Western and Chinese policy contexts on supply chain resilience.

Results: We uncovered 'red flags': geographically dispersed manufacturing failures due to complexity of sterile production; undetected supply chain concentration and interlinkages; and Chinese policy-led API supplier consolidation. We found these warning signals were ignored in the absence of a co-ordinated policy framework to identify and mitigate emerging global supply risks. Firstly, policy makers lacked visibility on growing 'volume dependency' in the chain. Secondly, national policy makers lacked a global view of supply risk. Thirdly, we show antibiotic API manufacturing economics were impacted by a number of non-pharmaceutical policy decisions (e.g. state aid, environmental standards, procurement rules) which contributed to supply chain vulnerability.

Conclusions: Our findings suggest possible policy gaps in governance of supply chain resilience. Firstly, disclosure of API suppliers including degree of dependency may better pre-empt bottlenecks, facilitating priority setting for public investments in re-shoring where global API supply currently relies on few, or single plants; secondly, a whole-of-government approach may counter the potential impact of non-pharmaceutical policies on supply chain resilience. Our findings confirm suggestions from previous studies that international data sharing would be beneficial considering the global shortage effects which can emerge from a single point of failure.

Background: Fraud in pharmaceutical tenders is a severe form of corruption that poses a significant threat to public health, patients, and the community. Due to the substantial financial volume in the pharmaceutical sector, vulnerable points in decision-making for market entry and purchase are at risk. As a result, the objective of this study was to measure the level of transparency and risk of corruption in pharmaceuticals' procurement practices in South Wollo, North-East Ethiopia.

Methodology: From October 1 to December 15, 2023, a multi-facility, cross-sectional study was conducted. The participants were pharmaceutical procurement committee (PPC) members. The World Health Organization's (WHO's) standardised interviewer-administered questionnaire was used to collect the data. The collected data was entered, cleaned, processed, and analyzed using Statistical Package for Social Sciences (SPSS) version 27. Both descriptive and inferential statistics (univariate and linear regression analyses) were computed. The relationship between the independent (health facility level) and dependent (level of transparency) variables was determined using beta with a p-value of less than 0.05 and a 95% CI.

Results: One hundred eighty-seven respondents, from 47 health centres (low, medium, and high volume) and 14 hospitals (primary, secondary, and tertiary), participated. The aggregate result showed that pharmaceutical procurement practice was very vulnerable to corruption, with a transparency level of only 33.0% (3.3 out of 10). The univariate analysis demonstrated a significant disparity in the mean transparency scores between health centres and hospitals. The linear regression also showed that for every one standard deviation increase in the facility level, there was an associated 0.39 increase in the transparency level of pharmaceutical procurement (β = 0.39, 95% CI: 0.02-0.04).

Conclusion: The pharmaceutical procurement practice at the health facilities was generally found to be very vulnerable to corruption, which slightly increased with a decrease in facility levels and vice versa.

Introduction: Pharmacogenomics implementation in clinical practice is anticipated to improve our understanding of individual variations in drug response and optimise the safety and efficacy of drug therapy. We aimed to assess the knowledge, perceptions, and readiness of physicians, pharmacists, and nurses in Qatar regarding the implementation of clinical pharmacogenomics.

Methods: A mixed-method study with an explanatory sequential design was conducted. Phase I was the quantitative phase which involved sending an online survey to physicians, pharmacists, and nurses. Phase II was the qualitative phase which involved conducting focus group discussions.

Results: A total of 802 responses were collected, with a response rate of 20%. Only 15.4% of participants had previous pharmacogenomics-related training. The median knowledge score for healthcare professionals was 4 out of 10 denoting low level of knowledge. However, compared to other professions, pharmacists had a higher knowledge score (p-value <0.001) and Doctor of Pharmacy (PharmD) holders scored higher than BSc holders (p-value <0.001). Despite the low level of knowledge, perceptions of healthcare professionals were positive. In addition, the majority believed knowledge of pharmacogenomics is necessary and that counselling patients on pharmacogenomics requires specialised training pharmacogenomic principles in practice. The main themes extracted from the focus group discussions were knowledge, outcome expectations, preparedness, facilitators, barriers, public education, and implementation planning. Regarding readiness, most healthcare professionals reported that they are not currently confident in applying.

Conclusions: Healthcare providers have a low level of knowledge of pharmacogenomics. Despite this, the majority have positive perceptions towards its implementation in practice. Compared to other professionals, pharmacists with a PharmD degree scored higher in the knowledge assessment. Most healthcare providers report low confidence regarding the readiness for the implementation of pharmacogenomics and report a lack of knowledge, specialised training, and clinical guidelines as barriers.