Journal of Pharmaceutical Policy and Practice最新文献

Background: This study's main goal was to closely monitor and record adverse events (AEs) related to the medication Etelcalcetide, which is used to treat secondary hyperparathyroidism (SHPT, which is defined as elevated parathyroid hormone (PTH) levels in response to abnormalities in the calcium, phosphate, and vitamin D homeostasis). Optimising patient safety and offering evidence-based recommendations for the proper use of this medication are the ultimate goals.

Methods: A thorough collection and analysis of reports from the FDA Adverse Event Reporting System (FAERS) database was conducted, encompassing the first quarter of 2014 to the first quarter of 2024. Robust algorithms including as ROR, PRR, BCPNN, and EBGM were employed for proportional analysis, enabling efficient data mining to measure signals linked to AEs related to Etelcalcetide.

Results: Based on the reports gathered, the number of patients in the Etelcalcetide population was found to be 2,472 (5,435 AEs). As expected, the study's findings revealed the occurrence of Decreased blood calcium, Hypophosphatemia, among other AEs, which are in line with the instructions in the medication insert. Furthermore, unforeseen major AEs were noted at the preferred term (PT) level. These included hunt stenosis, Shunt aneurysm, Shunt occlusion, Shunt infection and Peripheral arterial occlusive disease (PAOD) and so on. These results point to the possibility of AEs that are not presently listed in the medication description.

Conclusion: This work successfully identified previously unidentified and novel signals linked to AEs associated with the administration of Etelcalcetide, offering crucial insights into the intricate relationship between AEs and Etelcalcetide use. In the context of Etelcalcetide therapy, the study's findings highlight the vital significance of diligent surveillance and ongoing monitoring for the prompt detection and efficient management of AEs and to enhance overall patient safety and well-being.

Background: Respiratory syncytial virus (RSV) is a significant respiratory pathogen. Despite vaccine availability, uptake remains low, and healthcare professionals play a key role in promoting immunisation. This study aims to evaluate healthcare providers' knowledge, perceptions and practices regarding the RSV vaccine.

Methods: A validated survey was distributed to healthcare professionals. The study questionnaire contained sections to assess sociodemographic characteristics, knowledge of RSV and its vaccines, healthcare professionals' perception towards RSV and its vaccines, and their perception towards the potential barriers against RSV vaccination. The last section assesses physicians' previous practice in dealing with RSV infection.

Results: Over half of the participants (56.6%) had no prior awareness of RSV, though many recognised its potential severity, particularly in vulnerable populations like children and older adults (52.6%). Awareness of FDA-approved RSV vaccines was limited, with only 28.1% of respondents familiar with vaccines intended for older adults. Views on vaccination recommendations for older age groups were divided; 23.7% supported vaccination for those 75 and older, while 31.1% advocated for vaccination in those aged 60-74 at higher risk. Perceived barriers to RSV vaccination were prominent. Most respondents (85.1%) cited concerns about vaccine safety as a key obstacle, and 81.1% identified out-of-pocket costs as a significant barrier. Testing for RSV was infrequent (24.6%), mainly due to a lack of effective treatment. Most participants (96.9%) called for greater awareness and education about RSV vaccines, and 91.2% supported recommending the vaccine if it was available and free.

Conclusion: This study reveals significant gaps in healthcare professionals' knowledge and practices regarding RSV and its vaccines, with substantial barriers to vaccine adoption. Targeted education, improved diagnostics, and addressing vaccine barriers are essential strategies for improving the healthcare response to RSV.

Background: Poor handling practices and infrastructures for vaccine management, especially in remote rural areas, pose a challenge to the accessibility of safe and efficacious vaccines. This study assessed vaccine handling practices and conformity to cold chain systems in Tanzania.

Methods: A cross-sectional study was conducted from March 2022 to October 2022 using temperature loggers, checklists and questionnaires adopted from the WHO Vaccine Management Assessment Tool. The study sites were 35 facilities in Dar es salaam, Kigoma and Mtwara regions in Tanzania. Data was analysed by R statistical software.

Results: A total of 89 vaccine handling personnel with 22 personnel of less than 30 years old were included in this study. Seventy vaccine-handling personnel out of a total of 89 had adequate knowledge and 63 participants had good vaccine-handling practices. Fifty-three participants had no prior training in vaccine handling. Most (80%) of the facilities visited complied with the WHO cold chain storage standard of 2°C to 8°C in one month of observation; however, 29 facilities did not have temperature alarms to alert in cases of temperature changes and 24 facilities had no voltage regulators.

Conclusion: In this study, most of the facilities studied were compliant with WHO vaccine storage temperature requirements over a 30-day period. However, significant gaps were identified, including inadequate infrastructure for emergency situations and a lack of prior training on vaccine handling among the majority of personnel.

Background: Assessing faculty research productivity through scientometric analysis is crucial for academic institutions to promote and enhance research activities. Scientometric analysis guides institutional goals, identifies gaps and faculty contributions, and influences career development in academia. With advancements in the clinical pharmacy and practice field and Qatar's evolving research infrastructure, this study aimed to evaluate the research productivity and quality indicators of a clinical pharmacy and practice department at Qatar University through scientometric analysis.

Methods: Research articles published between 2012 and 2024 were retrieved using Web of Science (WoS) via InCites, Scopus via SciVal, and Google Scholar. Metrics analysed included total publications, journal impact factor, Q ranking, subject area coverage, and collaborations.

Results: Thirty-one faculty members produced 1,266 articles indexed in WoS, 1,270 in Scopus, and 1,737 in Google Scholar. The average annual publication rate was 5 articles per faculty member, resulting to an average of 41 publications per faculty member over their tenure. Active publication years accounted for 85% of faculty tenures. Furthermore, research output and productivity increased steadily, with the highest publication output observed between 2021 and 2023. Most publications appeared in journals with Q1 or Q2 rankings, with the International Journal of Clinical Pharmacy and Research in Social and Administrative Pharmacy being the most frequently targeted outlets. Publications covered diverse topics and subject areas, including pharmacy practice, health education, patient and medication safety, and chronic disease management. Database comparisons revealed differences in retrieval rates, journal impact indicators, and Q-rankings, with Google Scholar having the highest retrieval rate.

Conclusion: This scientometric analysis highlights the research contributions and growth trajectory of clinical pharmacy and practice faculty, emphasising quality and opportunities for future advancements. The findings provide a benchmark for regional and global trends in clinical pharmacy research and offer actionable insights for researchers, academic institutions, and policymakers.

Background: Nepal's Ministry of Health and Population piloted the Supervision, Performance Assessment, and Recognition Strategy (SPARS), a multipronged strategy to improve medicines management practices in health facilities. Medicines management supervisors (MMS) periodically assess facility performance using 25 indicators grouped into 5 domains - prescribing, dispensing, ordering and reporting quality and stock and storage management - and provide targeted on-the-job coaching. This study aimed to determine inter-rater reliability (IRR) and validity for SPARS indicators in Nepali context.

Methods: We assessed IRR and validity scores with three rater teams assessing medicines management in six public health posts. Each team of three MMS and one technical advisor evaluated two facilities, resulting in 24 total assessments. We calculated the mean and median validity and IRR scores for SPARS overall, and by domain and indicator. Acceptable scores were mean validity and IRR scores ≥75%, moderately acceptable were 50-75%, and unacceptable were <50%.

Results: The mean overall IRR (60%) and validity (74%) of all 25 SPARS indicators were significantly different (p < 0.003) but not by domain. Three domains related to dispensing, ordering and reporting, and storage had acceptable mean validity scores, while the prescribing quality domain had an unacceptable mean IRR score. We found significant difference (p < 0.0001) between the indicator IRR and validity acceptability scores. Four (16%) and 12 (48%) of the SPARS indicators had acceptable reproducibility and validity, respectively; 8 (33%) IRR scores and 1 (4%) validity score were unacceptable. Simple indicators (67%) had significantly (p < 0.02) higher reproducibility compared to complex indicators (42%), and higher validity of 80% and 72%, respectively, which was not significant.

Conclusions: This study demonstrated that the SPARS indicators produce moderately accurate findings. Validity was significantly higher than IRR and both need improvement, especially for complex indicators. As such, future SPARS implementation should endeavour to include validity and IRR assessments to help improve the indicators.

Background: Human Papillomavirus (HPV) infections can lead to various cancers globally, and immunization can prevent HPV-associated cancers. This study intended to evaluate university students' knowledge, awareness, and attitudes/beliefs toward HPV and HPV vaccine uptake in Punjab, Pakistan.

Methods: A descriptive cross-sectional study was conducted in ten institutes across six cities using pre-validated questionnaires. Descriptive statistics and Rasch analysis were utilized to describe awareness levels, knowledge, and attitudes scores respectively. Regression analysis was utilized to explore association between demographic factors, knowledge levels, and attitudes/ beliefs. SPSS® (IBM, version 23.0) and Winstep® (version 3.75.0) software were used for analysis.

Results: Out of 1200 students approached, 1056 responded (response rate 88.0%). The mean age of students was 19.5 ± 0.5 years; 31.3% had heard about HPV, 16.4% were aware of the HPV vaccine's availability, and 2.3% were vaccinated against HPV. The mean Rasch knowledge score was -0.368 logits (SD: 0.893; SEM: 0.027), depicting below-average HPV knowledge. The mean Rasch attitudes/beliefs score was 0.049 logits (SD: 1.013; SEM: 0.031), which depicted positive attitudes towards HPV and its vaccination. Females (OR:1.742; 95%CI: 1.352-2.320), health-sciences students (OR: 1.692; 95%CI: 1.290-2.220), and urban residents (OR:1.621; 95%CI: 1.244-2.223) possessed positive attitudes towards HPV vaccination. Recommendations from physicians (Median: 4.0; IQR: 4.0-5.0) followed by parents (Median: 4.0; IQR: 3.0-5.0), and friends (Median: 4.0; IQR: 3.0-4.0) shaped vaccination decisions.

Conclusion: Despite their inadequate knowledge levels and poor vaccine uptake, students showed positive attitudes towards HPV vaccination. Awareness about HPV, including testing and vaccination, should be raised through community outreach programs, social media, and university curricula.

Background: Adverse Events (AE) including both Adverse Drug Reactions (ADRs) and Medication Errors (MEs) are worldwide health issues tackled by Pharmacovigilance (PV) systems. In Lebanon, ADRs and MEs are monitored by the Lebanese National Pharmacovigilance Program (LNPVP) implemented under the supervision of the Lebanese Ministry of Public Health (MoPH) to ensure the post-marketing surveillance of each authorised medication. The objective of this paper is to evaluate the prevalence of detected AEs within the Lebanese population in a descriptive analysis.

Methods: This is a retrospective analysis-based study that describes collected national AE cases for all marketed medications as well as medications in the pre-marketed phase as part of clinical studies in Lebanon, the LNPVP data system spontaneously received that from Marketing Authorisation Holders (MAHs) between 2018 and 2023.

Results: Since the initiation of the LNPVP programme, a total of 21,631 Individual Case Safety Reports (ICSRs) have been processed; 3,855 of which were excluded and the remaining 17,776 ICSRs are the subject of this paper and correspond to 37,768 AEs associated with medications authorised for use in Lebanon. Among respondents, 55.3% were females, whereas 37.9% were associated with males. In addition, the LNPVP has received a total of 1,961 cases of suspected medication errors, constituting 5.2% of the overall reported AEs.

Conclusion: Our results showed that Lebanon, a country that suffers from a turbulent economic and health context, was able to implement a PV system and operate with efficiency while evaluating a 5-year worth of ICSR reports. The dissemination of this information promotes stakeholder awareness by encouraging a collaborative approach among patients, healthcare providers, and regulatory authorities in Lebanon. However, further research is warranted to investigate factors contributing to MEs in Lebanon.

Background: The issue of population access to medicines is relevant worldwide. Pandemics, natural disasters, wars negatively affect the population's access to medicines, as emphasised by the WHO and the UN.

Methods: The analysis of scientific publications in the Ukrainian scientometric databases (NRAT, OUCI); Scopus, Web of Science, Pubmed, Medline, BMJ and Embase; the legal field for providing medical care to patients with CHD and comorbid conditions and its pharmaceutical component. The EML of Europe and Ukraine are compared; the clinical recommendations and pharmacotherapy of European/American Societies of Cardiology (ESC/AHA) and Ukrainian for patients with CHD and comorbid conditions are compared.

Results: The prices of medicines that are not part of the 'Affordable Medicines' program and are included in the EML lists were analysed; their availability for Ukrainian patients in wartime conditions was determined. The legal field of providing medical care to patients with CHD and comorbid conditions has been formed. It was established that not all medicines specified in the EML are registered on the territory of Ukraine and included in the Program of Medical Guarantees (PMG).

Conclusion: The PMG includes most of the EML medicines. The modern pharmacotherapy of CHD and comorbid conditions has a positive impact on the budget of the health care system in clinical practice proposed by the ESC/AHA was determined. The lists of medicines in the PMG in Ukraine, need to be revised on the basis of the Health Technology Assessment for further inclusion in the state program 'Affordable Medicines' for long-term use by patients with CHD and comorbid conditions. These measures will improve the quality of pharmaceutical care for these patients.