Journal of Pharmaceutical Policy and Practice最新文献

Background: Nepal implemented a pilot of the Supervision, Performance Assessment, and Recognition Strategy (SPARS) program aimed to increase health workers' ability to manage medicines through on- the-job training and support from a new cadre of Medicines Management Supervisors (MMS). This study aims to assess the implementation costs.

Methods: Data from the SPARS central database and facilities was analysed to assess the total cost of the SPARS pilot including 293 public health facilities from 12 districts of 3 provinces, from May 2022 until July 2023. We estimated the number of health facilities to achieve a successful performance status, defined as a SPARS score ≥ 18.75 out of 25 (75%) and estimated the cost per facility to reach a successful score.

Results: In total, 293 facilities received 838 visits, performed by 48 MMS for an estimated total cost of $226,531. 124 facilities (44.3%) reached a score of 18.75 points after two or more visits. On average, it costs $1827 USD per facility to reach a successful SPARS score.

Conclusion: This study assesses the costs of implementing SPARS in 12 districts in Nepal. These findings can provide insights into further scaling up SPARS in Nepal or in other countries.

Background: Access to medicine is crucial for the effective functioning of healthcare systems. A robust regulatory framework is necessary to ensure the safety, effectiveness, and availability. However, weak regulatory frameworks persist in many low- and middle-income countries, leasing to the circulation of falsified and substandard medicines as well as anti-competitive restrictions on registering poor-quality medicines, which poses a significant public health threat. This study evaluated the evolution of Zanzibar's medicine regulatory system over the past two decades and identified the key factors contributing to its success by elaborating on the Zanzibar Food and Drug Agency, seeking the expertise of regional, continental, and global experts to assess its regulatory capacity and maturity level.

Methods: This study was conducted at the Zanzibar Food and Drug Agency (ZFDA) in Unguja, Zanzibar, using a retrospective cross-sectional review and qualitative approach. It thoroughly reviewed relevant regulatory documents, including Acts, policies, guidelines, and assessment reports. Data were collected using a standardised checklist and analysed to uncover patterns and insights regarding the evolution of Zanzibar's medicine regulatory system.

Results: This study revealed substantial legal provisions, organisational development, strategic planning, and resource allocation improvements. Notable achievements include establishing a structured organisational framework, developing a comprehensive strategic plan, and implementing a Quality Management System (ISO 9001:2015 certified). The ZFDA also addressed human resource limitations by creating job descriptions and a staff scheme of service, enhancing financial resources through revised fee regulations and government support, and improving infrastructure with new office and laboratory facilities.

Conclusion: Zanzibar's medicine regulations have evolved significantly, with marked regulatory capacity and infrastructure improvements. Future efforts should address the remaining challenges and foster collaboration with regional and international bodies to ensure the continued evolution and effectiveness of Zanzibar's medicine regulatory framework.

Background: Medicine shortages are a global problem. Prior studies have focused on hospitals, and staff views, with less information on community practice. This study aimed to estimate the prevalence of medicine shortages in community pharmacies and potential impact on patients.

Method: Four community pharmacies (two urban, two rural) in Ireland recorded details of prescription request shortages per items dispensed. Data were gathered one study day per month from February to April 2023. A prevalence across sites was estimated and trends examined using a Poisson regression.

Results: There were 76 medicine requests defined as shortages out of 3734 prescription item requests, giving a mean shortage prevalence of 2% (95% CI 1.6-2.5%). There was a non-significant, 17%, increase in shortage rate across the study period (p = 0.256). Higher rates were observed in the two urban pharmacies. In total, 61/76 (80%) of shortages were associated with a delay in patient treatment.

Conclusion: Shortages are prevalent in community pharmacy and cause delays in patient treatment and increase in workload of pharmacy staff. Regulatory initiatives to address the issue at a manufacturer level have been proposed, although workforce planning, resourcing and professional role expansion are also required to protect pharmacy staff and patient outcomes.

Background: The COVID-19 pandemic has greatly influenced many aspects of everyday life, particularly that of the general population health. In order to better understand the potential impacts of the COVID-19 pandemic on people's attitudes toward medicines use, a quantitative investigation was conducted in a territory of Sardinia region, Italy.

Methods: Stratification of the random multilevel population sample was based on gender, age range, and territory. The methodological strategy to verify the potential approach changes towards medicines due to the COVID-19 pandemic consisted of oral interviews with adult citizens and unrecognizability preservation. Investigation, also supported by a study completed before the insurgence of the pandemic about taking medicines, interrupting treatments without consulting, and reading the information leaflet, allowed to explore citizens' attitudes before and during pandemic, and changing.

Results: The most relevant findings are the tendency towards a higher occurrence of self-interruption of treatments and an increased interest in the information leaflet (package leaflet), but not an increased self-administration of medicines.

Conclusions: These results indicate new indirect effects of the COVID-19 pandemic that could exert an additional impact on the state of citizens' health and health systems. The study, with reference to prophylactic medical treatments and based on some considerations concerning the pandemic from its insurgence to today, also provides solutions for related problems for the present or future periods of health emergencies.

Background: Pharmacogenetic testing improves the efficacy and safety of antidepressant pharmacotherapy for moderate-severe major depressive disorder by identifying genetic variations that influence medication metabolism, and adjusting treatment regimens accordingly. This study aims to assess the cost-effectiveness of implementing a pharmacogenetic testing approach to guide the prescription of antidepressants.

Methods: From the public hospital perspective, we developed a two-stage decision tree diagram of a short-term 6-week follow up, and a lifetime Markov model with 3-month cycles. The analysis compared the current standard of care with the alternative strategy of Pharmacogenetic-guided (multi-gene panel) testing in adult patients with moderate-severe major depressive disorder. Clinical outcomes and utilities were obtained from published studies, while healthcare costs were locally available. The short-term incremental cost-effectiveness ratio was against treatment response without side effects and without relapse, and against treatment response with/without side effects and without relapse. The long-term incremental cost-effectiveness ratio was against the quality-adjusted life year gained and years of life saved.

Results: Adopting the pharmacogenetic-guided therapy for adult patients with moderate-severe major depressive disorder in Qatar resulted in cost savings of Qatari Riyal 2,289 (95% confidence interval, -22,654-26,340) for the health system. In the short term, the pharmacogenetic-guided testing was associated with higher response rates without side effects and without relapse (mean difference 0.10, 95% confidence interval 0.09-0.15) and higher response rates with or without side effects and without relapse (mean difference 0.05, 95% confidence interval 0.04-0.06). For long term, the pharmacogenetic-guided testing resulted in 0.13 years of life saved and 0.06 quality-adjusted life year gained, per person, along with cost savings of Qatari Riyal 46,215 (95% confidence interval-15,744-101,758). The sensitivity analyses confirmed the robustness of the model results.

Conclusion: Implementing pharmacogenetic testing to guide antidepressant use was found to improve population health outcomes, while also significantly reducing health system costs.

Background: This study aims to identify the factors that influence medical workers' enthusiasm for reporting adverse drug reactions (ADRs). Understanding these factors is essential to implement targeted interventions that can improve and refine pharmacovigilance systems.

Methods: We adopted the Capability, Opportunity, Motivation, and Behavior model (COM-B) model as the theoretical framework and conducted qualitative research using in-depth interviews with clinicians, nurses, pharmacists, and administrators. 24 one-on-one interviews were conducted and audio-recorded. The interviews were transcribed verbatim, and subjected to thematic analysis to uncover the key factors affecting ADR reporting among medical staff.

Results: The participation included 24 healthcare workers from six different healthcare organisations. Analysis revealed that decreased motivation to report ADRs was due to inadequate judgment or inconsistent judgment criteria within the capability domain, poor awareness of ADRs and deficient communication skills within the psychological domain, unclear responsibilities within the motivation domain, and limited or no access to necessary resources within the opportunity domain. Facilitators of ADR reporting included sufficient cognitive and operational abilities, spontaneous and incentivized motivation, clear responsibilities and role expectations, and robust social support.

Conclusion: There is a critical need to develop comprehensive interventions that address the identified factors influencing ADR reporting. By improving the motivation of medical staff to report ADRs, the pharmacovigilance system can be significantly improved.

The Pharmacovigilance system is aimed to promote and protect public health by ensuring the availability of essential medicines in the market and reducing the burden of ADRs. Pharmacovigilance is derived from two words; pharamakon rooted in the Greek word that means medicinal substance and vigilia rooted in the Latin word to keep watch. This concept evolved after Hannah Greener died in 1848 after having a tonsillectomy with chloroform. As a result of the Thalidomide tragedy, drug regulation in Europe has forever changed. From its earliest beginnings to its current state, pharmacovigilance has been shaped by several major milestones. The historical phases of pharmacovigilance can help us understand the value of pharmacovigilance and identify the challenges that lie ahead. Despite advancements in technology, it is imperative that we continue to strive for excellence in pharmacovigilance to ensure all individuals' safety and health. Through collaboration between the Council for International Organizations of Medical Sciences (CIOMS), World Health Organization (WHO), and the International Conference on Harmonization (ICH), Pharmacovigilance has evolved into a regulatory activity.

Background: Dry powder inhalers (DPIs) are commonly used among patients with Chronic Obstructive Pulmonary Disease (COPD). These inhalers are breath-actuated, and require patients to generate sufficient peak inspiratory flow (PIF) to disaggregate the drug powder into respirable fine particles and deliver it to the lower airway tracts. Inhaler personalisation based on PIF among DPI users has not been studied in Malaysia, thus we conducted the present pilot study to determine the feasibility of conducting such research among COPD patients.

Methods: This was an open-label pilot randomised control trial, conducted from June 2021-January 2022 at the respiratory clinic of Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia. Measurement of PIF was performed with In-Check DIAL G16 among adult COPD patients treated with DPI and had suboptimal PIF. Eligible subjects were randomised using block randomisation into two groups, either the interventional group or the control group.

Results: Twenty-two COPD patients fulfilled the study criteria and were randomised to intervention (n = 11) and control (n = 11) groups. For the interventional group, there were statistically significant improvements between baseline and at 12 weeks for both FEV₁ and CAT scores. The mean (% predicted) FEV₁ were 54.6 ± 20.4% and 56.6 ± 19.8% (p = 0.026), pre-and post-intervention. The mean CAT score at baseline was 24.4 ± 5.8 and reduced to 19.6 ± 4.4 at 12 weeks (p = 0.012). For the control group, the mean (% predicted) FEV₁ at baseline was 58.0 ± 21.9% and 56.5 ± 20.7% at 12 weeks, with no statistical significance difference (p = 0.143). However, there was a statistically significant difference in CAT scores at baseline and 12 weeks, with a mean of 26.5 ± 6.1 and 23.3 ± 5.6, respectively (p = 0.010).

Conclusion: The findings from the present pilot RCT highlighted that inhaler personalisation based on PIF among COPD patients was feasible and practical.

Background: Workplace bullying is a widespread occurrence that has been identified as a significant concern in enterprises all around the world. The research aimed to examine the impact of workplace bullying on self-esteem among pharmacists with the moderating role of defense styles.

Method: This study utilised stratified random sampling to include 498 pharmacists from public and private hospitals in Sanaa, Yemen. Data was collected through structured questionnaires on demographics, workplace bullying (NAQ-R), self-esteem (Rosenberg scale), and defense styles (DSQ-40). Data analysis involved descriptive statistics, regression, correlation, T-tests, and moderation analysis.

Results: Results of the current study showed that workplace bullying has a significant negative impact on self-esteem, and defense styles do not moderate self-esteem and workplace bullying. Female pharmacists have higher workplace bullying and lower self-esteem. Gender differences in defense styles have insignificant results.

Conclusion: This research supports overcoming workplace bullying among employees in any organisation. Comprehensive anti-bullying policies must be developed and implemented to create a safe and supportive workplace for pharmacists. Anti-bullying strategies that promote gender equality address power disparities and guarantee that female employees have access to particular resources for support should incorporate gender-sensitive practices. In order to reduce the adverse effects of workplace bullying on mental health and boost the self-esteem of victims by offering counseling services, frequent training sessions, and seminars. It is also helpful in enhancing self-esteem and improving interpersonal relationships among employees.