Academia-pharmaceutical industry linkage: An academic perspective.

Background: The pharmaceutical sector in Pakistan has grown over a period, however, there are several barriers in the framework governing the growth of the country's pharmaceuticals. The lack of academia-industry linkage (AIL) is among the critical barriers; hence the focus of the study is to find out the reasons for the lack in the above collaboration. Understanding barriers may help their redressal. Method: This qualitative phenomenology-based study has been conducted in the most prominent pharmacy institutes, located in Lahore, Islamabad, Peshawar, Sargodha, and Quetta. Academic participants, with a minimum experience of 10 years and designation of assistant professor or above were recruited with a two-stage selection process, purposive sampling and snowball sampling. The data were collected using semi-structured interviews with academic experts. Thematic content analysis was employed to conclude the data. Results: Analysis of data yielded 8 themes with 18 codes. The main reasons for neglected AIL were explained by a partial or complete lack of industrial research and development activities. Other key factors for the scarcity of AILs were the lack of positive attitude from both industry and academia, applied research in academics, and the research and development of the new molecules in the pharmaceutical industry. Support by the government and the drug regulatory authority of Pakistan in terms of regulatory and academic policies was also perceived to be absent. New horizons in research and development could be opened by providing applied research to industry, including but not limited to new molecule development. Conclusion: Academia-industry linkage could be boosted with government-backed funded projects and policies. Academia should focus on the industrial-demanded applied research.

Trends in antidiabetic drug use and expenditure in public hospitals in Northwest China, 2012-21: a case study of Gansu Province.

BACKGROUND: Since the twenty-first century, the prevalence of diabetes has risen globally year by year. In Gansu Province, an economically underdeveloped province in northwest China, the cost of drugs for diabetes patients accounted for one-third of their total drug costs. To fundamentally reduce national drug expenditures and the burden of medication on the population, the relevant departments of government have continued to reform and improve drug policies. This study aimed to analyse long-term trends in antidiabetic drug use and expenditure in Gansu Province from 2012 to 2021 and to explore the role of pharmaceutical policy. METHODS: Data were obtained from the provincial centralised bidding and purchasing (CBP) platform. Drug use was quantified using the anatomical therapeutic chemistry/defined daily dose (ATC/DDD) method and standardised by DDD per 1000 inhabitants per day (DID), and drug expenditure was expressed in terms of the total amount and defined daily cost (DDC). Linear regression was used to analyse the trends and magnitude of drug use and expenditure. RESULTS: The overall trend in the use and expenditure of antidiabetic drugs was on the rise, with the use increasing from 1.04 in 2012 to 16.02 DID in 2021 and the expenditure increasing from 48.36 in 2012 to 496.42 million yuan in 2021 (from 7.66 to 76.95 million USD). Some new and expensive drugs changed in the use pattern, and their use and expenditure shares (as the percentage of all antidiabetic drugs) increased from 0 to 11.17% and 11.37%, but insulins and analogues and biguanides remained the most used drug class. The DDC of oral drugs all showed a decreasing trend, but essential medicines (EMs) and medical insurance drugs DDC gradually decreased with increasing use. The price reduction of the bid-winning drugs was over 40%, and the top three drugs were glimepiride 2mg/30, acarbose 50mg/30 and acarbose 100mg/30. CONCLUSIONS: The implementation of pharmaceutical policies has significantly increased drug use and expenditure while reducing drug prices, and the introduction of novel drugs and updated treatment guidelines has led to changes in use patterns.

Patient perspectives on pharmacogenomic (PGx) testing for antidepressant prescribing in primary care: a qualitative description study.

Many patients with major depressive disorder (MDD) try multiple antidepressants before finding one that works well and is tolerable. Pharmacogenomic (PGx) testing was developed to facilitate more efficacious prescribing. This technology has not been robustly implemented clinically. Patient perspectives are critical to policy decisions, but the views of patients with MDD about the use of PGx testing to guide antidepressant prescribing have not been extensively examined, particularly in publicly funded healthcare systems. The purpose of this qualitative description study was to produce actionable patient perspectives evidence to inform future technology assessment of PGx testing. We conducted semi-structured interviews with 21 adults with MDD for which antidepressants were indicated in Ontario, Canada, and used the Ontario Decision Determinants Framework to conduct an unconstrained deductive content analysis. Patients expressed views about the overall clinical benefit of PGx testing in depression care, preferences for deployment of testing, perspectives on ethical considerations, opinions about equity and patient care, and beliefs regarding the feasibility of adopting PGx testing into the healthcare system. They also worried about the possibility of conflicts of interest between PGx test manufacturers and pharmaceutical companies. This study provides policymakers with patient priorities to facilitate the development of patient-centred policies. It highlights that formal adoption of PGx testing into the healthcare system requires a focus on equity of access and health outcomes.

Understanding Australian pharmacy degree holders' job preferences through the lens of motivation-hygiene theory.

Increasing the contribution of pharmacists to primary care has been long discussed, particularly in the context of health workforce shortages and the push to better integrate all providers across primary care. This study examines the employment preferences of Australian pharmacy degree holders (PDHs) elicited through a discrete choice experiment (DCE), to better understand the drivers of current labour force choices. A labelled DCE was developed incorporating the six employment sectors: hospital pharmacy, community pharmacy, primary healthcare settings, pharmaceutical industry, government/academia, and non-pharmacy-related sector. Each alternative was described by five attributes using Herzberg's Two Factor Theory as a conceptual framework. They include motivators - role and career opportunities, and hygiene factors-flexible work schedule, geographic location, and salary. Unforced choice data were analysed using conditional logit and mixed logit models. Based on a sample of 678 PDHs in Australia, our findings indicated pharmaceutical industry is the least preferred sector, followed by non-pharmacy-related sector. Motivators in the form of role and career opportunities are the most important attributes in hospital pharmacy while hygiene factors - geographic location and salary significantly drive the choice of community pharmacy and primary care settings. We provided evidence of a willingness to adopt expanded roles in community pharmacy. This unique interpretation of the key drivers of employment preference in light of motivators and hygiene factors provides policy makers with important information when designing policies to attract and retain PDHs across employment sectors.

Pharmacist access and training process for residency in Hospital Pharmacy in Argentina. / Proceso para el acceso y formación del farmacéutico a la residencia en Farmacia Hospitalaria en Argentina.

Hospital Pharmacy worldwide has proven to be a crucial element in healthcare. In Latin America, it draws inspiration from two main models: United States, which promoted clinical pharmacy and later pharmaceutical care, and Spain, which shares similar healthcare practices and the added advantage of a common language. Both models influenced the implementation of Hospital Pharmacy residencies in Argentina since the 1980s. Hospital Pharmacy residencies in Argentina constitute a paid system of intensive postgraduate training on a full-time basis with exclusive dedication. They are carried out in 11 provinces across Argentina in services with recognized teaching experience. Currently, there are 46 locations with a total of 75 annual vacancies for applicants. The objective of Hospital Pharmacy residencies is to train pharmaceutical professionals with the necessary competencies to ensure the care of patients through the optimization of the safe, effective, and efficient use of medications and healthcare products tailored to each patient's individual therapy. Hospital Pharmacy residencies have demonstrated that pharmacists acquire specialized training that can be decisive in influencing healthcare policies related to the safe use of medications and healthcare products. Therefore, actions to promote and encourage interest in this field among pharmaceutical professionals are necessary, involving scientific societies, universities, pharmaceutical associations, and the political sphere.

Negative impact of a health insurer-mandated de-simplification from a single-tablet regimen to a two-tablet regimen.

OBJECTIVES: Antiretroviral therapy (ART) accounts for a considerable proportion of HIV care expenses. In June 2021, a Dutch healthcare insurer implemented a mandatory policy to de-simplify branded RPV/TDF/FTC (Eviplera®) into a two-tablet regimen containing rilpivirine (Edurant®) plus generic TDF/FTC as part of cost-saving measures. The objectives of this study were to evaluate (1) the acceptance of this policy, (2) the trends in antiretroviral therapy dispensation, and (3) cost developments. DESIGN: A retrospective database study. METHODS: In this study, medication dispensation data were obtained from the Dutch Foundation for Pharmaceutical Statistics (SFK). This database covers 98% of all medication dispensations from Dutch pharmacies including people with HIV who receive ART. We received pseudonymized data exclusively from individuals insured by the insurer for the years 2020-2022. Costs were calculated using Dutch drug prices for each year. RESULTS: In June 2021, 128 people with HIV were on branded RPV/TDF/FTC. Following the policy implementation, 59 (46%) had switched to RPV + generic TDF/FTC, but after 1.5 years, only 17/128 individuals (13%) used the proposed two-tablet regimen. The other 111/128 used RPV/TDF/FTC with prescriptions for 'medical necessity' (n = 29), switched to RPV/TAF/FTC (n = 51), or other ART (n = 31). Despite expectations of cost-savings, costs increased from €72,988 in May 2021 to €75,649 in May 2022. CONCLUSIONS: A mandatory switch from an STR to a TTR in people with HIV proved unsuccessful, marked by low acceptance, and increased costs after one year. This underscores the necessity of incorporating patient and prescriber involvement in changing medication policies.

Assessing the Time Evolution of COVID-19 Effective Reproduction Number in Brazil.

In this paper, we use a Bayesian method to estimate the effective reproduction number ( R ( t ) ), in the context of monitoring the time evolution of the COVID-19 pandemic in Brazil at different geographic levels. The focus of this study is to investigate the similarities between the trends in the evolution of such indicators at different subnational levels with the trends observed nationally. The underlying question addressed is whether national surveillance of such variables is enough to provide a picture of the epidemic evolution in the country or if it may hide important localized trends. This is particularly relevant in the scenario where health authorities use information obtained from such indicators in the design of non-pharmaceutical intervention policies to control the epidemic. A comparison between R ( t ) estimates and the moving average (MA) of daily reported infections is also presented, which is another commonly monitored variable. The analysis carried out in this paper is based on the data of confirmed infected cases provided by a public repository. The correlations between the time series of R ( t ) and MA in different geographic levels are assessed. Comparing national with subnational trends, higher degrees of correlation are found for the time series of R ( t ) estimates, compared to the MA time series. Nevertheless, differences between national and subnational trends are observed for both indicators, suggesting that local epidemiological surveillance would be more suitable as an input to the design of non-pharmaceutical intervention policies in Brazil, particularly for the least populated states.

Four Years Since COVID-19 Day Zero: A Time to Evaluate Past and Future Pandemic Control Policies and Practices in Sub-Saharan Africa?

Four years after the first case of COVID-19, the world is still determining how best to prevent and control the long-term effects of SARS-CoV-2 infection. Non-pharmaceutical interventions (NPIs) were employed at the start of the pandemic as the only available options, prior to effective vaccines and antiviral agents. The World Health Organization recommended dual vaccination for 70% worldwide as the threshold for a return to "normal" community life. Immunization rates needed to increase in all global regions, irrespective of socioeconomic status, necessitating more equitable access. During the pandemic, wealthier countries hoarded vaccine supplies even when their citizens were immunized. This highlights the already enormous difficulties in healthcare provision faced by low-income sub-Saharan African countries, which remain at risk as industrialized nations have progressed to a post-pandemic era. Thus, in addition to redoubling vaccination efforts public health policymakers should consider ongoing and future use of NPIs. In this narrative account, we advocate that various NPI practices should not be shelved; rather, more research is needed to evaluate their impact in parallel with booster vaccination. This especially applies to so-called "long COVID". Lessons learned from implementing best practices in resource-limited settings should be incorporated into preparedness guidelines for future infectious disease outbreaks.

Association between expedited review designations and the US or global burden of disease for drugs approved by the US Food and Drug Administration, 2010-2019: a cross-sectional analysis.

OBJECTIVES: Pharmaceutical innovation can contribute to reducing the burden of disease in human populations. This research asks whether products approved by the US Food and Drug Administration (FDA) from 2010 to 2019 and expedited review programmes incentivising development of products for serious disease were aligned with the US or global burden of disease. DESIGN: Cross-sectional study. OUTCOME MEASURES: Association of FDA product approvals (2010-2019), first approved indications, designations for expedited review with the burden of disease (disability-adjusted life years (DALYs)), years of life lost (YLL) and years of life lived with disability (YLD) for 122 WHO Global Health Estimates (GHE) conditions in US and global (ex-US) populations. RESULTS: The FDA approved 387 drugs in 2010-2019 with lead indications associated with 59/122 GHE conditions. Conditions with at least one new drug had greater US DALYs (p=0.001), US YLL (p<0.001), global DALYs (p=0.030) and global YLL (p=0.004) but not US YLD (p=0.158) or global YLD (p=0.676). Most approvals were for conditions in the top quartile of US DALYs or YLL, but <27% were for conditions in the top quartile of global DALYs or YLL. The likelihood of a drug having one or more designations for expedited review programmes was negatively associated (OR<1) with US DALYs, US YLD and global YLD. There was a weak negative association with global DALYs and a weak positive association (OR>1) with US and global YLL. CONCLUSIONS: FDA drug approvals from 2010 to 2019 were more strongly aligned with US than global disease burden. Designations for expedited review were not aligned with either the US or global burdens of disease and may inadvertently disincentivise development of products addressing global disease burdens. These results may inform policies to better align pharmaceutical innovation with the burdens of disease.

Behavioral game of quarantine during the monkeypox epidemic: Analysis of deterministic and fractional order approach.

This work concerns the epidemiology of infectious diseases like monkeypox (mpox) in humans and animals. Our models examine transmission scenarios, including transmission dynamics between humans, animals, and both. We approach this using evolutionary game theory, specifically the intervention game-theoretical (IGT) framework, to study how human behavior can mitigate disease transmission without perfect vaccines and treatments. To do this, we use non-pharmaceutical intervention, namely the quarantine policy, which demonstrates the delayed effect of the epidemic. Additionally, we contemplate quarantine-based behavioral intervention policies in deterministic and fractional-order models to show behavioral impact in the context of the memory effect. Firstly, we extensively analyzed the model's positivity and boundness of the solution, reproduction number, disease-free and endemic equilibrium, possible stability, existence, concavity, and Ulam-Hyers stability for the fractional order. Subsequently, we proceeded to present a numerical analysis that effectively illustrates the repercussions of varying quarantine-related factors, information probability, and protection probability. We aimed to comprehensively examine the effects of non-pharmaceutical interventions on disease control, which we conveyed through line graphs and 2D heat maps. Our findings underscored the significant influence of strict quarantine measures and the protection of both humans and animals in mitigating disease outbreaks. These measures not only significantly curtailed the spread of the disease but also delayed the occurrence of the epidemic's peak. Conversely, when quarantine maintenance policies were implemented at lower rates and protection levels diminished, we observed contrasting outcomes that exacerbated the situation. Eventually, our analysis revealed the emergence of animal reservoirs in cases involving disease transmission between humans and animals.

Towards mission-driven investment in new antimicrobials? What role for Chinese strategic industrial financing vehicles in responding to the challenge of antimicrobial resistance?

BACKGROUND: Antimicrobial resistance (AMR) causes high levels of global mortality. There is a global need to develop new antimicrobials to replace those whose efficacy is being eroded, but limited incentive for companies to engage in R&D, and a limited pipeline of new drugs. There is a recognised need for policies in the form of 'push' and 'pull' incentives to support this R&D. This article discusses China, a country with a rapidly emerging pharmaceuticals and biotech (P&B) sector, and a history of using coordinated innovation and industrial policy for strategic and developmental ends. We investigate the extent to which 'government guidance funds' (GGFs), strategic industrial financing vehicles (a 'push' mechanism), support the development of antimicrobials as part of China's 'mission-driven' approach to innovation and industrial policy. GGFs are potentially globally significant, having raised approximately US$ 872 billion to 2020. RESULTS: GGFs have a substantial role in P&B, but almost no role in developing new antimicrobials, despite this being a priority in the country's AMR National Action Plan. There are multiple constraints on GGFs' ability to function as part of a mission-driven approach to innovation at present, linked to their business model and the absence of standard markets for antimicrobials (or other effective 'pull' mechanisms), their unclear 'social' mandate, and limited technical capacity. However, GGFs are highly responsive to changing policy demands and can be used strategically by government in response to changing needs. CONCLUSIONS: Despite the very limited role of GGFs in developing new antimicrobials, their responsiveness to policy means they are likely to play a larger role as P&B becomes an increasingly important component of China's innovation and industrial strategy. However, for GGFs to effectively play that role, there is a need for reforms to their governance model, an increase in technical and managerial capacity, and supporting ('pull') incentives, particularly for pharmaceuticals such as antimicrobials for which there is strong social need, but a limited market. Given GGFs' scale and strategic importance, they deserve further research as China's P&B sector becomes increasingly globally important, and as the Chinese government commits to a larger role in global health.

Drivers of vulnerability to medicine smuggling and combat strategies: a qualitative study based on online news media analysis in Iran.

BACKGROUND: Medicine smuggling poses a serious public health threat, limiting patients' safe and timely access to this essential resource. Thus, this study aims to identify the factors contributing to the vulnerability to medicine smuggling and propose effective strategies to combat this issue in Iran. METHODS: An analysis of news media was conducted using qualitative content analysis. News text items related to medicine smuggling were retrieved from various online news sources between March 21, 2017, and May 21, 2023. To select health-oriented and general online news stations, news agencies, and newspapers, the purposeful sampling method with a maximum variation strategy was used. The selected sources included Mehr News Agency, Khabar Online, Islamic Consultative Assembly News Agency (ICANA), Islamic Republic News Agency (IRNA), Iranian Students News Agency (ISNA), Hamshahri, Donya-e-Eqtesad newspapers, Webda, Sepid Online, and Iran's Food and Drug Administration News Agency (IFDANA). All data coding was manually done using Microsoft Excel software version 2016. RESULTS: A total of 277 news articles were found to meet the established criteria for inclusion. The analysis revealed four main themes, each with several sub-themes, that shed light on the factors that drive vulnerability and the strategies to combat medicine smuggling. These themes are the economic environment, government and stewardship, information technology systems, and socio-cultural factors. The economic environment emerged as the most significant theme, encompassing medicine selection, reimbursement, and procurement, all of which affect the smuggling of pharmaceuticals in Iran. CONCLUSION: To combat medicine smuggling, it is important to adjust policies based on the identified vulnerabilities. Effective strategies to reverse pharmaceutical smuggling include capacity building of pharmaceutical manufacturing companies, implementing regulated and enhanced supervisory and rulemaking policies, strengthening health insurance, improving e-infrastructure, and increasing public awareness through collaborative approaches involving various stakeholders within and outside the health system.

First-hand accounts of structural stigma toward people who use opioids on Reddit.

People who use opioids face multilevel stigma that negatively affects their health and well-being and drives opioid-related overdose. Little research has focused on lived experience of the structural levels of stigma toward opioid use. This study identified and qualitatively analyzed Reddit content about structural stigma toward opioid use. Iterative, human-in-the-loop natural language processing methods were used to identify relevant posts and comments from an opioid-related subforum. Ultimately, 273 posts and comments were qualitatively analyzed via directed content analysis guided by a prominent conceptualization of stigma. Redditors described how structures-including governmental programs and policies, the pharmaceutical industry, and healthcare systems-stigmatize people who use opioids. Structures were reported to stigmatize through labeling (i.e., particularly in medical settings), perpetuating negative stereotypes, separating people who use opioids into those who use opioids "legitimately" versus "illegitimately," and engendering status loss and discrimination (e.g., denial of healthcare, loss of employment). Redditors also posted robust formulations of structural stigma, mostly describing how it manifests in the criminalization of substance use, is often driven by profit motive, and leads to the pervasiveness of fentanyl in the drug supply and the current state of the overdose crisis. Some posts and comments highlighted interpersonal and structural resources (e.g., other people who use opioids, harm reduction programs, telemedicine) leveraged to navigate structural stigma and its effects. These findings reveal key ways by which structural stigma can pervade the lives of people who use opioids and show the value of social media data for investigating complex social processes. Particularly, this study's findings related to structural separation may help encourage efforts to promote solidarity among people who use opioids. Attending to first-hand accounts of structural stigma can help interventions aiming to reduce opioid-related stigma be more responsive to these stigmatizing structural forces and their felt effects.

Factors influencing the effects of policies and interventions to promote the appropriate use of medicines in high-income countries: A rapid realist review.

BACKGROUND: The appropriate use of medicines has long been recognized as a fundamental component of medicine policies. We aimed to extract lessons from published research on how policy contexts and mechanisms can affect the outcomes of national- or health-system level interventions to promote appropriate medicine use (defined as an increase in underutilized medications or decrease in inappropriate medication use). METHODS: We conducted a rapid realist review of published evidence concerning system-level policies to promote the appropriate use of medicines in high-income countries with universal prescription drug coverage. We searched MEDLINE and Embase to identify relevant publications. We used a realist evaluation framework to identify contexts, mechanisms, and outcomes for each intervention and to hypothesize which policy contexts and mechanisms supported successful outcomes in terms of relative changes in the prevalence of use of the specific medication classes targeted. RESULTS: From 1,318 identified studies, 18 met our inclusion criteria. 13 distinct policies were identified. Three main policy-related factors underpinned successful interventions: involving providers and patients through program interventions; central coordination through national agencies dedicated to medicine policies; and the establishment of an explicit and integrated national medicine policy strategy. CONCLUSION: Policymakers can improve coordination of national pharmaceutical policies to reduce harms from inappropriate medicines use, thus improving health outcomes through cost-effective programs.

Solid waste management practices and challenges in Besisahar municipality, Nepal.

This study is a comprehensive assessment of the waste management system in Besisahar municipality. Information and some data have been collected from the municipality of Besisahar, followed by interviews with municipal officials responsible for waste management, stakeholders, waste workers, and residents. A total of 230 households, 20 schools, 10 government and private offices, 10 financial institutions, 60 commercial hotels, restaurants, and shops, and 20 medical shops and healthcare institutions, were selected in this study by random sampling. An extensive field study was conducted within all municipal wards and at dump sites. The results indicated that 42.14% of solid waste was collected through door-to-door collection services, 5.87% was mismanaged in open public places, 11.21% was used as compost manure, and the rest was discarded on riverbanks, dug up, and burned. A large component of the characterization of household waste consisted of organic waste (68.03%), followed by paper/paper products (8.13%), agricultural waste (5.5%), plastic (5.21%), construction (3.81%), textile (2.72%), metals (0.54%), glass (1.01%), rubber (0.10%), electronic (0.05%), pharmaceutical (0.1%) and others (4.78%) in the Besishahar municipality. Solid waste generation was found to be at 197.604 g/capita/day, as revealed by cluster sampling in 230 households. Around 4.285 tons-solid waste/day were generated in urban areas, while 16.13 tons-solid waste/day was estimated for the whole municipality. An important correlation between the parameters of solid waste was found by statistical analysis. Currently, solid waste is dumped on riverbanks, open fields, and springs, creating environmental and health hazards. The findings of this study will be useful to Besisahar municipality and its stakeholders in forming policies that facilitate waste management practices in this region and promote sustainable waste management systems.

Maintaining essential health services during COVID-19 in Ghana: a qualitative study.

INTRODUCTION: Evidence suggests that non-pharmaceutical interventions such as lockdown policies, restriction of movement and physical distancing to control the novel COVID-19 contributed to the decline in utilisation of essential health services. We explored healthcare providers' and policy-makers' experiences of the barriers, interventions and response actions that contributed to ensuring the continuity of essential health services during the COVID-19 pandemic in Ghana to help inform future practice and policy. METHODS: We used a qualitative study approach. Data were analysed using thematic analysis. Thirty Four participants composed of 20 healthcare providers and 14 policy-makers who worked across regions with low and high recorded COVID-19 cases in Ghana during the COVID-19 pandemic were involved in this study. RESULTS: Participants reported that essential health services including maternal, reproductive and child health services, communicable and non-communicable disease care, and elective surgeries were disrupted during the COVID-19 pandemic. Barriers to the utilisation of essential services were constructed into three subthemes: (1) fear, (2) poor quality of care at the facility and (3) financial limitation. These barriers were mitigated with population-based interventions underpinned by the socioecological model at the individual and interpersonal level (including psychosocial care for families and home visits), institutional and community levels (such as allocation of funds, training of health workers, public education, triage stations, provision of logistics, appointment scheduling, telemedicine and redeployment of health workers) and public policy level (tax relief packages, transportation arrangements and provision of incentives), which helped in maintaining essential health services during COVID-19. CONCLUSION: Disruption of essential health services during COVID-19 in Ghana instigated population-based interventions which aided in expanding the populations' continuous access to essential health services and strengthened health service delivery.

Tackling medicine shortages during and after the COVID-19 pandemic: Compilation of governmental policy measures and developments in 38 countries.

In response to increasing shortages of medicines, governments have implemented legislative and non-legislative policy measures. This study aimed to map these policies across high-income countries in Europe and beyond as of 2023 and to analyse developments in governmental approaches since the beginning of the pandemic. Information was collated from 38 countries (33 European countries, Australia, Brazil, Canada, Israel and Saudi Arabia) based on a survey conducted with public authorities involved in the Pharmaceutical Pricing and Reimbursement Information (PPRI) network in 2023. 34 countries requested pharmaceutical companies to notify national registers of upcoming shortages and 20 countries obliged manufacturers and/or wholesalers to stock supply reserves of critically needed medicines. Further common measures included export bans for defined medicines (18 countries), regulatory measures to facilitate import and use of alternative medicines (35 countries) and multi-stakeholder coordination (28 countries). While the legislation of 26 countries allows imposing sanctions, particularly for non-compliance to reporting requirements, fines were rather rarely imposed. Since 2022, at least 18 countries provided financial incentives, usually in the form of price increases of some off-patent medicines. Overall, several policies to address medicine shortages were taken in recent years, in some countries as part of a comprehensive package (e.g., Australia, Germany). Further initiatives to secure medicine supply in a sustainable manner were being prepared or discussed.

Evaluating the role of intern pharmacists in pharmaceutical care in hospitals in Uganda.

Background: In Uganda, there is limited adoption of pharmaceutical care in hospitals due to pharmacist shortages and limited collaboration among healthcare professionals. Intern pharmacists are deployed annually to assist in patient care to address pharmacist shortages. Objectives: Evaluate intern pharmacist's extent of involvement in pharmaceutical care activities, assess facilitators and barriers, and explore healthcare professionals' perceptions, attitudes, and opinions on implementation of pharmaceutical care. Methods: A mixed-method concurrent study was carried out for four months. We conducted an online survey among 107 intern pharmacists from 26 hospitals, including National Referral, Regional Referral, Private Not-For-Profit, and General hospitals; predictors of extent of involvement were identified using linear regression models, using STATA 14. 24 key informants (nurses, prescribers, pharmacists) from five hospitals were interviewed; themes were developed using a deductive thematic analysis approach. Results: Intern pharmacists had a median (Interquartile range[IQR]) age of 25 years (25-27) and 74.7% were male. About half (54.1%) of key informants were female and had a median (IQR) of 10 years (4.0-15.5) of professional experience. Interns focused on patient counseling, lacked documentation, and showed positive attitudes, and knowledge. Key informants supported implementation, but prescribers expressed dissatisfaction with interns' performance. Conclusion: Enhancing pharmacy internship and training through developing policies and guidelines on pharmaceutical care practice, improving working conditions, and mentorship can address gaps impeding pharmaceutical care implementation by intern pharmacists.

Comparison of time to treatment initiation of specialty medications between an integrated health system specialty pharmacy and external specialty pharmacies.

BACKGROUND: Specialty medications are commonly dispensed through specialty pharmacies equipped to meet unique monitoring and dispensing requirements. Integrated health system specialty pharmacies (HSSPs) coordinate with health system providers to deliver specialty medications to patients and ameliorate barriers to care. However, payors may restrict specialty medication fills to specialty pharmacies external to the health system, potentially leading to delayed treatment. OBJECTIVE: To compare time to treatment initiation among patients whose specialty medications were transferred to external pharmacies and patients whose medications were filled at an internal HSSP. METHODS: This was a retrospective, propensity-matched cohort study examining time to treatment initiation in patients with a specialty medication referral to the University of Kentucky HealthCare Specialty Pharmacy between July 1, 2021, and July 1, 2022. Patients were classified into cohorts by receipt of dispensing services from the internal HSSP or an external specialty pharmacy. Data collected via chart review included insurance type, reason for prescription transfer, dates of service (including prescription order, transfer, and receipt of medication), and whether a prior authorization or clinical intervention was performed. Subgroup analyses were performed for patients requiring a prior authorization or clinical intervention. The Wilcoxon signed-rank test was used to assess for statistically significant differences in time to treatment initiation between cohorts. RESULTS: A total of 560 patients with external transfers were identified for inclusion into the study, and after exclusion criteria were applied, 408 external transfer patients were propensity matched 1:1 to 408 patients with internal fills (total n = 816). Time to treatment initiation was significantly longer in the external transfer cohort as compared with the internal fill cohort, (18 days vs 12 days; P < 0.0001). The internal fill cohort had a greater mean days from provider order to the medication being ready to fill compared with the external transfer cohort (10 days vs 6 days; P < 0.0001). The internal fill cohort had fewer mean days from the medication being ready to fill to patient receipt of the medication as compared with the external transfer cohort (2 days vs 12 days; P < 0.0001). Similar findings were observed in the subgroup analyses. CONCLUSIONS: Average time to treatment initiation was 6 days shorter for patients whose specialty medications were filled at this HSSP compared with externally transferred patients. Delays in therapy can cause a negative impact on patient care and disease state management, with increased concern for specialty populations. The results of this study highlight the need for continued discussion about policies that limit patient choice to in-network pharmacies.

Insights into insurance coverage for digital therapeutics: A qualitative study of US payer perspectives.

BACKGROUND: In the last decade there has been an increase in the development and marketing of digital therapeutic (DTx) products aiming to prevent, manage, or treat a medical disorder or disease. Health insurance coverage for these products is not well established, and payers are facing increasing pressure to include these products as a covered benefit. OBJECTIVE: To examine factors and characteristics that could drive health insurance coverage of DTx products from US payers' and coverage decision-makers' perspectives. METHODS: This was a qualitative noninterventional, cross-sectional study conducted from August 2022 to October 2022. Virtual focus group meetings with pharmacy benefit managers/directors or medical directors representing a range of health insurance organizations were held following a semistructured interview guide. Convenience and snowball sampling techniques were used to identify participants. Transcripts were coded and analyzed with Atlas.ti software to identify common themes and subthemes. RESULTS: Five focus group meetings and 1 individual interview were held from August to October 2022. Participants (n = 22) were mostly pharmacists (n = 18, 85%) with more than 15 years of experience (n = 18, 85%). Some participants indicated that DTx products for diabetes (n = 6, 29%), mental/behavioral health (n = 3, 14%), and substance abuse disorders (n = 3, 14%) were already covered by their organizations. The topics generating the most comments grouped by code were issues around the evidence for DTx (67 unique comments) and barriers for coverage (60 unique comments). Participants indicated they want to have evidence of effectiveness that is similar to traditional pharmaceutical products. Barriers for coverage included a need to revise benefit policies, exclusion of nonprescription products, and mechanisms for billing. DTx products with an indication for mental/behavioral health were viewed as most likely to be reimbursed. Coverage of DTx products may occur under either the pharmacy or medical benefit. CONCLUSIONS: Health care payers stated that evidence of effectiveness was a necessary condition for health insurance coverage of DTx products. Given these are relatively new in health care, payers had more questions than answers regarding how these products will be integrated into health benefits.