The knock-on effects of COVID-19 pandemic on the supply and availability of generic medicines in Ethiopia: mixed methods study.

BACKGROUND: COVID-19 pandemic posed a major impact on the availability and affordability of essential medicines. This study aimed to assess the knock-on effects of the COVID-19 pandemic on the supply availability of non-communicable chronic disease (NCD) medicines and paracetamol products in Ethiopia. METHODS: A mixed methods study was conducted to assess the supply and availability of twenty-four NCD drugs and four paracetamol products listed on the national essential medicines list for hospitals. Data were collected from twenty-six hospitals located in seven zones of Oromia region in the southwestern part of Ethiopia. We extracted data on drug availability, cost and stock out for these drugs between May 2019 and December 2020. The quantitative data were entered into Microsoft Excel and exported to statistical package software for social science (SPSS) version 22 (IBM Corporation, Armonk, NY, USA) software for analysis. RESULTS: The overall mean availability of selected basket medicines was 63.4% (range 16.7% to 80.3%) during the pre-COVID-19 time. It was 46.3% (range 2.8% to 88.7) during the pandemic. There was a relative increase in the availability of two paracetamol products [paracetamol 500 mg tablet (67.5% versus 88.7%) and suppository (74.5% versus 88%)] during the pandemic. The average monthly orders fill rates for the selected products range from 43 to 85%. Pre-COVID-19, the average order fill rate was greater or equal to 70%. However, immediately after the COVID-19 case notification, the percentage of order(s) filled correctly in items and quantities began decreasing. Political instability, shortage of trained human resources, currency inflation, and limited drug financing were considered as the major challenges to medicine supply. CONCLUSION: The overall stock out situation in the study area has worsened during COVID-19 compared to pre-COVID-19 time. None of the surveyed chronic disease basket medicines met the ideal availability benchmark of 80% in health facilities. However, availability of paracetamol 500 mg tablet surprisingly improved during the pandemic. A range of policy frameworks and options targeting inevitable outbreaks should exist to enable governments to ensure that medicines for chronic diseases are consistently available and affordable.

Shortages of antiseizure medications in Australia and the association with patient switching, and adherence in a community setting.

PURPOSE: To quantify sponsor-reported shortages of oral antiseizure medications in Australia, estimate the number of patients impacted, and the association between shortages and brand or formulation switching, and changes in adherence. METHODS: A retrospective cohort study of sponsor-reported shortages (defined as where the supply of a medicine will not or will not be likely to meet the demand over a 6-month period) of antiseizure medications reported to the Medicine Shortages Reports Database (Therapeutic Goods Administration, Australia); cross-referencing shortages to the IQVIA-NostraData Dispensing Data (LRx) database, a deidentified, population-level dataset collecting longitudinal dispensation data on individual patients from ∼75% of Australian community pharmacy scripts. RESULTS: Ninety-seven sponsor-reported ASM shortages were identified between 2019 and 2020; of those, 90 (93%) were shortages of generic ASM brands. Of 1,247,787 patients dispensed ≥1 ASMs, 242,947 (19.5%) were impacted by shortages. Sponsor-reported shortages occurred more frequently before the COVID-19 pandemic versus during the pandemic, however, shortages were estimated to affect more patients during the pandemic than before the pandemic. An estimated 330,872 patient-level shortage events were observed, and 98.5% were associated with shortages of generic ASM brands. Shortages occurred at a rate of 41.06 shortages per 100 person-years in patients on generic ASM brands versus 0.83 shortages per 100 person-years in patients on originator ASM brands. In patients taking a formulation of levetiracetam affected by a shortage, 67.6% switched to a different levetiracetam brand or formulation during shortages compared with 46.6% in non-shortage periods. CONCLUSIONS: Approximately 20% of patients on ASMs were estimated to have been impacted by an ASM shortage in Australia. The rate of patient-level shortages was approximately 50 times higher for patients on generic ASM brands versus originator brands. Shortages of levetiracetam were associated with formulation and brand switching. Improved supply chain management amongst sponsors of generic ASMs is needed to maintain the continuity of supply in Australia.

Availability, price, and affordability of medicines used for the management of Covid-19 in health facilities of Dessie town WHO/HAI survey.

BACKGROUND: The rapidly spreading nature of Covid-19 virus associated with its high mortality and mortality rate is triggering an unprecedented public health crisis. The study assessed the availability, price, and affordability of medicines used in the management of Covid-19 in health facilities of Dessie town. METHODS: A retrospective cross-sectional study design was employed in the health facilities of Dessie town from September 1 to September 20, 2021. Data was collected using a standard checklist adopted from the Logistics Indicator Assessment Tool and WHO/HAI. WHO/HAI methodology was applied to select the surveyed health facilities (30) and medicines (44). The daily wage of the lowest-paid unskilled government worker is used to estimate affordability. RESULTS: Fifteen and five medicines were not found at all public and private health facilities, respectively. The originator brand (OB) and lowest price generic (LPG) availability in private health facilities was 2.03% and 51.33%, respectively. In the public sector, the availability of OB and LPG was 0% and 34.44%, respectively. In public and private health facilities, the mean number of stock-outs was 2.25 and 2.91, and the mean number of stock-out days was 177.83 and 106.16 days, respectively. Eight and one LPG medicines were out of stock in public and private health facilities, respectively. Eight (33.33%) and 6 (28.57%) had higher prices than international prices in private and public health facilities, respectively. The median price ratio in public and private health facilities ranged from 0.02 and 3.05 and 0.04 to 2.70, respectively. Eighty percent of the products were unaffordable in both sectors. CONCLUSIONS: The availability of medicines was low. One-third of the medicines had higher prices than international prices. Eighty percent of the products were unaffordable. The regular supply of these medicines is crucial for better management of the disease.

Perception and Acceptance of Using Different Generic Types of COVID-19 Vaccine, the "Mix-and-Match" Strategy, in Saudi Arabia: Cross-Sectional Web-Based Survey.

Background: Soon after the COVID-19 pandemic was declared, a pharmaceutical company expressed rapid interest in developing a safe and effective vaccine candidate to contain the spread of SARS-CoV-2 infections. The FDA approved the Pfizer-BioNTech, AstraZeneca, Moderna, and Janssen vaccines. Here, we investigated the attitude and acceptance of using different generic types of COVID-19 vaccines in Saudi Arabia. Methods: This study is a cross-sectional study using an online survey conducted in Saudi Arabia from the 19th of October to the 6th of December 2021. The questionnaire was distributed using social media platforms such as Twitter, WhatsApp, and Facebook. The inclusion criteria to participate in this study were adults who live in Saudi Arabia (Saudis or non-Saudis) and had two doses of COVID-19 vaccinations. Result: 3486 participants were included in this study, and 67.5% of the participants had side effects after the first dose. Similarly, 66.7% of the study participants had side effects after administering the second dose. Our data showed that most participants were unsure if the heterologous COVID-19 vaccination could cause severe side effects. In addition, 47.6% of the participants refused to receive a different generic type of COVID-19 vaccine due to fear of health problems. However, most participants obtained information regarding COVID-19 vaccination from the Saudi Ministry of Health. Conclusions: We found a low level of acceptance for receiving different generic types of vaccines if the participants had a choice. Therefore, plans should focus on increasing the acceptance level among the Saudi population through official platforms such as the Saudi Ministry of Health and private clinics.

Improving the availability of prescription drugs in Lebanon: a critical analysis of alternative policy options.

The economic downfall in Lebanon and the destruction of the Beirut Port have had a crippling effect on all players in the health sector, including hospitals, healthcare providers, and the pharmaceutical and medical supply industry. The outbreak of COVID-19 has further aggravated the crisis. To address the challenges facing the pharmaceutical industry, Lebanon must create a stable and secure source of prescription drug production. Two alternative approaches are presented to address the crisis: (1) amending the subsidy system and supporting local pharmaceutical production, and (2) promoting the prescription and use of generic drugs. Investing in local production is promising and can lead to establishing trust in the quality of drugs produced locally. These efforts can be complemented by promoting the prescription and use of generic drugs at a later stage, after having had established a well-operating system for local drug production.

Antibiotic geographies and access to medicines: Tracing the role of India's pharmaceutical industry in global trade.

Access to medicines has become a major concern for countries worldwide during the COVID-19 pandemic, as pharmaceutical production and trade have been disrupted in the course of the crisis. Antibiotics are one group of medicines where worries about access have been raised. Access to the right antibiotic at the right time is important not only for curing infections of individual patients, but also for curbing antibiotic resistance globally. Reliable pharmaceutical supply is key to ensuring access to medicines. The global supply of generic medicines has over the last decades been transformed by the rise of India's pharmaceutical industry. In this paper, I trace the changing role of this industry for the global export of antibiotics, by mapping and describing changes in Indian antibiotic exports and discussing these in light of historical processes and events. The paper offers a novel approach to analyse global antibiotic trajectories by using international trade data from publicly available resources combined with a secondary literature review. I show that India's pharmaceutical industry today holds a key role as one of the world's biggest exporters of antibiotic medicines, but with an increasing dependency on China as a supplier of antibiotic ingredients. This produces both opportunities and concerns for access to antibiotics globally.

Does India need a new pharmaceutical policy? Examining the implications of the drug price control order.

OBJECTIVES: This article aims to analyse the impact of the pharmaceutical policy on the availability, accessibility and affordability of medicines to the Indian populace. The article delves into the shortcomings of the Drug Price Control Order 2013 and highlights its real-world implications. METHODS: Published literature in the form of scientific articles on the proposed reforms that took place in the pharmaceutical policy was reviewed. The study used the memorandums, laws and government decisions published by the Department of Pharmaceuticals, Ministry of Health and Family Welfare and National Pharmaceutical Pricing Authority|National Pharmaceutical Pricing Authorities. RESULTS: The pharmaceutical policy in India underwent several changes during 2013-2020 to enhance the affordability and accessibility of drugs. The stringent policy hampered innovation due to the lack of profitability to the Multinational Companies. Moreover, it was found that the impact of the price control order on the low-cost local generic manufacturers affected much of the country's price-sensitive population. CONCLUSION: The pharmaceutical policy of India needs to be amended to extend its benefit to its stakeholders. The government should shift its attention to improving the quality of drugs, increasing competition amongst manufacturers and enhancing the accessibility of medicines through state/centre sponsored initiatives.

[The sustainability of the health system and the pharmaceutical market: A permanent interaction between the cost of medications, the patent system, and disease care]. / La sostenibilidad del sistema de salud y el mercado farmacéutico: Una interacción permanente entre el costo de los medicamentos, el sistema de patentes y la atención a las enfermedades.

Taking into account the latent threat of future pandemics, the objective of this study is to analyze - particularly with respect to medications - the sustainability of the health system, healthcare coverage, budgetary efficiency, and connections with the pharmaceutical patent system. In this context, the pharmaceutical patent system acts as a determining factor, given that promoting its existence stimulates the production of research, but in turn its existence stands in the way of rapid advancements, primarily due to the development of protective legislation concerning patents, which has largely accommodated the industry. Given that the pharmaceutical industry has managed to extend the duration of patents and avoid the incorporation of generics, our analysis focuses on the influence of pharmaceutical patents; this influence has led to reflection on the possibility of combining efforts by forging alliances between numerous companies and the public sector in order to face the challenges posed by new diseases caused by viruses that give rise to epidemics and pandemics.

Ante la amenaza latente de futuras pandemias, este estudio tiene como objetivo analizar ­desde el eje de los medicamentos­ la sostenibilidad del sistema sanitario, la cobertura, la eficiencia del gasto y su vinculación al sistema de patentes farmacéuticas. En este marco, el sistema de patentes farmacéuticas adquiere un papel determinante, dado que fomentar su existencia estimula la producción de investigación pero, a su vez, su existencia no suscita un rápido avance, debido al desarrollo legislativo protector que han tenido las patentes y que ha dado lugar a un acomodamiento de la industria. Como la industria farmacéutica ha conseguido extender la duración de patentes y evitar la incorporación de genéricos, se analiza la influencia de las patentes farmacéuticas que ha dado lugar a reflexionar acerca de la posibilidad de consorciar esfuerzos realizando alianzas entre varias empresas y el sector público para afrontar los retos que plantean nuevas enfermedades producidas por virus que dan lugar a epidemias y pandemias.

Availability, prices and affordability of essential medicines: A cross-sectional survey in Hanam province, Vietnam.

OBJECTIVE: To measure medicines' prices, availability, and affordability in Hanam, Vietnam. METHODS: The standardized methodology developed by the World Health Organization (WHO) and Health Action International was used to survey 30 essential medicines (EMs) in 30 public health facilities and 35 private medicine outlets in 2020. The availability of medicine was computed as the percentage of health facilities in which this medicine was found on the data-collection day. International reference prices (IRPs) from Management Sciences for Health (2015) were used to compute Median Price Ratio (MPR). The affordability of treatments for common diseases was computed as the number of days' wages of the lowest-paid unskilled government worker needed to purchase medicines prescribed at a standard dose. Statistic analysis was done using R software version 4.1.1. RESULTS: The mean availability of originator brands (OBs) and lowest-priced generics (LPGs) was 0.7%, 63.2% in the public sector, and 13.7%, 47.9% in the private sector, respectively. In private medicine outlets, the mean availability of both OBs and LPGs in urban areas was significantly higher than that in rural areas (p = 0.0013 and 0.0306, respectively). In the public sector, LPGs' prices were nearly equal to their IRPs (median MPRs = 0.95). In the private medicine outlets, OBs were generally sold at 6.24 times their IRPs while this figure for LPGs was 1.65. The affordability of LPGs in both sectors was good for all conditions, with standard treatments costing a day's wage or less. CONCLUSION: In both sectors, generic medicines were the predominant product type available. The availability of EMs was fairly high but still lower than WHO's benchmark. A national-scale study should be conducted to provide a comprehensive picture of the availability, prices, and affordability of EMs, thereby helping the government to identify the urgent priorities and improving access to EMs in Vietnam.

Evidence-based public policy making for medicines across countries: findings and implications for the future.

Aim: Global expenditure on medicines is rising up to 6% per year driven by increasing prevalence of non-communicable diseases (NCDs) and new premium priced medicines for cancer, orphan diseases and other complex areas. This is difficult to sustain without reforms. Methods: Extensive narrative review of published papers and contextualizing the findings to provide future guidance. Results: New models are being introduced to improve the managed entry of new medicines including managed entry agreements, fair pricing approaches and monitoring prescribing against agreed guidance. Multiple measures have also successfully been introduced to improve the prescribing of established medicines. This includes encouraging greater prescribing of generics and biosimilars versus originators and patented medicines in a class to conserve resources without compromising care. In addition, reducing inappropriate antibiotic utilization. Typically, multiple measures are the most effective. Conclusion: Multiple measures will be needed to attain and retain universal healthcare.

A Non-Profit Approach to Address Foreign Dependence of Generic Drugs.

The COVID-19 pandemic has revealed the vulnerability of the US generic drug supply chain to foreign production. Many policies have been proposed to mitigate this vulnerability. In this article, we argue that nonprofit drug manufacturers have the potential to make important contributions.

National trends in prescription drug expenditures and projections for 2021.

PURPOSE: To report historical patterns of pharmaceutical expenditures, to identify factors that may influence future spending, and to predict growth in drug spending in 2021 in the United States, with a focus on the nonfederal hospital and clinic sectors. METHODS: Historical patterns were assessed by examining data on drug purchases from manufacturers using the IQVIA National Sales Perspectives database. Factors that may influence drug spending in hospitals and clinics in 2021 were reviewed-including new drug approvals, patent expirations, and potential new policies or legislation. Focused analyses were conducted for biosimilars, cancer drugs, generics, coronavirus disease 2019 (COVID-19) pandemic influence, and specialty drugs. For nonfederal hospitals, clinics, and overall (all sectors), estimates of growth of pharmaceutical expenditures in 2021 were based on a combination of quantitative analyses and expert opinion. RESULTS: In 2020, overall pharmaceutical expenditures in the United States grew 4.9% compared to 2019, for a total of $535.3 billion. Utilization (a 2.9% increase) and new drugs (a 1.8% increase) drove this increase, with price changes having minimal influence (a 0.3% increase). Adalimumab was the top drug in 2020, followed by apixaban and insulin glargine. Drug expenditures were $35.3 billion (a 4.6% decrease) and $98.4 billion (an 8.1% increase) in nonfederal hospitals and clinics, respectively. In clinics, growth was driven by new products and increased utilization, whereas in hospitals the decrease in expenditures was driven by reduced utilization. Several new drugs that will influence spending are expected to be approved in 2021. Specialty and cancer drugs will continue to drive expenditures along with the evolution of the COVID-19 pandemic. CONCLUSION: For 2021, we expect overall prescription drug spending to rise by 4% to 6%, whereas in clinics and hospitals we anticipate increases of 7% to 9% and 3% to 5%, respectively, compared to 2020. These national estimates of future pharmaceutical expenditure growth may not be representative of any particular health system because of the myriad of local factors that influence actual spending.

Development and validation of a predictive model to predict and manage drug shortages.

PURPOSE: Pharmacy departments across the country are problem-solving the growing issue of drug shortages. We aim to change the drug shortage management strategy from a reactive process to a more proactive approach using predictive data analytics. By doing so, we can drive our decision-making to more efficiently manage drug shortages. METHODS: Internal purchasing, formulary, and drug shortage data were reviewed to identify drugs subject to a high shortage risk ("shortage drugs") or not subject to a high shortage risk ("nonshortage drugs"). Potential candidate predictors of drug shortage risk were collected from previous literature. The dataset was trained and tested using 2 methods, including k-fold cross-validation and a 70/30 partition into a training dataset and a testing dataset, respectively. RESULTS: A total of 1,517 shortage and nonshortage drugs were included. The following candidate predictors were used to build the dataset: dosage form, therapeutic class, controlled substance schedule (Schedule II or Schedules III-V), orphan drug status, generic versus branded status, and number of manufacturers. Predictors that positively predicted shortages included classification of drugs as intravenous-only, both oral and intravenous, antimicrobials, analgesics, electrolytes, anesthetics, and cardiovascular agents. Predictors that negatively predicted a shortage included classification as an oral-only agent, branded-only agent, antipsychotic, Schedule II agent, or orphan drug, as well as the total number of manufacturers. The calculated sensitivity was 0.71; the specificity, 0.93; the accuracy, 0.87; and the C statistic, 0.93. CONCLUSION: The study demonstrated the use of predictive analytics to create a drug shortage model using drug characteristics and manufacturing variables.