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BackgroundPaediatric legislation has contributed to better access to appropriate treatments in the European Union and the USA by requiring paediatric research in return for financial incentives. This study explored whether similar policies could improve access to medicines in other countries.MethodsWe conducted 46 interviews with representatives from healthcare practice, patient organisations and health authorities from six countries (Australia, Brazil, Canada, Kenya, Russia and South Africa) as well as multinational pharmaceutical companies exploring their views regarding access barriers to paediatric medicines. Emphasis was placed on regulation-related barriers and the effect of the COVID-19 pandemic. Where participants were familiar with paediatric legislation, views regarding its relevance for domestic context were explored in depth.ResultsInsufficient paediatric research and development, regulatory hurdles and reimbursement constraints were reported to be relevant access barriers in all studied settings. In the absence of marketing registration or reimbursement, access to paediatric medicines was associated with increased legal, financial and informational barriers. Brazil, Kenya, Russia and South Africa additionally described overarching deficiencies in medicines provision systems, particularly in procurement and supply. The COVID-19 pandemic was said to have reduced regulatory hurdles while further heightening global access inequalities.Views regarding paediatric legislation were mixed. Concerns regarding the implementation of such policies focused on regulatory resource constraints, enforceability and potential reduction of industry activity.ConclusionsThe study findings suggest that paediatric legislation may be most impactful in mature health systems and should be accompanied by measures addressing access barriers beyond marketing registration. This could include strengthening domestic manufacturing capacities and technology transfer for medicines with high public health relevance. Ideally, legislative changes would build on global harmonisation of paediatric legislation, which could be achieved through existing WHO structures.
BackgroundPaediatric legislation has contributed to better access to appropriate treatments in the European Union and the USA by requiring paediatric research in return for financial incentives. This study explored whether similar policies could improve access to medicines in other countries.MethodsWe conducted 46 interviews with representatives from healthcare practice, patient organisations and health authorities from six countries (Australia, Brazil, Canada, Kenya, Russia and South Africa) as well as multinational pharmaceutical companies exploring their views regarding access barriers to paediatric medicines. Emphasis was placed on regulation-related barriers and the effect of the COVID-19 pandemic. Where participants were familiar with paediatric legislation, views regarding its relevance for domestic context were explored in depth.ResultsInsufficient paediatric research and development, regulatory hurdles and reimbursement constraints were reported to be relevant access barriers in all studied settings. In the absence of marketing registration or reimbursement, access to paediatric medicines was associated with increased legal, financial and informational barriers. Brazil, Kenya, Russia and South Africa additionally described overarching deficiencies in medicines provision systems, particularly in procurement and supply. The COVID-19 pandemic was said to have reduced regulatory hurdles while further heightening global access inequalities.Views regarding paediatric legislation were mixed. Concerns regarding the implementation of such policies focused on regulatory resource constraints, enforceability and potential reduction of industry activity.ConclusionsThe study findings suggest that paediatric legislation may be most impactful in mature health systems and should be accompanied by measures addressing access barriers beyond marketing registration. This could include strengthening domestic manufacturing capacities and technology transfer for medicines with high public health relevance. Ideally, legislative changes would build on global harmonisation of paediatric legislation, which could be achieved through existing WHO structures.
Objective Anti-cancer medicine shortages are advancing challenges for patients and hospitals. This study aims to evaluate anti-cancer and supportive medicine shortages in a tertiary hospital in Pakistan and propose solutions. Method A retrospective observational research was performed in a tertiary care hospital in Pakistan from 2016 to 2020. Data was retrieved from the hospital database using a questionnaire regarding short medicines’ generic name, brand, dosage, source, total source, frequency, causes, impact, management, and analyzed by Microsoft Excel 2013. Results Between January 2016 and December 2020, 43 individual medicine shortages were observed, with an average of 8.6 shortages per year. There were shortages of 22 medicines, including 8 anti-cancer (36.4%) and 14 supportive agents (63.6%). Total shortage days were 27,100, with an average of 1232 days (SD 757) per medicine. Supportive medicines’ shortages were frequent, but oncology agents’ shortages were constant. The most affected dosage form was injection. Cardiovascular drugs and alkylating agents were the most affected class in supportive and anti-cancer medicines, respectively. The use of “alternative medicine” and “patient needs based importation” were the most common mitigation strategies. Conclusion Shortages of oncology medicines are challenging in Pakistan. The most prominent causes are the lack of updated governmental regulations, registration, and import issues. The tertiary care hospital has very few sources of supply, so it imports these drugs on a need basis to manage the shortages. But it is still concerning because of the huge financial burden on patients and institutions due to expensive import, and therapy become delayed as the import process takes time. Moreover, the most affected drug class was alkylating agents, and dosage was both injectable and oral medicines.
Background Drug shortages significantly threaten public health and medical service provision worldwide. Research evidence on the complete picture of drug shortages is currently scant in China. This study aimed to provide a descriptive overview and a reference for alleviating of drug shortages in China. Methods National and provincial lists of drug shortages issued in China from 2018 to 2021 were collected and summarized. The information on essential medicines, medical insurance drugs, emergency drugs, and volume-based purchasing drugs was then matched with a drug shortage list to analyse the characteristics, proportion and incidence of drug shortage on each list based on the analysis of information such as dosage form, shortage frequency, and Anatomical Therapeutic Chemical (ATC) classification of the drugs in shortage. Results A total of 24 provinces issued drug shortages lists involving 408 drugs from 2018 to 2021. All 58 drugs in the national drug list were included on the provincial drug shortage list. Among all the drugs in shortage, the most significant shortage involved injections, accounting for 45.3% (185/408). Ninety-five drugs (23.3%) were in shortage 5 times (annual shortage > 1 time) or more in the provincial lists, and 199 drugs (48.8%) were on the shortage list only once. In terms of therapeutic property, nearly all categories of drugs had been reported in shortage, among which cardiovascular drugs, nervous system drugs, anti-tumor and immunomodulatory drugs, and blood and hematopoietic organ drugs accounted for more than 10%. There is no significant difference in drug shortage among economic regions. Comparing drugs in shortage and various lists, 81.9% (334/408), 51.0% (208/408) and 67.9% (277/408) fell on the National Medical Insurance Drug List, National Essential Medicines List, and WHO Model List of Essential Medicines, respectively, while the volume-based purchasing drugs accounted for 3.4% (14 drugs). The incidence of drug shortages on NEML, WHO Model List of Essential Medicines and medical insurance category A was significantly higher than that of medical insurance category B and volume-based purchasing drugs (P < 0.05). Of the Emergency Drugs List, 72.0% (36/50) also experienced shortages, significantly higher than all the above categories (P < 0.05). Conclusions In China, drug shortages were severe and complicated. Drug shortages vary among economic regions but are not significant. In comparison, the national procurement pattern of volume-based drug purchasing may be conducive to alleviating the drug shortage problem. Collaboration of all partners was recommended to ensure the supply of clinically necessary drugs.
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