To review existing regulations and policies utilised by countries to enable patient access to orphan drugs. A review of the literature (1998 to 2014) was performed to identify relevant, peer-reviewed articles. Using content analysis, we synthesised regulations and policies for access to orphan drugs by type and by country. Fifty seven articles and 35 countries were included in this review. Six broad categories of regulation and policy instruments were identified: national orphan drug policies, orphan drug designation, marketing authorization, incentives, marketing exclusivity, and pricing and reimbursement. The availability of orphan drugs depends on individual country’s legislation and regulations including national orphan drug policies, orphan drug designation, marketing authorization, marketing exclusivity and incentives such as tax credits to ensure research, development and marketing. The majority of countries (27/35) had in place orphan drug legislation. Access to orphan drugs depends on individual country’s pricing and reimbursement policies, which varied widely between countries. High prices and insufficient evidence often limit orphan drugs from meeting the traditional health technology assessment criteria, especially cost-effectiveness, which may influence access. Overall many countries have implemented a combination of legislations, regulations and policies for orphan drugs in the last two decades. While these may enable the availability and access to orphan drugs, there are critical differences between countries in terms of range and types of legislations, regulations and policies implemented. Importantly, China and India, two of the largest countries by population size, both lack national legislation for orphan medicines and rare diseases, which could have substantial negative impacts on their patient populations with rare diseases.
20 April 2020 in Journal of Pharmaceutical Policy and Practice
As the lockdowns are being observed all over the globe and the national level pharmacy professionals are performing frontline roles, this editorial highlights the role of pharmacists in the COVID − 19 pandemic. Pharmacists globally are providing services amidst pandemic, including TRIAGE services, seeing patients and reducing the patients’ burden on health care facilities such as hospitals and GP practices. Pharmacists are also working to providing home deliveries, as well as dealing with the increasing number of patients coming through to pharmacies with the other ailments. Pharmacy associations have issued their guidelines and in this editorial, several global examples of pharmacists’ role in the COVID 19 are being discussed. Pakistan is used as a country case study in this editorial. The editorial also elaborates how pharmacists in the UK and Pakistan have teamed up together to compile 10-steps protection guidelines for the pharmacy teams in Pakistan in English and Urdu language. This 10-point guidance educates community pharmacies for safety and standard operation as the number of patients in the country continues to rise. These guidelines are endorsed by the government and private bodies. These can be adopted and adapted by any country; keeping in view their laws and regulations.
19 April 2024 in Journal of Pharmaceutical Policy and Practice
Diabetes increases preventative sickness and costs healthcare and productivity. Type 2 diabetes and macrovascular disease consequences cause most diabetes-related costs. Type 2 diabetes greatly costs healthcare institutions, reducing economic productivity and efficiency. This cost of illness (COI) analysis examines the direct and indirect costs of treating and managing type 1 and type 2 diabetes mellitus. According to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, Cochrane, PubMed, Embase, CINAHL, Scopus, Medline Plus, and CENTRAL were searched for relevant articles on type 1 and type 2 diabetes illness costs. The inquiry returned 873 2011–2023 academic articles. The study included 42 papers after an abstract evaluation of 547 papers. Most articles originated in Asia and Europe, primarily on type 2 diabetes. The annual cost per patient ranged from USD87 to USD9,581. Prevalence-based cost estimates ranged from less than USD470 to more than USD3475, whereas annual pharmaceutical prices ranged from USD40 to more than USD450, with insulin exhibiting the greatest disparity. Care for complications was generally costly, although costs varied significantly by country and problem type. This study revealed substantial heterogeneity in diabetes treatment costs; some could be reduced by improving data collection, analysis, and reporting procedures. Diabetes is an expensive disease to treat in low- and middle-income countries, and attaining Universal Health Coverage should be a priority for the global health community.
At present, much of the attention within tuberculosis (TB) management is spent on microbiological cure, and its impact on health-related quality of life (HRQoL) is either undervalued or seldom considered. The aim of this study was to evaluate the impact of TB treatment on HRQoL of new smear positive pulmonary tuberculosis (PTB) patients. Moreover, we also aimed to determine whether the selected socio-demographic and clinical variables were predictive of variability in the HRQoL scores over time.
6 January 2021 in Journal of Pharmaceutical Policy and Practice
Medicines are important health interventions and their appropriate use could improve health outcomes. Throughout the globe, pharmacists play a very important role to improve the use of medicines. Though high-income countries are debating on futuristic approaches, independent prescribing of pharmacists, clinical skills, and to expand pharmacy services; a large majority of low and middle-income countries still lag behind to strengthen pharmacy practice. This paper presents a key set of recommendations that can improve pharmacy practice in low and middle-income countries (LMICs). The ten recommendations include (1) Mandatory presence of graduate-level pharmacists at community pharmacies (2) Clear demarcation of the roles and responsibilities of different categories of pharmacists (3) Effective categorization and implementation of medicines into (a) prescription medicines (b) pharmacists only medicines (c) over the counter medicines (4) Enforcement of laws and regulations for the sale of medicines (5) Prohibiting doctors from dispensing medicines (the dispensing separation between pharmacists and doctors). (6) Involving pharmacies and pharmacists in Universal Health Coverage Schemes to improve the affordability of medicines (7) Strengthening national medicines regulatory authorities to improve the quality, safety, and effectiveness of medicines (8) Training of pharmacists in clinical skills, vaccination, and minor ailment schemes (9) Promoting independent medicines information for consumers and healthcare professionals by developing national medicines information strategy (10) Mandatory Continuing Professional Development (CPD) programs for the Pharmacists.