Legalising the Drug Wars

Where did the regulatory underpinnings for the global drug wars come from? This book is the first fully-focused history of the 1961 UN Single Convention on Narcotic Drugs, the bedrock of the modern multilateral drug control system and the focal point of global drug regulations and prohibitions. Although far from the propagator of the drug wars, the UN enabled the creation of a uniform global legal framework to effectively legalise, or regulate, their pursuit. This book thereby answers the question of where the international legal framework for drug control came from, what state interests informed its development and how complex diplomatic negotiations resulted in the current regulatory system, binding states into an element of global policy uniformity.

Substandard and falsified medical products: bibliometric analysis and mapping of scientific research

Objective Substandard and falsified (SF) medical products are a global public health threat. The presence and spread of SF drugs negatively affect (1) patients’ safety and health outcomes, (2) national economy, (3) public trust in the healthcare system, and (4) the international fight against serious health challenges such as malaria and antimicrobial resistance. The objective of the current study was to investigate and provide a snapshot analysis of the evolution and developmental patterns of global research publications on SF products. Methods A bibliometric approach was adopted using terms such as fake, falsified, counterfeit, substandard, and others. No language restriction was made. The study period was from 1900 up to 2020. The search strategy was validated and implemented using Scopus database. Results The search strategy retrieved 978 documents authored by 2861 researchers from 100 different countries and published in 421 different journals. The retrieved documents received 11,237 citations (11.5 citations per document) with an H-index of 53. The 978 documents retrieved from Scopus were published from 1961 to 2020, giving an average of 16.6 publications per year. The present study indicated that research on SF medical products: (a) has experienced a steep growth from 2001 to 2012 followed by a steady-state growth; (b) was disseminated in a wide range of journals, mainly in the fields of the pharmaceutical industry, analytical chemistry, public health, infectious diseases, and internal medicine; (c) was published by scholars with diverse and distant geographical backgrounds; (d) was mainly produced in the United States, United Kingdom, and Germany; (d) has fragmented research networks and a limited number of researchers per network; (e) has limited cross-country collaboration except for that between the US and the UK in one hand and countries in the Mekong region in the other hand; (f) emphasized on medications related to malaria and sexual stimulants; and (g) received relatively inadequate funding. Conclusions Research on SF medical products is important and should remain a priority to ensure good quality of medications. Research activity in the field needs to be encouraged in world regions such as Africa and the Middle East where drug regulations are unsatisfactory and cross-border trade of illegal medications is common.

Orphan Drugs, Compounded Medication and Pharmaceutical Commons

Regulatory agencies installed orphan drug regulations to stimulate research and development of new innovative treatments for life-threatening diseases with a low prevalence (rare diseases). We established a list of well-known food-related ingredients with clinical evidence for rare diseases in the open medical literature that obtained marketing authorization as an expensive “orphan drug”, protected by intellectual property (IP) rights. We show that these ingredients are part of an established practice of medicinal compounding—a form of point of care manufacturing. We argue that these ingredients should be considered as “pharmaceutical commons”, and that regulatory incentives for private companies and market protection mechanisms such as IP rights are not justified in this case.

PHYTO-PHARMACEUTICAL DEFINITION UNDER DRUG REGULATIONS, INDIA NEEDS AN URGENT REVIEW

Dear Reader, An Amendment to the Drugs and Cosmetics Regulations to permit scientifically developed plant based leads as drugs named “phytopharmaceuticals”, was notified for the first time in November 2015. This regulation has now been further amended and revised to put it under new drug definitions and provided more provisions for greater clarity in 2019. However, having championed these regulations (as part of the Indian Pharmacopoeia Commission’s Expert Committee on Herbals) for nearly a decade a greater number of drugs should have come out through this route given the scientific capability of the Indian drug sector and academia. However, the only information in the public domain as on date is the approval for conducting human clinical trials of a plant based lead for testing the protective or curative potency of Coculous hirsutus against SARS – CoV-2 given by the Drugs Controller General of India. A purified fraction of the stem of this plant commonly called broom creeper has been tested for sinnococculine markers as the lead drug candidate.

Model-Informed Precision Dosing: Background, Requirements, Validation, Implementation, and Forward Trajectory of Individualizing Drug Therapy

Model-informed precision dosing (MIPD) has become synonymous with modern approaches for individualizing drug therapy, in which the characteristics of each patient are considered as opposed to applying a one-size-fits-all alternative. This review provides a brief account of the current knowledge, practices, and opinions on MIPD while defining an achievable vision for MIPD in clinical care based on available evidence. We begin with a historical perspective on variability in dose requirements and then discuss technical aspects of MIPD, including the need for clinical decision support tools, practical validation, and implementation of MIPD in health care. We also discuss novel ways to characterize patient variability beyond the common perceptions of genetic control. Finally, we address current debates on MIPD from the perspectives of the new drug development, health economics, and drug regulations.

Off-Label Use of Medicines: A Comparative Study on the Regulation of Medicinal Products in Selected European Union Member States

Many governments have implemented a controlled off-label use of medicines as a tool combined with reimbursement decisions, among other policies, to avoid pharmaceutical firms gaming regulatory systems based on the requirement for marketing authorisation. This article aims to compare the drug regulations in selected European Union countries (France, Italy and Germany) in order to identify specific provisions and concrete solutions implemented by them regarding that matter. The employment of an economic analysis of the law as a theoretical framework allows for the identification of the incentives created in the long run by the referred regulations. The scholarly literature identifies a myriad of drawbacks and advantages associated with off-label practices, and a welfare analysis is ambiguous. Off-label practices are a reality; thus, it is advisable to elaborate policy measures in order to address these practices and condition them on some requirements, taking into account that off-label practices imply trade-offs among access to healthcare, protection of public health, competitiveness and innovation in the industry.

A prescription for improvement: Health and Safety Measures

The strategy of price liberalization and privatization had been implemented in Sudan over the last decade, and has had a positive result on government deficit. The investment law approved recently has good statements and rules on the above strategy in particular to pharmacy regulations. Under the pressure of the new privatization policy, the government introduced radical changes in the pharmacy regulations. To improve the effectiveness of the public pharmacy, resources should be switched towards areas of need, reducing inequalities and promoting better health conditions. Medicines are financed either through cost sharing or full private. The role of the private services is significant. A review of reform of financing medicines in Sudan is given in this study. Also, it highlights the current drug supply system in the public sector, which is currently responsibility of the Central Medical Supplies Public Corporation (CMS). In Sudan, the researchers did not identify any rigorous evaluations or quantitative studies about the impact of drug regulations on the quality of medicines and how to protect public health against counterfeit or low quality medicines, although it is practically possible. However, the regulations must be continually evaluated to ensure the public health is protected against by marketing high quality medicines rather than commercial interests, and the drug companies are held accountable for their conduct.

Understanding and analysing competency based curriculum in pharmacology for developing syllabus and teaching schedules

The competency based curriculum has already been implemented in phase-I (1st professional MBBS) and medical institutes, through curriculum committees, are gearing up for designing and developing curricular contents for phase-II training beginning from October, 2020. We have analysed curricular components as given in CBME documents with respect to distribution of contents and time allotted for cognitive and skill training and assessment. The objectives of this analysis are to understand distinctive features, identify elements required for organization of teaching sessions and facilitate preparation of teaching schedules. We segregated competencies according to corresponding system and domain of learning to distribute teaching hours. It was observed that 64 competencies in cognitive domain shall be covered in 80 hours assigned for lectures. The new curriculum has given importance to clinically relevant topics such as drug regulations, pharmaco-economics, pharmacology of eye and skin disorders, vaccines, national health programs (would require integration), environmental pollutants, food adulterants, stings and bites, and pharmacological considerations in geriatric and paediatric therapy. Ironically, antimicrobial agents and anti-fungals do not appear in the document as separate competencies. The 138 non-lecture hours can be divided into small group discussions (seminars) and tutorials for 19 hours each and remaining 100 hours can be reserved for practicals (skill training). About 27% of time assigned for practical training shall be required for developing proficiency for certification in 4 competencies and 25 competencies in cognitive domain shall require integration. Finally, steps are described to construct subject specific sessions giving one example each for a non-integrated and an integrated session.