Access in a Crisis: The Modernization of OTC Drug Regulations

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.

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Legalising the Drug Wars

10.1017/9781009058278 ◽

2021 ◽

Author(s):

John Collins

Keyword(s):

Control System ◽

Focal Point ◽

Regulatory System ◽

Legal Framework ◽

Drug Control ◽

Global Policy ◽

Drug Regulations ◽

Single Convention ◽

History Of ◽

Narcotic Drugs

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.

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Stringent Drug Regulations

Science ◽

10.1126/science.162.3860.1330-b ◽

1968 ◽

Vol 162 (3860) ◽

pp. 1330-1331

Author(s):

Burton W. Rockliff

Keyword(s):

Drug Regulations

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FACTS ON DRUG REGULATIONS

International Journal of Drug Regulatory Affairs ◽

10.22270/ijdra.v2i3.140 ◽

2018 ◽

Vol 2 (3) ◽

pp. 43-47

Author(s):

Rajkumar Gupta

Keyword(s):

Life Cycle ◽

Drug Regulation ◽

Pharmaceutical Products ◽

Regulatory Requirements ◽

Ministry Of Health ◽

Drug Products ◽

Drug Regulations ◽

The Law ◽

Basic Facts

The pharmaceutical products are very much driven by the drug regulation imposed by ministry of health in individual countries. The basic facts on regulations is that they are mandatory and noncompliant are punishable under the law. Further, compliance is not a one time job but it is an exercise to be performed over the life cycle of the drug products. It starts from development of the products and continues till the product is in market. The information, registration, permission and extensions/withdrawals are the primary regulatory requirements for the drug products. The main focus of drug regulations is to check that safety, quality and efficacy of the drug products over its lifecycle.

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Drug Regulations, Europe

Encyclopedia of Toxicology ◽

10.1016/b978-0-12-386454-3.00583-2 ◽

2014 ◽

pp. 240-247

Author(s):

M.I. de San Andrés Larrea ◽

M. Escribano ◽

A. González-Canga

Keyword(s):

Drug Regulations

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Performance Horse Drug Regulations and Restrictions Association of Racing Commissioners International, Inc., Uniform Classification Guidelines for Foreign Substances (Revised January 2020)

Papich Handbook of Veterinary Drugs ◽

10.1016/b978-0-323-70957-6.15015-0 ◽

2021 ◽

pp. 1011-1012

Keyword(s):

Drug Regulations

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

The Annual Review of Pharmacology and Toxicology ◽

10.1146/annurev-pharmtox-033020-113257 ◽

2021 ◽

Vol 61 (1) ◽

pp. 225-245 ◽

Cited By ~ 1

Author(s):

Adam S. Darwich ◽

Thomas M. Polasek ◽

Jeffrey K. Aronson ◽

Kayode Ogungbenro ◽

Daniel F.B. Wright ◽

...

Keyword(s):

Drug Therapy ◽

Current Knowledge ◽

Clinical Care ◽

Clinical Decision ◽

Decision Support Tools ◽

Support Tools ◽

Drug Regulations ◽

The Common ◽

Clinical Decision Support Tools ◽

Practical Validation

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.

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Survey of Bottled Drinking Water Sold in Canada. Part 1. Lead, Cadmium, Arsenic, Aluminum, and Fluoride

Journal of AOAC International ◽

10.1093/jaoac/75.6.949 ◽

1992 ◽

Vol 75 (6) ◽

pp. 949-953 ◽

Cited By ~ 11

Author(s):

Robert W Dabeka ◽

Henry B S Conacher ◽

John Salminen ◽

Gerald R Nixon ◽

Gunther Riedel ◽

...

Keyword(s):

Water Quality ◽

Drinking Water ◽

Tap Water ◽

Bottled Water ◽

Mineral Waters ◽

Mineral Spring ◽

Bottled Drinking Water ◽

Drug Regulations ◽

Tap Water Quality

Abstract Samples of bottled water (n = 172) offered for sale in Canada were analyzed for lead, cadmium, arsenic, aluminum, and fluoride: means and ranges (μg/g) found were, respectively, 0.0026 (<0.0010- 0.074), 0.00018 (<0.0001-0.0004), 0.0030 (<0.001- 0.048), 0.027 (<0.010-0.568), and 0.543 (<0.050- 5.85). Comparison of levels among mineral waters (n = 64), spring waters (n = 77), and miscellaneous waters (n = 31) indicated appreciable differences only in the case of fluoride. For fluoride, the means and medians (μg/g) for mineral, spring, and miscellaneous waters were 1.179 and 0.455, 0.152 and 0.090, and 0.201 and <0.050, respectively. No samples were found in violation of the tolerances in the Canadian Food and Drug Regulations; however, 1 sample (in a lead-soldered can) contained lead and 15 samples contained fluoride at levels above the limits recommended by the Guidelines for Canadian Drinking Water (tap-water) Quality.

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