Medication safety: opening up the black box

JAMA Internal Medicine, 2019

3. Leventhal R. Maryland HIE connects to statewide prescription drug monitoring program. .

Pharmacoepidemiology and Drug Safety, 2020

This is the author manuscript accepted for publication and has undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as

In Vivo, 2022

Expert Opinion on Drug Safety, 2020

Introduction: Important drug safety issues are evaluated through a referral procedure in the EU by the Pharmacovigilance Risk Assessment Committee (PRAC) within the European Medicines Agency. We aim to describe all safety-related referrals assessed by the PRAC by June 2019. Methods: Publicly available data on safety issues assessed through referral procedures that reached a final decision during July 2012-June 2019 were identified, analyzed and classified according to predefined criteria. Results: Fifty-one safety issues were assessed by PRAC for 45 medicines/ combinations/ therapeutic classes during this timeframe. Referrals were initiated mostly by the European Commission (16) and France (8). Nine medicines were authorized in the last five years, the rest being well-established drugs. In four cases (flupirtine, hydroxyethyl-starch, valproate, codeine) PRAC reassessed the same risks as previous recommendations have not been effective. Post-referral recommendations consisted of updates of the summary of product characteristics and package leaflet (42), Direct Healthcare Professional Communication (32), and other additional risk minimization measures (RMMs). Withdrawal was recommended for seven active substances. Conclusions: PRAC recommended routine or additional RMMs for most referrals. Complete withdrawal of a drug or withdrawal of certain pharmaceutical forms or concentrations was advised only when the risk could not be managed by RMMs.

PLoS ONE, 2014

Background: The European Medicines Agency (EMA) and national regulators share the responsibility to communicate to healthcare providers postmarketing safety events but little is known about the consistency of this process. We aimed to compare public availability of safety-related communications and drug withdrawals from the EMA and European Union member countries for novel medicines.

Drug Development Research, 1994

The performance of general pharmacology procedures on new drug candidates supports both drug discovery and safety assessment activities; however, the potential contribution of general pharmacology to safety assessment has had less attention than other aspects of nonclinical testing. Pharmaceutical companies are divided as to whether or not general pharmacology is integrated with the rest of toxicology testing or carried out as part of the discovery program, and, recently, discussions have taken place within Europe as to whether or not these studies should be subject to Good Laboratory Practice (CLP) conditions. All three regions (the United States, Europe, and Japan) require data on the pharmacological properties of new drugs to be included in a marketing application. This should cover primary and secondary pharmacological effects, and should provide information concerning potential adverse reactions. In addition, Europe and the United States request non-clinical data on potential drug interactions. However, the most detailed requirements are described in the Japanese guidelines. This paper reviews the current regulatory environment in the European Community (EC), Japan, and the United States, highlighting some general features of the three regulatory systems which are relevant to general pharmacology, and summarising the specific guidelines for these studies in the three regions. Although there are significant differences between the detailed Japanese general pharmacology requirements and the more flexible Western approach, it i s not clear that it i s appropriate to include general pharmacology within the international harmonization discussions. Rather, deregulation in this area i s a desirable goal for the future. c IOY-I hiIey-Liss, i n i . A d d r r s i reprint reque5k to Cynthia t Lumley, Centre for Medicines Reiearc h, Wooclrnansterne Road, Carbhalton, surrey, U K SM54DS This article i s based on J presentation at the inaugural meeting of the General Pharm~~cology/Safetv Ph<irrnacology Uiscuwon

Social Science & Medicine, 2012

The user has requested enhancement of the downloaded file. All in-text references underlined in blue are added to the original document and are linked to publications on ResearchGate, letting you access and read them immediately.

BMJ Open, 2014

Objective: To explore the quality and safety of medicines in Canada.

Expert Review of Clinical Pharmacology, 2018

Background: Safety monitoring of all drugs throughout their entire life cycle is mandatory in order to protect the public health. Our objective was to describe all new safety signals assessed at EU level by the Pharmacovigilance Risk Assessment Committee (PRAC). Methods: Publicly available data on signals assessment from PRAC meeting minutes for the period January 2014-November 2017 were analyzed and classified. Results: A total of 239 new signals for 194 drugs/drug combinations/therapeutic classes were evaluated by PRAC. A total of 154 signals were triggered by spontaneous reporting, 31 by literature case reports, and 26 by observational studies. In 188 signals, the drugs involved were authorized for more than 5 years. The drug classes for which most signals were detected were antineoplastic/immunomodulators (n = 75), anti-infectives (n = 34), and drugs acting on the nervous system (n = 27). Signals were triggered for drug interactions (n = 15), in utero exposure (n = 7), medication errors (n = 6), and for different disorders, among which the skin/subcutaneous tissue disorders were more common. PRAC recommendations consisted in label updates (n = 86), in Direct Healthcare Professional Communications (n = 17), and in eight recommendations for a more complex evaluation through referral procedures. Conclusions: Most new signals assessed were triggered by spontaneous reporting and led to routine risk minimization measures, such as updating the product information.

International journal of Pharmacy and Pharmaceutical Sciences, 2014

A series of public health disasters (Thalidomide in the 1960s to Rofecoxib (Vioxx) at the beginning of this century have served to remind us that effective Pharmacovigilance (PV) is crucial for protection of citizens. The introduction of new PV legislation in July 2012 is the biggest change to the regulation of human medicines in the European Union (EU) since 1995. New requirements and procedures for Post-Authorization Safety Studies (PASS) open the gateway for development of real-world effectiveness outcomes. Similarly, the United States Food and Drug Administration (USFDA) has become more open to inclusion of non-safety data collection in its safety surveillance mandates and more proactive risk management approach. In addition, the Marketing Authorisation Holders (MAHs) need to be more efficient with their post-authorisation activities to maximize their utility. The main goal of this new PV path is to strengthen the public health. However it is also concerned with improved efficiency, clear decision-making processes, reduce duplication and better use of Information Technology in PV process.