Good Pharmacovigilance Practices Research Articles

Decreased warfarin effects in elder with recurrent Clostridium difficile infection during fidaxomicin therapy: a case report

Clostridium difficile infection is a disease with increasing incidence, particularly in high‑riskpatients such as the elderly, immunocompromised patients, etc.We report an unexpected decrease of International Normalized Ratio (INR) response to warfarin during a first recurrence of Clostridium difficile infection (CDI) treated with fidaxomicin. The patient, an old man who has prosthetic heart valves on anticoagulation therapy with warfarin, was treated with an association of vancomycin plus metronidazole for a first episode of CDI. Patient remained symptom‑free for few days and then he presented with recurrent diarrhea. A retreatment with vancomycin and metronidazole didn’t resolve symptoms of CDI, therefore he underwent fidaxomicin treatment for 10 days, with rapid resolution of diarrhea. In the meantime, warfarin effects diminished, and only with increases of dosage INR therapeutic range was achieved few days after discontinuing fidaxomicin. According to product information, fidaxomicin doesn’t interfere with warfarin. The authors highlight the different plausible mechanisms to explain the association between the unexpected decreased effect of warfarin and factors that could have influenced such event. The frequent update of product information through good pharmacovigilance practices could help clinicians in the management of unexpected events.

Good pharmacovigilance practice: Need of the hour from pharmaceutical companies.

Good pharmacovigilance practice: Need of the hour from pharmaceutical companies.

Responding to concerns over the PSMF: Inspectors offer key insights

The pharmacovigilance system master file (PSMF) is a detailed description of the pharmacovigilance system used by the marketing authorisation holder for their authorised medicinal products. The PSMF is intended to be a live, custom-made document that accurately reflects the pharmacovigilance system put in place for a given product. It is expected to contain meticulous detail so that the marketing authorisation holder's compliance with current good pharmacovigilance practices guidelines can be assessed. This article focuses on the feedback provided by the inspectors during their assessment of the PMSF with an emphasis on areas for improvement.

Cardiovascular safety of strontium ranelate: real-life assessment in clinical practice

Cardiovascular safety of strontium ranelate: real-life assessment in clinical practice

Interpretation of Guidelines on Good Pharmacovigilance Practices for European Union

Due to the limitations of pre-authorization clinical trials, the safety information obtained from them is relatively limited. Therefore, it is very necessary to carry out pharmacovigilance activities on drugs post-marketing. In order to promote the specific implementation of the new pharmacovigilance regulations, the European medicines agency (EMA) developed the Guideline on Good Pharmacovigilance Practices (GVP), as the new criteria for pharmacovigilance in the European Union (EU). Compared with the previously published, Guidelines on Pharmacovigilance for Medicinal Products for Human Use (2007), the GVP proposed more comprehensive and systematic provisions of pharmacovigilance systems, quality control systems, judgements, pharmacovigilance inspections and audits. In addition, it set more specific and comprehensive requirements on risk management systems, the management and reporting of adverse reactions to medicinal products, periodic safety update reports, post-authorization safety studies, signal management, and so on. Interpreting the basic principles, working mechanisms, key technologies and methods of the GVP provides a useful reference for us to carry out pharmacovigilance (especially regarding safety monitoring of parenterally administered Chinese medicine).

The Economic Savings of Queensland's Indigenous Cardiac Outreach Program

Background: Muscle adverse effects with statins are recognised, although generally considered mild. There is little information about statin myotoxicity in Aboriginal and Torres Strait Islanders. Methods: Observational case series of serious statin associated myotoxicity (SSAM) in ATSI’s conducted with Good Pharmacovigilance Practice. Cases identified from clinical experience, referral, reports to TGA, medical literature, internet and histopathology reports. Cases had (a) evidence of significant myotoxicity (CK>10× ULN), or biopsy consistent with statin myopathy (b) exposure to statin (c) ATSI ethnicity. Results: Fifteen cases identified, mean age 55 (R35-69), 7M 8F. Presentation was with predominantly weakness (five), rhabdomyolysis and/or acute renal failure (four), proximal myopathy (three), myalgia (two) and one incidental. Mean CK was 52,889 (R 6230–276,000U/L). Statin usedwas atorvastatin 11 cases (20–80mg), simvastatin, one case (80mg), and unspecified in three cases. Interacting drugswereprescribed infive cases. Six caseswereVitamin D deficient. Biopsies showed necrotizing myositis (five), and inflammatory polymyositis (three). Effect of ceasing statin was clear in 10 cases. Four had progression after stopping statin.Hypoventilatory respiratory failure developed in three cases due to respiratory muscle weakness requiring prolonged ventilation. There were three deaths and one permanent disability. Conclusion: SSAM occurs in ATSI populations. The most common presentation is weakness, rather than pain. Myositis may progress after statin cessation. Hypoventilatory respiratory failure requiring prolonged ventilation may occur. Increased awareness is required to improve recognition, and early diagnosis. Active pharmacovigilance is important for ATSI populations.

The EMA has released two more modules of its guideline on good pharmacovigilance practices (GVP).

The EMA has released two more modules of its guideline on good pharmacovigilance practices (GVP).

Two further modules of the guideline for good pharmacovigilance practices (GVP) have been issued

Two further modules of the guideline for good pharmacovigilance practices (GVP) have been issued

Good Pharmacovigilance Practice and the Curateʼs Egg

In February this year, the EuropeanMedicines Agency (EMA) placed on the Internet the first seven Good Pharmacovigilance Practice (GVP) modules, out of a full set of 16, for public consultation; the remainder will be available over the next few months. The consultation time is over, and I did not make any comments directly for reasons that are clear: the size and complexity of the documents; the cross referencing needed for consistency in the details; and that there is less than half of the full GVP available now. The GVP is coincident with new, important EU Directives (Directive 2010/84/EU) and Regulations (Regulation [EU] No 1235/2010) amending existing legislation that were adopted in the EU in December 2010. These are comprehensive developments in pharmacovigilance (PV) and need serious, critical reflection.

Role of hospital pharmacists in reporting adverse drug reactions – A review

Adverse drug reactions (ADRs) are one of the leading causes of morbidity and mortality. ADRs account for about 5% of the hospital admissions, though 60% of the ADRs are preventable. Being a medicine expert, the pharmacists in the hospital sectors can play a significant role in detecting, monitoring, and reporting ADRs. With sound knowledge on drug therapy and disease management, they are the preferred group of professionals in ensuring drug and patient safety. Underreporting of ADRs is a serious problem; and the possible reasons for that include the lack of awareness among healthcare professionals and inadequate patient education. There is a need for proper training to hospital pharmacists on ADR reporting. Implementing good pharmacovigilance (PV) practice in the hospital settings can lead to proper reporting of ADRs. This manuscript reviews the published literature on the consequences and under-reporting of ADRs, importance of PV, and the hospital pharmacists' contributions in drug and patient safety.

Preparing for a Safety Inspection

Large and small pharmaceutical companies alike face a growing and complex set of international regulations designed to protect patient safety and ensure good pharmacovigi-lance practices. Inspectors from FDA and European regulatory authorities are increasing their efforts to verify that companies comply with these regulations. The penalties for non-compliance can be severe, including revoking a product’s marketing authorization. To prepare for an inspection, companies must perform a thorough drug safety and pharmacovigilance audit. This will assess the company’s compliance with applicable worldwide laws, regulations, and guidance. Indeed, regulatory inspectors will look for evidence that such an audit has taken place. This article is designed to give companies operating in the United States and EU the information and insight needed to ensure compliance with global drug safety and pharmacovigilance regulations. It addresses the most recent drug safety regulations from both FDA and EMA.

Abstract Société Quebécoise de Néphrologie 2007. Château bonne entente àQuébec

The need for pharmacoepidemiology, defined as the study of the use of and the effects of drugs in large numbers of people, will increase exponentially in the next decade both in developed and in developing countries. Within Europe, a common market of over 350 million consumers, regulations and guidelines related to drug use were formulated, especially with respect to post-marketing surveillance and the detection, interpretation and management of rare but serious drug related adverse events. The activities of international organizations like the World Health Organization in this context are briefly addressed.In the European Union a choice has been made by the regulatory authorities for spontaneous reporting systems as a minimal requirement for post marketing surveillance in all member states. The French pharmacovigilance system has to some extend functioned as a blueprint for a common European post marketing surveillance system. Therefore the organization of this French system is explained in some detail. Also in this context the need for drug utilization studies to get quantitative information about drug use is stressed. For the creation of the databases needed for case control and cohort studies a variety of approaches is used in different countries, all with their own advantages and shortcomings. Some examples from England and the Netherlands are given. The efforts of the European Commission and various scientific organizations aiming to promote the harmonization of pharmacovigilance actions in Europe are discussed. Finally, some guidelines for good pharmacovigilance practice are suggested.

FDA Vows to Improve Drug-Safety Assessments

FDA Vows to Improve Drug-Safety Assessments

The case for good pharmacovigilance practice

The case for good pharmacovigilance practice

The case for good pharmacovigilance practice

The case for good pharmacovigilance practice

Pharmacovigilance in perspective.

Pharmacovigilance is more than spontaneous reporting alone, and the evaluation of marketed medicines is more than just pharmacovigilance. The positioning of a drug usually takes place during the years following introduction, when worldwide experience has accumulated. Originally a modest appendix of drug regulation, pharmacovigilance has become a major activity. The provision of the information needed for the evaluation of the benefits and risks of drugs is in the first place a scientific challenge. In addition, there are important ethical, logistical, legal, financial and commercial constraints. Good pharmacovigilance practice needs to be developed to ensure that data are collected and used in the right way and for the right purpose. Pharmacovigilance, and more generally the study of the benefits and risks of drugs, plays a major role in pharmacotherapeutic decision-making, be it individual, regional, national or international. In addition, pharmacovigilance is becoming a scientific discipline in its own right. A variety of changes are taking place in the complex system of drug development, regulation and distribution. Pharmacovigilance should be proactive in monitoring their possible consequences.

Some observations on pharmacoepidemiology in Europe

The need for pharmacoepidemiology, defined as the study of the use of and the effects of drugs in large numbers of people, will increase exponentially in the next decade both in developed and in developing countries. Within Europe, a common market of over 350 million consumers, regulations and guidelines related to drug use were formulated, especially with respect to post-marketing surveillance and the detection, interpretation and management of rare but serious drug related adverse events. The activities of international organizations like the World Health Organization in this context are briefly addressed.In the European Union a choice has been made by the regulatory authorities for spontaneous reporting systems as a minimal requirement for post marketing surveillance in all member states. The French pharmacovigilance system has to some extend functioned as a blueprint for a common European post marketing surveillance system. Therefore the organization of this French system is explained in some detail. Also in this context the need for drug utilization studies to get quantitative information about drug use is stressed. For the creation of the databases needed for case control and cohort studies a variety of approaches is used in different countries, all with their own advantages and shortcomings. Some examples from England and the Netherlands are given. The efforts of the European Commission and various scientific organizations aiming to promote the harmonization of pharmacovigilance actions in Europe are discussed. Finally, some guidelines for good pharmacovigilance practice are suggested.

Drug Safety: Legal Requirements in Europe and in the United States — A European Industry View

Legal requirements regarding drug safety remain a puzzling matter for a drug company even inside the European Union. In carrying out clinical trials, European investigators have achieved considerable progress in complying with the American rules, although the European Union has provided some indications in good clinical practices guidelines. Undoubtedly, the International Conference on Harmonization two (ICH2) process speeds up harmonization not only between the United States, Europe, and Japan but also between the European countries. As far as marketed drugs are concerned, the management of a pharmacovigilance network will be a major activity of the future European agency; the main rules will be similar to those of the Food and Drug Administration (FDA). Harmonization of drug safety requirements should be encouraged not only in the reporting of adverse drug reactions but also in the quality of recorded data. This would then require a consensus on good pharmacovigilance practices, definition of medical te...