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Pharmaceutical Medicine - Pharmacovigilance

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Developing a Crowdsourcing Approach and Tool for Pharmacovigilance Education Material Delivery. ENCePP Home Page. ENCePP Guide on Methodological Standards in Pharmacoepidemiology Section 4.6.

ENCePP Home Page

ETOX Project. Where to find information about drugs. Database Access - UNSW Library. Database Access - UNSW Library. Is Earlier Signal Detection Always Better? CASP Tools & Checklists. This set of eight critical appraisal tools are designed to be used when reading research, these include tools for Systematic Reviews, Randomised Controlled Trials, Cohort Studies, Case Control Studies, Economic Evaluations, Diagnostic Studies, Qualitative studies and Clinical Prediction Rule.

CASP Tools & Checklists

These are free to download and can be used by anyone under the Creative Commons License. CASP Checklists (click to download) Some Study Designs..... What is a Systematic Review? Frequently there will have been more than one study addressing a particular health question. What is a Randomised Controlled Trial (RCT)? EMA’s medical literature monitoring enters into full operation. Extended service will improve safety monitoring of medicines and simplify pharmacovigilance activities for companies The European Medicines Agency (EMA) starts its full medical literature monitoring service on 1 September 2015.

EMA’s medical literature monitoring enters into full operation

A total of 400 active substance groups (300 chemical active substance groups and 100 herbal active substance groups) will now be monitored by EMA. The service will benefit over 4,000 companies. The list of active substance groups and a reference to the journals covered by EMA’s medical literature monitoring service are available on the monitoring of medical literature page. Companies are advised to consult the list to check whether their products are covered by the service. The implementation of EMA’s full service follows a launch phase which began on 1 July 2015 and which included the 50 most common chemical active substance groups. Health Literacy Infographics. The Inclusion of Nurses in Pharmaceutical Industry–Sponsored Events:  Guess Who Is Also Coming to Dinner? This report describes the extent of inclusion of nurses in pharmaceutical company-sponsored educational events in Australia.

The Inclusion of Nurses in Pharmaceutical Industry–Sponsored Events:  Guess Who Is Also Coming to Dinner?

The release of the Open Payments data in the United States, which detail payments from pharmaceutical and medical device companies to physicians, enables analysis of the financial relationships between physicians and industry.1 However, the Physician Payments Sunshine Act, which mandates these disclosures, omits registered nurses.

Database Access - UNSW Library. Database Access - UNSW Library. Database Access - UNSW Library. Database Access - UNSW Library. Database Access - UNSW Library. Two years of sunshine: has openness about payments reduced industry influence in healthcare? Two years since the implementation of the US law that requires industry to disclose payments to doctors, Jeanne Lenzer assesses its impact The Physician Payments Sunshine Act, passed in March 2010, was heralded as a “watershed moment” that would expose physicians’ conflicts of interest to the “disinfecting effects” of sunlight.1 2 3 4 The act, intended to curb undue influence of drug and device makers over medical research and physicians’ prescribing habits, took effect in 2013, and industry payments to doctors were made publicly accessible through the Open Payments website of the Centers for Medicare and Medicaid Services (CMS) from September 2014.5 6 From the outset questions were raised: would doctors be less likely to take industry payments?

Two years of sunshine: has openness about payments reduced industry influence in healthcare?

If they did continue to take payments, would they be any less likely to prescribe brand name drugs when generics were available? Would patients question their doctors? Would the act reduce healthcare costs? Database Access - UNSW Library. FDA drug labeling: rich resources to facilitate precision medicine, drug safety, and regulatory science. Open Access Highlights FDA drug labeling contains information about drug efficacy, safety, and more.

FDA drug labeling: rich resources to facilitate precision medicine, drug safety, and regulatory science

FDALabel is a web-based database application of ∼80 000 drug labeling documents. FDALabel supports customizable searches with an easy navigation interface. Transparency is good, independence from pharmaceutical industry is better! Improving transparency in the pharmaceutical industry. Toward Enhanced Pharmacovigilance using Patient-Generated Data on the Internet. Interactions with Search Systems - Ryen W. White. Medicines New Zealand. Strategic Focus on 3R Principles Reveals Major Reductions in the Use of Animals in Pharmaceutical Toxicity Testing. Abstract The principles of the 3Rs, Replacement, Reduction and Refinement, are being increasingly incorporated into legislations, guidelines and practice of animal experiments in order to safeguard animal welfare.

Strategic Focus on 3R Principles Reveals Major Reductions in the Use of Animals in Pharmaceutical Toxicity Testing

In the present study we have studied the systematic application of 3R principles to toxicological research in the pharmaceutical industry, with particular focus on achieving reductions in animal numbers used in regulatory and investigatory in vivo studies. The work also details major factors influencing these reductions including the conception of ideas, cross-departmental working and acceptance into the work process. Data from 36 reduction projects were collected retrospectively from work between 2006 and 2010. Substantial reduction in animal use was achieved by different strategies, including improved study design, method development and project coordination. Editor: Kathrin Eller, Medical University of Graz, Austria Copyright: © 2014 Törnqvist et al. Introduction Figure 1.

Inconsistencies among European Union Pharmaceutical Regulator Safety Communications: A Cross-Country Comparison. Abstract 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.

Inconsistencies among European Union Pharmaceutical Regulator Safety Communications: A Cross-Country Comparison

PLOS Medicine: Complaints, Complainants, and Rulings Regarding Drug Promotion in the United Kingdom and Sweden 2004–2012: A Quantitative and Qualitative Study of Pharmaceutical Industry Self-Regulation. Abstract Background In many European countries, medicines promotion is governed by voluntary codes of practice administered by the pharmaceutical industry under its own system of self-regulation.

PLOS Medicine: Complaints, Complainants, and Rulings Regarding Drug Promotion in the United Kingdom and Sweden 2004–2012: A Quantitative and Qualitative Study of Pharmaceutical Industry Self-Regulation

Involvement of industry organizations in policing promotion has been proposed to deter illicit conduct, but few detailed studies on self-regulation have been carried out to date. Presentation: The TGA Pharmacovigilance Inspection Pilot Program: 2015-2016. TGA presentation: ARCS Scientific Congress Sydney, 11-12 May 2016 On this page: Disclaimer | Presentation | Transcript | Print version Disclaimer These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates.

Presentation: The TGA Pharmacovigilance Inspection Pilot Program: 2015-2016

Consumer Narratives in ADR Reporting: An Important Aspect of Public Health? Experiences from Reports to a Swedish Consumer Organization. Pharmacovigilance of biosimilars: challenges and possible s - GaBI Journal. Keywords: biologicals, biosimilars, immunogenicity, pharmacovigilance, traceability Author byline as per print journal: Thijs J Giezen, PharmD, PhD; Sabine MJM Straus, MD, PhD Submitted: 18 June 2012; Revised: 16 September 2012; Accepted: 17 September 2012; Published online first: 24 September 2012 Challenges are encountered during the pharmacovigilance of biosimilars, including traceability.

These challenges and possible solutions were presented at the Conference of the Drug Information Association (DIA) in Copenhagen, Denmark, in March 2012. This paper provides a summary of the presentation given at the DIA. Utilizing social media data for pharmacovigilance: A review - Journal of Biomedical Informatics. Fig. 1 Sample search queries used for article retrieval from Medline. Fig. 2 A framework for ADR detection and extraction from social media data.

Rob10069 fm. Nihms 148619. Lack of monitoring adverse drug reactions in developing countries. Adverse drug reaction active surveillance: developing a national network in Canada's children's hospitals. Sign In. Impact Factor:0.456 | Ranking:Medical Informatics 24 out of 24 | Pharmacology & Pharmacy 243 out of 255 Source:2014 Journal Citation Reports® (Thomson Reuters, 2015) This item requires a subscription to Therapeutic Innovation & Regulatory Science. To view this item, select one of the options below: Causality. Because of the variability of manifestations and the lack of specific diagnostic markers for drug induced liver injury, attribution of causality to a specific medication is difficult and depends upon identification of a typical clinical signature and exclusion of other causes of liver disease. Drug induced liver injury is a diagnosis of exclusion that rests upon ruling out other common causes of liver disease, and knowledge of the pattern of injury associated with the specific drug.

Unlike in hepatitis A or B, for instance, there are no specific diagnostic tests that establish causality for drug induced liver injury. The diagnosis can also be very challenging and even experts can disagree on the likelihood of the causality. For these reasons, attempts have been made to standardize causality assessment in drug induced adverse events including hepatotoxicity. Where to find information about drugs. Australian Prescriber is published by NPS MedicineWise which has a Privacy Policy.

Click here to see the Privacy Policy of NPS MedicineWise. All personal information collected by Australian Prescriber will be kept strictly confidential and stored securely. Variation in adverse drug reactions listed in product information for antidepressants and anticonvulsants, between the USA and Europe: a comparison review of paired regulatory documents. + Author Affiliations Correspondence to Dr Victoria R Cornelius; V.cornelius@imperial.ac.uk Received 18 November 2015 Revised 4 January 2016 Accepted 6 January 2016 Published 20 March 2016. Lha 031 pers J 0006D93E My%20Documents tume.

Excipient. Document_library. PhRMA Improving%20Medication%20Adherence Issue%20Brief. BioGrid Australia - Home. Home - ANDS. WC500136402. PBRERs. Presentation periodic safety update reports some commonly asked questions. Students and Health Professionals. Nurofen made misleading pain relief claims: Federal Court. Updated. Nurofen made misleading pain relief claims: Federal Court. European Patients’ Academy (EUPATI) – Patient education! SAPI (Singapore Association of Pharmaceutical Industries) Improving patient and health system outcomes. Adherence full report. Manual. PhRMA Improving%20Medication%20Adherence Issue%20Brief. Generic Biosimilar Medicines Association — Making Medicines Affordable.

GBMA Code 4thEdition PUBLISHED 160125. Disclosing conflicts of interest has unintended effects. Over the course of just five months in 2013, US doctors received more than US$3.5 billion in consulting fees, travel reimbursements and gifts from pharmaceutical and medical-device companies. That revelation comes from Open Payments, a database launched on 30 September by the US Centers for Medicare and Medicaid Services (CMS). Transparency advocates praise the move, but others say that such disclosures can have unintended effects on the relationships between patients, physicians and the companies that pay them. The CMS database was created by the Affordable Care Act, the health-care law better known as ‘Obamacare’, which requires biotechnology companies to disclose any payments greater than $10 made to any of the 546,000 physicians affected by the law.

Such disclosures appeal to patients, who want to know whether their doctors are compromised by industry ties, says Sunita Sah, an ethicist at Georgetown University in Washington DC. Generic Biosimilar Medicines Association — Making Medicines Affordable. Cochrane Handbook for Systematic Reviews of Interventions. Home - CEBM. PROSPERO - International prospective register of systematic reviews. Adverse Events Home. Open Payments. FDA to trawl PatientsLikeMe data to identify drug side effects.

The FDA entered a research collaboration agreement with online patient network PatientsLikeMe to "determine how patient-reported data can give new insights into drug safety," the parties announced Monday. Under the deal, the agency and PatientsLikeMe will "explore the potential of patient-generated data to inform regulatory review activities related to risk assessment and risk management. " Corporate/wp-content/uploads/2010/11/Final-social-media-and-pharma-case-study-EN1.pdf. Pharma and Healthcare Social Media Wiki.

Top 10 Pharma Efforts In Social Media. Medical Science Liaison Society - What is an MSL? The Medical Science Liaison (MSL) is a specific role within the pharmaceutical, biotechnology, medical device, CRO and other health-care industries. MSLs have advanced scientific training and academic credentials generally consisting of a doctorate degree (Ph.D., PharmD., M.D.) in the life sciences. They concentrate on a specific Therapeutic Area (i.e. Medical Science Liaison Institute — ADVOCATING FOR MSL PROFESSIONALS WORLD-WIDE!

Sign In. International SAE Consortium. Murray Deakin. Mr. Deakin's practice focuses on competition law, regulatory investigations and prosecutions and consumer protection law, having practised in these fields for more than 25 years. He provides legal representation and advice in relation to regulatory investigations and prosecutions by the Australian Competition and Consumer Commission (ACCC), the Australian Securities & Investments Commission (ASIC), state based regulators and other prosecution authorities. Mr. Madeleine Kearney, Gadens Lawyers - Privacy Law Update – How do refor… The University of Leeds - Academia.edu. Quality use of medicines – are we nearly there yet? - Australian Prescriber. Off-label prescribing - Australian Prescriber.

Tricks of the trade in drug promotion: Non-propositional content in pharmaceutical advertising to health professionals - Australian Prescriber. Cost shifting and the quality use of medicines: Is it time for National Medicines Policy 2.0? - Australian Prescriber. Database Access - UNSW Library.