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Embase webinar: Building searches for drug safety and post market device surveillance 26 Nov 2014
- 1. Building searches for drug safety and device postmarket surveillance Presented by Sherry Winter and Ian Crowlesmith 26 November 2014 s.winter.1@elsevier.com i.crowlesmith@elsevier.com Embase® is a registered trademark of Elsevier BV.
- 2. Building searches for drug safety and device postmarket surveillance AGENDA 1. Introduction 2. Finding adverse reactions for drugs 3. Post marketing surveillance for medical devices 4. Drug safety and risk 5. Conclusion Embase® is a registered trademark of Elsevier BV.
- 3. 3 Pharmacovigilance • Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. • Increasingly important in today’s world of big data analysis and regulation Sherry Winter & Ian Crowlesmith | 26 November 2014 | Drug safety and post-marketing surveillance for devices
- 4. 4 What Are Governments Doing? Growing regulatory pressure and focus on literature monitoring in EU & US VI.B.1.1.2. Literature reports The scientific and medical literature is a significant source of information for the monitoring of the safety profile and of the risk benefit balance of medicinal products, particularly in relation to the detection of new safety signals or emerging safety issues. Marketing authorization holders are therefore expected to maintain awareness of possible publications through a systematic literature review of widely used reference databases (e.g. Medline, Excerpta Medica or Embase) no less frequently than once a week. The marketing authorization holder should ensure that the literature review includes the use of reference databases that contain the largest reference of articles in relation to the medicinal product properties A. Good reporting Practice Spontaneous case reports of adverse events submitted to the sponsor and FDA, and reports from other sources, such as the medical literature or clinical studies, may generate signals of adverse effects of drugs. The quality of the reports is critical for appropriate evaluation of the relationship between the product and adverse events. FDA recommends that sponsors make a reasonable attempt to obtain complete information for case assessment during initial contacts and subsequent follow-up, especially for serious events, and encourages sponsors to used train… Marketing authorization holders are therefore expected to maintain awareness of possible publications through a systematic literature review of widely used reference databases (e.g. Medline, Excerpta Medica or Embase) no less frequently than once a week. The quality of the reports is critical for appropriate evaluation of the relationship between the product and adverse events. Sherry Winter & Ian Crowlesmith | 26 November 2014 | Drug safety and post-marketing surveillance for devices
- 5. 5 The Increasing Volume of Literature Is Making Adverse Event Monitoring a More Difficult Challenge 2013 2012 2011 2010 2005 2000 1995 1990 1985 1980 1975 0 5 10 15 20 25 30 Millions • Reliable tools for finding adverse events are needed Embase, October 2014 • Complex search strategies need to be employed to find the most relevant articles among the thousands that are published each year Sherry Winter & Ian Crowlesmith | 26 November 2014 | Drug safety and post-marketing surveillance for devices
- 6. 6 Our Framework Elsevier provides the capabilities necessary for Pharmacovigilance and Drug Safety groups to be more efficient, stay compliant and mitigate risk 1. Avoid missing critical information 2. Save time with better article pipeline management 3. Connect literature to broader ecosystem 4. Manage risk of late-stage failure Sherry Winter & Ian Crowlesmith | 26 November 2014 | Drug safety and post-marketing surveillance for devices
- 7. EMBASE FOCUSES ON DETECTING ADVERSE EVENTS IN THE SCIENTIFIC LITERATURE Every year >1,000,000 biomedical articles and 300,000 conference papers are published 7 Of all adverse events reported, 14% comes from the literature Sherry Winter & Ian Crowlesmith | 26 November 2014 | Drug safety and post-marketing surveillance for devices
- 8. Building searches for drug safety and device postmarket surveillance AGENDA 1. Introduction 2. Finding adverse reactions for drugs 3. Post marketing surveillance for medical devices 4. Drug safety and risk 5. Conclusion Embase® is a registered trademark of Elsevier BV.
- 9. FINDING ADVERSE REACTIONS FOR DRUGS TOPICS COVERED 9 • Searching with drug subheadings Used for: fully indexed records • Searching with free text (keywords) Used for: automatically indexed records • Saving search strategies • Setting up Email alerts Sherry Winter & Ian Crowlesmith | 26 November 2014 | Drug safety and post-marketing surveillance for devices
- 10. POSTMARKET SURVEILLANCE FOR MEDICAL DEVICES SEARCH OPTIONS 10 • Searching with device subheadings Used for: fully indexed records from 2014 • Searching with keywords and other terms Used for: automatically indexed AND older records Sherry Winter & Ian Crowlesmith | 26 November 2014 | Drug safety and post-marketing surveillance for devices
- 11. Building searches for drug safety and device postmarket surveillance AGENDA 1. Introduction 2. Finding adverse reactions for drugs 3. Post marketing surveillance for medical devices 4. Drug safety and risk 5. Conclusion Embase® is a registered trademark of Elsevier BV.
- 12. 12 Output Analysis: Risk Mitigation Key Challenges • How can we better manage risk? • Are we gathering all available safety/AE data about a drug/ class of drugs? • Are we leveraging best practices from precedent preclinical/ clinical studies? • Have all the potential and unanticipated risks been captured? Sherry Winter & Ian Crowlesmith | 26 November 2014 | Drug safety and post-marketing surveillance for devices
- 13. EMBASE & PHARMAPENDIUM IMPROVING BIOMEDICAL LITERATURE SEARCH AND RISK MONITORING 13 A single drug search in Embase seamlessly links to PharmaPendium to deliver: • Comprehensive information that better informs a risk management / pharmacovigilance strategy • Drug safety information reported in the literature • FDA/EMA approval and drug review reports that provides insights into historical regulatory precedents • A direct link to preclinical and clinical observations and reported adverse events (AERs) to better monitor and anticipate safety risks Sherry Winter & Ian Crowlesmith | 26 November 2014 | Drug safety and post-marketing surveillance for devices
- 14. EMBASE & PHARMAPENDIUM IMPROVING BIOMEDICAL LITERATURE SEARCH AND RISK MONITORING By accessing regulatory data as well as published literature, you can: 14 • Link critical post marketing findings to the drug and validate its relevance in the context of the studies that were performed as part of the drug approval process • Look at post marketing findings and understand how they could be relevant across different drugs and drug classes • Go directly to a study that was done to find ways in which study designs could be optimized in order to reduce the chance of seeing those same events take place with a drug that you are currently developing • Develop risk mitigation strategies that establish inclusion and exclusion criteria for patients who wish to participate in trials (for example by predicting the effect of drug-drug interactions with medications they are already on) Sherry Winter & Ian Crowlesmith | 26 November 2014 | Drug safety and post-marketing surveillance for devices
- 15. IDENTIFY AE REPORTED IN LITERATURE FIND AE ON ROFECOXIB IN EMBASE (SHOWN BY IAN) 15 Sherry Winter & Ian Crowlesmith | 26 November 2014 | Drug safety and post-marketing surveillance for devices
- 16. ACCESS INFORMATION FROM REGULATORY DATA DELVE INTO MORE DETAILS WITH THE FDA APPROVAL PACKAGE 16 Sherry Winter & Ian Crowlesmith | 26 November 2014 | Drug safety and post-marketing surveillance for devices
- 17. FIND DRUG-DRUG INTERACTIONS 17 E.g., search for drug interactions to find those identified with existing drugs. Sherry Winter & Ian Crowlesmith | 26 November 2014 | Drug safety and post-marketing surveillance for devices
- 18. FIND ADVERSE EVENTS REPORTED IN FDA/EMA PACKAGE 18 Search the FDA package for mentions of reported adverse events Sherry Winter & Ian Crowlesmith | 26 November 2014 | Drug safety and post-marketing surveillance for devices
- 19. ACCESS AE DATA AND AERS REPORTS 19 Access Preclinical and Clinical data on adverse events and Post-marketing (AERS reports) Sherry Winter & Ian Crowlesmith | 26 November 2014 | Drug safety and post-marketing surveillance for devices
- 20. 20 • Post-market surveillance of drugs • Post-market surveillance of medical devices • For drug safety/risk mitigation during drug development • Other POLL – WHAT IS YOUR MAIN REASON FOR SEARCHING FOR ADVERSE EVENTS IN EMBASE? Sherry Winter & Ian Crowlesmith | 26 November 2014 | Drug safety and post-marketing surveillance for devices
- 21. IN CONCLUSION… 21 Embase supports your pharmacovigilance workflow by: Finding adverse events in the literature Comprehensive content, deep drug, device and disease indexing and dedicated search tools mean you will avoid missing critical information Unique access to regulatory data Manage the risk of late stage failure by making more informed risk management/mitigation decisions with information reported in the literature as well as adverse events and drug-drug interactions reported in FDA/EMA documents Sherry Winter & Ian Crowlesmith | 26 November 2014 | Drug safety and post-marketing surveillance for devices
- 22. 22 • Q&A will be sent to you by email and for more information and questions please contact your regional office • Our next Embase webinar will take place January 2015 and will focus on Systematic Reviews. • Please click on at Embase.com for all Embase training materials and a webinar overview THANK YOU SEE YOU NEXT TIME! Please fill out the survey that appears on your screen after leaving the webinar. Sherry Winter & Ian Crowlesmith | 26 November 2014 | Drug safety and post-marketing surveillance for devices
- 23. THANK YOU ANY QUESTIONS? 23 Sherry Winter Product Marketing Manager s.winter.1@elsevier.com Ian Crowlesmith Sr Product Manager, Content Development i.crowlesmith@elsevier.com Sherry Winter & Ian Crowlesmith | 26 November 2014 | Drug safety and post-marketing surveillance for devices
Editor's Notes
- Welcome to our Embase webinar, my name is Sherry Winter. I’m the Product Marketing Manager for Embase and I will be one of your speakers today. I am here with our Embase expert Ian Crowlesmith. Ian will be familiar to regular Embase webinar attendees, but for those of you who don’t know him, Ian has been with Embase for over 30 years and he is currently Senior Product Manager for Content Development, playing a key role in managing the content and coverage of Embase. Ian has carried out several roles in his time at Elsevier, including leading the team that set up the Emtree thesaurus in the late 1980s and early 90’s.
- Today, Ian and I will discuss the key things to think about searching for adverse drug events and for drug safety, and Ian will also demonstrate how you can do post-market surveillance for medical devices in Embase. This webinar is aimed at users with some Embase experience, but we also offer introductory webinars regularly and will share more details on upcoming webinars at the end. We will share the slides and recording directly after this webinar, so you can review or share with your colleagues. During the session you can send us your questions by using the chat or Ask a Question function on the webinar control panel and we will answer as many of your questions as possible during the webinar. All questions will be answered and included in a Q&A email that will be sent to you after the webinar. If you wish to have a full screen view, please click on the red arrow. Your control panel will be hidden. Click again on the red arrow to see your control panel.
- Today we’ll be discussing important considerations for your pharmacovigilance workflows and how Embase is a key resource for post-market surveillance of adverse drug or device events, and also for drug safety, or risk mitigation. Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem, and thorough PV strategies are key to protect patients from drugs that are unsafe or ineffective and also to comply with increasingly strict reporting requirements. Not performing adequate pharmacovigilance can result in heavy fines and can also damage the company’s reputation.
- There is growing regulatory pressure and focus on literature monitoring in EU & US. Embase is mentioned as a source for biomedical literature in European Medical Association guidelines: (Marketing authorization holders are therefore expected to maintain awareness of possible publications through a systematic literature review of widely used reference databases (e.g. Medline, Excerpta Medica or Embase) no less frequently than once a week) The FDA notes that the quality of reports generated from sources, such as the medical literature, is critical for appropriate evaluation of the relationship between the product and adverse events.
- The increasing volume of literature makes finding adverse events more challenging every year. This graph demonstrated just how many more records have been added to Embase each year from 1974. With such an increase in information, the search strategies and tools that are used to find adverse events are critical to ensure that the most relevant information is found and that nothing is missed. More adverse events are also being reported due to our aging population that results in more chronic conditions (meaning that more people are on drugs and they are on more than one drug, which can lead to harmful drug-drug interactions).
- With these challenges in mind, Elsevier has developed the capabilities necessary for Pharmacovigilance and Drug Safety groups to be more efficient, stay compliant and mitigate risk. Although these capabilities extend into case processing and output with the use of Quosa, in today’s Embase-focused webinar, we will take a closer look at Case Input – searching the literature for reported adverse events and Risk Mitigation, or managing the risk of late-stage failure during drug development by using Embase to search for information found in the literature and in the regulatory information from PharmaPendium.
- Adverse events are reported in a variety of forums; the majority are reported directly to a health professional (these will then be reported to the FDA or other regulatory body and (for example) will be entered into the FDA Adverse Event Reporting System, which I’ll describe later on in the webinar). Although only 14% of adverse events are reported in the scientific literature, it’s critical to not miss any mentions of these, and this is where Embase comes in. Every year, more than 1,000,000 non-conference records and 300,000 conference abstracts are added to Embase. At this point, I’ll hand the presenter rights over to Ian, who will demonstrate in detail how to find adverse reactions for drugs and how you can also do post-market surveillance for medical devices using Embase. It may just take a minute or 2 while we change presenters…
- Switch presentation to Ian
- In addition to post-market surveillance, risk mitigation is another important aspect of pharmacovigilance, and is critical for any drug development/post-market surveillance plan. Typical questions that you might consider when thinking about a risk mitigation strategy are: How can we better manage risk? Are we gathering all available safety/AE data about a drug/ class of drugs? Are we leveraging best practices from precedent preclinical/ clinical studies? Have all the potential and unanticipated risks been captured? To answer these questions, it’s important to have all the information possible, which means accessing published biomedical literature as well as the vast amount of information that’s reported to the FDA or EMA during and after drug development.
- This is where Embase and PharmaPendium work together to provide the information that allows you to develop a better risk management or pharmacovigilance strategy. A single drug search in Embase will search PharmaPendium at the same time. If there is information in PP on that particular drug, then an information panel in Embase appears with links to drug safety information reported in FDA or EMA approval documents and to preclinical and clinical adverse events. Together, Embase and PharmaPendium provide more information and insights into historical regulatory precedents and allow you to better monitor and anticipate safety risks.
- Read slide
- As Ian showed you earlier, you can identify adverse events for rofecoxib that have been reported in the literature. Here I’ve done a search for any adverse events reported for rofecoxib. At the same time, PharmaPendium was automatically being searched for information on rofecoxib. You can see the results in this panel on the right-hand side of the screen that shows information including the chemical structure, brand and chemical names, and links to FDA and EMA regulatory documents.
- Access regulatory data found in the medical, chemistry, statistical and clinical pharmacology /biopharmaceutics reviews sections of the FDA’s drug approval packages, and similar input from the European Medicines Agency. In the case of Rofecoxib, PharmaPendium includes FDA approval package information. For example, a closer look at the Medical/Clinical Review section shows results of clinical trials and includes dosage, efficacy and safety information.
- You can search for specific information in the approval package - for example, for any reported drug-drug interactions. This allows you to anticipate drug-drug interactions that might be observed during the development of a similar drug, and to develop risk mitigation strategies with this in mind (for example, by excluding study participants who are on drugs that might interact, or by finding alternate drugs for them to be on)
- You can also search the FDA approval package for mentions of adverse events that were reported during the approval process for the drug
- And you can access adverse events directly from the PharmaPendium information window in Embase. From here, you can access preclinical Adverse events (e.g., those seen in preclinical animal models), or from clinical trials or post-clinical reports (these are the Adverse Events Reporting System reports I mentioned earlier, which may be generated when an adverse event is reported directly to a healthcare professional). An example of such a report for rofecoxib is shown here.
- At this point, I’d like to ask our audience if they’d mind sharing with us their main reason for looking for adverse events in Embase? Please select the reason that best applies to you from the poll now appearing on your screens. Thank you for your response. According to the poll, the majority of our uses look for AEs to …..
- Read slide
- We have come to the end of our Embase webinar. On behalf of Ian, I would like to thank you very much for attending and I hope you enjoyed the webinar. When you leave the session, a survey will pop up. We hope you have a few additional minutes to share your much appreciated feedback with us. As already mentioned, we will complete all questions and send to you by email and the slides and the recording will be shared with you today. Thanks again and good luck with further exploring Embase. We hope to meet you again soon.