MEDLINE (Medical Literature Analysis and Retrieval System Online) is a bibliographic database of life sciences and biomedical information.It is compiled by the United States National Library of Medicine (NLM).MEDLINE uses Medical Subject Headings (MeSH) for information retrieval. Engines designed to search MEDLINE (such as Entrez and PubMed) generally use a Boolean expression combining MeSH terms, words in abstract and title of the article, author names, date of publication.It mainly covers US journals.
Embase(Excerpta Medica), is a biomedical and pharmacological database produced by Elsevier.It tends to be more comprehensive with inclusion of more EU journals (plus US journals) as well as abstracts of scientific meetings, which you would not find in MedLine.
Monday, September 20, 2010
How do we get access to US FDA files containing Adverse Event Reports
The 1996 amendments to the Freedom of Information Act (FOIA) mandate publicly accessible "electronic reading rooms" with agency FOIA response materials and other information routinely available to the public, with electronic search and indexing features.Before submitting a FOIA request, we need to check to see if the information we are looking for is already available on FDA's Web site. We can use our search engine to find what you're looking for.
Cheat Sheet
A table of all AEs listed in a drugs package insert to aid in the rapid determination of whether an AE is labelled /listed or not.
“ A near miss” or “close call” -WHO
“ A near miss” or “close call” is a serious error or mishap that has the potential to cause an adverse event, but fails to do so by chance or because it was intercepted. It is assumed (though not proven) that the underlying systems failures for near misses are the same as for actual adverse events. Therefore, understanding their causes should lead to systems design changes that will improve safety.A key advantage of a near miss reporting system is that because there has been no harm the reporter is not at risk of blame or litigation. On the contrary, he or she may be deserving of praise for having intercepted an error and prevented an injury. This positive aspect of reporting of near misses, has led some to recommend near miss systems for internal reporting systems within health-care organizations or other
health-care facilities where a blaming culture persists. However, any hospital that is serious about learning will also invite reports of near misses.
health-care facilities where a blaming culture persists. However, any hospital that is serious about learning will also invite reports of near misses.
What is the ideal approach to pharmacovigilance- Signal Detection
Various methods are used throughout the life cycle of the product (from all phases of clinical trials and post-marketing) to evaluate new information that comes in routinely. This is called signal detection. Signal detection is one of the most important objectives of pharmacovigilance. The whole process of risk/benefit evaluation depends on effective detection of signals. Methods for signal detection include observations by clinicians and patients, case reports in the literature, assessment of individual case reports or clusters of reports that are received from healthcare professionals, patients and consumers etc, data from formal studies, e.g. clinical trials, epidemiological studies like cohort studies and case control studies.
The detection of signals require clinical assessment assisted by epidemiological and statistical analysis. Information technology tools also help in the generation of signals and enhancing its effectiveness. Automated signal generation is used by many MNCs, where reported safety profile of a particular product is compared with other products in the database using simple statistical methods like proportional reporting rates (PRR). Apart from PRR, which is very popular, there are other statistical tools used for signal detection that are used like incidence rates, frequency of adverse events and trend analysis.
The detection of signals require clinical assessment assisted by epidemiological and statistical analysis. Information technology tools also help in the generation of signals and enhancing its effectiveness. Automated signal generation is used by many MNCs, where reported safety profile of a particular product is compared with other products in the database using simple statistical methods like proportional reporting rates (PRR). Apart from PRR, which is very popular, there are other statistical tools used for signal detection that are used like incidence rates, frequency of adverse events and trend analysis.
Tools used in post-marketing pharmacovigilance
The various methods and resources used in post-marketing pharmacovigilance are data from healthcare professionals, marketing authorisation holders, regulatory authorities, world wide published literature and academic institutes. Several methods exist for studying adverse drug reactions in marketed medicines, including spontaneous reporting, prescription event monitoring, pharmacoepidemiological studies like cohort studies, case control studies, disease registries and various other automated databases.
Dealing with faulty medicines: Medicines & Medical Device Regulation
The MHRA’s Defective Medicines Report Centre (DMRC) issues alerts to healthcare professionals,
hospitals, GP surgeries, and wholesalers to tell them when a medicine is being recalled or when there are concerns about the quality that will affect its safety or effectiveness. These alerts are graded according to the seriousness of the threat to the public’s health: Class 1 requires immediate recall, because the product poses a serious or life threatening risk to health. Class 2 specifies a recall within 48 hours, because the defect could harm the patient but is not life threatening. Class 3 requires action to be taken within 5 days because the defect is unlikely to harm patients and is being carried out for reasons other than patient safety. Class 4 alerts advise caution to be exercised when using the product, but indicate that the product poses no threat to patient safety. Most recalls fall into classes 2 or 3.
hospitals, GP surgeries, and wholesalers to tell them when a medicine is being recalled or when there are concerns about the quality that will affect its safety or effectiveness. These alerts are graded according to the seriousness of the threat to the public’s health: Class 1 requires immediate recall, because the product poses a serious or life threatening risk to health. Class 2 specifies a recall within 48 hours, because the defect could harm the patient but is not life threatening. Class 3 requires action to be taken within 5 days because the defect is unlikely to harm patients and is being carried out for reasons other than patient safety. Class 4 alerts advise caution to be exercised when using the product, but indicate that the product poses no threat to patient safety. Most recalls fall into classes 2 or 3.
How are devices authorised- MHRA
In general, a medical device cannot be marketed in Europe without carrying a CE marking. A CE marking is applied by the manufacturer and means that the device meets the relevant regulatory requirements and, when used as intended, works properly and is acceptably safe.For all but the very lowest risk devices, such as unmedicated bandages, this must be verified by an independent certification body, called a Notified Body, before the CE marking can be affixed. The MHRA is responsible for appointing UK Notified Bodies and regularly audits them to ensure that they perform to high standards.
Manufacturers should be able to support their performance claims for the device. In many cases,
and in particular for higher risk devices, this information will come from a clinical trial. Where
a manufacturer plans to carry out a clinical trial in the UK, agreement must be obtained from the MHRA. On average, the Agency refuses one in five such requests on the grounds of patient safety or health policy restrictions.
Manufacturers should be able to support their performance claims for the device. In many cases,
and in particular for higher risk devices, this information will come from a clinical trial. Where
a manufacturer plans to carry out a clinical trial in the UK, agreement must be obtained from the MHRA. On average, the Agency refuses one in five such requests on the grounds of patient safety or health policy restrictions.
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