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  2. Pharmacovigilance - Wikipedia

    en.wikipedia.org/wiki/Pharmacovigilance

    A risk management plan is a documented plan that describes the risks (adverse drug reactions and potential adverse reactions) associated with the use of a drug and how they are being handled (warning on drug label or on packet inserts of possible side effects which if observed should cause the patient to inform/see his physician and/or ...

  3. Adverse drug reaction - Wikipedia

    en.wikipedia.org/wiki/Adverse_drug_reaction

    Type A: augmented pharmacological effects, which are dose-dependent and predictable [5]; Type A reactions, which constitute approximately 80% of adverse drug reactions, are usually a consequence of the drug's primary pharmacological effect (e.g., bleeding when using the anticoagulant warfarin) or a low therapeutic index of the drug (e.g., nausea from digoxin), and they are therefore predictable.

  4. Research on Adverse Drug Events and Reports - Wikipedia

    en.wikipedia.org/wiki/Research_on_Adverse_Drug...

    Between 1998 and 2007, 33 serious adverse drug or device reactions have been reported by RADAR investigators. The toxicities involved multiple biological system and included thrombotic thrombocytopenic purpura (TTP) (ticlopidine and clopidogrel), thromboembolism (thalidomide and lenalidomide), liver failure (gemtuzumab and nevirapine), hypersensitivity (drug eluting coronary arterial stents ...

  5. Medical error - Wikipedia

    en.wikipedia.org/wiki/Medical_error

    Variations in healthcare provider training & experience [46] [53] and failure to acknowledge the prevalence and seriousness of medical errors also increase the risk. [54] [55] The so-called July effect occurs when new residents arrive at teaching hospitals, causing an increase in medication errors according to a study of data from 1979 to 2006.

  6. List of medicine contamination incidents - Wikipedia

    en.wikipedia.org/wiki/List_of_medicine...

    The problem began in 2012, when the process for making tetrazole, a chemical intermediate in the production of various angiotensin II inhibitor medications for hypertension (popularly known by their common drug name suffix "sartan") was changed by generic drug manufacturers in favor of several cheaper and more efficient processes.

  7. Adverse effect - Wikipedia

    en.wikipedia.org/wiki/Adverse_effect

    Adverse reaction reporting is an important component of New Zealand's pharmacovigilance activities. The Centre for Adverse Reactions Monitoring (CARM) in Dunedin is New Zealand's national monitoring centre for adverse reactions. It collects and evaluates spontaneous reports of adverse reactions to medicines, vaccines, herbal products and ...

  8. Serious adverse event - Wikipedia

    en.wikipedia.org/wiki/Serious_adverse_event

    Serious adverse reactions are serious adverse events judged to be related to drug therapy. A SUSAR (suspected unexpected serious adverse reaction) should be reported to a drug regulatory authority under an investigational license by using the CIOMS form (or in some countries an equivalent form).

  9. Adverse event - Wikipedia

    en.wikipedia.org/wiki/Adverse_event

    AEs are classified as serious or non-serious; expected or unexpected; and study-related, possibly study-related, or not study-related. [ 2 ] For example, while a study that tests the effectiveness of a new blood pressure cuff for a period of 10 minutes might seem innocuous, the potential exists for the patient's skin to be irritated by the device.