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Who should report Pharmacovigilance What is Pharmacovigilance? Healthcare Professionals Nurses Patients & their relatives. Marketing authorization holder (MAH) according to the WHO, Pharmacovigilance is the science What should be reported and activities relating to the detection, assessment, If it is suspected that a patient has experienced an adverse understanding and prevention of adverse effects or any drug reaction (ADR ) it should be reported using a Yellow Card. other medicine related problem. For new medicines report all the suspected reactions, Importance of Pharmacovigilance Pharmacovigilance provides Information about rare but including minor ones. (medicines are still considered serious adverse reactions, chronic toxicity, use of drugs “new” up to five years after marketing authorization) in special groups (such as children, the elderly or For established medicines or well-known medicines pregnant women) or drug interactions This knowledge report all serious or unusual unexpected suspected can not be acquired from pre marketing phases as adverse reactions. Patients used in clinical trials are limited in number In Report all suspected ADRs associated with drug-drug, addition to, limited duration of drug use. drug food or drug-food supplements (including herbal and complementary products) interactions. Egyptian Pharmacovigilance Center (EPVC) has been established in the Egyptian Drug Report when suspected ADRs are associated with medicine (EPVC) Authority (EDA), Ministry of Health to be responsible for withdrawals. the collection and evaluation of information on Report ADRs occurring from overdose or medication error. pharmaceutical products marketed in Egypt with particular concern to adverse reactions. EPVC is taking Report ADRs in special fields of interest such as medicine all appropriate measures to: abuse and medicine use in pregnancy (teratogenicity) and a) Encourage physicians and other healthcare during lactation. professionals to report the suspected adverse reactions In children under the age of 18, all suspected ADRs to EPVC and occurring, should be reported regardless of whether the b) Oblige marketing authorization holders to medicine is licensed for use in children. systematically collect information on risks related to their medical products and to transmit them to EPVC. c) Provide information to end-users through adverse drug reaction news bulletins, drug alerts and seminars. How to recognize ADRs in patients?? ADRs are difficult and sometimes impossible to distinguish from the disease being treated since they may act through the same physiological and pathological pathways. However, the following approach is helpful in assessing possible drug-related ADRs: Ensure that the medicine ordered is the medicine received and actually taken by the patient at the dose advised. Take a proper history and do a proper examination of patient Establish time relationships by answering the following question: Did the ADR occur immediately following the medicine administration? Some reactions occur immediately after the medicine has been given while others take time to develop. The time from start of therapy to the time of onset of the suspected reaction must be logical. Carry out a thorough physical examination with appropriate laboratory investigations if necessary: Effect of Dechallenge and Rechallenge should be determined.Dechallenge (withdrawal of the suspected medicine):Positive dechallenge is the improvement of ADR when the suspected medicine is withdrawn in a strong, though not conclusive indication of medicinei nduced reaction. Rechallenge (re-introducing the suspected medicine after a dechallenge). Rechallenge is only justifiable when the benefit of reintroducing the suspected medicine to the patient overweighs the risk of recurrence of the reaction, which is rare. In some cases the reaction may be more severe on repeated exposure. Rechallenge requires serious ethical considerations.