Adverse drug reactions reporting requirements

WHO (1975). Requirements for Adverse Drug Reaction Reporting. WHO, Geneva. 

Monitoring and Managing Adverse Drug Reactions The nurse observes the patient at frequent intervals, especially during the first 48 hours of therapy. It is important to report to the primary health care provider the occurrence of any adverse reaction before the next dose of the drug is due The nurse should report serious adverse reactions, such as a severe hypersensitivity reaction, respiratory difficulty, severe diarrhea, or a decided drop in blood pressure, to the primary health care provider immediately because a serious adverse reaction may require emergency intervention. 

CIOMS. Basic requirements for the use of terms for reporting adverse drug reactions. Pharmacoepidemiol Drug Safety 1992 1 39-45. 

The requirements for reporting adverse drug reactions to prescription medicines occurring in Australia or overseas are described in the Australian Pharmacovigilance Guidehne, which is available at the TGA website. 

Sponsors are not required, as a matter of routine, to submit individual patient reports to the TGA of suspected adverse drug reactions occurring with use of the same product in another country, even if a trial is ongoing at Australian sites. However, the TGA requires that sponsors advise the Experimental Drugs Section of DSEB within 72 h of any significant safety issue which has arisen from an analysis of overseas reports or action with respect to safety taken by another country s regulatory agency. This advice must include the basis for such action. 

Reporting of suspicions of dependence should be to the national adverse drug reaction centre, but other reporting requirements under national laws must be followed. 

Soldatos et al. (1986) reported on serious adverse drug reactions in all five psychiatric inpatients during a clinical trial of 0.5 mg triazolam and placebo. The patients and nurses were blind in the study, but not the physician with medical responsibility for the patients. The study consisted of 1 week of placebo baseline, 2 weeks of triazolam administration, and 1 week of withdrawal on placebo. All five patients developed severe reactions to triazolam. Case 1 developed anxiety and hallucinations on the last two days of triazolam administration and the first withdrawal day. Case 2 had a sudden increase in anxiety and became irritable, uncooperative, and depressed. She became withdrawn and cried, and showed considerable impairment of memory and orientation. On withdrawal of triazolam, she became more incoherent, expressing paranoid ideas of persecution that persisted about a week. She required Haldol to control her delusions. Case 3 developed severe insomnia during withdrawal and reported considerable anxiety and irritability along with an uncontrollable fear of death, which persisted to the next day when she additionally manifested a marked degree of memory impairment. Case 4, by... 

In clinical trials of IMPs without a MA, sponsors must report all serious unexpected suspected adverse drug reactions (SUSARs) within eight calendar days if they were fatal or life threatening, and within fifteen days for other serious cases. The initial report has to be followed up within seven days for fatal or life-threatening cases and within fifteen days for other serious reports. These expedited reporting requirements mean that the treatment code in blinded trials must be broken, as it is otherwise impossible to decide which treatment the patient received and, therefore, impossible to determine whether an event could possibly be a reaction if a patient received placebo, then there is no suspicion of a possible adverse reaction to the IMP and authorities do not require expedited... 

A document prepared by the pharmaceutical manufacturer, containing [among other things] all relevant safety information, such as adverse drug reactions, which the manufacturer requires to be listed for the drug in all countries where the drug is marketed. It is the reference document by which labeled and unlabeled are determined [for the purpose of international ADR reporting]... 

CIOMS. Standardisation of definitions and criteria of causality assessment of adverse drug reactions - drug-induced cytopenia. Int J Clin Pharmacol Ther Toxicol 1991 29 75-81. CIOMS. Basic requirements for the use of terms for reporting adverse drug reactions. Pharmacoepidemiol Drug Safety 1992 1 39-45. 

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