Adverse drug reports

All drugs will pose some degree of risk, and completed clinical trials are the primary source of information in this subject. Clinical trials do, of course, have limitations. The principal one concerns the everpresent problem of sample size. Rare side effects, if they exist, cannot generally be detected in clinical trials involving limited numbers of patients. Adverse drug reports and case-reports provide early clues to such effects so-called pharmacoepidemiology studies may be mounted to evaluate such risks. 

Faich GA, Castle W, Bankowski Z, and the Council for International Organizations of Medical Sciences (CIOMS) ADR Working Group. 1990. International adverse drug reporting. The CIOMS project. J. Clin. Res. Pharmacoepidemiol. 4 83-90. 

To improve its ability to surveil marketed drugs, the FDA has recently conducted a successful educational demonstration program in Rhode Island to encourage physicians voluntarily to report suspected adverse reactions directly to the FDA or to the manufacturer. At the end of the 2-year project, adverse drug reports from this State were 17 times greater than the national average (374). 

Human and veterinary medicines have the potential to produce adverse effects and robust adverse drug reporting schemes have developed around the globe to address, collate and document these effects and where necessary to ensure that appropriate regulatory actions are taken. These efforts have assisted in the development of the discipline of pharmacovigilance, the structured study of all aspects of adverse reactions to human and veterinary drugs and vaccines. 

Adverse drug readions may be reported to the FDA by completing the MedWatch form and sending it to ... 

Drug reactions are potentially serious. The nurse should observe all patients for adverse drug reactions, drug idiosyncrasy, and evidence of drug tolerance (when applicable). It is important to report all drug reactions or any unusual drug effect to the primary health care provider. 

The nurse must use judgment about when adverse drug reactions are reported to the primary health care provider. Accurate observation and evaluation of the circumstances are essential the nurse should record all observations in the patient s record. If there is any question regarding the events that are occurring, the nurse can withhold the drug but must contact the primary health care provider. 

The nurse observes the patient closely for any adverse drug reactions, particularly signs and symptoms of a hypersensitivity reaction. It is important to report a... 

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. 

The nurse always listens, evaluates, and reports any complaints die patient may have certain complaints may be an early sign of an adverse drug reaction. The nurse should report all changes in die patient s condition and any new problems that occur (eg, nausea or diarrhea) as soon as possible. It is tiien up to the primary health care provider to decide if tiiese changes or... 

Adverse drug reactions are identified, reported to the primary health care provider, and managed successfully through appropriate nursing interventions. 

Continual cardiac monitoring assists the nurse in assessing the patient for adverse drug reactions. If the patient is acutely ill or is receiving one of these drugs par-enterally, the nurse measures and records the fluid intake and output. The primary health care provider may order subsequent laboratory tests to monitor the patient s progress for comparison with tests performed in the preadministration assessment, such as an ECG, renal and hepatic function tests, complete blood count, serum enzymes, and serum electrolytes. The nurse reports to the primary care provider any abnormalities or significant... 

The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS collects and analyzes information from reports of adverse reactions after immunization. Anyone can report to VAERS, and reports are sent in by vaccine manufacturers, health care providers, and vaccine recipients and their parents or guardians. An example of the VAERS and instructions for completing the form are found in Appendix F. Any clinically significant adverse event that occurs after the administration of any vaccine should be reported. Individuals are encouraged to provide the information on the form even if the individual is uncertain if the event was related to the... 

The FDA Safety Information and Adverse Event Reporting Program Food and Drug Administrstion 5600 Fishers Lene Rockville, MD 20852-9787... 

Establishing and maintaining a pharmacovigilance system to capture and evaluate all reports of suspected adverse drug reactions. 

MedWatch A centralised MedWatch programme is provided to encourage the voluntary reporting of adverse drug reaction(s) by the medical profession. 

Form FDA 3500A Mandatory reporting of adverse drug events by manufacturers Mandatory reporting of adverse device events by manufacturers, importers and device user facilities... 

Form FDA 1932 Mandatory reporting of Veterinary Adverse Drug Reactions, Lack of Effectiveness, or Product Defects by manufacturers... 

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