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The role of the Australian Adverse Drug Reactions Advisory Committee (ADRAC) in monitoring drug safety.

The Australian adverse drug reaction reporting system is acknowledged as one of the best in the world. Despite its small population of less than 20 million people, Australia's current ADR reporting rate of over 12,000 reports per year places it in the top few nations in terms of reports per capita. The ADRAC program has been in operation for over 30 years. Australia was a founding member of the WHO International Drug Monitoring Programme which commenced in 1968 and currently there are about 153,000 reports in the ADRAC database. Reports from health professionals have uncovered a number of significant safety problems over the years. Of particular importance are flucloxacillin-induced hepatitis, amoxycillin/clavulanate-induced hepatitis, and the association of cystitis with tiaprofenic acid. The number and quality of the reports has allowed an understanding of the characteristics of the reactions and, using ADRAC reporters as a major source of cases, case-control studies have been completed which have identified risk factors. ADRAC's review of Australian reports has highlighted many important associations that have been disseminated through the Australian Adverse Drug Reactions Bulletin.

Australia↗

Vaccine recommendations for patients on chronic dialysis. The Advisory Committee on Immunization Practices and the American Academy of Pediatrics.

Pediatric patients on dialysis should receive all the vaccines currently recommended by the ACIP and the AAP for healthy children, except the oral polio vaccine (34, 35). Adult patients should receive the hepatitis B vaccine series, pneumococcal vaccine, yearly influenza vaccinations, tetanus-diphtheria toxoids, and varicella vaccine, if they are susceptible (33, 48, 69). Vaccines are well tolerated by these patients (33), but higher doses and/or additional boosters may be required periodically to adequately protect dialysis patients from vaccine-preventable diseases (33, 36, 37, 82, 83). Following vaccination, antibody concentrations for hepatitis B vaccine should be measured annually and booster doses administered when antibody concentrations fall below protective levels (33, 38). Although both children and adults on dialysis may show an impaired and/or delayed immunologic response to certain antigens, particularly hepatitis B virus and S. pneumoniae, appropriate immunizations can significantly reduce the risk of serious complications from vaccine-preventable diseases (11, 84). Because the protection these vaccines provide may be incomplete or transient, infection control strategies at hospitals and other health care facilities should be implemented simultaneously. Health care providers are encouraged to assess each patients need for vaccinations individually and formulate immunization strategies early in the course of progressive renal disease, ideally before the patient requires dialysis.

Bacterial Vaccines↗