2005 Edition Report on Drug Administration Procedure & Practices ...

QUALITY ASSURANCE IN DRUG THERAPYHOSPITAL AUTHORITY ADVERSE DRUG REACTION REPORTING PROGRAMMEPurpose1. This memo announces the setting up of the Hospital Authority’s Adverse DrugReaction Programme and its implementation.Background2. As unexpected or undesirable effect may arise during the course of drug therapy,appropriate quality assurance system for medication use should be in place to identifythe causation and prevent the occurrence of these events.3. Currently, central quality assurance programs regarding medication incidents andpharmaceutical product quality are in place at the Hospital Authority. The MedicationIncident <strong>Report</strong>ing Program (MIRP), initiated by the Drug Utilization ReviewCommittee (DURC), was set up to identify opportunities for quality improvement andto assist health professionals in reducing and avoiding medication errors. As for themonitoring of the quality of pharmaceutical products, there are central proceduralguidelines for the reporting and the handling of quality complaints set forth by theChief Pharmacist’s Office.Adverse Drug Reaction reporting4. It is well aware that adverse drug reaction (ADR) may cause unnecessary physicianvisits, hospital admissions, and increased length of hospital stay. Local study showedthat 4.4% of acute admissions to a general ward were due to adverse drug reactions.To reduce these unnecessary admissions or hospitalization, it is thus important toidentify those ADRs which may be avoidable.5. Many overseas countries have a national ADR reporting system in place, whichcollects ADR reports from health care professionals for the purpose of assessing thesafety of the marketed drugs. Although the reporting of ADR is voluntary, manyhospitals have set up internal reporting programs to further improve the quality of carein their institutions. The ADR reports collected in the hospitals are forwarded to theirrespective agency for central review.6. Currently there is no systematic ADR reporting program in HA. A few hospitals arecollecting their own ADR reports without any inter-hospital communications orsharing of the reports. In order to unify the ADR reporting systems and to encouragemore active reporting throughout the HA, a centralized reporting system is considereddesirable.7. The potential problem of setting up a separate ADR reporting program in parallel tothe existing MIRP had been thoroughly considered and a pilot exercise had beenconducted in OLMH and QMH from October 2000 to March 2001. Taking referencefrom the pilot exercise and overseas experience it is now proposed that the HA ADRreporting program would be set up as from 1 January 2002.1