National Prescribing Service: creating an implementation arm for national medicines policy.

Medicines make an essential contribution to the health of the community, but rapidly rising drug budgets have caused governments to seek ways of ensuring this expenditure results in value for money. The National Prescribing Service was established against this background to implement a quality use of medicines service as part of the National Medicines Policy. A range of programmes that attempt to use evidence-based strategies to deliver evidence-based messages have been established. These use multifaceted interventions, such as newsletters, prescriber feedback, clinical audit and educational visiting, that are provided both centrally, through the national office, and locally, through Divisions of General Practice. The work is underpinned by an evaluation strategy that incorporates strong qualitative elements as well as an emphasis on time-series analyses for changes in drug utilization. Some 80% of Australian general practitioners have voluntarily participated in activities such as educational visiting and clinical audit within the National Prescribing Service programmes. New programmes for the community and consumers will be coordinated with the work that has become well established within general practice.

Indicators for drug and therapeutics committees.

AIMS: This study describes development and field testing of a set of indicators for drug and therapeutics committees (DTCs) in hospitals. It was intended that these indicators should be accessible, useful and relevant in the Australian setting. METHODS: Candidate indicators were written following consultation and data collection. A framework of outcome, impact and process indicators was based on DTC goals, objectives and strategies. The candidate indicators were field tested over a 2 month period in teaching, city non-teaching, rural and private hospitals. The field tests provided response data for each indicator and evaluation of the indicators against criteria for accessibility, relevance, usefulness, clarity and resource utilisation. Consensus on which indicators to accept, modify or reject was reached at a workshop of stakeholders and experts, taking account of the field test results. RESULTS: Thirty-five candidate indicators were tested in 16 hospitals. Twenty-two had a response from >80% of sites, 23 had a mean relevance rating >3.5, 19 had a mean usefulness rating >3.5, 27 were correctly interpreted by > 90% of sites and 25 could be collected in an acceptable time. The most acceptable indicators required least data collection or provided data deemed useful for purposes other than the field test. At the consensus workshop 13 indicators were accepted with no or minor change, nine were accepted after major modification and eight were discarded. It was recommended that a further five indicators should be merged or subsumed into one indicator. CONCLUSIONS: This study has developed and field tested a set of indicators for DTCs in Australia. The indicators have been taken up enthusiastically as a first attempt to monitor DTC performance but require ongoing validation and development to ensure continuing relevance and usefulness.

The application of adverse drug reaction data to drug choice decisions made by pharmacy and therapeutics committees. An Australian perspective.

Pharmacy and Therapeutics (P&T) committees undertake policy, regulatory and educational activities to promote rational use of medicines in their institutions with the aim of improving the quality of health and economic outcomes at these institutions. Formulary management is an important part of the P&T committees' activities and making drug choices is one of the committees' most difficult tasks. The 3 types of information most commonly identified by P&T committees as necessary for making drug choices are effectiveness, safety and cost data; usually in this order of importance. There is some evidence, however, that safety data are not considered by all committees when they make decisions about adding a new drug to a formulary. The role of adverse drug reaction (ADR) data in formulary decision-making (for registered drugs) occurs at several levels. First, ADR data obtained from pre-marketing studies of the drug are important and enable the committee to make an assessment of the risk of toxicity that should be anticipated for the drug. However, the limited nature of this information makes an absolute assessment impossible. Secondly, comparative safety information is necessary when deciding the place in therapy of a particular drug. Weighing up the comparative risks and benefits is a complex task which is a routine activity for most P&T committees whatever level of sophistication is applied. Thirdly, ADR data are an important ingredient of any economic assessment considered by a P&T committee. Calculation of the costs and consequences associated with the adverse effects of treatment demand careful assessment. Finally, aggregated adverse drug event reports which collate not only the consequences of adverse drug reactions but also medication incidents (medication errors) and which have been reported locally can be a useful quality assurance process for a P&T committee. This information will contribute to the identification of drugs for deletion from the formulary and less commonly in making decisions about additions to the formulary. As formulary management forms only part of a P&T committee's work, so the committee's interest in ADR is broader than the use of these data in making drug choices. The P&T committee may also be involved in promoting ADR reporting to either a central database or primary carers. Although often of limited availability, ADR information has an important role in the formulary management process of P&T committees.

Drug and Therapeutics Committees in Australia: expected and actual performance.

1. This study describes stakeholders' opinions on Drug and Therapeutics Committees (DTCs) and measures the composition, activities and perceived effectiveness of DTCs in Australia. 2. Focus groups explored the opinions of clinicians, consumers and administrators on the goals, objectives and strategies of DTCs. 3. A national survey was sent to 306 hospitals to collect data on the composition, committee processes, goals, objectives, educational activities, policies and decision making of DTCs. 4. Stakeholders believed the DTC should optimise therapeutic health outcomes for patients and economic outcomes for the hospital. Important objectives were availability of safe, efficacious and cost-effective medicines, affordability of medicines and quality use of medicines. 5. The national survey of DTCs found that over 92% of respondents had a DTC in their hospital. Composition was generally representational and most commonly included members from the disciplines of internal medicine, pharmacy and nursing. More than half the DTCs had executive authority although only 21% had an appeals mechanism. 6. The most commonly cited issues for DTCs in 1994-95 were quality drug use, drug policies and spending on high cost drugs. 7. While access to clinical pharmacologists and specialist drug utilisation evaluation (DUE) pharmacists was poor, 71% of DTCs had access to DUE data of some sort. Guidelines (61%), prescribing restrictions (60%) and pharmacist monitoring (63%) were the most commonly used strategies to implement DTC policies and decisions. Audit-feedback activities (61%) and drug bulletins (56%) were the most commonly used interventions. 8. Available information for formulary decision making varied with small rural hospitals having access to significantly less information. The most commonly used information was availability of a therapeutic alternative (87%), efficacy (83%), cost (80%) and estimated usage (78%). 9. On average DTCs reported an ability to implement 75% of decisions (range 0-95%) with teaching hospitals perceived to perform better than other hospital types. 10. This study reveals a high level of expectation for DTC activities and achievements. In Australia DTCs were involved in policy, education and management initiatives to promote best practice in therapeutics. Few committees appeared to have adequate resources to extend services to their wider community.

Pharmacokinetics of alcuronium in children with acyanotic and cyanotic cardiac disease undergoing cardiopulmonary bypass surgery.

The aim of this study was to determine the pharmacokinetic parameters for alcuronium in children with cyanotic or acyanotic congenital cardiac disease undergoing cardiopulmonary bypass surgery and to compare these parameters with previously reported values in children and adults with normal cardiac function. Seven children with acyanotic disease and seven with cyanotic disease were studied. Alcuronium (base) was administered in an initial dosage of 0.25 mg.kg-1 with additional doses as needed to maintain paralysis. Using time averaged data, cyanotic children had lower mean clearance, elimination half-life and volume of distribution at steady state than the acyanotic children; none of these differences was, however, statistically significant. In this study, children with acyanotic and cyanotic cardiac disease undergoing bypass, had a diminished clearance (P < 0.05) and a smaller volume of distribution (P < 0.05) than normal children and a shorter elimination half-life (P < 0.05) than adults. Onset of cardiopulmonary bypass caused an immediate marked decrease in alcuronium plasma concentrations which remained low in the acyanotic children at the completion of bypass.