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EVIDENCE-BASED PRACTICE

Satisfaction with Pharmacotherapy for Approved and Off-Label Indications—A Delphi Study

Chair of Social Pharmacy, Faculty of Pharmacy, University of Ljubljana, Ljubljana, Slovenia

Albert I Wertheimer, PhD MBA

Director, Center for Pharmaceutical Health Services Research, School of Pharmacy, Temple University, Philadelphia, PA

Ales Mrhar, PhD

Chair of Social Pharmacy, Faculty of Pharmacy, University of Ljubljana

Reprints: Dr. Kos, Faculty of Pharmacy, University of Ljubljana, Askerceva 7, 1000 Ljubljana, Slovenia, fax 386 1 4258 031, mitja.kos{at}ffa.uni-lj.si

BACKGROUND: Prescribing for non-approved uses is widespread in the treatment of AIDS, cancer, and pediatric illnesses, but it is by no means limited to these areas. Few studies have been performed evaluating reasons for off-label prescribing.

OBJECTIVE: To explore the satisfaction with drug therapy as one of the potential reasons for off-label uses by testing a hypothesis that the satisfaction with drug therapy for off-label indications is lower than for approved indications.

METHODS: The study compared the satisfaction with drug therapy for known off-label indications with a control group of approved indications. Twenty-four of the first 50 single-ingredient drugs, according to their share in the drug cost budget of the Slovenian Compulsory Health Insurance, had 86 different off-label indications eligible for inclusion. A control group of 86 approved indications was randomly selected from the list of all possible approved indications for the same 24 drugs. A 2-round Delphi technique, involving an expert panel of physicians who are members of the drug regulatory agency, was used to evaluate the satisfaction with drug therapy for selected indications.

RESULTS: After the second round of the Delphi study, the median scores of satisfaction with drug therapy for approved and off-label indications were 7.00 and 6.50, respectively (p = 0.001).

CONCLUSIONS: The study shows that the satisfaction with available drug therapy for off-label indications is lower than for approved indications. The statistical association, biologic plausibility, and coherence with existing information, as well as the temporality of the association, provide supporting evidence that low satisfaction with drug therapy is one of the incentives for off-label use.

Key Words: Delphi study, drug therapy, off-label indication

Published Online, March 8, 2005. www.theannals.com, DOI 10.1345/aph.1E455