Drug assessment by a Pharmacy and Therapeutics committee: from drug selection criteria to use in clinical practice

Abstract

BackgroundIn Spain, hospital medicines are assessed and selected by local Pharmacy and Therapeutics committees (PTCs). Of all the drugs assessed, cancer drugs are particularly important because of their budgetary impact and the sometimes arguable added value with respect to existing alternatives. This study analyzed the PTC drug selection process and the main objective was to evaluate the degree of compliance of prescriptions for oncology drugs with their criteria for use.MethodsThis was a retrospective observational study (May 2007 to April 2010) of PTC-assessed drugs. The variables measured to describe the committee’s activity were number of drugs assessed per year and number of drugs included in any of these settings: without restrictions, with criteria for use, and not included in formulary. These drugs were also analyzed by therapeutic group. To assess the degree of compliance of prescriptions, a score was calculated to determine whether prescriptions for bevacizumab, cetuximab, trastuzumab, and bortezomib were issued in accordance with PTC drug use criteria.ResultsThe PTC received requests for inclusion of 40 drugs, of which 32 were included in the hospital formulary (80.0%). Criteria for use were established for 28 (87.5%) of the drugs included. In total, 293 patients were treated with the four cancer drugs in eight different therapeutic indications. The average prescription compliance scores were as follows: bevacizumab, 83% for metastatic colorectal cancer, 100% for metastatic breast cancer, and 82.3% for non-small-cell lung cancer; cetuximab, 62.0% for colorectal cancer and 50% for head and neck cancer; trastuzumab, 95.1% for early breast cancer and 82.4% for metastatic breast cancer; and bortezomib, 63.7% for multiple myeloma.ConclusionThe degree of compliance with criteria for use of cancer drugs was reasonably high. PTC functions need to be changed so that they can carry out more innovative tasks, such as monitoring conditions for drug use.

Enzymatic replacement therapy for lysosomal storage disorders: Drug evaluations review in Spain

“…The PTCs specifically evaluate those drugs that are dispensed by the hospital pharmacy service or are administered directly to patients. The used drugs are selected by means of phamacoeconomic, efficacy, efficiency and safety relevance in comparison to the alternative drugs in the market and included in the hospital formulary [15].…”

Multi-Criteria Decision Analysis as a Decision-Support Tool for Drug Evaluation: A Pilot Study in a Pharmacy and Therapeutics Committee Setting

“…In Spain, health competences are transferred to the governments of the Autonomous Communities, that have recently published legal regulations to enhance the evaluation of drugs with centralized rational criteria, but no shared guidelines to rationalize the use of medicines in the Spanish National Health Service are set out (5;8). In this context, several collaborative initiatives between P&TCs and scientific societies have recently developed common methods and systems for evaluating new drugs, like the Group for Innovation, Assessment, Standardization and Research in the Selection of Drugs (GENESIS) of the Spanish Society of Hospital Pharmacy (SEFH) that has developed an evaluation report for new drugs, a procedures manual, a program for drafting of reports, and a standard request form to incorporate a new drug into the hospital formulary (9).…”