Risk Minimization Method Evaluation in Oncology
- PDF / 5,821,410 Bytes
- 6 Pages / 612 x 792 pts (letter) Page_size
- 74 Downloads / 153 Views
H A R MA C 0 V I G I t A N C E
77
Risk Minimization Method Evaluation in Oncology
Anne Kehely, FRCPlre, FRCPath, FFPM, Dip Epi Global Patient Safety. Eli Lilly i? C o , Lilly Research Centre. Windlesham. UK
Cheryl Smith, BPharm, MRPS, PhD Global Patient Safety. Eli Lilly E. Co. Lilly Research Centre. Windlesham. UK
Andrzej Czornetki, MD, PLD, DSc, FFPM, FISPE Global Patient Safety. Eli Lilly 6. Co. Lilly Research Centre. Windlesham. UK
Purpose: Pemetrexed is licensed for use in mesothelioma and non-small-cell lung cancer. Early clinical development indicated that it causes cytotoxicity with dose (eficacy) limiting gastrointestinal (GI) and blood toxic effects. Use of folic acid and vitamin B,, reduced these toxicities. This study was undertaken to assess the effectiveness of a risk minimization program based on administration of folic acid and vitamin B,, to reduce the therapeutic toxicity of pemetrexed and physicians' compliance with these measures. Methods: Lilly Safety Database was searched for reports of GI and blood toxicity associated with pemetrexed. The period of early development was compared with the subsequentperiod in which risk minimization measures were in place. Reports fiom the postmarketing period were assessed to determine the percentage reported with appropriate risk minimization supplemention. Results: The proportion of severe GI and
Key Words Risk minimization; Adverse reaction; Pemetrexed
Correspondence Address Dr. Andrzej Czamecki, Global Patient Safety, Lilly Research Centre. Erlwood M a n o r , Sunninghill Road, Windlesham G U 2 0 6 P H . Surrey, UK (email: czamecki-andrzej @lilly.com).
INTRODUCTION Key messages: It is feasible to verify the success of a risk minimization method by objective demonstration of a reduction in toxicity and, separately, to confirm physicians' compliance with the risk minimization program . Implementation of the risk minimization strategy demonstrated significant improvement in the safety profile of pemetrexed. as shown by a reduction in high-grade blood and gastrointestinal toxicity. There was a high level of physician compliance with risk minimization measures, which improved the safety profile for pemetrexed and delievered patient benefit.
Following the introduction of regulatory guidelines by the agencies in the United States, EU,
blood toxicity in clinical trials was lower after the introduction of supplementation (67.3% vs 84.8%, P
Data Loading...
