Changes in related drug class utilization after market withdrawal of cisapride.
BACKGROUND
Recent Food and Drug Administration-mandated and company-initiated withdrawals of drug products from the marketplace have had an impact on utilization in related drug classes.


OBJECTIVE
To investigate the impact of withdrawal of the prokinetic agent cisapride (Propulsid) on utilization of other gastrointestinal (GI) agents.


METHODS
A longitudinal, retrospective study using electronic prescription data from a state-funded geriatric prescription benefit program.


METHODS
Prescription claims for 2644 patients using cisapride between January 10, 2000, and October 1, 2000, were analyzed with respect to points in time at which (1) prospective drug utilization review edits were implemented denying reimbursement of cisapride because of drug interactions, (2) the manufacturer announced its intent to cease production, and (3) the agent was withdrawn from the market. Prevalence of use, claims volume, and expenditures were compared for cisapride, proton pump inhibitors, histamine-2 receptor antagonists, and the prokinetic agent metoclopramide during these periods.


RESULTS
Use of cisapride decreased precipitately even before implementation of a "medical exception only" reimbursement policy. After the change in policy, metoclopramide use increased, although this increase was not proportional to cisapride's decline. Although total GI expenditures declined within the cisapride cohort, this change had little impact on overall program GI expenditures.


CONCLUSIONS
The loss of cisapride did not significantly affect program-wide costs for GI drugs. However, the withdrawal of cisapride appears to have resulted in increased use of metoclopramide, a medication with a more serious adverse effect profile than cisapride. Further study is needed to evaluate the long-term clinical impact of such therapy changes.
Glessner
Margaret R
MR
First Health Services Corporation/The PACE Program, Harrisburg, PA 17112, USA. pglessner@fhsc.com
Heller
Debra A
DA
D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D020117:Cisapride / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D017723:Drug Utilization Review; D004335:Drug and Narcotic Control / Q000191:economics*; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy* / Q000191:economics; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D005102:Health Expenditures / Q000706:statistics & numerical data; D006801:Humans; D007349:Insurance, Health, Reimbursement; D007356:Insurance, Pharmaceutical Services / Q000331:legislation & jurisprudence*; D008137:Longitudinal Studies; D008297:Male; D009515:New Jersey; D011358:Product Surveillance, Postmarketing; D013221:State Health Plans / Q000191:economics*; D014481:United States
D005765:Gastrointestinal Agents; D020117:Cisapride