PROSPECTIVE AND RETROSPECTIVE SAFETY REVIEW OF PIOGLITAZONE IN A MEDICAL CENTER

Author(s)

Ng SP1, Shyu LJ2, Chien SY21Changhua Christian Hospital, Changhua city, Changhua county , Taiwan, 2Changhua Christian Hospital, Changhua city, Changhua county, Taiwan

OBJECTIVES: The FDA warned on June 15, 2011 of the bladder cancer risk associated with pioglitazone use. Therefore, we conducted a retrospective review of pioglitazone use in our hospital, to find out high risk patient, provide FDA safety advice by using electronic message in computerized physician order entry system (CPOE), aim to ensure physician aware of the risk at the moment of patient clinic visit. METHODS: We included outpatients with pioglitazone use from January 1, 2006 through July 31, 2011. For high risk patients, who are male, prescribed pioglitazone more than 1 year and cumulative dose reached 28000mg, clinical pharmacists will established warning message in CPOE. The message was to inform physician the patient was at high risk for bladder cancer, and should care about the symptoms of bladder cancer, such as  hematuria; urgent need to urinate or pain while urinating; pain in back or lower abdomen. RESULTS: Overall 3196 patients had ever prescribed pioglitazone. The mean age was 63.2 ± 11.9 years, and 1519 (49%) of the patients were male. Five (0.16%) patients with the diagnosis of bladder cancer. There were 1874 patients with currently pioglitazone use, 629 (33.5%) patients prescribed pioglitazone more than 1 year, 160 (8.5%) patients cumulative dose reached 28000mg, and 75 (4%) of our patients were at high risk for bladder cancer. Eighteen (24%) high risk patients were discontinued pioglitazone after FDA announcement, another 18 (24%) patients because of warning message established by clinical pharmacists. Twenty six (66.7%) patients have urine test, 5 (12.8%) with positive occult blood. CONCLUSIONS: From the retrospective results, there was no association between pioglitazone use and bladder cancer in our hospital. The communication by using electronic message in CPOE enhanced the awareness of physician. Clinical pharmacists will prospectively establish the warning message for patient with high risk.

Conference/Value in Health Info

2012-09, ISPOR Asia Pacific 2012, Taipei, Taiwan

Value in Health, Vol. 15, No. 7 (November 2012)

Code

PDB16

Topic

Epidemiology & Public Health

Topic Subcategory

Safety & Pharmacoepidemiology

Disease

Diabetes/Endocrine/Metabolic Disorders

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