PHARMACIST'S PERSPECTIVE ON RECENT LABELING CHANGES REQUIRED BY FDA FOR OVER-THE-COUNTER INTERNAL ANALGESIC, ANTIPYRETIC AND ANTIRHEUMATIC DRUGS
Author(s)
Bhattacharya R, Shah A, Kadakia A, Gupta P, Sansgiry SSUniversity Of Houston, Houston, TX, USA
Presentation Documents
OBJECTIVES: The US Food and Drug Administration (FDA) proposed labeling changes to be implemented by April 29, 2010 that would improve inappropriate and excessive use of over-the-counter (OTC) internal analgesic, antipyretic and antirheumatic drugs (IAAA). This study examined the attitude and knowledge of pharmacists about these labeling changes as pharmacists regularly advise on such products to consumers. METHODS: A prospective, cross-sectional study was conducted by surveying pharmacists working in a 15 mile radius of the Texas Medical Center. The survey instrument consisted of a 25 item questionnaire. Cronbach's alpha (0.89) was used to assess the internal consistency of the instrument. Two-sided studentized t-test (µ=3, α=0.05) and descriptive statistics were used to analyze pharmacist's attitude and awareness respectively for each individual parameter pertaining to the labeling changes. RESULTS: A total of 51 (out of 70) community pharmacist participated in this study. Of the respondents 55% were females, 69% worked in a chain pharmacy, with an average 11 years of work experience. 65% of the respondents were aware of the labeling changes introduced by the FDA. Attitude of pharmacists towards all the specific labeling changes introduced for acetaminophen and NSAIDs were positive. Pharmacists strongly and significantly agreed (p<0.001) that labeling changes like highlighting ingredient name or mentioning it in bold print (3.84 ± 1.08), appearance of “See New Warnings” statement on the principal display panel for one year (3.96 ± 1.06), age specific warnings for adults and for children below 12 years of age (4.12± 1.19), mentioning the maximum daily dosage units of acetaminophen under liver warnings (4.31±1.06), will be useful for patients. CONCLUSIONS: The results indicate that majority of pharmacists agreed with FDA’s labeling changes for OTC IAAA drug products. More information regarding these changes should be provided to pharmacists and consumers to increase appropriate use of these products.
Conference/Value in Health Info
2010-05, ISPOR 2010, Atlanta, GA, USA
Value in Health, Vol. 13, No. 3 (May 2010)
Code
PHP82
Topic
Health Policy & Regulatory, Organizational Practices
Topic Subcategory
Academic & Educational, Approval & Labeling
Disease
Multiple Diseases