Impact of regulatory labeling for troglitazone and rosiglitazone on hepatic enzyme monitoring compliance: findings from the state of Ohio medicaid program

Cluxton, Robert J.; Li, Zili; Heaton, Pamela C.; Weiss, Sheila R.; Zuckerman, Ilene H.; Moomaw, Charles J.; Hsu, Van Doren; Rodriguez, Evelyn M.

doi:10.1002/pds.1048

Cited by 36 publications

(48 citation statements)

References 14 publications

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“…The present findings are compatible with other studies that demonstrated lack of full adherence to drug safety recommendations in performing tests to monitor adverse effects in clinical practice (35,36).…”

Section: Limitations and Strengthssupporting

confidence: 92%

Echocardiography for the Detection of Valvulopathy Associated with the Use of Ergot-Derived Dopamine Agonists in Patients with Parkinson's Disease

et al. 2011

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Objective The ergot-derived dopamine agonists, cabergoline and pergolide, are associated with valvulopathy risk. In Japan, product labels were revised in April 2007 to recommend periodic echocardiography for patients taking these dopamine agonists, however, the compliance of physicians to follow through with this recommendation is unknown. This study assessed changes in echocardiography evaluation of patients with Parkinson's disease (PD) taking cabergoline or pergolide before and after the label revision and examined the factors related with echocardiography performance. Methods and PatientsMedical claim data from January 2005 to December 2008 were used. Patients were divided into a C-P group (prescribed either cabergoline or pergolide) or reference group (prescribed other anti-PD drugs), and further classified based on whether they were prescribed these drugs "pre-revision" or "post-revision." The Cochran-Armitage trend test was used to compare the proportion of echocardiograms obtained amongst these groups before and after the revision. The frequencies of echocardiograms performed among the treatment groups for each period were compared by Fisher's exact test. Results A total of 222 subjects (C-P, 73; reference, 149) were assessed. The proportion of C-P patients undergoing echocardiography increased from 4.8% to 27.9% after revision of product labels (p=0.001), which was higher than those in the reference group following label revisions (11.0%) (p=0.014). Prescription duration of C-P after the revision was longer in the patients with echocardiography than without echocardiography (p=0.026). Conclusion Although echocardiography evaluations increased, more than 70% of PD patients prescribed cabergoline or pergolide did not undergo such assessment despite the product label recommendation. Adherence to drug safety recommendations should be facilitated with more feasible and effective measures.

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Section: Limitations and Strengthssupporting

confidence: 92%

Echocardiography for the Detection of Valvulopathy Associated with the Use of Ergot-Derived Dopamine Agonists in Patients with Parkinson's Disease

et al. 2011

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“…A similarly poor impact of communication strategies has previously been reported [8][9][10][11][12][13][14] but this study goes further than previous ones by illustrating the limited capacity of such a strategy to inform health professionals. The difficulty in the present case was to disseminate a safety warning concerning medicines systematically prescribed to all infants and young children but also available without prescription and more often perceived as vitamin supplements than as medicines by the public.…”

Section: Discussionsupporting

confidence: 49%

Relevance of a “Dear Doctor letter” to alert healthcare providers to new recommendations for vitamin D administration

Théophile

Miremont-Salamé

Robinson

et al. 2011

Eur J Clin Pharmacol

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Results: Only 49% of responding paediatricians, 48% of GPs, and 67% of pharmacists were aware of the warning. Among the participating health professionals aware of the warning and who prescribed/dispensed these vitamins, 50% of paediatricians, 68% of GPs declared to have changed their prescription and 68% of pharmacists declared to have modified their advice when dispensing. For the responding health professionals, postal letters remained however the best way to issue safety warnings. Some of them suggested a better identification of the DDL and a wider dissemination of the information to other stakeholders involved in the health system. Conclusions:Health professionals paid little attention to the DDL that was therefore unlikely to change their practices. A relevant measure to disseminate recommendations for medicine administration could consist in applying stickers on medicine boxes, as it presents the advantage to directly inform the concerned population, i.e. the parents.3

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“…Mailings to prescribers have little impact on prescribers' behavior. [9][10][11] Several venues for black box warning information include the FDA Web site and a free Web site dedicated to providing a list of medications with warnings. 5 The identification of effective methods to disseminate information regarding black box warnings requires further study.…”

Section: Discussionmentioning

confidence: 99%

Pharmacy Students' Knowledge of Black Box Warnings

Moeller

Shireman

Generali

et al. 2010

American Journal of Pharmaceutical Education

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Objective. To evaluate the progression of pharmacy students' knowledge of black box warnings across 3 years of didactic training, and to determine how they stay current with new warnings. Methods. A cross-sectional survey instrument was administered to pharmacy students in their first (P1), second (P2), and third (P3) professional years. The survey assessed student awareness of medications possessing a black box warning and familiarity with the warning content for 20 medications (15 with and 5 without warnings).Results. Mean number of correct responses identifying the presence or absence of a black box warning among the 20 medications were 5.8 6 3.3, 9.6 6 4.0, and 14.8 6 2.8 for the P1, P2, and P3 students, respectively. Knowledge of black box warning content was variable. Students were least aware of the warning content for stavudine and enoxaparin. Students were most familiar with the warning content for paroxetine and estrogen. Conclusion. Students' awareness and understanding of black box warnings was proportional to their educational progression, but their knowledge level was inconsistent across drug groups.

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Impact of regulatory labeling for troglitazone and rosiglitazone on hepatic enzyme monitoring compliance: findings from the state of Ohio medicaid program

Cited by 36 publications

References 14 publications

Echocardiography for the Detection of Valvulopathy Associated with the Use of Ergot-Derived Dopamine Agonists in Patients with Parkinson's Disease

Echocardiography for the Detection of Valvulopathy Associated with the Use of Ergot-Derived Dopamine Agonists in Patients with Parkinson's Disease

Relevance of a “Dear Doctor letter” to alert healthcare providers to new recommendations for vitamin D administration

Pharmacy Students' Knowledge of Black Box Warnings

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