Pediatric Prescribing Practices and the FDA Black-box Warning on Antidepressants

Cheung, Amy; Sacks, Diane; Dewa, Carolyn S.; Pong, Jessica; Levitt, Anthony J.

doi:10.1097/dbp.0b013e31817bd7c9

Cited by 48 publications

(41 citation statements)

References 13 publications

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“…Encouraging is the number of health workers, 314 (89.71%) who admitted that these letters have influenced their behavior relating to prescription, dispensing, and administration of the medicines involved. The finding in this study was better than what was obtained in similar studies (Cheung et al, 2008;Karpel et al, 2009). Greater number of nurses, 65 (68.42%) were aware of the safety issues compared to other health workers, with the least being physician assistants.…”

Section: Discussioncontrasting

confidence: 57%

The effectiveness of dear healthcare professional letters as a risk minimization tool in Ghana

Sabblah¹,

Darko²,

Asamoa-Amoakohene³

et al. 2016

Afr. J. Pharm. Pharmacol.

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Dear Healthcare Professional (DHP) letter is a risk minimization tool used to inform health workers about new and emerging safety information during the marketing period of medicinal products. DHP letters in some cases may not be effective because targeted audience may not be aware of these letters or even understand them. The objectives of this study were to assess the effectiveness and relevance of DHP letters as effective risk minimization tool and to seek opinion of health workers about the most effective way of communicating safety information. A descriptive correlational study of 913 health workers selected by convenient sampling through face-to-face interviews from Apr. to June, 2014 was conducted, with a response rate of 83.15%. The data was analyzed using descriptive analysis and Pearson-chi square test (χ 2 ) with STATA version 13. A p-value of < 0.05 was considered significant during the analysis. Of the 913 respondents only 350 (38.34%) were aware of at least one of the letters distributed in 2013 and 314 (89.71%) out of these admitted that these letters have influenced their way of prescribing, dispensing and administering the medicines involved. One hundred and ninety-two (54.82%) of the respondents rated the level of understanding of the language used as good and there was no significant difference in the health workers rating of the language used in the letters (p=0.40). Health workers suggested electronic methods such as short messaging service to their mobile phones 56.81% (438), e-mail 91 (85.85%) and posting the letters on the Food and Drugs Authority's website 26.85% (207). The results suggest that DHP letters issued by the Food and Drugs Authority (FDA) are effective in changing behavior of those who receive them but they are received late or not at all. The FDA should therefore explore other means of communicating safety information such as electronic means as suggested by the health workers.

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Section: Discussioncontrasting

confidence: 57%

The effectiveness of dear healthcare professional letters as a risk minimization tool in Ghana

Sabblah¹,

Darko²,

Asamoa-Amoakohene³

et al. 2016

Afr. J. Pharm. Pharmacol.

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“…21 Similar sales declines were observed for droperidol 20,36 and antidepressants in children. 37,38 Consequently, drug companies resist altering the package labeling of their drugs. 22 5HT, 5-hydroxytryptamine (serotonin); ADP, adenosine diphosphate; COX-2, cyclooxygenase-2 enzyme; D, dopamine; SNDRIs, serotonin norepinephrine dopamine reuptake inhibitors; SNRIs, serotonin norepinephrine reuptake inhibitors; SSRIs, selective serotonin reuptake inhibitors *The BBW is considered pertinent only for those 5HT2-D2 antagonists that are administered intra-muscularly and have a prolonged effective half-life (Zyprexa Relprevv, Risperdal Consta, Invega Sustenna) †Meridia is indicated only for weight loss and has been recently withdrawn from the EU and US markets because of increased cardiovascular risk ‡The BBW for myocardial ischemia with some thiazolodinediones was not considered pertinent for those drugs withdrawn before its issuance [Rezulin, Prelay (both troglitzone)] §Drugs withdrawn in the US market for safety reasons ||Drugs discontinued from the US market for reasons other than safety…”

Section: Discussionmentioning

confidence: 99%

Different Black Box Warning Labeling for Same-Class Drugs

Panagiotou

Contopoulos‐Ioannidis

Papanikolaou

et al. 2011

J GEN INTERN MED

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“…While most of these studies examined black box warnings, such as the use of anti-psychotics among elderly patients with dementia or antidepressants for adolescents (11)(12)(13)(14)(15)(16)(17), even FDA communications without black box warnings had effects on prescribing patterns or physician monitoring (18,19). No prior studies have examined the effect of FDA warnings on use of prescription medications approved for the treatment of obesity.…”

Section: Introductionmentioning

confidence: 99%

Time series analyses of the effect of FDA communications on use of prescription weight loss medications

Block

Choudhry

Carpenter

et al. 2013

Obesity

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Objective: To determine the impact of FDA safety communications regarding the weight loss medications sibutramine and orlistat. Methods: The 2008 to 2011 pharmacy claims data from CVS Caremark were used to determine the effect of the relevant FDA warnings on (1) use of sibutramine and orlistat, (2) their rates of discontinuation, and (3) substitution to an alternate weight loss medication in the 3-month period following discontinuation.Results: The use of sibutramine, orlistat, or phentermine declined from 45 users per 100,000 Caremark enrollees in May 2008 to 24 users per 100,000 enrollees in December 2010. In the time series analyses of overall use of medications, a very small decline in the trend of use of sibutramine after the FDA communication (0.000002% per month decline after the communication; P < 0.001) was found. However, rates of discontinuation of sibutramine and orlistat were similar before and after relevant FDA communications (all P values >0.1 for both level and trend changes post-warning). Patients discontinuing sibutramine post-communication increased use of phentermine at a rate of 0.004% per month after discontinuation (P 5 0.01). Conclusion: From 2008 to 2010, use of prescription weight loss medications was low and declined over time. FDA communications regarding the safety of these medications had limited effect on use.Obesity (2014) 22, 943-949.

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Pediatric Prescribing Practices and the FDA Black-box Warning on Antidepressants

Cited by 48 publications

References 13 publications

The effectiveness of dear healthcare professional letters as a risk minimization tool in Ghana

The effectiveness of dear healthcare professional letters as a risk minimization tool in Ghana

Different Black Box Warning Labeling for Same-Class Drugs

Time series analyses of the effect of FDA communications on use of prescription weight loss medications

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