Dataset Information

Pediatric drug data in Canadian drug monographs: a descriptive analysis.

ABSTRACT:

Background

Optimal drug therapy in children relies on the availability of pediatric-specific information. We aimed to describe the current status of pediatric pharmacotherapy data in monographs of new drugs approved by Health Canada.

Methods

In this descriptive analysis, we reviewed the quality and quantity of monographs of new drugs approved by Health Canada between Jan. 1, 2007, and Dec. 31, 2016. We excluded drugs withdrawn from the Canadian market and drugs with primary indications irrelevant to pediatrics. We determined the percentage of included drug monographs that listed pediatric-specific information.

Results

During this study period, Health Canada approved 281 drugs, 270 of which met our inclusion criteria. Pediatric-specific information and indication were present in 127 (47.1%) and 75 (27.8%) of the drug monographs, respectively. Of all pediatric age groups, neonates had the lowest number of indications listed in the product monographs (7, 2.6%). Only 9 (60%) oral drugs indicated for children 6 years of age or younger were available in child-friendly, age-appropriate dosage forms.

Interpretation

Most of the new drugs approved by Health Canada do not contain pediatric or neonatal indications in their product monographs, and therefore, are used "off-label." Regulatory mechanisms are required to promote both neonatal and pediatric drug development and submission of available pediatric data by manufacturers to Health Canada.

SUBMITTER: Raja P

PROVIDER: S-EPMC7641187 | biostudies-literature | 2020 Jul-Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Pediatric drug data in Canadian drug monographs: a descriptive analysis.

Raja Preeya P Duffett Mark M Mazer-Amirshahi Maryann M Patel Ashaka A Gilpin Andrea A Litalien Catherine C Chan Anthony K AK van den Anker John J Lacaze-Masmonteil Thierry T Samiee-Zafarghandy Samira S

CMAJ open 20200701 3

<h4>Background</h4>Optimal drug therapy in children relies on the availability of pediatric-specific information. We aimed to describe the current status of pediatric pharmacotherapy data in monographs of new drugs approved by Health Canada.<h4>Methods</h4>In this descriptive analysis, we reviewed the quality and quantity of monographs of new drugs approved by Health Canada between Jan. 1, 2007, and Dec. 31, 2016. We excluded drugs withdrawn from the Canadian market and drugs with primary indica ...[more]

PMID: 32873580

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Project description:ObjectivesThis study examines financial conflict of interest (FCOI) of clinicians who made submissions to the pan-Canadian Oncology Drug Review (pCODR), the arm of the Canadian Agency for Drugs and Technology in Health that recommends whether oncology drug indications should be publicly funded. Final reports from pCODR published between October 2016 and February 2019 were examined.DesignDescriptive study.Data sourcesWebsite of pCODR.InterventionsNone.Primary and secondary outcomesThe primary outcome is the number of submissions declaring FCOI. Secondary outcomes are the number of times where clinicians agreed and disagreed with preliminary recommendation from pCODR and the association between the distribution of individual clinicians' FCOI and pCODR's funding recommendations.ResultsThere were 46 drug indication reports from pCODR. Clinicians made 261 submissions. Clinicians declared they received payments from companies 323 times and named 38 different companies making those payments a total of 500 times. Financial conflicts with drug companies were declared in 176 (66.3%) of all submissions. In 21 (45.7%) of the 46 drug indications, 50% or more of the clinicians had a conflict with the company making the drug. Clinicians commented on 37 preliminary recommendations. In all 25 where pCODR recommended funding or conditional funding, the clinicians either agreed or agreed in part. pCODR recommended that the drug indication not be funded 12 times and 9 times clinicians disagreed with that recommendation. The distribution of clinician responses was statistically significantly different depending on whether pCODR recommended funding/conditional funding or do not fund p<0.0001 (Fisher exact test). The distribution of clinicians' FCOI differed depending on whether the recommendation was fund/conditional fund or do not fund p=0.027 (Fisher exact test).ConclusionFinancial conflicts with pharmaceutical companies are widespread among experts making submissions to the pCODR.

Dataset Information

Pediatric drug data in Canadian drug monographs: a descriptive analysis.

Background

Methods

Results

Interpretation

Publications

Pediatric drug data in Canadian drug monographs: a descriptive analysis.

Similar Datasets

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