0
We're unable to sign you in at this time. Please try again in a few minutes.
Retry
We were able to sign you in, but your subscription(s) could not be found. Please try again in a few minutes.
Retry
There may be a problem with your account. Please contact the AMA Service Center to resolve this issue.
Contact the AMA Service Center:
Telephone: 1 (800) 262-2350 or 1 (312) 670-7827  *   Email: subscriptions@jamanetwork.com
Error Message ......
Research Letter |

Effect of US Food and Drug Administration–Approved Pediatric Labeling on Dispensing of Extended Release Oxycodone in the Outpatient Retail Setting ONLINE FIRST

Jing Xu, PhD, MA1; Rajdeep Gill, PharmD2; Marisa Cruz, MD1; Judy Staffa, PhD, RPh2; Peter Lurie, MD, MPH1
[+] Author Affiliations
1Office of Public Health Strategy and Analysis, Office of Commissioner, US Food and Drug Administration, Silver Spring, Maryland
2Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland
JAMA Pediatr. Published online September 09, 2016. doi:10.1001/jamapediatrics.2016.3197
Text Size: A A A
Published online

Extract

This study examined the effect of pediatric labeling for OxyContin on dispensing of all extended-release oxycodone products, using national data on dispensed prescriptions in outpatient retail pharmacies before and after the label change.

For years, extended-release (ER) oxycodone has been prescribed to children for management of pain.1,2 In August 2015, based on studies conducted under the Best Pharmaceuticals for Children Act that are designed to better inform pediatric prescribing, the US Food and Drug Administration approved the use of OxyContin (Purdue Pharma) for management of pain requiring treatment with an ER/long-acting opioid in children 11 years and older who are already tolerating a daily opioid dose equivalent to at least 20 mg of oxycodone, as described in the labeling.3 The new labeling was not intended to expand pediatric use of ER opioids, but rather to help clinicians use OxyContin safely in pediatric patients.

Figures in this Article

Sign in

Purchase Options

• Buy this article
• Subscribe to the journal
• Rent this article ?

First Page Preview

View Large
First page PDF preview

Figures

Place holder to copy figure label and caption
Figure 1.
Nationally Estimated Number of Pediatric Patients Dispensed Extended-Release Oxycodone Prescriptions From Retail Pharmacies, August 2014-April 2016

The error bars represent 95% CIs for the total pediatric population dispensed extended-release oxycodone prescriptions.

Graphic Jump Location
Place holder to copy figure label and caption
Figure 2.
Percentage of Oxycodone Extended-Release Prescriptions Dispensed to Pediatric Patients From Retail Pharmacies, August 2014-April 2016

Data were extracted in August 2016.6

Graphic Jump Location

Tables

References

Correspondence

CME
Also Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
Please click the checkbox indicating that you have read the full article in order to submit your answers.
Your answers have been saved for later.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.

Multimedia

Some tools below are only available to our subscribers or users with an online account.

260 Views
0 Citations
×

Sign in

Purchase Options

• Buy this article
• Subscribe to the journal
• Rent this article ?

Related Content

Customize your page view by dragging & repositioning the boxes below.

Articles Related By Topic
Related Collections
Jobs
JAMAevidence.com

Care at the Close of Life: Evidence and Experience
Use of Opioid Analgesics for a Pain Crisis in an Inpatient Setting

Care at the Close of Life: Evidence and Experience
Pain Management and Symptomatic Measures

brightcove.createExperiences();