FDA URGING HOSPITALS TO STOP USING SOME COMPOUNDED DRUGS
- Drugs compounded in hospitals or at 503B outsourcing facilities:
- Have no FDA premarket review for safety, effectiveness, and quality1*
- Have no FDA premarket inspection of manufacturing quality1*
- Can potentially pose higher risk to patients than FDA-approved drugs
- 503B outsourcing facilities are frequently subject to FDA actions that can interrupt supply1,2
- Since 2013, FDA has issued > 180 warning letters and has overseen > 150 recalls of compounded drugs1
PHENYLEPHRINE USE HAS BEEN ASSOCIATED WITH CERTAIN RISKS
Concentrated phenylephrine HCl injection (10,000 mcg/mL) must be diluted3 to 100 mcg/mL before use.
POTENTIAL MEDICATION ERRORS
The high-stress, time-sensitive operating room (OR) environment may lead to4:
• Higher rates of medication errors
• Errors of high severity compared with inpatient hospital settings
In a 2016 study4*:
POTENTIAL UNSAFE INJECTION PRACTICES
In a 2017 survey* of Canadian anesthesiologists5:
ACCORDING TO FDA, AN RTU PHENYLEPHRINE CAN HELP MITIGATE CERTAIN RISKS6*
According to the FDA6, a ready-to-use concentration and packing configuration can help mitigate risks of:
- Calculation and compounding errors
- Unsafe sterile technique
- Unsafe injection practices
- 2018 Compounding Policy Priorities Plan. US Food and Drug Administration website. https://www.fda.gov/drugs/human-drug-compounding/2018-compounding-policy-priorities-plan. January 2018. Updated June 21, 2018. Accessed November 14, 2019.
- Compounding Risk Alerts. US Food and Drug Administration website. https://www.fda.gov/drugs/human-drug-compounding/compounding-risk-alerts. Updated June 7, 2019. Accessed November 14, 2019.
- Vazculep [Package Insert]. Chesterfield, MO: Eclat Pharmaceuticals Inc; 2014.
- Nanji KC, Patel A, Shaikh S, Seger DL, Bates DW. Evaluation of perioperative medication errors and adverse drug events. Anesthesiology. 2016;124(1):25-34. doi:10.1097/ALN.0000000000000904.
- Breton S, van Vlymen J, Xia S, et al. A survey of medication preparation and administration practices among members of the Canadian Anesthesiologists’ Society. Can J Anesth/J Can Anesth. 2018;65:1000-1109. doi:10.1007/s12630-018-1164-5.
- Approval letter of NDA 203826. Drugs@FDA: FDA Approved Drug Products. US Food & Drug Administration website. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203826. Accessed November 15, 2019.