RISK MANAGEMENT

Pharmacy directors manage many risks, including a dynamic regulatory environment.

FDA URGING HOSPITALS TO STOP USING SOME COMPOUNDED DRUGS

The Food and Drug Administration (FDA) is moving to restrict hospitals’ use of compounded drugs when FDA-approved versions are available, according to a 2018 guidance document.1

Why?

  • 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
* Compounding facilities are inspected by the FDA for CGMP compliance; however, these are not premarket inspections related to the manufacturing process for a particular product. Clinical implications for Biorphen have not been determined. No claims are made about safety implications for Biorphen.

CONCENTRATED PHENYLEPHRINE
MUST BE COMPOUNDED BEFORE USE

Concentrated phenylephrine HCl injection (10,000 mcg/mL) is a high-alert medication3 that must be diluted4 to 100 mcg/mL before use.

What could go wrong?

POTENTIAL MEDICATION ERRORS

The high-stress, time-sensitive operating room (OR) environment may lead to5:

• Higher rates of medication errors

• Errors of high severity compared with inpatient hospital settings

In a 2016 study5*:

1 in 20 Graphic
Perioperative medication administrations included a medication error
1 in 10 Graphic
Medication errors associated with phenylephrine
*Prospective observational study at 1,046-bed tertiary care academic medical center to identify medication errors and adverse drug events over 8 months. Authors acknowledged that observed subjects might have altered their behavior, suggesting that actual event rate could be higher than reported. Authors also state that observers could have missed events; researchers also performed retrospective chart abstraction to flag events that observers missed.

POTENTIAL UNSAFE INJECTION PRACTICES

Some anesthesiologists may not entirely follow recommendations for injection and medication safety.

In a 2017 survey* of Canadian anesthesiologists6:

83%
Sometimes or routinely use a medication vial for more than one patient (using a clean needle and syringe)
Chart_89%
Sometimes or routinely use a diluted saline bag for more than one patient (using a clean needle and syringe)
83%
Sometimes or routinely use phenylephrine for more than one patient
* Anonymous 17-question online survey sent to Canadian Anesthesiologists’ Society (CAS) members on medication preparation and administration practices. Of 2,656 CAS members, 546 (21%) responded. Authors acknowledge that response rate is a limitation; findings are potentially impacted by the large number of non-responders. There are also differences in survey sample compared with all licensed anesthesiologists across Canada.

ACCORDING TO FDA, AN RTU PHENYLEPHRINE CAN HELP MITIGATE CERTAIN RISKS7*

According to the FDA7, a ready-to-use concentration and packing configuration can help mitigate risks of:

  • Calculation and compounding errors
  • Unsafe sterile technique
  • Unsafe injection practices
*Clinical implications for Biorphen have not been determined. No claims are made about safety implications for Biorphen.

References:

  1. 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.
  2. 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.
  3. High-Alert Medications in Acute Care Settings. Institute for Safe Medication Practices website. https://www.ismp.org/recommendations/high-alert-medications-acute-list. August 23, 2018. Accessed November 14, 2019.
  4. Vazculep [Package Insert]. Chesterfield, MO: Eclat Pharmaceuticals Inc; 2014.
  5. 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.
  6. 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.
  7. 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.