Why Remove Injectable Promethazine from the Formulary?

Clinical Queries

Why remove injectable promethazine from the formulary?

My hospital is removing inject- warning states that “severe tissue risk of tissue damage associated able promethazine from the injury can occur from perivascular with the injectable formulation. formulary because of safety extravasation, unintentional Many hospitals have weighed the concerns. What is the reason intra-arterial injection, and intra- risks and benefits of injectable for this?—S.N., MO. neuronal or perineuronal infiltra- promethazine and attempted to tion. Adverse reactions include mitigate the risks by limiting admin- Jenna M. Moodley, PharmD, burning, pain, thrombophlebitis, istration to the deep I.M. route, Julia C. Gardner, PharmD, and tissue necrosis, and gangrene. In reducing the dose, or further diluting Daniel J. Sheridan, MS, RPh, some cases, surgical intervention, the drug’s concentration.2 However, CPPS, reply: Promethazine is including fasciotomy, skin graft these strategies do not eliminate the a phenothiazine derivative and and/or amputation have been risk. Because of this, hospitals H1 receptor blocking agent with required.” The boxed warning also should follow ISMP’s recommenda- antihistaminic, sedative, antimotion- describes the risk of fatal respiratory tion to remove injectable prometha- sickness, antiemetic, and anticholin- depression in pediatric patients.1 zine from the formulary and offer ergic effects.1 This medication blocks Because of the high risk for error clinicians safer alternatives. Unfor- many receptors in the body, and serious complications, ISMP tunately, in a 2019 survey of 347 including dopamine and alpha- considers completely removing large US hospitals, ISMP found that adrenergic receptors. It is com- injectable promethazine from only 32% were fully compliant with monly used in both inpatient and formularies a best practice for this best practice.6 ■ outpatient settings to treat nausea hospitals, noting that even deep and vomiting, allergies, and motion I.M. administration can lead to REFERENCES sickness. Central nervous system tissue damage if the drug is acci- 1. Promethazine hydrochloride injection, USP. 5 Prescribing information. www.accessdata.fda.gov/ depressant effects such as drowsiness dentally injected intra-arterially. drugsatfda_docs/nda/2009/040454_s006_ are the most common adverse ISMP recommends use of safer promethazine_hydrochloride_injection.pdf. reactions associated with this drug.1 alternatives such as the 5-HT3 2. Grissinger M. Preventing serious tissue injury with intravenous promethazine (Phenergan). P T. Promethazine can be adminis- antagonist ondansetron. At one 2009;34(4):175-176. tered orally, rectally, or parenterally time, alternative drugs were 3. Institute for Safe Medication Practices. ISMP List of High-Alert Medications in Acute Care Settings. https:// via I.M. or slow I.V. bolus injection. significantly more costly than forms.ismp.org/Tools/institutionalhighAlert.asp. The preferred parenteral route is promethazine, but with the current 4. Rebelo K. FDA adds boxed warning to injectable deep I.M. injection.1 Inadvertent availability of generic versions, they promethazine. Medscape. 2009. www.medscape. administration into an artery or have become significantly less com/viewarticle/709055. 5. Institute for Safe Medication Practices. 2020-2021 subcutaneous tissue may result in expensive. Today, a dose of inject- ISMP Targeted Medication Safety Best Practices for soft tissue damage, leading to tissue able ondansetron is less expensive Hospitals. www.ismp.org/guidelines/best-practices- hospitals. necrosis and, in some cases, than a dose of promethazine, 6. Institute for Safe Medication Practices. Two new 2 gangrene and amputation. Inject- making it a viable and cost-effective best practices in the 2020-2021 targeted medication able promethazine has been on alternative.5 Other medications that safety best practices for hospitals. ISMP Medication Safety Alert! 2020;25(4):4. the Institute for Safe Medication can be used to treat nausea and Practices (ISMP) List of High-Alert vomiting include metoclopramide Jenna Moodley is a PGY-1 resident at Mount Carmel Medications in Acute Care Settings and prochlorperazine. Health in Columbus, Ohio Julia Gardner is a PGY-1 since 2007.3 Promethazine is also available in resident at Cincinnati Children’s Hospital Medical Center in Cincinnati, Ohio. Daniel Sheridan is medica- In 2009, the FDA required safer formulations, including oral tion safety pharmacist at OhioHealth Marion General Hospital in Marion, Ohio, and a member of the promethazine manufacturers to label tablets and solutions and a rectal Nursing2020 editorial board. the drug with a boxed warning suppository, which can be substi- about the potential for adverse tuted for the parenteral formulation. The authors have disclosed no ﬁ nancial relationships reactions associated with injectable Although these alternative adminis- related to this article. promethazine, regardless of the tration routes have a slightly longer 1,4 administration route. The boxed onset of action, they do not carry the DOI-10.1097/01.NURSE.0000668464.68553.00