Products Affected - Description

Reason for the Shortage

• Bedford is focusing manufacturing on prochlorperazine 2 mL vials.¹
• Bedford is the sole manufacturer of prochlorperazine injection.¹

Available Products

Prochlorperazine injection 5 mg/mL, Bedford
2 mL vial, 10 count (NDC 55390-0077-10)

Estimated Resupply Dates

Implications for Patient Care

• During this shortage use alternative antiemetics. Oral and rectal prochlorperazine products are effective; however, these routes may not be practical for all patients.

Alternative Agents & Management

• No antiemetic is completely effective in preventing nausea and vomiting in all patients. The selection of an antiemetic is often based on the type of nausea and vomiting (eg, chemotherapy-induced, or postoperative) and patient specific criteria.
• Administration route and recommended dose differ between prochlorperazine and other available agents used to manage CINV and PONV. Ensure that each specific product is administered at the correct dose and via the correct route.^2,3,13,14,15

• Treatment guidelines base antiemetic recommendations on the emetogenic potential of the chemotherapy being administered. Treatment guidelines on the management of acute and delayed CINV are available from American Society of Clinical Oncology (ASCO), the National Comprehensive Cancer Network (NCCN), the Antiemetic Subcommittee of the Multinational Association of Supportive Care in Cancer (MASCC), and the European Society for Medical Oncology (ESMO).^3-5
• The role of prochlorperazine in the management of acute CINV is limited to use for low or minimal emetogenic chemotherapy, and for refractory or breakthrough nausea and vomiting.^3-5  Tables 1 and 2 summarize the dose recommendations from the NCCN clinical guidelines.³  Alternative dosing regimens may be found in other resources.

• PONV is best managed by prevention, as response to prophylaxis is much higher than response to treatment of established nausea or vomiting. Various medications, working by multiple mechanisms of action, are used to manage PONV.⁶
• Guidelines on the management of postoperative nausea and vomiting are available from the International Anesthesia Research Society (2003), American Society of Anesthesiologists (2002), American Society of PeriAnesthesia Nurses (2006), Society for Ambulatory Anesthesia (2007), American Society of Plastic Surgeons Task Force and Committee for Patient Safety (2006), and Society for Obstetricians and Gynecologists of Canada (2008).^7-12
• The emphasis of these guidelines is to identify adults and children at moderate to high risk for PONV, reduce any baseline factors for PONV, and provide prophylaxis with 2 or 3 different types of antiemetic agents. If a patient has nausea and vomiting despite prophylaxis, treat with an antiemetic from a different pharmacological class.^7-12
• For the treatment of PONV, the 5-HT3 receptor antagonists are the most well-studied agents.⁶
• Table 3 provides doses for selected agents used for the management of PONV in adults.

Related Shortages

• Thiothixene Capsules— Resolved

1. Bedford, Customer Service (personal communication). September 15, October 6, and November 15 and 22, 2011; January 3, March 1, May 11, August 7, November 5, and December 17, 2012; January 25, February 22, March 20, and May 2, 2013.
2. McEvoy GK, Snow EK, Kester L, Litvak K, Miller J, Welsh OH, eds. AHFS 2011 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2011.
3. Ettinger DS, Armstrong D, Barbour S, et al. Antiemesis. National Comprehensive Cancer Network, Practice Guidelines in Oncology, v.1.2012. Accessed September 21, 2011.
4. Kris MG, Hesketh PJ, Somerfield MR, et al. American Society of Clinical Oncology guideline for antiemetics in oncology: update 2006. J Clin Oncol. Jun 20 2006;24(18):2932-2947.
5. Roila F, Herrstedt J, Aapro M et al. Guideline update for MASCC and ESMO in the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting: results of the Perugia consensus conference. Ann Oncol. May 2010:21(suppl 5):v232-v243.
6. Le TP, Gan TJ. Update on the management of postoperative nausea and vomiting and postdischarge nausea and vomiting in ambulatory surgery. Anesthesiology Clin 2010; 28:225-249.
7. Gan TJ, Meyer TA, Apfel CC, et al. Society for Ambulatory Anesthesia guidelines for the management of postoperative nausea and vomiting. Anesth Analg. Dec 2007;105(6):1615-1628.
8. Gan TJ, Meyer T, Apfel CC, et al. Consensus guidelines for managing postoperative nausea and vomiting. Anesth Analg. Jul 2003;97(1):62-71.
9. Practice guidelines for postanesthetic care: a report by the American Society of Anesthesiologists Task Force on Postanesthetic Care. Anesthesiology. Mar 2002;96(3):742-752.
10. ASPAN'S evidence-based clinical practice guideline for the prevention and/or management of PONV/PDNV. J Perianesth Nurs. Aug 2006;21(4):230-250.
11. Iverson RE, Lynch DJ. Practice advisory on pain management and prevention of postoperative nausea and vomiting. Plast Reconstr Surg. Sep 15 2006;118(4):1060-1069.
12. McCracken G, Houston P, Lefebvre G. Guideline for the management of postoperative nausea and vomiting. J Obstet Gynaecol Can. Jul 2008;30(7):600-607, 608-616.
13. Ignoffo RJ. Current research on PONV/PDNV: Practical implications for today's pharmacist. Am J Health Syst Pharm. Jan 1 2009;66(1 Suppl 1):S19-24.
14. Baughman VL, Golembiewski J, Gonzales JP, Alvarez W, eds. Anesthesiology and Critical Care Drug Handbook. 9^th ed. Hudson, OH: Lexi-Comp; 2011.
15. Hutchison, T. A., D. R. Shahan, et al., Eds. (2011. Updated periodically). Drugdex System [internet database]. Greenwood Village, CO, Thomson Healthcare.

Updated