Risk Management

Reduce the Risk of Compounded Drugs

Anne Menke, RN, PhD, OMIC Risk Manager

Digest, Fall 2012

State and federal legislatures are reviewing changes in law to increase the safety of compounded drugs. Even before new laws and regulations go into effect, ophthalmologists can take action to reduce the risk of administering compounded drugs.

Q  Am I required to use FDA-approved drugs instead of compounded ones?

A  No. OMIC is not aware of any law that prevents physicians from choosing the drug or device they feel is in the best interest of their patient. Physicians should certainly be aware of whether there are FDA-approved medications available to treat the condition, and document the decision-making process that led to choosing one drug over another. Bear in mind that compounded drugs do not undergo the same premarket review for safety and efficacy as FDA-approved manufactured drugs.

Q  What do I need to do to credential a compounding pharmacy?

A  You need to perform due diligence by evaluating the compounding pharmacy’s licensure, accreditation, and compliance with laws and regulations. First, check with the board of pharmacy in your state. Ask the pharmacy board to send you your state laws governing compounding pharmacies; this will help you determine if state law requires the pharmacy to be licensed in your state, and whether a patient-specific prescription is needed before ordering drugs. Ask the pharmacy board if it is aware of any concerns about the particular company. Second, determine whether the pharmacy has achieved voluntary accreditation by the Pharmacy Compounding Accreditation Board (PCAB), an organization composed of eight of the nation’s leading pharmacy organizations. Third, gather information about the compounding process. The IACP has created The Compounding Pharmacy Assessment Questionnaire (“CPAQ”), a comprehensive tool to help the medical community assess and select a compounding pharmacy. It is available online at www.iacprx.org. Ask the pharmacy if it complies with the United States Pharmacopeia Convention (a scientific nonprofit standard setting organization) 797 standards for the compounding, transportation, and storage of compounded sterile products.[1] Go in and actually meet the pharmacists and inspect the facility. Determine where the compounding pharmacy’s raw products are obtained, if they are pharmaceutical grade for humans, and how batches are sorted and tested.[2] Ask what sample size the pharmacists use and whether they have sterility tests performed independently at an unaffiliated lab. Although price shopping is tempting, do not base your choice of pharmacy on cost alone.

Q  What steps can my practice take?

A  When ordering products, ask the compounding pharmacy to prepare the medication specifically for ophthalmic use, confirm the dose and sterility, identify the syringe suitable for the medication, provide storage and beyond-use instructions, and include a copy of the sterility tests with each order. Follow the storage and beyond-use instructions provided by the compounding pharmacy. Keep a log of medications that were compounded, and document the lot number in the patient’s medical record so that you can easily contact affected patients in the event of a recall. Follow current clinical guidelines on the proper aseptic technique during the preparation and administration of injections. Report any suspected adverse events following use of compounded products to the FDA’s MedWatch program at www.fda.gov/medwatch. For help with adverse events, recalls, and patient communications OMIC insureds are encouraged to contact OMIC’s confidential Risk Management Hotline by calling (800) 562-6642, option 4.

Q  Am I required to obtain informed consent to administer or use compounded drugs?

A  Informed consent is generally required for procedures or treatments whose risks exceed those that a lay person with average knowledge of medical issues would understand. The standard is not what a physician feels a patient should know, but what a prudent layperson would want to know. Informed consent is thus not required for a simple x-ray, but would be for fluorescein angiogram since the dye can cause fatal, allergic reactions. In the case of medications, physicians are expected to obtain informed consent from patients by explaining the condition, the expected benefit from the medication, known complications, and available alternatives. If the drug is being used off-label, that information should be part of the consent process. Prior to the highly publicized meningitis cases discussed in the lead article, it is unlikely that ophthalmologists explained to patients where they obtained their drugs. In the current environment, some patients may ask, and most patients would probably want to know. While it is not necessary to obtain the patient’s informed consent to use compounded drugs, be prepared to answer any questions patients may have about the issue. Practices and ambulatory surgery centers who use many compounded drugs may want to prepare an information sheet that explains what compounding is, and the steps the practice has taken to credential the compounding pharmacy.

1. Welcome to USP797.org, http://usp797.org.

2. Sellers S, Utian WH. “Pharmacy compounding primer for physicians: prescriber beware.” Drugs 2012 Nov 12;72(16):2043-50.