Issue: July 25, 2020
Disclosures: Wiley reports he is a consultant to ImprimisRx.
July 21, 2020
3 min read
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Physicians need to mitigate risk with compounded drugs

It is important to ask questions about compounded pharmaceuticals, facilities and manufacturing standards.

Issue: July 25, 2020
Disclosures: Wiley reports he is a consultant to ImprimisRx.
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I have long been an advocate of compounded medications as a way to offer my patients cost-effective, preservative-free medications with convenient dosing.

Compounded intraocular medications also allow me to control delivery of essential medications, further reducing my concerns around patient compliance.

Physicians rightfully have questions about the quality and legality of compounded pharmaceuticals, however, and it is important to know that not all compounded medications are the same. Following these five simple rules can help to mitigate any risks associated with compounded medications.

William F. Wiley, MD
William F. Wiley

1. Avoid self-compounding

It used to be routine practice in ASCs for staff or physicians to essentially “self-compound” medications, adding ingredients to the irrigating solution or mixing their own buffered solutions for intracameral anesthesia and floppy iris syndrome prophylaxis, for example. Some centers had problems with stability or sterility, or mixed inaccurate concentrations. New ASC regulations a few years ago have largely eliminated these practices as having too much potential for human error.

2. Consider mode of delivery

Consider the level of risk associated with the mode of delivery: oral, topical or intraocular. Injected ophthalmic drugs generally have a higher level of risk than topical drops and should be held to the highest manufacturing and quality standards. Compounded formulations that use approved drug ingredients can meet this definition. In fact, the FDA has specifically established standards and regulations for compounded pharmaceuticals and does not classify them as higher risk than other types of drugs.

3. Understand what type of facility is making compounded medications

Under the U.S. Drug Quality and Security Act, there are two types of compounding pharmacies, with different regulatory requirements. 503A pharmacies are primarily state regulated and can only make formulations for an individual patient prescription. 503B outsourcing facilities are regulated by state authorities and the FDA, which has the authority to inspect 503B facilities. These pharmacies can provide larger quantities of drugs directly to clinics, hospitals or ASCs without patient-specific prescriptions, but they must follow Current Good Manufacturing Practices (CGMP) in doing so. The CGMP standards for drug identity, strength, quality and purity are the same standards to which large commercial pharmaceutical manufacturers are held. The oversight of 503B facilities is in many ways more stringent than oversight of generic drug products, many of which are manufactured outside the U.S.

4. Ask questions about company’s history, inspection and manufacturing standards

It is important to ensure that you are relying on a pharmacy with strict quality standards and a long track record. Purchasing from an FDA-registered 503B facility is one way to do this, but for many patient-specific drugs that are produced in 503A facilities, you will need to ask a few questions about the compounding pharmacy’s standards. I want to know, for example, where the pharmacy gets its active pharmaceutical ingredient raw material and whether it tests that raw material for potency before making new batches. Is every batch of a formulation tested for potency, sterility and endotoxins? Does the facility use validated, stability-indicating methods to determine the beyond-use date printed on the packaging? How often does the facility conduct environmental monitoring, and how often is it inspected? These are all important questions that high-quality compounding pharmacies should be able to answer to your satisfaction.

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5. Consider the risks of noncompliance

In addition to the risk of the drugs themselves, we also must consider mitigating the risks of the drugs not being used. When compliance is poor — whether that is due to the financial and logistical burden of filling prescriptions, confusion about the medication regimen, or problems with dexterity and eye drop application — the patient loses the intended benefit. That may have minimal consequences: Perhaps their dry eyes will still feel dry. But in other cases, the consequences could be far more severe, including endophthalmitis from missed antibiotics, cystoid macular edema from insufficient anti-inflammatory drugs or glaucoma progression from poor compliance with IOP-lowering drops.

Compounded medications have an important role to play in contemporary ophthalmic surgery. They offer more choices for physicians, compliance benefits and good value for patients. But not all compounded medications are created equal. It behooves physicians to spend a little time investigating how long a compounding pharmacy has been around and what standards it adheres to.