The Pew Charitable Trusts voices concerns that drug compounding could endanger the patients it seeks to help.

With the pharmaceutical industry working toward a means to bring down the price of drugs on the market, some eyes have been drawn to the potential of compounding pharmacies as one possible remedy.

“Compounding is a long-standing practice—as old as pharmacy itself—although it has evolved over time,” said Elizabeth Jungman, Director of Public Health Programs at The Pew Charitable Trusts, an independent, non-partisan research and policy organization with a long history of engagement in issues affecting public health, including drug safety and drug quality. “Compounded products are customized for patients whose clinical needs cannot be met by an approved or commercially available drug.”

There are two types of entities that produce compounded products, she explained:

1. Traditional compounders, who create customized drugs tailored to individual patient
2. Outsourcing facilities, which can sell stock supplies of compounded products to health care providers, who administer them to patients

However, industry experts have voiced concerns, cautioning that such an approach could endanger the patients that it seeks to help.

Elizabeth Jungman and Chuck Shih of The Pew Charitable Trusts said in an article:

Pharmacists often make drugs for patients whose clinical needs cannot be met by a commercially available product, a practice known as compounding. But should pharmacists compound drugs to reduce costs for patients and the health care system? Some large compounding firms have proposed themselves as a solution to recent sharp price increases for a number of medicines, including EpiPen-brand epinephrine auto-injectors and the anti-parasitic medicine Daraprim. High drug prices can be catastrophic for people with serious illnesses or allergies, but patients, health care providers, and policymakers must carefully consider the risks to patient safety that such an approach would bring.

Drug Compounding Today

How prominent is drug compounding today? It’s hard to get accurate reports, according to Jungman, because “states do not always track which of the pharmacies they regulate are compounding, which means they do not necessarily know what is being compounded or how much compounded product is administered or dispensed.”

Adding to the challenge, defining what technically ‘compounding’ is—whether that’s repackaging, mixing, or reconstituting—differs among industry experts.

In Pew’s 2016 National Assessment of State Oversight of Sterile Drug Compounding, assessing the total number of pharmacies in each state and the number that compound, pharmacies performing sterile compounding as a percentage of all pharmacies in each state ranged from three to 24 percent. In addition, 42 percent of states track the number of pharmacies that compound and 56 percent track the number that perform sterile compounding. However, it is likely that this number has improved since then.

According to the International Academy of Compounding Pharmacists, compounding occurs in virtually every hospital and home health specialty pharmacy, as well as in all nuclear pharmacies, because these products must be further manipulated to be ready for use. This estimate may capture repackaging, mixing, and reconstituting in addition to what FDA considers to be compounding.

FDA-Approved Medications vs. Compounded Drugs

Although compounded drugs hold some benefit, such as when a patient’s unique clinical need cannot be met by what is commercially available—i.e., a child who needs a liquid version of a drug approved by the FDA only in pill form—these drugs do not undergo the same testing required for FDA-approved medications.

“Compounded products pose a higher level of risk to patients than FDA-approved products because they have not been tested for safety and efficacy and they are typically not made under the same quality standards,” said Jungman. “Drug manufacturers bear the costs of extensive clinical testing before their products go to market, as well as the cost of maintaining quality standards (called ‘Good Manufacturing Practices’) in the factories where they produce drugs. Compounding firms are not subject to trial costs, and traditional compounders are not subject to GMP.”

However, any testing requirements would be prescribed by state law, said Jungman, as quality standards for compounded drugs are made in state-regulated pharmacies or physician offices.

“But because compounded drugs are often made for a particular patient with an immediate need, end-stage testing isn’t typically feasible,” she continued. “That’s why it’s important for states to ensure that quality standards establish adequate controls (related to personnel, the environment, and compounding processes) to ensure that compounds are made under conditions that control chance for contamination or other errors. 

“Our best practices recommend that states require traditional compounding comply with the U.S. Pharmacopeial Convention’s standards for sterile and nonsterile compounding and for the handling of hazardous drugs (chapters 795, 797, and 800).”

Although there is a risk for any product with lowered quality standards, sterile compounding, in particular, holds a high infection risk, such as an infection of the eye, bladder, or lungs. In addition, there are some drug products that are considered to be “too risky” to compound. The FDA’s Pharmacy Compounding Advisory Committee (PCAC) “is advising the agency on a list of drugs that should not ever be compounded,” said Jungman.

The Drug Quality and Security Act

In 2012-2013, approximately 750 people became ill and more than 60 people died after fungus-contaminated drugs from a compounding pharmacy in Massachusetts that has since been closed were injected into their spines and joints.

“Many surviving victims still struggle with chronic—and, in some cases, disabling—health problems. An executive from that pharmacy was recently convicted of racketeering and fraud, and another faces federal murder charges,” said Jungman.

“In response to that tragedy, Congress enacted the bipartisan Drug Quality and Security Act in 2013, which preserves access to safe compounded medications for Americans who need them, while helping shield patients from the risks of drugs produced under dangerous and illegal conditions. States are responsible for oversight of traditional compounding, where the majority of compounding takes place, and many have strengthened policies to help ensure safe compounded products.

“To protect patient safety, these laws need to be fully implemented and enforced.”

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