Cancer patients deserve peace of mind when it comes to medication

Amid this uncertainty, they should never have to question whether the medicine intended to help them is safe and authentic — particularly when health, and sometimes life, hangs in the balance.

Cancer medicines are complex, and with that complexity comes unique challenges within the pharmaceutical supply chain: drug shortages can disrupt treatment, manufacturing often spans multiple countries and patients frequently have few alternatives. Every treatment plan is carefully developed around a patient’s diagnosis and needs, making confidence in the quality and integrity of those medicines essential.

Many people assume counterfeit or falsified cancer medicines are a problem that happens elsewhere in the world. But in reality, these products have already reached U.S. clinics, and reports of counterfeit cancer medicines increased 60% worldwide between 2021-23.

While these incidents remain relatively uncommon, they underscore why protecting the integrity of cancer medicines matters so much.

I applaud some legislative and regulatory solutions already underway. The proposed Safeguarding Americans from Fraudulent and Experimental (SAFE) Drugs Act and the National Association of Boards of Pharmacy’s efforts to strengthen adverse-event reporting and information sharing are important steps toward improving medication safety. Greater transparency, clearer labeling, stronger oversight of large-scale compounding and more consistent reporting can help regulators identify unsafe practices and emerging risks earlier.

These reforms should preserve access to legitimate, patient-specific compounding while making it harder for unapproved, poor-quality, or deceptively marketed products to reach patients without appropriate safeguards.

Regulation and reporting alone, however, are not enough. Reports often surface only after someone has been harmed. Patient education must be a central part of any safety strategy, so people understand exactly what they are receiving, including whether a medication is approved by the U.S. Food and Drug Administration, compounded for an individual clinical need or sold through an unregulated or illicit channel.

Patients should be encouraged to ask who manufactured or compounded the product, why it is being recommended, whether FDA has evaluated it for safety, effectiveness and quality, and how to report an adverse reaction. No patient should discover only after experiencing harm that a medication was not FDA-approved or that its purity, potency, sterility or dosing had not been independently reviewed.

That education is especially important as patients become more engaged in their healthcare decisions while navigating an increasingly complex information environment. Telehealth platforms, online pharmacies, direct-to-consumer advertising and the inconsistent use of terms such as “FDA-approved” and “compounded medication” can make it difficult to distinguish reliable medical information from marketing.

Many patients understandably assume that every prescription medication reaches them through the same review process, but that is not always the case. This confusion has become so widespread that more than eight in 10 physicians report caring for patients who do not realize compounded medicines are not FDA approved.

That distinction should not diminish the legitimate and essential role of compounding in patient care. When an FDA-approved medicine cannot meet a patient’s specific medical needs, a pharmacist may prepare a customized medication for that individual. For some patients, these preparations are necessary, but they follow a different regulatory pathway than FDA-approved medicines.

Patients and families can take simple steps to protect themselves by asking physicians or pharmacists whether a medication is FDA approved or compounded, why it was selected, who made it and where it came from. They should be cautious of medicines offered through unfamiliar websites or social media and speak with a trusted healthcare professional before making any changes to their treatment.

Most importantly, they can report unexpected reactions or concerns promptly. Taking these steps is an important part of making informed decisions during the biggest health battle a patient will face.