Editor’s note: Dr. Hudis hosts the ASCO in Action Podcast, which focuses on policy and practice issues affecting providers and patients. An excerpt of a recent episode is shared below; it has been edited for length and clarity. Listen to the full podcast online or through iTunes or Google Play.
I’m very pleased to once again have Dr. Ray Page as my guest. Dr. Page is a past chair of ASCO’s Clinical Practice Committee and is the president of the Center for Cancer and Blood Disorders, where he also serves as a medical oncologist and hematologist.
Earlier this year, ASCO released a position statement on state drug repository programs outlining the Society's support for such programs solely for oral medications, provided that they are maintained within a closed system. ASCO's statement also makes recommendations to help ensure that these programs are implemented appropriately with sufficient patient protections in place. Dr. Page and I discuss the important role that these programs can play in helping our patients afford their treatment while reducing the financial toll on the cancer care delivery system. We will discuss the important guardrails that are needed to keep these programs safe.
CH: What are state drug repository programs? How do they work and what's the purpose?
RP: In its simplest definition, a drug repository program is a legal process that allows unused prescription drugs to be donated and reused rather than thrown away or set aside if they are no longer needed. Its purpose is to offer a practical way to increase access to prescription drugs for patients, and often this process can offer more timely access to drugs with a negligible financial impact for the patient.
These programs are of exceptional importance to patients with cancer who are constantly challenged today with getting affordable access to vital drug treatments for their disease, and these issues are described very well in ASCO's 2017 position statement on the affordability of cancer drugs.
CH: If readers look at ASCO's position statement, they'll see that we identify that appropriately implemented drug repository programs can help address some of the cancer drug waste.
For argument’s sake, let’s say that a patient is dispensed 60 pills. They later have a toxicity-based dosage adjustment and come back for a routine office visit and still have 20 pills leftover. The goal here is to essentially recycle those pills back into the supply, right?
RP: That is correct. As practicing physicians, we see this issue all the time of unused pills that we don't need anymore. If there is a mechanism that we can use to safely transfer a drug to somebody who needs it, then there can be a substantial positive impact for our patients.
CH: Is it only a financial benefit, or are there non-financial benefits as well that a repository program can somewhat mitigate?
RP: The financial impact of this is huge. But outside of that, in 2015 the Environmental Protection Agency estimated that about 740 tons of drugs are wasted just by nursing homes every year, and obviously this can't be good for our environment. We've all heard reports about many of these discarded drugs ending up in our water systems. Redistribution and enabling access to these unused drugs can help alleviate some of these problems that go outside the finances.
CH: Are there any pushbacks from patients or providers regarding these programs? Is there any clear objection to these that we should be thinking about and possibly working to mitigate?
RP: In general, most of my patients have negligible concern about getting a donated drug for immediate use. There should be informed consent and disclosure, obviously, but the patients generally trust their physician's recommendations and are truly interested in just getting the opportunity to get access to the drugs. From a patient's perspective, I generally think that their greatest concern is getting quick access to the oral drugs so they can get started on their cancer therapy as soon as possible, often to alleviate active symptoms that they're having, and to alleviate some of the fear of just not getting access to beneficial drugs.
I think the physicians share that same sentiment of the patients, but in addition, physicians have concerns, desires, and assurances that these donated drugs are indeed safe for re-distribution.
CH: As you know, ASCO strongly supports repository programs, but we're very focused on oral medications, and we assume that they will be maintained within a closed system. For our readers, can you describe the difference between a closed system and open system and why we would be favoring a closed system? What makes it safer?
RP: A closed system is a way to have an overabundance of precaution to assure patient safety. Basically, this allows for drugs that were prescribed to a patient to be brought back with appropriate disclosure and supervision. Those drugs are then reviewed by a pharmacist and assured that they're safe and able to be recycled according to state laws and pharmacy board rules.
An open system is one where, say, you have a patient that comes into the office and they have a bottle of pills that are unused and they give them to the physician, and then the physician turns around and redistributes those drugs to the next patient who's in need.
CH: I think when people think of cancer treatment, they are used to thinking about perennial therapies, infusions and the like, but this is really focused on oral medications. What are some of the oral treatments that have been successfully made available to patients through drug repository programs so far?
RP: I'll just emphasize that over 40% of cancer therapies that oncologists prescribed were oral drugs, and we have several hundred experimental oral cancer drugs that are in clinical trials. It's anticipated that as time goes on, we're going to be prescribing more and more oral cancer therapies rather than patients spending all day in a chemo chair getting IV infusions. That's a great thing for our patients.
Currently, I estimate that there's probably over 100 oral anti-cancer drugs and supportive care drugs that are being prescribed to our patients, and these encompass a wide range of treatments, including your classic cytotoxic chemotherapy pills, hormonal agents, molecularly targeted drugs, and symptom management drugs. Each state has a drug repository program and has its own pharmacy rules for that redistribution. In general, most of these drugs, in order to be available, must be in untampered and secure packaging such as blister packs.
Most states require inspection by a pharmacist; therefore, there are several great drugs that may not be readily available for redistribution based on state laws and pharmacy rules that are designed to protect patient safety.
CH: Are there other safeguards or any other provisions you think that state drug repository programs could take advantage of to improve their ability to serve patients? Is there anything else we should be doing as we gain experience with these programs?
RP: ASCO has made some recommendations to the states that are not in a closed system to address the concerns of drug-related redistribution in an open system, which stresses that the surplus medications are administered in a safe, effective, and private manner in accordance with the prescribing clinician's guidance. The state should have a liability protection in accordance with their state health regulatory authority, and that includes such things as the informed consent and disclosures.
ASCO and other professional medical organizations should continue to make efforts to educate physicians about the existence and the value of these programs. ASCO also suggests that this drug repository program should be implemented with no additional cost, or at least at a negligible cost to the patient.
CH: I think that's great, and I—personally and on behalf of the membership and our whole community—applaud you for your activism in this area. It really does matter to patients as we have been discussing.
For those of you who want to read more about this, I encourage you to open up ASCO's position statement on drug repository programs.