Recycling Discarded Drugs: Improving Access to Oral Antineoplastic Drugs.

It is common for patients to have limited access to oral antineoplastics or to discontinue treatment because of cost. Such oral treatments are also discontinued because of toxicity, disease progression, or death, resulting in unused portions of these medications. Policies for the subsequent use or destruction of unused drugs exist, but none completely address the need for methods of recycling back to the patients in need. This article addresses this wastefulness and ways to minimize it so that more patients benefit.

The high cost of new therapeutics has been well annotated. In particular, the financial toxicity of new cancer drugs to patients, their caretakers, and, indeed, to society is increasingly recognized. Virtually all agree that providing financial incentives for those who invent new life‐prolonging therapies is important. At the same time, virtually all agree that we need to improve the access and affordability of these new therapies so that the greatest number of patients can benefit.

Although many new anticancer drugs are costly, oral antineoplastics often have the most significant fiscal impact on patients. In part, this is because of the complex and often incomplete insurance coverage for oral drugs, which some patients have and some do not. In addition, there is a bewildering array of deductibles, “copays,” and “donut holes” that result in substantial variations in costs from patient to patient [1]. These complexities make it nearly impossible to determine the “out of pocket” cost of an oral drug for individual patients, complicating therapeutic decision making. Unfortunately, it is quite common for patients to have limited access to, or to discontinue treatment with, oral antineoplastics because of cost [2], [3].

Current efforts to improve access to expensive new oral drugs focus heavily on patient assistance programs (primarily funded by pharmaceutical companies). Although these programs can be helpful in reducing the onus of prohibitive cost, they are also associated with considerable controversy as they help keep drug prices high, do not apply to those federally insured, and incompletely solve the access problem [2], [3].

Oral treatments are discontinued because of toxicity, disease progression, or death in almost all patients. As a result, many patients have unused portions of these medications when their treatments are discontinued [4]. There are many well‐intentioned policies at multiple levels (Food and Drug Administration, pharmacies, hospitals, state laws) addressing the use and/or destruction of unused drugs. Some of these policies and programs are potentially helpful in solving the affordability problem, including establishing pharmacies that accept unused drugs for recycling back to patients in need. Many states that have passed laws allowing some drug recycling have yet to develop actual programs to achieve these recycling goals [5]. These programs have several requirements for donated drugs, including that drugs are unopened or sealed in the original dispensing packaging, are not expired, and cannot include controlled substances. Prior to redistribution, a pharmacist must assess these donated medications. We have not seen these programs be useful in terms of promoting more antineoplastic access for our patients. Thus, the current environment is one in which some patients are forced to forego the use of life‐prolonging drugs while others discard them. Inevitably, this is wasteful.

One opportunity for improving patient access to expensive medications is for physicians or practices to take responsibility for recycling drugs that would otherwise be discarded by patients. Who would argue against the fact that an unused drug from one patient potentially translates into benefit for another? A system that allows safe and efficient recycling of drugs from patients who no longer need them to those who do is a medically sound solution. Unfortunately, this seemingly simple solution presents a legal conundrum. We are aware of no provisions or policies that allow medical practitioners to engage in this process without involving a pharmacy intermediary.

Based on anecdotal accounts with physicians from numerous locations, because of legal issues, many physicians treating cancer patients are struggling with the issue of recycling. Some physicians simply recycle drugs despite the absence of an appropriate legal structure, whereas others ignore the issue. Of course, once a decision is made to receive donated drugs, store them, and then “recycle” them to patients in need, this is clearly beyond the scope of a typical physician's practice. Furthermore, if a physician acquires, stores, and dispenses drugs, are they not simply serving as an illegal pharmacy dispensing drugs that have an unclear chain of custody?

Several additional questions come to the fore. Is it safe to dispense opened bottles? Is it possible that someone has tampered with the drugs? Is such tampering likely? How have the drugs been stored since they were dispensed to the patient? Moreover, who should have access to the recycled drugs? Currently, insurance coverages, copays, access to copay assistance programs, and the patient's financial resources are rationing these expensive oral cancer drugs. If the physicians were in charge of choosing who will and who will not receive these valuable cost‐free medications, what dispensing rules should apply? There is a precedence in the aforementioned state‐sanctioned drug recycling programs to allow recycling of unused dispensed medications. The expansion of such programs to include antineoplastic drugs should be explored and the policies addressing these issues assessed for their applicability. A comprehensive assessment of current state and federal policies (many already in place for other drug recycling programs) would be important to determine practical issues as well as legal ones. Pharmaceutical companies have started dispensing some oral antineoplastic drugs in blister packs packaged in 1 week or 1 month supplies. Such an approach could not only minimize waste of dispensing but also improve safety and efficacy of redistribution of such packaged individual pills. Perhaps regulation requiring more thoughtful packaging to help promote redistribution of unused doses would help facilitate more effective recycling options.

Broad societal concerns are at play when it comes to maximizing the affordability of new cancer agents. This conversation mostly centers on the enormous up‐front costs of such medications, and rarely do discussions include the smaller, yet significant, problems associated with drugs being destroyed or wasted when patients no longer need them. Yes, potentially there are programs in place established by state legislation, charitable pharmacies, and the like. As noted above, we have not seen those programs benefit our patients.

We believe that it is time to directly empower physicians who are motivated to be able to recycle drugs, thus increasing access and minimizing waste. We suggest approaching this multifaceted problem from all directions and challenge current policies, or lack thereof: continued attention to efficacy of distribution, evaluation of packaging techniques that could ensure that integrity of the drugs are maintained once the drug leaves the pharmacy, and an approach to recapture unused drugs from patients once no longer needed with the intent to redistribute. A creative physician‐lead pharmacy for these unused drugs could facilitate recycling in a manner set according to a policy that would ensure they are distributed safely to those with a high level of need and urgency. This will require considerable relaxation or amendment of the rules and regulations that govern typical pharmacies and physician dispensing. If the recycled drugs are to be dispensed free of charge (we believe it unethical to sell them), then the recycling program must have trivial associated costs. Establishing and running a pharmacy is not trivial.

Who loses from such an arrangement? We submit that no one loses from such an arrangement because the medication would otherwise be thrown away and the receiving patients would not have purchased the medications anyway. Furthermore, waste would be minimized, more patients would get medications that they need, and, potentially, the overall cost of drugs to our patients and our nation would be less.