Sometimes our solutions are more complex than the problems they are trying to solve. That fact came to mind as I reviewed the new DEA regulations surrounding the retail pharmacy disposal of patient-returned prescription controlled substances.

As a retail pharmacist, I have never understood why we, the dispensers of prescriptions drugs and controlled substances, could not legally take back (for disposal purposes) the products we sold. I cannot count the number of times a customer of mine has shown up with a big plastic bag stuffed with pill bottles and painkillers they no longer needed, only to hear me give them the pathetic reply, "Sorry, we cannot dispose of those here."

Really? It makes no sense.

All pharmacies have in place some mechanism to dispose of their own expired and/or damaged controlled substances already. Companies (usually referred to as "reverse distributors") take back our damaged or expired drugs for proper disposal on a regularly scheduled basis, depending on our needs. It's pretty simple. And pharmacies that choose to expand their disposal service by inviting their own patients to return unused medications could, if they wanted, utilize existing systems to do so.

But then in steps the DEA. And in a 52-page manifesto on drug disposal and pharmacy take-back programs have managed to significantly confuse and frustrate what could otherwise be a pretty easy process.

Pharmacies interested in participation must first register with the DEA as a collection site. That seems strange since all pharmacies operating in the U.S. already have several active licenses they must maintain just to function as pharmacies. Why one more?

Having registered, such pharmacies must then meet the disposal-site criteria and purchase approved disposal receptacles. These receptacles must be situated such that customers have access to them — since pharmacy personnel are not allowed to handle the returned product prior to the patient dropping it in the bin.

Additional requirements imposed by the new regulations include the mandate that two employees be involved in changing the bin liners and the fact that all returns must be processed with a specified frequency.

The bin liners, by the way, must be "waterproof, tamper evident, tear-proof and sealable." They must also have to have a tracking number on them. I have no idea where pharmacies will purchase such liners, but clearly some business out there is making such things.

The whole process seems to be unnecessarily complex, expensive to operate, and therefore may not be widely embraced. That's too bad, because an effective and efficient mechanism for removing unwanted and unnecessary drugs (and especially controlled substances) from people's homes could be a useful tool in preventing accidental exposure. It won't solve our abuse problem, but it might help reduce some diversion or accidental ingestion by patients or their pets.

Of course, an even simpler solution to managing most expired and unwanted medicines, including controlled substances, would just be to tell people how to dispose of them on their own. The FDA has a recommended process and, unless other local options are available, this could be better communicated to our patients.

They advise as follows:

  1. Remove them [pills/capsules/etc.] from their original containers and mix them with an undesirable substance, such as used coffee grounds or kitty litter (this makes the drug less appealing to children and pets, and unrecognizable to people who may intentionally go through the trash seeking drugs).
  2. Place the mixture in a sealable bag, empty can or other container to prevent the drug from leaking or breaking out of a garbage bag.

Exceptions to this process exist for the most powerful Schedule II narcotic prescription drugs. For these products the FDA recommends flushing them down the toilet or sink whenever possible to entirely eliminate the possibility of accidental exposure by humans or animals.

Given the new regulations, will your pharmacy begin offering a controlled substance disposal option for your patients? I am glad the new regulations have made that option available. I wonder, however, whether the expense and complexity of the process will cancel any of its benefits.