A CDER Conversation with Douglas Throckmorton, M.D., Deputy Director for Regulatory Programs, Center for Drug Evaluation and Research, FDA
Last year Americans filled 4.3 billion prescriptions. It is clear that prescription drugs play an important role in managing a range of medical conditions and are widely used in homes across the United States. But the drug life-cycle is not complete until the medicine has been consumed in its entirety or eventually discarded properly. However, little attention is given to the potential risks, such as accidental exposure or intentional misuse, related to improper medicine disposal. Where should unused and expired medicines go? Let’s look at drug disposal and get a better understanding of why it’s important to safeguard medicines in the home and how to properly dispose them when no longer needed.
Let’s begin with the basics, how should consumers safeguard and store medicines at home?
Well, it’s important to keep medicines in a storage location out of the reach and sight of children and pets too. Be sure to put medicines away after every use. Don’t leave them out on the kitchen counter or some place where they can easily be grabbed by kids. Even simple measures like making sure that the safety cap is locked can help prevent accidents.
How should folks dispose of their medicines?
For most prescription medicines, we recommend they be returned through a local, or U.S. Drug Enforcement Agency-sponsored take-back program or DEA-authorized collector. For a small number of drugs, we recommend immediate removal from the home by flushing them down the toilet or sink.
There are several programs consumers can access to help them dispose of unused or unwanted prescription drugs. First, take-back programs. These events are held in many parts of the country and can help you dispose of unused and unneeded drugs quickly and safely. Check with your local government or the DEA’s website for information on the next take-back event in your community.
Another good option for safe disposal is to locate a DEA-authorized collection site. Authorized collection sites may be retail pharmacies, hospital or clinic pharmacies or law enforcement locations. Some authorized collection sites may also offer mail-back programs or collection receptacles, sometimes called drop-boxes.
If these options aren’t available, the drugs should be removed from their original containers, mixed with coffee grounds, cat litter or some other undesirable substance, and placed in sealable plastic containers or bags. This can be thrown into the trash for pick-up. And when you dispose of prescription medicine bottles, be sure to remove any personal identifying information before throwing them away.
DEA’s National Prescription Drug Take-Back program is back. What do you think of this action?
I’m very happy to see that this disposal option is once again available to consumers. We are definitely supportive of any safe and useful way to get medicines that are no longer needed out of the home and disposed of properly. And I’m proud to say FDA has hosted several take-back days at our facility, where we have collected unused medicines for disposal.
You mentioned flushing -- certain drugs should still be flushed?
A few prescription medicines are especially harmful or even fatal if taken accidentally by someone other than the patient. For this reason, if a drug take-back program is not available, these medicines should be flushed down the sink or toilet to eliminate them from the home. This provides an immediate way to prevent any possibility of accidental exposure or overdose.
FDA has a list of medicines on our website that we recommend be disposed of by flushing. If a medicine has special disposal instructions, the directions will be listed in multiple sections of the prescribing information for health care professionals and also in the product’s patient information.
Aren’t you concerned about the possible environmental impact of flushing?
Here at the agency, we understand that there are concerns about getting rid of drugs by flushing them. While we continue to study the issue, disposal of these select few medicines by flushing has not been shown to cause environmental harm. Actually, the vast majority of drugs that are detected in rivers and streams come from normal bodily excretion by people and animals.
Let me stress that we only recommend flushing a very small number of potentially dangerous drugs – these are drugs that can be especially harmful if taken by the wrong person or not used as intended. It’s important to get these drugs out of the home as soon as they are no longer needed to prevent harm to children and pets. For all other drugs, take-back programs or disposal through household trash are recommended.
We often hear about problems with the disposal of drug patches – what issues do they present?
These products pose a risk to others, especially children because a large amount of active medicine remains in the patches even after they’ve been used. In fact, usually more medicine remains in the patch after treatment than was delivered to the patient during treatment.
We have received reports of women and children accidentally exposed to testosterone from patches. Sadly, we are also aware of four children who have died and another six that required hospitalization from an accidental overdose of the potent pain medicine fentanyl. These children accidentally came into contact with used Duragesic patches. Proper disposal of medicine patches is very important to help keep children and other household members safe from accidental exposure.
Then how should someone dispose of a drug patch when they no longer need it?
To dispose of a drug patch, carefully remove it by the edges and avoid touching the used medicine pad; then fold the patch in half, sticky sides together. Nitroglycerin and testosterone patches can be placed in the trash. Fentanyl patches should be flushed immediately.
Flushing, wrapping, coffee grounds, why not just re-use the drugs when needed or pass them to someone else?
Certain localities and organizations operate medication reuse programs, which take unused and unexpired medicines from patients to give to others. The FDA does not endorse this practice for two reasons - first, the medication may have been tampered with and is no longer safe to take, and second, the medication may have been improperly stored and is no longer effective. The safety and efficacy of a medication cannot be guaranteed after it has been dispensed.
So, they may not work and they may not be safe.
Do you see a time when a flush list will no longer be needed; what must be in place for that to happen?
Well, one major step has already been taken, and that was the passage of the Secure and Responsible Drug Disposal Act in 2010. This legislation is designed to help decrease prescription drug abuse and related crime by allowing patients to turn in controlled substances to an authorized individual or site for collection and destruction. Let me take a step back to explain that controlled substances are drugs, which include some prescription medications that have potential for abuse or dependence. Ok...this act also helps families dispose of drugs that belonged to deceased relatives. Basically, it gives Americans more options to safely get rid of medical products they no longer need.
However, we still need more safe, and widely available disposal options for consumers. For now, we continue to work with our federal partners at the DEA and the Environmental Protection Agency to make sure that our recommendations align and to promote existing safe disposal options.
What else do you think needs to be done to encourage consumers to better dispose of outdated and unused medicine?
Well, from an agency standpoint, one goal is to educate consumers about the risks of leaving certain unused medicines in the home. Then we need to provide information to consumers on how to dispose of certain unused medicines, and explain the agency’s recommendations for medicine disposal. We do this by periodically evaluating our disposal recommendations and ensuring that our web pages reflect the most up-to-date information possible.
Overall, I think we are making good progress to educate people about the importance of drug disposal and giving them tools to do it. Of course more can be done – but so far, I’m encouraged by the results I have seen. I’m confident that efforts from FDA, its federal partners and, most importantly, consumers will continue and together we’ll be able to reduce medicine-related accidents in the home.