Don’t Flush Those Expired Medications!
About 3% of all purchased medications expire before their use. Like most medical practices, at some point, you must manage these expired medications. Whether your practice offers sample medications, in-office prepackaged dispensing, or merely administers medication to patients as part of their treatment, it’s inevitable that some of your on-hand stock may get damaged or expire and become unsuitable for patient use.
While this medication is certainly of no further value to your practice—and you don’t want to risk it remaining in inventory where it may be inadvertently administered to a patient—do you know the proper method for removing it so that it is not a danger? If you’re like many physician offices and small clinics, you might be tempted to simply flush it down the toilet. But that quick method of destroying old, expired, or damaged medication could not only be the incorrect way to get rid of it, but it could also be illegal!
Beginning on August 21st of this year, the Environmental Protection Agency (EPA) will be enacting a Final Rule on Management Standards for Hazardous Waste Pharmaceuticals and Amendments to P075 Listings. This ruling will impact how hazardous waste pharmaceuticals will be managed in hospitals as well as other health care facilities; this includes even private practices like urgent care centers and primary care.
If this new ruling sounds intimidating, it should. If for no other reason than it’s very rare for the EPA to mandate any such ruling affecting medical practices, AND because it’s being supported by the FDA, DEA, and several other well-known federal agencies. So, what’s it all about?
- A national prohibition of “sewering” any hazardous waste pharmaceuticals
- What is “sewering?” Essentially, this is the practice of drain-disposing of medication by means of pouring it down a sink or flushing it down a toilet.
- Prior to this date, only a few states or municipalities had rules or prohibitions against “sewering” hazardous waste pharmaceuticals. Many certainly “recommend” against it to avoid contamination of their water sources.
- Hazardous waste pharmaceuticals include, but are not limited to warfarin, nicotine, cyclophosphamide, lindane. But, in effect, this title covers “nearly any medication (solid or liquid) beyond saline, sugar, and electrolytes used for hydration.”
- Rule Effective Date(s)
- August 21, 2019, for all States or territories that are managed by the EPA (Iowa, Alaska, Puerto Rico, Indian Country, and all U.S. Territories except Guam)
- August 21, 2019, for states that have agreed to adopt the rule on that date: Pennsylvania, Kentucky, New Jersey, and North Carolina (limited basis)
- July 1, 2021 -July 1, 2022, All other states depending on their state legislature and statutory amendments. Be sure to watch your state’s notices to see when this ruling will be enacted.
NOTE: Some states—such as Ohio—already have similar ordinances in effect.
- Generator Status
- If your facility is either a large or small quantity generator of hazardous waste, you will be REQUIRED to participate in 40 CFR Part 266 subpart P by notifying the EPA of your status on the required EPA form. This will be in effect once your state adopts the ruling. Most urgent care centers or primary care offices will be small quantity generators or SQGs. In fact, most may qualify as VSQGs or “Very Small Quantity Generators” – the importance of this designation will be discussed in an upcoming section.
While all of this may seem like just another regulatory agency making life harder for a small operator, it’s really a good move for the environment. Improper disposal of unusable medications is not only a threat to our water sources but also contaminates the nearby soil and sediment, as well as plant and aquatic life.
What should an operator do with these unwanted pharmaceuticals? Well, the answer is NOT to stockpile them or give them away to patients. The liability associated with handing out free medicines that have expired is certainly not worth the little bit of goodwill you might generate. There is a reason the manufacturer puts an expiration date on those bottles and taking a chance that medication still has the same potency or efficacy isn’t worth the possible lawsuit if something goes wrong.
Then, there is the myth about crushing old pills and mixing them with coffee grounds or kitty litter before throwing them in the trash. While this may not be as outrightly harmful as dumping them down the drain or toilet, certain medications will still retain their chemical traits when they reach the landfill, mixing with rainwater and potentially affecting wildlife or even reaching portions of our ecosystem where they can be harmful if the quantities are large enough.
The first thing we can do in this new disposal method is to become educated. Learn which of your stock can be returned to the vendor for credit if expired or damaged. Select vendors carefully and work with those who will accept returns for credit or replacement to help you defer the cost of the product, or at the very least, the cost of disposal.
Second, closely watch and coordinate with any pharmaceutical reps leaving samples. Again, like the vendors you work with, have the pharma rep only stock your sample supply with those medications you’ll dispense in a reasonable time frame or that your practice can use. It’s not uncommon for urgent care practices to receive all sorts of products (cardiac medications, antihypertensives, etc.) that have a limited use within the episodic nature of their services. This can relieve the burden of your practice being responsible for disposal later.
Third, becoming a VSQG (Very Small Quantity Generator) will allow you to combine your hazardous pharmaceutical waste with other VSQGs and not only avoid the requirement of registering with the EPA but can also help avoid the costly waste pickup. VSQGs typically consolidate their waste to one centralized location under one common ownership who DOES register with the EPA and would pay for the pickup, so the fees may eventually be shared.
Finally, for most operators in urgent care and primary care, this isn’t a huge change to what you’ve been doing all along. Since most of you aren’t dealing in chemotherapy or warfarin and likely aren’t holding smoking cessation clinics, most of the medications you carry can, and should, be disposed of by either your usual biomedical waste management or through your current pharmaceutical vendor via returns. If you’re not sure or not confident that your method of managing your expired or damaged medications is compliant, consider outsourcing the service or follow up with your source vendor.
Above all else, just be sure that these medications are NOT ending up down the sink, down the toilet, or in the trash (or anywhere else they shouldn’t be going) and chances are your practice is going to be just fine. For more information, check out the FAQs HERE.
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