Letters

Conflicting Information, Regulations Add Confusion to the Drug Disposal Question

My previous experience in many settings of pharmacy practice has been that returned, non-hazardous drugs that cannot be re-used or sent back to the manufacturer have traditionally been disposed of using the sewer system (or, rarely, by incineration). I think we all know what the most common practice was (and may still be).

In past conversations, our state board inspector condoned proper handling and disposal of drugs, but he did not recommend a specific method, other than not using the sewer system.

In the long-term care pharmacy setting, we are witnessing a large increase in the types and quantities of drugs being returned to pharmacies. Many are drugs that technically are not returnable, either because they are not packaged in a way that legally allows reuse, or they cannot be returned for credit and therefore need to be discarded. There are many reasons for this trend, but at this time, many pharmacies accept the returns to "keep their customers happy" by fulfilling what is perceived by many long-term facilities as a "pharmacy responsibility."

In cases where nursing facilities understand and are willing to take responsibility for the destruction/disposal of non-returnable medications, they are having trouble knowing how to properly dispose of them-inhalers, for example, often present a problem.

In addition, one facility in northern California was recently told by their county environmental health department that they should not dispose of Schedule II medications via their sewer system. This presents something of a predicament, in that neither their biohazard waste hauler nor the pharmacy itself can accept them.

These changes in California law now greatly increase the volume of returned drugs that have to be disposed of by a medical waste hauler, and therefore increase costs of doing business for all parties involved. In my view, there are several factors that are currently making management of drug disposal more and more difficult to accomplish:

• The ability to credit returnable medications to most payers is either nonexistent, too cumbersome, or requires a full refund of any dispensing fees, which is the impetus behind most "no credit for returns" policies.
• Once a drug is repackaged, in "bingo cards," for example, the manufacturer will not handle it, nor will the drug return companies.
• Different regulatory agencies and departments oversee and inspect pharmacies, in contrast to the situation with the nursing facilities to which the pharmacists provide service.
• The problems associated with this issue lead me to question whether or not the state nursing facility surveyors, one county environmental agency, and the state board of pharmacy are "on the same page," leaving many of us confused as to which law or regulation predominates.
• State laws and regulations pertaining to skilled nursing facilities (Title 22 in California) have not kept up with the changes made at other levels by other agencies.

Greg Light, PharmD
Divisional CQI Manager
Vitalink Pharmacy Services
Stockton, California

ASCP's Government Affairs Department responds:

That is the case in the state of California. The Department of Health Service's Code of Regulations, Title 22, addresses the procedure that LTCFs must follow for the destruction and disposal of drugs. Section 72371(c)(1) states that drugs in Schedules II, III and IV shall be destroyed by the facility in the presence of a pharmacist and a nurse. Because the method of disposal is not defined, the sewer system has been the common disposal route-until now. Senate bill 1966, called the Medical Waste Management Act, amended in 1997, redefined pharmaceutical waste as medical waste that cannot be disposed of through the sewer system. This bill has stripped California's LTCFs of the traditional method of disposal and leaves those left with unused drugs searching for an alternative solution that ensures lawful disposal of medication.

One solution to this problem is to return some types of drugs to the dispensing pharmacy. Title 22, Section 72371(d) permits unopened drugs in sealed containers to be returned to the issuing pharmacy for disposition unless otherwise prohibited under applicable federal or state laws. Under the federal "Controlled Substances Act," controlled substances may only be returned between Drug Enforcement Administration registrants. LTCFs are not DEA registrants; therefore, pharmacies or reverse distributors may not accept controlled substances returned from such facilities. As a result, LTCFs are left with the burden of somehow disposing of controlled substances.

ASCP supports the return and reuse of non-controlled medications to the dispensing pharmacy to reduce waste and to offer substantial cost savings to the health care system, provided specific drug product safeguards and appropriate billing policies are in place. A mechanism (reasonable for both the payer and the dispensing LTC pharmacy) should be in place for billing only the number of doses used by the resident or crediting to the resident or the appropriate third-party payer the number of doses returned.

It is easy to see that regulations, including California regulations, do not necessarily provide the most effective answers for the disposal of drugs. ASCP is currently working with the DEA, boards of pharmacy, and regulators to find a solution for the disposal of all drugs that is realistic, cost-effective, and environmentally friendly. The California Department of Health is actively striving to develop a solution that will rescue LTCFs from the limbo that current regulations have created. ASCP will meet with the California Department of Health Services and the DEA in October to address specific concerns of long-term care pharmacy. To assist long-term care pharmacists in deciphering their current regulations, ASCP has created a product, titled State by State Guide to Controlled Substance Destruction and Disposal in Long-Term Care Facilities, which will be available in late October. For further information, please contact ASCP's Government Affairs department at 703-739-1316, ext.170.