American Society of Consultant Pharmacists Background

Transcription

1 American Society of Consultant Pharmacists 1321 Duke St. Alexandria, VA Phone: FAX: March 4, 2009 RCRA Docket Environmental Protection Agency Mailcode: 2822T 1200 Pennsylvania Avenue, NW Washington, DC Re: EPA-HQ-RCRA To Whom it May Concern: The American Society of Consultant Pharmacists is pleased to offer comments to the Environmental Protection Agency (EPA) regarding the addition of hazardous pharmaceutical wastes to the Agency s Universal Waste Rule outlined in the proposed rule published December 2, 2008 The American Society of Consultant Pharmacists (ASCP) is the international professional association that provides leadership, education, advocacy, and resources to advance the practice of senior care pharmacy. ASCP s 7,000+ members manage and improve medication therapy and improve the quality of life of geriatric patients and other individuals residing in a variety of environments, including nursing facilities, assisted living facilities, hospice programs, and home and community-based care. ASCP members provide both clinical consulting and medication dispensing services through independent professional practices, longterm care pharmacies, and retail pharmacies. Background The majority of ASCP members provide clinical consulting and/or medication dispensing services to long-term care facilities; therefore our comments will focus on the impact of the proposed rule to the long-term care industry both facilities and off-site pharmacies that service those facilities. Due to the contractual relationship between pharmacists/pharmacies and long-term care facilities, pharmacists are often involved in the disposal of unused medications. In fact, according to a recent

2 2 survey of ASCP members on the topic of unused medications, over half of the nearly 500 pharmacists who responded stated that the majority of medications dispensed to long-term care patients are returned to the dispensing pharmacy, either for credit or disposal by the pharmacy. For the those facilities that manage the disposition, consultant pharmacists are often involved in developing policies and procedures and are sometimes directly involved in the disposal process as a witness. Long-term care facilities generate a significant amount of pharmaceutical waste for a variety of reasons. Prescribed medications, some of which are categorized as hazardous, may go unused for a variety of reasons, including: a patient s medical condition has been resolved before the medication is totally consumed; the patient has an adverse effect from the medication and must stop therapy; the medication is not effective and the physician changes the patient to a different medication; the patient fails to adhere to the prescribed therapy; or the person dies and leaves behind a supply of medications. A recent survey of ASCP membership on the topic of unused medications and disposal, to which nearly 500 pharmacists working in the long-term care industry responded, revealed that, on average, 17% of dispensed medications go unused. It is unknown what percentage of these medications is considered hazardous. Some of the unused medications are returned to the pharmacy for credit, restocking, and redispensing if certain criteria are met and state laws/regulations allow such practice. Nevertheless, a substantial volume of pharmaceutical waste is undoubtedly generated by long-term care facilities. The reason for the substantial volume of unused medications is multi-fold. First and foremost, the mere number of medications ordered for long-term care residents is voluminous. There are over 1.4 million patients residing in nursing facilities (not counting assisted living and other long-term care institutions), and according to a 2003 unpublished study, each patient uses an average of eight scheduled (routine) medications and an additional three PRN medications as needed. Secondly, most long-term care facilities, unlike hospitals, do not have on-site pharmacies. Off-site pharmacies that service these facilities may be located many miles away from the facility. Pharmacies must dispense enough medication to ensure that the facility has an adequate supply on-hand to meet each patient s needs at all times. In addition, most long-term care patients are covered by insurance, which the pharmacy bills for their medications. These third party payers are often reluctant to pay multiple dispensing fees, resulting in reimbursement to the pharmacy to dispense and deliver medications only once per month.

3 3 Number of Generators and Quantities Generated Despite the operational and patient safety issues that account for the volume of medications dispensed, most long-term care facilities and pharmacies that service them are likely to fall under either the Small Quantity Generator (SQG) or Conditionally Exempt Small Quantity Generator (CESQG) classification of hazardous waste generators, as defined by the Resource Conservation and Recovery Act (RCRA). Therefore, ASCP is not sure how many or to what extent long-term care facilities and pharmacies will be impacted by this proposed rule. Waste Determination and Labeling The proposed rule states that, many long-term care facilities may be unaware of the applicability of the RCRA hazardous waste regulations to their hazardous pharmaceutical waste. ASCP would agree with that statement. In addition to facilities being unaware, pharmacists also do not routinely receive training on pharmaceutical waste either. Therefore, many pharmacists may be unaware of the hazardous waste regulations and which medications fall under the scope of those regulations. ASCP recommends that a list of medications deemed hazardous that uses medical terminology, not chemical names be made available online. National and state professional pharmacist/pharmacy organizations should be specifically alerted to the availability of such a list so that they can disseminate the information to their pharmacist members. Not only will this be helpful in determining how certain unused medications should be handled and disposed of, but it will be essential if pharmacies are required to label applicable packages with the words Universal Waste Pharmaceuticals or Waste Pharmaceuticals as mentioned in the proposed rule. Long-term care facility staff will likely rely upon pharmacy staff to provide them with this information; therefore, even if the pharmacy is not disposing of the unused product themselves, they may be labeling dispensed medications proactively so that facility staff are aware of the classifications when it comes time for disposition. Waste Management ASCP believes that most pharmacists, particularly those servicing the long-term care industry, would welcome a clearly defined and more simplified approach to disposal of unused medications. In theory, having only one disposal method to contend with by treating all pharmaceutical waste as universal waste, as proposed, would be appealing. The reality is that contracting with biohazard companies or reverse distributors is a significant expense; thus the reason why flushing has become a predominant disposal method (nearly half of ASCP survey respondents stated that the majority of unused medications in their organizations

4 4 are flushed). It is ASCP s speculation that long-term care pharmacies and facilities will not treat all pharmaceutical waste as universal waste due to the expense associated with such disposal. Some medications not classified as hazardous may be dealt with in the same fashion as hazardous waste (e.g, controlled substances, drugs meeting OSHA s hazardous drug criteria), but this will vary from facility to facility. However, facilities and pharmacies will likely welcome the flexibility provided in the proposed rule to deal with hazardous as universal waste. Therefore, if choosing among the options provided in the proposed rule, ASCP believes that most long-term care facilities and pharmacies will choose to manage their hazardous pharmaceutical wastes and only certain categories of pharmaceutical wastes not currently regulated as hazardous waste as universal wastes. Containers and Sorting ASCP encourages the EPA to allow but not require sorting of pharmaceutical wastes for those entities that wish to use multiple disposal methods for various types of pharmaceutical wastes. Most unused medications in the long-term care setting are oral tablets and are dispensed and maintained in sealed unit-dose pods or blister cards until they are administered; they are not tablets that are dispensed loosely in prescription vials. They remain in these unit-dose systems until disposition. Therefore, placing the items into separate containers or storage bags is not necessary for most pharmaceutical wastes in the long-term care setting. Conclusion ASCP would like to thank EPA for addressing these disposal issues. If we can answer any questions about long-term care pharmacy services or provide clarification about any of our comments, please let us know. Sincerely, Carla Saxton McSpadden, RPh, CGP Assistant Director, Professional Affairs American Society of Consultant Pharmacists 1321 Duke St.

5 5 Alexandria, VA (703) ext