LDEQ Finalizes Several Rules in June
EPA recently published a draft guidance document entitled Best Management Practices for Unused Pharmaceuticals at Health Care Facilities, No. EPA-821-R-10-006, August 26, 2010. EPA requested comments from the health care industry regarding the proposed practices. 75 Fed. Reg. 54627 (Sept. 8, 2010). This is an opportunity for hospitals, medical clinics, doctor’s offices, and long-term care facilities to provide input to EPA on practices that may, at some point in the future, be made into regulatory requirements.
Unused pharmaceuticals include dispensed prescriptions that patients do not use as well as materials that are beyond their expiration dates. EPA identified several typical reasons why pharmaceuticals become wasted. These include expiration before use (because of excessive purchases or samples left with doctors expire before use), dispensed pharmaceuticals go unused (a dosage is changed, the patient refuses to take dispensed mediations, the patient dies or is transferred prior to taking all medications, the patient has an adverse reaction and the use of the dispensed medication is halted), or an error occurs in dispensing the medication.
According to EPA, a standard practice at many facilities was to flush unused pharmaceuticals into the sewer system. These unused pharmaceuticals made their way into the nation’s waterways and discernable concentrations of these materials have been detected. As a result, EPA engaged in an extensive data collection and outreach effort, consulting with over 700 stakeholders, visiting health care facilities, and reviewing disposal data from hospitals and long-term care facilities. The result of this effort is a collection of best management practices designed to reduce the amount of unused pharmaceuticals entering our waterways.
In general, EPA identified several major steps (discussed in more detail below) that can be taken to identify and properly manage unused pharmaceuticals:
*Conduct an inventory of pharmaceuticals and unused pharmaceuticals to quantify the amount of medication being disposed.
*Reduce unused pharmaceuticals by reviewing purchasing practices, using limited dose or unit dose dispensing, replacing pharmaceutical samples with vouchers, and performing ongoing inventory control and stock rotation.
*Properly manage unused pharmaceuticals by identifying types of pharmaceuticals and any federal and state requirements; when possible: reusing or donating unused pharmaceuticals, returning them to the pharmacy; sending them to a reverse distributor for credit and proper disposal; and using EPA recommended practices to dispose of pharmaceutical waste at the facility.
*Segregate waste for disposal to ensure regulations are met and to reduce costs (e.g., nonhazardous pharmaceutical waste disposal in a solid waste landfill may be less expensive than disposal via hazardous waste hauler).
The first step should be obtaining an overall understanding of unused pharmaceutical generation. A list of pharmaceuticals used at the facility should be developed. The on-site pharmacy, suppliers, and purchasing records can be consulted to create a list reflecting the universe of pharmaceutical on-site.
The next step is to identify how each pharmaceutical becomes ‘unused’ and how that specific unused pharmaceutical is currently managed. At each possible waste generation station (for example, the pharmacy or nurse station), the reason for waste generation and the disposition of the waste should be tracked and recorded.
Once an inventory is taken, the facility should take steps to reduce the creation of unused pharmaceuticals. EPA suggests several ‘best management practices’ that a facility should take to reduce or avoid the generation of unused pharmaceuticals. These include:
1. The facility should review purchasing practices to determine ways to reduce waste. The facility should identify any pharmaceuticals that commonly expire before use and buy less of those medications to reduce waste. The facility should also identify pharmaceuticals used by multiple departments within a facility and purchase a standard package size, doses, or form.
2. The facility should limit the amount of medication dispensed at one time to a patient (called unit dose dispensing).
3. Smaller portions of bottled liquid pharmaceuticals should be purchased. For example, instead of purchasing a 50 mL bottle that expires 30 days after opening, a 15 mL bottle should be purchased.
4. Dispense ‘trial prescriptions’ (i.e., a 7 day supply instead of a 30 day supply) so that any adverse effects may be observed. If any are found, there is less that goes unused.
5. Replace pharmaceutical samples with vouchers. Sales representative provide samples of medication, many of which expire prior to being dispensed or provided to the patient. Instead, a redeemable voucher should be provided to the patient that may be taken to a pharmacy for a free sample.
6. Rotate ‘short-dated’ pharmaceuticals to areas of the facility where they are needed and most used.
7. Periodically review the initial inventory so that the list may be updated and identify pharmaceuticals nearing expiration. This will also allow the facility to determine if its waste reduction practices are working.
However, despite the best efforts of any facility and even with the implementation of the best management practices, unused pharmaceuticals will be generated. Once generated, they must be properly managed and EPA provided additional practices to assist facilities in this regard.
8. For those unused pharmaceuticals that can be reused (which EPA calls nonwaste medications), a facility may reuse unopened pharmaceuticals, where possible, either through the pharmacy or through state donation programs, or send creditable pharmaceuticals to reverse distributors. Reverse distributors are companies that provide a service to the health care industry by keeping track of manufacturer reimbursement policies so that facilities obtain credit for returned pharmaceuticals.
9. For those unused pharmaceuticals that cannot be reused, proper waste management is required. In order to determine the proper method of disposal, the medication must be classified, which will determine the proper waste management option.
9a. Some unused pharmaceuticals may actually be classified as a hazardous wastes and must be handled accordingly. The determination is complicated and is too detailed to address herein. However, should it be so classified, it must be handled under the hazardous waste rules which require “cradle to grave” management and disposal in permitted facilities. EPA emphatically stated that unused pharmaceuticals classified as a hazardous waste from small and large quantity generators cannot be disposed of with biohazardous (red bag) waste.
9b. EPA noted that it has proposed (but has not yet finalized) that unused pharmaceuticals classified as a hazardous waste may be handled under the so-called ‘universal waste’ rules, which provides a less stringent handling regime. EPA is reviewing comments on the proposed rule and expects to finalize the rule in 2011.
9c. Most unused pharmaceuticals are not classified as hazardous waste. EPA recommended that such materials be sent to a reverse distributor. If that is not possible, the material should never be ‘sewered’ (i.e., flushed down the toilet) or commingled with red bag waste. Instead, it should be sent to a solid waste landfill or incinerator. EPA stated that the facility should take the material out of the original containers, mix the medication with an absorbent material, and place it in a sealable bag to prevent leakage.
10. EPA noted that facilities generate trace chemotherapy waste (yellow bag waste), hazardous chemotherapy waste (also known as bulk chemotherapy waste) and nonhazardous chemotherapy waste. Yellow bag waste should be picked up by a specialty waste hauler and incinerated. Facilities generating other unused chemotherapy waste should treat all such waste as a hazardous waste.
11. Controlled substances are highly regulated under the Controlled Substances Act (CSA). All disposal practices must be in conformance with that act. EPA identified two current methods of disposal – disposal down the drain and crushing and mixing with an absorbent material. EPA obviously does not recommend disposal down the drain nor does it recommend, for personnel safety reasons, that the materials be crushed. For unused controlled substances, EPA recommended the use of a reverse distributor or return to the pharmacy (if such practices are allowed under the CSA). If the material cannot be returned and is classified as a hazardous waste, it should be handled in conformance with the hazardous waste rules (i.e., disposal in a hazardous waste facility). If the material cannot be returned and is classified as a non-hazardous waste, it should be disposed of as a solid waste after being taken out of the original containers, mixed with an absorbent material, and placed it in a sealable bag to prevent leakage.
12. EPA also recommended that all facility personnel be trained in the proper procedures to minimize the creation of unused pharmaceuticals and the proper methods for handling any such materials that are generated.
Many facilities may already meet and/or exceed the recommended best management practices. Others, however, may not. The comment period provides an opportunity to contribute to the final wording of the best management practices. These practices are not yet in regulatory form. Once the draft is finalized, though, EPA may, at some point in the future, impose the recommended best management practices as a regulatory requirement.
A copy of the Guidance Document may be found at http://water.epa.gov/scitech/wastetech/guide/upload/unuseddraft.pdf. Comments must be submitted by November 8, 2010. EPA asked that all comments be submitted by e-mail to firstname.lastname@example.org.
John B. King's principal areas of practice include environmental and oil and gas regulatory permitting and defense, compliance assistance, toxic tort defense, and litigation.