Medical Industry
Waste Prevention Round Table

PHARMACEUTICAL WASTE:
Regulatory Tangles & Environmental Uncertainties

Wednesday, May 15, 2002
8:00 AM - 12:30 PM
Center for Urban Horticulture,

1) Introduction: Dave Waddell

2) Management Options:
a) What materials are we talking about?
Cheri Grasso, King County Local Hazardous Waste Management Program
Click here for the PowerPoint presentation

• Unusable drugs sent to a Reverse Distributor are not a waste until the RD declares them a waste.
• There are many ways for a drug to become unusable: expired, dispensed but not administered, spilled, unlabeled, contaminated, recalled, adulterated, incorrectly compounded.
• If the drug designates as an EHW, then the container should be declared waste as well as the contents.
• Controlled Substances are regulated from the point of manufacture to administration or destruction.
• Each CS schedule (I, II, III, IV, or V) has separate reporting requirements

Q: What about special chemo research drugs where not a lot of information is available?
A: Answer in later session.

b) How have these materials been managed historically in Washington?
Richard Morrison, Washington Board of Pharmacy
Click here for the PowerPoint presentation

• Reverse Distributors are licensed by the state Board of Pharmacy.
• State legislature authorizes who may prescribe drugs.
• Board of Pharmacy also oversees drug distribution.
• FDA determines what a drug is. Many Spanish-labeled drugs imported from Mexico are illegal drugs (by FDA and Washington State Board of Pharmacy)
• DEA issues registration certificates- inspect manufacturing and research sites on a routine basis
• DEA usually only visits a pharmacy if there has been a complaint
• Authority of health care providers are expanding greatly
• At one time in the past the pharmacy board used to accept drugs from prescribers and then paid to dispose of it properly. They now do some drug seizures and must dispose of contraband drugs.
• Prescribers have been encouraged to make use of reverse distributors
• By Washington State law, drug disposal records must be kept for 2 years.

Q: What is the availability of legend drugs via the internet?
A: We don't have a handle on this yet. The federal agencies are taking the lead on this. Most of these sellers are outside of WA. Have investigated some rogue site individuals. Some have been legal healthcare providers that thought internet selling was legal.

Q: Any difficulty with mail order drugs lost?
A: They don't get any feedback regarding losses via the mail. Loss of drugs in mail systems doesn't seem to be that big of an issue but would be interesting to hear what postal service does with unshippable and non-returnable drugs.

Q: There are accountability rules made by board of pharmacy. Where can we get more info on this?
A: All legend drugs and controlled drugs must be kept on record for two years see RCW 69.41~.030 for more details.

Q: What was that about reverse distributors?
A: We license the reverse distributors which are based in this state. Also register out of state reverse distributors but rely on that state's pharmacy board for assurances.

c) National Perspective: Managing expired, unused and waste pharmaceuticals?
Charlotte Smith, PharmEcology
Click here for the PowerPoint presentation

• P listed chemicals - with these chemicals (EHW) you must also count the weight of the container it's in (syringes etc.)
• Lindane, a U-listed drug, has been banned as a pesticide in California and Canada. There are many new chemo drugs on the market that are not U-listed and should be.
• Selenium sulfide is in shampoos
• Wart remover base is highly flammable and classifies under the ignitability standards: D001
• Designating finished dosage forms is complicated because they are nearly always mixtures and the toxicity characteristic and ignitability characteristic must be applied. . Washington Dangerous Waste (DW) and Federal HW regulations were developed for pure chemicals.
• Substituting less hazardous chemicals is usually not possible; in most cases, this would eliminate the drug's efficacy.
• RCRA fines for mismanagement can total $27,500 per violation per day. One drug product qualifies as one violation.
• The EPA has made clear that RDs are not to be used for drug disposal. Items that are obviously not useable may not be returned to an RD.
• There were (2 years ago) 38 RDs nationally. The industry has developed rapidly.
• If a pharmacy uses a third party to sort returnable expired products and prepare them for shipping to the manufacturer, the pharmacy has the responsibility to designate waste.
• Manufacturers have developed more than 3000 different drug return policies that are tracked by RDs. Millions of dollars annually are credited for drug returns through RDs.
• Biohazard waste disposal vendors often provide yellow chemo sharps containers and bags to prescribers, who don't realize that these bags are for empties only.
• Pharmacies should perform an inventory every 2 years, then contract a DW vendor to come in, pack, and remove DW.
• PharmEcology expects to have its drug designating Wizard online by Fall of 2002. Will cross-reference by NDC number and give a waste classification.

Q: What % of hospitals are using reverse distributors for pharmaceutical waste disposal and what are those not using a reverse distributor doing?
A: Almost 100% are using some type of reverse distribution system. A concern with not using a reverse distributor is that if someone is just coming into the hospital and sorting the drugs the hospital is then responsible for waste designation.

Q: What is the state of the regulations regarding formulations in which the hazardous constituent is not the sole active ingredient?
A: It technically won't be a listed discarded chemical product. For example: a freezing anesthetic has two listed ingredients and since there are two key ingredients it is not regulated. It should be checked for characteristics (corrosivity, ignitability, reactivity, or TCLP) and State criteria (persistence or toxicity).

Q: Once the material reaches a reverse distributor and the 70-80% that can be reused is diverted where does the rest go? (Post meeting note by Charlotte: The manufacturer makes the decision whether to reuse, recycle or dispose of the returned drugs. In the case of a few items, the active ingredient may be valuable enough to retrieve and reformulate. My understanding is the majority are discarded by the manufacturer. I do not know the level of expertise at each manufacturer in terms of the methods of disposal.)
A: I don't know. In most cases the manufacturers probably dispose of the drugs, as it is not cost effective to reprocess these.

Q: How soon will the Wizard be available?
A: Sep/Oct 2002

Q: What health care providers can access the services of the reverse distributor?
A: Right now it would be primarily a pharmacy - it has to be any organization that has an account with a wholesaler as this is the way for the credit to come back.

Q: A basic tenet of hazardous waste management is that the generator is always the generator. How is it that a generator can shed liability by going through a secondary processor?
A: It's not considered a waste until it gets reverse distributed and they determine that it can (or can not) go back to manufacturer. Hospitals are still liable for picking a reliable reverse distributor who will handle their materials properly.

d) Washington Perspective: Pharmaceuticals as State-Only Dangerous Waste
Cheri Grasso, King County Local Hazardous Waste Management Program
Click here for the PowerPoint presentation

• Toxicity bioassays cost ~$400-$500 per test
• Coal Tar (in shampoo) contains polycyclic aromatic hydrocarbons
• Was very interesting that the presentation this morning by Richard did not list EPA or WA DOE as drug regulators
• Most pharmacists are well-aware of DEA's role in drug waste management. Few are aware of EPA and Ecology's roles.

Q: With regard to Washington State-only toxic waste, table salt would be considered as a hazardous waste when in a concentration over 10%
A: Additional things need to be considered when looking at this listing - households are exempted and, for businesses, dilution is allowed as a treatment solution. You could dilute with permission from the sewer authority at below 10% concentration. Baking soda is the same. This process must be counted toward your generator status.

Q: How soon do you expect answers from Ecology?
A: In about 30 minutes

Q: As a pharmacist I would not think of DOE as a regulating authority as they have no presence in the labs and pharmacies. I've been here for 2.5 hours and I'm still not clear on where stuff should go. There isn't a pharmacist in this room that will sit and calculate these amounts.
A: You can collect this information and designate things appropriately or you can send everything to a reverse distributor or designate it all as hazardous waste
Retort: We came to hear guidelines not regulations
A: We're part way through this process and that's what we'll talk about that later, after the break.

3) How Have We Responded to this Issue?
Debra Oliver, Interagency Regulatory Analysis Committee

Debra walked us through the process IRAC's Pharmaceuticals Workgroup went through to arrive at the proposed exemption, describing the participant's roles and the interactions.

Debra also introduced the waste incineration guide (pdf) and the IRAC proposal (Q&A) document (pdf).

4) The IRAC Pharmaceuticals Proposal
Alice Chapman, Local Hazardous Waste Management Program in King County
See the IRAC Proposal (Q&A) Document (pdf) for details.

• Alice reviewed highlights of the IRAC proposal. The proposal is the letter from IRAC to Ms. Hervieux at Washington State Department of Ecology, subject "Response to Preproposal Statement of Inquiry" which is included in the handouts.
• Department of Ecology issued an Emergency Rule in January 2002 to conditionally exclude controlled substances that are state-only dangerous wastes and held by law enforcement agencies. If these wastes are disposed through incineration at a controlled combustion unit permitted to handle solid waste, then they are excluded from other requirements of the dangerous waste regulations.
• The emergency rule is temporary, and will go through a rule-making process before becoming a final rule. The IRAC proposal was submitted to Ecology in mid-March, in response to Ecology initiating the rule-making process.
• Contact Ecology with your comments about the proposal or the rule-making process. This is a unique opportunity to work with Ecology and help shape future regulations concerning drug waste management.
• Radioactive materials, mercury, sharps, biohazardous wastes, and gas cylinders are not included in the proposal.
• The IRAC proposal would conditionally exclude all drug wastes which are dangerous waste under Washington State regulations only. (Drug wastes which are hazardous under Federal regulations cannot be excluded by Ecology because Ecology can only change Washington State regulations.) All generators, except households, are addressed in the proposal. Households are already excluded.
• Compared to the emergency rule, the IRAC proposal expands the scope of waste (beyond Controlled Substances) and the scope of applicable generators (beyond police organizations).
• Whether or not the proposal becomes a rule, several legal options for managing drugs are already in the regulations and are separate from the IRAC proposal. These are: reverse distributors for viable products, fully regulated dangerous waste (some generators have chosen this option rather than to try and separate the different types of drugs), small quantity generators have simplified requirements, some drugs may go to the sewer when approved in writing by the local sewer authority, some drugs may be treated on-site by the generator, and some drugs may fall into the category of "special waste" and go to a solid waste landfill.
• The handout "Disposal Services for Pharmaceutical Waste Available to King County Generators" was prepared by the IRAC workgroup and lists vendors that currently provide disposal services for drugs.

Q: We were told we are going to receive an answer from Ecology. Are you that answer?
A: No, I am not with Ecology. I was a member of the team that wrote the proposal.

Q: Do you anticipate Spokane to be the only alternative? How would someone in Tacoma get waste to Spokane?
A: Currently, the waste-to-energy plant in Spokane is the only Washington facility that meets the criteria in the exclusion. It would go to Spokane via waste haulers.
Damon Taam (Spokane): We work with waste distributors and other contractors that clean up sites. We charge them accordingly, they would charge you. We charge $165 per ton.

Q: Is the Spokane facility run by the state or is it private?
A: It is run by the City of Spokane and run by a regional waste system. Garbage is handled for the Spokane region. The site is operated by Wheelabrator Inc. (a company).
A: Tiffany Yelton (Ecology): the rule notes that waste could be sent to future incinerators.

Q: I am assuming that prefilled syringes would not be accepted.
A: Damon Taam (Spokane): True; our grate system has holes and small pieces could fall through and workers would be exposed. Therefore, sharps are not accepted at the facility.
A: Alice Chapman: Unused sharps could be sent via some hazardous waste haulers.

Q: Could this waste be shipped out of state to another incinerator?
A: Alice Chapman: Yes, if the incinerator is permitted to incinerate solid waste;
A: Tiffany Yelton confirmed.

Q: Is there a regulation on how they would fill out their paperwork?
A: Alice: It would be under the solid waste system.

Q: Would the responsibility be on the entity doing the shipping?
A: Alice: The waste would need to end up in an incinerator that is permitted to burn the waste; it couldn't go out of state to a landfill; the generator is responsible for knowing where the material ends up; you may have to educate the service providers.

Q: That's a huge problem; it puts a burden on the generator and adds a level of complexity; you have to interview all these haulers; this should be regulated at a higher level.
A: Alice: It is, but the responsibility is still with the generator.

5) Ecology's Response to the IRAC Proposal
Tiffany Yelton, Department of Ecology
Overheads not available

• Tiffany discussed the proposed rule

• Ecology's original emergency rule included only controlled substances held by law enforcement agencies. IRAC's proposal included legend and OTC drugs as well as controlled substances and all generators. The rule introduced at the MIRT seminar was Ecology's compromise - it expanded the generators from law enforcement agencies to all DEA-licensees and registrants, but did not expand the waste stream.

Proposed Rule:
Controlled substances that are state-only dangerous wastes. Controlled substances as defined and regulated by 21CFR Parts 1300-1399 and chapter 69.50 RCW (Schedule I through V drugs) that are held in the custody of law enforcement agencies or possessed by any registrant or licensee as defined and regulated by 21 CFR Parts 1300-1399 and chapter 69.50 RCW and authorized to possess drugs within the state of Washington, and managed for destruction: Provided, That they are disposed of by incineration in a controlled combustion unit with a heat input rate greater than 250 million British thermal units/hour and a combustion zone temperature greater than 1500 degrees Fahrenheit or disposed by other methods approved by Ecology.

The full pdf document containing the proposed rule can be found on-line at http://www.ecy.wa.gov/laws-rules/wac173303/x0210a.pdf.

• The IRAC proposal was not accepted in its entirety. The scope of acceptable generators was expanded (to those licensed or registered by the DEA or State Board of Pharmacy) but the list of pharmaceutical wastes that are exempt from State-only DW regulations was not expanded beyond Controlled Substances.
• There is no hard data on what happens to controlled substances when incinerated.
• There is little data on the annual volume of pharmaceutical wastes generated in Washington.
• Ecology recognizes that more work needs to be done on this topic.
• Universal waste rule is still under consideration (especially in the context of working with other states). To keep other options open, they didn't conditionally exclude everything at this time.

Q: Does this mean the emergency rule door is closed?
A: Tiffany: It expires this month. We received one proposal to change language. Couldn't accept it in entirety, so developed this language at this time. Rule making is still an option.

Q: Is this the final language?
A: Tiffany: This is the language for the public hearing for acceptance or rejection, but not amending.

Q: If its rejected will there be another rule?
A: Tiffany: Don't know

Q: What happens between now and June, is this the interim guidance?
A: Tiffany: The emergency rule is in effect at this time. Don't know when the trade off happens.

Q: If Spokane closes doors after 5/25, everyone will know. Damon says this won't happen.
A: Tiffany: Thinks the emergency rule will continue until other rule goes into effect.

Q: Regarding the article in Spokane Review. Did DOE decline to accept the proposal because they want to regulate the pharmaceuticals in WA, or because they can't figure out how?
A: Tiffany: The statement in the article was unfortunate. DOE as a whole doesn't back this up. There is nothing from DOE that shows intention to regulate or not. They are asking, "is the current rule capturing what is best to capture". Is this the best mechanism? No, but neither is complete unconditional exclusion, the tough questions of land, air, water protection can't be answered.

Q: Did you get any input other than IRAC?
A: Tiffany: No.

Q: . With the IRAC proposal, drug wastes would not be unregulated. The existing rules have been in place for 20 years, and it appears that little drug waste is managed in accordance with those rules (instead it goes to the sewer, the red bags or the garbage). The IRAC proposal would improve drug waste disposal by getting it out of those systems and destroyed through incineration instead.
A: Tiffany: Yes, its an improvement. But we can't assess the risk. Anything that's a drug would be conditionally exempt under the IRAC proposal. And we don't know what those would be. The state-regulated drugs are still a huge grouping, and we didn't have sufficient information on risk. We are still working on this issue.

6) Perpetual Ubiquitous Bioactive Substances (PUBS) in the Environment
Sandy Rock, Interpretive Consultations, Inc.
Click here for the PowerPoint presentation

No questions recorded.

• There is a very strong correlation between what we eat and our urinary metabolites.
• People are today exposed to a cocktail of manmade chemicals.
• The Orca whale that was recently autopsied in Puget Sound was found to have tissue PCB levels four times higher than ever previously measured: 1,000 ppm.
• Cows, and especially cow's milk, are very efficient accumulators of Persistent Bioaccumulative Toxins (PBTs) and Persistent Organic Pollutants (POPs)
• Freshwater fish are the largest dietary source of dioxins, furans, and PCBs
• Bacteria can transfer antibiotic resistance among themselves through plasmids, viruses, and free DNA transfers.
• The trend to greater antibiotic resistance among pathogenic bacterial populations can be changed if the practice of administering antibiotics changes.
  

Seminar Concluded

UPCOMING SEMINARS:

• Mercury Update - October 2002
• Cleaning Chemicals - December 2002

For more information on the seminars or MIRT in general, please visit the web site at www.nwmedicalwaste.org or contact Dave Waddell at (206) 263-3069 or dave.waddell@metrokc.gov.