California Department of Resources Recycling and Recovery (CalRecycle) 

Pharmaceuticals Stakeholders (SB 966) Meeting, August 25, 2008

The California Department of Resources Recycling and Recovery (CalRecycle) conducted a pharmaceuticals stakeholders meeting to inform participants and to solicit suggestions on how to implement Senate Bill (SB) 966 and properly collect and dispose of pharmaceuticals.

The purpose of the meeting was to hear about some of the ways that local governments, businesses, and nonprofit organizations are working to ensure that pharmaceuticals are properly disposed of and how the State will assist in these efforts.

The following presentations and notes examine potential solutions to appropriately managing pharmaceuticals waste in California. The meeting notes summarize stakeholders’ concerns and suggested options for implementing successful pharmaceuticals waste collection and disposal programs.

Agenda

  • 9:00-9:15: Review Board's Implementation Plan
  • 9:15-10:30: Speakers
    • Kelvin Yamada/Steve Kubo
      CA Dept. of Public Health
      Disposal of Home-Generated Pharmaceuticals
    • Virginia Herold
      State Board of Pharmacy
    • Jen Jackson-East Bay Municipal Utilities District
      No Drugs Down The Drain Campaign and Local Efforts to Collect Pharmaceutical Waste
  • 10:30-10:45: Break
  • 10:45-11:45: Results of SB 966 Pharmaceutical Collection Survey
    • Best Management Practices--Reporting Standardization
    • Criteria for Model Programs and Which Programs Meet Criteria
    • How The CIWMB Will Utilize This Information
    • Report to the Legislature
  • 11:45-12:00: Wrap Up and Next Steps

Presentations

Meeting Notes

Jim Cropper, CIWMB

  1. Reviewed the SB 966 Implementation Plan
    • Goal is to develop model programs
    • Work with stakeholders
    • Identify programs that meet “statutory criteria.”
  2. Described the CIWMB website and the information contained in it, the listserv, the agenda item in November 2008, and invited people to provide information/input on:
    • Model programs due in December 2008
    • Report preparation is due late summer 2010

Questions on Implementation Plan

Q: When is the comment period for the agenda item?
A: You can comment after Jim Cropper sends it to you or it goes out on the listserv.

Q: Do you have plans to coordinate with the Drug Enforcement Agency?
A. If they do come out with their plan, we will try to incorporate their guidance.

Kelvin Yamada
Chief of the California Department of Public Health’s (CDPH) Medical Waste Management Program

  1. Described the differences in the laws that effect pharmaceutical waste.
  2. CDPH regulates medical waste generators and determines if it is hazardous waste or medical waste.
  3. United States Drug Enforcement Agency (DEA) regulates controlled substances.
  4. Mixed waste-as long as the medical waste is being regulated (i.e. hazardous, radiological wastes, they are fine. Medical waste generators don't have to be regulated as medical waste to be in compliance.
  5. Pharmaceutical consolidation issues:
    • Who regulates?
    • Abuse issue is real and is occurring.
    • Who regulates consolidation points? CDPH, Board of Pharmacy, CIWMB, Department of Toxic Substances Control, or all of them?

Virginia Herold, Executive Director of the California State Board of Pharmacy

  1. Dangers of prescription drug
    • 7 million Americans abuse prescription drugs,
    • 20,000 international prescription drug overdoses per year.
    • 15 percent of 12th graders said they've abused prescription drugs.
    • 10 percent of teenagers have abused Vicodin.
    • Easy to get from the internet, street, parents, medicine cabinets.
  2. Prescription drugs have a very high value and the Board of Pharmacy is concerned about any collection point.
  3. Three Classes of Pharmaceuticals
    • Over the Counter. Generally safe to buy and take by yourself (Federal Drug Enforcement Administration determines if it can be over the counter).
    • Prescription Drugs. Determined to be unsafe without a prescription from a medical practitioner.
    • Controlled Drugs. Have a medical use, but have a high street value and must be handled carefully. DEA narcotics officers are involved in licensing the practitioners and pharmacies.
  4. Controlled Substances
    • Schedule 1: LSD, medical marijuana
    • Schedule 2: Regulated with increased street value
    • Schedule 3: Vicadin, Codeine, other pain killers
    • Schedule 4: Tranquilizers
    • Schedule 5: Cough Syrups
  5. 10 percent of prescription drugs are controlled substances.
  6. Drug wholesalers are licensed by Board of Pharmacy and pharmacies generally buy drugs from wholesalers.
  7. Physicians, dentists, nurse practitioners (prescribers) are regulated by the Board of Pharmacy.
  8. Anything a pharmacy purchases must be catalogued and records kept for 3 years.
  9. Reverse distributors are licensed by Board of Pharmacy and DEA (if accepting controlled substances)
  10. Board of Pharmacy does not currently have a way of tracking what happens to a drug when a resident/patient brings them back to a collection point.
  11. Operationally, pharmacists are in short supply in the U.S. and are the most expensive staff at pharmacies. There are 6,500 pharmacies in California.

Q: What about hospice facilities returning expired/unwanted pharmaceuticals?
A: If you are a licensed hospice, you can send pharmaceuticals back through a reverse distributor.

Q: Board of Pharmacy developed a fact sheet that says to take back pharmaceutical waste to pharmacies. Doesn't this contradict what was just said that pharmacies can't take back pharmaceuticals.
A: We need to change the fact sheet.

Jen Jackson
East Bay Municipal Utilities District Community Affairs Representative
"No Drugs Down the Drain (NDDD) Campaign"

  1. 10 million pounds of pharmaceuticals generated every year (extrapolated from Australian Study)
  2. How can wastewater agencies help? By providing expertise, pollution prevention, and a public process for collection of pharmaceuticals
  3. NDDD got together with agencies, organizations, regulators to put together a consistent message on pharmaceutical disposal and to raise awareness
  4. Statewide Campaign Goals developed to raise awareness, provide a unified message, provide local disposal options
  5. NDDD provided tools for local jurisdictions and provided press materials
  6. NDDD helps with local agency implementation
  7. NDDD Events: DEA approved specifying that public is not to bring controlled substances to collection events. At collection events, staff does not touch pharmaceutical waste, but by a medical waste hauler
  8. Ongoing collection programs-HHW facilities, police stations, pharmacies (Teleosis), and medical offices

Q: Is there a current legal regulation (prohibition) against flushing pharmaceuticals into the sewer?
A: Sewerage agencies regulate this and try to work collaboratively.

Results from SB 966 Survey

  1. Reviewed the Pharmaceutical Collection Program survey results.
  2. Developed Best Management Practices from survey results. They include Ongoing Programs, One-Time Events, and Mail Back Programs.
  3. Best Management Practices comments are due by September 15, 2008.

Q: What do you mean by documenting amounts and types collected at a program?
A: Total amounts of pharmaceuticals collected.

Q: The portion on consequences should be removed. It doesn’t seem to be something that would be easily enforced.
A: We will take that comment into consideration.

Additional Comments to Best Management Practices for Unused/Expired Pharmaceuticals

  1. You need to clarify the overall purpose of the document. In other words, what will it be used for??
  2. You need to wait for a study from University of California, Berkeley on drug excretion before making any recommendations
  3. You need to include in the staffing section something on enhanced medical monitoring of staff that are collecting pharmaceuticals.
  4. BMP #11. There needs to be a mention of manufacturer funding
  5. The document says not to accept sharps? Collection facilities should let people know that they will accept them, because you’ll get them anyway
  6. Delete the reference to electricity, because it is not necessary
  7. Segregation of controlled substances is overkill and difficult to perform
  8. It would be difficult to count all of the pharmaceuticals collected and this should only be done on a sampling basis. Counting all pharmaceuticals collected is not for all programs
  9. You should tell l people what permits are needed. Don’t just say contact the local enforcement agencies.
  10. Make sure proper handling procedures are in a place
  11. You need Department of Toxic Substances Control’s opinion on “surveying of pharmaceuticals in diesel and acid?"
  12. It may be best to assume that all unlabeled pills/pharmaceuticals are controlled, and so maybe you should use a “don’t ask policy”
  13. You need to check the legality of HHW door-to-door collection programs
Last updated: November 14, 2008
Sharps Waste Disposal Program http://www.calrecycle.ca.gov/HomeHazWaste/Sharps/
Medication Waste Disposal http://www.calrecycle.ca.gov/HomeHazWaste/Medications/
Contact: PharmaSharps@calrecycle.ca.gov