Editor’s Note: The following report details recent moves by Alameda County, Calif., to institute an extended producer responsibility-based drug take-back program to ensure the proper handling of pharmaceutical waste without placing an undue financial burden on traditional waste handlers.
“What should I do with my unused medications?”
People ask this question every day and are rarely satisfied with the answer: “Don’t flush them. Put them in the trash with kitty litter.”
Elected officials are at a loss. Their stopgap disposal solution is disappointing to the public and highlights the fact that they do not have the resources for a different approach. So, what should local governments do? What can they afford to do? What should the water districts, pharmacies, hospitals, waste handlers and law enforcement do?
These are questions that are being asked all over California. Since the pharmaceutical industry and federal and state governments have failed to provide adequate disposal solutions, California municipalities have been forced to take matters into their own hands.
Although the Drug Enforcement Agency’s (DEA) twice-yearly collection events are appreciated, they aren’t the solution. The events aren’t fully funded and still leave local governments with a sizable tab. Most importantly, they aren’t convenient to the public.
Frustration around this issue in California came to a head in the city and county of San Francisco in 2010. The city had operated a series of one-day collection events but there was not enough funding to continue, let alone to expand the program to permanent collection sites. Temporary solutions involved providing the public with mail-back envelopes and tasking city staff with running occasional weekend take-back events. Again, these did not prove to be the solution.
This led San Francisco County Supervisor Ross Mirkarimi’s office to develop the country’s first local ordinance mandating that producers of pharmaceuticals design, fund and operate the collection program. However, the Safe Drug Disposal Ordinance was put on hold while the city worked with Pharmaceutical Research and Manufacturers of America (PhRMA), a group representing all pharmaceutical companies, on a voluntary pilot take-back project. The pilot has been funded at $110,000 and is the first drug collection program voluntarily funded by pharmaceutical companies. The pilot was structured as follows:
- The pilot will follow an 18-month time frame
- There will be 20 or more collection sites, facilitating acceptance of non-controlled substances at a number of participating pharmacy locations, and acceptance of both controlled and non-controlled substances at several designated police stations. (An up-to-date list of collection points can be found at http://sfenvironment.org.)
- The pilot will strictly follow the CA Model Guidelines (Model Guidelines -- see “criteria and procedures”), which includes two-key collection bins, use of a licensed medical waste hauler, etc.
- The pilot includes $35,000 budgeted for public outreach.
While implementing this program, the city found that many large (chain) pharmacies and retailers of drugs were not eager to serve as voluntary collection locations. In response, on May 24, 2011, San Francisco passed the Safe Drug Disposal Information Ordinance. This ordinance was meant to supplement the pilot program and requires all local pharmacies to conduct outreach on safe medicine disposal options for the public. Practically speaking, pharmacies that refuse to participate in the take-back program must direct customers to stores that have agreed to serve as collection points, even if they are direct competitors. Thus, the city chose to use competition to drive additional collection locations by forcing retailers who refused to collect the medications to advertise those who did.
After less than six months of the pilot’s operation, San Francisco residents have safely disposed of more than 6,000 pounds (3 tons) of medicine. While San Francisco was rolling out their pilot pharmaceutical collection program, across the Bay Bridge, Alameda County was also receiving a lot of public pressure to have a convenient medication collection program.
Cut to Alameda County
Alameda County has been operating a household hazardous waste (HHW) program since 1993 and has four HHW facilities that all accept medications. These facilities service 42,000 individuals per year. “It will take 22 years at the current rate for the equivalent of all households to make one trip to a HHW facility,” says Alameda HHW Program Manager Bill Pollock.
Additionally, Alameda County was faced with other factors necessitating medication collection:
- In 2006 Alameda County Behavior Health Care Services identified substance abuse by older adults as a prevention priority in its strategic plan.
- In Alameda County nonfatal hospitalized injuries from unintentional poisonings for adults 60 and older increased 43 percent between 1998 and 2006.
- The Alcohol and Other Drug (AOD) Prevention Work Group determined there needed to be a countywide initiative to conveniently collect unused medications.
- The district attorney was seeing an increase in crime related to break-ins of older adult homes to steal pain medication.
- Young people were accessing drugs in homes and having “skittle parties.”
- Water districts are unable to “treat out” pharmaceuticals from wastewater.
Over the years, the many concerned community groups and the county worked together and tried several ways to make medication disposal more convenient through:
- A mail-back program for non-controlled medications.
- Disposal bins for non-controlled medications at pharmacies and water districts.
- One-day take-back events for all medications.
Because the DEA requires law enforcement to be on-site to collect controlled substances, there were very few locations or events that could accept the most important 10 percent of drugs. Controlled drugs include opiates, other painkillers and drugs sold on the street that drive crime and drug abuse.
The efforts of the Safe Medication Disposal Coalition resulted in 14 one-day events held between 2009 and 2011, but the conclusion was still that they needed permanent sites. The County then established 27 permanent sites, hosted by volunteers, and costing the county a whopping $300,000 per year. The county soon found that 27 sites were not enough to provide convenience to everyone in the county and achieving their goal of 60 sites would be too costly.
The public had made themselves heard; a permanent solution was needed to protect the community. The public articulated its demands in three short videos collectively titled “Taking Back Lives with Drug Take-Back.” After reviewing their options, they came to the same conclusion as San Francisco and decided to pursue a program designed, operated and fully funded by the producers of pharmaceuticals.
The Producer Responsibility Solution
Extended Producer Responsibility (EPR) is a policy approach to managing many types of problematic waste products, such as pharmaceuticals. The approach transfers the cost of product waste management to the producers, who ultimately pass those costs on to consumers. This way, the costs are no longer born by the general public through increased taxes or garbage rates. The approach is used widely around the world as a way to stop socializing the costs of expensive waste products. It also allows consumers to see the full cost of the products they buy and choose if that is the right purchase for them.
When Alameda County Board President Nate Miley introduced the Safe Medication Disposal Ordinance, the board of supervisors was approached by several industry groups and asked to slow down the process. The county agreed and held a series of six public stakeholder meetings, brought in speakers to educate stakeholders, and ultimately refined and improved the ordinance.
Speaker Ginette Vanasse, executive director of the Post-Consumer Pharmaceutical Stewardship Association (PCPSA) in Canada, shared her 10 years of experience operating the collection system on behalf of the pharmaceutical companies. Some key points from her presentation:
- The program was founded in 1999.
- The board of PCPSA is composed of all industry members.
- The program collects all drugs; prescribed and over-the-counter.
- Collection is handled through voluntary participation by 96 percent of pharmacies.
- Cost is nominal and has not increased cost of pharmaceuticals.
After providing months of opportunity for input, presentations and suggestions by all parties, the county of Alameda determined they would proceed with the refined ordinance. Final adoption came on July 24, 2012 with a 5-0 vote.
The key requirements of producers subject to the ordinance are as follows:
- Companies can join together to design, fund and operate the drug collection system.
- Must draft written stewardship plan and submit it to county for approval.
- Must develop and implement program.
- Submit annual reports on the program’s progress and results to the county.
- Pay the county an administrative fee for oversight costs.
The County Environmental Health Department is now writing the regulations to implement the ordinance. The county also is going to hold a series of meetings in the spring of 2013 to educate stakeholders on roles and responsibilities under the ordinance and rally support for program implementation.
What Will Pharmaceutical Companies Do?
To date, Alameda County has received no formal response from the pharmaceutical companies, so any prediction as to their next move would be pure speculation. Supervisor Scott Haggerty stated at the July 10th hearing, “I would strongly suggest that instead of us all hiring a bunch of attorneys in these next 30 days, we should figure out how to make that very simple program work, and become a model for the other 57 counties in the state of California. I would much rather spend our money trying to figure out how to make it happen than fight about how we don’t want it to happen.”
Heidi Sanborn is the executive director of the California Product Stewardship Council (CPSC) based in Sacramento, Calif. She speaks domestically and internationally on producer responsibility.