Maine Unused Drug Disposal Project

Stevan Gressitt, Len Kaye,Jennifer Crittenden, and Lorna Bullard

Photo Courtesy of PSF-CI, France Site is Banda Aceh, status of post-tsunami donations.

I. Context

Prescription drug abuse has been increasingly recognized as a significant problemboth in Maine and nationally. Public and press attention to the issue of diverted pharmaceuticals can be somewhat quantified as shown in the two graphs below. Note thesearch phrase in the Google search box which is copied (retrieved 11/2/08):

It is of interest as well to compare the number of “hits” on each search.

Data from the 2008 National Drug Threat Survey performed by the NationalDrugIntelligenceCenter shows 40% of Mainelaw enforcement agencies perceive prescription drug misuse as the most serious drug threat. Thisrate places Mainefirst in the country. For yet another year Mainealso retains its first place standing in the percentage of agencies that believe pharmaceuticals contribute most to violent crime and its 2ndplace standing in the country with respect to property crime.

NationalDrugIntelligenceCenter
National Drug Threat Survey - 2008
NDTS 2008-Question 1a -- GREATEST DRUG THREAT[1]
STATE / Percent Reporting as GREATEST DRUG THREAT by State--Sorted by Diverted Pharmaceuticals Response
Cocaine / Crack / Heroin / Powder Meth / Ice Meth / Mari-
juana / MDMA / ODDs / Diverted Pharms / No
Response / TOTAL
ME / 12.8 / 20.3 / 9.1 / 1.2 / 0.0 / 16.4 / 0.0 / 0.0 / 40.2 / 0.0 / 100.0
New England Region / 17.4 / 22.2 / 30.0 / 0.2 / 0.0 / 15.2 / 0.0 / 0.3 / 14.5 / 0.2 / 100.0
United
States / 8.7 / 32.2 / 9.8 / 10.3 / 19.1 / 11.3 / 0.2 / 0.2 / 8.1 / 0.1 / 100.0

One source of drugs diverted to drug abusers are unused precription medications. Such medications may be taken from medicine chests by family members to whom they were not prescribed, stolen from the home, or taken from household trash. Given the volume of prescription use in the United States, this is a major issue. The pharmaceutical manufacturers’ association, PhARMA,estimates the number of prescriptions at roughly 3.8 billion a year in the United States, with a weight of 40 million pounds. Packaging increases the weight to 143 million pounds. Based on a conservative 3% rate of “wastage” (i.e., medications unused due to patient failure to follow prescriptions as directed), anticipated waste would equal 4.3 million pounds.[2] The literature suggests that patients do not take 25-50% of prescribed medication at 30, 60, or 180 day time periods.[3][4][5] Therefore, the volume of unused prescription medication in the United States is likely to be far in excess of 4.3 million pounds annually.

Software, hardware, and paper-based products have all been developed to help address this nonadherence with medications, with spotty results.[6]The National Council on Patient Information and Education released a report on the lack of action on the issue since 2000. For example only 3 million dollars was allocated for use by the NIH Adherence Research Network that yearout of the $18 billion NIH budget, and none has been allocated since then.[7]

Though DEA at one time accepted controlled drugs for destruction, current DEA regulations preclude transfer of controlled drugs between non-registrants or from non-registrants to registrants.[8] Various individual state and multiple federal regulations also restrict the transportation, storage, and destruction of pharmaceuticals.[9]

Proposals to resolve the issue have frequently sought guidance from procedures developed in projects such as those underway in British Columbia, France, andAustralia.[10]Those procedures, however, are pharmacy-based, and are impractical for U.S. use in view of our regulatory environment. Moreover,beyond regulatory issues, the diversion of returned drugs at pharmacies is asignificant issue in the United States. For example, a survey of DEA Form 106 mandatory reports on controlled drug loss or theft across the United States in 2005 noted 89.3% of all controlled drug loss in the distribution system was at pharmacies. This report is unfortunately not sufficiently noted.[11]

Disposal of unused medication is also a significant environmental problem. A chart from the US EPA summarizes pathways of pharmaceuticals and personal care products entering the environment[12]:

II. History of Maine Legislation[13]

Following the 2002 Maine Benzodiazepine Study Group annual meeting, the need to develop an unused-medication disposal method to assist in combating the escalating rate of prescription drug abuse was discussed with Senator Lynn Bromley. The Senator, in turn,offered to introduce a billprescribing such a method. With staffing and office space provided by the Maine Medical Association the Maine Hospital Association, work began on drafting a proposed bill. At that early point, it was recognized that staff fromhealthcare, environmental protection, and law enforcement, would need to get together and find common ground upon which a practical and efficient regulatory method could be built. After completion of drafting and introduction of the bill, it was considered by the Legislature’s Joint Health and Human Services Committee. The Committee was presented with letters of support or testimony from MaineRivers, the Maine Children’s Alliance, the NorthernNew EnglandPoisonControlCenter, the Maine Psychiatric Association, the Maine Substance Abuse Providers’ Group, the Memorial University of Newfoundland Department of Psychiatry, Theo Colborn, the Maine Dental Association, and the United States Pharmacopeia (USP). USP was one of the first organizations to take a formal organizational position to address unused medicine disposal.[14]

Passage of the bill resulted in creation of the Maine Mailback Program. Under the Program, patientsare asked to mail their unused and unwanted medications directly to the Maine Drug Enforcement Administration (MDEA), using a prepaid mailer obtained at pharmacies. . Mailers are coded to track the movement of envelopes from pharmacy to user to MDEA. MDEA ultimately destroys the medications according to hazardous-controlled classification.

We developed and articulated six reasons why the Program is good public policy. It would serve to:

  1. Curtail childhood overdoses[15]
  2. Reduce household theft and diversion and “pharming.” (“pharming” refers to taking from a bowl of mixed drugs indiscriminately.)
  3. Reduce risk of overaccumulation and adverse drug events amongst the elderly
  4. Prevent environmental impact[16]
  5. Reduce inappropriate international drug donations[17](see picture of donated drug storage on page 1)
  6. Provide pharmacoeconomic data and assist with reducing healthcare waste[18]

The six reasons were ultimately formalized at the Second International Conference on theEnvironment in Athens,Greece in 2007.[19]In turn they were unanimously adopted as the basis for the Athens Declaration.[20] Presenting the Athens Declaration to the Governor of Maine led to a Proclamation based on those 6 principles.[21]This was the first Gubernatorial Proclamation on the subject in the US. October31, 2008was designated “Proper Drug Disposal Day” by proclamation of the governor.[22]

The sole amendment to the bill was express authorization for MDEA to perform unused drug disposal. This established MDEA as the lead agency, and ensured that potential funders would not question the legitimacy of the efforts. The bill’s sponsors rejected consideration of lobbying for a federal regulatory change, based on their perception of insufficient federal interest. National organizations seemed to beawaiting evelopments at the state level.

Though the bill was successfully enacted in 2003, it contained a prohibition against funding to support it. The bill’s supporters decided instead to seek federal grant money or foundation grants. Unfortunately the bill’sbroad funding prohibition needed to be amended to make it clear that the ban applied only to state general revenue funds, not federal dollars. Now authorized to seek federal money, the University of Maine Center on Aging took the lead in 2005 in developing a U.S. EPA Aging Initiative grant application. While that application was pending,we reconsidered our earlier decision and approached the legislature in 2006 requesting state funds to support the program. Representative Anne Perry of Calais,Maine[23]sponsored legislation (LD 411) that would allocate state dollars to the program. At this point in time, the Legislative Study Committee that had been established through the first bill (Public Law, 2003, Chapter 679) had been meeting for a year and issued a report of their findings, which helped get the bill through the state legislature. Ultimately, the grant submitted to the U.S. EPA Aging Initiative was awarded in the amount of $150,000, and LD411passed, providing an additional $150,000.

III. Issues around the statute itself

There was some intial expression of concern that “white powder” or anthrax might be mailed. That concern was dismissed with the recognition that there would be no motivation to do so. Confidentiality concerns were not an issue, and though a question was raised concerning lack of an agreement with the DEA, we were confident that none was needed as we would be acting in compliance with applicable regulations.

Though there was input to the ONDCP, and the Maine Benzodiazepine Study Group had some, the guidelines promulgated have no regulatory authority and were to have a 2 year review.[24]

IV.Early Experience with the Program

Upon receipt of the EPA Grant, a Community Advisory Board (CAB) was developed to help with formulating educational material and monthly phone calls set-up. In addition, a professional advisory board of state, federal, and non-profit agencies was assembled to provide guidance to the project as a whole. In addition to Advisory Board meetings, a series of phone calls were held with DEA, EPA, US Postal Service, the National Council of Patient Information and Education and the Maine Benzodiazepine Study Group to discuss and finalize specific programmatic details. All meetings were coordinated by the Grant Administrator, Dr. Lenard Kaye, and Jennifer Crittenden,Project Director at the Center on Aging at the University of Maine.

The US Postal Service maintained that controlled substances could not be mailed by end users. After lengthy negotiations necessitating a delay in our project schedule, the USPS issued a waiver that allowed the mailings. Envelope selection was approved by the US Postal Service Engineering Department, and MDEA.As of 11/2/08, the US Postal Service Inspectors have not identified a single diversion or expressed a single concern. The Co-Principal Investigators are optimistic as neither DEA nor MDEA have identified a problem. The sole remaining issue under discussion is whether or not there may be the possibility of a waiver in-state to incinerate returned product outside of state Hazardous Waste requirements. Significant cost savings could ensue with such a waiver.

To test project design,four counties ( Aroostook, Washington, Kennebec, and CumberlandCounties) were chosen, and 11 distribution sites at pharmacies targeted to the elderlywere selected for participation. The plan was then for a second phase, in which the entire state was covered. With the passage of LD411, the expectation was then toexpand the target population to all age and demographic groups.

In May 2008, mailers were finally distributed in four counties at the 11 designated pharmacies. Some 600 have returned, and two sessions of drug identification, both day-long, have been held to collect returns data.[25]Returns data highlights the importance of this program for diversion prevention, including one envelope that was identified as containing 8,815 mg of oxycodone with a street value in excess of $7,000.00. No radioactivity was documented during the first count (Ten years ago a bottle of Radithor was found in a barn in Maine. [26]) As of November 1, 2008, 455 envelopes have beenopened and catalogued.

From the first cataloging session we know that:

90% of returns were prescription drugs, 10% over the counter

10% of drugs returned were controlled drugs, consistent with findings from other drug take-back events

One of the top psychotropic drugs returned comes from the benzodiazepine class of drugs

From surveys returned by our end users we know:

The average age of program participants is 70 years old

Top reasons for accumulation include: Death of a relative or loved one, Medicine expired or outdated, Doctor told patient to stop taking the medicine

15% of survey respondents did not know what kind of medicine they were returning

57% were returning medicine for themselves, 53% were returning medicine for a relative.

Top reason for using the program: It’s best for the environment (83%). Safety for themselves and their families was second (8%)

This data will continue to be augmented by subsequent cataloging and survey data.

At present, we are not sure that the data collected are adequate for use in policy decisions. Unfortunately, there exists no comparable data from other states for verification of our findings.When enough statewide data has been collected, it may be useful to compare drug-return patterns with those seen in other datasets.Though arrest rates for prescription drug abuse are highly problematic, they do constitute a comparative data set. Pharmaceutical sales by category such as medicaid, medicare, private insuror, or cash are all particularly of interest in Maine as it has one of the few all payor data banks in the country. DEA controlled drug sales by zip code are of interest, US Postal Service rates of delivery by prescription drug management companies versus the drug returns is of interest. USPS and US Customs rates of overseas drug deliveries has relevance. FDA determinations of counterfeit drug location are also of interest. Board of Medicine Records regarding location of physicians who have overprescribed are also relevant, as well as Board of Pharmacy. In addition, the Office of Adult Mental Health data on incidence of pharmaceutical problems and prescriber involvement, currently under development, are of interest and likely of policy recommendation quality.

V. Lessons learned and recommendations

Our experience to date provides a number of lessons. We did offer a unique approach to addressing each of the sixreasons and the organizations for whom those particular reasons were significant. We should have been more careful in drafting the original funding language. But it is our ignorance of what we could have done differently that is most compelling. We had no resources to squander, no time that was diverted as it was all time actually diverted from other activities to this project. There was no financial mogul who was directing us, no grant controlling our moves and actions. What has been learned by this is the benefit of collaboration amongst the most unlikelypartners.

We believe thata great deal more needs to be done about this issue in Maine and nationally. We would like to see state Offices for Adherence and Compliance. NASMHPD, the association of State Mental Health Program Directors, has not initiated any action on this. NIH is edging around to funding academically based units and EPA has funded additional research. We would also like to see other conferences on this issue in the US besides the Maine Benzodiazepine Study Group and Unused Drug Return Group Conferences (now entering its 6th year). There seems more interest now than ever, with more people recreating the wheel in this general topic daily. We strongly recommend that other programs incorporate mechanisms for collecting information about the returned drugs. Lack of clear and consistent data remains a considerable road block to effective policymaking.Improvements to health care cannot be realized if medicine is sent to the landfill uncounted but fastidiously weighed.

Recommendations for addressing this problem have been made by others. Daughton has provided one set of suggestions which are broadly from the environmental perspective. [27] A summary of how-to do event driven take backs is nicely summarized. This should continue to be more widely distributed.[28]

1

[1] Data Courtesy of the NationalDrugIntelligenceCenter, Data selection by Gressitt, 2008. Reference: 2008 National Drug Threat Survey, Maine and New England Preview, Presented Nov 10-11, 6th Annual Maine Benzodiazepine Study Group Conference, Portland, Maine. See:

[2]

[3]

[4]

[5]One of the sources for frequencies of specific medication prescribing can be found at:

[6]

[7]

[8]

[9]For Instance specific listing on P or U list or designation by characteristic from the US EPA: and: and:

[10]See: and for data:

[11]

[12]Taken from: and a brief note in the Lancet provides an introduction: and the informational web page at:

[13]

[14]A lengthier outline of the history and process is at: The legislative report can be seen at:

[15]

[16]see: and and

[17]see: and and and and and and

[18]

[19]Ruhoy, and Gressitt,

[20]

[21]

[22]

[23]

[24] is further information note on page 34 at : and and see 3rd point under Prevention at:

[25]

[26]

[27]

[28]