[Pharmwaste] Current Estimates of Drug Waste

Mon Mar 23 14:17:26 EDT 2015

Karen and Group,

I’ll attach the slides here again. I am preparing a manuscript as we speak, with Kenna Payne (Texas Tech), Heather Stewart, Ali Malinowski, and Leslie Ochs (all 3 of University of New England) about the controlled substances that we’ve collected. We chose to publish the data on controls first because there is so much emphasis on the problem with the abuse of prescription opiates/opioids. With this data (a large portion of which was used for the attached slides), we excluded any entries in which the “original fill” amount was unknown, as well as any entries in which the quantity we collected exceeded the original fill amount (indicating mixing of two bottles). Because controlled substances are primarily narcotics used to treat pain, my thought is that it is logical that people would “waste” (i.e. not use) a greater percentage as compared to non-controls because many pain meds are prescribed on a prn (as needed) basis rather than scheduled. This obviously lends itself to having more on hand than one might need.

We will be looking at the non-control data for publication next and I can run those numbers on an informal basis. Burke is right, or rather, I agree that the meds that we receive at take back events are from people who needed to utilize the service of a take back event. So, inherently, these are people that did not use all of their meds. If we could peek into an entire populations’ med cabinets, I think we’d find that there are very few homes out there in which people use all of their meds.

It would make for a fascinating “multi-center” study if we could follow randomly selected individuals for a period of time and assess what they received, what they took, what they didn’t, and what they did with the rest. There is a small study that looked at this in a group of post-op patients. 67% of these patients had “leftover” pain med – of those 91% kept it at home. (Bates C, Laciak R, Southwick A, Bishoff J. Overprescription of postoperative narcotics: a look at postoperative pain medication delivery, consumption and disposal in urological practice. J Urol. 2011;185:551-555. doi: 10.1016/j.juro.2010.09.088 .)  In another study by Harris and colleagues, opioids were prescribed to 72 of 212 patients undergoing single skin excision. 25 of these patients did not use them at all and 49 of 57 that filled their prescriptions had leftovers. Of those 49, 26 planned to keep them. (Harris K, Curtis J, Larsen B, et al. Opioid pain medication use after dermatologic surgery: a prospective observational study of 212 dermatologic surgery patients. JAMA Dermatol. 2013;149(3): 317-321. doi: 10.1001/jamadermatol.2013.1871 .)

I agree that using one specific number is not justified at this point and due to regional variations, perhaps ever. And actually, I don’t think it’s necessary to have “a number”. There’s plenty of evidence that meds are wasted and that this waste is significant. The point now is to do something about it. I remain perplexed as to why there is so much focus on expanding disposal options when the root of the problem lies at the front end. Meds are over-prescribed, over-dispensed, and over-marketed (i.e. pushed to consumers who don’t need them; and packaged in quantities that are unnecessary). And, we as a society need to stop pushing to get as much drug as possible for our co-pay whether we need it or not. We need to stop buying two-for-one 250 count bottles of ibuprofen because it saves us 50 cents. I love a good bargain, but when it comes to meds, this is just a poor practice.

Back in the day (when I was young….), pharmacies weren’t open in the evening or on weekends and superstores didn’t exist. At that time, it made sense to have a stock of odds and ends OTCs in the med cabinet because you couldn’t run out and buy what you needed anytime 24/7. Times have changed, but the mindset of the public has not. We don’t need a supersize of everything – it’s likely to expire before we could humanly use it.

Jeanie Jaramillo, PharmD
Managing Director, Texas Panhandle Poison Center
Asst. Professor, Texas Tech UHSC School of Pharmacy
Director, Medication Cleanout
1300 S. Coulter St., Suite 105
Amarillo, TX 79106
(office): (806)414-9299
(mobile): (806)376-0039

From: Karen Shapiro [mailto:Karen at productstewardship.us]
Sent: Friday, March 20, 2015 5:26 PM
To: Lucy, Burke at CalRecycle; 'Fabisiak - CDPHE, Greg'; pharmwaste at lists.dep.state.fl.us; Jaramillo, Jeanie
Cc: Scott Cassel; Amanda Nicholson
Subject: RE: [Pharmwaste] Current Estimates of Drug Waste

Greg and Burke,

Jeanie Jaramillo also emailed her presentation from the National Association of State Controlled Substances Authorities annual conference to this listserv at the end of October. Her results show a range of 38% to 91% of drugs were unused. Jeanie, do you have any additional insight to add?

Best,
Karen

__________________________________
Karen Shapiro
Senior Associate of Policy and Programs
Product Stewardship Institute, Inc.
29 Stanhope St., 3rd Floor
Boston, MA 02116
Phone: (617) 236-4866
www.productstewardship.us
karen at productstewardship.us<mailto:karen at productstewardship.us>

From: pharmwaste-bounces at lists.dep.state.fl.us<mailto:pharmwaste-bounces at lists.dep.state.fl.us> [mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Lucy, Burke at CalRecycle
Sent: Friday, March 20, 2015 3:39 PM
To: 'Fabisiak - CDPHE, Greg'; pharmwaste at lists.dep.state.fl.us<mailto:pharmwaste at lists.dep.state.fl.us>
Subject: RE: [Pharmwaste] Current Estimates of Drug Waste

Greg,

I think “40% of dispensed drugs go unused” was likely based on the proportion of returned drugs and not the full prescription.  That’s not to say 40% is not close to the actual number, I just don’t see it supported.  Unfortunately, it was used as one of the assumptions in the University of Michigan published study, Life Cycle Comparison of Environmental Emissions from Three Disposal Options for Unused Pharmaceuticals<http://pubs.acs.org/doi/pdfplus/10.1021/es203987b>, which recommended trash disposal over take-back programs.

I don’t think we can currently say how much medication goes unused.  As far as I’ve seen, we’re still dealing with widely varying guesstimates.  You can see below unsupported 5%, 10%, and 15% unused drug guesstimates, 73.1% of the pill bottle returned, 32% of a some prescriptions discontinued, and 67.3% of some full prescriptions returned.  Those all chip away around the actual value but I haven’t seen a comprehensive study that fully addresses it.

There are a variety of sources:

PhRMA has often said take back programs would be at best less than a 1% solution, referencing their 2007 report, Potential Contribution of Unused Medicines to Environmental Concentrations of Pharmaceuticals.  That study said “…estimated releases to surface water of active pharmaceutical ingredients (APIs) in landfill leachate for 24 example APIs (which include one API metabolite) were calculated for three assumed disposal scenarios – 5%, 10%, and 15% of the total annual quantity of API sold is discarded unused to landfills.”  However, the unpublished study provided no references or justification for those disposal scenarios.

Yet, 5% to 15% may be low considering these other sources:

The 2008 Teleosis Preliminary Data Report<http://www.teleosis.org/pdf/GreenPharmacy_FullPreliminaryReport.pdf> shows 44.8% for prescribed drugs and over 52% for Rx and OTC combined.  However, there’s no description of whether 44.8% accounts for what’s left in the bottle collected as opposed to the full prescription or the total sold, which is an important distinction.  According to Teleosis’ October 26, 2010 Bay Area Medication Disposal Study 2009, An Inventory of Household Pharmaceutical Waste, Final Report: “One of the more misleading figures when considering the nature of unused pharmaceutical returned for disposal at household take-back sites is the percentage of unused medications returned…Overall with the average percentage of medications returned unused as compared to the original containers was 73.1%. It must be noted that this does not imply that 73.1% of all medication purchased or prescribed go unused. Rather, when medications are unwanted or unused, only 22.9% of the original dosage had been consumed leaving 73.1% remaining.”

Secure Medicine Return in Washington State, The PH:ARM Pilot<http://www.takebackyourmeds.org/pdf-files/pharm-final-report> says, “A significant amount of medicine goes unused–estimates range from 10 to 33 percent of medicines sold.”  This does suggest they looked at the full amount prescribed or sold but doesn’t provide any support for how they came up with the estimates, so it’s not exactly purporting to be a scientific study of it.

PSI’s July 27, 2012 Protecting our Health and the Environment: The Need for Sustainably Financed Drug Take-Back Programs<http://productstewardship.us/associations/6596/files/Pharmaceuticals%20White%20Paper%20on%20EPR_Final.pdf> said, “The exact quantity of unused and expired pharmaceuticals in American homes is currently unknown; however, evidence from a broad range of sources indicates that between 10 to 43% of the almost 4 billion prescriptions dispensed in the U.S. every year go unused and become waste.”  They reference the Secure Medicine Return in Washington State study above as well as at best, 3,536,000,000<http://www.census.gov/prod/2009pubs/10statab/health.pdf> prescriptions sold at brick-and-mortar retailers in the U.S. in 2008, 45.3%<http://www.census.gov/prod/2005pubs/06statab/health.pdf> of the population using at least one prescription drug in the past month between 1999-2002, 3,764,698,318<http://kff.org/other/state-indicator/total-retail-rx-drugs/> retail drug prescriptions filled at pharmacies in the U.S. in 2011, and 187,500,000,000<http://www.imshealth.com/imshealth/Global/Content/IMS%20Institute/Documents/IHII_UseOfMed_report%20.pdf> oral standard units (pills, capsules, vials and ampoules) and 2,700,000,000 injectable standard units for total volume of medicines sold in the U.S. in 2010 (the April 2012 updated report for the latter values show 136.6<http://www.imshealth.com/ims/Global/Content/Insights/IMS%20Institute%20for%20Healthcare%20Informatics/IHII_Medicines_in_U.S_Report_2011.pdf> standard units per capita sold/dispensed in the U.S. in 2011).  I could be missing it and it may be worth asking PSI about it but at this point I see nothing to indicate specific volume/usage of those nearly 4 billion prescriptions so it appears to me 10 to 43% is still just a guesstimate and as they put it, exact quantity is currently unknown.

Federal Register rules<http://www.gpo.gov/fdsys/pkg/FR-2012-04-12/html/2012-8071.htm> encouraging trial prescriptions by providing a pro-rated co-pay included this: “We cited in the proposed rule a previous review of 2009 PDE data by us that suggested that just under 32 percent of approximately 78.6 million first fills for chronic medications are not refilled by Medicare Part D enrollees.  We assumed for purposes of estimating savings to the Part D program that the lack of refills indicates the prescribed medications were discontinued…we reduced the total costs by approximately 13 percent in accordance with CMS data…to remove a proportion representing long-term care expenses.”  Of course there are limitations to those numbers; for instance prescriptions for chronic conditions do not represent all drugs collected at take-back programs such as the much larger amounts of acetaminophen and ibuprofen and 32 percent not refilled doesn’t necessarily represent the actual amount unused after the patient tried using a course of that medication.

Jeanie Jaramillo (on this listserv) wrote a 2011 report: National Medication Take Back Day Report of Sampling of Items Received, which said, “there is no real data that is comparable” and found the average percent of medication collected out of the original amount prescribed was 67.3%.  However, some patients combine the contents of separate bottles and it appears that only refers to controlled substances, which represent 6% of the 289,000 units (pills, milliliters, patches, etc.) counted.  That 67.3% number could be high considering those returning pills to a collection event don’t necessarily represent the full population, who may be more compliant in taking all their meds.

The U.S. EPA’s Dr. Christian Daughton’s Types and Quantities of Leftover Drugs Entering the Environment via Disposal to Sewage - Revealed by Coroner Records <http://www.epa.gov/esd/bios/daughton/SOTE2007.pdf>  provides a “proof of concept,” which says, “The data for beta-blockers represented an approximate 33% rate of noncompliance among the decedents for all the medications listed in the inventory.”

It may be possible to come up with a means of estimating the actual amount that goes to waste though.

In Reasons why medicines are returned to Swedish pharmacies unused<http://www.ncbi.nlm.nih.gov/pubmed/17221141>, there’s a good breakdown of the percent of drugs returned (e.g., 18.9% from patient death, 18.3% old treatment/not needed anymore, 13.1% ongoing medication expired, 5.3% Change in care and/or drug handling, 1.3% Non-compliance, 0.1% new treatment, etc.).  If you look at the 32% of all Medicare Part D enrollees that don’t refill their drugs from Federal Register rules<http://www.gpo.gov/fdsys/pkg/FR-2012-04-12/html/2012-8071.htm> (above) and assume that could represent a certain percent of returned drugs above (e.g., at least 5.3% Change in care and/or drug handling, 1.3% Non-compliance, 0.1% new treatment), then assume the average percent of medication collected at a DEA event out of the original amount prescribed was 67.3% (above) and could represent at least 18.3% old treatment/not needed anymore from above, then maybe other pieces of that puzzle could be plugged in so we could get a better view of the whole picture of all drugs that go unused.  If 18.9% or 33% come from patient deaths, then it might be possible to estimate how many deaths, the average number of pills at death, etc. to fill that piece of the puzzle too.  Considering other surveys (e.g., though somewhat dated from other countries: Patient Practices and Beliefs Concerning Disposal of Medications<http://www.ncbi.nlm.nih.gov/pubmed/17090787>, An economic assessment of the extent of medication use and wastage among families in Saudi Arabia and Arabian Gulf countries<http://www.ncbi.nlm.nih.gov/pubmed/12809973>), and averaging their results could help in getting a more accurate picture too.  Ultimately you might wind up with a calculation that looks something like (0.189 * 0.12) + (0.183 * 0.673) + (0.067 * 0.32)… = x% drugs unused.  But then, this would just cover the broad strokes.  It’d be even better to get a sense of which drugs go unused the most and delve into those details spreadsheet style.

Also, Dr. Daughton’s 2010 EPA publication, Drugs and the Environment: Stewardship & Sustainability<http://www.epa.gov/nerlesd1/bios/daughton/APM200-2010.pdf> states: “To date, only two papers have appeared in the peer-reviewed literature that delineate the requirements for determining the relative contributions of APIs to the aquatic environment from disposal to sewers versus excretion. These papers discuss the variables that must be addressed and the types and quality of data required for the calculations (Daughton and Ruhoy 2009a; Ruhoy and Daughton 2007). No study to date has met these requirements.”

So, in lieu of actually supporting the oft-quoted 40% number or someone doing their dissertation on this, because the current estimates vary so widely, I’d be wary of using a specific number in the middle of any range.

Mr. Burke Lucy
Environmental Scientist
Department of Resources Recycling and Recovery (CalRecycle)
1001 I Street, PO Box 4025
Sacramento, CA 95812
Burke.Lucy at CalRecycle.ca.gov<mailto:Burke.Lucy at CalRecycle.ca.gov>
916.341.6592
[California Department of Resources Recycling and Recovery (CalRecycle)]<http://www.calrecycle.ca.gov/>
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From: pharmwaste-bounces at lists.dep.state.fl.us<mailto:pharmwaste-bounces at lists.dep.state.fl.us> [mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Fabisiak - CDPHE, Greg
Sent: Friday, March 20, 2015 11:20 AM
To: pharmwaste at lists.dep.state.fl.us<mailto:pharmwaste at lists.dep.state.fl.us>
Subject: [Pharmwaste] Current Estimates of Drug Waste

I was wondering if anyone has links to relatively current statistics on the amount of medications wasted in the U.S. The "40% of dispensed drugs go unused" and "200 million pounds dispensed outside of hospitals are wasted" seem to still pop up often, but I'm having trouble finding citations for these statistics.

What surveys or studies are others citing?

--
Greg Fabisiak
Environmental Integration Coordinator
[https://6bc585c3ac975c15d2250e882c44ab669f6363cd.googledrive.com/host/0B8gdupL6hOgVNDVKVVJBcXhoaWs/images/co_cdphe_div_env_72_rgb_email.png]
Colorado Department of Public Health and Environment
4300 Cherry Creek Drive South, DEHS-A2
Denver, CO 80246-1530
office: 303.692.2903 | fax: 303.782.4969
e-mail: greg.fabisiak at state.co.us<mailto:greg.fabisiak at state.co.us>
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