JEANIE JARAMILLO-STAMETZ, PHARMD

Jeanie Jaramillo-Stametz is an assistant professor for Texas Tech’s School of Pharmacy and serves as the director of the poison control center and the director of their Medication Cleanout program. She graduated with her Doctor of Pharmacy degree in 2001 and completed a residency in drug information in 2002.

Jeanie’s research interests include the abuse of prescription medications as well as their accumulation in homes, and the role of unused medications in poisonings, misuse, and abuse. She began a community medication take back program in 2009 and to date, has coordinated 47 events collecting over 30,000 pounds of unused medication for appropriate disposal. Data related to a portion of the medications received at these events is entered into a surveillance database by student volunteers and provides the basis for her presentation.

Current projects include analysis of mail-order medications received at take back programs, the financial implications of overprescribing and unused medications, and the role of pharmaceutical manufacturers in medication disposal.

DISCLOSURE

• I have no financial relationships to disclose

MEDICATION CLEANOUT PROGRAMS: WHAT IS

OVERPRESCRIBED? DR. JEANIE JARAMILLO-STAMETZ

OCTOBER 30, 2016

TEXAS PAIN SOCIETY’S 8TH ANNUAL SCIENTIFIC MEETING

OBJECTIVES

• Describe medication take back/ cleanout programs

• Illustrate the degree to which controlled prescription medications remain unused

• Identify specific classes/agents that are more likely to remain unused

• Provide recommendations for reducing the accumulation of medications in homes

WHAT IS MEDICATION CLEANOUT?

• Combined community medication take back and research program

• Designed to prevent poisonings, abuse, misuse and environmental contamination by providing appropriate disposal

• Research to identify classes/agents likely to remain unused

• Texas Tech’s School of Pharmacy Medication Cleanout program

• Began 2009

• 47 events across the panhandle to date

• Over 34,000 pounds of medications collected

• Coordination with DEA National Medication Take Back Days when possible

DATA COLLECTION

• Affiliation with School of Pharmacy provides access to large number of volunteers

• Information collected through logging system

• Interface with Micromedex for consistent classification of meds

DATA POINTS COLLECTED

• Car number

• Controlled, non-controlled, OTC

• Drug name

• Strength

• Formulation

• Original quantity

• Collected quantity

• Fill date

• Expiration date

• Sample (y/n)

• Mail-order (y/n)

• Factory sealed (y/n)

CONTROLLED SUBSTANCES

• Some law enforcement agencies require line item inventory of items they accept for disposal

• All controlled substances are logged (5-10% of total collections by weight)

• Limited amount allows logging of all collected controls

Unused Medications: A Case Report - Show Me the Money Jeanie E. Jaramillo, Ronica D. Farrar

Texas Panhandle Poison Center of Texas Tech University Health Sciences Center School of Pharmacy

Background: Unused medications are a known source for poisonings, abuse, misuse, and environmental contamination. In 2009, our poison center and host university began implementing periodic community unused medication take back days to facilitate the removal of these items from households. At each event detailed information is collected. This information is entered into the Pharmaceutical Collection Monitoring System™ (PCMS), a web-based tool developed by Computer Automation Systems, Inc. to facilitate the on-going collection and reporting of consistent data regarding the collection of unused medications. This information includes drug name, strength, original quantity, collected quantity, fill date, use by or expiration date, manufacturer/distributor, and identifies each product as a sample, a factory sealed item, or an item that appears to be a mail-order. We report an uncommon case in which a large number of items were brought from one household. Although many more items were brought, only the collected controlled substances are reported here.

Case Report: An individual brought the medication of his deceased parents to our take back event in the open bed of a pickup truck. These items were contained in two cardboard boxes that were approximately 3 ft. X 3 ft. X 2 ft. Items bore prescription labels, thus allowing them to be identified as prescribed to family members. Identifiers were obscured and not recorded. See Table for results.

Case Discussion: This report reveals a case in which a large number of prescribed medications remain unused. Many were dispensed by a mail-order pharmacy, perhaps continuing to be dispensed following the patient’s death. These results may partially have occurred as a consequence of an automatic refill process – a practice commonly used by both local and mail –order pharmacies. An investigation into such processes seems warranted. The controlled substances alone, brought to this collection event from a single household had an AWP of over $6,000 with estimated low and high street values of $85,000 and $368,000. One hundred and eleven containers holding 13,994 pills cam from one household. While we hope this scenario is a rare occurrence, this case leads us to believe similar cases likely exist.

Conclusion: This case reveals an extreme example of medication waste and displays the importance of collecting and reporting data regarding unused medications. Without such efforts, the current practices that result in unused medications and their subsequent wastage are unlikely to change.

Why all the fuss? While unused medications are a known source for poisonings, abuse, misuse, and environmental contamination, there is currently very little being done to assess the root cause of this problem. According to the CDC, prescription drug abuse is the fastest growing drug problem in the U.S. Efforts to document and quantify the problem of unused medications are greatly needed in order to drive prescribing, dispensing, and marketing practice changes that could potentially address the problem at the front end rather than the disposal end. Although we’ve used a monetary example to illustrate one aspect of the problem of unused medications, the non-monetary implications as well as the indirect monetary implications due to increased morbidity and mortality should not be overlooked.

The Pharmaceutical Collection Monitoring System (PCMS) is located at:

http://pcms.pharmcollect.org . Initial and on-going development by:

Controlled Substance Medications Collected from a Single Household During a Take Back Event

Drug Name Strength # of Containers Qty Collected Average Wholesale Price Low – High Street Value

Diazepam 5 mg 18 2,320 $167 $2,320 - $46,400

Hydrocodone/ APAP

10/325 mg 4 520 $363 $1,040 - $10,400

Lorcet® 5/500 mg 2 2 $3 $6 - $18

Lyrica® 75 mg 6 84 $227 $420 - $1,680

Morphine sulfate 30 mg 61 10,080 $5,352 $80,640 – $302,400

MS Contin® 30 mg 3 6 $17 $90 - $300

Oxycodone/ APAP

5/500 mg 15 802 $95 $802 - $4,010

temazepam 30 mg 2 180 $32 $180 - $3,600

111 13,994 $6,256 $85,498 - $368,808

AWP obtained from 2010 Redbook. Street values obtained from National Drug Intelligence Center.

Drug Name Strength # of

Containers Qty Collected

Average Wholesale Price

Low – High Street Value

Diazepam 5 mg 18 2,320 $167 $2,320 - $46,400

Hydrocodone/ APAP

10/325 mg 4 520 $363 $1,040 - $10,400

Lorcet® 5/500 mg 2 2 $3 $6 - $18

Lyrica® 75 mg 6 84 $227 $420 - $1,680

Morphine sulfate

30 mg 61 10,080 $5,352 $80,640 – $302,400

MS Contin® 30 mg 3 6 $17 $90 - $300

Oxycodone/ APAP

5/500 mg 15 802 $95 $802 - $4,010

temazepam 30 mg 2 180 $32 $180 - $3,600

111 13,994 $6,256 $85,498 - $368,808

Controlled Substance Medications Collected from a Single Household During a Take Back Event

AWP obtained from 2010 Redbook. Street values obtained from National Drug Intelligence Center.

RESULTS OF A MULTI-STATE COLLECTION INITIATIVE 2011-2015

• Data collected at 80 events across 6 states

• Arkansas

• Florida

• Maine

• Missouri

• Pennsylvania

• Texas

• 10,600 participants

Category

Average Percent

Unused

(state variation)

Average Prescribed

Quantity

(state variation)

Average Returned

Quantity

(state variation)

Collected

Prescriptions

Total

Collected

Pregabalin 74.8 (51.1 – 85.7) 53 (21 – 75) 36 (18 – 37) 543 19,296

Fentanyl patches 70.1 (61.0 – 80.0) 10 (5 – 10) 7 (4 – 7) 283 1,914

Morphine 68.4 (59.4 – 81.1) 85 (55 – 180) 59 (15 – 111) 250 14,873

Tramadol* 65.5 (57.5 – 68.9) 62 (35 – 65) 39 (25 – 41) 1213 47,384

Benzodiazepines 63.9 (60.7 – 74.2) 49 (30 – 51) 31 (23 – 37) 1964 61,241

Oxycodone* 62.8 (56.1 – 71.4) 50 (36 – 65) 29 (22 – 35) 603 17,280

Hydrocodone* 61.9 (59.0 – 63.5) 37 (24 – 38) 22 (14 – 23) 4717 104,460

Carisoprodol 58.9 (57.8 – 71.5) 59 (36 – 63) 35 (26 – 59) 134 797

Stimulants 51.1 (38.6 – 62.8) 49 (40 – 60) 24 (21 – 28) 569 13,568

Controlled Prescription Medication Waste & State Variation Summary

*Includes combination products

Arkansas Florida Maine Missouri Pennsylvania Texas

#1 oxycodone oxycodone oxycodone hydrocodone hydrocodone hydrocodone

#2 hydrocodone benzodiazepines hydrocodone oxycodone benzodiazepines benzodiazepines

#3 benzodiazepines hydrocodone benzodiazepines benzodiazepines tramadol tramadol

#4 stimulants tramadol tramadol tramadol oxycodone pregabalin

#5 pregabalin pregabalin stimulants * morphine morphine

Top Five Collections by State

*Missouri data was available for only four of the selected substances

RESULTS – SPRING 2016

• Three events

• Amarillo, Abilene, Lubbock events

• 1,256 participants

• 3,275 pounds of medications collected

• Average 2.6 pounds per participant

• 6% of collections were controlled substances by weight

RESULTS – SPRING 2016

benzos, 9%

codeine, 19%

[CATEGORY NAME]*, [VALUE]

tramadol, 20%

others combined,

21%

Percent of Controls Collected

* Hydrocodone rescheduled as C-II October 2014

RESULTS – SPRING 2016 Medication Number of Line Items Average Amount Not Used

/ Wasted

AWP Cost of Wasted

Medication

Benzodiazepines 203 61% $18,692

Testosterone products 32 83% $13,407

Pregabalin 50 72% $11,437

Sedatives/sleep aids 91 61% $10,986

Tramadol 315 65% $10,302

Hydrocodone 625 61% $ 9,196

Stimulants 44 57% $ 3,315

Fentanyl 28 69% $ 3,222

Oxycodone 42 60% $ 3,047

Codeine 184 62% $ 2,922

Buprenorphine 10 61% $ 2,644

Hydromorphone 11 75% $ 2,149

Propoxyphene 78 57% $ 909

Atropine/diphenoxylate 39 73% $ 633

Morphine 21 61% $ 483

Carisoprodol 14 46% $ 189

TOTAL 1787 $ 93,533

Qualitest, 18%

Mylan, 15%

Malllinckrodt, 15% Watson,

14%

Amneal, 11%

Zydus, 6%

Pfizer 6%

Teva, 6% Actavis, 5% Morton

Grove, 4%

Proportional Breakdown from Top Ten Manufacturers by Quantity

DATA EXTRAPOLATION

• Extrapolating to DEA collections

• Estimated 385,147 pounds of controlled medications have been collected from the beginning of the DEA program in 2010 through the spring of 2016 with an AWP estimate of almost $204 million dollars

• Given an average participation rate of 0.63% at our Texas events (participants/community households), our collections represent the unused medications of less than 1% of the population

• Assuming that similar amounts of controlled substances remain unused in the homes of 5% of households, the AWP for our three Texas communities alone increases to almost half of a million dollars.

• Nationally, the figure increases to just over one billion.

LIMITATIONS

• Only those who HAVE unused medications participate in take-back events

• Not possible to account for quantities of meds that resulted from deceased individuals

• Human error

MEDICATION ACCUMULATION SOLUTIONS

Contributors

• Over-prescribing

• Over-dispensing

• Auto refills

• Mail order

• No checks and balances

• Over-marketing

• Lack of education

Disposal

• Pharmaceutical manufacturers

• Retail pharmacies

• Mail-back

CASE EXAMPLE: 14/15 YEAR OLD FEMALE, 150 POUNDS

ACL/MCL reconstruction & meniscus repair June 2015 HC/APAP 7.5/325 #90 Used #6 ACL reconstruction August 2016 HC/APAP 7.5/325 #60 Used #12

QUESTIONS

Jeanie Jaramillo-Stametz

jeanie.Jaramillo@ttuhsc.edu

Poison center office: (806) 414-9402

Voice mail: (806) 414-9299