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 8 TH 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. The Pharmaceutical Collection Monitoring System (PCMS) is located at: http://pcms.pharmcollect.org. Initial and on-going development by: 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. 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 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. 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.
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.
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
Controlled Prescription Medication Waste & State Variation Summary 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 *Includes combination products
Top Five Collections by State 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 *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 others combined, 21% Percent of Controls Collected benzos, 9% codeine, 19% tramadol, 20% [CATEGORY NAME]*, [VALUE] * 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
Proportional Breakdown from Top Ten Manufacturers by Quantity Actavis, 5% Teva, 6% Pfizer 6% Zydus, 6% Qualitest, 18% Mylan, 15% Morton Grove, 4% Amneal, 11% Watson, 14% Malllinckro dt, 15%
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