Pharmacy Track:Lessons Learned fromRx Disposal Programs

Presenters:

• Kathleen Egan, MS, Research Associate, Department of Social Science & Health Policy, Wake Forest School of Medicine

• Eric Gregory, EdD, CPS, Executive Director, Save Our Kids Coalition

• Jeffrey Gray, PharmD, RPh, Associate Professor, GattonCollege of Pharmacy, & Adjunct Professor, College of Public Health, East Tennessee State University

Moderator: Dan Smoot, Director of Drug Prevention & Education, Appalachia High Intensity Drug Trafficking Area (HIDTA)

Disclosures

• Kathleen Egan, MS, has disclosed no relevant, real, or apparent personal or professional financial relationships with proprietary entities that produce healthcare goods and services.

• Eric Gregory, EdD, CPS, has disclosed no relevant, real, or apparent personal or professional financial relationships with proprietary entities that produce healthcare goods and services.

• Jeffrey Gray, PharmD, RPh, has disclosed no relevant, real, or apparent personal or professional financial relationships with proprietary entities that produce healthcare goods and services.

• Dan Smoot has disclosed no relevant, real, or apparent personal or professional financial relationships with proprietary entities that produce healthcare goods and services.

Disclosures

• All planners/managers hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.

• The following planners/managers have the following to disclose:– Kelly Clark – Employment: Publicis Touchpoint Solutions;

Consultant: Grunenthal US– Robert DuPont – Employment: Bensinger, DuPont &

Associates-Prescription Drug Research Center– Carla Saunders – Speaker’s bureau: Abbott Nutrition

Learning Objectives

1. Describe the Rx drug disposal methods of DEA take-back events, permanent drop boxes and retail pharmacies.

2. Evaluate the effectiveness of these disposal methods.

3. Identify best practices for implementing these disposal methods.

Disclosure

• Kathleen Egan, M.S., has disclosed no relevant, real or apparent personal or professional financial relationships with proprietary entities that produce health care goods and services.

• Eric Gregory, Ed.D., CPS has disclosed no relevant, real or apparent personal or professional financial relationships with proprietary entities that produce health care goods and services.

• Describe the Rx drug disposal methods of DEA-approved take-back events, permanent drop boxes and retail pharmacies.

• Evaluate the effectiveness of these disposal methods.

• Identify best practices for implementing these disposal methods.

Between 1991 and 2010, prescriptions for opioid analgesics increased from 30 million to 180 million (Phillips, 2013).

Millions of pounds of prescription medications go unused each year in the United States (Shrank, 2011).

Source: AwareRXSource: Nova Southeastern University

To prevent diversion of RX drugs for misuse & abuse.“Providing individuals with a secure and convenient way to dispose of medications will help prevent diversion and abuse, and help to reduce the introduction of drugs into the environment.” (ONDCP, 2011; Stewart et al., 2014)

“Proper disposal is crucial in countering this illegal activity.” (Herring et al., 2008).

To prevent accidental poisoning among children.(Gray and Hagermeier, 2012; Stewart et al., 2014)

To prevent crime in communities.“Medication storage can increase the risk of home invasions.” (Stewart et al., 2014)

To prevent environmental hazards. “Proper disposal of drugs is a straightforward way for individuals to prevent pollution.” (U.S. Environmental Protection Agency, 2010)

• The Galaxy Project

– The Partnership

– Objectives & Research Questions

– DEA Take-Back Events & Permanent Disposal Units

– Collections Assessment

– Results

• Implications for the Field

Permanent Disposal Units at Law Enforcement Offices

Bi-annual DEA-Sponsored Take-Back Events

Source: Bangor Daily News

• Minimal published reports on pill count and substance type

Source: http://www.dea.gov/docs/results_final.pdf

• Primarily weight-based assessments

Save Our Kids Coalition

Wake Forest School of Medicine

LifeSkills, Inc.

Law Enforcement Agencies

Pharmacists

SparksInitiatives, Inc.

Objectives• To examine the potential impact of RX disposal through the assessment of

collections from DEA-sponsored take-back events and permanent disposal units using a community-based participatory research (CBPR) approach.

• To disseminate our findings with researchers, practitioners, & policy-makers.

Research Questions1) What is disposed at take-back events and in permanent disposal units (i.e.,

controlled prescription medications, non-controlled medications, trash, etc.)?

2) How many & what type of controlled prescription medications are collected?

3) How does the collection compare to what is dispensed in the participating communities?

4) Is the assessment protocol feasible?

10/26/2013 4/26/20146/13/2014

-6/20/2014

8/15/2014 -

8/22/201410/25/2014

11/14/2014 -

11/21/2014

2/20/15–

2/27/15

Take Back Event

Take Back Event

Permanent Disposal

Permanent Disposal

Take Back Event

Permanent Disposal

Permanent Disposal

DEA Take-back Events Permanent Disposal Units

Number Conducted 3 4

Number of LEAs ParticipatedEvent/Permanent Collection #1Event/Permanent Collection #2Event/Permanent Collection #3Event/Permanent Collection #4

2-32 agencies3 agencies3 agenciesNA

4 – 77 agencies6 agencies4 agencies6 agencies

Timeframe 1 Day from 10am-2pm 1 Week

LocationAgency #1Agency #2Agency #3

Police DepartmentHigh School Parking LotSheriff’s Department

Law Enforcement Offices

Procedure • Events were advertised by law enforcement agencies hosting the events.

• Boxes were emptied immediately prior to the start of the collection.

• Medications were collected after 1 week.

• No additional advertising the week of collection.

• Collection assessment occurred in the office of the local Drug Task Force (DTF). – Collections were transported to assessment location by Law

Enforcement Officers of the home collection.

• Assessment was conducted by Eric Gregory (Assessment Supervisor), Law Enforcement Officers, Pharmacist, three Pharmacy Technicians, and two additional assistants.

• Collection assessment was divided into four stages:1) Pre-Sort

2) Sort & Drug Identification

3) Measurement

4) Analysis

• Collections were pre-sorted:– First stage of trash reduction

– Safety inspection using magnet & Turtle Skin LE Search Gloves (28 ga)

– Handling of bottles, blister packs, and loose pills

• Sort collection into controlled, non-controlled, and trash– Removed and identified pills from bottles or packs

– Identified loose pills

– Used color-coded bins to separate controlled, non-controlled, & trash

• Controlled prescription medications were identified and recorded by generic name.

• Trash and non-controlled substances were measured by weight (g/kg)

• Controlled pills measured by weight (g/kg) and counted by pill

• Controlled liquids measured by weight (kg) and volume (ml)

• Controlled patches measured by weight (g/kg) and counted by patch

• Two scales: Royal DG200 and Acculab VI-1200

• Hand written forms were converted to Excel files by Assessment Supervisor and transferred to Wake Forest School of Medicine (WFSM).

• Supplemental anecdotal report provided by Assessment Supervisor.

• WFSM Team compiled, reviewed, and analyzed the data.– Pills, liquids, and patches were converted

to “units.”

– Unit = 1 pill, 1 ml, or 1 patch (Stewart et al., 2014)

263

10180

38

94

35

80

266 14 0

0

50

100

150

200

250

300

Take Back Events (n=3) Permanent Disposal (n=3)

We

igh

t (k

g)

Overall Weight

Total

Trash

Non-controlled pills

Non-controlled liquids

Controlled pills

Controlled liquids

% of Total Weight Take Back & Permanent

Trash = 30%; 38%Non-controlled = 66%; 61%

Controlled = 4%; 1%

18069

3435

9554

2418

4784

8483065

92130 50536

280

5000

10000

15000

20000

Take Back Events (n=3) Permanent Disposal (n=4)

Overall Units of Controlled RX Medication Collected

Total Pain Reliever Tranquilizer Stimulant Muscle Relaxer Other

Nu

mb

er

of

un

its

988

4857

959

45

3845

425106

2006

953

0 0 096

981315

0

1000

2000

3000

4000

5000

10/26/2013 (n=2) 4/26/2014 (n=3) 9/27/2014 (n=3)

Nu

mb

er

of

un

its

All Agencies (range; n=2-3)

988

2068

659

45

490

47106 176 00 0 096 346 254

0

1000

2000

3000

4000

5000

10/26/2013 (n=2) 4/26/2014 (n=2) 9/27/2014 (n=2)

Nu

mb

er

of

un

its

Restricted to agencies that participated at all events (n=2)

491

703

141

714

235

843

526

0 0 25 673 0 0

470 0 0 28

0

200

400

600

800

June '14 (n=4) Aug. '14 (n=4) Nov. '14 (n=4) Feb. '15 (n=4)

Nu

mb

er

of

Un

its

Restricted to agencies that participated in all assessments (n=4)

491

737

141

764

235

840

526

0 0 25 673 0 0

470 0 28

0

200

400

600

800

June '14 (n=7) Aug. '14 (n=6) Nov. '14 (n=4) Feb. '15 (n=6)

Nu

mb

er

of

Un

its

All Agencies (range; n=4-7)

• Total Controlled Units Dispensed• Units dispensed in 2013 based on KASPER reports.

• Units Used• Estimate based on 30% of “Total Controlled Units Dispensed”

(Stewart et al., 2014).

• Units Disposed: • Estimate based on an average of the four permanent collections

multiplied by 52. • Estimate based on an average of the three DEA Sponsored Take-

Back Events multiplied by 2.

• Units left in Community• Total Dispensed – (Used + Disposed)

County Population*Total

Controlled Dispensed

Units UsedUnits

DisposedUnits left in Community

County A 113,792 13,288,979 3,986,694 22,832 9,279,453

County B 42,173 5,318,516 1,595,555 33,982 3,688,979

County C 17,327 2,214,703 664,411 3,717 1,546,575

Estimated Units Used30%

Estimated Units Disposed

1%

Estimated Units in Community

69%

County B

*2010 Census

• All collections were weighed, sorted, and categorized within one day.

• Assessments were conducted ~ 9 individuals (Assessment Supervisor, Law Enforcement Officers, Pharmacist, three Pharmacy Technicians, and two additional assistants).

• The protocol was adapted during the first two assessments based on lessons learned.

• While assessment of a limited number of collections over the year is feasible, assessment of collections over an entire year is likely not feasible or efficient.

• It may be difficult to get agencies who collected substances to participate in all assessments.– Two out of seven agencies participated in every collection.

• RQ 1: What is disposed (based on weight)?

– ~3% Controlled Substances, ~65% Non-Controlled Substances, ~32% Trash

• RQ 2: How many controlled RX medications were collected?

– 21,504 units were collected from 3 take-back events (18,069) and 4 week-long permanent disposal collections (3,435).

– Pain relievers followed by tranquilizers were the most common controlled substances.

• RQ 3: How does the collection compare to what is dispensed in the participating communities?

– Disposed controlled prescription medications accounted for ~1% of all dispensed into the community.

• RQ 4: Is the assessment protocol feasible?

– Yes, but maybe not on an annual or more frequent basis.

• What is the denominator (# of doses dispensed)?

– Availability of information

– Timeframe

– Location

• Limited information about how many of dispensed medications are actually used (as intended).

• Variability in context of communities and disposal opportunities.

• Importance of conducting collection assessments

• Disposal is only one strategy to reduce the number of controlled prescription drugs in communities

• Value of partnerships

– Law Enforcement, Pharmacists, Prescribers, Community Coalitions, Researchers

• Improve disposal efforts– *New policy* Authorized collectors - manufacturers, distributors,

reverse distributors, narcotic treatment programs, hospitals/clinics with an on-site pharmacy, and retail pharmacies - can now register to participate in Rx collection

– Engage in local partnerships

– Advertise disposal locations & educational information on medicine bottles, materials, and in the pharmacy

• National and long-term assessments of disposal efforts

Gray, J. A., & Hagemeier, N. E. (2012). Prescription drug abuse and DEA-sanctioned drug take-back events: characteristics and outcomes in rural Appalachia. Archives of internal medicine, 172(15), 1186-1187.

Herring, M. E., Shah, S. K., Shah, S. K., & Gupta, A. K. (2008). Current regulations and modest proposals regarding disposal of unused opioids and other controlled substances. JAOA: Journal of the American Osteopathic Association, 108(7), 338-343.

Phillips, J. (2013). Prescription drug abuse: Problem, policies, and implications. Nursing outlook, 61(2), 78–84. doi:10.1016/j.outlook.2012.06.009.

Shrank, W. H. (2011). Our Bulging Medicine Cabinets — The Other Side of Medication Non-adherence. New England Journal of Medicine, 364(17), 1591–1593. doi:10.1056/NEJMp1011624.

Stewart, H., Malinowski, A., Ochs, L., Jaramillo, J., McCall III, K., & Sullivan, M. (2015). Inside Maine’s Medicine Cabinet:Findings From the Drug Enforcement Administration's Medication Take-Back Events. American journal of public health, 105(1), e65-e71.

Office of National Drug Control Policy. (2011). Prescription Drug Abuse. Retrieved April 5, 2013, from http://www.whitehouse.gov/ondcp/prescription-drug-abuse

U.S. Environmental Protection Agency. (2010). Pharmaceutical and Personal Care Products (PPCPs). Retrieved October 29, 2013, from http://www.epa.gov/ppcp/basic2.html

• Joy White, Lifeskills Regional Prevention Center

• Michael Sparks, M.A., SparksInitiatives, Inc.

• Mark Wolfson, PhD, Wake Forest School of Medicine

• Funding: Partnerships for Success II, Substance Abuse and Mental Health Services Administration

• Tommy Loving, Director, Warren County Drug Task Force

• Tod Young, Detective, Warren County Drug Task Force

• Amy Stillwell, The Save Our Kids Coalition

• Lisa Mason, The Save Our Kids Coalition

• Missy Greathouse, Pharmacist

• Alan Hudson, Pharmacy Tech

• Cindy Whitmore, Pharmacy Tech

• Jana Young, Pharmacy Tech

• Latasha Bunton, Pharmacy Tech

Lessons Learned from a Rx Disposal Program in NE Tennessee

April 8, 2015

Jeffrey A Gray, PharmD, CDEAssociate Professor, ETSU College of Pharmacy

Adjunct Professor, ETSU College of Public Health

Disclosure Statement of

Unapproved/Investigative Use

I, Jeff Gray,

DO NOT have a financial interest/arrangement or affiliation with one or more organizations that

could be perceived as a real or apparent conflict of interest in the context of the subject of this

presentation.

DO NOT anticipate discussing the unapproved/investigative use of a commercial

product/device during this activity or presentation.

Prevention

1° 2° 3° 4°(?)

Non-use Death

RxMonitoring

Programs&

DiversionControl

Dependence Addiction

1st

Initiation

Traditional&

MedicallyAssisted

Treatment

Dissemination&

ImplementationofEffective

PreventionPrograms

OverdoseReversal

withNaloxone

Level of Prevention

NeonatalAbstinenceSyndrome:

TreatmentofMother,Infant&

PreventingSecondPregnancy

Evidence-

BasedDrug

Courts

HealthProfessions

Training&Continuing

Education

Screening,Brief

Intervention&

ReferraltoTx

Study Objectives

• List quantitative metrics for reoccurring (Live Take Back) and consistently available (Amnesty Box) donation options

• Describe donor tendencies related to medications storage and destruction

• Explain population density variables which influence donation behaviors

• Identify characteristics of a successful public awareness campaign

Methodology

• Active partnership with the DEA and local law enforcement

• Onsite donor survey (LTB only), sorting, identification, label interpretation, counting, and recording

• Research sites– 5 Live Take Back Sites over 18 months

– 5 + 3 Amnesty Box Sites over 30 months

• Awareness campaign (TV, print)

Data Collected

• Total donation weight (lbs)• Total Controlled Substance (CS) weight (lbs)• CS Active ingredient (C II- CV)• Therapeutic category (Opioids, Stimulants, etc)• Quantity of CS in dosage units

– Tablet, capsule, film, lozenge, nasal spray– Milliliter, patch, syringe, suppository, IV drip

• Date of dispensing• Donation location• Municipality population as 2012

Live Take Back Collections

Live Take Back Day Volunteers

Controlled Substances Collected

25859

6585

436

3018

Units of Controlled Substances Collected, by Therapeutic Class

Opioids Sedative/ Hypnotics Stimulants Miscellaneous

Donations by Weight

0

50

100

150

200

250

300

350

400

450

500

Blountville Bristol Elizabethton Johnson City Jonesborough

213.5

497

250.5

301.2

388.5

14 18 10.5 16.3 23

Total Pounds of Rx and Controlled Substances Collected, by Municipality

Total Rx CS

Donations by CS Units

0 2000 4000 6000 8000 10000 12000

Blountville

Bristol

Elizabethton

Johnson City

Jonesborogh

Units Collected

Units of Controlled Substances Collected, by Municipality

Dispensing to Donation Time

56.72

67.36

59.27

42.39

0.00

10.00

20.00

30.00

40.00

50.00

60.00

70.00

80.00

Sedative/ Hypnotics Miscellaneous Opioids Stimulants

Mea

n N

um

ber

of

Mo

nth

s

Average Number of Months Between Dispensing and Donation, By Therapeutic Class

Public Awareness CampaignBaseline 2013, Intervention 2014

Total Donation Wt (lbs)

Spring 2013 Fall 2013 Spring 2014 Fall 2014

Blountville 40.6 19 157 37.5

Bristol 154 253 154 90

Elizabethton 60 29.5 140 81

Johnson City 141 79.2 133 89

Jonesborough 116 12.5 342 34

904.8 1,257.5

39% Increase

Amnesty Box Collections

Permanent Drug Disposal Boxes

Controlled Substances Collected

97560

28031

2481

7102

Total Controlled Substance Units Collected by Drug Class

Opioids Sedative Hypnotics Stimulants Misc.

Donations by Weight

0

500

1000

1500

2000

2500

966

313.5518

1380

444.5

2184

82261.5

58.5 11 22 55 31.596

4 21.5

Po

un

ds

Total Pounds of Rx and Controlled Substances by Collection Site

Total Rx Controlled Substances

Donations by CS Units

0 5000 10000 15000 20000 25000 30000 35000 40000 45000

Blountville

Bristol

Elizabethton

Johnson City

Jonesborough

Kingsport

Mt. City

Rogersville

Units of Controlled Substances By Collection Site

Dispensing to Donation Time

53.93

43.3241.52

50.00

0

10

20

30

40

50

60

Opioids Sedative Hypnotics Stimulants Misc.

Mean Number of Months Between Dispensing and Donation

Monthly Donations/1,000 Residents

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0

50

100

150

200

250

S1 S2 S3 S4 S5 S6 S7 S8 Total

Mo

nth

ly A

vera

ge lb

s p

er

10

00

Re

sid

en

ts

Mo

nth

y A

vera

ge #

of

Pill

s p

er

10

00

Re

sid

en

ts

Average Monthly CS Donations per 1000 Residents, by Pounds and Number of Pills

Monthly pills per 1000 Monthly lbs per 1000

Pop. Over 10,000Pop. Under 10,000

American Journal of Public Health (Approved with Revision March 2015)

Combined

Amnesty and Take Back

0

10

20

30

40

50

60

Blountville Bristol Elizabethton Johnson City Jonesborough Average

1418

10.5

16.3

23

16.36

31.5

1122

4131.5

27.4

Pounds of Controlled Substances Collected from Amnesty Boxes and Drug Take Back Events, by Municipality, May 2013 - October 2014

Take Back Amnesty

0.0%

1.0%

2.0%

3.0%

4.0%

5.0%

6.0%

7.0%

8.0%

Percent Controlled Substance for Amnesty and Take Back Collections, May 2013-October 2014

Take Back

Amnesty

0

10

20

30

40

50

Pounds of Controlled Substances for Amnesty and Take Back Collections, May 2013-October 2014

Take Back

Amnesty

Donor Storage Tendencies

Number of Months Between Dispensing and Donation by Therapeutic Class

Class Mean Median

Take Back Amnesty Take Back Amnesty

Opioids 59 54 45 38

Sedative/ Hypnotics

57 43 40 28

Stimulants 42 42 32 22

Misc. 67 50 77 29

Conclusions

• Amnesty Box and traditional Take Back options are effective primary prevention mechanisms

• Amnesty Box donations outpace Live Take Back donations in the same municipalities (total & CS)

• CS donation percentage by weight is similar between the two options

• The number of CS dosage units collected is higher per capita for Amnesty Box donors

• Time from dispensing to donation is approximately six months earlier for Amnesty Box donations

Diversity-promoting Institutions Drug Abuse Research Program Team

NIH/NIDA R24 – Sponsored Research 2013-18

Pharmacy Track:Lessons Learned fromRx Disposal Programs

Presenters:

• Kathleen Egan, MS, Research Associate, Department of Social Science & Health Policy, Wake Forest School of Medicine

• Eric Gregory, EdD, CPS, Executive Director, Save Our Kids Coalition

• Jeffrey Gray, PharmD, RPh, Associate Professor, GattonCollege of Pharmacy, & Adjunct Professor, College of Public Health, East Tennessee State University

Moderator: Dan Smoot, Director of Drug Prevention & Education, Appalachia High Intensity Drug Trafficking Area (HIDTA)