Return of Unused Pharmaceuticals · 2018-04-14 · Mozambique, elaborate manual record -keeping...

Return of Unused PharmaceuticalsPromising Legal Responses to the Epidemic of Prescription Drug Overdoses in the

United States

December 2-3, 2008Centers for Disease Control and Prevention

4770 Buford Highway • Chamblee, Georgia 30341 • Building 106

Stevan Gressitt, M.D. Medical DirectorOffice of Adult Mental Health ServicesDepartment of Health and Human Services

This document was prepared as a presentation to the CDC. Neither the State of Maine, nor OAMHS, DHHS nor any of its employees makes any warranty, expressed or implied, or assumes any legal liability or responsibility for the accuracy, completeness, or usefulness of any information, product, or process disclosed, or represents that its use would not infringe on privately owned rights. Reference herein to any specific commercial products, process, or service by trade name, trademark manufacturer, or otherwise, does not necessarily constitute or imply its endorsement, recommendation, or favoring by the State of Maine, nor the OAMHS, DHHS. The opinions of the authors expressed herein do not necessarily state or reflect those of the State of Maine nor the OAMHS, DHHS and shall not be used for advertising or product endorsement purposes.

2Gressitt, Return of Unused Pharmaceuticals

Stevan Gressitt, M.D.Medical Director, OAMHS, DHHSState of MaineMaine Benzodiazepine Study GroupDrug Disposal GroupLorna Bullard, OAMHS, DHHSNovember 10-November 11, 2008 Portland Maine

Data courtesy of the National Drug Intelligence Center

3,049 of 3,469 law

enforcement agencies in the

NDTS sample responded for

an overall response rate of

87.9 percent.


• What drug poses the greatest threat to your area? (Choose only ONE.)

Powder cocaine O Heroin O Marijuana O Other dangerous drugs……...O

Crack cocaine O Methamphetamine… O MDMA (ecstasy) O Diverted pharmaceuticals……O

6

National Drug Intelligence Center National Drug Threat Survey- 2008

Question 1a- Greatest Drug Threat

New England Focus

Sum of percents may not add to 100.0% due to rounding.

New England Region is composed of: CT, ME, MA, NH, RI, and VT.

ME 12.8 20.3 9.1 1.2 0.0 16.4 0.0 0.0 40.2 0.0 100.0

VT 10.6 26.2 15.0 0.0 0.0 11.2 0.0 0.0 37.0 0.0 100.0

NH 14.4 5.7 41.8 0.0 0.0 12.9 0.0 2.2 23.0 0.0 100.0

MA 27.2 15.8 35.6 0.0 0.0 13.9 0.0 0.0 7.4 0.0 100.0

CT 0.0 43.6 35.2 0.0 0.0 19.0 0.0 0.0 2.3 0.0 100.0

RI 17.0 45.5 13.6 0.0 0.0 20.4 0.0 0.0 0.0 3.4 100.0

NE

Region 17.4 22.2 30.0 0.2 0.0 15.2 0.0 0.3 14.5 0.2 100.0

32.2

Mari-

juana

0.1 100.011.3 0.2 0.2 8.18.7 10.3

STATE

PERCENT REPORTING AS GREATEST DRUG THREAT BY STATE- SORTED BY PHARMACEUTICALS RESPONSE

Cocaine Crack Heroin

Powder

Meth MDMA ODDsIce Meth

No

Response

United

States 19.1

Pharms TOTAL

9.8

Gressitt, Return of Unused Pharmaceuticals

7

0

10

20

30

40

50

20

03

20

04

20

05

20

06

20

07

20

08

Maine

NE

US

Linear

(Maine)

Linear (NE)

Linear (US)

Maine NE US

2003 21.5 3 2.4

2004 30.7 4.9 3.1

2005 31.2 5.2 3.9

2006 32.9 9.3 3.9

2007 36.8 10.4 4.6

2008 40.2 14.5 8.1

Question 1a- Greatest Drug Threat


ONDCP will convene a

meeting later this year

with pharmaceutical

manufacturers to discuss

better labeling and patient

education regarding the

proper use and disposal of

controlled substance

prescription drugs. ( 2006)


Gressitt, Return of Unused Pharmaceuticals 11

� 2699§2700-A Title 22: HEALTH AND WELFARE� Subtitle 2: HEALTH � Part 5: FOODS AND DRUGS� Chapter 604: DISPOSAL OF UNUSED PHARMACEUTICALS HEADING: PL 2003, C. 679, §1 (NEW); §4 (AFF); EFFECTIVE 7/1/05 � §2700. Unused Pharmaceutical Disposal Program � 1. Establishment; purpose. There is established the Unused Pharmaceutical Disposal Program, referred to in this chapter as "the program." The purpose of the

program is to ensure the safe, effective and proper disposal of unused pharmaceuticals. For purposes of compliance with federal law and regulation, the return of pharmaceuticals under this section is deemed to be for law enforcement purposes.

� [ 2003, c. 679, §1 (NEW); 2005, c. 297, §3 (AFF) .] � 2. Administration. The program is administered by the Maine Drug Enforcement Agency, referred to in this chapter as "the agency," established in Title 25,

section 2955. � [ 2003, c. 679, §1 (NEW); 2005, c. 297, §3 (AFF) .] � 3. Return of pharmaceuticals. The agency shall create a system for the return of unused pharmaceuticals. The system must use prepaid mailing envelopes into

which the unused pharmaceuticals are placed and returned to a single collection location. The prepaid mailing envelopes must be made available to the public at various locations, including, but not limited to, pharmacies, physicians' offices and post offices. The agency may randomly assess the toxicity of materials received under the program as long as the assessment results do not identify the patient, person who mailed the material, prescriber or pharmacy.

� [ 2003, c. 679, §1 (NEW); 2005, c. 297, §3 (AFF) .] � 4. Disposal of pharmaceuticals. The agency shall ensure that only agency officers handle the unused pharmaceuticals received pursuant to subsection 3. The

unused pharmaceuticals must be disposed of by the agency in a manner that is designed to be effective, secure and in compliance with local, state and federal environmental requirements, including the federal Resource Conservation and Recovery Act of 1976, as amended.

� [ 2003, c. 679, §1 (NEW); 2005, c. 297, §3 (AFF) .] � 5. Unused Pharmaceutical Disposal Program Fund; funding. The Unused Pharmaceutical Disposal Program Fund, referred to in this chapter as "the fund," is

established within the agency to be used by the director of the agency to fund or assist in funding the program. Any balance in the fund does not lapse but is carried forward to be expended for the same purposes in succeeding fiscal years. The fund must be deposited with and maintained and administered by the agency. The agency may accept funds into the fund from any non-General Fund source, including grants or contributions of money or other things of value, that it determines necessary to carry out the purposes of this chapter. Money received by the agency to establish and maintain the program must be used for the expenses of administering this chapter.

� [ 2005, c. 297, §1 (AMD); 2005, c. 297, §3 (AFF) .] � 6. Rulemaking. The agency shall adopt rules to carry out the purposes of this chapter. Rules adopted pursuant to this subsection are routine technical rules as

defined in Title 5, chapter 375, subchapter 2-A. � [ 2003, c. 679, §1 (NEW); 2005, c. 297, §3 (AFF) .] � 7. Contingency. The program must operate with funding solely from the fund provided in subsection 5. The program may begin operation for 2 years on July 1st of

any year in which notice is given by April 1st by the director of the agency to the State Budget Officer that funding has been procured for the fund that is sufficient to operate the program for 2 years.

� [ 2005, c. 297, §2 (NEW); 2005, c. 297, §3 (AFF) .] � SECTION HISTORY 2003, c. 679, §1 (NEW). 2003, c. 679, §4 (AFF). 2005, c. 297, §§1,2 (AMD). 2005, c. 297, §3 (AFF). � Data for this page extracted on 10/24/2008 01:00:06. � The Revisor's Office cannot provide legal advice or interpretation of Maine law to the public.

If you need legal advice, please consult a qualified attorney. Office of the Revisor of Statutes7 State House Station State House Room 108 Augusta, Maine 04333-0007


� Guidelines for Safe Disposal of Unwanted Pharmaceuticals

� in and after Emergencies

� World Health Organization

� Churches’ Action for Health of the World Council of Churches

� ECHO International Health Services Ltd

� International Committee of the Red Cross

� International Federation of Red Cross and Red Crescent Societies

� International Pharmaceutical Federation

� International Solid Waste Association

� Médecins Sans Frontières

� Office of the United Nations High Commissioner for Refugees

� OXFAM

� Pharmaciens Sans Frontières

� United Nations Children’s Fund

� United Nations Industrial Development Organization

� © World Health Organization 1999

� This document is not a formal publication of the World Health Organization

(WHO), and all

� rights are reserved by the Organization. The document may, however, be freely

reviewed,

� abstracted, reproduced and translated, in part or in whole, but not for sale nor for

use in

� conjunction with commercial purposes.

� The views expressed in documents by named authors are solely the responsibility

of those

� authors.

� Ordering information

� Guidelines for the Safe Disposal of Unwanted Pharmaceuticals in and after

� Emergencies

� Interagency Guidelines

� 1999, 31 pages [E]

� WHO/EDM/PAR/99.2


16

Paper prepared for the Development Marketplace Grant 2000Paper prepared for the Development Marketplace Grant 2000

AEDES, WHO, World BankAEDES, WHO, World Bank

Abstract: The objectives of this project were to conduct situatiAbstract: The objectives of this project were to conduct situation analyses on drug donations in East Timoron analyses on drug donations in East Timor

(post(post--conflict country), El Salvador and Gujarat State in India (both conflict country), El Salvador and Gujarat State in India (both affected by earthquakes), and Mozambiqueaffected by earthquakes), and Mozambique

(floods), applying criteria derived from the Interagency Guideli(floods), applying criteria derived from the Interagency Guidelines for Drug Donations; to determine how andnes for Drug Donations; to determine how and

whether the implementation of the Guidelines has affected the prwhether the implementation of the Guidelines has affected the processes and outcomes of drug donations; and toocesses and outcomes of drug donations; and to

build evidence to facilitate wider acceptance of the Guidelines.build evidence to facilitate wider acceptance of the Guidelines. The study teams undertook to identify theThe study teams undertook to identify the

organizations responsible for inappropriate donations, a step noorganizations responsible for inappropriate donations, a step not often taken in earlier investigations. Thist often taken in earlier investigations. This

information can now be used to facilitate educational initiativeinformation can now be used to facilitate educational initiatives aimed at preventing similar problems in the future.s aimed at preventing similar problems in the future.

Awareness of the Guidelines was high and appropriate drug donatiAwareness of the Guidelines was high and appropriate drug donations were made in El Salvador, Gujarat State inons were made in El Salvador, Gujarat State in

India and East Timor. In Mozambique, it was found that even withIndia and East Timor. In Mozambique, it was found that even with strong recipient awareness of the Guidelines andstrong recipient awareness of the Guidelines and

country ownership of the drug donation process, dumping and inapcountry ownership of the drug donation process, dumping and inappropriate donations occurred. Internationalpropriate donations occurred. International

donors did not follow requests made by the Mozambique Governmentdonors did not follow requests made by the Mozambique Government, and disruption of administrative systems by, and disruption of administrative systems by

the floods affected capacity to ensure proper management of drugthe floods affected capacity to ensure proper management of drug supplies. In the four countries, drug needs in thesupplies. In the four countries, drug needs in the

first few days following the emergency were often met through bufirst few days following the emergency were often met through buffer stocks. A common feature noted in Gujarat,ffer stocks. A common feature noted in Gujarat,

East Timor and El Salvador was that, in most instances, adequateEast Timor and El Salvador was that, in most instances, adequate drug supplies were provided during the acutedrug supplies were provided during the acute

phase of the disaster through the use of local buffer stocks, asphase of the disaster through the use of local buffer stocks, as well as by major donor agencies with expertise inwell as by major donor agencies with expertise in

providing immediate disaster aid of good quality. In the case ofproviding immediate disaster aid of good quality. In the case of Gujarat, the presence of a large domesticGujarat, the presence of a large domestic

pharmaceutical production capacity in India significantly aided pharmaceutical production capacity in India significantly aided the swift response following the occurrence of thethe swift response following the occurrence of the

earthquake. In Mozambique, warehouses that contained buffer stocearthquake. In Mozambique, warehouses that contained buffer stocks were flooded. The effectiveness of logisticsks were flooded. The effectiveness of logistics

software systems was closely dependent on local capacity and sussoftware systems was closely dependent on local capacity and sustainability of the systems. The decision to usetainability of the systems. The decision to use

them for emergencies needs to be rethem for emergencies needs to be re--examined since the effectiveness of these tools is disputed. In examined since the effectiveness of these tools is disputed. In India andIndia and

Mozambique, elaborate manual recordMozambique, elaborate manual record--keeping systems that the local staff were familiar with and expekeeping systems that the local staff were familiar with and experienced inrienced in

maintaining, served as a better source of information than compumaintaining, served as a better source of information than computer based systems that were not updated, lackedter based systems that were not updated, lacked

functioning equipment and required staff knowledgeable in the usfunctioning equipment and required staff knowledgeable in the use of the program. In all four countries, noe of the program. In all four countries, no

evidence was found to suggest that improvements are needed to thevidence was found to suggest that improvements are needed to the Guidelines. However, there is a continuing neede Guidelines. However, there is a continuing need

for improved dissemination, mainly among specific donor groups sfor improved dissemination, mainly among specific donor groups such as bilateral organizations, diasporas anduch as bilateral organizations, diasporas and

smaller organizations. Such targeting of information on drug donsmaller organizations. Such targeting of information on drug donation practices would improve future outcomes.ation practices would improve future outcomes.


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