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CALIFORNIA SOCIETY OF HEALTH-SYSTEM PHARMACISTS
PROPOSAL IN STP FORMAT
PROPOSAL:
Drug Take-Back
SUBMITTED BY:
Board of Directors
DATE:
July 15, 2016
PROPOSAL I
SITUATION:
1.
CSHP Professional Policy #2010-04 directs CSHP to adopt ASHP policies and other
guidance documents as CSHP Professional Policy
2.
To adopt as CSHP policy all ASHP Policy Positions, Guidelines, Bulletins, and all official
Statements in the current edition of the Best Practices for Health-System Pharmacy of the
ASHP, except when such policies differ substantially from CSHP policy.
3.
To endorse the use of ASHP Position Statements, Guidelines, and Technical Assistance
Bulletins by its members in their practice settings.
4.
CSHP will review all ASHP Policy Positions by 2020 for possible adoption as CSHP
Professional Policy.
5.
The Centers for Disease Control and Prevention and the National Institute on Drug Abuse
reports nearly 26,000 prescription drug overdose deaths in 2014 and nearly 19,000
overdose deaths from opioid prescription drugs in 2014. Annual overdose deaths from
heroin have skyrocketed since 2011 to more than 10,500 in 2014. A lesser known fact is
that most waste-water treatment facilities do a poor job of removing drugs from wastewater and sewage before releasing the treated water back into the environment. The
California Medical Waste Management Act addresses medical and pharmaceutical waste
in healthcare facilities.
Senate Bill 966 (Simitian, Chapter 542, Statutes of 2007) requires the California Integrated
Waste Management Board (CIWMB) to develop model programs for the collection from
consumers and proper disposal of unused or expired home-generated pharmaceuticals,
which will also remove a source of drug diversion that can help decrease drug abuse and
death from the illegal use of such drugs. A Model Home-Generated Pharmaceutical Waste
Collection and Disposal Program was developed in California in collaboration with several
state agencies, including the Board of Pharmacy to help remove pharmaceutical waste
generated by ultimate users from entering the uncontrolled waste stream and waste water.
New California Pharmacy regulations on prescription drug collection and take-back are the
culmination of these endeavors. DEA regulations below specify that illicit drugs may not be
disposed of in prescription drug take-back collection containers, and only Schedule II-V
controlled substances legally possessed may be disposed of in such collection containers.
Hospitals, as DEA registrants, may not lawfully take possession of or destroy controlled
substances brought by patients/ultimate users into the facility. Controlled substances from
such users should be provided to any person lawfully entitled to retain, hold, or dispose of
the patient’s or decedent’s property, and only such person may dispose of the
pharmaceutical controlled substances. California drug take-back regulations do not
supersede DEA regulations.
CALIFORNIA SOCIETY OF HEALTH-SYSTEM PHARMACISTS
PROPOSAL IN STP FORMAT
On September 9, 2014, in Docket DEA-316, the Drug Enforcement Administration
published its final rule on the disposal of controlled substances, which implemented the
Secure and Responsible Drug Disposal Act of 2010 by expanding the options available to
collect controlled substances from ultimate users for the purpose of disposal, including:
Take-back events, mail-back programs, and collection receptacle locations. These
regulations went into effect on October 9, 2014 and allow authorized manufacturers,
distributors, reverse distributors, narcotic treatment programs (NTPs), hospitals/clinics with
an on-site pharmacy, and retail pharmacies that choose to participate to administer mailback programs and maintain collection receptacles for controlled substances. These
regulations also permit authorized hospitals/clinics and retail pharmacies to maintain
collection receptacles at long-term care facilities.
The Board of Pharmacy has developed [proposed regulations as of initial date of this
policy] corresponding state regulations in Article 9.1 Prescription Drug Take-Back
Programs and 16 CCR Section 1776 Prescription Drug Take-Back Programs:
Authorization, that specifies the Board of Pharmacy requirements so that pharmacies,
hospitals/clinics with onsite pharmacies, distributors and reverse distributors licensed by
the board and licensed skilled nursing facilities may offer the specified prescription drug
take-back services to the public to provide options for the public to destroy unwanted,
unused or outdated controlled or non-controlled prescription drugs. Each of these entities
must comply with regulations of the federal Drug Enforcement Administration and the
Board of Pharmacy regulations contained in this article. The Board of Pharmacy currently
opposes AB 45 (Mullin) Household Hazardous Waste and AB 1069 (Gordon) Prescription
Drugs: Collection and Distribution Program unless amended.
6.
ASHP has policy 0614 Safe Disposal of Patients’ Home Medications that addresses this
topic in regard to advocating for and creating models and education for such processes.
ASHP does have an October 20, 2014 FAQ on the DEA rule titled “Frequently Asked
Questions: DEA Rule on the Disposal of Controlled Substances (DEA-316).”
7.
CPhA has a policy on Disposal of Waste Medications and Medical Supplies that is also in
broad terms and not specific to drug take-back.
8.
CSHP has policy 2013-26 Safe Disposal of Patients’ Home Medications that mirrors ASHP
policy 0614:
CSHP supports minimizing the patient safety consequences and public health impact of
inappropriate disposal of patients' home medications by working collaboratively with
other interested organizations to:
Develop models for patient-oriented medication disposal programs that will minimize
accidental poisoning, drug diversion, and potential environmental impact;
Encourage that the pharmaceutical industry and regulatory bodies support the
development and implementation of such models; and
Educate health professionals, regulatory bodies, and the public regarding safe disposal
of unused home medications.
CALIFORNIA SOCIETY OF HEALTH-SYSTEM PHARMACISTS
PROPOSAL IN STP FORMAT
TARGET:
1.
CSHP provides resources to its members, their patients, and the public per the 2012-2015
Strategic Plan.
2.
CSHP develops professional policy in congruence with other professional organizations, but
adopts policy as an independent professional society.
3.
CSHP has a professional policy on drug take-back in alliance with Drug Enforcement
Administration and California State Board of Pharmacy regulations, in addition to current
policy 2013-26. An alternative to the proposal below is to add, “Encourages hospitals and
pharmacies to participate in the DEA and Board of Pharmacy drug take-back programs
when practical” to policy 2013-26 and rename the policy “Safe Disposal of Patients’ Home
Medications and Drug Take-Back.”
PROPOSAL:
Adopt the following as CSHP Professional Policy:
The California Society of Health-System Pharmacists:
1. Supports the endeavors of the State of California and the Drug Enforcement
Administration to decrease the abuse of prescription opioid and non-opioid drugs
and decrease deaths due to illegal use of these drugs by collecting such drugs from
ultimate users in authorized take-back drug collection bins located at law
enforcement facilities, registered hospitals with pharmacies, registered pharmacies,
and skilled nursing facilities.
2. Encourages hospitals and pharmacies that are unable to participate in the DEA and
Board of Pharmacy drug take-back programs to provide information on where in
the community expired or no longer needed prescription medications from home
are being collected for destruction.
3. Encourages pharmacists or their trained designee to educate patients and others on
the disposal of prescription medications that are out of date or no longer being
used by disposing of them in drug take-back collection containers located at
specified law enforcement facilities, hospitals, and pharmacies registered to collect
and dispose of such drugs to help protect the environment and help remove opioid
and non-opioid prescription drugs from the street, where they can lead to
overdoses and death.
CSHP BOARD ACTION: The CSHP Board of Directors has approved this proposal for
consideration by the 2016 House of Delegates.