1 of 8 programmatic policy and procedure

D R A F T Y M u ñ i z 1 1 / 3 0 / 2 0 1 8 P a g e | 1 of 8

Santa Barbara County Department of Behavioral Wellness Office of Quality and Strategy Management

Alice Gleghorn, PhD

Section

Sub-section

Psychiatric Health Facility (PHF)

Medications

Effective:

Version:

8/24/2016

1.5

Policy Medication Disposal and Destruction Last Revised:

DRAFT

Director’s Approval Date

PHF Medical Director’s Approval

Date

Supersedes:

Approvals:

Medication Disposal and Destruction rev. 8/23/2017

PHF Medical Practice Committee:

Audit Date:

DRAFT

1. PURPOSE/SCOPE

1.1. To comply with all state and federal laws and regulations regarding the proper disposaland destruction of controlled and non-controlled medications.

2. DEFINITIONS

The following terms are limited to the purposes of this policy:

2.1. Licensed nursing staff (LNS) – an individual employed or contracted by the PHF whoholds a valid California license as a: registered nurse (RN); licensed vocational nurse (LVN); or licensed psychiatric technician (LPT).

2.2. Medication disposal – to remove a medication from inventory for any reason and discarding it into a designated collection receptacle until it can be processed and shipped for destruction. Also referred to as “medication wasting”.

2.3. Medication destruction – process utilized to render a medication “non-retrievable” by permanently altering the medication’s physical or chemical condition or state through irreversible means and thereby rendering the medication unavailable and unusable for all practical purposes.

2.4. Schedule II, III-V medications (“controlled medications”) – a classification of drugs as defined by the United States Controlled Substances Act that have a high potential for abuse and may lead to physical and psychological dependence. Disposal of Schedule II, III-V medications requires two (2) witness signatures, which can be either one (1) LNS and one (1) RN, or a pharmacist and one (1) RN. Preparation of Schedule II, III-V medications for destruction requires signatures by a pharmacist and a PHF RN.

Ole Behrendtsen, MD

Programmatic

Policy and Procedure

Exhibit 7h

PHF Policy: Medication Disposal and Destruction P a g e | 2 of 8


2.5. Pyxis MedStation – an automated dispensing system that performs the storage, dispensing, and distribution of medications.

2.6. Non-hazardous waste – any non-controlled medication that can be disposed of together in the same container without risk of chemical reaction.

2.7. Hazardous waste or P-Listed waste – pharmaceutical waste that is considered

hazardous and must be separated for disposal. P-Listed medications are those that pose an acute threat to the environment by contaminating fresh water. This includes but is not limited to warfarin, nicotine patches, epinephrine, nitroglycerin, insulin, lice treatment, vaccines, and wrappers of all P-Listed waste.

2.8. Incompatible container – a separate disposal container for aerosols, inhalers and other

pharmaceuticals that are pressurized.

3. POLICY

3.1. Medications that are found to be expired, abandoned, not released to the patient at discharge, refused, unverifiable, not administered and outside of its original unit dose packaging, partial-doses (i.e. half tablets, unused portions of single dose vials or leftover ampules) or contaminated will be disposed of and destroyed in accordance with Drug Enforcement Administration (DEA) regulations and this policy.

3.2. The PHF utilizes the Pyxis MedStation, an automated medication dispensing system or unit dose medication system. Disposal for medications removed from the Pyxis MedStation must be documented within the Pyxis MedStation system. A witness to medication disposal using the Pyxis MedStation system will have to provide digital authentication (by entering user name and bio ID or password) instead of a physical signature.

3.3. Controlled medications will be processed for disposal by either one (1) LNS and one (1)

RN, or a pharmacist and one (1) RN. Controlled medication disposal and preparation for destruction will be inputted and recorded within the Pyxis MedStation, or according to the procedure in Section 3.5 below. Controlled medications will be prepared for destruction by a pharmacist and retrieved by the pharmaceutical waste disposal vendor processed and packaged for shipment to the certified return distribution vendor. All processing and packaging will be carried out in the presence of a pharmacist and a PHF RN and signed by both witnesses.

3.4. Drugs not listed under Schedules II, III-V (hereafter “non-controlled medications”) will be

processed for disposal by the assigned Medication Nurse by either two (2) LNS, or a pharmacist and one (1) LNS. Medication disposal and preparation for destruction will be inputted and recorded within the Pyxis MedStation, or according to the procedure Section 3.5 below.



3.5. Medication disposal must be documented on the paper-based Controlled Medication Disposal Log (see Attachment A) or Non-Controlled Medication Disposal Log (see Attachment B) if:

1. The Pyxis MedStation system is inoperable (downtime procedures go into effect)1;

2. The medication is a patient’s own medication; or

3. The medication is an over-the-counter medication stored outside the Pyxis MedStation.

3.6. Staff responsible for medication disposal at the PHF may refer to the PHF Medication

Disposal Chart (see Attachment C) for quick step-by-step instructions on proper return and disposal of medications based on the medication’s classification (i.e., controlled vs. non-controlled) and type (e.g., stored in Pyxis MedStation, patients’ own medication).

3.7. All medication disposal logs will be retained onsite for at least 10 years from the term end date of the contract with the Department of Health Care Services (DHCS), or in the event the PHF has been notified that an audit or investigation of the contract has been commenced, until such time as the matter under audit or investigation has been resolved, including the exhaustion of all legal remedies, whichever is later. [42 CFR §438.3(h), 438.230(c)(3)(i-iii)]

4. MEDICATION RETURN

4.1. If a medication is removed from the Pyxis MedStation or other medication storage location, but is not administered to the patient for any reason, it may be returned to the Pyxis MedStation or other medication storage location.

1. Controlled medications removed from the Pyxis MedStation but not administered to the patient are returned to the bin designated specifically for returned controlled substances. A second licensed nursing staff (LNS) is required as a witness when returning controlled medications. When returning controlled substances to the Pyxis MedStation, at least one LNS and one RN must be present.

4.2. If the original unit dose packaging is not intact, the medication cannot be returned to the Pyxis MedStation and must be disposed.

5. CONTROLLED MEDICATION DISPOSAL AND DESTRUCTION PROCEDURE

5.1. Disposal of controlled medications must be completed by either one (1) LNS and one (1) RN, or a pharmacist and one (1) RN. When disposing of controlled medication, staff will place the controlled medication in a labeled, small envelope and deposit the envelope in the designated locked drop box stored in the PHF medication room. The small envelope will be labeled with the patient’s name, medication name, dosage, prescription number, number of pills and initials of one (1) LNS and one (1) RN. staff will place the medication

1 For more information on procedures during a Pyxis MedStation downtime period, see the Department’s “Pyxis Downtime” policy.



into the container designated specifically for the disposal of controlled substances. This disposal container is a one-way disposal path and pharmaceutical products placed in the container are non-retrievable. Elements in the container immediately deactivate the controlled substance.

1. All medications, including tablets, capsules, liquids and patches, may be placed directly into this disposal container. Liquid medications do not have to be placed in a separate vial or container prior to disposal.

5.2. The disposal container for controlled substances is locked at all times and will be permanently affixed to the wall in the PHF medication room.

5.3. The disposal will be documented on the patient’s individual Controlled Drug Record (see

Attachment C).

5.4. The disposal will be inputted and recorded into the Pyxis MedStation. The one (1) LNS and one (1) RN, or the pharmacist and one (1) RN completing the disposal must both provide digital authentication (by entering user name and bioID or password).

5.5. If the Pyxis MedStation system is inoperable, or the controlled medication is a patient’s

own medication, the disposal will be documented in the Controlled Medication Disposal Log (see Attachment A). All documentation must include:

1. Patient’s name;

2. Medication name and strength;

3. Prescription number;

4. Amount disposed;

5. Reason for disposal;

6. Date of disposal; and

7. Signature of one (1) LNS and one (1) RN, or a pharmacist and one (1) RN.

5.6. Only a pharmacist may possess the key providing direct access to the contents of the locked drop box disposal container for controlled substances.

5.7. When the disposal container has reached the max fill line, or a replacement disposal

container arrives at the PHF, a pharmacist will:

1. Replace the used disposal container with a new one;

2. Pour a solidifier into the used disposal container;

3. Place the used disposal container into the black pharmaceutical hazardous waste container; and

4. Request a pick-up of the black pharmaceutical hazardous waste container by the pharmaceutical waste disposal vendor.



5.8. Processing, packaging and shipment of controlled medication for destruction will be carried out by a pharmacist and PHF RN on a monthly basis at a minimum of every 90 days or more frequently as needed.

5.9. Destruction of controlled medication requires two (2) signatures. On the Controlled

Medication Disposal Log (Attachment A), this should be recorded under the column labeled “Destruction”. Signatures are required from:

1. A pharmacist; and

2. One (1) RN. 5.10. During processing, the pharmacist will input medication information electronically via the

certified return distribution vendor’s website. The pharmacist will provide the PHF Nursing Supervisor a printed inventory of all medications shipped for destruction.

5.11. All controlled medication will be packaged for shipment in the presence of the pharmacist and a PHF RN. The packaged controlled medication must be sealed and shipped to the certified return distribution vendor for destruction immediately.

6. NON-CONTROLLED MEDICATION DISPOSAL AND DESTRUCTION PROCEDURE

6.1. Non-controlled medication will be placed in the designated disposal container in the PHF medication room by either two (2) LNS, or a pharmacist and one (1) LNS. When disposing of non-controlled medications that are considered non-hazardous waste, staff will place medications into a container designated specifically for disposal of non-controlled medications. The disposal container will be removed from the PHF when the disposal container is at least ¾ full.

1. Liquid medications must be placed in the designated bottle or vial for non-controlled liquid disposal. The liquid cannot be poured directly into the container. Once a liquid medication is placed in a bottle, it must be placed into the disposal container and cannot be reused for future liquid disposals.

6.2. P-listed waste must be disposed of in the P-listed container labeled “RCRA Hazardous

Waste Container”. These medications will be specially marked as P-listed by a pharmacist.

1. The contents of the P-listed disposal container must not exceed 2.2 lbs. A pharmacist will weigh the container on a weekly basis and remove and replace the disposal container when the weight gets to around 2 lbs.

6.3. Inhalers and other aerosols must be placed in the incompatible container labeled

“Hazardous Pharmaceutical Waste Pressurized Aerosols and Inhalers.”

6.4. All disposals will be inputted and recorded into the Pyxis MedStation. Staff completing the disposal must both provide digital authentication (by entering user name and bioID or password).

6.5. If the Pyxis MedStation system is inoperable, or a patient’s own medication or an over-the-counter medication must be processed for disposal, the disposal will be documented



in the Non-Controlled Medication Disposal Log (see Attachment B). All documentation must include:

1. Patient’s name;

2. Medication name and strength;

3. Prescription number (if applicable);

4. Amount disposed;

5. Reason for disposal;

6. Date of disposal; and

7. Signature of two (2) LNS or a pharmacist and one (1) LNS. 6.6. Destruction of non-controlled medication requires two (2) signatures. On the Non-

Controlled Medication Disposal Log (Attachment B), this should be recorded under the column labeled “Destruction”. Signatures are required from:

1. A pharmacist; and

2. One (1) RN. 6.7. Non-controlled medications that require disposal and are still bubble-packed do not have

to be placed in the designated disposal container. These non-controlled medications can remain in the packaging until the scheduled monthly destruction. LNS will log the disposal on the Non-Controlled Medication Disposal Log (see Attachment B) as set forth in Sections 5.1 and 5.2 of this policy. The bubble-packs will be placed in the designated disposal storage area in the PHF Medication Room until they can be removed and destroyed by the pharmacist.

7. ONGOING MONITORING

7.1. All medications are reviewed upon delivery and on a nightly basis. Staff will monitor expiration dates, potential contaminations and other circumstances to ensure such medications are disposed promptly.

8. DOCUMENTATION

8.1. Disposal documentation is stored within the Pyxis MedStation system and can be generated and printed upon request. Disposal information is available within the system for up to 10 years.

8.2. The completed paper medication disposal logs will be stored in the medication room in a binder labeled “Medication Disposal Log Book” with the date range indicated. Filled binders will be stored off unit in a secured storage space for a period of at least three (3) years. At the end of that time the documents will be securely shredded to prevent exposure of confidential medical information.



REFERENCE

California Code of Regulations – Social Security Title 22, Section 77079.10(c)(1)-(2)

Code of Federal Regulations – Drug Enforcement Administration, U.S. Department of Justice Title 21, Part 1317, Section 1317.95

Code of Federal Regulations – Public Health Title 42, Sections 438.3(h), 438.230(c)(3)(i-iii)

ATTACHMENTS

Attachment A – Controlled Medication Disposal Log

Attachment B – Non-Controlled Medication Disposal Log

Attachment C – Controlled Drug Record

Attachment D – PHF Medication Disposal Chart

RELATED POLICIES

PHF Medication Disposal and Destruction

Pyxis Medication Disposal

Pyxis Downtime REVISION RECORD

DATE VERSION REVISION DESCRIPTION

9/13/16 1.1 Added partial-doses as a type of medication subject to disposal procedures.

Added the Controlled Drug Record as required documentation for controlled medication disposal.

Explained contracted pharmacist’s responsibility to input controlled medications to be destroyed into the certified return distribution vendor’s website.

9/25/16 1.2 Added definitions for “medication disposal” and medication destruction”.

Removed definition of “manifest”.

1/23/17 1.3 In Section 2.4, clarified that Disposal of Schedule II, III-V medications require two (2) witness signatures by one (1) LNS and one (1) RN.

In Section 3.2, clarified that controlled medications are processed and packaged for shipment to the certified return distribution vendor for destruction by the contracted pharmacist and a PHF RN.

In Section 4.1.1, clarified that controlled medication disposal envelopes must be labeled with the initials of one (1) LNS and one (1) RN.



Added Section 6, Medication Review and Monitoring.

8/16/17 1.4 In Section 5.2, clarified the disposal of non-controlled medications requires two (2) witness signatures by licensed staff; this is, either two (2) LNS, or one (1) LNS and a pharmacist.

In Section 5.5, clarified the preparation for the destruction of non-controlled medications requires two (2) witness signatures by a pharmacist and one (1) LNS.

10/15/18 1.5 Incorporated Pyxis MedStation storage and documentation procedures.

Introduced PHF Medication Disposal Chart.

Culturally and Linguistically Competent Policies The Department of Behavioral Wellness is committed to the tenets of cultural competency and understands that culturally and linguistically appropriate services are respectful of and responsive to the health beliefs, practices and needs of diverse individuals. All policies and procedures are intended to reflect the integration of diversity and cultural literacy throughout the Department. To the fullest extent possible, information, services and treatments will be provided (in verbal and/or written form) in the individual’s preferred language or mode of communication (i.e. assistive devices for blind/deaf).

CONTROLLED MEDICATION DISPOSAL LOGPsychiatric Health Facility

PATIENT NAMEMEDICATION Name/

StrengthRX#

AMOUNT

DISPOSEDREASON FOR DISPOSAL

DATE

DISPOSEDDISPOSED OF BY + Witness

(signatures)

**This form is to be used for CONTROLLED medication disposal ("WASTE") - either one (1) LNS and one (1) RN, or a pharmacist and one (1) RN

Updated 11/2/2018 Attachment A

NON-CONTROLLED MEDICATION DISPOSAL LOGPsychiatric Health Facility

PATIENT NAMEMEDICATION Name/

StrengthRX#

AMOUNT

DISPOSEDREASON FOR DISPOSAL

DATE

DISPOSEDDISPOSED OF BY + Witness

(sinatures)

**This form is to be used for NON-CONTROLLED medication disposal ("WASTE") - either two (2) LNS, or a pharmacist and one (1) LNS

Updated 11/2/2018 Attachment B

PHF MEDICATION DISPOSAL CHART

Revised 12/7/18

The information within this chart applies to medications prescribed (and verified, if patients’ own med) and actively being administered to patients. For example, this chart addresses

the scenario in which a patient’s own medication has been verified and ordered for administration while the patient is at the PHF instead of being locked and stored in a security bag.

If a medication is not administered for any reason:

If packaging is intact...

If packaging is

NOT intact...* Disposal process: Disposal documentation:

Pharmacy-Dispensed Controlled Medication

Return to the bin designated specifically for returned controlled substances in Pyxis MedStation.

Follow disposal procedures.

Place into container designatedspecifically for disposal of controlledsubstances.

All medications (e.g., tablets, capsules,liquids, patches) placed directly in thecontainer. No separate bottle needed forliquids.

Record disposal in Pyxis MedStation.

Digital authentication:

1 LNS and 1 RN; OR

1 pharmacist and 1 RN

If Pyxis MedStation inoperable, use Controlled Medication Disposal Log (Att. A).

Patients’ Own Medication (Controlled)

Return to designated storage area.


Place medication into containerdesignated specifically for disposal ofcontrolled substances.

All medications (e.g., tablets, capsules,liquids, patches) placed directly in thecontainer. No separate bottle needed forliquids.

Record disposal in Controlled Medication Disposal Log (Att. A).

Physical signatures:

1 LNS and 1 RN; OR

1 pharmacist and 1 RN

Non-Controlled Medication

Return to original medication bin in Pyxis MedStation.


For all non-controlled medications:

Non-Hazardous: Place into containerdesignated specifically for disposal ofnon-controlled medications.

P-listed: Place into container labeled“RCRA Hazardous Waste Container”.

Inhalers/Other Aerosols: Place intoincompatible container labeled“Hazardous Pharmaceutical WastePressurized Aerosols and Inhalers”.

Liquid medications must be placed in a designated bottle or vial prior to disposal. Liquids cannot be poured directly into the container.

Record disposal in Pyxis MedStation.

Digital authentication:

2 LNS; OR

1 pharmacist and 1 LNS

If Pyxis MedStation inoperable, use Non-Controlled Medication Disposal Log (Att. B).

Patients’ Own Medication

(Non-controlled)

Return to designated storage area.


Record disposal in Non-Controlled Medication Disposal Log (Att. B).


2 LNS; OR


Over-the-Counter

Medication Return to storage area.


Record disposal in Non-Controlled Medication Disposal Log (Att. B).


2 LNS; OR


Attachment C

PHF MEDICATION DISPOSAL CHART

Revised 12/7/18

* Other reasons for medication disposal...

medication is expired

only partial doses remain

medication has been contaminated

medication has entered a room in which the patient is on Isolation Precautions

What is digital authentication?

When witnessing a medication disposal, enter user name and bio ID or password into the Pyxis MedStation system insteadof a physical signature.

For more information, see these policies:

PHF Medication Disposal and Destruction

Pyxis Medication Disposal

Pyxis Downtime

1 of 8 programmatic policy and procedure

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