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SOP 4.21: Managing Pharmaceuticals - sop for compounding pharmacy




SOP 4.21: Managing Pharmaceuticals


Contents
1. Introduction 1
2. Regulatory requirements 1
3. Health and safety precautions 2
4. Accepting and managing pharmaceuticals at an HHW facility 2
5. Accepting pharmaceuticals utilizing a local law enforcement mobile collection event 3
6. Accepting pharmaceuticals utilizing a local law enforcement drop-off container 6

Attachment A: Identifying Controlled Substances 7
Attachment B: Example Template Letter from Program to Minn. Board of Pharmacy 8


1. Introduction

Household generated pharmaceutical waste includes all expired, unwanted or unusable prescriptions or over-the-counter medications used by family members or pets. This Standard Operating Procedure (SOP) guidance is specific to on-going collection of pharmaceutical waste at a household hazardous waste (HHW) facility for the sole purpose of proper disposal; additional requirements apply to events conducted with law enforcement. Pharmaceuticals may only be collected if this Program is in complete compliance with this SOP. This SOP specifically prohibits the possession of controlled substance pharmaceuticals as defined by the Drug Enforcement Administration (DEA). BE ADVISED that there is a growing market for all pharmaceuticals and a high potential for diversion. The procedures described in this SOP are intended to obstruct any potential for inappropriate possession.

2. Regulatory requirements

Before considering a pharmaceutical take-back program, be well informed of local, state and federal requirements. The HHW programs are restricted in their ability to collect certain pharmaceuticals due to federal DEA regulatory limitations related to possession. Only law enforcement agencies may possess controlled substances that have been dispensed to an ultimate user. In order to collect waste pharmaceuticals from households for the purpose of disposal, an entity must notify the Minnesota Pollution Control Agency (MPCA) at least 30 days in advance.
Collectors shall also comply with Minnesota Board of Pharmacy (telephone: 651-201-2825 or
612-344-4130, or facsimile: 612-348-1968). Statutes related to legend (prescription)
pharmaceuticals 151.37 and 151.44, Minnesota Hazardous Waste Rules 7045.0320 and 7045.0292,
subp. 6, very small quantity generator (VSQG) regulations, the MPCA Program Management Decision dated January 18, 2011, which allows collection and management of household pharmaceutical waste in accordance with Minn. R. 7045.0310, and all applicable metropolitan or county licensing, fee, and ordinance requirements.

3. Health and safety precautions

3.1 Staff handling pharmaceuticals shall use Personal Protective Equipment (PPE) to prevent exposure; see SOP 2.4, Personal Protective Equipment.
3.2 Due to their extreme toxicity, it is recommended no chemotherapy pharmaceutical waste is accepted. If this Program does choose to accept this waste, the processing procedures shall be posted and strictly followed.
3.3 The Program shall not dispose of pharmaceutical wastes in the trash or by sewering to either an
on site or municipal sewer system. Improper disposal of pharmaceutical wastes results in adverse impacts on human, aquatic/animal health, and/or the environment.
3.4 This Program is responsible for implementing safe and secure management practices. Keep alert for suspicious activities or behaviors, and take immediate action if danger threatens staff and/or property; see SOP 4.15, Security Issues.
3.5 This Program shall not respond to, or attempt to control, spill situations requiring assistance beyond the capabilities of facility staff. This Program shall make prior agreements with appropriate response teams to use in emergency situations; see SOP 2.6, Spill Response.

4. Accepting and managing pharmaceuticals at an HHW facility

The designated staff for proper pharmaceutical waste management at this Program is the Facility Manager. This HHW Program may accept pharmaceutical wastes from households and VSQG business generators (if licensed as a VSQG Consolidation Site) using the following guidelines:
4.1 Accepting household generated pharmaceuticals.
4.1.1 Unacceptable pharmaceuticals materials include controlled substances and chemotherapy or radioactive wastes; see Attachment A of this SOP.
4.1.2 Prohibited pharmaceutical wastes shall remain in the possession of the participant. Staff shall attempt to provide disposal information to ensure proper management of unacceptable wastes.
4.1.3 Note: All pharmaceuticals have potential value; rendering them unusable immediately upon receipt is important to ensure the facility is not targeted for theft. This Program shall not accept any pharmaceutical considered a controlled substance. Possession of a controlled substance that has been dispensed to an ultimate user by anyone other than the person to whom they are prescribed or to law enforcement is a federal offense and is punishable by fines and/or prison. Immediately upon receipt, render all pharmaceutical waste non-recoverable by:
• prepare a quart-sized can by filling it half full with oil base paint or waste oil;
• add pharmaceutical waste to container and mix with the contents to destroy all chemical constituents;
• seal the filled container and lab-pack into a 14-gallon or smaller fiber drum. No inventory is required for this direct charge incineration stream; and
• label the container following the HW disposal contractor recommendations. For additional questions on pharmaceutical waste packaging or processing, contact the Program’s HW disposal contractor.
[If different than listed above, insert this Program’s pharmaceutical destruction process here. Any alternative destruction process must be reviewed by the MPCA]
4.2 Accepting business generated pharmaceuticals at a VSQG licensed consolidation site.
4.2.1 Prior to transport into the facility, review each request received from a business requesting pharmaceutical disposal to determine whether or not the wastes can be accepted. Verify the business’s (clinic, pharmacy or hospital) HW generator size; see www.pca.state.mn.us/waste/epaID/. This Program may specify additional pre-acceptance criteria and may request the pharmaceutical waste be non-recoverable prior to delivery.
4.2.2 Inform the business that it is illegal for the Program to accept controlled substances and that they will be required to sign and date a statement to verify that no controlled substances will be presented for disposal. Use available resources to confirm no controlled substances will be presented for disposal; see Attachment A of this SOP.
4.2.3 Ensure drug content information on each pharmaceutical container remains intact; inform the business to deliver the pharmaceutical waste in an outer package. Immediately upon receipt, render all pharmaceutical waste non-recoverable: see section 4.13 of this SOP and lab pack in accordance with HW disposal contractor and DOT requirements.

5. Accepting pharmaceuticals utilizing a local law enforcement mobile collection event

Hosting a pharmaceutical take-back collection event is an environmentally responsible choice and a wonderful service to the public.
5.1.1 It is important to be well informed before embarking upon a local take-back program, which requires the following notifications:
• The MPCA pharmaceutical collection site notification form http://www.pca.state.mn.us/index.php/view-document.html?gid=15592;
• An HW ID generator number if pharmaceuticals are to be collected either at a fixed site (drop-off box) or mobile event, or if the event is located somewhere other than an HHW facility. The MPCA staff can assist in obtaining an HW ID generator number;
• DEA notification and program pre-approval: provide a description of your pharmaceutical take-back program to: Jack L. Henderson, Diversion Group Supervisor, Minneapolis/St. Paul District Office; telephone: 612-344-4130; fax: 612-348-1968; or
e-mail Jackie.l.henderson@usdoj.gov.
• Regulation checklist. All collected pharmaceuticals must be shipped off site using a licensed law enforcement officer or HW hauler at the end of the event day (do not store any pharmaceutical waste after the event). Ensure the final method of destruction is incineration at a solid waste MPCA-approved incinerator within the State of Minnesota. Keep necessary tracking of paperwork and/or certification of destruction.
5.1.2 Personnel required on site
• If not transporting collected pharmaceuticals to a solid waste licensed incinerator within the State of Minnesota, you must use qualified staff (pharmacists, HW contractor, or trained HHW staff) to properly sort, identify and inventory incoming wastes, and determine if it is classified as a controlled substance or a Resource Conservation and Recovery Act of 1976 (RCRA) hazardous waste, or regulated by the DEA or the Minnesota Department of Health; see Attachment A of this SOP.
Note: if disposal will be solid waste incineration within the State of Minnesota, no sorting of collected HW pharmaceuticals will be required, except for segregating out the items listed in 5.15;
• A law enforcement officer must be present for the entire duration of the event;
• Law enforcement may request HHW Program assistance; staff should assist wherever needed; and
• An event greeter to welcome participants and oversee surveys; keep track of the number of participants utilizing the collection event as this will need to be reported annually to the MPCA.
5.1.3 Advertise prior to event
• Inform the local media at least two weeks in advance of the event and post signs in local pharmacies. Provide clear location instructions;
• Use the event as an opportunity to educate the public on the importance of proper pharmaceutical disposal and safety issues related to pills and drugs stored at home;
• Ensure the event is located in a highly visible location.
• Information included on event flyers may include:
✓ Bring pharmaceuticals in their original containers, if possible.
✓ Prior to bringing in the pharmaceuticals, block out personal information with markers but keep information about the pharmaceutical contents legible.
✓ Do not remove labels.
✓ No sharps (provide specific instructions on separation and containerization if Program is choosing to also collecting sharps during event).
✓ No thermometers (provide specific instructions on separation and containerization if Program is choosing to also collecting thermometers during event).
✓ No medical waste will be accepted or items contaminated with body fluids (bandaging, empty
IV bags, etc.).
✓ List other unacceptable wastes.
✓ Pharmaceuticals will be incinerated.
✓ No refunds.
✓ Pharmaceuticals will immediately be rendered non-recoverable or removed from the event site for destruction.
5.1.4 Supplies needed during event
• large table for pharmaceutical turn-in and counting;
• chair for each individual processing waste;
• pens, paper, clipboards, permanent markers, packing tape, hand sanitizer, and counting trays;
• a tracking mechanism (form) to document participants and waste generation totals;
• reference materials to identify unknown pharmaceuticals; assume waste to be a controlled substance if there are no clear indicators. See Attachment A of this SOP;
• HW containers to place in-coming pharmaceuticals into; the HW contractor may also provide the necessary bins.
5.1.5 A separate collection container will be needed for each of the following:
1. controlled and non-controlled substances (keep separated in five-gallon pail or large plastic bag);
2. loose pharmaceuticals (Ziploc® bags; label with the name of the pharmaceutical if it can be determined. Law enforcement officers may require other evidence bags);
3. mercury items (bucket with kitty litter; must be dealt with separately which may require an alternate disposal service);
4. any materials under pressure;
5. sharps; (unused Epipens may be placed in the HW containers if needle is not exposed);
6. cancer medications (potentially radioactive); and
7. trash and recycling (for solid waste or non-pharmaceutical materials such as sun block, chap stick, hand lotion, extra packaging).
5.1.6 All staff handling loose or uncontained pharmaceuticals shall wear PPE to avoid dermal exposure, absorption, and/or inhalation, including:
1. latex or vinyl gloves (discard used gloves in HW bins);
2. white coat or Tyvek apron;
3. face mask (optional for individuals counting pharmaceuticals); and
4. high visibility traffic vests (for survey staff and those unloading vehicles).
5.1.7 Event layout for event
• Ensure clear roles are established for all individuals assisting at the event;
• Ensure pharmacist and law enforcement officer arrive at the staging site at least
one-half hour prior to event start to set up and organize the proposed procedure. Instruct the law enforcement officer to remain until the non-controlled pharmaceuticals are secured and/or locked in the HW transport vehicle;
• Create a layout for the event that reduces the risk of diversion. Place the law enforcement officer in a position that prevents public access from the rear; and
• Keep food or beverages away from the pharmaceutical area to prevent contamination.
5.1.8 Disposal of pharmaceutical wastes
• Obtain a copy and keep for your records any manifests or waste inventories as verification that the law enforcement officer took possession of the controlled pharmaceuticals and that proper disposal took place. Disposal amounts of all pharmaceutical wastes will need to be reported annually to the MPCA.

6. Accepting pharmaceuticals utilizing a local law enforcement drop-off container

The public is allowed to bring in waste pharmaceuticals to pre-approved take-back locations. For more information see: http://www.pca.state.mn.us/index.php/view-document.html?gid=17100
Attachment A

Identifying Controlled Substances

NOTE: Absolute identification of controlled substances typically requires the specialized and technical knowledge of a certified pharmacist or hazardous waste hauler. The following is meant only as a general guideline in determining chemical constitution.

Pharmaceutical waste shall be examined at the time of drop off. Staff accepting pharmaceutical materials shall attempt to learn as much as possible from the participant and verify container markings to determine contents. Staff shall immediately assess container integrity; leaking items shall immediately be placed into secondary containment.

Pharmaceutical waste classified or regulated as a RCRA HW shall be properly packaged and stored in compliance with Minnesota HW and DOT regulations. Pharmaceutical waste may be its own specific waste stream, be listed as HW (D, P, or U waste code) or display RCRA hazardous characteristics. HHW Programs are not allowed to accept controlled substances. Use the following web link to determine if a specific pharmaceutical waste qualifies as a controlled substance:
http://www.deadiversion.usdoj.gov/schedules/index.html#list

Attachment B


Example Template Letter from Program to Minn. Board of Pharmacy


To: Minn. Board of Pharmacy
2829 University Avenue, Suite 530
Minneapolis, MN 55414-3251
Telephone: 651-201-2825


From: Program:
County:
Street Address
City, State Postal Code
Telephone






I am providing notification of and protocol to conduct drug disposal events where we will take in unused pharmaceuticals from patients or their family members, including:

1. List methods to prevent diversion.


2. List intended safety measures to be in place for individuals working the event.


3. List intended safety measures to be in place for individuals bringing in waste pharmaceuticals for disposal.

This information is being provided as a courtesy. Please recognize I am also working with the
Drug Enforcement Agency and the Minnesota Pollution Control Agency to obtain approval to ensure correct acceptance and disposal of the incoming pharmaceutical wastes. Removing these pharmaceuticals from the possibility of potential abuse and keeping them out of the environment is important to all of us.

Sincerely,



(county name)
(county office information)

cc: (event host, pharmacist, other personnel or event team members)

What are the requirements to open a compounding pharmacy? The compounding pharmacy must be registered with BNDD and DEA as a distributor since controlled substances will be sent to other registered practitioners and not just dispensed to patients as a retail pharmacy;