WSR 04-23-092



(Board of Pharmacy)

[ Filed November 17, 2004, 9:21 a.m. , effective November 17, 2004 ]

Purpose: The proposed rule will alleviate a serious problem in nursing home/extended care facilities concerning the mass accumulation of outdated, discontinued, or unwanted controlled substance prescriptions. Currently, these facilities do not have a legitimate method to destroy these prescriptions. The proposed amendment will address the problem by allowing pharmacies to obtain a controlled substance registration to receive outdated, discontinued, and/or unwanted controlled substances from nursing home/extended care facilities.

Citation of Existing Rules Affected by this Order: Amending WAC 246-865-060.

Statutory Authority for Adoption: RCW 18.64.005.

Under RCW 34.05.350 the agency for good cause finds that immediate adoption, amendment, or repeal of a rule is necessary for the preservation of the public health, safety, or general welfare, and that observing the time requirements of notice and opportunity to comment upon adoption of a permanent rule would be contrary to the public interest.

Reasons for this Finding: The board has determined that the accumulation of outdated, unwanted, and deteriorated controlled substance prescriptions in nursing homes and/or extended care facilities poses a threat to public health and safety. Large amounts of controlled substances in these facilities provide an opportunity for staff members to divert and abuse these substances. Adoption of the rule amendment will protect the public from the illegal distribution of controlled substances.

Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.

Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 1, Repealed 0.

Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 0, Repealed 0.

Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.

Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 1, Repealed 0.

Date Adopted: June 1, 2004.

October 1, 2004

George Roe

Board Chair


AMENDATORY SECTION(Amending WSR 94-02-077, filed 1/5/94, effective 2/5/94)

WAC 246-865-060   Pharmaceutical services.   (1) Administration of pharmaceutical services.

(a) There shall be provision for timely delivery of drugs and biologicals from a pharmacy so a practitioner's orders for drug therapy can be implemented without undue delay.

(b) Unless the nursing home operates a licensed pharmacy and employs a director of pharmaceutical services, the nursing home shall have a written agreement with one or more licensed pharmacists who provide for pharmaceutical consultant services. The staff pharmacist or consultant pharmacist supervises the entire spectrum of pharmaceutical services in the nursing home.

(c) There shall be a pharmaceutical services committee whose membership includes at least a staff or consultant pharmacist, a physician, the director of nursing or his/her designee, and the administrator or his/her designee. The pharmaceutical services committee develops and maintains written policies and procedures for safe and effective drug therapy, distribution, control, and use which are current and followed in practice.

(d) Reference material regarding the use of medication, adverse reactions, toxicology, and poison control center information shall be available to facility staff.

(e) There shall be procedures established for the reporting and recording of medication errors and adverse drug reactions.

(2) A staff pharmacist or consultant pharmacist shall be responsible for coordinating pharmaceutical services which include:

(a) Provision of pharmaceutical services evaluations and recommendations to the administrative staff.

(b) On-site reviews to ensure that drug handling and utilization procedures are carried out in conformance with recognized standards of practice.

(c) Regularly reviewing each resident's therapy to screen for potential or existing drug therapy problems and documenting recommendations.

(d) Provision of drug information to the nursing home staff and physicians as needed.

(e) Planning and participating in the nursing home staff development program.

(f) Consultation regarding resident care services with other departments.

(3) Security and storage of drugs.

(a) The nursing home shall store drugs under proper conditions of sanitation, temperature, light, moisture, ventilation, segregation, and security as defined by regulation and accepted standards of practice.

(b) All drugs shall be stored in locked cabinets, rooms, or carts, and shall be accessible only to personnel licensed to administer or dispense drugs.

(c) Schedule III controlled substances shall be stored apart from other drugs on a separate shelf or in a separate compartment or cabinet, provided, however, Schedule III controlled substances may be stored with Schedule II controlled substances. Schedule III controlled substances can be stored with other drugs when distributed in a unit dose drug distribution system.

(d) Drugs for external use shall be stored apart from drugs for internal use, on a separate shelf or in a separate compartment or cabinet. Any shelf, compartment, or separate cabinet used for storage of external drugs shall be clearly labeled to indicate it is to be used for external drugs only.

(e) At all times, all keys to drug boxes, cabinets, and rooms shall be carried by persons legally authorized to administer drugs and on duty on the premises.

(f) If a supplemental dose kit within a unit dose drug distribution system is provided it must comply with WAC 246-865-040.

(g) If an emergency kit is provided, it shall comply with Washington state board of pharmacy regulations WAC 246-865-020 and 246-865-030.

(4) Labeling of drugs.

(a) The label for each legend drug which is not dispensed in a unit dose shall have the name and address of the pharmacy from which the drug was dispensed; the prescription number; the physician's name; the resident's full name; the date of issue; the initials of the dispensing pharmacist; the name and strength of the drug; a controlled substances schedule, if any; the amount (e.g., number of tablets or cc's) of the drug dispensed, and the expiration date. In the case of a compounded drug which contains Schedule II or III controlled substances, the quantity of each controlled substance per cc or teaspoonful shall be shown on the label.

(b) In a unit dose drug distribution system, a clear, legible label shall be printed or affixed securely to each unit dose package. Each unit dose drug label shall include: the name, strength and, for each unit dose package, the dosage amount of the drug; the expiration date for any time-dated drug; the lot or control number; and controlled substances schedule number, if any. Each individual drug compartment shall be labeled with the full name of the resident whose drug the compartment contains and the name of the resident's physician.

(c) Nonlegend drugs shall be clearly labeled with at least the patient's name, date of receipt by the facility, as well as display a manufacturer's original label or a pharmacy label if repackaged by the pharmacist. Nonlegend drugs supplied by the extended care facility pursuant to WAC 388-88-050 need not be labeled with the patient's name.

(d) A label on a container of drugs shall not be altered or replaced except by the pharmacist. Drug containers having soiled, damaged, incomplete, or makeshift labels shall be returned to the pharmacy for relabeling or disposal. Drugs in containers having no labels or illegible labels shall be destroyed.

(5) Control and accountability.

(a) The nursing home shall maintain and follow written procedures which provide for the accurate control and accountability of all drugs in the nursing home.

(b) No drugs may be returned from the nursing home to a pharmacy except as provided in paragraph (4)(d) or if the drug is returned in unopened unit dose packages.

(c) Drugs shall be released to a resident upon discharge only on specific written authorization of the attending physician. A receipt containing information sufficient to document the drug's destination, the person who received the drug, and the name and quantity of drugs released shall be entered in the resident's health record.

(d) All of an individual resident's drugs including Schedule III, IV and V controlled substances, that are discontinued by the physician and remain unused, shall be destroyed by a licensed nurse employee of the nursing home in the presence of a witness within 90 days after having been discontinued, and accurate records of destruction maintained except ((from)) for drugs which are sealed in unit dose packages or when procedures in subsection (7) of this section are utilized.

(e) Outdated, unapproved, contaminated, deteriorated, adulterated, or recalled drugs shall not be available for use in the nursing home.

(f) Except in the case of Schedule II controlled substances and drugs which are sealed in unit dose packages, drugs which remain in the nursing home after the patient has died or been discharged, and drugs in containers with illegible or missing labels, shall be immediately and irretrievably disposed of by a licensed nurse employee in the presence of a witness and proper records maintained of such disposal. Destruction of Schedule II drugs shall be handled in accordance with (6)(g). Unit dose packages may be returned to the pharmacy.

(6) Special requirements for controlled substances.

(a) All Schedule II controlled substances shall be stored in separately keyed and locked secure storage within a drug facility.

(b) Schedule III controlled substances shall be stored apart from other drugs and may be stored on a separate shelf, drawer, or compartment with Schedule II controlled substances.

(c) There shall be a record book for Schedule II and Schedule III controlled substances which shall be a bound book with consecutively numbered pages in which complete records of receipt and withdrawal of Schedule II and III controlled substances are maintained.

(d) At least once each 24 hours, the amount of all Schedule II controlled substances stored in the facility shall be counted by at least two persons who are legally authorized to administer drugs. A similar count shall be made of all Schedule III controlled substances at least weekly. Records of counts shall be entered in the Schedule II and III controlled substances book(s).

(e) When a resident is discharged, a record of release for any Schedule II or III controlled substances released shall be entered on the appropriate page for the given drug in the controlled substances record book.

(f) Any discrepancy in actual count of Schedule II or III controlled substances and the record shall be documented in the Schedule II or III controlled substances books and reported immediately to the responsible supervisor who shall investigate the discrepancy. Any discrepancy which has not been corrected within seven calendar days shall be reported to the consultant pharmacist and the Washington state board of pharmacy.

(g) Discontinued Schedule II controlled substances and all Schedule II controlled substances which remain after the discharge or death of residents shall:

(i) Be destroyed at the nursing home within 30 days by two of the following individuals: A licensed pharmacist, the director of nursing or a registered nurse designee, and a registered nurse employee of the nursing home with appropriate documentation maintained, or

(ii) Be destroyed at the nursing home by a representative of the Washington state board of pharmacy if so requested by the board or the nursing home, or

(iii) Be returned to a pharmacy authorized to receive Schedule II controlled substances as provided in subsection (7) of this section.

(h) A nursing home may establish procedures which vary from those paragraphs (6)(a)(g) if they are using a unit dose drug distribution system and if that system provides for the accurate accounting, by the nursing home and the supplying pharmacy, of the receipt and disposition of all Schedule II and III controlled substances.

(7) Return of controlled substances to contracted pharmaceutical services pharmacy.

(a) The board may issue a controlled substance registration solely for the purpose of return and disposal of excess and unusable controlled substances to a contracted pharmacy which provides services under subsection (1)(b) of this section.

(b) The applicant pharmacy shall submit its policies and procedures to the board identifying the extended care facility(ies) with which it contracts and specifying its methods of accountability, including periodic controlled substances audits. The contracted pharmacy is responsible for ensuring compliance with the policies and procedures. Revisions of its policies and procedures must be submitted to the board.

(c) The distribution of excess and unusable controlled substances from the extended care facility is limited to:

(i) The contracted pharmacy issued a controlled substances registration under this section, or

(ii) A state and DEA licensed reverse distributor employed by the contracted pharmacy.

(d) The board may rescind the registration issued under this section for failure of the contracted pharmacy to comply with the requirements of this section. The proceedings to rescind the registration shall be conducted consistent with chapter 34.05 RCW. The failure to comply may also serve as grounds for disciplinary action against licenses under chapter 18.130 RCW.

(8) Drug administration.

(a) Staff shall follow written procedures which provide for the safe handling and administration of drugs to residents.

(i) Drugs shall be administered only by persons licensed to administer drugs.

(ii) The resident shall be identified prior to administration.

(b) All drugs shall be identified up to the point of administration.

(c) Drugs shall be prepared immediately prior to administration and administered by the same person who prepares them except under a unit dose system.

(d) Drug administration shall be documented as soon as possible after the act of administration, and shall include:

(i) Verification of administration

(ii) Reasons for ordered doses not taken

(iii) Reasons for administration of, and response to drugs given on ((and)) an as needed basis (PRN).

(e) Drug orders shall be received only by a licensed nurse and administered only on the written or verbal order of a practitioner. Verbal orders shall be signed by the prescribing practitioner in a timely manner.

(f) The self-administration of medication program shall provide evidence of:

(i) Assessment of the resident's capabilities

(ii) Instructions for administration

(iii) Monitoring of progress and compliance with orders

(iv) Safe storage of drugs.

[Statutory Authority: RCW 18.64.005. 94-02-077, 246-865-060, filed 1/5/94, effective 2/5/94; 92-12-035 (Order 277B), 246-865-060, filed 5/28/92, effective 6/28/92. Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW. 91-18-057 (Order 191B), recodified as 246-865-060, filed 8/30/91, effective 9/30/91. Statutory Authority: RCW 18.64.005. 88-11-007 (Order 214), 360-13-066, filed 5/9/88. Statutory Authority: RCW 18.64.005(11). 81-14-055 (Order 161), 360-13-066, filed 6/30/81.]

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