Cal. Code Regs. tit. 15 § 1216

Current through Register 2024 Notice Reg. No. 20, May 17, 2024
Section 1216 - Pharmaceutical Management
(a) The health authority in consultation with a pharmacist and the facility administrator, shall develop written plans, establish procedures, and provide space and accessories for the secure storage, the controlled administration, and disposal of all legally obtained drugs. Such plans, procedures, space and accessories shall include, but not be limited to, the following:
(1) securely lockable cabinets, closets, and refrigeration units;
(2) a means for the positive identification of the recipient of the prescribed medication;
(3) procedures for administration/delivery of medicines to incarcerated persons as prescribed;
(4) confirming that the recipient has ingested the medication or accounting for medication under self-administration procedures outlined in Section 1216(d);
(5) that prescribed medications have or have not been administered, by whom, and if not, for what reason;
(6) prohibiting the delivery of drugs by incarcerated people;
(7) limitation to the length of time medication may be administered without further medical evaluation; and,
(8) limitation to the length of time required for a physician's signature on verbal orders.
(9) A written report shall be prepared by a pharmacist, no less than annually, on the status of pharmacy services in the institution. The pharmacist shall provide the report to the health authority and the facility administrator.
(b) Consistent with pharmacy laws and regulations, the health authority shall establish written protocols that limit the following functions to being performed by the identified personnel:
(1) Procurement shall be done by a physician, dentist, pharmacist, or other persons authorized by law.
(2) Storage of medications shall assure that stock supplies of legend medications shall be accessed only by licensed health personnel. Supplies of legend medications that have been dispensed and supplies of over-the-counter medications may be accessed by either licensed or non-licensed personnel.
(3) Repackaging shall only be done by a physician, dentist, pharmacist, or other persons authorized by law.
(4) Preparation of labels can only be done by a physician, dentist, pharmacist or other persons, either licensed or non-licensed, provided the label is checked and affixed to the medication container by the physician, dentist, or pharmacist before administration or delivery to the incarcerated person. Labels shall be prepared in accordance with section 4076, Business and Professions Code.
(5) Dispensing shall only be done by a physician, dentist, pharmacist, or persons authorized by law.
(6) Administration of medication shall only be done by licensed health personnel who are authorized to administer medication acting on the order of a prescriber.
(7) Delivery of medication may be done by either licensed or non-licensed personnel, e.g., custody staff, acting on the order of a prescriber.
(8) Disposal of legend medication shall be done in accordance with pharmacy laws and regulations and requires any combination of two of the following classifications: physician, dentist, pharmacist, or registered nurse. Controlled substances shall be disposed of in accordance with the Drug Enforcement Administration disposal procedures.
(c) Policy and procedures on "over-the-counter" medications shall include, but not be limited to, how they are made available, documentation when delivered by staff and precautions against hoarding large quantities.
(d) Policy and procedures may allow self-administration of prescribed medications under limited circumstances. Policies and procedures shall include but are not limited to the following considerations:
(1) Medications permitted for self-administration are limited to those with no recognized abuse potential. Medications for treatment of tuberculosis, psychotropic medication, controlled substances, injectables and any medications for which documentation of ingestion is essential are excluded from self-administration.
(2) Incarcerated persons with histories of frequent rule violations of any type, or who are found to be in violation of rules regarding self-administration, are excluded from self-administration.
(3) Prescribing health care staff document that each incarcerated person participating in self-administration is capable of understanding and following the rules of the program and instructions for medication use.
(4) Provisions are made for the secure storage of the prescribed medication when it is not on the incarcerated person.
(5) Provisions are made for the consistent enforcement of self-medication rules by both custody and health care staff, with systems of communication among them when either one finds that an incarcerated person is in violation of rules regarding self-administration.
(6) Provisions are made for health care staff to perform documented assessments of an incarcerated person's compliance with self-administration medication regimens. Compliance evaluations are done with sufficient frequency to guard against hoarding medication and deterioration of the person's health.

Cal. Code Regs. Tit. 15, § 1216

1. Editorial correction of Note filed 9-30-82 (Register 82, No. 40).
2. Change without regulatory effect (Register 86, No. 32).
3. Change without regulatory effect (Register 88, No. 17).
4. Amendment of subsections (a), (a)(9) and (b) filed 8-4-94; operative 9-5-94 (Register 94, No. 31).
5. Amendment of section heading and section filed 1-26-98; operative 2-25-98 (Register 98, No. 5).
6. Amendment of subsections (a)(3), (a)(6), (b)(4), (d) and (d)(2)-(6) filed 11-17-2022; operative 1-1-2023 (Register 2022, No. 46).

Note: Authority cited: Section 6030, Penal Code. Reference: Section 6030, Penal Code.

1. Editorial correction of NOTE filed 9-30-82 (Register 82, No. 40).
2. Change without regulatory effect (Register 86, No. 32).
3. Change without regulatory effect (Register 88, No. 17).
4. Amendment of subsections (a), (a)(9) and (b) filed 8-4-94; operative 9-5-94 (Register 94, No. 31).
5. Amendment of section heading and section filed 1-26-98; operative 2-25-98 (Register 98, No. 5).
6. Amendment of subsections (a)(3), (a)(6), (b)(4), (d) and (d)(2)-(6) filed 11-17-2022; operative 1/1/2023 (Register 2022, No. 46).