§ 4.112.040. Establishment of procedures and protocols.

(a)

Required Procedures and Protocols. Prior to commencing a voluntary drug repository and distributor program, the Chief Executive Officer of the San Mateo Medical Center shall establish procedures and protocols that ensure compliance with Health and Safety Code Division 116 "Surplus Medication Collection and Distribution," sections 150200 et seq. and any amendments thereto. These procedures and protocols shall address, at a minimum, all of the following:

(1)

Establishing eligibility for medically indigent patients who may participate in the program;

(2)

Ensuring that patients eligible for the program shall not be charged for any medications provided under the program;

(3)

Developing a formulary of medications appropriate for the repository and distribution program;

(4)

Ensuring proper safety and management of any medications collected by and maintained under the authority of a County-owned or County-contracted, licensed pharmacy;

(5)

Ensuring the privacy of individuals for whom the medication was originally prescribed;

(6)

Ensuring that medication donated to the repository and distribution program shall comply with the requirements specified in Health and Safety Code Division 116 shall meet all of the following criteria:

(i)

The medication shall not be a controlled substance,

(ii)

The medication shall not have been adulterated, misbranded, or stored under conditions contrary to standards set by the United States Pharmacopoeia (USP) or the product manufacturer,

(iii)

The medication shall not have been in the possession of a patient or any individual member of the public, and in the case of medications donated by a skilled nursing facility, shall have been under the control of staff of the skilled nursing facility.

(7)

Ensuring that only medication that is eligible for donation is donated. The medication must be in unopened, tamper-evident packaging or modified unit dose containers that meet USP standards and provided lot numbers and expiration dates are affixed;

(8)

Ensuring that pharmacists use their professional judgment in determining whether donated medication meets the standards of this division before accepting or dispensing any medication under the repository and distribution program;

(9)

Ensuring that pharmacists adhere to standard pharmacy practices, as required by state and federal law, when dispensing all medications;

(10)

Ensuring that medication that is donated to the repository and distribution program shall be handled in any of the following ways:

(i)

Dispensed to an eligible patient,

(ii)

Destroyed,

(iii)

Returned to a reverse distributor.

(11)

Ensuring medication that is donated to the repository and distribution program that does not meet the requirements of Health and Safety Code Division 116 shall not be distributed under the program and shall be either destroyed or returned to a reverse distributor. This medication shall not be sold, dispensed, or otherwise transferred to any other entity;

(12)

Ensuring that medication donated to the repository and distribution program shall be maintained in the donated packaging units until dispensed to an eligible patient under the program, who presents a valid prescription;

(13)

Ensuring that medication that is dispensed to an eligible patient is in a new and properly labeled container, specific to the eligible patient and ensuring the privacy of the individuals for whom the medication was initially dispensed;

(14)

Ensuring that expired medication is not dispensed;

(15)

Ensuring that medication donated to the repository and distribution program is segregated from the pharmacy's other drug stock by physical means, for purposes including, but not limited to, inventory, accounting and inspection;

(16)

Ensuring that the pharmacy keeps complete records of the acquisition and disposition of medication donated to and dispensed under the repository and distribution program. These records shall be kept separate from the pharmacy's other acquisition and disposition records and shall conform to the Pharmacy Law contained in Chapter 9 commencing with section 4000, of Division 2 of the Business and Professions Code and any amendments thereto, including being readily retrievable;

(17)

Protocols established pursuant to this chapter shall conform to the Pharmacy Law regarding packaging, transporting, storing, and dispensing all medications.

(b)

Medications that Require Refrigeration. All protocols established for packaging, transporting, storing, and dispensing medications that require refrigeration, including, but not limited to, any biological product as defined in section 351 of the Public Health and Service Act (42 U.S.C. Sec. 262), an intravenously injected drug, or an infused drug, include specific procedures to ensure that these medications are packaged, transported, stored, and dispensed at their appropriate temperatures and in accordance with USP standards and the state Pharmacy Law.

(Ord. 4302, 03/28/06)