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CODE OF RHODE ISLAND RULES
AGENCY 14. DEPARTMENT OF HEALTH
SUB-AGENCY 130. PHARMACY BOARD
CHAPTER 001. PHARMACISTS, PHARMACIES AND MANUFACTURERS, WHOLESALERS AND DISTRIBUTORS
Date:
08/31/2009
Document:
14 130 001. PHARMACISTS, PHARMACIES AND MANUFACTURERS, WHOLESALERS AND DISTRIBUTORS
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Emergency Dispensing of Pharmaceuticals
21.10 Notwithstanding any other provision of these Regulations to the contrary, any practitioner authorized to deliver health care services at a facility licensed pursuant to the Rules and Regulations for Licensing Organized Ambulatory Care Facilities [R23-17-OACF] may dispense pharmaceuticals provided by the Director only during a period covered by a federal or state emergency declaration. However, all such emergency dispensing shall only be performed in accordance with specific written protocols provided by the Director for these pharmaceuticals.
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Immunization Administration Policies and Procedures
23.9 All immunizing pharmacists shall adhere to written policies and procedures that include no less than the following:
23.9.1 A statement of the procedures, decision criteria, or plan the pharmacist will follow when exercising the administration authority, including when to refer the patient to the physician/prescriber.
23.9.2 A statement of the procedures for emergency situations.
23.9.3 A statement of record keeping and documentation procedures.
23.9.4 A statement related to the handling and disposal of used or contaminated equipment and supplies.
23.9.5 A statement requiring that the pharmacy give the appropriate Vaccine Information Statement ( VIS ) to the patient or legal representative with each dose of immunization covered by these forms.
23.9.6 A statement that the pharmacy report adverse events to the Vaccine Adverse Events Reporting System (VAERS) and to the primary care provider, as identified by the patient.
23.9.7 If a patient is immunized pursuant to a valid prescription, a notation of such prescription shall be made in the patient's pharmacy profile.
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26.24 Written policies and procedures: Wholesale drug distributors and/or manufacturers shall establish, maintain and adhere to written policies and procedures, which shall be followed for the receipt, security, storage, inventory, and distribution of prescription drugs, including policies and procedures for identifying, recording, and reporting losses or thefts, and for correcting all errors and inaccuracies in inventories. Wholesale drug distributors and/or manufacturers shall include in their written policies and procedures the following:
(a) A procedure whereby the oldest approved stock of a prescription drug product is distributed first. The procedure may permit deviation from this requirement if such deviation is temporary and appropriate.
(b) A procedure to be followed for handling recalls and withdrawals of prescription drugs. Such procedure shall be adequate to deal with recalls and withdrawals due to:
(1) Any action initiated at the request of the Food and Drug Administration or other federal, state or local law enforcement or other government agency, including the Board;
(2) Any voluntary action by the manufacturer to remove defective or potentially defective drugs from the market, or
(3) Any action undertaken to promote public health and safety by replacing of existing merchandise with an improved product or new package design.
(c) A procedure to ensure that wholesale drug distributors and/or manufacturers prepare for, protect against, and handle any crisis that affects security for operation of any facility in the event of strike, fire, flood, or other natural disaster, or other situations of local, state, or national emergency.
(d) A procedure to ensure that any outdated prescription drugs shall be segregated from other drugs and either returned to the manufacturer or destroyed. This procedure shall provide for written documentation of the disposition of outdated prescription drugs. This documentation shall be maintained for two years after disposition of the outdated drugs.
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**Note: Only the section analyzed by the PHASYS team is included here as the entire regulation exceeded ~100 pages.
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