GUIDELINE FOR THE DEVELOPMENT OF PROTOCOLS FOR MEDICATION REPLACEMENT, BY THE AFFILIATED MEDICAL CONTROL SERVICE HOSPITAL TO AN ADVANCED LIFE SUPPORT (ALS) AMBULANCE

Purpose: To assist hospitals in developing written protocols for EMS Services at the Advanced Life Support (ALS) level (including Intermediate and Paramedic level of service) to obtain replacement medications from the affiliate hospital pharmacy.

Regulation:  Hospital Licensure Regulation 105 CMR 130.1502 (M)
Each hospital which provides a Medical Control Service shall establish policies and procedures through which the EMS Service may obtain medications from the hospital’s pharmacy.

Guideline: Hospital policies and procedures include but are not limited to the following provisions for EMS personnel to obtain replacement medications from authorized hospital personnel.  

Protocols define when replacement medications are to be provided to EMS personnel, e.g., after patient use of a medication, when the medication is expired, the seal is broken or the label is illegible, incomplete, missing. 

Protocols include provisions for medication replacement during pharmacy hours of operation, during hours when the pharmacy is not in operation, and/or emergency situations.

Protocols address patient billing and recordkeeping to ensure patients are not charged by more than one entity. 

Hospital personnel ensure that:
•	An affiliation agreement exists between the Hospital and the EMS Service;
•	The Ambulance Service has a valid Advanced Life Support (ALS) provider license from the MDPH, Office of Emergency Medical Services, and a valid Massachusetts Controlled Substance Registration (MCSR) from the MDPH, 
Drug Control Program (DCP);
•	A list of all EMT personnel authorized to administer controlled substances is provided to the hospital by the EMS Service and is revised as applicable to ensure it is current; 
•	EMT personnel (Paramedic/Intermediate) have valid identification and are included on the list of EMT personnel who are authorized to administer 
controlled substances;
•	Medications provided by the hospital pharmacy are limited to certain types and quantities of approved medications (in accordance with OEMS protocol and approved controlled substance schedules from the MDPH, DCP).  A list of such medications is readily available to applicable hospital staff.
•	The Ambulance Service Medication Order Form (ASMOF) is complete;
•	The ASMOF record for all controlled substances is maintained in the pharmacy;
•	EMT personnel record their signature for medications received;
•	Hospital personnel record their signature for medications delivered;
•	The appropriate deductions are recorded on the perpetual inventory for controlled substances.

Related Statute/Regulations:

Massachusetts General Laws Chapter 94C

105 CMR 700.000, et seq. - DPH, Drug Control Program regulations

In accordance with EMS regulations 105 CMR 170.300 (A) (9), an Affiliation Agreement must include policies and procedures for EMS Services to obtain medications from the hospital’s pharmacy.

Please note: Paramedics can receive one for one exchange of Schedule II and IV controlled substances stock from a hospital pharmacy with which the Service has an affiliation agreement for medication exchange.  Intermediate EMTs may only have access to Schedule VI controlled substances and can only exchange Schedule VI drugs, as the item is used for a specific patient.