Section 325.14423. Additional medication controls; labeling and packaging; compiling list of pharmaceutical reference materials; automatic stop orders; monthly review of client case record; development of written emergency procedure for programs using controlled substances as part of chemotherapeutic regimen; development of formulary of pharmaceuticals; control records; inspections; development of policies to define qualifications of staff members; verbal orders for medication;

acceptance and receipt of controlled substances.

(1) A dispensed drug shall be labeled and packaged according to R 338.479, administered by the board of pharmacy of the Michigan department of commerce, and the regulations  of  the  food  and  drug administration and the consumer product safety commission. The provisions of 21 C.F.R. S291.505 (April 1, 1978) and 16 C.F.R. S1700.14 (May 14, 1973) are incorporated in these rules by reference. Copies  of  21  C.F.R. S291.505  and  16  C.F.R.   S1700.14  may  be obtained from the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402, at a cost of $4.25 or from the Center for Substance Abuse Services, Department of Public Health, 3500 North Martin Luther King, Jr.Blvd., P.O. Box 30035, Lansing, Michigan 48909, at a cost of $4.25.

(2)   The coordinator of the medication control component shall compile a list of up-to-date pharmaceutical reference materials to be procured and made available on- site.

(3)   There shall be automatic stop orders in dispensing all medications.

(4)         A program  that uses controlled   substances  as  part of  a chemotherapeutic regimen shall develop a written emergency procedure to be implemented in the case of an employee strike, fire, or other  emergency situation which would stop,  or  substantially  interfere   with,  normal dispensing procedures. The emergency procedure shall include  all  of  the following:

(a)   Arrangements with security providers for immediate security of   drug stocks.

(b)     Written  agreements,  updated   annually,  with  back-up  medical personnel, such as a physician or nurses, for the  coverage  of   dispensing and other medical needs if regular personnel are not available.

(c)   A reliable system to  confirm the  identities  of  clients  before dispensing.

(d)   Written agreements, updated annually, for the use of an alternate program, hospital, or other site for dispensing   during   an   emergency period.

(5)   The individual in charge of medication control shall, with the advice of licensed  staff  physicians,  develop   a  formulary   of   those pharmaceuticals that are to be used in the program. The formulary shall serve as a program's catalog of approved therapeutic agents and shall include information regarding the use, dosage, contraindications, and unit dispensing size of the agents. There shall be a procedure for adding drugs and dosage forms to, or deleting them from, the formulary. There shall  be a mechanism for notifying appropriate staff  members  of  changes  in  the formulary.

(6)    Prescriptions, medication orders, narcotic records, and inventory control records shall be kept in an organized and easily retrievable manner, shall be maintained in accordance with federal and state law, and shall be retained by a program for not less than 5 years.

(7)   At least quarterly, the individual in charge of  medication   control shall make an inspection of all drug storage areas, medication centers, and nurse stations to insure that these areas are maintained in compliance with federal, state, and local regulations. A dated record  of  these inspections shall be maintained  to   verify  that  all of  the   following requirements are met:

(a)   Disinfectants and drugs for external use are stored separately from oral and injectable drugs.

(b)      Drugs that require special conditions for storage to insure stability are properly stored.

(c)   Containers for bulk storage for flammable liquids comply with local fire safety regulations.

(d)  No outdated drugs are stocked.

(e)   Distribution, administration, and receipt of controlled drugs are adequately documented.

(f)   Controlled substances and other  abusable  drugs   are  stored  in accordance with federal, state, and program rules and regulations.

(g)   Drugs listed in the formulary are in adequate and proper supply.

(h)     Copies of the formulary  and  other   program  drug-related   rules  and regulations are available in appropriate areas.

(i)    Metric and apothecary weight and measure  conversion   charts  are posted where needed.

(8)    A program shall develop policies that define the qualifications for staff members who dispense and administer medications. These policies shall be in accordance with laws and regulations governing such acts and shall be approved in writing by the governing authority.

(9)   A verbal order for medication shall be given  only  by   a  program physician and shall be received only by another physician, a pharmacist, or a registered or licensed practical nurse. When a verbal or telephone order is given, it shall be authenticated in writing by a   physician  not  later than 48 hours after the order was originally given.

(10)   A supply of controlled substances that is delivered to a program shall be accepted and receipted by a licensed physician, pharmacist, registered nurse, or licensed practical nurse.

History: 1981 AACS.