Section 325.14422. Medication control; qualification of individual in charge; formulation of written policies and procedures required; written policy for medication removal in absence of pharmacist required; reporting medication errors and adverse drug reactions; dispensing medication orders and prescriptions; orders that involve abbreviations and chemical symbols; prescribing drugs with abuse potential; informing client of benefits and hazards of drug; observation of medication ingestion during clinic visit; provision for self-administration of drugs with abuse potential.

(1) The individual in charge of medication control shall be a duly licensed  physician  or  duly  licensed  pharmacist,   unless  another licensed medical staff member is authorized in writing by the physician  or pharmacist. A registered nurse or licensed practical nurse, in conjunction with the licensed physician, shall formulate   written  policies   and procedures for all of the following:

(a)   The safe storage, handling, prescribing, and dispensing of drugs, especially controlled substances, investigational  drugs,   and  hazardous drugs and chemicals.

(b)      Controlling  the  activities  of  representatives  of  pharmaceutical manufacturers and suppliers who make contact with the program.

(c)   Procuring drugs, chemicals, and  pharmaceutical   preparations  in accordance with the provisions of 21 C.F.R. SS1305 and 1301.74(2).

(d)  Pharmaceutical services to be provided by outside resources.

(e)   Recordkeeping.

(2)   There shall be a written policy that designates which licensed practitioner is authorized to remove medications from the pharmacy or bulk storage area when a pharmacist is not available. This policy shall assure that only prepackaged, properly labeled drugs   are     removed     and     removed only in amounts sufficient to meet

immediate therapeutic  needs.   A   written record of such withdrawals shall be  made  and shall  be   verified   by   a pharmacist.

(3)   A medication error and adverse  drug   reaction  shall   be  reported promptly to the responsible physician and to the coordinator   of  the medication control component. A dated entry of the medication given and any drug reaction shall be recorded in  the  client's  case  record.   The coordinator shall take steps to insure that any unexpected or significant adverse drug reactions   are  reported  to  the  federal food and drug administration and to the manufacturer and are reported in  a  manner that does not violate the client's right to confidentiality.

(4)   Only medication orders and prescriptions that originate within  the program shall be dispensed by the program pharmacy or  administered   by licensed medical staff members.

(5)   An order that involves abbreviations and chemical symbols shall  be carried out only if it appears on a list of approved abbreviations and symbols. An order for medication and a dose of medication administered on-site shall be recorded in the client's case record using a standardized form and in a manner that complies with established program policy.

(6)   The prescribing of drugs  that   have  abuse   potential  shall  be undertaken only when all of the following requirements have been met:

(a)   There is a written set of policies and procedures covering the use of these drugs in the program.

(b)   A staff physician has reviewed the  client's  case  record  and  has entered into the record the reasons for prescribing the given drug.

(c)   The drug to be prescribed appears in the program's formulary.

(7)      Before  the   initiation  of  chemotherapy   utilizing    controlled substances other than methadone, the client and, where required by law, the parent or guardian shall be informed both orally and in writing,  in the client's native language if possible, of the benefits and hazards of the drug to be ordered. The information given shall include all of the following:

(a)  The drug to be ordered.

(b)   What the drug is expected to accomplish.

(c)   The method and frequency of administration.

(d)  The drug's ability to bring about a state of physiological or psychological dependence, or both.

(e)   Where applicable, the nature of the tolerance that may develop with continued use, as well as the ordered drug's ability to  affect  the client's tolerance to other drugs.

(f)  The dangers of the use of the ordered drug in conjunction with other drugs.

(g)   A general description of adverse reactions.

(h)   Emergency procedures to be followed when there is an adverse reaction, overdose, or withdrawal.

(i)   What alternative therapies exist to treat the problem and what the risks and benefits are of each.

(8)   At the time of a clinic visit, a client shall ingest medication under the direct observation of the dispensing licensed practitioner. There shall be only 1 client in the dispensing area at a time.

(9)    When drugs with abuse potential are dispensed to clients for self- administration, the  reasons  shall  be  clearly   documented  in  the client's case record.

(10)   If a program permits the self-administration of drugs with abuse potential, there shall be a written policy governing such activity. The policy shall require that decisions to permit self-administration be based on individual needs and be undertaken in a manner that complies  with  any  laws and regulations   applicable  to  such   acts. Such   policy   shall   be approved by the governing authority.

(11)     A client who receives drugs for self-administration shall be given instructions concerning the safe storage and usage of such drugs and the appropriate emergency procedures, especially when   there  are children living with the client.

History: 1981 AACS.