DEPARTMENT OF COMMUNITY HEALTH

               MENTAL HEALTH AND SUBSTANCE ABUSE ADMINISTRATION

                  METHADONE TREATMENT AND OTHER CHEMOTHERAPY

(By authority conferred on the director of the department of community health 
by section 6231 of 1978 PA 368, MCL  333.6231  and  Executive  Reorganization 
Order Nos. 1991-3, 1996-1, and 1997-4, MCL 333.36321, 330.3101, and 333.26324)


R 325.14401   Drug treatment; license required.
  Rule 401. A program shall  not  employ  a  treatment   modality   using   a 
controlled substance unless it is  licensed  to  provide   service   in   the 
outpatient, inpatient, or residential service category and  complies  with  R 
325.14402 to R 325.14423.

  History:  1981 AACS.


R 325.14402   Prescription drugs; nonexistence of federal or state  rules for 
use in treatment programs.
  Rule 402. If neither federal nor state rules exist specific to  the  use of 
prescription drugs in treatment programs, the treatment  programs   that  use 
such drugs shall include,  at  a  minimum,  a   complete   medical   history, 
comprehensive physical examination, and the necessary  laboratory  tests  for 
each patient at admission.

  History:  1981 AACS.


R 325.14403   Medical staffing patterns.
  Rule 403. (1)  A  program  licensed  under  this  part   shall   employ   1 
full-time physician, duly licensed and  registered,  per   300   clients   to 
deliver the medical services described in this part. This  ratio   shall   be 
maintained in programs serving less than 300 clients.
  (2) A program licensed under this part shall employ  2  full-time   nurses, 
duly licensed and registered, per 300 clients to  administer  medication  and 
deliver other nursing services. This ratio shall be  maintained  in  programs 
serving less than 300 clients.
  (3) A physician's  assistant,  duly  licensed  and   registered,   may   be 
utilized to meet up to 30% of the physician's hours if   supervised   by   an 
approved physician as specified in section 16103(1) of the act.

  History:  1981 AACS.


R 325.14404   Medical director; designation;  medical  director   and   other 
physicians; responsibilities; minimum client-physician encounters.
  Rule 404. (1) A program shall have a  designated   medical   director   who 
assumes responsibility for the  administration  of   all   medical   services 
performed by the  program.  The  medical  director   and   other   authorized 
program physicians shall be licensed to practice in   the   jurisdiction   in 
which the program is located. The medical director   shall   be   responsible 
for ensuring that the program complies with all federal,  state,  and   local 
laws, rules, and  regulations  regarding  medical   treatment   of   narcotic 
addiction.
  (2) The responsibilities of the medical director   and   other   authorized 
physicians within the program shall include all of the following:
  (a) Ensuring that evidence of current physiologic  dependence,  length   of 
history  of  addiction,  or  exceptions  to  criteria   for   admission   are 
documented in the patient's record before the patient  receives  the  initial 
methadone dose.
  (b) Ensuring that a medical evaluation, including a  medical  history   and 
physical examination, has been performed before the  patient   receives   the 
initial methadone dose. However, in an  emergency   situation   the   initial 
dose of methadone may be given before the physical examination.
  (c) Ensuring that appropriate laboratory studies have  been  performed  and 
reviewed.
  (d) Signing or countersigning all oral medical  orders   as   required   by 
federal or state law. Such medical orders include all of the following:
  (i) Initial medication orders.
  (ii) Subsequent medication order changes.
  (iii) Changes in the frequency of take-home medication.
  (iv) Medication orders for additional take-home  methadone  for   emergency 
situations.
  (e) Reviewing and countersigning treatment plans as follows:
  (i) The program physician or counselor  shall   review,   reevaluate,   and 
alter, where necessary, each client's treatment plan at least  once  every 60 
days.
  (ii) The program physician shall ensure that the  treatment  plan   becomes 
part of each client's chart and  that  it  is  signed  and   dated   in   the 
client's chart by the counselor and is  countersigned  and   dated   by   the 
supervisory counselor.
  (iii) At least once a year, the program physician   shall   date,   review, 
and countersign the treatment plan recorded in  each   client's   chart   and 
shall ensure that each client's progress or lack of  progress  in   achieving 
the treatment goals is entered in the  client's   counseling   record.   When 
appropriate, the treatment plan and progress notes  shall   deal   with   the 
client's mental and physical problems, apart from drug   abuse,   and   shall 
include reasons for prescribing any medication for  emotional   or   physical 
problems.
  (f) Ensuring that justification is recorded in the  patient's  record  when 
the frequency of clinic visits for observed medication is reduced.
  (3) There shall be a minimum of 1 client per physician  encounter  every 60 
days. This contact shall be documented in the client's record.

  History:  1981 AACS.


R 325.14405   Ancillary medical services.
  Rule 405. A client record shall indicate that  ancillary  medical  services 
were made available to a client whose physical exam,  medical   history,   or 
complaints indicated abnormalities that could   require   ancillary   medical 
services.

  History:  1981 AACS.


R 325.14406   Urinalysis services.
  Rule 406. (1) Urinalysis shall be performed for  clients   in   maintenance 
treatment at least once  a  week  for   opiates,   methadone,   barbiturates, 
amphetamines, cocaine, and other drugs  as  appropriate.   Urine   shall   be 
collected randomly in  a  manner  which  minimizes   falsification   of   the 
samples.
  (2) If the patient has maintained drug-free urines for  a   period   of   6 
months, and for  as  long  as  the  patient   maintains   drug-free   urines, 
urinalysis may be performed on a monthly  basis   for   opiates,   methadone, 
barbiturates, amphetamines, cocaine, and other  drugs   as   appropriate.   A 
positive urine for drugs other than methadone or  legally  prescribed   drugs 
shall require resumption of a weekly schedule of urinalysis.

  History:  1981 AACS.


R 325.14407   Vocational rehabilitation services.
  Rule 407. (1) A program shall provide opportunities,  directly  or  through 
referral to community resources, for those patients  who   desire,   or   who 
have been deemed ready by the program staff, to participate  in  education or 
job training programs or to  obtain  gainful  employment.  A  program   shall 
maintain  a  list  of  referral  resources   if   vocational   rehabilitative 
activities are not directly provided. The referral  resources  shall  include 
agencies with resources to provide  vocational   training,   education,   and 
employment in addition to the community resources that might be  available to 
provide assistance for such activities.
  (2) A  client's  needs  and  readiness   for   vocational   rehabilitation, 
education, and employment shall be evaluated and recorded  in  the   client's 
records during the preparation of the initial treatment plan  and  shall   be 
reviewed  and  updated,  as  appropriate,  in   subsequent   treatment   plan 
evaluations. It is recognized that some clients are not ready  for,  or   are 
not in need of, these services. Such  a  statement  in   the   record   shall 
suffice to meet the requirement of subrule (1) of this rule.  For  a   client 
who is deemed ready and who is referred for such services,  a  program  staff 
member shall document in the client's record the type of  referral  made  and 
the results of the referral.

  History:  1981 AACS.


R 325.14408   Informed consent.
  Rule 408. (1) There shall  be  a  fully  completed   and   signed   FD-2635 
"Consent to Methadone Treatment"  form  for  all  active   clients.   A   new 
consent form shall be completed for any readmission or for   a   client   who 
transfers from another program either  permanently   or   temporarily.   Care 
shall be exercised to indicate the pregnancy status for females.
  (2) Upon being informed of the benefits and hazards of the drug  ordered by 
the physician, the client or parent or guardian shall  sign  a  consent  form 
authorizing the program to commence such  chemotherapy.   The   consent  form 
shall be witnessed and dated and shall become part  of   the   client's  case 
record.

  History:  1981 AACS.


R 325.14409   Methadone  maintenance   program;   minimum    standards    for 
admission.
  Rule 409. (1) Each person who is selected as a client   for   a   methadone 
maintenance program, regardless of age, shall be  determined   by   a   staff 
physician to be currently physiologically  dependent   upon   narcotics   and 
shall have first become physiologically dependent at least  1   year   before 
admission to methadone maintenance treatment. A  1-year   history   of   drug 
dependence  means  that  an  applicant  for  admission   to    a    methadone 
maintenance program has been continuously physiologically   addicted   to   a 
narcotic for at least 1 year before admission to a program.
  (2) In determining current physiologic dependence,  the   physician   shall 
consider signs and symptoms of intoxication, a positive urine specimen for  a 
narcotic drug, and old or fresh needle  marks.  Other  evidence  of   current 
physiologic  dependence  can  be  obtained  by  noting   early    signs    of 
withdrawal, such as  lacrimation,  rhinorrhea,   pupilary   dilatation,   and 
piloerection, during the initial period of   abstinence.   Withdrawal   signs 
may be observed during the initial period of hospitalization  or  while   the 
person is an outpatient undergoing diagnostic evaluation,  such  as   medical 
and personal  history,  physical  examinations,  and  laboratory  studies.
Increased body temperature, pulse rate, blood   pressure,   and   respiratory 
rate are also  signs  of  withdrawal,  but  their   detection   may   require 
inpatient observation. It is unlikely, but possible, that a  person  could be 
currently dependent on narcotic drugs without having a  positive  urine  test 
for narcotics. Thus, a urine sample that is positive for narcotics is not  a  
requirement  for  admission  to  detoxification   or   maintenance treatment.
  (3) A patient who has been  treated  and   subsequently   detoxified   from 
methadone maintenance treatment may be readmitted  to  methadone  maintenance 
treatment without evidence to  support  findings   of   current   physiologic 
dependence up to 6 months after discharge provided   that   prior   methadone 
maintenance treatment of 6 months or more is documented  from   the   program 
attended  and  that  the  admitting  program  physician,  in   his   or   her 
reasonable clinical judgment, finds readmission  to   methadone   maintenance 
treatment to be medically justified. For patients  meeting  these   criteria, 
the quantity of take-home medication shall be determined  in  the  reasonable 
clinical judgment of the program physician,  but  in  no   case   shall   the 
quantity of take-home medication be greater than would have  been  allowed at 
the time that person terminated previous treatment.  Documented  evidence  of 
prior treatment and evidence of all  other  findings  and  criteria  used  to 
determine such findings shall be recorded in the patient's   chart   by   the 
admitting program physician or program personnel under  supervision  of   the 
admitting program physician. The admitting program   physician   shall   date 
and sign the recordings or date, review, and countersign  such  recordings in 
the  patient's  chart  prior   to   the   administration   of   the   initial 
methadone dose to the patient.
  (4) Documented evidence of prior treatment and  evidence   of   all   other 
findings and criteria used to determine such findings shall  be  recorded  in 
the client's chart by the admitting program physician  or  program  personnel 
under supervision  of  the  admitting  program   physician.   The   admitting 
program physician shall date, review, and countersign  such   recordings   in 
the client's chart before the administration of the initial methadone dose to 
the client.
  (5) A person who is between the ages of 16 and 18 years shall  have  had  2 
documented attempts at detoxification and at least  a   1-year   history   of 
addiction before admission to maintenance. A 1-year  history  of   dependence 
means that an applicant for admission to a maintenance  program  shall   have 
been continuously physiologically dependent to a narcotic for  at   least   1 
year before admission to a program. A person under 16 years of  age  is   not 
eligible for methadone maintenance treatment without the  prior  approval  of 
the state methadone authority and the food and  drug   administration.   This 
subrule does not preclude a person who is under 16 years of age  and  who  is 
currently physiologically dependent on a narcotic   from   being   detoxified 
with methadone if it  is  deemed  medically  appropriate   by   the   program 
physician and is in accordance with the requirements  for  detoxification.

  History:  1981 AACS.


R 325.14410   Detoxification treatment; minimum standards.
  Rule 410. (1) For detoxification from narcotic drugs,  methadone  shall  be 
administered daily by the program  under  close   observation   in   reducing 
dosages over a period of not more than  21  days.   All   requirements   that 
pertain to maintenance treatment apply to  detoxification   treatment,   with 
the following exceptions:
  (a) Take-home medication shall not be allowed during detoxification.
  (b) A history of a 1-year physiologic dependence shall  not   be   required 
for admission to detoxification.
  (c) Clients who have been determined by  the  program   physician   to   be 
currently physiologically dependent on narcotics may   be   detoxified   with 
methadone regardless of age.
  (d) Urine testing is not required, except for initial drug screening.
  (e) An initial treatment plan and periodic treatment  plan  evaluation  are 
not required, except that a counselor shall be  assigned   to   monitor   the 
client's  progress  toward  achievement  of   realistic   short-term    goals 
designed to be completed by the client within 21 days.
  (2) A waiting period of at  least  1  week  shall   be   required   between 
detoxification attempts. Before a detoxification attempt  is  repeated,   the 
program physician shall document in the client's record   that   the   client 
continues to be or is again physiologically dependent on  narcotic  drugs.
  (3) Detoxification treatment is not recommended for a  pregnant  client.

  History:  1981 AACS.


R 325.14411   Admission procedures.
  Rule  411.  (1)  A  program  shall  provide  its  clients   access   to   a 
comprehensive range of medical services and shall inform a  new   client   in 
writing which services are available on-site and which   are   available   by 
referral as part of an orientation procedure.
  (2) A  program  that  is  licensed  and  authorized   to   use   controlled 
substances shall have the results of a complete   physical   examination,   a 
medical history, and a personal history before  dispensing  or  administering 
medication. Appropriate lab work shall be entered  in   the   client's   file 
within 30 days of admission.
  (3) A prior physical examination that is completed by a  physician  may  be 
utilized if it meets the criteria outlined in R 325.14412  and   if   it   is 
dated not more than 90 days before the current admission  date.   The   staff 
physician shall document his or her evaluation of the  prior  examination.

  History:  1981 AACS.


R 325.14412   Physical examination.
  Rule 412. (1) A complete physical examination shall consist   of   all   of 
the following:
  (a) A physical  examination  stressing   infectious   disease;   pulmonary, 
liver, and cardiac abnormalities; dermatologic sequelae  of  addiction;   and 
possible concurrent surgical problems.
  (b) A complete blood count and differential.
  (c) Serologic tests for syphilis.
  (d) Routine and microscopic urinalysis.
  (e) Urine screening for drugs (toxicology).
  (f) Sequela multiple analyzer 12/60 or equivalent.
  (g) Australian antigen test.
  (h) Tuberculin skin test or chest x-ray.
  (i) Sickle cell test, as appropriate.
  (j) A test for pregnancy, as appropriate.
  (2) The licensed staff physician shall document the number  of  years  that 
the  individual  has  been  dependent  on,  or  addicted   to,   opiates   or 
opiate-like drugs.

  History:  1981 AACS.


R 325.14413   Medical history.
  Rule 413. (1) A complete  medical  history  shall  contain   all   of   the 
following information:
  (a) Head injuries.
  (b) Nervous diseases.
  (c) Convulsive diseases.
  (d) Major and minor operations.
  (e) Major accidents.
  (f) Fractures.
  (g) Venereal infections.
  (h) Cardiovascular diseases.
  (i) Respiratory diseases.
  (j) Endocrine diseases.
  (k) Rheumatic diseases.
  (l) Gastrointestinal diseases.
  (m) Allergic diseases.
  (n) Gynecological-obstetrical history.
  (2) The licensed staff physician shall document his or her  review  of  the 
medical history.

  History:  1981 AACS.


R 325.14414   Personal history.
  Rule 414. A complete personal history shall contain all  of  the  following 
information:
  (a) Name, address, and telephone number.
  (b) Educational history.
  (c) Date of birth and sex.
  (d) Psychosocial and family history.
  (e) Employment and vocational history.
  (f) Prior treatment experience or attempts at detoxification,  or  both.
  (g) Legal or court-related history.
  (h) Thorough substance abuse history.
  (i) Name of referring agency, when appropriate.
  (j) Name, address, and telephone number of nearest relative  in   case   of 
emergency.
  (k) Name, address, and telephone number of most recent  family  or  private 
physician.

  History:  1981 AACS.


R 325.14415   Take-home medication.
  Rule 415. (1) Take-home medication shall be formulated in such a way  as to 
minimize parenteral abuse and shall be packaged pursuant to   section   3  of 
the poison prevention packaging act, 15 U.S.C. S1472.
  (2) Take-home medication shall be labeled  with  all   of   the   following 
information:
  (a) The name of the medication.
  (b) The treatment center's name, address, and phone number.
  (c) Client name or code number.
  (d) Medical director's name.
  (e) Directions for use.
  (f) Date to be used.
  (g) A cautionary statement that the drug should be kept out of the reach of 
children.

  History:  1981 AACS.


R 325.14416  Take-home methadone; determination of client responsibility.
  Rule 416. (1) Take-home methadone shall only be given to a  client  who, in 
 the  reasonable  clinical   judgment   of   the   program   physician,    is 
responsible in the handling of methadone. Before reducing  the  frequency  of 
clinic visits, the rationale for this decision shall be   recorded   in   the 
client's chart by a program physician or one  of  his   or   her   designated 
staff. If a physician's designated staff member records  the  rationale   for 
the decision, a program physician shall review, countersign,  and  date   the 
client's record. Additionally, take-home methadone shall only be dispensed in 
an oral, liquid form so as to minimize its potential for abuse.
  (2) It is recommended practice that this liquid  vehicle  be  non-sweetened 
and contain a preservative so that a client  can  be   instructed   to   keep 
take-home methadone out of the refrigerator in an attempt  to  minimize   the 
likelihood of accidental overdoses by children  and   fermentation   of   the 
vehicle.
  (3) The  program  physician  shall,  in  the  exercise  of   his   or   her 
reasonable clinical judgment, utilize all of the  following  information   in 
determining whether or not  a  client  is  responsible   enough   to   handle 
take-home methadone:
  (a) Background and history of the client.
  (b) General and special characteristics of the client and the  community in 
which the client resides.
  (c) Absence of recent abuse of non-narcotic drugs, including alcohol.
  (d) Absence of current abuse  of  non-narcotic  drugs   and   alcohol   and 
narcotic drugs, including methadone.
  (e) Regularity of clinic attendance.
  (f) Absence of serious behavioral problems in the clinic.
  (g) Stability of the client's home environment and social relationships.
  (h) Absence of recent criminal activity.
  (i) Length of time in methadone maintenance treatment.
  (j) Assurance that take-home medication can be safely stored at home.
  (k) Whether the rehabilitative  benefit  to  the   patient   derived   from 
decreasing the frequency of  clinic  attendance   outweighs   the   potential 
risks of diversion.

  History:  1981 AACS.


R 325.14417   Take-home medication; procedures, exceptions.
  Rule 417. (1) A client who is in maintenance treatment  shall  ingest   the 
drug under observation daily or not less than 6 days a week for a  minimum of 
the first 3 months.
  (2) If, in the judgment of the program physician,  a  client   demonstrates 
satisfactory adherence to program rules for not less than   3   months;   has 
made  substantial  progress  in  rehabilitation;  is   responsible   in   the 
handling of methadone; and is  working,  enrolled  in   an   educational   or 
training program, or has homemaking responsibilities, and  if  the   client's 
rehabilitative progress will be enhanced by decreasing   the   frequency   of 
clinic attendance, the client may be permitted to reduce  the  frequency   of 
clinic attendance for drug ingestion under observation to 3 times  weekly.
Such a client shall not receive more than  a  2-day   take-home   supply   of 
methadone.
  (3) If, in the judgment of the program physician,  a  client   demonstrates 
satisfactory adherence to program rules for not less than 2  years  from  the 
time of entrance into  the  program;  has  made   substantial   progress   in 
rehabilitation; is responsible  in  the  handling  of   methadone;   and   is 
working, enrolled in an educational or training program,  or  has  homemaking 
responsibilities, and if the  client's  rehabilitative   progress   will   be 
enhanced by decreasing the frequency of clinic attendance, the client  may be 
permitted to  reduce  the   frequency   of   clinic   attendance   for   drug 
ingestion under observation to twice  weekly.  Such  a   client   shall   not 
receive more than a 3-day take-home supply of methadone.
  (4) In calculating 2  years  of  methadone   maintenance   treatment,   the 
period shall be considered to begin upon the first day  of  administration of 
methadone or upon readmission of a  client   who   has   had   a   continuous 
absence of 90 days or more. Cumulative time spent by the   client   in   more 
than 1 program shall be counted toward the 2 years   of   treatment,   unless 
there has been a continuous absence of 90 days or more.
  (5) If a client is found to have a physical  disability  which   interferes 
with his or her ability to conform to the applicable  mandatory  schedule, he 
or she may be permitted a temporarily or permanently  reduced  schedule if he 
or she is also found to be responsible  in  the  handling  of   methadone  as 
specified in R 325.14416 (3)(a) to (k).
  (6) If because of exceptional circumstances, such as illness or personal or 
family crisis,  a  client  is   unable   to   conform   to   the   applicable 
mandatory schedule, he or she  may  be  permitted   a   temporarily   reduced 
schedule if he or she is also found to be responsible in  the   handling   of 
methadone as specified in R 325.14416 (3)(a)  to  (k).  In   any   event,   a 
client shall not be given more than a 1-week supply of   methadone   at   one 
time without the prior approval of the state methadone  authority   and   the 
food and drug administration.

  History:  1981 AACS.


R 325.14418   Methadone treatment; voluntary withdrawal;  discontinuation  of 
use.
  Rule 418. (1) A client in treatment shall be  given  careful  consideration 
for discontinuation of methadone use.  Social   rehabilitation   shall   have 
been maintained for a  reasonable  period  of  time.  A   client   shall   be 
encouraged to pursue the  goals  of  eventual   voluntary   withdrawal   from 
methadone and of becoming completely drug-free. Upon successfully reaching  a 
drug-free state, the client shall be retained in the program for as  long  as 
necessary  to  assure  stability   in   the   drug-free   state,   with   the 
frequency of his or her required visits adjusted in   accordance   with   the 
treatment plan.
  (2) Maintenance treatment shall be discontinued  within   2   years   after 
such treatment has begun, unless, based on the recorded clinical  judgment of 
the staff physician,  justification  is  provided  to  continue   maintenance 
beyond the 2-year limitation. This justification  shall   be   reviewed   and 
updated every year thereafter by the staff physician.

  History:  1981 AACS.


R 325.14419   Client records.
  Rule 419. (1) A client record shall be maintained by a program for a period 
of 3 years after services are terminated.
  (2) A client record shall contain, at  a  minimum,  all  of  the  following 
information:
  (a) A signed consent form (use federal food and drug administration form FD 
2635).
  (b) The date of each visit for medication or counseling, or both.
  (c) The amount of methadone dispensed for take-out or administered on-site.
  (d) The results of each urinalysis.
  (e) A detailed account of any adverse reactions to medication (use  federal 
food and drug administration form 1639, "Drug Experience Report").
  (f) Any significant physical or  psychological  disability  and  plans  for 
referral or on-site treatment.
  (g) If the  client's  treatment  plan  identifies  a  need  for  counseling 
services and includes the provision of these services, then signed and  dated 
progress reports by the counselor must be included in the clinical record.
  (h) The termination and readmission  evaluation  written  or  endorsed  and 
dated by the program physician.
  (i) Monthly medical progress notes by the dispensing nurse.
  (j) Monthly renewal of the methadone order.
  (k) Documentation of a physician-client encounter every 60 days.
  (l) Documentation of methadone authority approval of any exceptions to  the 
applicable rules and regulations.
  (m) The initial, and any subsequent, treatment plan.
  (n) The periodic treatment plan evaluation  by  the  program  physician  or 
counselor at least once every 60 days.
  (o) The annual treatment plan review by the program physician.
  (3) Deaths which may be methadone related shall be reported to the  federal 
food and drug administration on form FD 1639, "Drug Experience Report" within 
2 weeks of the death. Births to clients that are premature or show  signs  of 
adverse reaction to methadone shall also be reported on form FD 1639.

  History:  1981 AACS; 2006 AACS.


R  325.14420   Holiday dispensing.
  Rule 420. (1) Where it is not contrary to state law and  where  the   state 
methadone authority has given approval, a 1-day's supply of methadone  may be 
dispensed to all clients, regardless  of   time   in   treatment,   for   the 
following holidays:
  (a) July 4.
  (b) Thanksgiving day.
  (c) Christmas day.
  (d) New Year's day.
  (2) Subject to state law and the state methadone  authority's  approval, an 
additional 1-day supply of methadone may be provided to all clients  for  the 
holidays in subrule (1) of this rule which fall on Monday.  The   client  who 
has to ingest methadone 6 days per week would be  dispensed   a   supply  for 
Sunday and Monday. A client who  is  allowed  a  2-day  take-home  supply  of 
methadone would be allowed  a  3-day  take-home  supply  when   he   or   she 
presents himself or herself for medication on  the   Friday   preceding   the 
Monday holiday. When 1 of the above holidays falls on  Friday,  clients   who 
must attend the program 6 days per week to obtain medication may be  given  a 
take-home supply for that Friday. These clients shall report on  Saturday  to 
obtain the usual seventh day take-home dose normally allowed,  if  Sunday  is 
the customary day to provide the 1  take-home  dose.  The  remainder  of  the 
clients may be provided additional quantities of take-home methadone.
  (3) Subject to state law and the state methadone  authority's  approval, an 
additional 1-day supply  of   take-home   medication   may   be   given   for 
official state holidays without prior FDA approval. These  holidays  are   as 
follows:
  (a) New Year's day.
  (b) Lincoln's and Washington's birthdays.
  (c) Memorial day.
  (d) July 4.
  (e) Labor day.
  (f) Veterans' day.
  (g) Thanksgiving day.
  (h) Christmas day.
  (4) Not more than a 3-day supply of methadone shall be  dispensed  to   any 
client because of holidays without prior approval from  the  state  methadone 
authority.

  History:  1981 AACS.


R  325.14421   Security of drug stocks and dispensing area.
  Rule 421. (1) A program of adequate security shall   be   maintained   over 
drug stocks. The storage of  drug  stocks  shall  be   in   accordance   with 
federal  drug   enforcement   administration    criteria    for    controlled 
substances, 21 C.F.R. SS1301.71-1301.93 (April 1, 1979).  The  criteria   set 
forth  in  21  C.F.R. SS1301.71-1301.93   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.
Records shall be  maintained  which  show  the  dates   that   shipments   of 
methadone are received, the quantity received, and the   lot   numbers.   The 
inventory of methadone stocks shall reflect daily  usage   and   balance   on 
hand.
  (2) Accurate drug dispensing records shall be maintained which show  all of 
the following information:
  (a) The date of client visit.
  (b) The amount dispensed.
  (c) Whether the drug was ingested on-site or was  dispensed  for  take-home 
purposes.
  (d) The client's signature.
  (e) The signature or initials of the dispensing  licensed  practitioner.
  (3) If a client fails to show for a visit, his or her  absence   shall   be 
recorded and the record shall be signed or  initialed   by   the   dispensing 
licensed practitioner. Information shall be recorded for each client as he or 
she is seen. Dispensing records  and  records  that   document   receipt   of 
substances shall comply with the provisions  of  21   C.F.R.  SS1304.28   and 
1304.29 (April 1, 1979). The criteria set forth in 21  C.F.R.  SS1304.28  and 
1304.29 are incorporated  in  these  rules  by  reference.   Copies   of   21 
C.F.R. SS1304.28 and 1304.29 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.
  (4) A program that is involved in dispensing or administering medication as 
a part of its treatment regimen shall  not  allow  any  person   inside   the 
dispensing area who is not a  licensed  practitioner.   Exceptions   may   be 
granted on an individual basis by the  state   methadone   authority.   Under 
exceptional circumstances, for specific purposes, other  individuals  may  be 
allowed to accompany the licensed practitioner inside the dispensing area.
The reasons for  these  exceptional  cases  shall  be   documented   by   the 
practitioner and the record shall be maintained in the dispensing area.

  History:  1981 AACS.


R  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.
  Rule 422. (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 labelled 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.


R  325.14423   Additional medication controls;   labelling   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.
  Rule 423. (1) A dispensed drug shall be labelled 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.