METHADONE RULES

SUBSIDIARY LEGISLATION 101.06

METHADONE RULES

4th November, 2005

LEGAL NOTICE 365 of 2005, as amended by Legal Notice 426 of 2012.

The title of these rules is the Methadone Rules.

(Rules 6 and 7)

PRESCRIPTION FOR NARCOTIC AND PSYCHOTROPIC DRUGS

(Only one item may be prescribed on this Form)

A. TO BE FILLED BY PRESCRIBER

B. TO BE FILLED BY DISPENSING PHARMACIST

PATIENT

PATIENT

Name and Surname

Name and Surname

Male

Female

I.D. No.

Male

Female

I.D. No.

Address

Address

ITEM (incl. dosage form

Quantity

ITEM (incl. dosage form

Quantity

& dose)

& dose)

Directions for use

Signature of Pharmacist .............................................

Pharmacy Board Reg. No ................. Date .................

Dispensary address ....................................................

DH Licence No ............................

A d d i t i o n a l i n f o r m a t i o n i n r e s p e c t o f Additional information in respect of prescriptions for

prescriptions for METHADONE

METHADONE

Methadone (incl. dosage form and dose)

Date

Quantity

Signature &

dispensed

Pharmacy Board

(mg/volume)

Reg No

Expected duration of treatment

No. of times prescription may be

dispensed

Directions for use

Directions for use

Medical indication

Total quantity prescribed

(Units/Weight/Measure)

PRESCRIBER

Name, Surname and Med Council Reg. No

Signature .......................... Date ................

PRESCRIPTION ORIGIN (Address)

Hospital/Government Clinic

Private Clinic

Prescription Serial No. .........................

In these rules, unless the context otherwise requires

"adm inistration" m ean s t he supe rvised oral intake of the

medicine by the patient as prescribed;

" t h e C e n t r e " m e a n s s u c h d e p ar t m e n t a l s e c t o r a s m a y b e

identified by the Superintendent;

"dispensing" means the supply of the medicine, as prescribed, to

the patient or to an agent on his behalf against a prescription;

"designated clinic" means a clinic designated by the

Superintendent for the treatment by methadone of opiate dependent

individuals or other persons needing such drug;

"designated pharmacy" means a pharmacy designated by the

Superintendent for the stocking and supply of methadone to

registered clients;

"designated practitioner" means any medical practitioner or

dental surgeon who is authorised by the Superintendent to work in

a designated clinic;

"medication record" means an entry made by the designated

practitioner on the treatment chart kept at such designated clinic or

an electronic entry in a database dedicated for the treatment of

methadone;

"methadone" includes any salt or ester thereof;

"the Superintendent" means the Superintendent of Public Health.

No medical practitioner or dental surgeon shall issue a

prescription for methadone in any form unless such medical

practitioner or dental suraeon, as the case may be, is a designated

practitioner and unless such prescription is issued from a

designated clinic. Before a patient is started on methadone it is the

duty of the practitioner to make sure, after consulting with the

Centre, that such patient is not being prescribed this drug in any

other desianated clinic.

No methadone may be prescribed or supplied from a

designated clinic other than in oral liquid formulations

Provided that in exceptional circumstances, the designated

practitioner may in writing authorise the prescribing or supply of

such drug in any other form as may be indicated for the patient

under his care.

(1) No person, other than a person licensed for the purpose

by the Superintendent shall import, stock or supply any methadone.

(2) Methadone may only be stocked or supplied to and from

areas designated by the Superintendent.

(1)

There shall be kept at each designated pharmacy -

(a) a register of persons collecting methadone supplies

from such designated pharmacy; and

(b) individual records in which shall be entered details of

every prescription including the amount dispensed,

and the name and address of the designated

practitioner prescribing the drug, and signed by the

pharmacist supplying the drug.

(2) Any prescription for methadone as is referred to in the

Schedule shall only be dispensed from a designated pharmacy.

(1) When any designated practitioner issues a prescription

for methadone to a patient, he shall issue the prescription on the

form set out in the Schedule.

(2) The designated practitioner who prescribes methadone, as

provided for in this rule, shall enter in a legible manner all the

details contained in Part A of the said form.

(3) The pharmacist dispensing a prescription for methadone

shall enter in a leaible manner all the details required in Part B of

the said form, in accordance with any instructions contained

therein.

(4) For the purpose of this rule, the prescription may be

dispensed more than once on the same form for a period not

exceeding one calendar month, at the discretion of the prescriber.

(5) A new prescription form shall be issued for any change in

the dosage prescribed.

(6) The prescription shall be kept under the custody of the

dispensing pharmacist during the period of treatment.

(7) The prescription of methadone for administration to

patients in hospitals shall be according to hospital rules which have

been previously authorized by the Superintendent.

(1) The prescription and administration of methadone to

opiate dependent individuals or other patients that are under the

care of a designated practitioner within a designated clinic, shall be

effected in terms of this rule.

(2) The designated practitioner shall ensure that strict

procedures are enforced in respect of the security and

accountability of methadone preparations stocked at a designated

clinic.

(3) The medication record should be kept by the designated

practitioner at the clinic and shall be considered as the official

prescription for patients receiving treatment at the designated

clinic.

(4) The designated practitioner shall ensure that strict

procedures are enforced in respect of the administration of

methadone for patients under his care. Daily individual records,

together with the amount of methadone administered, shall be kept

by the designated clinic.

(5) The following records shall be included in a Purchasing and

Supplies Register to be kept for the purpose mentioned in sub-rule

(4)

(a) Purchasing records

(i) Name and dose of substance purchased

(ii) Date on which supply received

(iii) Name of person, body or firm from whom

obtained

(iv) Address of person, body or firm from whom

obtained

(v) Amount obtained

(vi) Form in which obtained;

(b) Supplies records

(i)

Name of substance supplied

(ii)

Date on which the transaction was effected

(iii)

Name of person, body or firm to whom supplied

(iv)

Legally valid identification document number of

person, body or firm to whom supplied

(v)

Authority of person, body or firm to be in

possession of the substances

(vi)

Amount supplied

(vii)

Form in which supplied

(c) Such records shall be kept for a minimum of ten years.

(6) The notification of new patients, irrespective of indication

and for their treatment and prior to the initiating of methadone

treatment, shall be made by the designated practitioner to the

Centre.

(7) The Superintendent may withdraw the control card of

opiate dependent individuals. Such control cards are to be kept

under custody of the designated practitioners at the designated

clinics.

METHADONE