Methadone Rules, 2005

L.N.365 of 2005

DANGEROUS DRUGS ORDINANCE

(CAP. 101)

Methadone Rules, 2005

IN exercise of the powers conferred by article 9 of the

Dangerous Drugs Ordinance, the Minister of Health, the Elderly and

Community Care has made the following rules:-

The title of these rules is the Methadone Rules, 2005.

(Sub-rule 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 & dose)

Quantity

ITEM (incl. dosage form & dose)

Quantity

Directions for use

Signature of Pharmacist………………………..

Pharmacy Board Reg. No………… Date……..

Dispensary address……………………………….

DH Licence No………………….

Additional information in respect of

Additional information in respect of prescriptions

prescriptions for METHADONE

for METHADONE

Methadone (incl. dosage form and dose)

Date

Quantity

Signature &

dispensed

Pharmacy

(mg/volume) Board Reg No.

Expected duration of treatment

No. of times prescription may be dispensed

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. ………

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press

In these rules, unless the context otherwise requires :-

“administration” means the supervised oral intake of the

medicine by the patient as prescribed;

“the Centre” means such departmental sector as may be

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 Restricted

prescription.

prescription for methadone in any form unless such medical

practitioner or dental surgeon, 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 designated clinic.

No methadone may be prescribed or supplied from a Form of

methadone.

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 Restricted

importation, stock

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

(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:-

Dispensing of

methadone from

designated

(a) a register of persons collecting methadone supplies

pharmacies.

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 Form of

prescription.

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

form set out in the Schedule to these rules.

(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 legible 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) hereof>-

(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

(ii)

Name of person, body or firm to whom supplied

(iv) Identity card 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.

B