[ S.L.101.06 METHADONE 1 SUBSIDIARY LEGISLATION 101.06 METHADONE RULES 4th November, 2005 LEGAL NOTICE 365 of 2005, as amended by Legal Notice 426 of
- The title of these rules is the Methadone Rules. Title.
- In these rules, unless the context otherwise requires: Interpretation. "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. Restricted prescription.
- No methadone may be prescribed or supplied from a designated clinic other than in oral liquid formulations: Form of methadone. 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. 5.
(1)No person, other than a person licensed for the purpose by the Superintendent shall import, stock or supply any methadone. Restricted importation, stock and supply. 2 [ S.L.101.06 METHADONE
(2)Methadone may only be stocked or supplied to and from areas designated by the Superintendent. Dispensing of methadone from designated pharmacies. 6.
(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. Form of prescription. 7.
(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. Administration of methadone at designated clinics. Amended by: L.N. 426 of 2012. 8.
(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 [ S.L.101.06 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)(
- ii)(iii) (
- iv)(
- vi)Name of substance supplied Date on which the transaction was effected Name of person, body or firm to whom supplied Legally valid identification document number of person, body or firm to whom supplied Authority of person, body or firm to be in possession of the substances Amount supplied (vii) Form in which supplied (
- v)(
- 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. 3 4 [ S.L.101.06 METHADONE SCHEDULE (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 Address Female ITEM (incl. dosage form & dose) Directions for use I.D. No. Male Address Female I.D. No. Quantity ITEM (incl. dosage form Quantity & dose) 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. .........................