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Transcript
The Bahamas Medical Council Guidelines for Prescribing Narcotic Drugs Chairman’s Note These guidelines are intended for physicians registered and licenced by the Bahamas Medical Council for independent practice in the Commonwealth of The Bahamas. Physicians who practice under supervision must have all narcotic prescriptions co-signed by their supervisor. All narcotic prescriptions must be dated and signed on the date of issuance. The prescription must include: 1).The patient’s full name and address; 2). The physician’s full name and address; and 3). The physician’s Bahamas Medical Council’s registration and licence number. Dr. Franklin Walkine Chairman Bahamas Medical Council November 30, 2015 Table of Contents Definitions1 Legal Framework 1 General Requirements 2 Security Matters 4 Record-keeping Requirements 5 Inventory5 Disposal of Controlled Substances 6 Valid Prescription Requirements 6 Appendix I 7 1 Definitions Legal Framework Narcotics Addictive drugs that reduce the user’s perception of pain and induce euphoria (a feeling of exaggerated and unrealistic well-being). Prescription An order for medication which is dispensed to or for an ultimate user. Practitioner Individual licensed to practice medicine within the Commonwealth of The Bahamas All registered and licensed medical practitioners practicing in the Commonwealth of The Bahamas who prescribe narcotic drugs are governed by: • The Dangerous Drug Act Chapter 228 and the Amendment Bill 2011 • The Pharmacy Act 2013 • Medical Regulations 2014 The Dangerous Drugs Act regulates the importation, exportation, manufacture, sale and use of dangerous drugs in accordance with the provisions of the Single Convention, the Vienna Convention and the United Nations Convention, The 1961 Convention exercises control over more than 116 narcotic drugs. They include mainly plant-based products such as opium and its derivatives morphine, codeine and heroin, but also synthetic narcotics such as methadone and pethidine, as well as cannabis, coca and cocaine. 2 General Requirements A doctor may prescribe medicine to a patient only after proper consultation and only if drug treatment is appropriate. The doctor should establish suitable procedures for ensuring that drugs are properly labelled and dispensed. A doctor who dispenses medicine to patients has the personal responsibility to ensure that the drugs are dispensed strictly in accordance with the prescription and are properly labelled before they are handed over to the patients. Patients should be given the choice of either receiving medicine directly from the doctor or taking a prescription from him. In either case, the doctor has the responsibility to decide the proper dosage. All medications dispensed to patients directly or indirectly by a doctor should be properly and separately labelled with all the following information: a. name of prescribing doctor or proper means of identifying him; b. full name of the patient, except where the full name is unusually long (in which case the family name and such part of the given name or initials sufficient to identify the patient should be written); c. date of dispensing; d. name of medicine, which can be either the generic, chemical or pharmacological name of the medicine; e. method of administration; f. dosage to be administered; and g. precautions where applicable. Where a drug is commonly known to have serious side effects, the doctor has the responsibility to properly explain the side effects to the patient before prescribing the drug. A doctor should not prescribe or supply drugs of addiction or dependence otherwise than in the course of bona fide and proper treatment. The Bahamas Medical Council is empowered to withdraw from a doctor the authorization to possess, supply or manufacture dangerous drugs, where it is in the public interest to do so. The Bahamas Medical Council is also empowered, upon such withdrawal, to direct that it shall not be lawful for the doctor to give prescriptions prescribing dangerous drugs. A doctor should not permit unqualified assistants to be in charge of any place in which scheduled poisons and dangerous drugs or preparations containing such substances are supplied to the public. The Bahamas Medical Council recommends that doctors be aware of the schedules that are published annually on an updated basis in the DEA Regulations, Title 21 of the Code of Federal Regulations, Sections 1308.11 through 1308.15. Substances are placed in their respective schedules based on whether they have a currently accepted medical use in treatment and their relative abuse potential and likelihood of causing dependence when abused. (The specified form of dangerous drugs register is at the First Schedule to the Dangerous Drugs Regulations, at Appendix 1 Doctors are to note that drugs such as heroin; lysergic acid diethylamide (LSD); marijuana (cannabis); peyote; methaqualone; and methylene-dimethoxymethamphetamine (“ecstasy”). have no currently accepted medical use in treatment in The Bahamas and therefore may not be prescribed, administered, or dispensed for medical use. Narcotic substances and their common name brand products that are often prescribed are: meperidine (Demerol or pethedine), oxycodone (OxyContin®), and 3 fentanyl (Sublimaze® or Durages Stimulants include (methylphenidate (Ritalin®, concerta). Others include zolipidem (ambiem), tramadol, tramacet, phentobarbital and hydromorphone (Dilaudid®), Narcotics that are less addictive include combination products containing less than 15 milligrams of hydrocodone per dosage unit (i.e., Vicodin®) and products containing not more than 90 milligrams of codeine per dosage unit (i.e., Tylenol with codeine®) Non-narcotics include ketamine, and anabolic steroids such as oxandrolone Drugs with a lower potential for abuse include propoxyphene (Darvon® and Darvocet-N 100®). Other substances include alprazolam (Xanax®), clonazepam (Klonopin®), clorazepate (Tranxene®), diazepam (Valium®), lorazepam (Ativan®), midazolam (Versed®), temazepam (Restoril®), bromazepam, and triazolam (Halcion®). Drugs that have a lower potential for abuse include antitussive, antidiarrheal and analgesic and cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams (Robitussin AC®, and Phenergan with Codeine®). 4 Security Matters The Bahamas Medical Council recommends that all registered and licensed medical practitioners provide effective controls and procedures to guard against theft and diversion of controlled substances. Practitioners are required to store stocks of controlled substances in a securely locked, substantially constructed cabinet. Practitioners authorized to possess carfentanil, etorphine hydrochloride and/or diprenorphine, must store these controlled substances in a safe or steel cabinet Registrants should not employ as an agent or employee any person who has access to controlled substances; or any person who has been convicted of a felony offense related to controlled substances Additional measures to ensure security include: 1. Keep all prescription blanks in a safe place where they cannot be stolen; minimize the number of prescription pads in use. 2. Write out the actual amount prescribed in addition to giving a number to discourage alterations of the prescription order. 3. Use prescription blanks only for writing a prescription order and not for notes. 4. Never sign prescription blanks in advance. 5. Use tamper-resistant prescription pads. A doctor is required to keep a register of every quantity of dangerous drug obtained or supplied by him. Failure to comply with these requirements is a criminal offence, and will also result in disciplinary action. All entries with the specified particulars must be entered in chronological sequence, on the date of receipt or supply of the dangerous drug. Every entry must be made in ink or other indelible form. No cancellation, obliteration or alteration is allowed. Any correction can only be made by a marginal note or footnote specifying the date of correction. The BMC will initiate disciplinary proceedings against a doctor convicted of drugs related offences committed in order to gratify his own addiction. 5 Record-keeping Requirements Inventory Records must be maintained separately or in such a form that they are readily retrievable from the ordinary business records of the practitioner. Inventory requirements extend to controlled substance samples provided to practitioners by pharmaceutical companies. A registered practitioner is required to keep records of controlled substances that are dispensed to the patient, other than by prescribing or administering, in the lawful course of professional practice. A registered practitioner is required to keep records of controlled substances if the practitioner regularly engages in the dispensing or administering of controlled substances and charges patients, either separately or together with charges for other professional services, for substances so dispensed or administered. 6 Disposal of Controlled Substances Valid Prescription Requirements A practitioner may dispose of out-of-date, damaged, or otherwise unusable or unwanted controlled substances, including samples, by transferring them to a registrant who is authorized to receive such materials. The practitioner should maintain copies of the records documenting the transfer and disposal of controlled substances for a period of two years. A prescription for a controlled substance must be dated and signed on the date when issued. The prescription must include the patient’s full name and address, and the practitioner’s full name, address, and BMC registration number. The prescription must also must be written in ink or indelible pencil or typewritten and must be manually signed by the practitioner on the date when issued. The BMC recommends that all records related to controlled substances must be maintained and be available for inspection for a minimum of two years. A prescription for a controlled substance may be issued by a medical doctor who is authorized to prescribe controlled substances in the Commonwealth of The Bahamas where he is licensed to practice. A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patient. To be valid, a prescription for a controlled substance must be issued for a legitimate medical purpose by a registered and licensed medical practitioner acting in the usual course of professional practice. The practitioner is responsible for the proper prescribing and dispensing of controlled substances. In addition, a corresponding responsibility rests with the pharmacist who fills the prescription. The individual practitioner must demonstrate due diligence in concluding that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse. The individual practitioner complies fully with all other applicable requirements under the Dangerous Drug Act and the Medical Regulations, as well as any additional requirements under laws of The Bahamas. Controlled substances that are dispensed pursuant to a legitimate prescription may not be delivered or shipped to individuals in another country. Any such delivery or shipment is a prohibited export under the Dangerous Drug Act. The practitioner is responsible for ensuring that the prescription conforms to all requirements of the law and regulations, as in the Medical Regulations 2014. 7 Appendix I (1) The drugs to which this Part applies are — a) medicinal opium; b)any extract or tincture of Indian hemp; c) morphine and its salts and diacetyl-morphine (commonly known as diamorphine or heroin) and the other esters of morphine and their respective salts; d)cocaine (including synthetic cocaine) and ecgonine and their respective salts, and the esters of ecgonine and their respective salts; e) any solution or dilution of morphine or cocaine or their salts in an inert substance whether liquid or solid, containing any proportion of morphineper cent of cocaine or of ecgonine; f ) any preparation, admixture, extract or other substance containing any proportion of diacetylmorphine; g)dihydrohydroxycodeinone, dihydrocodeinone, dihydromorphinone, acetyldihydrocodeinone, (commonly known as ascedicone), dihydromorphine, their esters and the salts of any of these substances and of their esters, morphine-N-oxide (commonly known as genomorphine), the morphine-N-oxide derivatives, and any other pentavalent nitrogen morphine derivatives; h)thebaine and its salts, and (with the exception of methylmorphine, commonly known as codeine, and ethylmorphine, commonly known as dionin, and their respective salts) benzylmorphine and the other esters of morphine and their respective salts; i) any preparation, admixture, extract or other substance containing any proportion of any of the substances mentioned in paragraph (g) or in paragraph (h); j) amphetamines(beta-aminopropylbenzene and betaaminoisopropylbenzene); k)pholcodine and diethylthiambutene (“themalon”); l)normethadone; (2) For the purpose of subsection (1) — a) the percentage in the case of liquid preparations shall, unless other provision in that behalf is made by regulations, be calculated on the basis that a preparation containing one per cent of any substance means a preparation in which one gramme of the substance, if a solid, or one millilitre of the substance, if a liquid, is contained in every one hundred millilitres of the preparation, and so in proportion for any greater or less percentage; b)the expression “ecgonine” means laevoecgonine and includes any derivatives of ecgonine from which it may be recovered industrially; and c) the percentage in the case of morphine shall be calculated as in respect of anhydrous morphine