Download BMC Guidelines for Prescribing Narcotic Drugs

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