Medicines
(Prescription Only) (Jersey) Order 1997[1]
THE HEALTH AND SOCIAL SERVICES COMMITTEE in pursuance of Articles 57 and 110 of the Medicines
(Jersey) Law 1995, after consultation with the Medicines
Advisory Council and having otherwise complied with Article 110 of the Law,
orders as follows –
Commencement [see endnotes]
1 Interpretation
(1) In
this Order, unless the context otherwise requires –
“aerosol”
means a product that is dispersed from its container by a propellent gas or
liquid;
“controlled drug”
has the same meaning as it has in Article 3 of the Misuse
of Drugs (Jersey) Law 1978;
“cyanogenetic
substances” means preparations –
(a) that are presented for sale or supply under
the name of, or as containing, amygdalin, laetrile or vitamin B17; or
(b) that contain more than 0.1% by weight of any
substance having the formula α-cyanobenzyl-6-O-ß-d-glucopyranosyl-ß-d-glucopyranoside or α-cyanobenzyl-ß-d-glucopyranosiduronic acid;
“dosage unit”
means –
(a) where a medicinal product is in the form of
a tablet or capsule or is an article in some other similar pharmaceutical form,
that tablet, capsule or other article; and
(b) where a medicinal product is not in any such
form, the quantity of the product that is used as the unit by reference to
which the dose is measured;
“external use”
means application to the skin, hair, teeth, mucosa of the mouth, throat, nose,
ear, eye, vagina or anal canal, when a local action only is intended and
extensive systemic absorption is unlikely to occur; but does not mean
application by means of a throat spray, throat pastille, throat lozenge, throat
tablet, nasal drop, nasal spray, nasal inhalation or teething preparation;
“health prescription”
means a prescription described in Article 15(2) of the Health
Insurance (Jersey) Law 1967;
“health
record” has the same meaning as in the Data
Protection (Jersey) Law 2018;
“inhaler” does
not include an aerosol;
“Law” means
the Medicines
(Jersey) Law 1995;
“master” has
the same meaning as it has in the Merchant Shipping Act 1894 of the United
Kingdom;
“maximum daily dose”
or “MDD” means, in relation to a substance contained in the amount
of a medicinal product for internal use, the recommended maximum quantity to be
taken or administered in a period of 24 hours;
“maximum dose”
or “MD” means, in relation to a substance contained in the amount
of a medicinal product for internal use, the recommended maximum quantity to be
taken or administered at any one time;
“maximum strength”
means such of the following as may be specified –
(a) the maximum quantity of a substance by
weight or volume contained in a dosage unit of a medicinal product;
(b) the maximum number of units of activity
contained in a dosage unit or a weight of a medicinal product; and
(c) the maximum percentage of a substance
contained in a medicinal product calculated in terms of weight in weight,
weight in volume, volume in weight or volume in volume, as appropriate;
“medicinal product”
does not include a veterinary drug;
“occupational health
scheme” means a scheme in which a person in the course of a business
carried on by him or her provides facilities for his or her employees, for the
treatment or prevention of disease;
“operator”, in
relation to an aircraft, means the person for the time being having the
management of the aircraft;
“parenteral administration”
means administration by breach of the skin or mucous membrane;
“prescription only
medicine” means a medicinal product that is specified by this Order as a
prescription only medicine;
“registered
optometrist” has the same meaning as it has in Article 1(1) of the Opticians
(Registration) (Jersey) Law 1962;
“repeatable
prescription” means a prescription containing a direction that it shall
or may be dispensed more than once;
“soaps” means
any compounds of a fatty acid with an alkali or amine;
“state registered
paramedic” means a person who is registered in the register established
and maintained under section 60 and paragraph 1(a) of Schedule 3 to the Health
Act 1999 of the United Kingdom;
“supplementary
prescriber” means any of the following –
(a) a midwife or nurse, whose entry on the
register established and maintained under article 5 of the Nursing and
Midwifery Order 2001 of the United Kingdom indicates that he or she is, or may
act as, only a supplementary prescriber;
(b) an optometrist, whose entry on the register
established and maintained under section 7(a) of the Opticians Act 1989 of
the United Kingdom indicates that he or she is, or may act as, only a
supplementary prescriber;
(c) a pharmacist, whose entry on the register
established and maintained under article 19 of the Pharmacy Order 2010 of
the United Kingdom indicates that he or she is, or may act as, only a
supplementary prescriber;
(d) a physiotherapist, podiatrist or
radiographer, whose entry on the register established and maintained under
article 5 of the Health and Social Work Professions Order 2001 of the
United Kingdom indicates that he or she is, or may act as, only a supplementary
prescriber.
“unit preparation” means a
preparation (including a mother tincture) that is prepared by a process of
solution, extraction or trituration, with a view to being diluted tenfold or
one hundredfold (either once or repeatedly) in an inert diluent and then used
either in that diluted form or (where applicable) by impregnating tablets,
granules, powders or other inert substances.[2]
(2) In
this Order –
(a) in Schedules 1 and 2, the following
abbreviations are used –
“g” for gram;
“iu” for international
unit of activity;
“mcg” for microgram;
“mg” for milligram; and
“ml” for millilitre; and
(b) in Schedule 1 –
(i) entries in any of
columns 2, 3 and 4 of Parts 1 and 2 relate only to the substances
specified in column 1 against which they appear,
(ii) where,
in relation to a particular substance specified in column 1, an entry in any of
columns 2, 3 and 4 bears a number or letter, that entry relates only to entries
in the other of columns 2, 3 and 4 that bear the same number or letter, and
(iii) the
entries in column 4 of Part 1 shall be read subject to the note at the end
of that Part.
(3) Without
prejudice to Article 10 of the Interpretation
(Jersey) Law 1954, every provision in the Medicines
(Jersey) Law 1995 that relates in any other way to its
interpretation shall also apply in the same way to this Order, unless the context
otherwise requires.
2 Prescription
only medicines
The following
descriptions and classes of medicinal products are specified for the purposes
of Article 57(1)(a) of the Law, and are accordingly prescription only
medicines, namely –
(a) medicinal
products that consist of or contain a substance specified in column 1 of Part 1
of Schedule 1 to this Order;
(b) medicinal
products that are controlled drugs;
(c) medicinal
products that are for parenteral administration, whether or not they fall
within sub-paragraph (a) or (b) of this paragraph;
(d) medicinal
products that –
(i) are not of a description and do not
fall within a class specified in any of sub-paragraphs (a), (b) and (c) of
this paragraph,
(ii) are of a description in respect of
which the conditions in Article 58(1) of the Law are fulfilled, and
(iii) are products in respect of which a product
licence is granted, after the commencement of this Order, containing a
provision to the effect that the method of sale or supply of the medicinal
product is to be only in accordance with a prescription given by a person who
is an appropriate practitioner; and
(e) cyanogenetic
substances, other than preparations for external use.[3]
3 Medicinal
products that are not prescription only medicines
(1) Notwithstanding
Article 2, a medicinal product shall not be a prescription only medicine
by reason that it consists of or contains a substance specified in column 1 of Part 1
of Schedule 1, where –
(a) in relation to that substance there is an
entry in any of columns 2, 3 and 4;
(b) the maximum strength in the product of that
substance does not exceed the maximum strength (if any) specified in column 2;
and
(c) the medicinal product is sold or
supplied –
(i) if a
pharmaceutical form or a route of administration is specified in column 3, in
such pharmaceutical form, and for administration only by such route, as may be
so specified,
(ii) if
a use is specified in column 3, in a container or package labelled (in either
case) to show a use so specified to which the medicinal product is to be put
but no use not so specified,
(iii) if a
maximum dose is specified in column 4, in a container or package labelled (in
either case) to show a maximum dose not exceeding that specified, and
(iv) if a
maximum daily dose is specified in column 4, in a container or package labelled
(in either case) to show a maximum daily dose not exceeding that specified.
(2) Notwithstanding
Article 2 of this Order, a medicinal product shall not be a prescription
only medicine by reason that it is a controlled drug, where –
(a) it contains not more than one of the
substances specified in column 1 of Part 2 of Schedule 1 to this Order
and no other controlled drug;
(b) it contains that substance at a strength
that does not exceed the maximum strength specified in column 2; and
(c) it is sold or supplied –
(i) in such
pharmaceutical form as may be specified in column 3, and
(ii) in
or from a container or package labelled (in either case) to show a maximum dose
not exceeding that specified in column 4.
(4) Notwithstanding
Article 2, a medicinal product specified in Part 3 or 4 of Schedule 1
shall not be a prescription only medicine.
4 New
medicinal products
For the purposes of Article 58(2)(a)
of the Law their duration shall be a period of 5 years.
5 Appropriate
practitioner[4]
(1) For the purposes of
Article 57(1), the following are appropriate practitioners –
(a) doctors;
(b) dentists;
(c) veterinary
surgeons;
(d) nurse
independent prescribers;
(e) optometrist
independent prescribers, but only in relation to a medicinal product that is
not a controlled drug and that is not for parenteral administration;
(f) paramedic
independent prescribers, but only in relation to a medicinal product that does
not contain a controlled drug other than –
(i) Codeine,
(ii) Fentanyl,
(iii) Midazolam,
or
(iv) Morphine;
and
(g) pharmacist
independent prescribers;
(h) physiotherapist
independent prescribers, but only in relation to a medicinal product that does
not contain a controlled drug other than –
(i) Dihydrocodeine,
(ii) Fentanyl,
(iii) Morphine,
(iv) Oxycodone,
or
(v) Temazepam;
(i) podiatrist
independent prescribers, but only in relation to a medicinal product that does
not contain a controlled drug other than Dihydrocodeine or Temazepam;
(j) supplementary
prescribers;
(k) therapeutic
radiographer independent prescribers, but only in relation to a medicinal
product that does not contain a controlled drug other than –
(i) Codeine,
(ii) Fentanyl,
(iii) Midazolam,
(iv) Morphine,
(v) Oxycodone,
(vi) Temazepam,
or
(vii) Tramadol.
(2) In this Article, a
reference to the following occupations is taken to be a reference to a person
registered in respect of that occupation under the Health Care (Registration) (Jersey)
Law 1995 –
(a) nurse
independent prescriber;
(b) optometrist
independent prescriber;
(c) paramedic
independent prescriber;
(d) pharmacist
independent prescriber;
(e) physiotherapist
independent prescriber;
(f) podiatrist
independent prescriber;
(g) therapeutic
radiographer independent prescriber.
6 Conditions
for prescriptions relating to sale and supply[5]
(1) For
the purposes of Article 57(2)(a) of the Law (read with paragraph (4)
of that Article), a prescription only medicine shall not be taken to be sold or
supplied in accordance with a prescription given by an appropriate practitioner
unless the conditions in paragraph (2) of this Article are fulfilled.
(2) The
conditions to which paragraph (1) refers are –
(a) the prescription shall be written in ink or
otherwise so as to be indelible, unless it is a health prescription that is not
for a controlled drug specified in any of Schedules 1, 2 and 3 to the Misuse
of Drugs (General Provisions) (Jersey) Order 1989, in which case it may be
written using carbon paper or similar material;
(b) the prescription shall be signed in ink,
with his or her own name, by the practitioner giving it;
(c) the prescription shall contain the following
information –
(i) the address of
the practitioner giving it,
(ii) the
appropriate date,
(iii) by
virtue of which of the paragraphs of Article 5 the practitioner giving it
is an appropriate practitioner,
(iv) where
the practitioner giving it is an appropriate practitioner other than a
veterinary surgeon, the name and address of the person for whose treatment it
is given and (if that person is under 12) his or her age, and
(v) where the practitioner
giving it is a veterinary surgeon, the name and address of the person to whom the
prescription only medicine is to be delivered, and a declaration by that
veterinary surgeon that the prescription only medicine is prescribed for an
animal or herd under his or her care;
(ca) in the case of a prescription given by a
supplementary prescriber, the supplementary prescriber –
(i) has given the
prescription in accordance with the terms of a clinical management plan
containing the information specified in Schedule 4, such plan relating to
an individual patient and to which the following are parties –
(A) the
patient,
(B) the
patient’s doctor or dentist, and
(C) the
supplementary prescriber, and
(ii) has
access to the health records of the patient to whom the clinical management
plan relates to the extent that such records are used by the doctor or dentist
who is a party to the plan;
(d) the prescription shall not be dispensed
after the end of the period of 6 months from the appropriate date unless it is
a repeatable prescription, in which case it shall not be dispensed for the
first time after the end of that period or otherwise than in accordance with
the direction contained in the repeatable prescription; and
(e) in the case of a repeatable prescription
that does not specify the number of times that it may be dispensed, the
prescription shall not be dispensed on more than 2 occasions unless it is a
prescription for oral contraceptives, in which case it may be dispensed 6 times
before the end of the period of 6 months from the appropriate date.[6]
(3) The
restrictions in Article 57(2)(a) of the Law shall not apply to a sale or
supply of a prescription only medicine that, by reason only that a condition in
paragraph (2) of this Article is not fulfilled, is not in accordance with
a prescription given by an appropriate practitioner, where the person selling
or supplying the prescription only medicine, having exercised all due
diligence, believes on reasonable grounds that that condition is fulfilled in
relation to that sale or supply.
(4) In
paragraph (2), the “appropriate date” means –
(a) in the case of a health
prescription –
(i) the date on which
it was signed by the practitioner by whom it was given, or
(ii) if
it also contains a date indicated by him or her as being the date before which
it shall not be dispensed, the later of the 2 dates; and
(b) in every other case, the date on which the
prescription was signed by the practitioner by whom it was given.
6A Conditions for
prescriptions – administration[7]
(1) For
the purposes of Article 57(2)(b) of the Law (read with paragraph (4)
of that Article), a prescription only medicine shall not be taken to be
administered by a supplementary prescriber or by a person acting in accordance
with the directions of a supplementary prescriber unless the conditions in
paragraph (2) are met.
(2) Those
conditions are that –
(a) the supplementary prescriber is acting in
accordance with the terms of a clinical management plan containing the
information specified in Schedule 4, such plan relating to an individual
patient to which the following are parties –
(i) the patient,
(ii) the
patient’s doctor or dentist, and
(iii) the
supplementary prescriber; and
(b) the supplementary prescriber has access to the
health records of the patient to whom the clinical management plan relates to
the extent that such records are used by the doctor or dentist who is a party
to the plan.
7 Exemption
for highly diluted medicinal products
The restrictions in Article 57(2)
of the Law shall not apply to the sale, supply or administration of a medicinal
product that is not for parenteral administration and only consists of or only
contains one or more of the substances specified in column 1 of Part 1 or
2 of Schedule 1 to this Order, where –
(a) each
unit preparation has been diluted to at least one part in a million (6x), and
the person selling, supplying or administering the medicinal product has been
requested by or on behalf of a particular person and in that person’s
presence to use his or her own judgment as to the treatment required; or
(b) each
such unit preparation has been diluted to at least one part in a million
million (6c).
8 Exemptions
for specified categories of persons
(1) The
restrictions in Article 57(2)(a) of the Law shall not apply –
(a) to the sale or supply by a person specified
in column 1 of Part 1 of Schedule 2 to this Order; or
(b) to the supply by a person specified in
column 1 of Part 2 of Schedule 2 to this Order,
of a prescription only
medicine specified in column 2 of Part 1 or 2 of that Schedule in relation
to that person, where the conditions in the corresponding paragraph in column 3
of that Part are fulfilled.
(2) The
restriction in Article 57(2)(b) of the Law shall not apply to the
administration by a person specified in column 1 of Part 3 of Schedule 2
to this Order of a prescription only medicine for parenteral administration
specified in column 2 of that Part in relation to that person, where the
conditions in the corresponding paragraph in column 3 of that Part are
fulfilled.
9 Exemption
for emergency sale or supply
(1) The
restrictions in Article 57(2)(a) of the Law shall not apply to the sale or
supply of a prescription only medicine by a person who is lawfully conducting a
retail pharmacy business, where the conditions in paragraph (2) of this Article
or the alternative conditions in paragraph (3) of this Article are
fulfilled.
(2) The
conditions to which paragraph (1) of this Article refers are –
(a) the pharmacist by or under whose supervision
the prescription only medicine is to be sold or supplied is satisfied that the
sale or supply has been requested by a doctor who, by reason of any emergency,
is unable to furnish a prescription immediately;
(b) the doctor has undertaken to furnish the person
lawfully conducting the retail pharmacy business with a prescription within 72
hours;
(c) the prescription only medicine is sold or
supplied in accordance with the directions of the doctor requesting it;
(d) the prescription only medicine is not a
controlled drug specified in any of Schedules 1, 2 and 3 to the Misuse of
Drugs (General Provisions) (Jersey) Order 1989; and
(e) an entry is made in the register to be kept
under Article 3(1) of the Medicines
(Sale and Supply) (Miscellaneous Provisions) (Jersey) Order 1997, within the appropriate time specified in that Article, of the
information in paragraph 1 of Schedule 2 to that Order.
(3) The
alternative conditions to which paragraph (1) of this Article refers
are –
(a) the pharmacist by or under whose supervision
the prescription only medicine is to be sold or supplied has interviewed the person
requesting a prescription only medicine and is satisfied –
(i) that there is an
immediate need for that prescription only medicine to be sold or supplied and
that it is impracticable in the circumstances to obtain a prescription without
undue delay,
(ii) that
treatment with that prescription only medicine has been prescribed on a
previous occasion by a doctor for the person requesting it from the pharmacist,
or (as far as the pharmacist is reasonably able to ascertain) has been lawfully
prescribed on a previous occasion by a medical practitioner outside Jersey for
the person requesting it from the pharmacist, and
(iii) as to
the dose which, in the circumstances, it would be appropriate for that person
to take;
(b) the prescription only medicine –
(i) will be sold or
supplied in no greater quantity than will provide 5 days’ treatment,
(ii) is
a preparation of insulin, an aerosol for the relief of asthma, an ointment or a
cream, and has been made up for sale in a container elsewhere than at the place
of sale or supply, and is the smallest pack that the pharmacist has available
for sale or supply,
(iii) is an
oral contraceptive and is sufficient, but no more than sufficient, for a full
cycle, or
(iv) is an
antibiotic for oral administration in liquid form, and is the smallest quantity
that will provide a full course of treatment;
(c) the prescription only medicine does not
consist of or contain a substance specified in Schedule 3 to this Order
and is not a controlled drug specified in any of the Schedules to the Misuse of
Drugs (General Provisions) (Jersey) Order 1989;
(d) an entry is made in the register to be kept
under Article 3(1) of the Medicines
(Sale and Supply) (Miscellaneous Provisions) (Jersey) Order 1997 within the appropriate time specified in that Article, of the
information in paragraph 3 of Schedule 2 to that Order; and
(e) the container or package of the prescription
only medicine is labelled so as to show –
(i) the date on which
the prescription only medicine is sold or supplied,
(ii) the
name, quantity and (unless it is apparent from the name) the pharmaceutical
form and strength of the prescription only medicine,
(iii) the
name of the person requesting the prescription only medicine,
(iv) the
name and address of the registered pharmacy from which the prescription only
medicine is sold or supplied, and
(v) the words
“Emergency Supply”.[8]
(4) The
conditions in paragraph (2)(d) of this Article and in paragraph (3)(c)
of this Article shall not apply where the prescription only
medicine –
(a) consists of or contains phenobarbitone or
phenobarbitone sodium (but no other substance specified in Schedule 3 to
this Order or in any of the Schedules to the Misuse of Drugs (General
Provisions) (Jersey) Order 1989); and
(b) is sold or supplied for use in the treatment
of epilepsy.
10 Exemption for
sale or supply in hospitals or the prison[9]
(1) The
restrictions in Article 57(2)(a) of the Law shall not apply to the sale or
supply of any prescription only medicine –
(a) in the course of the business of a hospital;
or
(b) by a pharmacy to the prison under the terms
of a contract to supply medicinal products for the benefit of prisoners,
in accordance with the
written directions of an appropriate practitioner, other than a supplementary
prescriber, even though those directions do not fulfil the conditions in
Article 6(2) of this Order.
(2) In
the case of directions given by a supplementary prescriber, paragraph (1)
applies except that the condition in Article 6(2)(ca) must be fulfilled as
if the references to a prescription in that sub-paragraph were references to
the directions given by the supplementary prescriber.
11 Exemption for
authorised needle supply services[10]
The restrictions of
Article 57(2)(a) of the Law shall not apply to the supply by a person, for
parenteral administration, of ampoules of sterile water, if the supply is made
by the person in the course of acting on behalf of a service provided by or on
behalf of the States for the purpose of enabling the supply of syringes, and
associated articles, so as to reduce the spread of disease.
12 Exemption
for sale or supply in cases involving another’s default
The restrictions in Article 57(2)(a)
of the Law shall not apply to the sale or supply of a prescription only
medicine by a person who, having exercised all due diligence, believes on
reasonable grounds that the product sold or supplied is not a prescription only
medicine, and it is because of an act or default of another person that the
product is a product to which that sub-paragraph applies.
13 Exemption
in the case of forged prescription
The restrictions in Article 57(2)(a)
of the Law shall not apply to the sale or supply of a prescription only
medicine by a pharmacist in accordance with a forged prescription where the
pharmacist, having exercised all due diligence, believes on reasonable grounds
that the prescription is genuine.
14 Exemption
for parenteral administration to human beings
The restriction in Article 57(2)(b)
of the Law shall not apply to the administration to human beings of any of the
following medicinal products for parenteral administration, namely –
adrenaline
injection BP;
atropine
sulphate injection;
chlorpheniramine
injection;
cobalt edetate injection;
dextrose injection strong B.P.C.;
diphenhydramine
injection;
glucagon
injection;
hydrocortisone
injection;
mepyramine
injection;
naloxone injection;
promethazine hydrochloride
injection;
snake venom antiserum;
sodium nitrite injection;
sodium thiosulphate injection; and
sterile pralidoxime injection,
where it is administered
for the purpose of saving life in an emergency.
15 Exemption
for non-parenteral administration to human beings
The restriction in Article 57(2)(b)
of the Law shall not apply to the administration to human beings of a
prescription only medicine that is not for parenteral administration.
16 Citation
This Order may be cited
as the Medicines (Prescription Only) (Jersey) Order 1997.