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• Prescription Only Medicines (Human) (Bailiwick of Guernsey) Ordinance, 2009

Prescription Only Medicines (Human) (Bailiwick of Guernsey) Ordinance, 2009

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The Prescription Only Medicines (Human) (Bailiwick of Guernsey) Ordinance, 2009

ARRANGEMENT OF SECTIONS

1.      Appropriate practitioners.

2.      Medicinal products on prescription only.

3.      Conditions relating to prescribing and administration by supplementary prescribers.

4.      Exempt medicinal products.

5.      Exemption for administration of smallpox vaccine.

6.      Exemption in relation to radioactive medicinal products.

7.      Exemptions for emergency sale and supply.

8.      Exemption for non-parenteral administration.

9.      Exemptions for aloxiprin, aspirin or paracetemol.

10.     Exemptions for pseudoephedrine salts or ephedrine base or salts.

11.     Exemption for parenteral administration in an emergency.

12.     Exemption for medicinal products at high dilutions.

13.     Exemptions for certain persons.

14.     Exemption for sale and supply in hospitals.

15.     Exemptions for use of Patient Group Directions.

16.     Exemption in cases involving another's default.

17.     Exemptions relating to prescriptions given by certain health professionals.

18.     Exemption in the case of a forged prescription.

19.     Formalities for preparation of prescriptions.

20.     Interpretation.

21.     Extent.

22.     Consequential amendments to the Misuse of Drugs Ordinance.

23.     Citation and commencement.

SCHEDULE 1:      Exemptions for certain persons from section 35(4) of the Law.

SCHEDULE 2:      Patient Group Directions.

SCHEDULE 3:      Consequential amendments to the Misuse of Drugs (Bailiwick of Guernsey) Ordinance, 1997.

The Prescription Only Medicines (Human) (Bailiwick of Guernsey) Ordinance, 2009

THE STATES, in pursuance of their Resolution of 29^th September, 2004[a], and in exercise of the powers conferred on them by sections 35 and 132 of the Medicines (Human and Veterinary) (Bailiwick of Guernsey) Law, 2008[b], and by sections 6, 9, 21 and 30 of the Misuse of Drugs (Bailiwick of Guernsey) Law, 1974[c] and all other powers enabling them in that behalf, hereby order:-

Appropriate practitioners.

1.      For the purposes of section 35 of the Law (medicinal products on prescription only) the following are appropriate practitioners -

(a)      in relation to the descriptions and classes of medicinal products specified in section 2 -

(i)      doctors,

(ii)      dentists,

(iii)      veterinary surgeons,

(iv)      nurse independent prescribers,

(v)      pharmacist independent prescribers,

(vi)      supplementary prescribers,

(b)      in relation to the descriptions and classes of medicinal products specified in Schedule 3 to the UK Order (descriptions and classes of prescription only medicines in relation to which community practitioner nurse prescribers are appropriate practitioners), community practitioner nurse prescribers,

(c)      in relation to the descriptions and classes of medicinal products specified in section 2, other than medicinal products that are controlled drugs or for parenteral administration, in addition to the persons specified in paragraph (a), optometrist independent prescribers.

Medicinal products on prescription only.

2.      (1)      A medicinal product is specified for the purposes of section 35 of the Law (medicinal products on prescription only) if -

(a)      it is of a description or falls within a class set out in Article 3 of the UK Order (medicinal products on prescription only), and

(b)       it is not an emergency contraceptive or any other kind of contraceptive.

(2)      For the purposes of this section, references in Article 3 of the UK Order to controlled drugs shall be taken as being references to controlled drugs within the meaning of this Ordinance.

Conditions relating to prescribing and administration by supplementary prescribers.

3.      (1)      The conditions attaching to prescribing and administration by supplementary prescribers in the United Kingdom under the provisions of -

(a)      Article 3B of the UK Order (prescribing and administration by supplementary prescribers),

(b)      Article 3C of the UK Order (exemptions from conditions in respect of the cases or circumstances in which a supplementary prescriber may administer a medicinal product),

(c)      Schedule 3B of the UK Order (particulars for clinical management plans), and

(d)      any other relevant provisions of the UK Order,

shall apply to prescribing and administration by supplementary prescribers in the Bailiwick.

(2)      For the purposes of this section, references in the UK Order to appropriate practitioners shall be taken as being references to appropriate practitioners within the meaning of this Ordinance.

Exempt medicinal products.

4.      A medicinal product shall be exempt from the restrictions imposed by section 35(4)(a) of the Law if it satisfies the conditions set out in Article 5 of the UK Order (exempt medicinal products) in respect of medicinal products exempt from the restrictions imposed by section 58(2)(a) of the Medicines Act 1968[d].

Exemption for administration of smallpox vaccine.

5.      (1)      The restrictions imposed by section 35(4)(b) of the Law do not apply to the administration to human beings of smallpox vaccine where the conditions specified in subsection (2), or alternatively subsection (3), are satisfied.

(2)      The conditions referred to in subsection (1) are -

(a)      the vaccine has been supplied by, or on behalf of, or under arrangements made by the Department, and

(b)      the vaccine is administered for the purpose of providing protection against smallpox virus in the event of a suspected or confirmed case of smallpox in the Bailiwick.

(3)      The conditions referred to in subsection (1) are -

(a)      the vaccine has been supplied by, or on behalf of, or under arrangements made by Her Majesty's Forces, and

(b)      the vaccine is administered for the purpose of providing protection against smallpox virus to -

(i)      members of Her Majesty's Forces, or

(ii)      other persons employed or engaged by those Forces.

Exemption in relation to radioactive medicinal products.

6.      (1)      The restrictions imposed by section 35(4)(b) of the Law do not apply to -

(a)      a radioactive medicinal product, administration of which results in a medical exposure, or

(b)      any other prescription only medicine if it is being administered in connection with a medical exposure,

where the conditions specified in subsection (2) are satisfied.

(2)      The conditions referred to in subsection (1) are that -

(a)      the radioactive medicinal product or other prescription only medicine is administered in accordance with such procedures and protocols as the Department thinks fit,

(b)      the radioactive medicinal product or other prescription only medicine is administered by a person who is, in the opinion of the Department, suitably qualified,

(c)      that medical exposure has been authorised by a person who is, in the opinion of the Department, suitably qualified or, where it is not practicable for that person to authorise the exposure, the person administering it has authorised it in accordance with written guidelines issued by a person who is, in the opinion of the Department, suitably qualified, and

(d)      the radioactive medicinal product or other prescription only medicine is not a controlled drug.

Exemptions for emergency sale and supply.

7.      (1)      The restrictions imposed by section 35(4)(a) of the Law do not apply to the sale or supply of a prescription only medicine by a person lawfully conducting a retail pharmacy business where the conditions specified in subsection (2) are satisfied.

(2)      The conditions referred to in subsection (1) are -

(a)      that 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 an appropriate prescriber who by reason of an emergency is unable to furnish a prescription immediately,

(b)      that the appropriate prescriber has undertaken to furnish the person lawfully conducting the retail pharmacy business with a prescription within 72 hours of the sale or supply,

(c)      that the prescription only medicine is sold or supplied in accordance with the directions of the appropriate prescriber requesting it,

(d)      subject to subsection (5), that the prescription only medicine is not a controlled drug specified in Schedule 1, 2 or 3 to the Misuse of Drugs Ordinance, and

(e)      that an entry is made in the record kept under regulation 1 of the Prescription Only Medicines (Human) (Pharmacy Records) (Bailiwick of Guernsey) Regulations, 2009 within the time specified in that regulation stating the particulars required under the Schedule to those Regulations.

(3)      The restrictions imposed by section 35(4)(a) of the Law do not apply to the sale or supply of a prescription only medicine by a person lawfully conducting a retail pharmacy business where the conditions specified in subsection (4) are satisfied.

(4)      The conditions referred to in subsection (3) are -

(a)      that the pharmacist by or under whose supervision the prescription only medicine is to be sold or supplied has interviewed the person requesting it and has satisfied himself -

(i)      that there is an immediate need for it to be sold or supplied and that it is impracticable in the circumstances to obtain a prescription without undue delay,

(ii)      that treatment with it has on a previous occasion been prescribed by an appropriate prescriber for the person requesting it, and

(iii)      as to the dose which in the circumstances it would be appropriate for that person to take,

(b)      that no greater quantity of it than will provide 5 days' treatment in the case of a controlled drug, or 30 days' treatment in any other case, is sold or supplied except where -

(i)      it is a preparation of insulin, an aerosol for the relief of asthma, an ointment or cream, and has been made up for sale in a container elsewhere than at the place or sale of supply, the smallest pack that the pharmacist has available for sale or supply may be sold or supplied,

(ii)      it is an oral contraceptive, a quantity sufficient for a full treatment cycle may be sold or supplied, or

(iii)      it is an antibiotic for oral administration in liquid form, the smallest quantity that will provide a full course of treatment may be sold or supplied,

(c)      subject to subsection (5), that it does not consist of or contain a substance specified in Schedule 4 to the UK Order and is not a controlled drug specified in Schedule 1, 2 or 3 of the Misuse of Drugs Ordinance,

(d)      that an entry is made in the record kept under regulation 1 of the Prescription Only Medicines (Human) (Pharmacy Records) (Bailiwick of Guernsey) Regulations, 2009 within the time specified in that regulation stating the particulars required under the Schedule to those Regulations, and

(e)      that the container or package of the product is labelled so as to show -

(i)      the date on which it is sold or supplied,

(ii)      its name, quantity and, except where it is apparent from its name, its pharmaceutical form and strength,

(iii)      the name of the person requesting it, and

(iv)      the words "Emergency Supply".

(5)      The conditions specified in subsections (2)(d) and (4)(c) do not apply where the prescription only medicine consists of or contains phenobarbitone or phenobarbitone sodium (but no other substance specified in Schedule 4 to the UK Order or Schedule 1, 2 or 3 to the Misuse of Drugs Ordinance) and is sold or supplied for use in the treatment of epilepsy.

(6)      In this section "appropriate prescriber" means a doctor, supplementary prescriber, community practitioner nurse prescriber, nurse independent prescriber, optometrist independent prescriber or pharmacist independent prescriber.

Exemption for non-parenteral administration.

8.      The restrictions imposed by section 35(4)(b) of the Law do not apply to the administration to human beings of a prescription only medicine which is not for parenteral administration.

Exemptions for aloxiprin, aspirin or paracetemol.

9.      A medicinal product which is specified for the purposes of section 35 of the Law (medicinal products on prescription only) because it falls within a description or class set out in Article 3(g) of the UK Order (certain products containing aloxiprin, aspirin or paracetemol) is exempt from the restrictions imposed by section 35(4) of the Law (restrictions on sale, supply and administration) if the quantity of that product sold or supplied to a person at any one time does not exceed 100 tablets or capsules.

Exemptions for pseudoephedrine salts or ephedrine base or salts.

10.      A medicinal product which is specified for the purposes of section 35 of the Law because it falls within a description or class set out in Article 3(h) of the UK Order (certain products containing pseudoephedrine salts or ephedrine base or salts) is exempt from the restrictions imposed by section 35(4) of the Law if it satisfies the conditions set out in Article 5B of the UK Order (quantitative limits of pseudoephedrine salts or ephedrine base or salts).

Exemption for parenteral administration in an emergency.

11.      The restrictions imposed by section 35(4)(b) of the Law do not apply to the administration to human beings of any of the medicinal products for parenteral administration specified in Article 7 of the UK Order (exemption for parenteral administration in an emergency to human beings of certain prescription only medicines) where the administration is for the purposes of saving life in an emergency.

Exemption for medicinal products at high dilutions.

12.      The restrictions imposed by section 35(4) of the Law do not apply to the sale, supply or administration of a medicinal product which is not for parenteral administration -

(a)      which consists of or contains any of the substances referred to in Article 10(1) of the UK Order (exemption for certain medicinal products at high dilutions), which satisfies the conditions set out in that paragraph,

(b)      which consists of or contains solely any of the substances referred to in Article 10(2) of the UK Order (exemption for certain medicinal products at high dilutions), which satisfies the conditions set out in that paragraph.

Exemptions for certain persons.

13.      (1)      The restrictions imposed by section 35(4)(a) of the Law do not apply -

(a)      to the sale or supply by a person listed in column 1 of Part I of Schedule 1 of the prescription only medicines listed in relation to that person in column 2 of that Part where the conditions specified in the corresponding paragraphs in column 3 of that Part are satisfied,

(b)      to the supply by a person listed in column 1 of Part II of Schedule 1 of the prescription only medicines listed in relation to that person in column 2 of that Part where the conditions specified in the corresponding paragraphs in column 3 of that Part are satisfied.

(2)      The restrictions imposed by section 35(4)(b) of the Law do not apply to the administration by a person listed in column 1 of Part III of Schedule 1 of the prescription only medicines for parenteral administration listed in relation to that person in column 2 of that Part where the conditions specified in the corresponding paragraphs in column 3 of that Part are satisfied.

Exemption for sale and supply in hospitals.

14.      (1)      Subject to subsection (3), the restrictions imposed by section 35(4) of the Law do not apply to the sale or supply of a prescription only medicine in the course of the business of a hospital where the medicine is sold or supplied for the purpose of being administered (whether in the hospital or elsewhere) to a particular person in accordance with directions satisfying the conditions specified in subsection (2).

(2)      The conditions specified in subsection (1) are that the directions -

(a)      are in writing,

(b)      relate to the particular person to whom the medicine is to be administered, and

(c)      are given by a person (other than a veterinary surgeon) who is an appropriate practitioner in relation to that medicine.

(3)      A supplementary prescriber may give these directions only if he complies with any conditions applying under section 3 to the giving of a prescription for that medicine, as if the directions were a prescription.

(4)      The exemption in subsection (1) applies even if the directions do not satisfy the conditions specified in section 19(2).

(5)      For the purposes of subsection (1), the directions may, as an alternative to fulfilling the condition specified in subsection (2)(a), fulfil the conditions specified in subsection (6).

(6)      The conditions referred to in subsection (5) are that the directions are created in electronic form and signed with an advanced electronic signature and transferred to the person by whom the medicinal product is dispensed as an electronic communication (including where it is transferred through one or more intermediaries).

Exemptions for use of Patient Group Directions.

15.      (1)      The restrictions imposed by section 35(4) of the Law do not apply to the sale, supply or administration of a prescription only medicine by -

(a)      the Department,

(b)      any person, other than an excepted person, with whom the Department has entered into an arrangement for the sale, supply or administration of prescription only medicines, or

(c)      any hospital, infirmary, health centre, dispensary, clinic, nursing home or other institution at which human ailments are treated,

(the "authorising person") where the medicine is sold or supplied for the purpose of being administered, or is administered to a particular person in accordance with a Patient Group Direction and where the conditions set out in subsection (2) are satisfied.

(2)      The conditions referred to in subsection (1) are that -

(a)      the Patient Group Direction relates to the sale, supply or administration by the person who sells, supplies or administers the prescription only medicine, or description or class of prescription only medicine, and the Direction has effect at the time at which the medicine is sold, supplied or administered,

(b)      the Patient Group Direction contains the particulars specified in Part I of Schedule 2,

(c)      the period during which the Patient Group Direction is to have effect, as set out in the particulars, is less than 5 years,

(d)      where the authorising person is not the Department, the Patient Group Direction is signed by the authorising person,

(e)      the individual who sells, supplies or administers the prescription only medicine belongs to one of the classes of individuals specified in Part II of Schedule 2,

(f)      the individual who sells, supplies or administers the prescription only medicine is designated in writing by the authorising person for the purpose of the sale, supply or administration of the prescription only medicine under the Patient Group Direction,

(g)      at the time when the medicine is sold, supplied or administered, a recognised marketing authorisation is in force in respect of it, and

(h)      where the authorising person is not the Department, the Department has consented to the Patient Group Direction and that consent has not been withdrawn.

(3)      In this section "excepted person" means -

(a)      a doctor or dentist, or

(b)      a person lawfully conducting a retail pharmacy business.

(4)      In this Ordinance "Patient Group Direction" means a written direction relating to the sale, supply or administration of a description or class of prescription only medicine which -

(a)      is signed by -

(i)      a doctor or dentist, and

(ii)      a pharmacist, and

(b)      relates to the sale, supply or administration to persons generally, subject to any exclusion which may be set out in the Direction.

(5)      Any Patient Group Direction which has been consented to by the Department and which is in effect immediately before the coming into force of this Ordinance shall be treated as if it complies with the requirements of this section, provided that the Department can still withdraw its consent in accordance with subsection (2)(h).

Exemption in cases involving another's default.

16.      The restrictions imposed by section 35(4)(a) of the Law do 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.

Exemptions relating to prescriptions given by certain health professionals.

17.      (1)      The restrictions imposed by section 35(4)(a) of the Law do not apply to the sale or supply of a prescription only medicine by a pharmacist in accordance with a prescription given by -

(a)      another pharmacist,

(b)      a registered nurse,

(c)      a registered midwife,

(d)      a person whose name is registered in the part of the register maintained under section 3 of the Registered Health Professionals Ordinance, 2006 relating to -

(i)      chiropodists and podiatrists,

(ii)      physiotherapists,

(iii)      radiographers: diagnostic or therapeutic, or

(e)      a registered optometrist,

who is not an appropriate practitioner in relation to that medicine where the pharmacist selling or supplying the medicine, having exercised all due diligence, believes on reasonable grounds that the person is such a practitioner.

(2)      The restrictions imposed by section 35(4)(a) of the Law do not apply to the sale or supply of a prescription only medicine by a pharmacist in accordance with a prescription given by a supplementary prescriber where the pharmacist, having exercised all due diligence, believes on reasonable grounds that the supplementary prescriber has complied with any condition with which he is required to comply under section 3.

Exemption in the case of a forged prescription.

18.      The restrictions imposed by section 35(4)(a) of the Law do 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.

Formalities for preparation of prescriptions.

19.      (1)      For the purposes of section 35(4)(a) of the Law 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 specified in subsection (2) are fulfilled.

(2)      The conditions referred to in subsection (1) are that the prescription -

(a)      is signed in ink with his own name by the appropriate practitioner giving it,

(b)      without limiting paragraph (a), is written in ink or otherwise so as to be indelible,

(c)      contains the following particulars -

(i)      the address of the appropriate practitioner giving it,

(ii)      the appropriate date,

(iii)      such particulars as indicate whether the appropriate practitioner giving it is a doctor, dentist, supplementary prescriber, community practitioner nurse prescriber, nurse independent prescriber, optometrist independent prescriber, pharmacist independent prescriber or veterinary surgeon,

(iv)      where the appropriate practitioner giving it is a doctor, dentist, supplementary prescriber, community practitioner nurse prescriber, nurse independent prescriber, pharmacist independent prescriber or optometrist independent prescriber, the name, address and age, if under 12, of the person for whose treatment it is given, and

(v)      where the appropriate 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 the veterinary surgeon that the prescription only medicine is prescribed for an animal or herd under his care,

(d)      is not dispensed after a period of 6 months from the appropriate date, unless it is a repeatable prescription in which case it is not dispensed for the first time after that period, nor otherwise than in accordance with the directions contained in the repeatable prescription,

(e)      in the case of a repeatable prescription which does not specify the number of times it may be dispensed, is not dispensed on more than 2 occasions unless it is a prescription for an oral contraceptive in which case it may be dispensed 6 times before the end of the period of 6 months from the appropriate date.

(3)      For the purposes of subsection (1) the prescription may, as an alternative to fulfilling the conditions specified in subsection (2)(a) and (b), fulfil instead the conditions specified in subsection (4) unless -

(a)      it is for controlled drug specified in Schedule 1, 2 or 3 of the Misuse of Drugs Ordinance, or

(b)      it is given by a veterinary surgeon.

(4)      The conditions referred to in subsection (3) are that the prescription shall be created in electronic form and signed with an advanced electronic signature and transferred to the person by whom it is dispensed as an electronic communication (including where it is transferred through one or more intermediaries).

(5)      The prohibition on sale and supply imposed by section 35(4)(a) of the Law do not apply where a prescription only medicine is sold or supplied other than in accordance with a prescription given by an appropriate practitioner and -

(a)      the reason the sale or supply is not in accordance with such a prescription is that a condition specified in subsection (2) or (4) is not fulfilled, and

(b)      the person selling or supplying the prescription only medicine has exercised all due diligence and believes on reasonable grounds that the condition is fulfilled.

(6)      In subsection (2) "appropriate date" means the date on which it was signed by the appropriate practitioner giving it or a date indicated by him as being the date before which it shall not be dispensed, and for the purposes of paragraphs (d) and (e) of that subsection, where the prescription bears both the date on which it was signed and a date indicated as being that before which it shall not be dispensed, the appropriate date is the later of those dates.

Interpretation.

20.      (1)      In this Ordinance, unless the context requires otherwise -

"additional supply optometrist" means a person -

(a)      who is a registered optometrist, and

(b)      against whose name particulars of the additional supply speciality have been entered in the relevant register;

"advanced electronic signature" means an electronic signature which is -

(a)      uniquely linked to the signatory,

(b)      capable of identifying the signatory,

(c)      created using means that the signatory can maintain under his sole control, and

(d)      linked to the data to which it relates in such a manner that any subsequent change of data is detectable;

"aerosol" means a product which is dispersed from its container by a propellent gas or liquid;

"anaesthetic assistant" means a nurse or operating department practitioner against whose name is recorded in the relevant register, or a comparable register kept in the United Kingdom, an annotation or entry signifying that he is qualified to practise as an anaesthetic assistant;

"community practitioner nurse prescriber" means a person -

(a)      who is a registered nurse or registered midwife, and

(b)      against whose name is recorded in the professional register an annotation or entry signifying that he is qualified to order drugs, medicines and appliances from the Nurse Prescribers Formulary for Community Practitioners in the current edition of the British National Formulary;

"controlled drug" has the meaning given by section 1 of the Misuse of Drugs (Bailiwick of Guernsey) Law, 1974[e];

"electronic communication" means a communication transmitted (whether from one person to another, from one device to another or from a person to a device or vice versa) -

(a)      by means of a telecommunications system, or

(b)      by other means but while in electronic form;

"the Law" means the Medicines (Human and Veterinary) (Bailiwick of Guernsey) Law, 2008[f];

"master" has the same meaning as in section 294 of the Merchant Shipping (Bailiwick of Guernsey) Law, 2002[g];

"medical exposure" means exposure of a person to ionising radiation for the purposes of his medical or dental examination or treatment;

"medicinal product" has the same meaning as in the Law;

"Misuse of Drugs Ordinance" means the Misuse of Drugs (Bailiwick of Guernsey) Ordinance, 1997[h];

"nurse independent prescriber" means a person -

(a)      who is a registered nurse or a registered midwife, and

(b)      against whose name is recorded in the professional register an annotation or entry signifying that he is qualified to order drugs, medicines and appliances as a nurse independent prescriber or a nurse independent/ supplementary prescriber;

"occupational health scheme" means a scheme in which a person, in the course of a business carried on by him, provides facilities for his employees for the treatment or prevention of disease;

"operator" means the person for the time being having management of an aircraft;

"optometrist independent prescriber" means a person -

(a)      who is a registered optometrist, and

(b)      against whose name is recorded in the relevant register an annotation or entry signifying that he is qualified to order drugs, medicines and appliances as an optometrist independent prescriber;

"parenteral administration" means administration by breach of the skin or mucous membrane;

"Patient Group Direction" has the meaning given by section 15;

"person lawfully conducting a retail pharmacy business" has the meaning given by section 47 of the Law;

"pharmacist independent prescriber" means a person -

(a)      who is a pharmacist, and

(b)      against whose name is recorded in the relevant register an annotation or entry signifying that he is qualified to order drugs, medicines and appliances as a pharmacist independent prescriber;

"prescription only medicine" means a medicinal product of a description or falling within a class specified in section 2;

"professional register" means the register maintained by the Nursing and Midwifery Council under Article 5 of the Nursing and Midwifery Order 2001[i];

"radioactive medicinal product" means a medicinal product which is, which contains or which generates a radioactive substance and which is, contains or generates that substance in order, when administered, to utilize the radiation emitted from it;

"recognised manufacturer's licence" means a manufacturer's licence recognised by regulations made under section 7(3) of the Law;

"registered chiropodist" means a person whose name is registered in the part of the register maintained under section 3 of the Registered Health Professionals Ordinance relating to chiropodists;

"registered dietician" means a person whose name is registered in the part of the register maintained under section 3 of the Registered Health Professionals Ordinance relating to dieticians;

"Registered Health Professionals Ordinance" means the Registered Health Professionals Ordinance, 2006[j];

"registered midwife" means a person registered in the Midwives' Part of the professional register;

"registered nurse" means a person registered in the Nurses' Part, or the Specialist Community Public Health Nurses' Part of the professional register;

"registered occupational therapist" means a person whose name is registered in the part of the register maintained under section 3 of the Registered Health Professionals Ordinance relating to occupational therapists;

"registered operating department practitioner" means a person whose name is registered in the part of the register maintained under section 3 of the Registered Health Professionals Ordinance relating to operating department practitioners;

"registered optometrist" means a person whose name is registered in the register of opticians maintained under section 7(a) of the Opticians Act 1989[k];

"registered orthoptist" means a person whose name is registered in the part of the register maintained under section 3 of the Registered Health Professionals Ordinance relating to orthoptists;

"registered paramedic" means a person whose name is registered in the part of the register maintained under section 3 of the Registered Health Professionals Ordinance relating to paramedics;

"registered physiotherapist" means a person whose name is registered in the part of the register maintained under section 3 of the Registered Health Professionals Ordinance relating to physiotherapists;

"registered prosthetist and orthotist" means a person whose name is registered in the part of the register maintained under section 3 of the Registered Health Professionals Ordinance relating to prosthetists and orthotists;

"registered radiographer" means a person whose name is registered in the part of the register maintained under section 3 of the Registered Health Professionals Ordinance relating to radiographers;

"registered speech and language therapist" means a person whose name is registered in the part of the register maintained under section 3 of the Registered Health Professionals Ordinance relating to speech and language therapists;

"relevant register" means -

(a)      in relation to a registered nurse or registered midwife, the professional register,

(b)      in relation to a pharmacist, the register maintained by the Department under section 2 of the Doctors, Dentists and Pharmacists Ordinance, 1987[l],

(c)      in relation to a person whose name is registered in the part of the register maintained under section 3 of the Registered Health Professionals Ordinance relating to-

(i)      chiropodists and podiatrists,

(ii)      physiotherapists, or

(iii)      radiographers: diagnostic or therapeutic,

that register, and

(d)      in relation to a registered optometrist, the register of optometrists maintained under section 7(a) of the Opticians Act 1989[m];

"repeatable prescription" means a prescription which contains a direction that it may be dispensed more than once;

      "signatory" means the appropriate practitioner giving the direction;

"supplementary prescriber" means -

(a)      a registered nurse,

(b)      a pharmacist,

(c)      a registered midwife,

(d)      a person whose name is registered in the part of the register maintained under section 3 of the Registered Health Professionals Ordinance relating to -

(i)      chiropodists and podiatrists,

(ii)      physiotherapists, or

(iii)      radiographers: diagnostic or therapeutic, or

(e)      a registered optometrist,

against whose name is recorded in the relevant register an annotation or entry signifying that he is qualified to order drugs, medicines and appliances as a supplementary prescriber or, in the case of a nurse or midwife, as a nurse independent / supplementary prescriber; and

"UK Order" means the Prescription Only Medicines (Human Use) Order 1997[n].

(2)      A reference in this Ordinance to an enactment, or any provision or part of it, is a reference to it as amended, or re-enacted or re-made (with or without modification), or extended or applied by or under any enactment.

(3)      The Interpretation (Guernsey) Law, 1948[o] applies to the interpretation of this Ordinance throughout the Bailiwick.

(4)       For the avoidance of doubt, unless paragraph (1) or the context otherwise requires, an expression used in this Ordinance has the same meaning as in the Law.

Extent.

      21.     This Ordinance has effect throughout the Bailiwick.

Consequential amendments to the Misuse of Drugs Ordinance.

22.      The Misuse of Drugs Ordinance is amended as set out in Schedule 3.

Citation and commencement.

23.      This Ordinance may be cited as the Prescription Only Medicines (Human) (Bailiwick of Guernsey) Ordinance, 2009 and comes into force on the 1^st October, 2009.

Section 13

SCHEDULE 1

EXEMPTIONS FOR CERTAIN PERSONS FROM SECTION 35(4) OF THE LAW

Part I

Exemptions from Restrictions on Sale and Supply

Part II

Exemptions from the Restriction on Supply

Part III

Exemptions from the Restriction on Administration

Section 15

SCHEDULE 2

PATIENT GROUP DIRECTIONS

Part I

Particulars to be included in a Patient Group Direction

(a)      the period during which the Direction shall have effect,

(b)      the description or class of prescription only medicines to which the Direction relates,

(c)      whether there are any restrictions on the quantity of medicine which may be sold or supplied on any one occasion, and if so, what restrictions,

(d)      the clinical situations which prescription only medicines of that description or class may be used to treat,

(e)      the clinical criteria under which a person shall be eligible for treatment,

(f)      whether any class of person is excluded from treatment under the Direction and, if so, what class of person,

(g)      whether there are circumstances in which further advice should be sought from a doctor or dentist and, if so, what circumstances,

(h)      the pharmaceutical form or forms in which prescription only medicines of that description or class are to be administered,

(i)      the strength, or maximum strength, at which prescription only medicines of that description or class are to be administered,

(j)      the applicable dosage or maximum dosage,

(k)      the route of administration,

(l)      the frequency of administration,

(m)      any minimum or maximum period of administration applicable to prescription only medicines of that description or class,

(n)      whether there are any relevant warnings to note, and, if so, what warnings,

(o)      whether there is any follow up action to be taken in any circumstances, and, if so, what action and in what circumstances,

(p)      arrangements for referral for medical advice, and

(q)      details of the records to be kept of the supply, or the administration, of medicines under the Direction.

Part II

Classes of individuals by whom prescription only medicines may be supplied or administered

Anaesthetic assistants.

Pharmacists.

Registered chiropodists.

Registered dieticians.

Registered midwives.

Registered nurses.

Registered occupational therapists.

Registered operating department practitioners.

Registered optometrists.

Registered orthoptists.

Registered paramedics.

Registered physiotherapists.

Registered prosthetists and orthotists.

Registered radiographers.

Registered speech and language therapists.

Section 22

SCHEDULE 3

AMENDMENTS TO THE MISUSE OF DRUGS (BAILIWICK OF GUERNSEY) ORDINANCE, 1997

      1.      Section 1(1) (interpretation) is amended as follows -

(a)      in the definition of "authorised as a member of a group", for "section 8(3), 9(3) or 10(3)", substitute "section 7(3), 8(3) or 9(3)",

(b)      in the definition of "medicinal product", for "Medicines Act 1968", substitute "Medicines (Human and Veterinary) (Bailiwick of Guernsey) Law, 2008[q]",

(c)      in the definition of "prescription" immediately after the words "by a medical practitioner for the medical treatment of a single individual,", insert the words "by a supplementary prescriber for the medical treatment of a single individual, by a nurse independent prescriber for the medical treatment of a single individual, by a pharmacist independent prescriber for the medical treatment of a single individual,",

(d) for the definition of "registered midwife", substitute the following definition -

""registered midwife" means a person registered in the Midwives' Part of the professional register,",

(e)      insert the following definitions in the correct alphabetical order -

""clinical management plan" means a written plan (which may be amended from time to time) relating to the treatment of an individual patient agreed by -

(a)      the patient to whom the plan relates,

(b)      the doctor or dentist who is a party to the plan, and

(c)      any supplementary prescriber who is to prescribe, give directions for administration or administer under the plan;

"nurse independent prescriber" has the same meaning as in the Prescription Only Medicines (Human) (Bailiwick of Guernsey) Ordinance, 2009,

"Patient Group Direction" has the meaning given by section 15 of the Prescription Only Medicines (Human) (Bailiwick of Guernsey) Ordinance, 2009,

"pharmacist independent prescriber" has the same meaning as in the Prescription Only Medicines (Human) (Bailiwick ofGuernsey) Ordinance, 2009,

"professional register" has the same meaning as in the Prescription Only Medicines (Human) (Bailiwick of Guernsey) Ordinance, 2009,

"registered chiropodist" has the same meaning as in the Prescription Only Medicines (Human) (Bailiwick of Guernsey) Ordinance, 2009,

"registered nurse" has the same meaning as in the Prescription Only Medicines (Human) (Bailiwick of Guernsey) Ordinance, 2009,

"registered occupational therapist" has the same meaning as in the Prescription Only Medicines (Human) (Bailiwick of Guernsey) Ordinance, 2009,

"registered operating department practitioner" has the same meaning as in the Prescription Only Medicines (Human) (Bailiwick of Guernsey) Ordinance, 2009,

"registered optometrist" has the same meaning as in the Prescription Only Medicines (Human) (Bailiwick of Guernsey) Ordinance, 2009,

"registered orthoptist" has the same meaning as in the Prescription Only Medicines (Human) (Bailiwick of Guernsey) Ordinance, 2009,

"registered paramedic" has the same meaning as in the Prescription Only Medicines (Human) (Bailiwick of Guernsey) Ordinance, 2009,

"registered physiotherapist" has the same meaning as in the Prescription Only Medicines (Human) (Bailiwick of Guernsey) Ordinance, 2009,

"registered prosthetist and orthotist" has the same meaning as in the Prescription Only Medicines (Human) (Bailiwick of Guernsey) Ordinance, 2009,

"registered radiographer" has the same meaning as in the Prescription Only Medicines (Human) (Bailiwick of Guernsey) Ordinance, 2009,

"supplementary prescriber" has the same meaning as in the Prescription Only Medicines (Human) (Bailiwick of Guernsey) Ordinance, 2009,".

2.      In section 5(2), (general authority to supply and possess) immediately after "prescription of a practitioner", insert ", a pharmacist independent prescriber, a registered nurse, a supplementary prescriber or a person specified in Schedule 6A".

3.      Section 6 (administration of drugs in Schedules 2, 3 4 and 5) is amended as follows -

(a)      in subsection (2), immediately after "medical practitioner" insert ", nurse independent prescriber, pharmacist independent prescriber",

(b)      between subsections (2) and (3), insert the following subsection -

"(2A)      A supplementary prescriber, acting under and in accordance with the terms of a clinical management plan, may administer to a patient any drug specified in Schedule 2, 3 or 4.",

(c)      immediately after subsection (3), insert the following subsections -

"(4)      Any person may administer to a patient, in accordance with the directions of a nurse independent prescriber or a pharmacist independent prescriber, any drug specified in Schedule 2, 3 or 4.

(5)      Any person may administer to a patient, in accordance with the directions of a supplementary prescriber acting under and in accordance with the terms of a clinical management plan, any drug specified in Schedule 2, 3 or 4.

(6)      A person specified in Schedule 6A may administer to a patient, under and in accordance with a Patient Group Direction, any drug specified in Schedule 2, 3 or 4.".

4.      Section 7 (production and supply of drugs in Schedules 2 and 5) is amended as follows -

(a)      in subsection (2), immediately after paragraph (g), insert the following paragraphs -

"(h)      a supplementary prescriber acting under and in accordance with the terms of a clinical management plan,

(i)      a nurse independent prescriber;

(j)      a pharmacist independent prescriber;",

(b)      in the proviso to subsection (2), in paragraph (ii), for the words "or dentist" substitute the words ", nurse independent prescriber, pharmacist independent prescriber, dentist or supplementary prescriber acting under and in accordance with the terms of a clinical management plan",

(c)      immediately after subsection (6), insert the following subsection -

"(7)      Notwithstanding the provisions of section 3(1)(b) of the Law -

(a)      a registered nurse, when acting in his capacity as such, may supply or offer to supply, under and in accordance with the terms of a Patient Group Direction, diamorphine for the treatment of cardiac pain to a person admitted as a patient to a coronary care unit or an accident and emergency department of a hospital;

(b)      a registered nurse or a person specified in Schedule 6A may, when acting in their capacity as such, supply or offer to supply, under and in accordance with the terms of a Patient Group Direction, any drug specified in Schedule 5 to any person who may lawfully have that drug in his possession.".

5.      Section 8 (production and supply of drugs in Schedules 3 and 4) is amended as follows -

(a)      in subsection (2), immediately after paragraph (g), insert the following paragraphs -

"(h)      a supplementary prescriber acting under and in accordance with the terms of a clinical management plan;

(i)      a nurse independent prescriber;

(j)      a pharmacist independent prescriber;",

(b)      in the proviso to subsection (3), in paragraph (ii), for the words "or dentist" substitute the words ", nurse independent prescriber, pharmacist independent prescriber, dentist or supplementary prescriber acting under and in accordance with the terms of a clinical management plan",

(c)      immediately after subsection (6), insert the following subsection -

"(7)      Notwithstanding the provisions of section 3(1)(b) of the Law, a registered nurse or a person specified in Schedule 6A, when acting in his capacity as such, may supply or offer to supply, under and in accordance with the terms of a Patient Group Direction, any drug specified in Schedule 4 or Midazolam to any person who may lawfully have that drug in his possession, but this exception does not apply to -

(a)      the supply or offer to supply of any of the anabolic steroids specified in Part II of Schedule 4; or

(b)      any drug or preparation which is designed for administration by injection and which is to be used for the purpose of treating a person who is addicted to a drug,

and for the purposes of paragraph (b), a person shall be regarded as being addicted to a drug if, and only if, he has as a result of repeated administration become so dependent upon the drug that he has an overpowering desire for the administration of it to be continued.".

6.      Section 9 (possession of drugs in Schedules 2, 3 and 4) is amended as follows -

(a)      in subsection (1)(a), for "subsections (a) to (g)" substitute "subsections (a) to (j)",

(b)      in subsection (1)(b), for "subsections (a) to (e)" substitute "subsections (a) to (j)",

(c)      in subsection (1), immediately after paragraph (c) insert -

"(d)      a person specified in section 8(3)(b) or (c) or section 8(6) may have in his possession any drug specified in Part I of Schedule 4 which is contained in a medical product,",

(d)      in subsection (2), for the word "practitioner" where it first appears, substitute the words "practitioner, nurse independent prescriber, pharmacist independent prescriber or a supplementary prescriber acting under and in accordance with the terms of a clinical management plan",

(e)      in subsection (2) in the proviso, for the words "medical practitioner" where they first appear, substitute the words "medical practitioner, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber",

(f)      in subsection (2)(a) -

(i)       for the words "another medical practitioner", substitute the words "another medical practitioner, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber", and

(ii)      for the words "first mentioned medical practitioner" substitute the words "first mentioned medical practitioner, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber".

7.      In section 10(1) (exemptions for midwives), immediately after "Nurses, Midwives and Health Visitors Ordinance, 1987", insert "or the Medicines (Human and Veterinary) (Bailiwick of Guernsey) Law, 2008[r] or any enactment made under it".

8.      In section 12(4) (documents to be obtained by the supplier of controlled drugs), immediately after paragraph (e), insert the following paragraphs -

"(f)      a supplementary prescriber;

(g)      a nurse independent prescriber;

(h)      a pharmacist independent prescriber.".

9.      In section 16(2)(c) (marking of bottles and other containers), for the word "practitioner", substitute the words "practitioner, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber".

10.      In section 23(2) (furnishing of information with respect to controlled drugs), immediately after paragraph (h), insert the following paragraphs-

"(i)      a supplementary prescriber;

(j)      a nurse independent prescriber;

(k)      a pharmacist independent prescriber.".

11.      Immediately after Schedule 6 insert the following schedule -

"Sections 7(7) and 8(7)

SCHEDULE 6A

CLASSES OF PERSONS BY WHOM CONTROLLED DRUGS MAY BE

SUPPLIED OR ADMINISTERED UNDER A PATIENT GROUP DIRECTION

Any of the following persons may supply or administer a specified controlled drug under a Patient Group Direction -

Anaesthetic assistants

Registered midwives

Registered occupational therapists

Registered operating department practitioners.

Registered optometrists

Registered orthoptists

Registered orthotists and prosthetists

Registered paramedics

Registered physiotherapists

Registered radiographers".

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