Various parts of the Medicines Act 1968 and the Human Medicines Regulations 2012 place restrictions on the supply of medicines by restricting who may sell medicines and where they may be sold.
CONTROL OF RETAIL SALES
The underlying principle of the control on the retail sales of medicines is that they should normally be supplied through pharmacies.
There are three main exceptions to that.
First, certain medicines are designated as ones which may be sold to the public by an ordinary shop.
Secondly, medicines may be sold by a hospital or health centre even where there is no pharmacy if the products are sold or supplied:
● in the course of the business of the hospital or health centre, and
● they are for the purpose of being administered in accordance with the directions of a doctor or dentist.
It does not matter whether they are to be administered in the hospital or health centre or elsewhere. The doctor or dentist is not required to be an employee of the hospital or to be associated with it in any way.
The ‘directions of a doctor’ need not comply with the requirements for a prescription set out in the prescription only medicine (POM) Order (as amended).
Thirdly, Patient Group Directions may empower certain health profession- als to supply medicines to the public in accordance with protocols. This supply may take place anywhere.
In addition to the principle that the retail sales of medicines should be through pharmacies, the Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008, SI No. 2789 require that a ‘Responsible Pharmacist’ is ‘in charge of the business at the premises’ where this relates to the retail sale and supply (i.e., in circumstances corresponding to retail sale) of all medicinal products, including General Sale List (GSL) medicines.
Legal Categories of Medicines
The European Community (EC) Directive on Legal Classification (2001/82/
EC) consolidated a number of earlier directives. This Directive requires Member States to classify medicines into those which may only be sold or supplied on prescription, and those which may be obtained without a prescrip- tion. The Directive is amended by Directive 2004/27/EC.
The Directive lays down the criteria which must be used to determine whether a product should be subject to prescription control. These criteria have been incorporated into law by the Human Medicines Regulations 2012.
Classification of UK Marketing Authorisation
Regulation 62 of the Human Medicines Regulations requires each application for the grant of a marketing authorisation (MA) to indicate whether the prod- uct is one that could be available:
(a) only on prescription (b) only from a pharmacy (c) on general sale.
The application must also indicate whether the authorisation should include any other restrictions on the sale or supply of the product, for example, a restriction on promotion.
Where the community marketing authorisation contains such restrictions, Ministers are required to include the product in the POM Order.
Regulation 62(2) also lists criteria to which the licensing authority must have regard when determining the classification:
(a) the maximum single dose (b) the maximum daily dose (c) the strength of the product (d) its pharmaceutical form (e) its packaging and
(f) such other circumstances relating to its use as the licensing authority considers relevant.
Regulation 62(3) requires that a product must be available only on pre- scription if it is:
(a) is likely to present a direct or indirect danger to human health, even when used correctly, if used without the supervision of a doctor or dentist;
(b) is frequently and to a very wide extent used incorrectly, and as a result is likely to present a direct or indirect danger to human health;
(c) contains substances, or preparations of substances, of which the activity requires, or the side effects require, further investigation; or
(d) is normally prescribed by a doctor or dentist for parenteral administration.
Schedule 1 of the Human Medicines Regulations contains descriptions of certain medicinal products which are made available only on prescription, or only from pharmacies.
General Sale List
This is a list of medicines which can be sold, with reasonable safety, without the supervision of a pharmacist. The sales have to take place from proper shops, that is ones which can be closed so as to exclude the public. This prohibits sales being made from vans or other vehicles, or from open market stalls.
There is a separate list of products which may be sold from automatic vending machines.
The legislation is Regulation 221 of the Human Medicines Regulations 2012.
To sum up, GSL medicines may be sold:
● without the supervision of a pharmacist
● from any ordinary shop (not a pharmacy)
● shop must be one which can be closed up
● not from a vehicle or market stall.
Pharmacy Medicines (P)
Pharmacy medicines may be sold only in a registered pharmacy by or under the supervision of a pharmacist. This is the default category, into which all medicines fall unless placed by legislation into either of the other two categories.
Pharmacy medicines may only be sold:
● in a registered pharmacy
● by or under the supervision of a pharmacist.
Regulation 220 states:
(1) Unless paragraph (2) applies, a person (“P”) may not sell or supply, or offer for sale or supply, a medicinal product that is not subject to general sale.
(2) This paragraph applies if:
(a) P is a person lawfully conducting a retail pharmacy business;
(b) the product is sold, supplied, or offered for sale or supply, on premises that are a registered pharmacy; and
(c) P or, if the transaction is carried out on P’s behalf by another person, that other person is, or acts under the supervision of, a pharmacist.
(3) This regulation is subject to Chapter 3.
Chapter 3 sets out exemptions relating to supply in specific circumstances (e.g., via a Patient Group Direction).
Prescription Only Medicines POM may only be sold or supplied:
● in a registered pharmacy
● by or under the supervision of a pharmacist
● in accordance with the prescription of a doctor, dentist or veterinary practitioner.
Regulation 49 of the Human Medicines Regulations requires each application for the grant of an MA to indicate whether the product is one that could be available:
(a) only on prescription (b) only from a pharmacy (c) on general sale.
Regulation 214 of the Human Medicines Regulations requires that a person may not sell or supply a POM except in accordance with a prescription given by an appropriate practitioner.
A product is to be designated as a POM if:
(a) it needs medical supervision in use to prevent a direct or indirect danger to human health;
(b) it is widely and frequently misused, and so presents a danger to health;
(c) it is a new active substance;
(d) it is for parenteral administration.
RECLASSIFICATION OF MEDICINES
New medicines are usually authorised for use as POMs. Additional safety data may become available after use which allows a change. If there is sufficient evidence of safety, a medicine may be reclassified for sale or supply under the supervision of a pharmacist (P).
Before a medicine can be reclassified from POM to P, Ministers must be satisfied that it would be safe to allow it to be supplied without a prescription.
It must be a medicine which no longer meets any of the criteria in Regulation 62(3).
Reclassifying from P to GSL
Similarly, a medicine can be reclassified from P to GSL if Ministers are be sat- isfied that it ‘can with reasonable safety be sold or supplied otherwise than by or under the supervision of a pharmacist’.
‘Reasonable safety’ may be usefully defined as: ‘Where the hazard to health and the risk of misuse and the need for special precautions in handling are small, and where wider sale would be a convenience to the purchaser’.
The POM Order
Although most of the POM (Human Use) Order 1997 No. 1830 has been repealed by the Human Medicines Regulations, some provisions remain in effect.
Schedule 1 of the POM Order contains a list of substances. Medicinal products containing any of them are usually classed as POM.
Articles 1(1)–1(5) of the Order remain – containing a list of definitions.
Article 5 sets out certain exemptions for specified products or ingredients.
Article 10 sets out provisions, which exempt from the POM rules, some homeopathic products which are highly diluted. Regulation 242 of the Human Medicines Regulations expands this.
Medicinal Products on Prescription Only Generally the following medicinal products are POM:
(a) medicinal products consisting of or containing a substance listed in col- umn 1 of Schedule 1 of the POM Order
(b) controlled drugs (CDs)
(c) medicinal products that are for parenteral administration (d) cyanogenetic substances other than preparations for external use (e) radiopharmaceuticals and generators
(f) medicinal products for human use which are licensed by the EC and classed as prescription only.
There are a number of exceptions.
Schedule 1 sets out a list of medicines together with the conditions which make a product exempt from POM.
Four categories are set out in Schedule 1. They are based on:
(a) maximum strength
(b) route of administration, use or pharmaceutical form (c) treatment limitations
(d) maximum quantity.
Schedule 2 excludes some CDs from POM when the preparation complies with the conditions.
Administration of POMs
The Regulations state that no one can administer a POM, except to himself, unless he or she is either:
● a prescriber, or
● a person acting in accordance with the directions of a prescriber.
Regulation 214(2) reads:
A person may not parenterally administer (otherwise than to himself or herself) a prescription only medicine unless the person is:
(a) an appropriate practitioner other than an EEA health professional; or (b) acting in accordance with the directions of such an appropriate
practitioner.
INJECTIONS
All parenteral products are POM.
Water for Injection
Sterile water for injection is a POM. Water for injection may be supplied with- out prescription ‘in the course of provision of lawful drug treatment services’
in 2 ml vials. (Schedule 17 Part 2 of the Human Medicines Regulations) Pharmacies may supply water for injection without a prescription if the sale or supply is to a person:
(a) for a purpose other than parenteral administration; or
(b) who has been prescribed dry powder for parenteral administration but has not been prescribed the water for injection that is needed as a dilu- ent. (Schedule 17 Part 1of the Human Medicines Regulations)
Administration of Certain Medicines in an Emergency
Some injections are specifically exempted from the blanket prohibition. They are the ones which might be needed in an emergency.
Regulation 238 states:
Regulation 214(2) does not apply to the administration of a prescription only medicine specified in Schedule 19 where this is for the purpose of saving life in an emergency.
The medicines specified in Schedule 19 are:
Adrenaline 1:1000 up to 1 mg for intramuscular use in anaphylaxis Atropine sulphate and obidoxime chloride injection
Atropine sulphate and pralidoxime chloride injection Atropine sulphate injection
Atropine sulphate, pralidoxime mesilate and avizafone injection Chlorphenamine injection
Dicobalt edetate injection Glucagon injection Glucose injection Hydrocortisone injection Naloxone hydrochloride
Pralidoxime chloride injection Pralidoxime mesilate injection Promethazine hydrochloride injection Snake venom antiserum
Sodium nitrite injection Sodium thiosulphate injection Sterile pralidoxime
Ambulance paramedics may administer a range of injections only for the immediate, necessary treatment of sick or injured persons. (Schedule 17 Part 3 of the Human Medicines Regulations)
A number of other exceptions are made to allow the supply and use of POMs for research, business or in various unusual circumstances.
Prescription Requirements
POMs may generally only be supplied on prescription. A prescription for POMs must meet the conditions set out in the Regulation 217 of the Human Medicines Regulations.
(1) All prescriptions must be signed in ink by the practitioner.
(2) Private prescriptions must be written in ink, or otherwise be indelible.
(3) NHS prescriptions, other than for a CD, may be written by means of car- bon paper or similar material.
(4) No prescription may be dispensed more than 6 months after the appropri- ate date, except:
(a) scripts may bear a date before which they may not be dispensed. The 6 months runs from that date if it is later than the date of signing.
(b) where a script contains a direction that it may be dispensed more than once, then the first dispensing must be within the 6-month period.
(5) Where a script contains directions that it may be dispensed more than once, those directions must be followed. If the number of repeats is not specified, only one repeat is allowed, except:
(a) oral contraceptives may be dispensed six times in total before the end of the 6-month period.
(6) All scripts shall contain the following particulars:
(a) address of the practitioner giving it (b) the appropriate date
(c) an indication of the kind of prescriber, for example, doctor, dentist, pharmacist, etc.
(d) name and address of patient (e) age of patient (if under 12 years).
(7) For vet scripts:
(a) name and address of person in charge of the animal
(b) declaration by vet that the medicine is for an animal or herd under his care.
EUROPEAN ECONOMIC AREA HEALTH PROFESSIONALS
A prescription from an appropriate practitioner who is an European Economic Area (EEA) health professional must meet the following conditions:
(1) it is an EEA prescription
(2) signed in ink by the EEA health professional giving it (3) written in ink or be indelible
(4) indicate whether the EEA health professional is a doctor or dentist (5) give the name of the patient
(6) may not be dispensed more than 6 months after the date it was signed or if a repeatable script not be dispensed for the first time after that period (7) where a script contains directions that it may be dispensed more than
once, those directions must be followed. If the number of repeats is not specified, only one repeat is allowed, except:
oral contraceptives that may be dispensed six times in total before the end of the 6-month period.
Due Diligence Clause
Regulation 214(1) states that a person may not sell or supply a POM except in accordance with a prescription given by an appropriate practitioner.
However, Regulation 246 states that if the person making the sale or supply has exercised due diligence and accordingly believes on reasonable grounds that the conditions are fulfilled, he or she will not commit an offence if it turns out that the practitioner did not in fact fulfil the conditions.
246. Regulation 214(1) does not apply to the sale or supply of a prescription only medicine otherwise than in accordance with a prescription given by an appropriate practitioner if:
(a) the sale or supply is otherwise than in accordance with such a prescription because a condition in regulation 217, 218 or 219 is not met; and
(b) the person selling or supplying the prescription only medicine, having exercised all due diligence, believes on reasonable grounds that the condition is met.
(Regulation 246)
Records of Transactions
Records must be kept of the retail sale or supply of POMs. Entries must be made in a written or computerised record kept for that purpose. The entry must be made on the day of the transaction, or on the next day. The record must con- tain the details set out in Schedule 23 of the Human Medicines Regulations.
Regulation 253.—(1) A person lawfully conducting a retail pharmacy business must, in respect of every sale or supply of a prescription only medicine, make or cause to be made an entry in a written or computerised record kept for that purpose.
(Human Medicines Regulations)
Records are not required for:
(1) the sale or supply on an NHS prescription (2) the sale or supply of oral contraceptives (3) where records are made in the CD Register
(4) sale or supply to persons in respect of a drug testing scheme
(5) sale or supply in Scotland, to a doctor under the Stock Order scheme (6) sale or supply in Northern Ireland to a doctor for NHS use by way of
immediate administration
(7) sale by way of wholesale dealing when a copy order or invoice is retained.
What Details of Scripts Must Be Recorded For sale or supply of POMs on a script:
(1) date of transaction
(2) name and quantity of medicine
(3) form and strength of medicine (unless obvious) (4) date of script
(5) name and address of prescriber
(6) name and address of patient (or of owner of animal).
Repeat Scripts
When second or third, etc., supplies are made on repeat scripts, a shortened record may be made. The date of supply must be recorded together with a ref- erence to the original entry.
Emergency Supplies at Request of Prescriber
Where the sale or supply is made under Regulation 224 (emergency sale, etc., by a pharmacist where the prescriber is unable to provide a prescription), the date on the prescription and the date on which the prescription relating to that sale or supply is received may be entered on the day that the prescription is received.
Emergency Supplies at Request of Patient
Where the sale or supply is made under Regulation 225 (emergency sale, etc., by a pharmacist at the patient’s request), the details below must be recorded:
(1) the date on which the POM was sold or supplied;
(2) the name, quantity and, except where it is apparent from the name, the pharmaceutical form and strength of the POM sold or supplied;
(3) the name and address of the person requiring the POM; and (4) the nature of the emergency.
Schedule 18 contains a list of substances that may not be sold or supplied at the request of a patient in the absence of a prescription.
Ammonium bromide Calcium bromide
Calcium bromidolactobionate Embutramide
Fencamfamine hydrochloride Fluanisone
Hexobarbitone Hexobarbitone sodium Hydrobromic acid
Meclofenoxate hydrochloride Methohexitone sodium Pemoline
Piracetam
Potassium bromide Prolintane hydrochloride Sodium bromide
Strychnine hydrochloride Tacrine hydrochloride Thiopentone sodium
ELECTRONIC PRESCRIPTIONS
Electronic prescriptions may be signed with an ‘advanced electronic signa- ture’, provided the prescription is transferred as an electronic communication to the person who dispenses it.
Electronic prescriptions are not valid for CDs in Schedules 1, 2 and 3 of the Misuse of Drugs Regulations 2001.
Regulation 219—(1) This regulation applies to a prescription that is not a health prescription for a controlled drug.
Electronic prescriptions for POMs must meet the following conditions:
If given by an appropriate practitioner who is not an EEA health professional, then the script must be:
(a) created in electronic form;
(b) signed with an advanced electronic signature; and
(c) sent to the person by whom it is dispensed as an electronic communication (whether or not through one or more intermediaries);
must contain
(a) the address of the appropriate practitioner giving it;
(b) the appropriate date;
(c) an indication of the kind of appropriate practitioner giving it;
(d) the name and address of the person for whose treatment it is given; and (e) if that person is under 12, that person’s age.
(a) is not dispensed after the end of the period of six months beginning with the appropriate date; or
(b) in the case of a repeatable prescription:
(i) it is not dispensed for the first time after the end of that period, and (ii) it is dispensed in accordance with the directions contained in the
prescription.
(6) Condition E is that, in the case of a repeatable prescription that does not specify the number of times it may be dispensed:
(a) it is not dispensed on more than two occasions, or
(b) in the case of a prescription for an oral contraceptive, it is not dispensed on more than six occasions or after the end of the period of six months beginning with the appropriate date.
‘Advanced Electronic Signature’
‘Advanced electronic signature’ means an electronic signature that is:
(a) uniquely linked to the person (‘P’) giving the prescription;
(b) capable of identifying P;
(c) created using means that P can maintain under P’s sole control; and (d) linked to the data to which it relates in such a manner that any subsequent
change of data is detectable.
Supervision of Sales
In addition to the principle that the retail sales of medicines should be through pharmacies, the Medicines Act also requires the involvement of the pharmacist in the process.
Prior to the introduction of the Responsible Pharmacist, Sections 70–72 of the Medicines Act required each pharmacy business to be under the personal control of a pharmacist. The Medicines Act did not define ‘personal control’ nor how the pharmacist was to comply with the requirement. There was little case law.
Personal Control Changes to Responsible Pharmacist
Sections 27–29 of the Health Act 2006 amend Sections 70–72 of the Medicines Act 1968 to remove the ‘personal control’ requirement and to pro- vide for the new requirement for a ‘Responsible Pharmacist’ to be in charge of each registered pharmacy.
Like ‘personal control’, the new requirement relates to all registered phar- macies in the community and in hospitals. If a pharmacy does not have a responsible pharmacist, it is operating illegally in relation to the retail sale and supply of all medicines.