SUPPLY OF MEDICINES IN AN EMERGENCY
In an emergency a pharmacist can lawfully sell or supply most prescription only medicines (POMs), provided certain conditions are satisfied.
Regulation 214 of the Human Medicines Regulations generally requires that a person may not sell or supply a POM except in accordance with a pre- scription given by an appropriate practitioner.
Regulations 224 and 225 set out exemptions from this requirement in cer- tain circumstances. The supply must be made by a person lawfully conducting a retail pharmacy business.
Two situations are envisaged:
● a request made by a relevant prescriber,
● a request made by a patient.
Which Prescribers Are Covered?
Regulation 213 defines ‘relevant prescriber’ as any of the following:
(a) a doctor, (b) a dentist,
(c) a supplementary prescriber, (d) a nurse-independent prescriber, (e) a pharmacist-independent prescriber, (f) a community practitioner nurse prescriber, (g) an optometrist-independent prescriber, and
(h) a European Economic Area (EEA) health professional.
Supply Made at the Request of a Prescriber
Regulation 224 allows a pharmacy to sell or supply a POM if certain condi- tions are met.
The conditions are:
(a) the pharmacist must be satisfied that the sale or supply has been requested by a prescriber who by reason of an emergency is unable to furnish a pre- scription immediately,
(b) the prescriber has undertaken to furnish the pharmacy with a prescription within 72 h,
(c) the POM is sold or supplied in accordance with the directions of the pre- scriber requesting it,
(d) the POM is not a controlled drug in Schedule 1, 2 or 3 of the Misuse of Drugs Regulations 1985,
(e) a record must be made of:
(i) name and address of the patient, (ii) date on the prescription,
(iii) the date on which the prescription is received.
The date on the prescription and the date on which the prescription relating to that sale or supply is received may be entered in the record on the day that the prescription is received.
Emergency Supplies at Request of Patient
Regulation 224 allows a pharmacy to sell or supply a POM at the request of the patient if certain conditions are met:
(1) The pharmacist by or under whose supervision the POM is to be sold or supplied has interviewed the person requesting it and is satisfied:
(a) that there is an immediate need for the POM to be sold or supplied and that it is impracticable in the circumstances to obtain a prescrip- tion without undue delay;
(b) that treatment with the POM has on a previous occasion been pre- scribed by a relevant prescriber for the person requesting it; and (c) as to the dose which in the circumstances it would be appropriate for
that person to take.
(2) The quantity of the product that is sold or supplied does not exceed set limits.
(3) The POM:
(a) does not consist of or contain a substance specified in Schedule 18; and (b) is not a controlled drug, other than a POM that:
(i) consists of or contains phenobarbital or phenobarbital sodium, and (ii) is sold or supplied for use in the treatment of epilepsy.
(4) A record must be made within the specified time, stating:
(a) the date on which the POM was sold or supplied;
(b) the name, quantity and, except where it is apparent from the name, the pharmaceutical form and strength of the POM sold or supplied;
(c) the name and address of the person requiring the POM; and (d) the nature of the emergency.
(5) The inner or outer packaging of the POM is labelled to show:
(a) the date on which the POM is sold or supplied;
(b) the name, quantity and (unless apparent from the name) the pharma- ceutical strength of the POM;
(c) the name of the person requesting the POM;
(d) the name and address of the registered pharmacy from which the POM is sold or supplied; and
(e) the words ‘Emergency Supply’.
Substances that May Not Be Supplied at the Request of a Patient 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
Fencamfamin 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
Maximum Quantities A POM that:
(a) is a preparation of insulin, an aerosol for the relief of asthma, an ointment or cream, and
(b) has been made up for sale in a package elsewhere than at the place of sale or supply.
The smallest pack that the pharmacist has available for sale or supply.
An oral contraceptive. A quantity sufficient for a full treatment cycle.
An antibiotic for oral administration in liquid form.
The smallest quantity that will provide a full course of treatment.
A controlled drug within the meaning of Schedule 4 or 5 of the Misuse of Drugs Regulations 2001 or Schedule 4 or 5 of the Misuse of Drugs Regulations (Northern Ireland) 2002.
Five days’ treatment.
Any other POM. Thirty days’ treatment.
In this regulation ‘aerosol’ means a product that is dispersed from its container by a propellant gas or liquid.
Controlled Drugs
Schedule 1, 2 or 3 controlled drugs cannot be supplied in an emergency – except for Phenobarbital for epilepsy.
Doctors and dentists from EEA or Switzerland cannot request emergency supplies of controlled drugs, including Phenobarbital.
In an emergency a practitioner can personally obtain a Schedule 2 or 3 drug if he cannot immediately supply a signed requisition. This does not authorise supply direct to the patient. The practitioner must undertake to deliver a signed requisition within 24 h of receiving the drug.
Royal Pharmaceutical Society Guidance
You should be mindful of patients abusing emergency supplies, for example where the patient medication record shows the patient has on a number of occasions requested a medicine as an emergency supply on several occasions.
It is possible to make an emergency supply even when the surgery is open. Trying to obtain a prescription may sometimes cause undue delay in treatment and potentially cause harm to the patient.
If patients are away from home and have run out of their medicines, referring them to the nearest surgery to register as a temporary patient may not always be appropriate. You could make an emergency supply if you were satisfied conditions in this guidance were met.
Urgent Supply Without a Prescription Under the NHS
Paragraph 6 of Schedule 4 of the 2012 Pharmaceutical Services Regulations applies where, in a case of urgency, a prescriber requests an NHS pharmacist to provide a drug or appliance.
A pharmacist may provide the drug or appliance requested before receiving a prescription form or repeatable prescription in respect of that drug or appli- ance, provided that:
(a) in the case of a request for a drug, the drug is neither:
(i) a Scheduled drug, nor
(ii) a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001 (which relate to controlled drugs excepted from certain prohibitions under the Regulations); and
(b) in the case of a request for a drug or an appliance, the prescriber under- takes to:
(i) give the pharmacist a non-electronic prescription form or non-electronic repeatable prescription in respect of the drug or appliance within 72 h of the request being made, or
(ii) transmit an electronic prescription to the Electronic Prescription Service within 72 h of the request being made.
There is no procedure in England and Wales for a patient to request an emergency NHS supply.
Scotland
In Scotland a national Patients Group Direction (PGD) has been in place since 2006. This enables pharmacists in Scotland located in premises with an NHS Pharmaceutical Care Service Contract to provide patients with up to one cycle of their repeat medicines (or appliances) when they cannot obtain a pre- scription during out-of-hours periods, for example, at weekends or on public holidays.
The PGD can only be used when the patient’s most recent prescription for the particular medicine requested was issued by the patient’s prescriber, that is two successive supplies of the same medicine is not permissive under this PGD.
The request may come direct from the patient, the patient’s representa- tive, the patient’s prescriber, an out-of-hours collaborative, NHS 24 or hospital A & E departments.
The pharmacist must satisfy themselves that the situation is appropriate for a PGD. The patient must be registered with a NHS GP in Scotland or have temporary registration in Scotland
EEA Practitioners
The Human Medicines Regulations 2012 permit a UK pharmacist to make an emergency supply at the request of a doctor or dentist from an EEA country or Switzerland, and also at the request of a patient who has previously been pre- scribed a particular medicine by an EEA or Swiss doctor or dentist.
Emergency supplies of Schedules 1, 2, and 3 controlled drugs cannot be made on the basis of a non-UK EEA prescription. The Royal Pharmaceutical Society (RPS) advises that pharmacists should be mindful of patients abusing emergency supplies.
Supply of Emergency Hormonal Contraception
The POM (Human Use) Amendment (No. 3) Order 2000 SI No. 3231 came into force on 1 January 2001.
This enables emergency hormonal contraception (EHC) consisting of or containing Levonorgestrel to be sold by pharmacists without a prescription.
The maximum strength allowed is 0.75 mg. The tablets may only be sold or supplied exclusively for use as an emergency contraceptive in women aged 16 and over.
PGDs may allow for supply of EHC to women aged under 16 who are Gillick competent.
Pharmacists Who Choose Not to Supply EHC The GPhC Code states:
If you do not supply Emergency Hormonal Contraception (EHC) (either over the counter or against a prescription), women should be referred to an alternative appropriate source of supply available within the time limits for EHC to be effective.
Administration by Ambulance Paramedics for Immediate, Necessary Treatment of Sick or Injured Persons
A list of medicines which may only be administered by ambulance paramedics on their own initiative for immediate, necessary treatment of sick or injured persons
Diazepam 5 mg/ml emulsion for injection,
Succinylated modified fluid gelatin 4% intravenous infusion.
POMs containing one or more of the following substances but no other active ingredient:
Adrenaline acid tartrate Adrenaline hydrochloride Amiodarone
Anhydrous glucose Benzylpenicillin
Compound sodium lactate intravenous infusion (Hartmann’s solution) Ergometrine maleate
Frusemide Glucose
Heparin sodium (NB: Administration is only allowed for the purpose of cannula flushing.)
Lignocaine hydrochloride Metoclopramide
Morphine sulphate
Nalbuphine hydrochloride Naloxone hydrochloride Ondansetron
Paracetamol Reteplase Sodium chloride Streptokinase Syntometrine Tenecteplase
Registered paramedics may obtain stocks of these medicines from a phar- macy (or from a wholesaler) as well as pharmacy medicines for administration in the course of a business operated by them.
COLLECTION AND DELIVERY SCHEMES
Certain types of collection and delivery schemes are given special exemption from the general Medicines Act requirement that the supply of medicines must be from a pharmacy.
Section 248 of the Human Medicines Regulations disapplies Regulations 220 and 221 where the medicine:
● is for human use,
● is supplied in accordance with a prescription from a doctor, dentist, nurse- independent prescriber, pharmacist-independent prescriber or optometrist- independent prescriber,
and where the supply is as part of a collection and delivery arrangement used by a pharmacy.
Regulation 220 restricts supply of POM and pharmacy medicine to phar- macy premises.
Regulation 221 normally imposes conditions on the sale of general sales list (GSL) products so that:
(a) the supply is only from premises which can ‘be closed so as to exclude the public’,
(b) products are made up for sale elsewhere,
(c) the immediate and outer packaging has not been opened since the product was made up for sale in it.
A ‘collection and delivery arrangement’ means any arrangement whereby a person takes or sends a prescription to premises other than a pharmacy, and later collects or has collected the dispensed medicine from those premises.
A common example is where a grocery shop in an isolated village acts as a collecting point for scripts written by visiting GPs. After dispensing they are held in the shop until the patient collects them.
The script must have been dispensed at a registered pharmacy, by or under the supervision of a pharmacist. The premises used must be capable of being closed so as to exclude the public.
The arrangements are not limited to the NHS. There are no other formal legal requirements.
Delivery Direct from the Pharmacy
Many pharmacists have a service where they collect prescriptions from a doc- tor, dispense them and deliver the medicines to the patient’s home. These arrangements are not covered by the restrictions outlined above. They are sub- ject to normal legal requirements.
The RPS offers the following guidance:
DELIVERY SERVICES STANDARDS
A delivery service is where the medicine is handed to the patient, their carer or other designated person other than on registered pharmacy premises. When providing medicines via a delivery service you still have a professional responsibility to ensure that patients or their carers know how to use the medication safely, effectively and appropriately and check that they are not experiencing adverse effects or compliance difficulties. You must ensure that:
6.1. on each occasion a delivery service is provided you use your professional judgement to determine whether direct face-to-face contact with the patient or their carer is necessary.
6.2. you obtain consent from the patient or their carer to provide the delivery service on a single occasion or for a set period of time.
6.3. delivery to a person other than the patient or carer is undertaken only where they have been specifically designated by the patient or their carer.
6.4. you maintain appropriate records of requests for the service.
6.5. the delivery mechanism used:
● enables the medicine to be delivered securely and promptly to the intended recipient with any necessary information to enable safe and effective use of their medicine;
● caters for any special security/storage requirements of the medicine;
● incorporates a verifiable audit trail for the medicine from the point at which it leaves the pharmacy to the point at which it is handed to the patient, their carer or other designated person, or returned to the pharmacy in the event of a delivery failure;
● safeguards confidential information about the medication that a patient is taking.
GOOD PRACTICE GUIDANCE
● Wherever possible a signature should be obtained to indicate safe receipt of the medicines.
● Systems should be in place to inform a patient who is not at home that delivery was attempted.
Faxed Prescriptions
The Human Medicines Regulations require that ‘prescriptions’ be signed by the prescriber. A fax received in a pharmacy does not meet that requirement and is therefore not itself a valid prescription. However, views differ on what this means in practice.
According to advice given by the RPS in 2010
A faxed prescription is not a legally valid prescription and a supply against a faxed prescription is therefore not a legal supply.
The RPS suggests a similar result can usually be achieved by the use of emergency supply legislation:
Emergency supply exists as a legal mechanism and can achieve a similar outcome in most scenarios. It is the legal and recommended route for providing urgent prescription only medicines in the absence of a prescription. For example, a doctor may fax a prescription to you for a POM, requesting you to dispense from it and the prescription will be posted to you the next day. In this instance there is a legal alternative
mechanism in place (i.e., emergency supply at the request of a prescriber) for you to supply the POM without having the original legally valid prescription to hand, provided the conditions of emergency supply discussed in this guidance are met.
The Society acknowledges that in some ‘secure environments’ the use of faxed prescriptions has become routine.
An alternative view is that the legislation does not specifically require a prescription to be in the hand of the pharmacist at the time of dispensing – merely that it be in existence. The fax is good evidence of the existence of the prescription and can therefore be dispensed.
Controlled drug legislation contains more stringent requirements for pre- scriptions for Schedule 2 and 3 medicines, in particular that the prescription must be in the handwriting of the prescriber. Accordingly such medicines can- not be dispensed against a fax.
Emergency Sale by Pharmacist During a Pandemic
Regulation 226 sets out arrangements to allow pharmacists to sell POMs with- out a prescription during a pandemic:
(1) Regulation 214(1) does not apply to the sale or supply of a POM by a per- son lawfully conducting a retail pharmacy business if conditions A and B are met.
(2) Condition A is that the supply is made whilst a disease is, or in anticipa- tion of a disease being imminently:
(a) pandemic; and
(b) a serious risk, or potentially a serious risk, to human health.
(3) Condition B is that the pharmacist by or under whose supervision the POM is to be sold or supplied is satisfied:
(a) that treatment with the POM has on a previous occasion been pre- scribed by a relevant prescriber for the person to be treated with it;
and
(b) as to the dose which in the circumstances it would be appropriate for that person to take.
Regulation 247 allows for a protocol to specify the treatment:
(1) Regulations 214(1), 220 and 221 do not apply to the supply of a medicinal product that meets the following conditions.
(2) Condition A is that the supply is made whilst a disease is, or in anticipa- tion of a disease being imminently:
(a) pandemic; and
(b) a serious risk, or potentially a serious risk, to human health.
(3) Condition B is that the supply is in accordance with a protocol that:
(a) is approved by the Ministers, an NHS body or the Health Protection Agency;
(b) specifies the symptoms of and treatment for the disease; and (c) contains requirements as to the recording of:
(i) the name of the person who supplies the product to the person to be treated (‘the patient’) or to a person acting on the patient’s behalf, and
(ii) evidence that the product was supplied to the patient or to a per- son acting on the patient’s behalf.
Supply in Response to Spread of Pathogenic Agents, etc.
174. The prohibitions in regulation 46 (requirement for authorisation) do not apply where the sale or supply of a medicinal product is authorised by the licensing authority on a temporary basis in response to the suspected or confirmed spread of:
(a) pathogenic agents;
(b) toxins;
(c) chemical agents; or (d) nuclear radiation,
which may cause harm to human beings.
Sale of Medicinal Products from Automatic Machines Only GSL medicines may be sold from automatic vending machines.
222. A person may not sell or offer for sale a medicinal product by means of an automatic machine if the product is not subject to general sale.
(Human Medicines Regulations)
Self-Assessment Questions
1. What are the conditions to a successful request by a prescriber for an emer- gency supply of medicines?
Answers:
a. The pharmacist must be satisfied that the sale or supply has been requested by a prescriber who by reason of an emergency is unable to furnish a prescription immediately.
b. The prescriber has undertaken to furnish the pharmacy with a prescrip- tion within 72 h.
c. The POM is sold or supplied in accordance with the directions of the pre- scriber requesting it.
d. The POM is not a controlled drug in Schedule 1, 2 or 3 of the Misuse of Drugs Regulations 1985.
e. A record must be made of:
i. name and address of the patient, ii. date on the prescription,
iii. the date on which the prescription is received.
2. What conditions govern the supply of EHC by a pharmacist?
Answers: The only product which may be sold by a pharmacist without a prescription is Levonorgestrel. The maximum strength allowed is 0.75 mg.
The tablets may only be sold or supplied exclusively for use as an emergency contraceptive in women aged 16 and over.
3. Describe how a collection and delivery arrangement works?
Answers: Section 248 of the Human Medicines Regulations disapplies Regulations 220 and 221 where a medicine is supplied on a prescription as part of a collection and delivery arrangement used by a pharmacy. A ‘col- lection and delivery arrangement’ means any arrangement whereby a person takes or sends a prescription to premises other than a pharmacy, and later collects or has collected the dispensed medicine from those premises. A common example is where a grocery shop in an isolated village acts as a collecting point for scripts written by visiting GPs. After dispensing they are held in the shop until the patient collects them. The script must have been dispensed at a registered pharmacy, by or under the supervision of a pharma- cist. The premises used must be capable of being closed so as to exclude the public.