Prescription-only medicines supply

Where a patient orders a product for his own use direct from a supplier in another country, that will not normally be caught by the rules on particular patient supply, since the product will not be placed on the market. However, it is possible that the supplier of that product (which is likely to be a prescription-only medicine) will be committing an offence in the country in which it operates, particularly if it has advertised the product or supplied it otherwise, than in response to a prescription. 

In the United Kingdom, prescriptions are required for all medicines supplied under the National Health Service (NHS) and for all prescription-only medicines. Prescriptions may only be written by a doctor or dentist registered in the United Kingdom. 

Prescription-only medicines (POMs) (see Section 1.3.3) are usually obtained on the authorisation of a valid prescription form (either an NHS or a private prescription form) written by a recognised prescriber registered in the UK and presented at a registered pharmacy (although exceptions to this do exist, for example, dispensing doctors (see Section 2.3.1), in-patient hospital supply (see Section 4.2.1) and emergency supply at the request of a patient (see Sections 7.2 and 7.3)). 

A pharmacy medicine is the definition given to medicinal products not included on the Prescription Only Medicines Order or the General Sale List or to products that are supplied outside the GSL package limit or maximum dosage limit. A few medicines are called pharmacy only (PO) medicines these include medicines that would normally be included on the GSL but where the manufacturer has limited the supply of the medicines to pharmacies only (see Section 1.3.1). Examples include ... 

The dispensing procedure for non-NHS (private) prescriptions is similar to the dispensing procedure followed with NHS prescriptions (see Section 3.3). The main differences are that in most cases, an entry detailing the supply will always need to be made in the prescription-only medicines register (see Section 5.1.4) and that the pharmacist or pharmacy technician will not need to check that the item is allowed on the NHS. In summary, the procedure to be followed is as follows ... 

All supplies of medication will need to be entered in the prescription-only medicines register. However, if the supply is a repeat (and the pharmacy where the repeat is being dispensed has previously dispensed the medication), it is sufficient for the new entry in the prescription-only medicines register (which will have a new reference number) to refer to the details of the older entry (by referring to the older entry s reference number). Therefore, it is useful when stamping a non-NHS (private) prescription form... 

In addition, an entry will need to be made of the supply in the prescription-only medicines register. 

Every community pharmacy will have a prescription-only medicines register, along with any other registered pharmacy (for example, a registered pharmacy within a hospital setting). Hospital pharmacies only need to keep such records if the supply of the prescription-only medicine requires registration as a pharmacy. Under the Medicines Act, medicines supplied in the course of the business of the hospital (see Chapter 4) do not need to be recorded. 

The prescription-only medicines register usually takes the form of a bound book where the details of the supply of certain medicinal products are made, although nowadays computer records are permissible. The title of prescription-only medicines register is a little misleading as there will be circumstances (either as legal requirements or as good practice requirements) where the supply of medicines other than prescription-only medicines (POMs) will be recorded. 

It is a legal requirement to record the sale or supply of all prescription-only medicines (POMs) not supplied via the NHS (i.e. on an NHS prescription form) in the community unless ... 

Records of medication supply are made in the prescription-only medicines register in the following instances ... 

In both cases (for the supply of prescription-only medicines (POMs)), it is a legal requirement that an entry is made in the prescription-only medicines register (see Section 5.1.4). 

It is good practice to make an entry in the prescription-only medicines register at the time of supply it is only a good practice requirement as the requisition will be retained within the pharmacy for two years from the date of supply (the exception to this is for Schedule 2 and Schedule 3 controlled drugs see Section 6.3.6). However, if the request for the supply of a prescription-only medicine (POM) was an oral request (see Section 5.3) the prescription-only medicines register entry would be a legal requirement (as there is no paper requisition detailing the sale to keep for two years). 

For completeness, it is also worth mentioning that it is not a legal requirement to make an entry in the prescription-only medicines register if a separate record of the sale or supply is made in the controlled drugs register (see Section 6.3.7). However, it is still good practice to make an entry in the prescription-only medicines register. 

There are no restrictions in the supply of prescription-only medicines to hospitals and health centres provided that the prescription-only medicine is to be supplied either in response to a prescription that has been written by an appropriate practitioner or an order written by an appropriate practitioner. This applies to both hospitals and health centres within the NHS and private sector. The restrictions that... 

The controls over retail sale of medicines do not apply to the above practitioners. A doctor or dentist may offer to supply or sell prescription-only medicines to a patient or patient s carer (and similar arrangements apply to veterinary practitioners/surgeons for animals or herds under their care). Supplies may be obtained from pharmacies by way of wholesale dealing and requested via a written requisition. 

Although controlled drugs are dealt with in Chapter 6, for completeness, it is worth mentioning midwives supply orders here. Midwives supply orders are needed for the lawful supply of certain controlled drugs to a midwife from a pharmacist (i.e. those items listed above that are Schedule 2 or Schedule 3 controlled drugs diamorphine, morphine, pentazocine and pethidine). They are not required for the supply of other listed prescription-only medicines. 

They may also supply certain prescription-only medicines (POM) which are not for parenteral administration. Commonly, this includes the following prescription-only medicines ... 

Additional supply optometrists may sell or supply additional prescription-only medicines (POMs) provided it is in the course of their professional practice and in an emergency. Additional supply optometrists have undergone additional training and accreditation which is only available to optometrists who have completed at least two years in practice following registration. 

Table 5.1 Prescription-only medicines (POMs) that may be supplied to optometrists ...

In occupational health schemes if the person supplying the prescription-only medicine to the patient is not a doctor then they must be a registered nurse acting on instructions provided by a registered doctor. The supply may be made under Patient Group Directions (see Section 3.4). The prescriber must make clear when the use of a prescription-only medicine would be permissible, and the supply would only be made under the terms of the occupational health scheme. 

For supply against a non-NHS (private) prescription form, a prescription-only medicines register entry is not legally required if a controlled drugs register entry is made (see Section 6.3.7), but it is still good practice to do so. 

All prescription-only medicines may be supplied by emergency supply at the request of a practitioner, except controlled drugs in Schedules 1, 2 and 3 of the Misuse of Drugs Regulations (apart from phenobarbital or pheno-barbital sodium for the treatment of epilepsy). Please note that the emergency supply of phenobarbital or phenobarbital sodium for the treatment of a medical condition other than epilepsy would therefore be unlawful. 

Figure 7.1 An example of a prescription-only medicines register entry for an emergency supply made at the request of a practitioner.

The prescription-only medicines register entry for this supply would appear in the register as follows ... 

In both cases, an entry in the prescription-only medicines register will be made. This will provide details of, and reason for, the supply. 

The BP Commission can also call on expertise available in the British Pharmacopoeia laboratories situated in the premises of the Laboratory of the Government Chemist in West London. The BP laboratory carries out and validates assay procedures for the Commission and in addition, is responsible for the procurement, establishment, maintenance and sale of British Pharmacopoeia Chemical Reference Substances (BPCRS). These reference substances, as their name suggests, are authentic samples of a drug or decomposition product which are used as standards in a drug assay. The BP laboratory also fulfils an important forensic role in the control of counterfeit medicines. With the advent of the internet, the public can easily gain access to supplies of prescription-only medicines online. These medicines are often adulterated, contaminated or simply counterfeit, and comparison with authentic samples is necessary to ensure that the correct preparation is supplied. 

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