Medicines: Licensing and Regulations
There are a number of regulations which exist to control and protect the use of medications; anyone who has responsibility for handling medicines should be aware of the following:
- Human Medicines Regulations 2012
- Misuse of Drugs Act 1971
- Health & Safety at Work Act 1974
- Access to Health Records Act 1990
- Data Protection Act 1998
- Care Standards Act 2000
- Control of Substances Hazardous to Health 2002
- Hazardous Waste regulations 2005
This article looks, in particular, at the licensing and handling of controlled drugs and prescription medicines.
The Human Medicines Regulations 2012 defines three legal categories of medicines:
- General Sales List medicines (GSL)
- Pharmacy medicines (P)
- Prescription only medicines (POM)
Under this act, most medicines can only be sold or supplied at a pharmacy under the supervision of a pharmacist. Some medicines (GSL) can be sold at other premises, such as supermarkets, as long as they are pre-packed and the premises can be closed to exclude the public.
General sales list medicines
GSL medicines can be sold by a wide range of shops, such as newsagents, supermarkets and petrol stations. Usually only a small pack size or low strength of the medicine may be sold, for example;
- the largest pack size of paracetamol that shops can sell is 16 tablets but pharmacies can sell packs of 32 tablets.
- the highest strength of ibuprofen tablets that shops can sell is 200mg but pharmacies can sell tablets at 400mg strength.
Only pharmacies may sell these medicines and a pharmacist must make or supervise the sale.
You will be asked if you have any medical conditions or take any other medicines, to check that it’s safe for you to take the medicine. Some pharmacy medicines may only be sold if the pharmacist is satisfied that you meet the criteria for that medicine. For example, emergency contraception (the morning after pill) may only be sold to the woman who needs it, and she must be over 16.
For other medicines the pharmacist may suggest that you see your GP; if you’ve used a particular medicine twice in six months for a particular ailment you might be advised to see your GP so they can decide whether this is the most appropriate treatment.
Prescription Only Medicines (POM)
You cannot get these medicines without a prescription, usually from your GP. In some cases, your medicine may be prescribed by your dentist, a nurse, pharmacist or other healthcare professional.
Some prescription-only medicines are classed as controlled drugs, such as morphine, pethidine and methadone. Stricter legal controls apply to these medicines.
Some medicines are reclassified from:
- prescription only to pharmacy
- from pharmacy to general sales list
This may happen after several years when it's known that the medicine is safe for most people to use. For example, aciclovir cream (used to treat cold sores) was first available as a POM. After a few years, it was reclassified as a pharmacy medicine and later it was reclassified again to GSL.
Schedule 19 medicines
Certain POM drugs can be used without prescription in an emergency. These drugs are listed in Schedule 19 of the Regulations. For a lay person, the this only applies to Adrenaline in the form of an automatic injector (such as an EpiPen) for the emergency treatment of Anaphylaxis.
Regulation 214(2) of the Human Medicines Regulations 2012 specifies that, for prescription only medicines (POMs), no person shall administer (otherwise to himself) any such medicinal product unless he is an appropriate practitioner or a person acting in accordance with the directions of an appropriate practitioner. (An appropriate practitioner is a doctor, a dentist, a supplementary prescriber and, within the terms of the legislation covering their prescribing, independent nurse prescribers.) Regulation 238 provides an exemption from the requirements to enable the parenteral ( = other than ingested or absorbed) administration of specified medicines where the administration is for the purpose of saving life in an emergency.
What is a controlled drug?
Some prescription medicines contain drugs that are controlled under the Misuse of Drugs legislation. These medicines are called controlled drugs or 'CD'. Examples include:
Stricter legal controls apply to controlled medicines to prevent them being misused, being obtained illegally or causing harm. These legal controls govern how controlled medicines may be stored, produced, supplied and prescribed.
Controlled medicines are classified (by law) based on their benefit when used in medical treatment and their harm if misused.
The Misuse of Drugs regulations include five schedules that classify all controlled medicines and drugs: Schedule 1 has the highest level of control, but drugs in this group are virtually never used in medicines. Schedule 5 has a much lower level of control.
How does this affect me?
When you collect a Schedule 2-controlled medicine, such as morphine or pethidine, your pharmacist will ask for proof of your identity, such as your driving licence or your passport. You will also be asked to sign the back of your prescription, to confirm that you’ve received the medicine.
To collect a Schedule 3-controlled medicine, such as flunitrazepam, you just need to sign the back of the prescription.
If you’re prescribed a controlled medicine, it’s particularly important that you:
- store your medicine properly and safely at home
- keep your medicine out of the sight and reach of children
- never give your medicine to anyone else
Special requirements apply to destroying controlled medicines, so return any unused controlled medicines to your pharmacist who will dispose of them.
Who can prescribe controlled medicines?
Doctors and dentists can prescribe all controlled medicines to treat illness or injury. However, doctors must hold a licence from the Home Office to prescribe controlled medicines to treat addiction.
Specially trained nurses can prescribe some controlled medicines for specific conditions, such as pain relief in palliative care. Midwives may use a limited range of controlled medicines, for example, to relieve pain during childbirth.
Other healthcare professionals, including nurses and pharmacists, may prescribe controlled medicines as part of an agreed care plan for a specific patient.
While only certain people can prescribe controlled medications, administering them can be done by any reasonable person. Read more about administering medicines here.
Prescriptions for controlled medicines
Prescriptions for controlled medicines in Schedules 2, 3 and 4 are valid for only 28 days.
Prescriptions for Schedule 2 and 3 controlled medicines (except temazepam) must include specific details about the medicine, such as
- its name and what form it’s in
- strength and dose
- total quantity or number of doses, shown in both words and figures
Prescriptions for temazepam and Schedule 4 and 5 controlled medicines are exempt from these requirements.
Pharmacists must record prescriptions for controlled medicines in a special register. Before supplying the medicine, they must check that the prescription is correctly written. If it’s not, it may need to be rewritten by the prescriber.
Taking controlled medicines abroad – Personal Medication
If you take your prescribed controlled medicines abroad, you must carry them:
- in the original packaging
- in your hand luggage (airline regulations permitting)
You must also take a letter from your GP giving the information below:
- your name and address
- your date of birth
- the dates you're departing and returning
- the country you're visiting
The letter should also list the controlled medicines that you’re carrying and for each medicine it should show:
- the dosage
- the total amount you are carrying
Controlled drugs should be kept in your hand luggage in a clear plastic bag measuring 20cm x 20cm together with any liquids to comply with current hand baggage regulations for air travel2.
Taking controlled medicines abroad – Group Medication
On occasion a Group Leader or Expedition Medic may choose to include controlled drugs as part of a First Aid and Medical kit - especially for trips which are far from help, for an extended period or with a high risk of illness or injury.
Controlled drugs can be exported out of the country but there are strict rules governing the movement of drugs across international boarders. In some countries drug smugglers are executed. Do not make any assumptions and seek clarification and written permission from all authorities in the host countries.
Licensing Department (Drugs)
Queen Anne's Gate
Tel:020 7273 3806 (direct line)
You will also need to consider import licences for your country of destination. In theory you are supposed (having secured the UK export licence) to also obtain an import licence through the relevant embassy or high commission.
- Keep a detailed record of all the drugs you have in your medical kit, and divide them into controlled drugs (CD), keeping one separate list for these and one for all other drugs. This generally satisfies the officials when entering most countries (e.g. Nepal, India), however it may be best to check if an export license will be required for more out of the way destinations.
You are strongly advised to carry controlled drugs (together with their listing) with you in your personal baggage, but the rest can be freighted with other expedition kit. You can obtain an export licence for CD's from the Home Office by writing to:
- You must state the type and quantity of controlled drugs you are carrying. This licence allows you to export (and re-import if you wish) controlled drugs from Britain.
- Medical Documents - If you are a Healthcare Professional, carry evidence of qualifications or professional membership as well as a reference from a colleague state you are who you say you are.