A range of drugs are routinely stocked on board an ambulance for administration to patients by paramedics and ambulance technicians. Paramedics and technicians should be aware of the legislation that authorizes them to administer these medicines to patients, in order to be able to justify their actions and to understand the law that allows them to administer drugs such as prescription only medicines and controlled drugs.
Formularies
A formulary is a list of approved medicines. Most hospital and primary care prescribers work within an agreed formulary of medicines (which may differ between regions), and ambulance services have their own formularies. Your ambulance trust formulary has been agreed locally and approved by key local stakeholders such as pharmacists, clinicians and other medical professionals. It contains all of the medicines that paramedics and ambulance technicians can administer in his/her trust. These are the only medicines that you can administer in your place of work.
You may also be familiar with another formulary—The Joint Royal Colleges Ambulance Liaison Committee (JRCALC) formulary, which is listed within the JRCALC guidelines (2006). The JRCALC formulary is a list of common drugs available for administration by paramedics and it has been prepared and approved by key stakeholders from across the UK. Individual trust formularies are local adaptations of the larger JRCALC document.
There is more than one piece of legislation that allows paramedics to administer medicines and the legal basis for the inclusion of drugs within the formulary differs between the medicines listed. These different pieces of legislation, as relevant to paramedic practice, are as follows:
All of the above will be discussed within this article.
What legislation covers medicines?
In the UK, most medicine legislation is contained within the Medicines Act 1968 and the Misuse of Drugs Act 1971. These Acts affect all health professionals, including paramedics, who handle medicines, as they set out ‘who can do what with which medicines’. If we, as health professionals, were to act in any way that contravenes the legislation within these Acts, we would be breaking the law and therefore we would be committing a criminal offence.
The Medicines Act 1968
This Act governs all aspects of the manufacture, sale and supply of medicines in the UK. Its primary purpose is to protect the public from harm by ensuring that medicines are safe and effective. The Medicines Act is enforced by the medicines and the Medicines and Healthcare Products Regulatory Agency (MHRA). The MHRA is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe (MHRA, 2011).
This includes the regulation of medicines and medical devices and equipment used in healthcare, and the investigation of harmful incidents. The principle aim of the agency is to safeguard the public's health. It does this by making sure that medicines and medical devices—from painkillers to pacemakers—work properly and are acceptably safe; and by responding promptly when new concerns come to light. No product is completely free of risk but sound evidence underpins all the MHRA's decisions to ensure that these risks are minimized.
The Medicines Act divides medicines into three lists:
Ambulance formularies contain medicines from each of the three lists.
Prescription only medicines (POM)
As the name suggests, pharmacists normally require a valid prescription from a practitioner in order to make a supply of these medicines. Practitioners who are authorized to write prescriptions are:
Once prescribed, POMs must be administered according to the directions of the prescriber. Their directions are usually seen in the form of either:
Prescription only medicines: exemptions
There are exemptions to the usual routes to the supply and administration of prescription only medicines (POMs), and one of these exemptions is particularly relevant to paramedic practice.
Part III of Schedule 5 of the Prescription Only Medicines (Human Use) Order 1997 allows registered paramedics to administer, but not supply, a selected list of drugs in specified circumstances. This means that a prescription is not required.
For instance, paramedics, certain people and organizations are also exempt from the restrictions on administration (and in some cases, the supply). Examples include: hospitals and health centres, midwives, chiropodists, optometrists, shipping personnel, Royal National Lifeboat Institution, aircraft personnel, first aid organizations and the armed forces (Royal Pharmaceutical Society of Great Britain (RPSGB), 2010).
The list of medicines that paramedics are allowed to administer under the POM exemption are listed in Table 1. All of these are included in the JRCALC formulary (JRCALC, 2006). Many are also likely to be listed in your own ambulance trust's formulary. Paramedics can administer these medicines under the condition that the administration shall be only for the immediate, necessary treatment of sick or injured persons.
| Adrenaline acid tartrate |
| Amiodarone |
| Anhydrous glucose |
| Benzylpenicillin |
| Bretylium tosylate |
| 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 (Lidocaine) hydrochloride |
| Metoclopramide |
| Morphine sulphate (injection to a maximum strength of 20 mg) |
| Nalbuphine hydrochloride |
| Naloxone hydrochloride |
| Polygeline |
| Reteplase |
| Sodium bicarbonate |
| Sodium chloride |
| Streptokinase |
| Syntometrine |
| Tenecteplase |
Administration of parenteral medicines for the purpose of saving a life in an emergency
As highlighted previously, the law states that no-one may administer a POM to anyone other than him/herself unless he is an appropriate practitioner or is acting in accordance with the directions of an appropriate practitioner such as a doctor, dentist or non-medical prescriber. Some parenteral POMs are exempt from this restriction when administered for the purpose of saving life in an emergency. Both paramedics and ambulance technicians (and anyone else) are therefore legally allowed to administer the medicines on this list and many of them (but not all) are included on the JRCALC formulary (RPSGB, 2010) (Table 2).
| Adrenaline injection 1 in 1000 (1 mg in 1 ml) |
| Atropine sulphate injection |
| Atropine sulphate and obidoxime chloride injection |
| Atropine sulphate and pralidoxime chloride injection |
| Atropine sulphate, pralidoxime mesilate and avizafone injection |
| Chlorphenamine injection |
| Dicobalt edetate injection |
| Glucagon injection |
| Glucose injection 50% |
| Hydrocortisone injection |
| Naloxone hydrochloride |
| Pralidoxime chloride injection |
| Pralidoxime mesilate injection |
| Promethazine hydrochloride injection |
| Snake venom antiserum |
| Sodium nitrite injection |
| Sodium thiosulphate injection |
| Sterile pralidoxime |
Pharmacy medicines (P)
These may only be supplied from a registered pharmacy by, or under the supervision of, a registered pharmacist. There are no legal restrictions on who can administer P medicines. Ambulance trusts can legally receive these into their stock and therefore paramedics and ambulance technicians working within the ambulance service can legally obtain P medicines for use in the course of their business, and administer them. Glyceryl trinitrate (GTN) tablets are an example of a P medicine.
General sales list (GSL)
GSL medicines have fewer restrictions than P medicines on their sale and supply, and they can be supplied from non-pharmacy retail outlets without any involvement of a pharmacist. However, as GSLs are medicines (unlike food supplements, i.e. herbal remedies), some restrictions do apply and these medicines must only be sold from lockable premises (excludes market stalls for example), and the container for sale must not have been opened since its manufacture.
Ambulance trusts are legally allowed to obtain these medicines and there are no restrictions on who can administer them to other people. Both paramedics and ambulance technicians can administer GSL medicines. Paracetamol 500 mg tablets and aspirin 300 mg tablets are examples of GSL medicines.
Patient group directions (PGDs)
A PGD is a written direction to supply or administer POMs to groups of patients. PGDs authorize certain registered health professionals to supply or administer medicines to groups of patients who may not have been identified before they present for treatment (MHRA, 2010). They can be used by paramedics, dental hygienists, pharmacists, nurses, optometrists and physiotherapists, as well as some other professional groups. They must be signed by a doctor or dentist, and a pharmacist, and approved for use by the relevant ambulance trust. Only the individual paramedics named on the PGD can administer the medicines covered by it.
The Misuse of Drugs Act 1971
The Misuse of Drugs Act 1971 controls ‘dangerous or otherwise harmful drugs’ which are designated as ‘controlled drugs’ (CDs). The primary purpose of the Misuse of Drugs Act is to prevent the misuse of CDs. It does this by imposing a total prohibition on the possession, supply, manufacture, import or export of controlled drugs, except as allowed by regulations or by license from the Secretary of State. The use of CDs in medicine is permitted by the Misuse of Drugs Regulations 2001, as amended. In other words, the Act bans all activities regarding CDs, and the regulations create exemptions for certain activities by certain health professionals.
The penalties applicable to offences involving the different drugs are graded broadly according to the harmfulness attributable to a drug when it is misused and for this purpose the drugs are defined in the following three classes:
The classification of the above drugs under the Act is of little practical importance to paramedics, but the classification of CDs into five schedules under the Misuse of Drugs Regulations governs the restrictions on their use in practice. Only the restrictions affecting paramedic practice are mentioned here.
Schedule 1 controlled drugs
Schedule 1 CDs include hallucinolgenic drugs e.g LSD, ecstacy-type substances and cannabis. Drugs included in this schedule have no medicinal use, and a license from the Home Office is needed for production, possession and supply. Sometimes paramedics or ambulance technicians may encounter substances removed from patients, which may be Schedule 1 CDs. As a license is required to possess Schedule 1 products, the paramedic or technician can not take possession other than in the following two cases where an exemption to the restrictions is granted in law:
Schedule 2 controlled drugs
Schedule 2 CDs include opiates and major stimulants such as amphetamines. These must be stored under safe custody. Records of all transactions must be kept for at least two years in a CD register—good practice dictates that they should be kept for at least seven years; destruction must only take place in the presence of an authorized witness (this is someone appointed by your trust accountable officer); and paramedics can not administer these medicines under a PGD.
Schedule 3 controlled drugs
Schedule 3 CDs include buprenorphine, midazolam, phenobarbitone and temazepam. These drugs require safe custody (although midazolam is a Schedule 3 CD, it is exempted from safe custody requirements so does not need to be locked in the CD cupboard) and they can not be used by paramedics under a PGD. There is no legal requirement to record transactions in a CD register or have their destruction witnessed.
Schedule 4 and 5 controlled drugs
Schedule 4 CDs include benzodiazepines and anabolic steroids, and Schedule 5 CDs include medicines containing lower strengths of some CDs e.g codeine and morphine. There are fewer restrictions on the handling of these medicines.
The accountable offcer
The government's response to the Fourth Report of the Shipman Inquiry (Department of Health (DH), 2004) set out the changes needed to ensure safer management of controlled drugs through improved monitoring and inspection; prescribing; audit; patient information and training and professional development. As a result of this, all NHS trusts must have appointed an accountable officer—a senior manager who is responsible for the safe, appropriate and effective management and use of controlled drugs within their organization.
There is now a legal duty to share intelligence and information about the use of CDs within health and social care, and the accountable officer is part of a local intelligence network to support this process (DH, 2004). Further information on the legislation surrounding CDs is available on the website of the National Prescribing Centre (NPC) at: http://tinyurl.com/43rscco.
Licensing of medicines
In the UK, all medicines go through strict checks to make sure that they are safe and effective. When a medicine passes all the checks, it is granted a marketing authorization (formerly called a product licence) and can be used to treat specific medical conditions (MHRA, 2010).
To sell a medicine in the UK, the manufacturer must apply for a product licence from the MHRA. The MHRA will only agree a product licence if:
The details of how any medicine should be used including its dosage, cautions, contra-indications and side-effects are included within the manufacturer's summary of product characteristics (SPC). SPCs for most medicines can be viewed online at: www.medicines.org.uk.
Medicines should be prescribed in accordance with the licence, otherwise their use is referred to as ‘off-label’, and the prescriber carries increased legal responsibility and liability if the supply of an unlicensed product causes harm. Clearly when medicines are used in the ambulance service there is no prescriber involved, but paramedics should carefully follow the instructions in their local formulary regarding dosage, dilution and route of administration because these instructions are likely to have been prepared using the SPC for guidance.
To deviate from the instructions in your formulary may mean that you are inadvertently using the medicine ‘off-label’, and this carries an increased risk to yourself and the patient.
Possible future developments: non-medical prescribing
Non-medical prescribing is prescribing by nurses, pharmacists, podiatrists, physiotherapists, optometrists and radiographers. The aim is to improve patient care by increasing access and allowing health professionals to complete an episode of care without needing to refer on to a doctor for a prescription.
There are proposals to extend this group of health professionals to include paramedics, which would allow paramedics to prescribe any medicine within their competence. Further information on this possible future development is available from the Department of Health at: http://tinyurl. com/3s8n7qf.
Conclusion
When administering medicines to patients you should always adhere to the guidance in your local ambulance trust formulary. It is likely that this has been prepared by local experts, and is based on the national formulary. This will ensure that you are working within the law, and also using the medicine according to its licence.
The rationale for inclusion of medicines within your formulary is underpinned by legislation. The range of medicines is limited according to the legislation contained within the Medicines Act (1968), and the requirements for safe storage and CD registers are mandated by the Misuse of Drugs regulations. Having an awareness of the relevant legislation will underpin your understanding of the mechanism that allows you to administer medicines. In future, paramedic non-medical prescribing may offer an alternative route for patients to receive the medicines they need.