Drug Legislation and Paramedic Practice

Paramedics are able to administer several medications to patients autonomously, meaning without a discussion with a prescriber, but these medications do not all fall under the same legislation.

Schedule 19 of the Human Medicines Regulations 2012

These are medications that anyone can administer in an emergency [1]. This is why anyone can give an EpiPen® to someone suffering from suspected anaphylaxis and there is increasing training in 'Take Home Naloxone' for opiate overdoses. Medications under this legislation include:

• 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 mesylate and avizafone injection
• Chlorphenamine injection
• Dicobalt edetate injection
• Glucagon injection
• Glucose injection
• Hydrocortisone injection
• Naloxone hydrochloride
• Pralidoxime chloride injection
• Pralidoxime mesylate injection
• Promethazine hydrochloride injection
• Snake venom antiserum
• Sodium nitrate injection
• Sodium thiosulphate injection
• Sterile pralidoxime

Note that the only indication here is for anaphylaxis and there is no clear guidance on when other medications should be indicated. Regulation 214 [2] may also be quoted in reference to paramedics which suggests prescription-only medications can only be administered parenterally in the presence of an 'appropriate practitioner' of whom paramedics are not identified. However, Regulation 238 states that Regulation 214 should be disregarded in the instance of Schedule 19 medicines in order to save a life in an emergency. Therefore, these medications can still be given by anyone; however, the indication for giving them is not clear.

Schedule 17 of the Human Medicines Act (Part 3.8)

These prescription medications can be given by paramedics for the 'necessary' treatment of sick people [2]. This schedule covers different professions that have their own exemptions to allow them to provide certain prescription medications. These may be referred to as 'exemption medications'. Not all medications we use are covered by this legislation and some of the medications here have fallen out of favour (e.g. streptokinase). Some medications are listed but not indicated for the use that they are now mainly given - for example, heparin is only stated to be used as a flush and not as part of cardiac thrombolysis. Again, there are no indications stated for all these medications.

These medications include:

• Adrenaline acid tartrate
• Adrenaline hydrochloride
• Amiodarone
• Anhydrous glucose
• Benzylpenicillin
• Compound sodium lactate (Hartmann's Solution)
• Diazepam 5?mg/ml
• Ergometrine 500?mcg
• Ergometrine maleate 500?mcg and oxytocin 5 units (Syntometrine®)
• Furosemide
• Glucose
• Heparin sodium (only to flush a cannula)
• Lidocaine hydrochloride
• Metoclopramide
• Morphine sulphate
• Nalbuphine hydrochloride
• Naloxone hydrochloride
• Ondansetron
• Paracetamol
• Reteplase
• Sodium chloride
• Streptokinase
• Succinylated modified fluid gelatin
• Tenecteplase

Patient Group Directives

Patient Group Directives (PGDs) are legislation that allows for a certain group of health care professionals to administer a specific medication to a specific patient group [3]. An example is heparin; ambulance services create a PGD to allow paramedics to administer heparin to people expecting Primary Percutaneous Coronary Intervention (PPCI) treatment or thrombolysis. Different ambulance services will have different medications available as PGDs and this can include a 'new' medication for paramedics such as codeine for moderate pain or a medication we use but in a different form or route, e.g. nebulised adrenaline for croup. What is important to understand is that these medications can only be given for the presentations mentioned on the PGD and if you change employment to another ambulance service or trust you cannot give this medication unless it is also a PGD in your new service.

Associate of Ambulance Chief Executives Protocols

The Joint Royal College Ambulance Liaison Committee (JRCALC) list medications that ambulance services and trusts have generally agreed will benefit people if paramedics are able to administer them. These medications are more colloquially known as 'JRCALC medicines'. This includes medications such as clopidogrel. Individual ambulance trusts may have their own specific guidelines for these medications through PGD, or they will follow JRCALC guidance.

Prescribing

Some paramedics will choose to do additional training to gain their Non-Medical Prescribing qualification at Bachelors or Masters level. This allows them to prescribe medications from the BNF and they will be listed as an independent or supplementary prescriber on the Health and Care Professions Council (HCPC). However, at the time of writing, paramedic prescribers are only able to prescribe a limited list of controlled drugs [4].

Controlled Drugs

Since I've mentioned it, let's talk about controlled drugs.

Paramedics can autonomously administer a selection of what are known as 'controlled' medications such as morphine sulphate and benzodiazepines through various forms of legislation. The Misuse of Drugs Act 1971 [5] places drugs in different 'classes' which are organised on a scale based on the potential harm when misused and includes both prescription drugs and illicit drugs.

• Class A - Includes cocaine, heroin, LSD, MDMA, morphine, methadone.
• Class B - Includes oral amphetamines, cannabis, codeine, dihydrocodeine, ketamine and barbiturates.
• Class C - Includes buprenorphine, benzodiazepines, tramadol, zopiclone, androgenic and anabolic steroids, gabapentin, pregabalin and most recently nitrous oxide.

The Misuse of Drugs (Safe Custody) regulations 1973 is related to the safe storage of controlled drugs and the Misuse of Drugs Regulations 2001 discusses who can provide controlled drugs and the requirements for supply, prescribing and record keeping (Table 1). This is where the terminology of having different 'schedules' of controlled medications comes in. This is why morphine and midazolam need to be double locked in a safe whereas diazepam does not.

This legislation originates from attempts to prevent misuse of drugs to cause harm. The knowledge behind drug misuse is evolving and a greater understanding of life experiences that contributes to drug use is becoming clearer. There is greater appreciation that drug use and addiction is a coping mechanism for early childhood trauma which can be supported through appropriate rehabilitation. Legislation is yet to reflect this; however, there is growing acceptance within the medicine and psychology fields that to tackle drug misuse legislation needs to be supportive not punitive [6].

Table 1 Controlled Drug Schedules

SCHEDULE EXAMPLES REQUIREMENTS PREHOSPITAL EXAMPLES Schedule 1 Hallucinogenic drugs, ecstasy-like drugs, opium, cannabis Home office licence required for production, possession+supply. Controlled drugs register kept with pharmacy details. NONE Schedule 2 Opiates, stimulants, cocaine, ketamine, medicinal cannabis products Controlled drugs register to be kept detailing administration of supply. Must be stored in a locked safe. Morphine sulphate (IV preparation)
Ketamine Schedule 3 Most barbituates, gabapentin, pregabalin, midazolam, temazepam Some groups must be stored in a locked safe. Retention of invoices for 2 years Midazolam Schedule 4 other benzodiazepines, Z-drug, anabolic + androgenic steroids Retention of invoices for 2 years Diazepam Schedule 5 Codeine phosphate, oral preparations of morphine Retention of invoices for 2 years Codeine, oramorph®

References

1. 1 United Kingdom. The Humans Medicines Regulation 2012 No 1916 Schedule 19
2. 2 United Kingdom. The Human Medicines Regulation 2012 no 1916 Schedule 17 Part 3.8
3. 3 Medicines and Healthcare Products Regulatory Authority. Patient Group Directions: who can use them [internet] 2017 [cited 2024 03 18]. Available at: https://www.gov.uk/government/publications/patient-group-directions-pgds/patient-group-directions-who-can-use-them
4. 4 England, Wales and...