Legal Updates

Healthcare – Medical Law – Regulatory – Prescription Only Medicine – Administration of Medicines – Pharmaceutical Law

The Prescription Only Medicine (Human Use) Amendment Order 2010 (“the Order”) amends the Prescriptions Only Medicine (Human Use) Order 1997 (“the 1997 Order”) by amending:-

the list of prescription only medicines which can be administered by injection by anyone in an emergency situation for the purpose of saving life; and

the list of prescription only medicines which can be administered by registered paramedics.

The 1997 Order

The 1997 Order specifies the description, classes and circumstances under which medicinal products may be sold, supplied or administered including any exceptions that may apply to those provisions.

Amendments

• Article 2 amends the exception embodied in Article 7 of the 1997 Order which allows for certain parenteral medicines to be administered by anyone for the purpose of saving life in an emergency. The list of medicines which could be administered included glucose at concentration 50%.
  • Wording:           “Glucose injection 50%” substituted for “Glucose Injection”.
  • Effect:              To ensure that in an emergency, glucose is available for parenteral administration at any level of dilution, by anyone.
  • Why?                Whereas the 1997 Order stated glucose had to be at a concentration of 50%, the amendment intends that glucose be administered at other strengths if required. According to the explanatory memorandum by the Medicines and Healthcare products Regulatory Agency (MHRA), this reflects best medical practice which is to use glucose in concentrations of 10% or 20%.
• Article 3 amends the exception embodied in part 3 of schedule 5 of the 1997 Order which allows registered paramedics to administer a specific list of medicines on their own initiative.
  • Wording:           In the list in column 2 of entry 9, after “Adrenaline Acid Tartrate” add “Adrenaline Hydrochloride”.
  • Effect:              To ensure that Adrenaline Hydrochloride is available for parenteral administration by paramedics.
  • Why?                Whereas the 1997 Order included Adrenaline Acid Tartrate within the paramedics’ list for use in anaphalaxis and cardiac arrest, the addition of Adrenaline Hydrochloride (which is on the market for the same indications) offers an alternative if the former is unavailable.

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© RT COOPERS, 2011. This Briefing Note does not provide a comprehensive or complete statement of the law relating to the issues discussed nor does it constitute legal advice. It is intended only to highlight general issues. Specialist legal advice should always be sought in relation to particular circumstances.