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Nursing & Midwifery Council Updates on Advice On Mixing Medicines



Due to a change in the law, the Nursing & Midwifery Council or NMC updated their advice for nurses and midwives on mixing medicines.

The changes in the legislation mean that nurse and midwife independent prescribers are able to mix medicines themselves and direct others to mix them.

Below are the following updates found on NMC website.

Mixing medicines

Background

  • The Medicines Act 1968 defines manufacture in relation to a medicinal product, as any process carried out in the course of making the product. This does not include dissolving or dispersing the product in, or diluting or mixing it with, some other substance used as a vehicle for the purpose of administering it.
  • Mixing two licensed medicines where one is not a vehicle for the administration of the other, falls within the definition of manufacture and results in a new, unlicensed product being administered. In addition, as a new product is being manufactured, a manufacturer’s license would be required.
  • The Medicines and Healthcare products Regulatory Agency (MHRA) established from inquiries and discussions with palliative care interests, that it had been long standing accepted practice in this field to prescribe a mixture of licensed medicines for administration to patients, usually via a syringe driver.
  • The MHRA recognized that the then legal position had the potential to obstruct the provision of effective pain relief to patients receiving palliative care.
  • Following a public consultation and advice from the Commission on Human Medicines, medicines legislation was amended on 21 December 2009. The changes enabled nurse and midwife independent prescribers to mix medicines themselves and direct others to mix them. ‘Mixing’ is defined in legislation as ‘the combining of two or more medicinal products together for the purposes of administering them to meet the needs of a particular patient.
  • More specifically the changes allow:
    • Doctors and dentists (who can already legally mix medicines) to direct others to mix.
    • Nurse and midwife independent prescribers to mix medicines and to direct others to mix.
    • Supplementary nurse and midwife prescribers to mix medicines and to direct others to mix, but only where that preparation forms part of the clinical management plan for an individual patient.
  • We would expect nurses and midwives who are involved in the mixing of medicines to be supported by local polices and guidance. The Commission on Human Medicines Working Group has produced a report of their consideration into the mixing of medicines which contains a summary of key points for guidance.
  • The changes apply to all clinical areas where the mixing of medicines prior to administration is accepted practice and supported by the employer’s policies for the delivery of healthcare.
  • The changes do not apply to Patient Group Directions.

Controlled drugs

  • A number of medicines used within palliative care are subject to the additional controls contained in the Misuse of Drugs Regulations (MDRs) which are the responsibility of the Home Office.
  • The MDRs have a similar concept relating to the mixing of drugs which is referred to as ‘manufacturing’ or ‘compounding’. Under the MDRs only practitioners (doctors, dentists and vets) or pharmacists have the authority to manufacture or compound. Nurse or midwives do not have any such authority.
  • Amendments are awaited to the MDRs.
  • In the meantime, existing good practice should continue in relation to mixing of controlled drugs based on the MHRA’s existing public statements, of which the Home Office are aware.
  • Nurses and midwives are advised that the MHRA guidance would be considered in any NMC fitness to practice proceedings. As with any legal, regulatory or disciplinary proceedings each case would be considered on its merits.

Mixing of medicines for the purpose of administration

  • Mixing should be avoided where possible. It must only be undertaken when clinically appropriate and essential to meet the needs of the patient, rather than for the convenience of a health professional.
    Instructions to mix must be in writing.
  • The person mixing the medicines must be competent.
  • No-one should be obliged to mix and administer medicines, if they do not feel competent or content to do so.
  • Guidance should be developed to aid those involved in the mixing of medicines.

Further resources

The National Prescribing Center will be issuing guidance on the mixing of medicines prior to administration in clinical practice.

References

1. “Nursing & Midwifery Council – Advice sheet: Mixing Medicines”

2. The Medicines (Exemptions and Miscellaneous Amendments) Order 2009. SI 2009/3063

3. Report of the CHM Working Group on Mixing of Medicines

4. MHRA statement on non-medical prescribing and mixing medicines in palliative care

5. MHRA Statement – updated information July 2009

6. Taken from guidance issued by the Commission on Human Medicines Working Group on Mixing Medicines

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