Principles of drug administration
Legal aspects, pharmacokinetics and anaphylaxis
Learning outcomes
Having read this chapter, the reader should be able to:
This chapter considers the legal regulations covering drug administration by the midwife. It includes guidelines for the safe administration of medicines, including controlled drugs, and guidelines for the management of anaphylaxis. Pharmacokinetics aids the midwife’s understanding of drug administration, this is discussed for both the woman and the baby.
Effective drug therapy needs the appropriately researched and manufactured medicine to enter, get around and ultimately leave the body. The action of the medicine and the effects on the person should be as expected (Jordan 2010). This all suggests that safe and effective medicine administration is a complex issue, beginning long before the midwife administers the medicine to the woman.
Some drugs in the maternal circulation do not pass through to the fetus during pregnancy and labour, as the placenta acts as a barrier. However, some drugs are able to pass through the placental barrier and can have an effect on the fetus (e.g. pethidine). Drugs may also pass from the maternal circulation to the baby via breast milk. This chapter does not consider fetal pharmacokinetics or drugs and breastfeeding, as the reader is directed towards the growing number of books that look specifically at these issues.
Legislation
There are a number of Statutory Acts and Regulations that govern midwifery practice with regard to medicines management in the United Kingdom (see Alexis & Caldwell (2013) for specific details). The Nursing and Midwifery Council (NMC) provide the minimum standard of practice expected, based on the laws that govern. All midwives adhere to Standards for Medicines Management (NMC 2007) for example, or risk losing their registration to practice.
The Human Medicines Regulations 2012 categorized medicines in three ways:
Each of the above categories is reviewed periodically. The abbreviation ‘POM’ can be found on the packaging the medicine is supplied in, making it clear that it cannot be supplied without a prescription, except under certain circumstances (see Midwives Exemptions below). Sometimes medicines may be used in a different way from what they were originally licensed for, e.g. given via a different route. When a medicine is used in this way (‘off label’ or ‘off licence’), the prescriber and dispenser take full responsibility for its use (NMC 2007), recognizing that it is a risky action to undertake. It can also mean that gaining informed consent is more difficult. Medicines should always be stored according to the guidance on the label and, in hospitals, in agreed storage facilities (in locked cupboards or fridges, with only approved staff able to carry or access the keys).
Midwives Exemptions
Under the Acts of Parliament that govern midwifery practice, midwives are given exemption to supply medicines, in the course of their professional practice, that are on the P and GSL lists, and some items that are POM. Midwives exemptions were previously called standing orders, but this term is no longer applicable. Midwives should be clear that they can only administer medication if they are familiar with its use, dosage, side effects, precautions, contraindications and method of administration (NMC 2007, Anon 2010). This administration does not need a prescription, a patient-specific direction (PSD) or a patient group direction (PGD) (see below). If, however, the medicine is not on the exemptions list then one of these will be required.
Which medicines may be given under ‘Midwives Exemption’?
The full Midwives Exemptions POM list can be viewed on the NMC website (NMC 2011). Examples include diclofenac, hydrocortisone acetate, miconazole, nystatin, phytomenadione, sodium chloride 0.9%, cyclizine lactate, anti-D immunoglobulin, pethidine hydrochloride, oxytocin, and lidocaine. Student midwives were, from 2011, permitted, when under the supervision of a sign-off mentor, to administer the medications on the Midwives Exemption list, except for controlled drugs (NMC 2011). Being supervised by a sign-off mentor means in this context that the student must be physically watched administering the medicines. Student midwives may participate in the preparation and checking of controlled drugs if they are again being directly supervised by a sign-off mentor.
The administration of any medicine
Medicines, prescribed and given correctly, can make a significantly positive difference to patients. However, given incorrectly, the harm caused can have far-reaching consequences both in human and monetary terms. Matthew (2007) suggested that up to 10,000 preventable deaths occur each year due to medication errors. In promoting safer administration of medicines, Elliott & Liu (2010) describe the nine ‘rights’ that should be considered with each medicine administration:
It is clear that all systems need to be robust; there is the possibility for error to occur within research and development, manufacture, packaging and prescribing as well as administration. Elliott & Liu (2010) cite studies that show that the largest and most consistent errors in drug administration are human errors, ‘at the bedside’. These may result from inexperience, lack of care and attention or the pressures of the daily workload. The midwife does not blindly comply with instructions but has to be knowledgeable and fully aware of what they are complicit in. For drug administration the midwife should be familiar with the drug to be administered, knowing why it is to be given, normal dosage, precautions, contraindications and side effects (NMC 2007). If this knowledge is not known, the British National Formulary (BNF)/BNF for Children (BNFc), other colleagues, the prescriber or the pharmacist could all be consulted. The electronic BNF/BNFc is updated monthly and should be the initial checking reference.
Prescriptions
Medicines that are on the POM list require a prescription. Midwives Exemptions (NMC 2011), as discussed earlier, allow midwives in the UK to administer some medicines from this list under their own autonomous practice. For all other POM, a PSD or prescription is required. This means that the prescriber (medical or approved non-medical) has reviewed the patient and assessed their need. For inpatients a PSD is often recorded on a medicine administration record; in the community, anti-forgery prescription forms are used.
Given that a PSD is specific to an individual, it should be written clearly as to identify that named client. Three identifiers constitute good practice; name and address, date of birth and NHS number are the best three. The presence of allergies should be established and documented. If appropriate, an alert identity band should be on the client’s wrist when hospitalized. Any prescription should be written in black ink and should be legible. It should also contain details of:
• the name, form and strength of the drug (generic name where possible)
• route/method of administration
• frequency of administration, including maximum dose over 24 hours if appropriate
• date of prescription and if appropriate, date of completion
• prescriber’s signature. This should be recognizable as that of one of the medical team overseeing the woman or the baby (GMC 2013).
E-prescribing (electronically) has been shown to reduce some of the errors; all of the above information still has to be included.
Patient group direction
A PGD is a specific written instruction covering the supply and administration of a named (prescription only) medicine or vaccine. It allows specific health care professionals to supply/administer a medicine directly to a patient with an identified clinical condition, without the need for a prescription, e.g. for labour care. The midwife is responsible in these circumstances for establishing that the client they are working with meets the criteria laid out as part of the PGD before the medicine is administered (Bussey 2011). PGDs are determined locally in consultation with medical staff, pharmacists and relevant healthcare professionals. They have a set of specific legal requirements (Griffith 2010) and can include controlled and ‘off licence’ medicines. A midwife must know and understand the PGD in order to practice under it; in many NHS Trusts midwives sign annually to confirm their understanding and compliance.
PROCEDURE: administration of a non-controlled drug
Self-administration of medicines
The majority of women will be fully competent and able to self-medicate, both at home and in hospital. When in hospital it is necessary to assess the situation carefully; risk management requires that medicines are stored securely (generally at the bedside) and that clients have an assessment to ensure suitability for the task. The assessment includes:
• willing participation, leading to signed consent
• no history of drug or substance abuse, or self-harm
• level of understanding of the medicines, their dosage, timings, effects, and possible side effects.