Introduction

The practice of midwifery is concerned with supporting women and their families through the normal, physiological process of childbirth. However, women may complain of discomfort or minor disorders associated with childbirth, they may become unwell during pregnancy or labour or they may have a ­pre-existing medical condition. In these cases, the midwife may be required to administer medicine to relieve the discomfort or to treat the condition. Headley et al. (2004) have reported that 92.4% of pregnant women in their research group had taken a medicinal product at least once during their pregnancies. At least a third of the women reported taking a pain-relieving medicine such as paracetamol, while 23% reported using an antacid to relieve symptoms of indigestion.

The use of medicinal products during pregnancy is such that it is important that midwives are competent to safely undertake all aspects of drug administration. This chapter aims to give an overview of issues relating to the use of medicines in the context of midwifery practice.

Legislation governing the administration of drugs

The Nursing and Midwifery Council (NMC) Standards for Medicines Management (NMC 2007) highlights the fact that the administration of medicines is an important aspect of the professional practice of all individuals registered with the Council. However, it is emphasised that it should not be viewed as a mechanical task which is performed exactly in accordance with the written prescription of a medical practitioner. This is where professional judgement and thought are important when each practitioner views the client as an individual, taking all aspects of her care into consideration (the holistic approach). This includes issues such as what other drugs the woman is taking, how they might interact with each other and what reactions she has had to a drug previously.

Rule 5 of the Midwives’ Rules and Standards (NMC 2012) states that a practising midwife should only supply and administer those drugs for which she has received appropriate training. This includes being familiar with the dosage of the drug, any potential side-effects, restrictions to its use and method of administration.

The Medicines Act 1968

This legislation was introduced by the then Department of Health and Social Security following a review of legislation relating to medicines, prompted by the thalidomide tragedy of the early 1960s. During this time, many pregnant women took the drug thalidomide as treatment for morning sickness. It was not known at the time that this drug could have an adverse effect on the developing fetus as no testing on pregnant animals had been done prior to the drug being released to the public. This led to thousands of babies being born with severe and very distinctive limb deformities.

The Medicines Act 1968 brought together most of the previous laws relating to medicines and introduced other legal provisions for the control of medicines, including supply, possession and manufacture. It classifies medicinal drugs into three categories depending on the dangers they pose to the public and the risk of misuse:

Prescription-only medicines (POM)

These are medicines that can only be supplied and given to a client on the instruction of an appropriate practitioner (for example, a doctor or dentist). Since the Medicinal Products Prescription by Nurses Act 1992, health visitors and district nurses who have recorded their nurse prescribing ­qualification with the NMC are also able to prescribe certain medicines from the approved nurse prescribers list.

Pharmacy-only medicines (P)

Pharmacy-only medicine can only be bought from a registered pharmacy provided that the sale is supervised by the pharmacist, enabling the pharmacist to confirm with the client that it is safe for them to take the medicine. For example, the client will be asked if they are taking any other types of medicine which might interact or interfere with the requested medicine, or if they have any other condition, such as pregnancy, high blood pressure or cardiac problems, which might be affected by the medicine.

Some medicines may only be sold once the pharmacist is satisfied that certain circumstances have been fulfilled. For example, emergency contraception (also known as the ‘morning-after pill’) may only be sold to the person who actually requires the contraception and she must be over the age of 16 years.

General sale list medicines (GSL)

These do not need a prescription or the supervision of a pharmacist and can be obtained by members of the public from supermarkets or other retail outlets. Usually only a small pack size of the medicine may be sold in these stores. For example, the largest pack size of paracetamol that may be sold from a shop is 16 tablets whereas packs of 32 tablets may be sold from a pharmacy. Similarly, only low strengths of the medicine may be sold from a general store. For example, the highest strength of ibuprofen tablets that may be sold from a shop is 200 mg whereas tablets containing 400 mg may be sold from a pharmacy.

Some medicines may be reclassified from prescription only to pharmacy or from pharmacy to general sale list. This can happen once it is considered that the medicine is safe for most people to use. For example, aciclovir cream, which is used to treat cold sores, was initially available as prescription only. After a few years, it was reclassified to a pharmacy medicine, and recently it has been reclassified again to a general sale list medicine.

Midwives’ exemptions and prescription-only medicines

Specific drugs, including those usually available only on prescription, may be supplied to midwives for use in their professional practice. In this case midwives are recognised as being exempt from certain restrictions on the sale or supply and administration of medicines under the Medicines Act 1968. Examples of drugs commonly used in midwifery practice include Syntometrine, which may be given during the third stage of labour to facilitate the delivery of the placenta, and pethidine, which may be administered as pain relief during labour. The midwife can administer both these drugs on her own responsibility without the need for a prescription.

A midwife may use these drugs only in her professional midwifery capacity. For example, she would not be permitted to administer the drug to a friend or family member unless she was caring for them during childbirth.

Preparations for use by midwives are shown in the list below. They are included in Schedule 5 (Parts 1 and 3) of the Prescription Only Medicines (Human Use) Order 1997 (often referred to as the ‘POM’ Order), the Medicines (Pharmacy and General Sale-Exemption) Order 1980 (SI 1980/1924) and the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980 (SI 1980/1923).

In Part 1 of the POM Order (exemptions from restrictions on sale or supply), the midwife can supply the following medicines on her own initiative:

• Diclofenac
  
• Hydrocortizone acetate
  
• Miconazole
  
• Nystatin
  
• Phytomenadione

In Part 3 of the POM Order (exemptions from restrictions on administration), the midwife can administer the following medicines on her own initiative:

• Adrenaline
  
• Anti-D immunoglobulin
  
• Carboprost
  
• Cyclizine lactate
  
• Diamorphine
  
• Ergometrine maleate
  
• Gelofusine
  
• Hartmann’s solution
  
• Hepatitis B vaccine
  
• Hepatitis immunoglobulin
  
• Lidocaine
  
• Lidocaine hydrochloride
  
• Morphine
  
• Naloxone hydrochloride (Narcan)
  
• Oxytocins (natural and synthetic)
  
• Pethidine hydrochloride
  
• Phytomenadione (vitamin K)
  
• Prochlorperazine
  
• Sodium chloride 0.9%

Whatever drugs a midwife uses in her practice, it is clearly stated in the Midwives’ Rules and Standards (NMC 2012) that a midwife should not administer any drug unless she is familiar with its usage and has received appropriate training with regard to its use. This becomes particularly important now that the number of medicines included on the midwives’ exemptions list has increased. There are implications for the continuous professional development and training needs of all midwives to ensure that they are updated on how to use and administer any particular drug.

Case study 11.1

Sharma is a first-year student midwife and is undertaking her first placement on the delivery suite. The woman she is caring for is in the first stage of labour and is requesting pethidine as a method of pain relief. Sharma asks Samantha, her mentor, if she should call the senior house officer to the ward to prescribe the drug. She is surprised when Samantha informs her that this is not necessary as pethidine is one of the drugs on the midwives’ exemption list.

    Samantha also explains to Sharma that as a student, while she can be involved in the checking and preparation of the pethidine with her, Sharma will not be permitted to actually administer the injection to the woman. The injection will need to be administered by a qualified midwife as it is a controlled drug.

    Thankfully, though, as Samantha is a ‘sign off mentor’, Sharma will be still be able to practise administering other injections (such as Syntometrine) which are on the midwives’ exemptions list under Samantha’s direct supervision. This means that by the time she qualifies as a midwife in 3 years, she will feel competent to administer drugs by injection. Sharma is pleased to hear that she will get plenty of practice as giving injections is an area of midwifery practice she feels particularly anxious about!

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Midwives’ exemptions: the situation for students

The midwifery exemptions list was revised in 2010 (NMC 2010). This implemented changes in relation to the sale, supply and administration of medicine to allow midwives to supply and/or administer an updated range of POM. However, the change in legislation meant that student midwives were unable to achieve their competencies in the administration of medicines included on the exemptions list as the law permitted only qualified practitioners to do this and the responsibility could not be delegated to anyone else. There was some concern and confusion amongst students, educationalists and midwives about these issues. The NMC discussed the matter with the Medicine and Healthcare products Regulatory Authority (MHRA) to try to seek a solution to this dilemma which affected student midwives’ ability to develop their competence in certain aspects of drug administration.

Another NMC circular in July 2011 (NMC 2011) led to further changes to midwives’ exemptions, meaning that student midwives can now administer medicines contained on the exemptions list under the direct supervision of a ‘sign off’ mentor. This means that they have received specific mentor training and are qualified to assess (‘sign off’) students’ competencies in practice. Direct supervision means that the midwife and student work alongside each other with the mentor actively watching the student undertake the preparation and administration of the drug.

However, while students may be involved in the preparation and checking of controlled drugs included on the midwives’ exemptions list, under current legislation they are not able to actually administer them. This must still be done by a qualified midwife who cannot delegate this task.

Midwifery wisdom

Students must never administer/supply medicinal products without direct supervision.

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The British National Formulary

The British National Formulary (BNF) is a joint publication of the British Medical Association and the Royal Pharmaceutical Society of Great Britain. It is published twice a year under the authority of a Joint Formulary Committee which comprises representatives of the two professional bodies and of the UK health departments. The BNF aims to provide all healthcare professionals with sound, up-to-date information about the use of medicines. It includes key information on the selection, prescribing, dispensing and administration of medicines. Medicines generally prescribed in the UK are covered and those considered less suitable for prescribing are clearly identified. It is available in hard copy or electronically (www.bnf.org).

Administering medication

Principles

The midwife should ask herself the following questions before administering any medication to the women or babies in her care. These form the basic principles for the safe administration of medicines and are recommended by the NMC (NMC 2007).

• Are you familiar with the drug? For example, do you know how it works, the normal dosage, any potential side-effects or possible reason why it should not be given to this particular woman (contraindications)?
  
• Are you aware of the woman’s plan of care and do you know that there is actually a need for her to receive the medication?
  
• Has all the relevant information about the medication been given to the woman and has she made an informed decision to have the drug?
  
• Have you confirmed the identity of the woman to ensure that the correct drug is given to the correct client? In maternity care, most women are conscious and are able to confirm who they are, but if the woman is unconscious, then her identity will need to be confirmed by checking the name and hospital number on her identity band.
  
• Does the woman have any known allergies?
  
• If appropriate, is the prescription chart clearly written and unambiguous?
  
• Does the prescription chart include the correct name of the drug, how it is to be administered (for example, orally or by injection into the muscle or vein), the amount to be given, how frequently it is to be given, when treatment started and the date when it should be completed?
  
• Has the medication reached its expiry date and is therefore unsuitable to use?

Checking of drugs

In order to reduce the number of drug errors, the NMC (2007) considers that it is unacceptable for a drug to be prepared before it is needed. An example of this in midwifery practice would be when a midwife draws up an injection of Syntometrine or Syntocinon into a syringe and leaves it by the bedside of the woman in labour ready for the third stage. If labour does not proceed as expected and there is a delay, then there is the potential for this drug to be given in error during rather than following labour. If an oxytocic drug such as Syntometrine is given during labour, this would lead to the potentially disastrous situation of the uterus undergoing a strong, sustained contraction with the fetus still inside.

With the same principle in mind, a midwife should not administer a drug which has been prepared by a colleague unless she was present while it was being prepared and is satisfied with the checking procedure (NMC 2007). An exception to this is when a woman already has an intravenous infusion in place which was prepared by a midwife and another midwife then takes over her care.

Controlled drugs

Certain POM are further classified as controlled drugs. Examples that a midwife might use in her professional practice are pethidine, diamorphine, morphine and pentazocine. In some cases, these medicines may be misused or sold illegally, so for this reason there are stricter legal controls on their supply – hence the term ‘controlled drugs’.

There are controls on:

• who may prescribe these medicines
  
• how the prescription is written
  
• how much may be prescribed
  
• how the medicines are stored.

However, a registered midwife is able to administer certain controlled drugs on her own responsibility without a prescription from a medical practitioner under midwives’ exemptions. Remember, a student may be involved in the preparation and checking of a controlled drug with her midwife mentor but is not permitted to actual administer it to the client.

Misuse of Drugs Act 1971

This Act prevents the possession, supply and manufacture of medicinal and other products, except where this has been made legal by the Misuse of Drugs Regulations 1985. This was amended by the Misuse of Drugs Regulations 2001.

These regulations further divide the controlled drugs into five categories or schedules. The schedules are as follows:

• Schedule 1: drugs which may be used illegally and for social enjoyment such as drugs which stimulate hallucinations and a sense of euphoria. These drugs currently have no recognised medicinal uses. They include cannabis, coca leaf, LSD (lysergic acid diethylamide – ‘acid’) and mescaline. Only individuals with a Home Office licence may legally possess schedule 1 drugs for use in medical research.
  
• Schedule 2: drugs which may become addictive, for example, pethidine, diamorphine and morphine.
  
• Schedule 3: some barbiturates and pentazocine.
  
• Schedule 4: the benzodiazepine tranquillisers, for example, diazepam, nitrazepam and temazepam. Midwives may administer these drugs to help women sleep or relax during pregnancy or following childbirth.
  
• Schedule 5: medicines which may contain a small amount of a controlled drug, for example, certain pain-relieving drugs and cough mixtures.

Issues in the handling of controlled drugs

Supply

Community midwives or independent midwives may sometimes want to obtain a supply of a controlled drug such as pethidine for use at a homebirth. Legislation surrounding this is in accordance with the Prescription Only Medicine (Human Use) Order 1997. The midwife will need to obtain a Midwives Supply Order form from a supervisor of midwives ( SOM). This order must be in writing, including the full name and occupation of the individual requesting the drug; it must state the purpose for which the drug is intended and include the total quantity of the drug to be obtained. As well as these details, it might be helpful for audit purposes for the midwife’s NMC personal identification number (PIN) to be included as well as the contact details of the SOM and the name of the woman for whom the drug is to be administered.

The controlled drug is then supplied to the midwife by a pharmacist for use in her own professional practice only. In other words, it cannot be given to another midwife or healthcare practitioner to administer (NMC 2005a). The pharmacist should have a prior agreement with the midwife to supply the drug and should have a record of the midwife’s signature.

On providing the drug, the name and amount of the drug supplied and name and address of the supplier should be recorded in the midwife’s drugs book. This should also contain information about the dates the drug was given, the woman’s name and the amount used.

The procedure as described above is intended for use by community-based midwives or independent midwives attending homebirths. Midwives working in NHS hospitals need to comply with local policies and procedures when administering controlled drugs, although it may be decided that they will follow the same procedures as community-based midwives (RCM 2010). In some NHS trusts, a standing order (see p.207) may be signed by a consultant obstetrician and the head of midwifery authorising the administration of controlled drugs by midwives based in the hospital.

For a homebirth, rather than the midwife obtaining a supply of controlled drugs, the woman may obtain a prescription for pethidine from her general practitioner. In this case, the drugs are owned by the woman and she becomes responsible for the destruction or return of any unwanted ampoules.

Storage of controlled drugs

Controlled drugs on schedules 1 and 2 must be kept in a locked cupboard within another non-moveable locked cupboard. Drugs on schedules 3, 4 and 5 do not need to be kept in the controlled drugs cupboard (i.e. double-locked), but should still be locked away.

Administration of a controlled drug

Two people, one of whom is a registered midwife or nurse, are required to check the drug, observe it being given and then sign the controlled drug register.

The recommended procedure is as follows:

• Confirm that the stock of the drug in the cupboard tallies with the drug register total.
  
• Record the woman’s name, amount of drug to be given, date of administration and amount of stock remaining in the drug register.
  
• Check the name, amount and expiry date of the drug.
  
• Draw up the drug if being given by injection and take to the woman.
  
• Confirm her identity by checking her name band or asking her name and date of birth.
  
• Give the drug in the appropriate way and dispose of all equipment.
  
• Sign the drug register, including the time that the drug was actually administered.
  
• Record the name of drug, amount, route, time and date of administration in the appropriate documentation – for example, the prescription sheet and the woman’s notes.

Destruction of unused controlled drugs

If a midwife has obtained a supply of controlled drugs which are no longer needed then she must destroy them, but only in the presence of an authorised person. This procedure is stipulated in the Misuse of Drugs Regulations 1985. An authorised person varies slightly throughout the UK but includes the following:

• A supervisor of midwives
  
• A regional pharmaceutical officer (England)
  
• A pharmaceutical officer of the Welsh Office
  
• A chief administrative pharmaceutical officer of the Health Boards (Scotland)
  
• An inspector appointed by the Department of Health and Social Services (Northern Ireland)
  
• Medical officers (England, Scotland, Wales)
  
• An inspector of the Royal Pharmaceutical Society of Great Britain
  
• A police officer
  
• An inspector of the Home Office drugs branch

A midwife is also permitted to take any unused controlled drugs back to the pharmacist who originally supplied them or to an appropriate medical officer but not to a supervisor of midwives.

If a woman has obtained her own prescription for pethidine, then by law these drugs are her property and she is responsible for destroying any which are not used. She should be advised to destroy the unused drugs, preferably with the midwife in attendance. Alternatively, they can be returned to the pharmacist but this must be done by the woman and not by the midwife acting on her behalf.