The majority of the world’s children do not live in the UK or the USA where legislation supports and encourages the improvement of drug interventions; therefore the world’s most vulnerable children are arguably still at risk. According to Choonara (2008), the majority of the world’s children do not live where they have easy access to child appropriate medicines; within the UK in 2002, it was estimated that 200 million prescriptions for children and adolescents were issued (Costello et al 2004). In spite of these statistics, approximately 50–90% of all medicines administered to children have never been evaluated for use with children (Schaad 2001, European Commission 2002). This has had the effect of children becoming ‘therapeutic orphans’, which has led to the death of some children (Sutcliffe 2003). As a consequence, the European Commission proposed regulation of orphan medicinal products and this was adopted in December 1999 (European Commission 2002).

Within the UK, marketing authorisation is required from the Medicines Control Agency before medicines can be marketed and promoted (Wong et al 2006); however, it is common practice to prescribe unlicenced medicines (UL), also known as off label medicines (OL), to children; it is not illegal for a doctor to prescribe a medicine with different indicators or to children of different ages (McLay et al 2006, Stephenson 2000, 2001). Prescribing medicines that are off label is necessary when there is no suitable alternative (Watt 2003a). However, this practice of using ‘off label medicines’ is being associated with increased adverse reactions and has also been known to have fatal consequences particularly in neonatal care (Choonara & Conroy 2002). Of all admissions of children to hospital, at least one-third of the child population and 90% of infants in neonatal intensive care units, receive UL or OL drugs (Conroy et al 2000, Stephenson 2001); in primary care approximately 11–33% of prescriptions for children are UL or OL (McIntyre et al 2000). Medicines for Children (RCPCH 2003) is a relatively new formulary that provides practitioners with consensus views on correct dosages for children of all ages and is an important point of reference for all those involved in prescribing medicines to children. Please also note that the British National Formulary for children is an important reference point to use.

With reference to the administration of medicines, there are two key principles of common law, the first of which is the person’s right to self-determination. Griffith et al (2003) cite Lord Goff in Airdale NHS Trust v Bland [1993] and maintain that self-determination requires healthcare professionals to respect the wishes of patients and carers. The second principle involves the practitioner’s responsibility when administering medicines in any environment. A medicine that does have a product licence would be deemed to be unlicensed if, for example, tablets are crushed or capsules are opened, in which case the practitioner must be able to justify the reasons why this was done and may find themselves personally liable if harm comes to those receiving the medicine (Griffith et al 2003).

What is a medicine?

A medicinal product may be defined as any substance or combination of substances presented for treating or preventing disease in human beings or animals (Article 1.2 EC Directive 65/65 cited by the Crown Report, DoH 1999, p 79).

Within the Medicines Act (1968, section 130), there are three legal categories in which medicines can be grouped: according to potency, potential adverse effects and the need for the supply of some medicines to be professionally supervised (Crown Report, DoH 1999).

• POM: prescription only medicines – This group of medicines is sold or supplied with the signed authorisation of an ‘appropriate practitioner’; this may be a doctor, dentist or, in some instances, a nurse prescriber. These medicines must be supplied by or under the supervision of a pharmacist.

• P: pharmacy medicines – These medicines must be supplied or sold by or under the supervision of a pharmacist on registered premises.

• GSL: general sales list medicines – These can be supplied and purchased directly by members of the public at ‘any lockable business premises’.

GUIDELINES FOR ADMINISTERING MEDICINES TO CHILDREN

The National Service Framework for Children (DoH 2003) clearly states that the administration of medicines to children must be based on the best available evidence to underpin practice. The NMC Standards for Medicine Management (NMC 2008a) clearly indicate that it is not a rule book to be adhered to, covering all potential situations that may be encountered in practice; instead it is a set of guiding principles that must be used in conjunction with local trust/hospital policy (DoH 2003), thereby attempting to reduce the potential for errors in the administration of medicines (Watt 2003b). Standard 18 of the NMC (2008a) Standards for Medicine Management clearly states: Students must never administer/supply medicinal products without direct supervision.

The Standards for Medicine Management (NMC 2008a) must be used in conjunction with local trust/hospital policies on how to administer and who can administer medicines, as policies and protocols will vary to meet local needs. The NMC (2008a) requires that the registered nurse or midwife be able to administer medicines in a way that is technically safe and that they should also be able to contribute to any decisions regarding the prescription in a clinically competent and professional manner. Nurses are accountable for the drugs that they administer; therefore a prerequisite must be knowledge about drug actions, side-effects and dosages of any drugs that are administered to the child (Standard 8 of the Standards for Medicine Management, NMC 2008a). Kaushal et al (2001) suggest that Adverse Drug Events (ADEs) in children may be more common than had been originally thought; Ghaleb et al (2005) suggest that this is because what constitutes ‘administering children’s medications’ is difficult to define.

Watt (2003b) identified the five ‘Cs’ as important principles to ensure the safe administration of medicines to all children:

To administer medication safely, the nurse must ensure that:

• The correct child receives the medication. The identity of the child must be checked. Name bands are used. However, if a parent is available, confirmation of identity by them is a useful resource. If in doubt, ask, because you may encounter children with similar names, or children from multiple births and potentially the patient can be confused with another child if engaging in activities on the ward or play room.

• The correct medicine must be given to the child. Hand-written prescriptions must be clear and unambiguous; in addition the label on the medicine to be dispensed must have guidelines that are also clear and easy to follow. There are times when seeing a drug written on a prescription may be assumed to be one thing when, in fact, it is something else (e.g. ceftazidime, cefotaxime). The nurse must be clear and understand exactly what is to be dispensed; if there is any element of doubt, the doctor must rewrite the prescription in a clear and legible manner. It is also important that the expiry dates on all medicines are checked for each drug, every time they are given.

• The correct dose must be given to the child. It is important that nurses ensure that the child receives the correct dose of medication; if in doubt there are numerous formularies to refer to, including Medicines for Children (RCPCH 2003) and the latest British National Formulary for children. The NMC (2008b) position is clear in that nurses must check the dose to be given. This requires numeracy skills that are not dependent upon the use of a calculator; relying on a calculator and a formula is not sufficient. If there is any element of doubt, stop – do not give the medicine. Check with the doctor and pharmacist and read the appropriate drug information. Where there is more than one checker, calculations need to be completed independently and you should not feel intimidated if you arrive at different answers; check again separately and then with a third person if necessary (Watt 2003b). It is possible to administer an overdose if you do not understand the difference between milligrams (mg) and micrograms (μg). It is important to request that prescriptions are written out in full and abbreviations are not used, as this helps to avoid such confusion.

• The correct time. It is important that the medicine is given at the correct time; in some instances therapeutic doses need to be maintained. The NMC guidelines (2008b) state that when administering medicines, the checking of the route of administration as well as the time that the medicine is given are important parts of the process. Therefore all medicines that are administered must be an integral part of caring for the child and family and considered within the context of the child’s current condition and other treatments that the child may be receiving. If there is any doubt that a dose has already been given but there is no evidence to indicate that the medicine has been administered, do not repeat the dose, but check with the person concerned and inform the doctor and ward manager. All events and actions taken must be documented in the nursing records (Watt 2003b).

• The correct route. Ensuring that the medicine is administered by the correct route is fundamental to the NMC’s principles, which clearly indicate that nurses must consider the method of administration and its appropriateness and that the instructions written by the doctor match the information written on the medicine label (Dimond 2003b). If there are discrepancies, the doctor and pharmacist need to be alerted to the situation and this action documented in the child’s nursing care records.

Record-keeping

Good record-keeping should be regarded as an important part of the process of administering medicines (NMC 2007b; see also local trust/hospital policies). It is the duty of the nurse administering the medicine to ensure that a record is made of the dose administered, the time given, the drug given and the administration route (Dimond 2003c). In the event of an error in medication administration being noted, it is important to follow trust policies for such an event; this usually includes ensuring the child is safe, informing the ward manager, doctor, parent and child. If appropriate, an incident form must be completed and the error documented in the patient’s notes (Watt 2003b). Dimond (2003c) acknowledges that there is a danger that if a mistake is made by a nurse, they will not acknowledge that it has happened for fear of reprisals. In the event that an error in administration of a medicine occurs, the NMC’s position is very clear in terms of advice to practitioners: What is important to recognise is that in the event that you do make an error in medicine administration, you must report it immediately to your line manager or employer (NMC 2008a). For individuals to admit when mistakes have been made, employers need to facilitate an open culture and one in which individuals are not fearful of reprisals. The NMC (2008b) is supportive of critical incident panels as a forum in which lessons can be learnt and improvements made to local practice, in light of such incidents (Dimond 2003c). As Dimond (2003c, p 761) highlights:

The NMC takes great care to distinguish between those cases where the error was the result of reckless or incompetent practice or was concealed, and those that resulted from other causes, such as serious pressure of work, and where there was immediate, honest disclosure in the patient’s interest.

Employers should therefore be encouraging a work culture in which it is considered to be normal working practice to challenge and question all members of the healthcare team, irrespective of who or what they do as a member of that team.

Storage of medicines

The manufacturers of medicines will usually indicate the type of storage conditions required, for example avoid sunlight or store at low temperatures, to ensure that drugs do not lose therapeutic effectiveness. There are legal obligations that each trust or care setting must adhere to as in cases where the manufacturer of a medicine is not known then the last person in the supply chain will be deemed to be the manufacturer and can be held liable for any damages against the person (Griffith et al 2003). It is essential that all trusts/hospitals/care settings where medicines are administered keep accurate details of all supplies of medicines and ensure that they are securely stored (Griffith et al 2003).

The storage of all medicines is subject to legal requirements and statutory instruments (Dimond 2003a) and to local trust/hospital policies; therefore all practitioners working within a trust are responsible for familiarising themselves with those policies. These will include the following guiding principles, as adapted from Griffith et al (2003):

• Medicines should be stored and assembled in temperatures that remain below 25°C

• Medicines for taking orally (by mouth) should be stored in a locked trolley, cupboard or room

• All controlled drugs must be stored in a locked cabinet

• A locked refrigerator must be employed for the exclusive use of storing medicines and should have a thermometer to monitor the temperature on a daily basis.

Self-administration of medicines

The NHS Plan (DoH 2000) has, as a central theme, the importance of empowering patients to take an active role in their own care. The Audit Commission (2001) clearly indicates that patients are given the opportunity to learn about and take responsibility for their own medicines. Self-administration of medicines is not a new concept within the realms of adult care (DoH 2000), with many parts of the UK fully embracing this as everyday practice. However, self-administration in children’s nursing is a less established practice. Wright et al (2002) maintain that the role of the nurse in terms of administering medicines to children is not that of a ‘traditional role of administering’; adversely, it is now becoming a role that involves children and families managing their own medicines, with nurses focusing on education and facilitation of the child and family.

Nurse prescribing

To date, doctors, dentists and certain nurses are legally authorised to prescribe medicines. The Crown Report (DoH 1999) recommended the further development of the prescribing role and The NHS Plan (DoH 2000) highlighted that the prescribing of medicines and treatments is a key role for nurses. The Crown Report (DoH 1999) also identified that there needs to be training for the preparation of specific practitioners and needs to include Children’s Nurses (Dimond 2003d, Hutchinson & Hall 2003, NMC 2006, Pontin & Jones 2007).

Gibson et al (2003) have been able to demonstrate how nurse prescribing can be seen as a means of improving care delivery to children and families, and the expansion of the role of the clinical nurse specialist (CNS) as a ‘logical development’ in the expanding role of nurses. While it is anticipated that nurses are the most likely group of healthcare professionals to develop prescribing skills, it is also important to note that other health professionals such as physiotherapists may be accommodated within the legislation in the future (Dimond 2003d).

Developmental issues for consideration

As students, you will be constantly reminded of the fact that children are not ‘mini adults’. This is a complex phenomenon that includes social, cultural, ethnic, biological and physiological differences, which all impact on the ways in which children understand and make sense of their world and communicate with others. Therefore, gaining the child’s trust and cooperation to effectively and safely administer medicines requires a sound understanding of the forces at play. There is an abundance of literature that explains the developmental progression of the infant through to adolescence, and this work has provided the basis for researchers to explore how children understand their bodies, health, illness and the experiences of being in hospital.

There is a growing body of evidence that explores children’s knowledge and attitudes towards medication (Hämeen-Anttila et al 2006). Hämeen et al (2006) found that children’s understanding of medicines and related topics increased and became more complex with chronological development; therefore when children are being given medications, it is important that they are offered an explanation/education that not only reflects chronological development but also takes into account cognitive development (Hämeen-Anttila et al 2006). Preparation of children for any procedure is vital; this includes the giving of medicines and remembering to assess the child’s understanding (Hämeen-Anttila et al 2006). By communicating effectively and getting to know the children and families that you are involved in caring for will begin to gain their trust, understanding and cooperation, not only when administering medicines but in all other aspects of care.

Routes of administration

The administration of medicines to children is frequently an aspect of nursing care that causes concern for the child, family and nurse. Medicines may vary in form and are given by a range of routes (see Table 42.1). The child’s dignity, individuality and understanding need to be paramount when giving medicines (NMC 2008a, Standard 8), and whenever possible the family needs to be fully involved to reduce any trauma experienced by the child (Duff 2003). Additional consideration needs to be paid by the children’s nurse to the individual child’s cognitive development, communication and understanding throughout the whole procedure.

Table 42.1 Medication administration routes

Route	Form
Gastric tube (via naso/oropharyngeal/direct)	Solutions, suspensions, syrups, elixirs, emulsions, oils
Inhaled (into the lung)	Compressed air nebulisers, metered dose inhalers, powder devices, sterile liquids
Injected:
Subcutaneous (under the skin)	Dependent on route: aqueous solutions, suspensions, lipid (fat) solutions, dilutions
Intramuscular (into the muscle)
Intravenous (into the vein)
Intrathecal (into the cerebrospinal fluid)
Intraosseous (into the bone)
Arterially (into the artery)
Intra-aural (into the ear)	Solutions, suspensions, drops
Intraocular (into the eye)	Solutions, suspensions, drops, ointments
Intravaginal (into the vagina)	Pessaries, liquids, solutions, ointments, creams, lotions
Nasally (into the nose)	Solutions, suspensions, drops, ointments, sprays
Orally (by mouth)	Liquid: solutions, suspensions, syrups, elixirs, emulsions, oils Solid: tablets, capsules, granules, lozenges, beads
Rectally (into the rectum)	Enemas, aqueous solutions, suspensions, oils, suppositories, ointments
Sublingual (beneath the tongue)	Capsules, beads, granules, tablets, drops
Topically (onto the skin)	Solutions, suspensions, ointments, sprays, creams, lotions, pastes, powders, shampoos, soaps, liquids

Adapted from Royal College of Paediatrics and Child Health 1999.

Principles of medicine administration

When administering any medicine to a child, certain key principles apply regardless of route. It is also important to note that in some hospitals/trusts the local policy will require two people to check all medicines given.

For all routes, the following key aspects of technique/method apply:

• Full explanations need to be given to the child and family, prior to and during the procedure, which outline the ideal positioning, action to be taken and reason for the administration of the medication. It is also important that the nurse is honest about how the medication is to be given, including the possibility of pain, and any after-effects that may be experienced.

• Education of the child and family and the sharing of information are important roles which are the nurse’s responsibility (NMC 2008b).

• Prior to any intervention, the nurse should undertake a thorough hand wash and wear gloves to reduce the possibility of cross-contamination and recurrent exposure to the medication.

• The medication should be prepared according to the manufacturer’s instructions and checked in accordance with the NMC Standards of Medicine Management (2008a) and individual NHS trust guidelines.

• All contaminated equipment should be disposed of immediately following the procedure.

• Following any intervention, the nurse should undertake a thorough hand wash to reduce the possibility of cross-contamination.

• The administration of medication, and site of injection where applicable, should be recorded in the child’s health records (i.e. drug chart) (NMC 2007b).

• The child must be monitored following medication administration to ensure recognition of any reaction to the medication and prompt treatment to deal with this.

ORAL MEDICATION

In children, the most common route for administration of medicines is the oral route, i.e. medication administered by mouth. Most medications come in a choice of tablet or suspension form, and there are frequently a number of different strengths and flavours. If suspensions are unavailable, tablets can be crushed and mixed with sterile water, using a tablet crusher; however, advice should be sought from the pharmacist about whether such methods are suitable and which diluents are appropriate.

Some suspensions have a high sugar content, or the medication itself can cause damage to gums and teeth if used over a prolonged period (e.g. phenytoin); rinsing the mouth with water after administration and good oral hygiene are essential. Some tablets cannot be crushed or dissolved, for example those with enteric coating, or slow-release tablets. Care should be taken if dividing tablets to ensure as accurate a dose as possible. Medicines can be administered by spoon, syringe or cup; however, when using a syringe care must be taken not to force the syringe into the mouth or between the teeth, as trauma can result and the action may have the potential to trigger an oral aversion in the child. Oral syringes are available with connectors that cannot be fitted to intravenous equipment, thus making the risk of administering oral drugs through the intravenous route less likely.

TECHNIQUE

When administering oral medications, solutions should be shaken before use and measured into an appropriate container at eye level and on a solid flat surface, or drawn up into a syringe to ensure accurate medication volume measurement. Advice should be sought from the pharmacist when tablets need to be cut or crushed. Following the administration of the medication, the child needs to be observed closely for any signs of aspiration or choking.

Young infants

The young infant is likely to have a strong attachment to a parent and may become anxious with a ‘stranger’. The nurse’s role is to encourage parental involvement, provide positive reinforcement and promote sensory soothing measures (i.e. cuddling and stroking the infant) throughout the procedure (Watt 2003b).

• Ask the parent to hold the infant firmly on their lap in a semi-reclining position

• Encourage the infant to open their mouth, and place the syringe onto their tongue

• Gently introduce the suspension into the infant’s mouth

• Depressing the infant’s tongue slightly with the syringe or gently stroking their cheek and under the chin will encourage the sucking and swallowing reflex and aid administration of the medication

• Record the medication administration in the child’s health records (i.e. drug chart) (NMC 2007b, 2008a).

Toddlers

As a toddler, the child is considered to be developing autonomy and striving for independence (Watt 2003b). Characteristically, the toddler will need clear instructions and a firm direct approach. The toddler is likely to have a strong bond with their parents but may be interested in exploring new tastes and sensations; therefore, whenever possible, allow the child to participate and take the medication independently. Promote the full involvement of the parents and the use of positive reinforcement, encouragement and praise. Toddlers can be encouraged through play and fun; however, medications should not be disguised in a drink, such as a milk shake, as the full volume may not be taken and the child may feel betrayed if they discover the deception, and refuse to drink at all.

Older children

Older children need to be encouraged to participate fully in the administration of medicines. The sharing of information, communication and encouragement will encourage the child to cooperate fully and self-administer the oral medication. Children learn to swallow tablets at different ages, and this does require some coordination, but learning to swallow tablets is a skill worth encouraging, as tablets can be far easier to swallow and taste less bitter than suspensions. Swallowing tablets can also represent a welcome sign of growing up and learning new skills, especially important for children with chronic illness who may struggle to attain any independence.

NASOGASTRIC, OROGASTRIC OR GASTROSTOMY MEDICATION

Medication administration via the nasogastric, orogastric or gastrostomy route is directly into the stomach via a tube (see Ch. 40). For the child who has an indwelling tube placed directly into the stomach, medications may be prescribed via this route instead of orally. However, there are a number of precautions associated with this route.

GUIDELINES AND PRECAUTIONS

• Always check for correct placement of the tube.

• Always monitor the child for any sign of aspiration, distress or deterioration.

• Use an elixir or suspension preparation of the medication.

• Avoid the use of tablets whenever possible.

• If using tablets, crush to a fine powder and mix with sterile water.

• Never crush enteric-coated or sustained-release tablets.

• Avoid the use of fat/lipid-based medicines, as they tend to cling to the sides of the tube.

• Do not mix any medication with another solution, as interactions may occur (check with a pharmacist for compatibility).

• Administer medications at room temperature.

• Flush the tube with (sterile) water between medications and following use (utilise a flush volume appropriate to the size of the child and length/gauge of the tube) to avoid blockages and medication interactions.

• Record the medication administration in the child’s health records (i.e. drug chart) (NMC 2007b, 2008a).

INTRAVENOUS MEDICATION

While there is a requirement that prior to registration a student nurse will have been involved in the monitoring and assessment of children receiving intravenous fluids (NMC 2007a), the administration of intravenous medication is a role that requires the completion and assessment competence after registration in line with local trust policy. Intravenous (i.v.) medication (administered directly into the vein) may be given by intermittent bolus injection, continuous or intermittent infusion, or via peripheral or central access devices (see Chs 34 and 41). The choice of technique will depend on the pharmacological characteristics of the medication (half-life, preferred plasma levels) and the lifestyle of the child (e.g. intermittent bolus injections may be preferable to continuous infusion in children who are at school).

Intravenous medication has the following benefits:

• It can sustain high plasma drug levels

• It can be used in an emergency when a child cannot swallow, and will have an immediate effect

• The drug will reach the ‘target’ rapidly when transported in the bloodstream

• The drug can be absorbed if gastrointestinal absorption is impossible

• It requires fewer needles than other forms of injection as it uses an in situ cannula, and is therefore less traumatic

• The intravenous route is the preferred route if the child is critically ill.

However, intravenous medication also carries with it the following potential complications:

• Anaphylaxis

• Once injected, reversal is almost impossible unless an antidote exists

• Contamination: microorganisms, foreign matter (e.g. latex from a rubber bung, drug precipitate)

• Extravasation (or ‘tissuing’, as the vein walls break down)