Chapter 15: Medicines optimization: ensuring quality and safety
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Enteral (oral) administration
Definition
Enteral (oral) medication is taken by mouth – that is, it is swallowed by the patient (e.g. liquid, tablets or capsules; Merck [200]) or administered via a feeding tube (e.g. nasogastric tube or percutaneous endoscopic gastrostomy) (Potter and Perry [289]) (Figure 15.5).
Oral administration is the most convenient route for medicine administration and may result in high levels of compliance (Kelly and Wright [152]). It is usually the safest and least expensive route. Due to the widespread use of oral drugs, they are prepared in a variety of dosage forms.
Related theory
Solid dosage forms
Tablets
Tablets come in a great variety of shapes, sizes, colours and types. The formulation may be very simple (a plain white uncoated tablet) or complex (designed with specific therapeutic aims, e.g. sustained‐release preparations). Sugar coatings are used to improve appearance and palatability. In cases where the drug is a gastric irritant or is broken down by gastric acid, an enteric coating may be used; this is designed to allow the tablet to remain intact in the stomach and to pass unchanged into the small bowel, where the coating dissolves and the drug is released and absorbed.
Tablets may be formulated specifically to control the rate of release of the drug from the tablet as it passes through the GI tract. Terms such as ‘sustained release’, ‘controlled release’ and ‘modified release’ are used by manufacturers to describe these preparations. Care should be taken with these as different formulations of modified‐release preparations may not be bioequivalent (BNF [25]). These preparations may be prescribed by brand name to ensure the patient gets the same formulation each time (BNF [25]). Tablets may also be formulated specifically to dissolve or disperse readily in water before administration (‘soluble’ or ‘effervescent’). Other tablets are formulated to disperse in the mouth (‘oro‐dispersible’), while others must be chewed. The contents of these are swallowed by the patient after the contents have dispersed. Other tablets are designed to be placed and held under the tongue (‘sublingual’) or placed between the gum and inside of the mouth (‘buccal’). On release, the drug from these formulations is absorbed through the sublingual or buccal mucosa. Unscored or coated tablets should not be crushed or broken, nor should most modified‐release tablets, since this can affect the pharmacokinetic profile of the drug and may result in excessive peak plasma concentrations and side‐effects (Smyth [337]). Advice on whether modified‐release preparations can be split should be sought from a pharmacist.
Capsules
Capsules offer a useful method of formulating drugs that are difficult to make into a tablet or that are particularly unpalatable. Capsules can also be easier for some patients to swallow.
Medicines are formulated in both hard and soft capsule shells. Capsule shells are usually made of gelatine and this may pose a problem for patients who are vegetarian or vegan, as well as some with religious beliefs with regard to products of animal origin. Capsule contents may be solid, liquid or of a paste‐like consistency. The contents do not cause deterioration of the shell. The shell, however, is dissolved by the digestive fluids and the contents are then released. Delayed‐release capsule formulations also exist. Gastro‐resistant capsules are delayed‐release capsules that are intended to resist the gastric fluid and to release their active substance or substances in the intestinal fluid (British Pharmacopoeia [31]).
If for any reason a capsule is unpalatable or the patient is unable to take it, the contents should not routinely be removed from the shell without first seeking advice from a pharmacist. Removing the contents from the capsule could destroy its properties and cause gastric irritation or premature release of the drug into an incompatible pH (Downie et al. [82]).
Lozenges and pastilles
Lozenges and pastilles are solid, single‐dose preparations intended to be sucked to obtain a local or systemic effect to the mouth and/or throat (British Pharmacopoeia [31]).
Oral liquid dosage forms
There are a variety of liquid oral dosage forms, including solutions, suspensions, mixtures, syrups, linctuses, elixirs and emulsions. The nature of the liquid dosage form will depend on the nature of the drug, particularly its solubility and stability (Aulton and Taylor [16]). The nature of the condition being treated will also have some bearing in some circumstances – for example, the use of linctuses for the management of coughs.
Solutions
Oral solutions are swallowed and the drug may exert a local effect on the GI tract or be absorbed into the blood to exert a systemic effect. Solutions can be relatively simple aqueous solutions but to be acceptable they must be palatable to patients and must be of an appropriate viscosity for pouring and palatability. Solutions can contain flavourings, colourings and sweeteners to improve taste; agents to increase viscosity; and preservatives. These are known as ‘excipients’. Some solutions are complex and may require the use of excipients to improve solubility (co‐solvents and surfactants) and/or stability (Aulton and Taylor [16]).
Patients may be allergic to excipients and details of excipients can be found in the summary of product characteristics for the medicine. These are readily available online at https://www.medicines.org.uk/emc.
A few medicines are formulated in non‐aqueous solutions and these may pose adherence challenges due to their palatability.
Suspensions
Suspensions are used where a drug is not water‐soluble but remains as solid particles dispersed throughout a liquid. A suspension will be formulated to ensure that the drug is optimally dispersed (Aulton and Taylor [16]) but this is challenging to achieve and most suspensions settle. It is essential, therefore, to thoroughly shake a suspension to disperse the drug before each use.
Mixtures
Mixtures are usually aqueous preparations, frequently containing more than one active ingredient. They can be in the form of either a solution or a suspension.
Syrups
Syrups are formulations where the active ingredients are dissolved or suspended in an aqueous liquid containing a high proportion of dissolved sugar to form a syrup. The high sugar content acts as a preservative as well as making the medicine more palatable. The sugar content can contribute to dental caries (especially with long‐term medication), and patients should be advised on good dental hygiene (Roberts and Roberts [302]).
Due to long‐term stability problems in water, some liquid medicines are presented as powders or granules for reconstitution before use. The correct amount of water should be added and the medicine discarded after its expiry date. This will frequently be a relatively short period, typically 1–2 weeks.
Linctuses
These are viscous oral liquids that may contain one or more active ingredients; the solution usually contains a high proportion of sucrose. Linctuses are intended for use in the treatment or relief of coughs.
Elixirs
Traditionally elixirs are liquid medicines that contain alcohol as a cosolvent to dissolve the active ingredient. However, not all medicines that contain alcohol are designated as elixirs (Aulton and Taylor [16]).
Emulsions
Emulsions are formulations of two or more liquids that do not normally mix, with the drug usually dissolved in one of the liquids. They contain an emulsifier to produce either small water droplets in oil (water in oil emulsion) or small droplets of oil in water (oil in water emulsion). Like suspensions, oral emulsions must be shaken thoroughly to ensure even dispersion of the active ingredient. Although there some oral emulsions available, the majority of commercially available emulsions are currently for topical or injectable products (Aulton and Taylor [16]).
Evidence‐based approaches
Older observational studies suggest that medication administration errors for oral medicine range from 3% to 8% (Ho et al. [130], Taxis et al. [346]) but the rate has been found to be twice as high in mental health patients who have swallowing difficulties (Haw et al. [122]). However, more recent work suggests the rate of error may be higher; a systematic review of 91 research studies found that the median error rate for medication administration errors (MAEs) was 19.6% (8.6–28.3%) of the total opportunities for error including wrong‐time errors, and 8.0% (5.1–10.9%) without timing errors (Keers et al. [151]). A higher median MAE rate was observed for the intravenous route (53.3% excluding timing errors; 26.6–57.9%) compared to when all administration routes were studied (20.1%; 9.0–24.6%). There was consistency in the types of error reported: wrong time, omission and wrong dosage were among the three most common MAEs. Common medication groups associated with MAEs were those affecting nutrition and blood, the GI system, the cardiovascular system and the central nervous system, and antimicrobials. The MAE rates varied greatly as the research studies used a variety of medication error definitions, data collection methods and settings.
Another review looking primarily at the effects of methodological variations and their effects on MAE rates (McLeod et al. [191]) reviewed 16 studies. Overall, adult MAE rates were 5.6% out of a total of 21,533 non‐intravenous (IV) opportunities for error and 35% of a total of 154 IV opportunities for error. As in the review by Keers et al. ([151]), MAEs were more prevalent in IV compared to non‐IV doses, this time by a factor of five. Including timing errors of ±30 minutes increased the MAE rate from 27% to 69% of 320 IV doses in one study. Five studies were unclear as to whether the denominator included dose omissions; omissions accounted for 0–13% of IV doses and 1.8–5.1% of non‐IV doses.
Swallowing difficulties
Problems occur when patients have an aversion to swallowing tablets, or difficulties in swallowing (Kelly and Wright [152]). When giving medicines to patients with dysphagia, both the patient and the medicine should be reviewed on a regular basis. Guidance has been published by a working group that advocates a multidisciplinary approach (Wright et al. [377]). If patients cannot swallow tablets then licensed liquid or dispersible medications should be considered next (NEWT [226]). If the oral route is not patent then alternative routes should be used.
Covert drug administration
Medicines should only be administered covertly (e.g. by disguising them in food or drink) as part of an agreed management plan, to people who refuse their medication and who are considered to lack mental capacity (RPS [318]); this should be in exceptional circumstances only (CQC [48], Griffith [109]). A pharmacist must be involved in these decisions as adding medication to food or drink can alter its pharmacological properties and thereby affect its performance.
It is vital to meet the requirements of the Mental Capacity Act ([199]) when considering covert drug administration:
- All the relevant circumstances should be considered.
- Is it likely the patient will regain capacity and can treatment be delayed until then?
- As far as is reasonably possible, the patient should be encouraged and assisted in participating in any decision making.
- Decisions regarding life‐sustaining treatments must not be motivated by a desire to hasten death.
- The patient's past and current wishes must be taken into account where available (particularly those written at a time when the patient had capacity).
- The patient's beliefs and values that might have influenced their decision (if they had capacity) should be considered.
- Other factors that might have influenced their decision if they had capacity should be taken into account.
- Where practical, the views of the following should be considered: any person named by the patient to be consulted on such decisions, carers and other people with an interest in the patient's welfare, and any person with lasting power of attorney for the patient.
- What is deemed to be in the patient's best interests must be taken into account.
NICE ([245]) provides guidance on covert administration of medicines in care homes:
The covert administration of medicines should only be used in exceptional circumstances when such a means of administration is judged necessary, in accordance with the Mental Capacity Act [199]. However, once a decision has been made to covertly administer a particular medicine (following an assessment of the capacity of the resident to make a decision regarding their medicines and a best interests meeting), it is also important to consider and plan how the medicine can be covertly administered, whether it is safe to do so and to ensure that need for continued covert administration is regularly reviewed (as capacity can fluctuate over time). Medicines should not be administered covertly until after a best interests meeting has been held. If the situation is urgent, it is acceptable for a less formal discussion to occur between the care home staff, prescriber and family or advocate to make an urgent decision. However, a formal meeting should be arranged as soon as possible. (p.29)
Pre‐procedural considerations
Equipment
Medicine pots
Medicine pots (Figure 15.6) allow a dosage form to be taken from its original container for immediate administration to a patient. The person who removes medication from its original container and places it into a medicine pot must oversee the administration of this medication. This responsibility cannot be transferred to someone else.
Tablet splitters
The practices of crushing, opening and splitting tablets should be avoided wherever possible due to a number of potential factors (RPS [311]):
- risks to healthcare workers and carers due to exposure of toxic or irritant materials
- drug instability, although in most circumstances this is less of an issue if the dosage form is crushed, opened or split immediately before administration
- changes in the pharmacokinetics and/or bioavailability of the drug
- irritation to the patient's GI tract from the drug
- unmasking unpleasant taste.
If the practice is necessary, then commercially available tablet splitters (Figure 15.7) may increase the accuracy of tablet splitting (Verrue et al. [358]). Tablets that are unscored, unusually thick or oddly shaped, sugar coated, enteric coated or modified release are not suitable for splitting. Areas for consideration when using a tablet splitter include the following:
- Can the tablet be split? This must always be discussed with the pharmacy department.
- Does the patient have the manual dexterity to use a tablet splitter when at home?
- Will splitting the tablets affect patient adherence when they are at home? Will the patient skip or double dose rather than split tablets?
- How will the storage of split tablets affect the stability of the tablets? What about the effect of light and air (Marriott and Nation [186])?
Tablet crushers
Tablet crushers (Figure 15.8) can be used when a patient has swallowing difficulties and no alternative dosage form exists. The crushing or splitting of dosage forms will be an unlicensed use of the medicine (unless this form of manipulation is covered by the product's marketing authorization). The Human Medicines Regulations ([133]) state that unlicensed medicines can only be authorized by a prescriber, so if tablets are going to be crushed, there should be discussion and agreement between the prescriber and the person who will administer the medicine. Discussion should also take place with a pharmacist to check that the tablet is suitable for crushing and that the efficacy of the medication will not be changed as a result. Tablets that are enteric coated, sustained release or chewable cannot be crushed. Areas for consideration when crushing a tablet include the following (RPS [311]):
- Can the tablet be crushed? This must always be discussed with the pharmacy department.
- Will crushing make the tablet unpalatable?
- Will crushing the tablet cause any adverse effects for the patient, for example burning of the oral mucosa?
- Will crushing the tablet result in inaccurate dosing (Kelly and Wright [152])?
When a tablet crusher is used, water should be added to the crushed tablet and the resulting solution drawn up using an oral syringe. The crusher should then be rinsed and the process repeated if necessary. Tablet crushers should be rinsed before and after use to prevent cross‐contamination with other medicines (Fair and Proctor [91], Smyth [337]). When a tablet crusher has been used, it should be opened and washed under running water, dried with a tissue and left to air dry on a tissue or paper towel.
Monitored dosage systems and compliance aids
Monitored dosage systems and compliance aids, for example dosette boxes (Figure 15.9), are designed to help patients remember when to take their medication. They can also let carers know whether patients have taken their medication. However, the default approach should be to dispense medicines in their standard packaging, on the assumption that patients can manage their medicines unless indicated otherwise. This is in line with NICE ([241]) guidance stating that monitored dosage systems should be considered as an option to improve adherence on a case‐by‐case basis, and only if there is a specific need to overcome practical problems. This should follow a discussion with the patient to explore possible reasons for nonadherence and the options available to improve adherence, if that is their wish. More recent guidance from NICE ([250]) on managing medicines for adults receiving social care reinforces this with the following recommendation:
Consider using a monitored dosage system only when an assessment by a health professional (for example, a pharmacist) has been carried out, in line with the Equality Act 2010, and a specific need has been identified to support medicines adherence. Take account of the person's needs and preferences, and involve the person and/or their family members or carers and the social care provider in decision‐making. (p.19)
NICE has also produced a quality and productivity case study (NICE [249]), which outlines actions intended to reduce the inappropriate use of monitored dosage systems by ensuring they are only issued on a case‐by‐case basis to address specific practical problems with medicines adherence. The inappropriate use of monitored dosage systems can make patients and carers less familiar with their medicines. The preparation and checking of unnecessary monitored dosage systems creates significant additional workload for hospital pharmacies, which can be reduced.
Therefore, monitored dosage systems should only be initiated in patients where there is a likely benefit and full assessment and consultation have been carried out. The RPS ([313]) reinforces these principles as well as providing guidance for pharmacists and their staff on filling and dispensing these devices.
The following should be considered when using these systems (RPS [313]):
- They can only be used for tablets and capsules.
- Medicines that are susceptible to moisture should not be put in these systems.
- Light‐sensitive medicines should not be put in these systems.
- Medicines that are harmful when handled should not be put in these systems.
- If the patient is on medications that cannot be stored in these systems, precautions should be put in place to ensure that they can cope with two systems.
- If the patient's drug regimen is not stable, consideration should be given to how easy it will be to make changes to the system.
- As‐required medication cannot be placed in these systems.
- These systems are subject to labelling and leaflet legislation so they must always be dispensed by a pharmacy department.
Oral syringes
The BNF for children (BNF [26]) recommends that an oral syringe should be used for accurate measurement and controlled administration of an oral liquid medicine to a child. For adults, the BNF ([25]) recommends that an oral syringe is supplied when oral liquid medicines are prescribed in doses other than multiples of 5 mL. The oral syringe should be marked in 0.5 mL divisions from 1 to 5 mL to measure doses of less than 5 mL (other sizes of oral syringe may also be available). It should be provided with an adaptor and an instruction leaflet. Otherwise, a 5 mL medicine spoon must be used for doses of 5 mL (or multiples thereof).
If a syringe is needed to measure and administer an oral dose, an oral syringe (Figure 15.10) that cannot be attached to intravenous catheters or ports should be used. These syringes are purple in colour. All oral syringes containing oral liquid medicines must usually be labelled by the person who prepared the syringe with the name and strength of the medicine, the time it was prepared and the patient's name. However, labelling is unnecessary if the preparation and administration is one uninterrupted process and the labelled syringe does not leave the hands of the person who prepared it. Only one unlabelled syringe should be handled at any one time (NHS England [230], NPSA [267]).
Specific patient preparation
Before administering oral medication, the nurse should assess for:
- the patient's ability to understand the purpose of the medication being administered
- any medication allergies and hypersensitivities
- nil‐by‐mouth status
- the patient's ability to swallow the form of medication
- the patient's cough and gag reflexes
- any contraindications to oral medications including nausea and vomiting, absence of bowel sounds or reduced peristalsis, nasogastric suctioning, or any circumstance affecting bowel motility or absorption of medication, for example general anaesthesia, GI surgery or inflammatory bowel disease
- any possibility of drug–drug or drug–food interactions
- any pre‐administration assessment for specific medications, for example pulse or blood pressure (Chernecky et al. [39], Perry [281]).
Procedure guideline 15.2
Medication: oral drug administration
Table 15.11 Prevention and resolution (Procedure guideline 15.2)
Problem | Cause | Prevention | Action |
---|---|---|---|
Patient vomits when taking or after taking tablets | Patient suffering from nausea | Administer antiemetics prior to administration of tablets. These may need to be given via the rectal, intramuscular or intravenous routes. | If the patient vomits immediately after swallowing the tablet then it may be given again (potentially after antiemetics). If the patient vomits some time after the tablet is taken, it may depend on the type and frequency of medication as to whether it can be retaken. Ensure that the patient retakes the medication if they can see a whole tablet in the vomit. |
Patient unable to swallow tablets | Patient suffering from dysphagia or has issues swallowing tablets | Ask the pharmacy whether the medication is available in liquid, sublingual, buccal or percutaneous forms ( Barnett and Parmar [18]). | Discuss with the prescriber as to administering the medicine in another form or route. |