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International Journal of Nursing Practice 2015; 21: 125–131
RESEARCH PAPER
Mixing medication into foodstuffs: Identifying the issues for paediatric nurses Gazala Akram MPH PhD Lecturer and Specialist Psychiatric Pharmacist (NHS Greater Glasgow and Clyde), Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, UK
Alex B Mullen PhD Professor of Pharmacy Practice, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, UK
Accepted for publication May 2013 Akram G, Mullen AB. International Journal of Nursing Practice 2015; 21: 125–131 Mixing medication into foodstuffs: Identifying the issues for paediatric nurses Medication is often mixed into soft foods to aid swallowing in children. However, this can alter the physical/chemical properties of the active drug. This study reports on the prevalence of the modification procedure, the nature of foodstuffs routinely used and factors which influence how the procedure is performed by nurses working in the National Health Service in Scotland. Mixed methods were employed encompassing an online self-administered questionnaire and semi-structured interviews. One hundred and eleven nurses participated, of whom 87% had modified medication prior to administration. Fruit juice (diluted and concentrated) and yoghurts were most commonly used. The interviews (i) identified the limitations of the procedure; (ii) explored the decision-making process; and (iii) confirmed the procedure was a last resort. This study intends to address some of the uncertainty surrounding the medicine modification procedure within the paediatric population. Key words: food, medication, modification, nurses, paediatric.
INTRODUCTION Children often struggle with swallowing oral liquid medication because of its unpleasant taste or smell, or because the size of the tablet or capsule is too large to swallow whole. In such instances, the liquid or crushed solid medication is often mixed into a soft food product (e.g. yoghurt or jam) or into a suitable beverage such as diluted juice.1,2 In doing so, the unpleasant taste or smell is masked, and swallowing is made easier. Modification of any oral dosage form can affect the physical or chemical stability of the active drug or alter its
Correspondence: Gazala Akram, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow G4 0RE, UK. Email: [email protected] doi:10.1111/ijn.12222
clinical performance by changing its bioavailability. These changes might result in reduced efficacy or increased toxicity, thereby adversely affecting patient outcomes.3 In hospitals, it is usually the nurse who administers medication which means any modification is also performed by the nurse. In the UK, if the prescriber has not specifically authorized the nurse to modify the dosage form, then legal and professional liability ultimately rests with the nurse.4 Additionally, once a dosage form has been altered, the manufacturer cannot be held liable for any subsequent harm that might occur to the patient.5 The literature on this topic is predominately concerned with the elderly population in hospital or in residential/nursing homes.6–9 In these situations, medicine is often mixed into foodstuffs to conceal it from the patient who might lack mental capacity to consent to treatment. For example, in their © 2013 Wiley Publishing Asia Pty Ltd
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investigation of a 450 bedded psychiatric hospital,7 Stubbs et al. found that 50% of all doses administered (n = 133/ 266) were crushed because the patient regularly spat out or refused to take their medicine. In contrast, within paediatrics, lack of (parental) consent is rarely an issue. Little is known about how nurses caring for children perceive the practice of modifying medicines and also how this is actually performed in practice. The authors had previously conducted a small pilot study10 among a sample of paediatric nurses in mental health (n = 14) and general medicine (n = 16) and found that although the majority (n = 29, 97%) did modify the medication prior to administration, 27% did not feel sufficiently knowledgeable about drug stability issues. The most common foodstuffs into which medicines were mixed included fruit yoghurts, diluted juice and (concentrated) fruit juices. Training issues including more information about drug/food compatibilities and the need for standardized documentation to be used at ward level were also identified. Anecdotal evidence about this practice is widespread, but published information about the practical issues is lacking. This paper reports a mixed method study which set out to determine (i) the prevalence of the modification/mixing procedure; (ii) the nature of foodstuffs routinely used; and (iii) the factors which influence and determine how the procedure is performed in clinical practice. The study was conducted using a sample of qualified nurses working in the National Health Service in Scotland (NHS Scotland).
METHODS Quantitative using a self-administered questionnaire Eligible participants were ‘all registered nurses currently working in Scotland who administer medicine to children as part of their professional duties’. The questionnaire was hosted via Survey Monkey (an online survey resource) during July and August 2012. Details of the study and invitation for participation were advertised to nurses in the proceeding weeks via two professional bodies: the Royal College of Nursing and the Scottish Practice Nurses Association. Invitations for participation were also circulated to the Nursing Directors across each of the 14 Scottish Health Board areas. The semi-structured questionnaire which had been developed for the previous study10 was reused but modified slightly with some previously closed questions now using a Likert-type index for agreement. Face and content validity of the modified questionnaire were determined by a Practice Development © 2013 Wiley Publishing Asia Pty Ltd
nurse, a staff nurse, two nursing managers and a senior paediatric clinical pharmacist. All had between 5 and 15 years experience of working with children. Minor changes to more accurately identity nursing grades and job titles were made as a consequence.
Qualitative using semi-structured interviews Respondents to the questionnaire were given the option of providing their contact details (email or telephone) if they were agreeable to be contacted by the research team, so as to take part in a telephone interview. Prior to the interviews, respondents were given an information sheet detailing the aims of the interview study and a consent form which was signed by all interviewees. Advice concerning ethics approval was sought from the University of Strathclyde Research and Development personnel. It was advised that as the study was an investigation into current nursing practice (i.e. service evaluation) and did not involve direct patient contact, ethics approval was deemed unnecessary.
RESULTS Quantitative A total of 111 nurses responded to the questionnaire. There are approximately 2800 nurses who work predominately with children within NHS Scotland. The response rate to the study was therefore 4% of eligible nurses. Table 1 provides a breakdown of respondent demographics. The majority of respondents were paediatric staff nurses with > 10 years of experience. Eighty-seven per cent of the sample had modified medication prior to administration to a child patient.
Frequency and nature of modification Overall, medication appears to be modified to better suit the needs of the child, rather than as a method to ensure total compliance with the prescribed regime. Nevertheless, a number of nurses (n = 24) did report to ‘sometimes’ and ‘very often’ concealing the medicine (Table 2). Adding medication to the foodstuff, as opposed to adding foodstuff to the medicine, appears to be the most common manner of mixing. Figure 1 illustrates the most common foodstuffs into which medicines are mixed: fruit juice (diluted and concentrated) and yoghurts (adult type, e.g. Ski, Surrey, UK; those which are marketed directly at children, e.g. Petit Filous, Surrey, UK) are used most
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127
Table 1 Sample demographics (n = 111) Job title
Clinical speciality
Length of time working with children
Nurse prescriber Have you EVER modified a medicine by mixing in foodstuff prior to administration?
Senior charge nurse Charge nurse Senior staff nurse Staff nurse Others (nurse practitioners; specialist nurses in respiratory, community medicine, neonates and cancer) Paediatrics General medicine Learning disability/mental health Midwifery Other < 1 year 2–5 years 6–10 years > 10 years Yes No Yes No
10 (9) 6 (5) 4 (4) 56 (50) 35 (31) 94 (85) 7 (6.5) 5 (4.5) 4 (3.5) 1 (0.5) 6 (5) 13 (12) 14 (13) 78 (70) 20 (18) 91 (82) 97 (87) 14 (13)
The last column refers to n (%).
Table 2 Frequency and nature of modification procedure Question
n†
Never (%)
Rarely (%)
Sometimes (%)
In past 3 months, have you modified any medicine? Potential reasons The tablet/capsule is too large for the patient to swallow whole To disguise the sour or bitter taste of the medicine The patient will not accept the medicine as a whole tablet/capsule To disguise/conceal the medicine from the patient Nature of modification Have you crushed or opened the tablet/capsule and given the medicine as a powder? Have you crushed or opened the tablet/capsule and mixed the medicine into juice (drink)? Have you crushed or opened the tablet/capsule and mixed the medicine into food (e.g. yoghurt)? Have you added juice to a spoonful of liquid medicine? Have you added some soft food (i.e. yoghurt) to a spoonful of liquid medicine?
78
16 (20)
28 (36)
22 (28)
6 (8)
6 (8)
69 74 71 73
10 (15) 7 (10) 8 (11) 25 (34)
17 (25) 16 (22) 12 (17) 24 (33)
25 (36) 24 (32) 31 (44) 20 (28)
12 (17) 21 (28) 13 (18) 0
5 (7) 6 (8) 7 (10) 4 (5)
73
21 (29)
21 (29)
20 (27)
6 (8)
5 (7)
74
17 (23)
23 (31)
21 (28)
9 (12)
4 (5)
74
13 (18)
24 (32)
23 (31)
12 (16)
2 (3)
76 71
25 (33) 32 (45)
19 (25) 17 (24)
22 (29) 15 (21)
4 (5) 3 (4)
6 (8) 4 (6)
†
Often (%)
Very often (%)
Not all respondents answered every question (numbers ranged from 69 to 78).
© 2013 Wiley Publishing Asia Pty Ltd
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Limitations of procedure The majority of nurses explicitly stated their concerns regarding the effectiveness of the medication once it had been modified and of the likelihood that not all of the dose was actually being administered or taken. [Y]ou don’t know what your adding-if it has an effect on it, will it stop absorption, will it increase absorption, does it mix properly? This concerns me a bit. (#2) [Y]ou make it in as small amounts as possible, make sure they drink it, I would put some juice in the cup again and make them drink it again, to make sure they get the whole lot. (#3) Figure 1. Foodstuffs commonly used in modification procedure. ( ) milk, ( ) fruit juice (including diluted), ( ) soft drinks, ( ) jam, ( ) yoghurt, ( ) crushed fruit and ( ) others.
often. Jams and milk, alongside chocolate spreads and peanut butter which are represented under ‘other’, are also routinely used.
Clinical practice Information detailing the transparency of the modification procedure and whether it is performed in accordance with written or set criteria was also collected (Table 3). The data show that although not all admixing procedures for medicines are explicitly detailed in nursing care plans or on the actual prescription (kardex), there is some, albeit a small amount of record keeping and accountability.
Qualitative Interviews were conducted until saturation was reached. Nine female nurses of various grades and experience were interviewed using a semi-structured interview schedule. Each interview lasted ≈ 30–40 min and was audio recorded. Each recording was transcribed verbatim. The transcripts were read several times by both authors allowing familiarity with the dataset and to capture key concepts to begin building a thematic framework. For each transcript, similar words and phrases were colour coded, enabling categories to be developed and refined until comprehensive themes were established.11,12 NVivo software Version 10 (QSR International, Cheshire, UK) was used to aid the analysis (Table 4). Three main themes emerged from the data. Each theme is discussed in detail with participant quotes to illustrate the issue. © 2013 Wiley Publishing Asia Pty Ltd
Decision making All the interviewees stressed that the decision to modify was not made in isolation by the nursing staff but in consultation with the wider care team and often at the suggestion of the child’s parents. It was not uncommon for parents to directly advise staff at the start of a treatment regime as to whether it would require modification. Parents would often pre-empt how their child would react to a particular presentation of medicine. It was felt important for nurses to actively engage the parents, particularly when treatment would need to be continued after discharge. [E]ven the parents suggest what to put it in, like ice cream, or yoghurt or . . . put it in bottles they drink their juice out of. (#9) [I]t’s always the decision that’s made with the parents because these children have to go home and take the antibiotics at home . . . so it needs to be. (#1) The same nurse also highlighted a situation where parental involvement could actually be counter productive. An occasion had arisen where a parent had inadvertently used language that could potentially create barriers between the nurse and the child and hence further exacerbate the medicine administration process. It’s that what makes our job harder . . . it’s not (the administering) the medicine, it’s trying to get through to the parents the importance of being able to take the medicine . . . the importance of what vocabulary they use in front of the children . . . some of the parents just stand there and one of them is . . . oh here’s that bad nurse coming to give you you’re medicine again. (#1)
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Table 3 Transparency of modification procedure Question asked
n
Never (%) Rarely (%) Sometimes (%) Often (%) Always (%)
When you administer the medicine in this way, is the patient 78 2 (2) aware that their medicine is mixed into the foodstuff? Is the procedure of mixing medicine into the foodstuff ‘care 78 13 (17) planned’ in the nursing notes? Is the requirement of mixing the medicine into the foodstuff 78 24 (31) explicitly mentioned in the prescription (kardex)?
10 (13)
40 (51)
13 (17)
13 (17)
23 (29)
21 (27)
7 (9)
14 (18)
22 (28)
13 (17)
9 (11)
10 (13)
Table 4 Interviewee profile Respondent
Job title
Speciality
Number of years working with children
#1 #2 #3 #4 #5 #6 #7 #8 #9
Charge nurse Nurse specialist Senior charge nurse Senior staff nurse Nurse specialist Staff nurse Nurse specialist Nurse specialist Charge nurse
Paediatrics Paediatrics Paediatrics Paediatrics General medicine General medicine Paediatrics Paediatrics Paediatrics
> 10 years > 10 years > 10 years 6–10 years 6–10 years 6–10 years > 10 years > 10 years > 10 years
All the interviewees discussed how the decision to modify the medicine was approached and finally implemented. [T]he nurses would try various methods and report that to the doctor. If that failed, there would be discussions with the doctors and the pharmacists, discuss alternatives to the medicine or different types, liquids, powders, alternatives- one that was more palatable. (#9) [I]f we’re still unable to get the child to take it, then we contact pharmacy and the doctors who have a chat with pharmacy and decide what the best step forward is. (#4) The pharmacist was repeatedly mentioned as important source of information regarding the procedure and subsequent stability or other physical or chemical properties. Nurses appeared to turn to ‘pharmacy’ as a source of reassurance to almost authenticate the practice. I wouldn’t modify the medication unless I discuss it with pharmacy first- we’ve got a really good pharmacist and I’d
phone for advice first and I know a lot of the others would do that as well. (#6) [O]ur pharmacist advises us and gives information, so tells us if we should open or not. (#2)
Last resort Even though the modification procedure appeared to have an element of acceptability, almost all the interviewees (n = 8) mentioned that it was only largely carried out when there was no other alternative. I am aware that it’s not good practice and it really shouldn’t be done . . . but it’s a last resort . . . every paediatric ward that you are asking in the country . . . they will do it, I can tell you that right now. (#1) It was also recognized that the practice could potentially have an adverse effect on the child and their future relationship with medication. © 2013 Wiley Publishing Asia Pty Ltd
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The disadvantages are what they teach in nursing school . . . you put the child off its food, if it’s in the baby’s bottle of food . . . Researcher: is that because the associate the taste of the medicine with the milk? Yes, so you’ve given yourself an additional problem- Also if they are old enough, you’re sort of continuing their behaviour; you’re accepting their behaviour of not taking their medication. You end up going along the lines of ‘I’ll do what you say’ rather than try to get them to adopt positive behaviours. (#9) All the interviewees mentioned the ethics of the procedure and were adamant that consent (either from the child and/or the parent) would need to have been established. In the few instances, where medication was given covertly, it was usually in pre-school-aged children or with the parent’s consent only. [Y]ou’ve got to be an advocate . . . and you know at three years old letting a child decide whether they can take an antibiotic or not is absolutely ridiculous and they’re not cognitively able to do that . . . . you can’t let children choose to take antibiotics at three years old. (#1) It’s mixed in with her food . . . as a powder, you empty the capsules and you mix it with the food, if she knew she was getting the medicine added . . . she wouldn’t eat the food. (#5)
DISCUSSION Modification of oral medicine dosage forms by mixing into fruit juices and yoghurts prior to administration appears to be a practice that Scottish nurses working with children are familiar with. However, given the relatively poor response to the online survey, it is difficult to accurately define the true extent and prevalence of this practice. Nevertheless, it has recently been suggested that it is the representativeness of a sample that gives validity to the findings rather than its size.13 However, despite the variability of our respondent’s demographics, the majority of those completing the questionnaire had considerable experience in paediatric practice and had previously modified a medicine by mixing it with a foodstuff. On this basis, it is likely that the breath of practices described is likely to be reflective of other nurse working practices with children at least in the UK, if not further afield. Within the elderly, the modification literature puts the prevalence of crushing tablets/opening capsules at 346–61%.9 When modification is necessary for administration of medicines to children, only a limited number of foodstuffs © 2013 Wiley Publishing Asia Pty Ltd
appear to be used. Other studies, albeit mainly in the elderly, have found jams to be the preferred medium.7,14 It might be that the high sugar content of jams is seen as a limiting factor for their use in children which might explain why among our sample, fruit juices and yoghurts are preferred. The choice of foodstuff merits further investigation. It is important to determine if decisions are primarily made according to the compatibility of the foodstuff in relation to the medicine that it is being used with or upon other less scientific reasons (e.g. availability, texture, palatability, cost). We found few instances of medication being concealed in the foodstuff. Only two respondents indicated that their patient was unaware that medicine was being mixed into food for administration purposes. This contrasts sharply with the elderly literature. For example, in a UK study of 34 residential nursing and inpatient units caring for people with dementia,9 71% of units reported to sometimes covertly administering medication with food and drinks. Encouragingly, we found evidence of good practice in that 54% of respondents replied in the affirmative that the modification procedure is detailed in the patient’s notes. This number is higher than the 40% reported in a Norwegian study of nursing homes.15 Nevertheless, details of which medicines are mixed into which food stuff and how are more importantly needed at the point of administration and hence should be clearly indicated on the prescription sheet. However, only 41% of our sample reported this to be the case. This is concerning, as too often the prescription sheet might be the only easily accessible written record of the procedure— if it is not accurately detailed, then, there is a high chance of variability between nurses and how the medicine is ultimately delivered. The interview data allowed a more detailed examination of the issues considered most pertinent by the nurses. Although possible changes to the clinical effect of the medicines were recognized, there was acknowledgement that the total dose is also unlikely to be fully administered when admixed with food or beverages. This mirrors previous findings by the authors10 and also by Stubbs et al.7 who noted that spillage and potential loss in the crushing vessel, as well as the patient not eating or drinking the whole portion of foodstuff or beverage respectively, would mean that the ingested dose was smaller than intended. The decision-making process was discussed in much detail. Our interviewees appeared to adhere very closely
Mixing medication into foodstuffs
to the guidance issued to them by their professional body. The Nursing & Midwifery Council is explicit in their advice that the prescriber must give permission to crush the dosage form and that it should be discussed with the prescriber and a pharmacist.16 This contrasts sharply with Treloar et al.8 who found that the decision was often made by the nurse on duty, and only 9% of their respondents had ever consulted a pharmacist about the possibility of crushed tablets interacting with foodstuff. Stubbs et al.7 in their Australian sample also found low levels of authorization (i.e. of 266 tablets crushed or capsules opened, 44% had not been authorized by the prescriber). Again, this should be explored in more detail as it is possible that this aspect more than any other is closely dependent on the relationships between different team members, the availability and extent of (clinical) pharmacy services, and existence of written guidance or protocols. In conclusion, this study attempts to address some of the concern and uncertainty which surround the procedure of modifying medicines and subsequent administration for the paediatric population. It is envisaged that an observation study of nursing practice during the ‘medicines round’ will be carried out. In doing so, we will be better placed to provide guidelines in how best to perform the procedure in a similar manner to those currently available for the elderly.17,18
ACKNOWLEDGEMENTS The authors are grateful to K Tobin for her help with the data collection and all the nurses who participated in the study. The project was supported by a grant from Tenouvus Scotland, UK (grant number S09/2)
REFERENCES 1 Shah T, Tse A, Gill H et al. Administration of melatonin mixed with soft foods and liquids for children with neurodevelopment difficulties. Developmental Medicine and Child Neurology 2008; 50: 845–849. 2 Verrue C, Mehuys E, Boussery K, Remon JP, Petrovic M. Tablet-splitting: A common yet not so innocent practice. Journal of Advanced Nursing 2011; 67: 26–32. 3 Standing J, Tuleu C. Paediatric formulations-Getting to the heart of the problem. International Journal of Pharmaceutics 2005; 300: 56–66.
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4 Wright D. Tablet crushing is a widespread practice but it is not safe and may not be legal. The Pharmaceutical Journal 2002; 269: 132. 5 Griffith R. Tablet crushing and the law. The Pharmaceutical Journal 2003; 271: 90–91. 6 Paradiso L, Cosh D, Barnes L. Crushing or Altering medications: What’s happening in residential aged care facilities? Australasian Journal on Ageing 2002; 21: 123–127. 7 Stubbs J, Haw C, Dickens G. Dose form modification—A common but potentially hazardous practice. A literature review and study of medication administration to older psychiatric inpatients. International Psychogeriatrics 2008; 20: 616–627. 8 Treloar A, Beats B, Philpot M. A pill in the sandwich: Covert medication in food and drink. Journal of the Royal Society of Medicine 2000; 93: 408–411. 9 Wright D. Medication administration in nursing homes. Nursing Standard 2002; 16: 33–38. 10 Akram G, Mullen A. Paediatric nurses knowledge and practice of mixing medication in to foodstuff. The International Journal of Pharmacy Practice 2012; 20: 191–198. 11 Pope C, Ziebland S, Mays N. Qualitative Research in Health Care: Analysing qualitative data. BMJ (Clinical Research Ed.) 2000; 320: 114–116. 12 Richie J, Spencer L. Qualitative data analysis for applied policy research. In: Bryman A, Burgess RG (eds). Analysing Qualitative Data, 1st edn. London: Routledge, 1994; 173– 194. 13 Krosnick J. Survey research. Annual Review of Psychology 1999; 50: 537–567. 14 Nissen M, Haywood A, Steadman K. Solid medication dosage from modification at the bedside and in the pharmacy of Queensland hospitals. Journal of Pharmacy Practice and Research 2009; 39: 129–134. 15 Kirkevold O, Engedal K. Concealment of drugs in food and beverages in nursing homes. British Medical Journal 2005; 330: 20–22. 16 Nursing and Midwifery Council. A to Z Advice Sheet on Medicines Management. London: Nursing & Midwifery Council, 2006. 17 Australian Pharmaceutical Advisory Council. Guidelines for Medication Management in Residential Aged Care, 3rd edn. Canberra: Australian Government Publishing Service, 2002. 18 Wright D. Consensus guidance on the medication management of adults with swallowing difficulties. In: Foord-Kelcey G (ed.). Guidelines—Summarising Clinical Guidelines for Primary Care. Berkhamsted, UK: Medendium Group Publishing Ltd, 2006; 373–376.
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International Journal of Nursing Practice 2015; 21: 125–131
RESEARCH PAPER
Mixing medication into foodstuffs: Identifying the issues for paediatric nurses Gazala Akram MPH PhD Lecturer and Specialist Psychiatric Pharmacist (NHS Greater Glasgow and Clyde), Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, UK
Alex B Mullen PhD Professor of Pharmacy Practice, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, UK
Accepted for publication May 2013 Akram G, Mullen AB. International Journal of Nursing Practice 2015; 21: 125–131 Mixing medication into foodstuffs: Identifying the issues for paediatric nurses Medication is often mixed into soft foods to aid swallowing in children. However, this can alter the physical/chemical properties of the active drug. This study reports on the prevalence of the modification procedure, the nature of foodstuffs routinely used and factors which influence how the procedure is performed by nurses working in the National Health Service in Scotland. Mixed methods were employed encompassing an online self-administered questionnaire and semi-structured interviews. One hundred and eleven nurses participated, of whom 87% had modified medication prior to administration. Fruit juice (diluted and concentrated) and yoghurts were most commonly used. The interviews (i) identified the limitations of the procedure; (ii) explored the decision-making process; and (iii) confirmed the procedure was a last resort. This study intends to address some of the uncertainty surrounding the medicine modification procedure within the paediatric population. Key words: food, medication, modification, nurses, paediatric.
INTRODUCTION Children often struggle with swallowing oral liquid medication because of its unpleasant taste or smell, or because the size of the tablet or capsule is too large to swallow whole. In such instances, the liquid or crushed solid medication is often mixed into a soft food product (e.g. yoghurt or jam) or into a suitable beverage such as diluted juice.1,2 In doing so, the unpleasant taste or smell is masked, and swallowing is made easier. Modification of any oral dosage form can affect the physical or chemical stability of the active drug or alter its
Correspondence: Gazala Akram, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow G4 0RE, UK. Email: [email protected] doi:10.1111/ijn.12222
clinical performance by changing its bioavailability. These changes might result in reduced efficacy or increased toxicity, thereby adversely affecting patient outcomes.3 In hospitals, it is usually the nurse who administers medication which means any modification is also performed by the nurse. In the UK, if the prescriber has not specifically authorized the nurse to modify the dosage form, then legal and professional liability ultimately rests with the nurse.4 Additionally, once a dosage form has been altered, the manufacturer cannot be held liable for any subsequent harm that might occur to the patient.5 The literature on this topic is predominately concerned with the elderly population in hospital or in residential/nursing homes.6–9 In these situations, medicine is often mixed into foodstuffs to conceal it from the patient who might lack mental capacity to consent to treatment. For example, in their © 2013 Wiley Publishing Asia Pty Ltd
126
G Akram and AB Mullen
investigation of a 450 bedded psychiatric hospital,7 Stubbs et al. found that 50% of all doses administered (n = 133/ 266) were crushed because the patient regularly spat out or refused to take their medicine. In contrast, within paediatrics, lack of (parental) consent is rarely an issue. Little is known about how nurses caring for children perceive the practice of modifying medicines and also how this is actually performed in practice. The authors had previously conducted a small pilot study10 among a sample of paediatric nurses in mental health (n = 14) and general medicine (n = 16) and found that although the majority (n = 29, 97%) did modify the medication prior to administration, 27% did not feel sufficiently knowledgeable about drug stability issues. The most common foodstuffs into which medicines were mixed included fruit yoghurts, diluted juice and (concentrated) fruit juices. Training issues including more information about drug/food compatibilities and the need for standardized documentation to be used at ward level were also identified. Anecdotal evidence about this practice is widespread, but published information about the practical issues is lacking. This paper reports a mixed method study which set out to determine (i) the prevalence of the modification/mixing procedure; (ii) the nature of foodstuffs routinely used; and (iii) the factors which influence and determine how the procedure is performed in clinical practice. The study was conducted using a sample of qualified nurses working in the National Health Service in Scotland (NHS Scotland).
METHODS Quantitative using a self-administered questionnaire Eligible participants were ‘all registered nurses currently working in Scotland who administer medicine to children as part of their professional duties’. The questionnaire was hosted via Survey Monkey (an online survey resource) during July and August 2012. Details of the study and invitation for participation were advertised to nurses in the proceeding weeks via two professional bodies: the Royal College of Nursing and the Scottish Practice Nurses Association. Invitations for participation were also circulated to the Nursing Directors across each of the 14 Scottish Health Board areas. The semi-structured questionnaire which had been developed for the previous study10 was reused but modified slightly with some previously closed questions now using a Likert-type index for agreement. Face and content validity of the modified questionnaire were determined by a Practice Development © 2013 Wiley Publishing Asia Pty Ltd
nurse, a staff nurse, two nursing managers and a senior paediatric clinical pharmacist. All had between 5 and 15 years experience of working with children. Minor changes to more accurately identity nursing grades and job titles were made as a consequence.
Qualitative using semi-structured interviews Respondents to the questionnaire were given the option of providing their contact details (email or telephone) if they were agreeable to be contacted by the research team, so as to take part in a telephone interview. Prior to the interviews, respondents were given an information sheet detailing the aims of the interview study and a consent form which was signed by all interviewees. Advice concerning ethics approval was sought from the University of Strathclyde Research and Development personnel. It was advised that as the study was an investigation into current nursing practice (i.e. service evaluation) and did not involve direct patient contact, ethics approval was deemed unnecessary.
RESULTS Quantitative A total of 111 nurses responded to the questionnaire. There are approximately 2800 nurses who work predominately with children within NHS Scotland. The response rate to the study was therefore 4% of eligible nurses. Table 1 provides a breakdown of respondent demographics. The majority of respondents were paediatric staff nurses with > 10 years of experience. Eighty-seven per cent of the sample had modified medication prior to administration to a child patient.
Frequency and nature of modification Overall, medication appears to be modified to better suit the needs of the child, rather than as a method to ensure total compliance with the prescribed regime. Nevertheless, a number of nurses (n = 24) did report to ‘sometimes’ and ‘very often’ concealing the medicine (Table 2). Adding medication to the foodstuff, as opposed to adding foodstuff to the medicine, appears to be the most common manner of mixing. Figure 1 illustrates the most common foodstuffs into which medicines are mixed: fruit juice (diluted and concentrated) and yoghurts (adult type, e.g. Ski, Surrey, UK; those which are marketed directly at children, e.g. Petit Filous, Surrey, UK) are used most
Mixing medication into foodstuffs
127
Table 1 Sample demographics (n = 111) Job title
Clinical speciality
Length of time working with children
Nurse prescriber Have you EVER modified a medicine by mixing in foodstuff prior to administration?
Senior charge nurse Charge nurse Senior staff nurse Staff nurse Others (nurse practitioners; specialist nurses in respiratory, community medicine, neonates and cancer) Paediatrics General medicine Learning disability/mental health Midwifery Other < 1 year 2–5 years 6–10 years > 10 years Yes No Yes No
10 (9) 6 (5) 4 (4) 56 (50) 35 (31) 94 (85) 7 (6.5) 5 (4.5) 4 (3.5) 1 (0.5) 6 (5) 13 (12) 14 (13) 78 (70) 20 (18) 91 (82) 97 (87) 14 (13)
The last column refers to n (%).
Table 2 Frequency and nature of modification procedure Question
n†
Never (%)
Rarely (%)
Sometimes (%)
In past 3 months, have you modified any medicine? Potential reasons The tablet/capsule is too large for the patient to swallow whole To disguise the sour or bitter taste of the medicine The patient will not accept the medicine as a whole tablet/capsule To disguise/conceal the medicine from the patient Nature of modification Have you crushed or opened the tablet/capsule and given the medicine as a powder? Have you crushed or opened the tablet/capsule and mixed the medicine into juice (drink)? Have you crushed or opened the tablet/capsule and mixed the medicine into food (e.g. yoghurt)? Have you added juice to a spoonful of liquid medicine? Have you added some soft food (i.e. yoghurt) to a spoonful of liquid medicine?
78
16 (20)
28 (36)
22 (28)
6 (8)
6 (8)
69 74 71 73
10 (15) 7 (10) 8 (11) 25 (34)
17 (25) 16 (22) 12 (17) 24 (33)
25 (36) 24 (32) 31 (44) 20 (28)
12 (17) 21 (28) 13 (18) 0
5 (7) 6 (8) 7 (10) 4 (5)
73
21 (29)
21 (29)
20 (27)
6 (8)
5 (7)
74
17 (23)
23 (31)
21 (28)
9 (12)
4 (5)
74
13 (18)
24 (32)
23 (31)
12 (16)
2 (3)
76 71
25 (33) 32 (45)
19 (25) 17 (24)
22 (29) 15 (21)
4 (5) 3 (4)
6 (8) 4 (6)
†
Often (%)
Very often (%)
Not all respondents answered every question (numbers ranged from 69 to 78).
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Limitations of procedure The majority of nurses explicitly stated their concerns regarding the effectiveness of the medication once it had been modified and of the likelihood that not all of the dose was actually being administered or taken. [Y]ou don’t know what your adding-if it has an effect on it, will it stop absorption, will it increase absorption, does it mix properly? This concerns me a bit. (#2) [Y]ou make it in as small amounts as possible, make sure they drink it, I would put some juice in the cup again and make them drink it again, to make sure they get the whole lot. (#3) Figure 1. Foodstuffs commonly used in modification procedure. ( ) milk, ( ) fruit juice (including diluted), ( ) soft drinks, ( ) jam, ( ) yoghurt, ( ) crushed fruit and ( ) others.
often. Jams and milk, alongside chocolate spreads and peanut butter which are represented under ‘other’, are also routinely used.
Clinical practice Information detailing the transparency of the modification procedure and whether it is performed in accordance with written or set criteria was also collected (Table 3). The data show that although not all admixing procedures for medicines are explicitly detailed in nursing care plans or on the actual prescription (kardex), there is some, albeit a small amount of record keeping and accountability.
Qualitative Interviews were conducted until saturation was reached. Nine female nurses of various grades and experience were interviewed using a semi-structured interview schedule. Each interview lasted ≈ 30–40 min and was audio recorded. Each recording was transcribed verbatim. The transcripts were read several times by both authors allowing familiarity with the dataset and to capture key concepts to begin building a thematic framework. For each transcript, similar words and phrases were colour coded, enabling categories to be developed and refined until comprehensive themes were established.11,12 NVivo software Version 10 (QSR International, Cheshire, UK) was used to aid the analysis (Table 4). Three main themes emerged from the data. Each theme is discussed in detail with participant quotes to illustrate the issue. © 2013 Wiley Publishing Asia Pty Ltd
Decision making All the interviewees stressed that the decision to modify was not made in isolation by the nursing staff but in consultation with the wider care team and often at the suggestion of the child’s parents. It was not uncommon for parents to directly advise staff at the start of a treatment regime as to whether it would require modification. Parents would often pre-empt how their child would react to a particular presentation of medicine. It was felt important for nurses to actively engage the parents, particularly when treatment would need to be continued after discharge. [E]ven the parents suggest what to put it in, like ice cream, or yoghurt or . . . put it in bottles they drink their juice out of. (#9) [I]t’s always the decision that’s made with the parents because these children have to go home and take the antibiotics at home . . . so it needs to be. (#1) The same nurse also highlighted a situation where parental involvement could actually be counter productive. An occasion had arisen where a parent had inadvertently used language that could potentially create barriers between the nurse and the child and hence further exacerbate the medicine administration process. It’s that what makes our job harder . . . it’s not (the administering) the medicine, it’s trying to get through to the parents the importance of being able to take the medicine . . . the importance of what vocabulary they use in front of the children . . . some of the parents just stand there and one of them is . . . oh here’s that bad nurse coming to give you you’re medicine again. (#1)
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Table 3 Transparency of modification procedure Question asked
n
Never (%) Rarely (%) Sometimes (%) Often (%) Always (%)
When you administer the medicine in this way, is the patient 78 2 (2) aware that their medicine is mixed into the foodstuff? Is the procedure of mixing medicine into the foodstuff ‘care 78 13 (17) planned’ in the nursing notes? Is the requirement of mixing the medicine into the foodstuff 78 24 (31) explicitly mentioned in the prescription (kardex)?
10 (13)
40 (51)
13 (17)
13 (17)
23 (29)
21 (27)
7 (9)
14 (18)
22 (28)
13 (17)
9 (11)
10 (13)
Table 4 Interviewee profile Respondent
Job title
Speciality
Number of years working with children
#1 #2 #3 #4 #5 #6 #7 #8 #9
Charge nurse Nurse specialist Senior charge nurse Senior staff nurse Nurse specialist Staff nurse Nurse specialist Nurse specialist Charge nurse
Paediatrics Paediatrics Paediatrics Paediatrics General medicine General medicine Paediatrics Paediatrics Paediatrics
> 10 years > 10 years > 10 years 6–10 years 6–10 years 6–10 years > 10 years > 10 years > 10 years
All the interviewees discussed how the decision to modify the medicine was approached and finally implemented. [T]he nurses would try various methods and report that to the doctor. If that failed, there would be discussions with the doctors and the pharmacists, discuss alternatives to the medicine or different types, liquids, powders, alternatives- one that was more palatable. (#9) [I]f we’re still unable to get the child to take it, then we contact pharmacy and the doctors who have a chat with pharmacy and decide what the best step forward is. (#4) The pharmacist was repeatedly mentioned as important source of information regarding the procedure and subsequent stability or other physical or chemical properties. Nurses appeared to turn to ‘pharmacy’ as a source of reassurance to almost authenticate the practice. I wouldn’t modify the medication unless I discuss it with pharmacy first- we’ve got a really good pharmacist and I’d
phone for advice first and I know a lot of the others would do that as well. (#6) [O]ur pharmacist advises us and gives information, so tells us if we should open or not. (#2)
Last resort Even though the modification procedure appeared to have an element of acceptability, almost all the interviewees (n = 8) mentioned that it was only largely carried out when there was no other alternative. I am aware that it’s not good practice and it really shouldn’t be done . . . but it’s a last resort . . . every paediatric ward that you are asking in the country . . . they will do it, I can tell you that right now. (#1) It was also recognized that the practice could potentially have an adverse effect on the child and their future relationship with medication. © 2013 Wiley Publishing Asia Pty Ltd
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The disadvantages are what they teach in nursing school . . . you put the child off its food, if it’s in the baby’s bottle of food . . . Researcher: is that because the associate the taste of the medicine with the milk? Yes, so you’ve given yourself an additional problem- Also if they are old enough, you’re sort of continuing their behaviour; you’re accepting their behaviour of not taking their medication. You end up going along the lines of ‘I’ll do what you say’ rather than try to get them to adopt positive behaviours. (#9) All the interviewees mentioned the ethics of the procedure and were adamant that consent (either from the child and/or the parent) would need to have been established. In the few instances, where medication was given covertly, it was usually in pre-school-aged children or with the parent’s consent only. [Y]ou’ve got to be an advocate . . . and you know at three years old letting a child decide whether they can take an antibiotic or not is absolutely ridiculous and they’re not cognitively able to do that . . . . you can’t let children choose to take antibiotics at three years old. (#1) It’s mixed in with her food . . . as a powder, you empty the capsules and you mix it with the food, if she knew she was getting the medicine added . . . she wouldn’t eat the food. (#5)
DISCUSSION Modification of oral medicine dosage forms by mixing into fruit juices and yoghurts prior to administration appears to be a practice that Scottish nurses working with children are familiar with. However, given the relatively poor response to the online survey, it is difficult to accurately define the true extent and prevalence of this practice. Nevertheless, it has recently been suggested that it is the representativeness of a sample that gives validity to the findings rather than its size.13 However, despite the variability of our respondent’s demographics, the majority of those completing the questionnaire had considerable experience in paediatric practice and had previously modified a medicine by mixing it with a foodstuff. On this basis, it is likely that the breath of practices described is likely to be reflective of other nurse working practices with children at least in the UK, if not further afield. Within the elderly, the modification literature puts the prevalence of crushing tablets/opening capsules at 346–61%.9 When modification is necessary for administration of medicines to children, only a limited number of foodstuffs © 2013 Wiley Publishing Asia Pty Ltd
appear to be used. Other studies, albeit mainly in the elderly, have found jams to be the preferred medium.7,14 It might be that the high sugar content of jams is seen as a limiting factor for their use in children which might explain why among our sample, fruit juices and yoghurts are preferred. The choice of foodstuff merits further investigation. It is important to determine if decisions are primarily made according to the compatibility of the foodstuff in relation to the medicine that it is being used with or upon other less scientific reasons (e.g. availability, texture, palatability, cost). We found few instances of medication being concealed in the foodstuff. Only two respondents indicated that their patient was unaware that medicine was being mixed into food for administration purposes. This contrasts sharply with the elderly literature. For example, in a UK study of 34 residential nursing and inpatient units caring for people with dementia,9 71% of units reported to sometimes covertly administering medication with food and drinks. Encouragingly, we found evidence of good practice in that 54% of respondents replied in the affirmative that the modification procedure is detailed in the patient’s notes. This number is higher than the 40% reported in a Norwegian study of nursing homes.15 Nevertheless, details of which medicines are mixed into which food stuff and how are more importantly needed at the point of administration and hence should be clearly indicated on the prescription sheet. However, only 41% of our sample reported this to be the case. This is concerning, as too often the prescription sheet might be the only easily accessible written record of the procedure— if it is not accurately detailed, then, there is a high chance of variability between nurses and how the medicine is ultimately delivered. The interview data allowed a more detailed examination of the issues considered most pertinent by the nurses. Although possible changes to the clinical effect of the medicines were recognized, there was acknowledgement that the total dose is also unlikely to be fully administered when admixed with food or beverages. This mirrors previous findings by the authors10 and also by Stubbs et al.7 who noted that spillage and potential loss in the crushing vessel, as well as the patient not eating or drinking the whole portion of foodstuff or beverage respectively, would mean that the ingested dose was smaller than intended. The decision-making process was discussed in much detail. Our interviewees appeared to adhere very closely
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to the guidance issued to them by their professional body. The Nursing & Midwifery Council is explicit in their advice that the prescriber must give permission to crush the dosage form and that it should be discussed with the prescriber and a pharmacist.16 This contrasts sharply with Treloar et al.8 who found that the decision was often made by the nurse on duty, and only 9% of their respondents had ever consulted a pharmacist about the possibility of crushed tablets interacting with foodstuff. Stubbs et al.7 in their Australian sample also found low levels of authorization (i.e. of 266 tablets crushed or capsules opened, 44% had not been authorized by the prescriber). Again, this should be explored in more detail as it is possible that this aspect more than any other is closely dependent on the relationships between different team members, the availability and extent of (clinical) pharmacy services, and existence of written guidance or protocols. In conclusion, this study attempts to address some of the concern and uncertainty which surround the procedure of modifying medicines and subsequent administration for the paediatric population. It is envisaged that an observation study of nursing practice during the ‘medicines round’ will be carried out. In doing so, we will be better placed to provide guidelines in how best to perform the procedure in a similar manner to those currently available for the elderly.17,18
ACKNOWLEDGEMENTS The authors are grateful to K Tobin for her help with the data collection and all the nurses who participated in the study. The project was supported by a grant from Tenouvus Scotland, UK (grant number S09/2)
REFERENCES 1 Shah T, Tse A, Gill H et al. Administration of melatonin mixed with soft foods and liquids for children with neurodevelopment difficulties. Developmental Medicine and Child Neurology 2008; 50: 845–849. 2 Verrue C, Mehuys E, Boussery K, Remon JP, Petrovic M. Tablet-splitting: A common yet not so innocent practice. Journal of Advanced Nursing 2011; 67: 26–32. 3 Standing J, Tuleu C. Paediatric formulations-Getting to the heart of the problem. International Journal of Pharmaceutics 2005; 300: 56–66.
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4 Wright D. Tablet crushing is a widespread practice but it is not safe and may not be legal. The Pharmaceutical Journal 2002; 269: 132. 5 Griffith R. Tablet crushing and the law. The Pharmaceutical Journal 2003; 271: 90–91. 6 Paradiso L, Cosh D, Barnes L. Crushing or Altering medications: What’s happening in residential aged care facilities? Australasian Journal on Ageing 2002; 21: 123–127. 7 Stubbs J, Haw C, Dickens G. Dose form modification—A common but potentially hazardous practice. A literature review and study of medication administration to older psychiatric inpatients. International Psychogeriatrics 2008; 20: 616–627. 8 Treloar A, Beats B, Philpot M. A pill in the sandwich: Covert medication in food and drink. Journal of the Royal Society of Medicine 2000; 93: 408–411. 9 Wright D. Medication administration in nursing homes. Nursing Standard 2002; 16: 33–38. 10 Akram G, Mullen A. Paediatric nurses knowledge and practice of mixing medication in to foodstuff. The International Journal of Pharmacy Practice 2012; 20: 191–198. 11 Pope C, Ziebland S, Mays N. Qualitative Research in Health Care: Analysing qualitative data. BMJ (Clinical Research Ed.) 2000; 320: 114–116. 12 Richie J, Spencer L. Qualitative data analysis for applied policy research. In: Bryman A, Burgess RG (eds). Analysing Qualitative Data, 1st edn. London: Routledge, 1994; 173– 194. 13 Krosnick J. Survey research. Annual Review of Psychology 1999; 50: 537–567. 14 Nissen M, Haywood A, Steadman K. Solid medication dosage from modification at the bedside and in the pharmacy of Queensland hospitals. Journal of Pharmacy Practice and Research 2009; 39: 129–134. 15 Kirkevold O, Engedal K. Concealment of drugs in food and beverages in nursing homes. British Medical Journal 2005; 330: 20–22. 16 Nursing and Midwifery Council. A to Z Advice Sheet on Medicines Management. London: Nursing & Midwifery Council, 2006. 17 Australian Pharmaceutical Advisory Council. Guidelines for Medication Management in Residential Aged Care, 3rd edn. Canberra: Australian Government Publishing Service, 2002. 18 Wright D. Consensus guidance on the medication management of adults with swallowing difficulties. In: Foord-Kelcey G (ed.). Guidelines—Summarising Clinical Guidelines for Primary Care. Berkhamsted, UK: Medendium Group Publishing Ltd, 2006; 373–376.
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