Modifying—a necessary evil

Modifications of oral medicines were viewed by participants as being a routine and necessary part of clinical practice and were undertaken on a daily basis as part of drug rounds. It was strongly felt that the older cohort in particular require modified medicines more frequently, “ To be honest I think that modifying medicines is a necessity, especially in elderly patients” (Nurse 2, Long Term Care (LTC)), “It would be very common here in the unit. It’s a geriatric ward. it would be very common I suppose here because of our patient group” (Nurse 10, Acute Care (AC)). Participants discussed a number of different types of modifications that they encountered, including tablet crushing, capsule opening, tablet splitting, dispersing or dissolving tablets and mixing medications with food. However, the modification that was reported as being most common was tablet crushing, “In 95% of cases when we are talking about modifying medicines we are talking about crushing” (Nurse 5, LTC). The necessity to modify medications was seen to be an inevitable part of older patient care and participants highlighted common reasons for this including: swallowing difficulties or dysphagia, medical conditions with dysphagia as a sequela, patient preference or difficulty with large dosage forms, family input and formulation characteristics. Overall, age-related swallowing difficulties and dementia were the most commonly implicated reasons for ODF modification. It was clear from the interviews that formulation suitability is extremely individualised, “all patients are so different… so you’d be looking at lots of different types of medications… whatever fits in with the individual patient” (Nurse 9, AC) and it is vital that each patient’s needs are assessed on a regular basis due to the potential for fluctuations in formulation suitability,

…you can see progressively the swallow or the level of cognition fluctuates, that affects the swallow and it’s something that you are looking at and thinking, oh my god (sic), this patient actually was taking oral tablets a matter of weeks ago and now it’s a case of that we’re dispersing them and giving them different suspensions… we are just keeping an eye out for ourselves[nurses watch for changes in patient’s ability to take different mediciation formulations] (Nurse 9, AC).

Participants reported that alternative formulation options are investigated when patients experience difficulty with solid ODFs. Options discussed included changing the route of administration or the formulation of the medication for example, liquid formulations, transdermal patches, dispersible tablets, etc. The availability of appropriate alternative formulations was satisfactory for certain classes of medications, for example, antibiotics and antidementia medications; and participants expressed that in many instances the use of these alternatives was preferable to modifying oral medicines. However, there was an almost universal acknowledgement that there were significant limitations associated with alternatives that often resulted in modifications of ODFs being required or even preferred including: lack of availability or difficulty sourcing alternatives; cost; alternatives not being covered on reimbursement schemes; difficulties administering large or small volumes and issues with the viscosity of the liquids that may increase the risk of aspiration, “…then we have liquid forms, again it’s hard to give liquid form medications to people with swallowing difficulties because of aspiration” (Nurse 13, LTC).

Participants expressed a wide variety of attitudes and beliefs about ODF modification. As stated, it was clear that the majority of participants felt that modifications were a routine part of practice. Participants highlighted a number of benefits of modifying ODFs including ensuring that vital medications are administered and overcoming concerns about not modifying medications, for example, the risk of choking or discontinuation of necessary medication, “Your choice is … crush the medicine which is what we do. or give the medication in its uncrushed form and run the risk of the person choking on it or not give the medicine at all and then, you know, the risk of the illness that’s treating” (Nurse 5, LTC). However, notwithstanding the general acceptance of modifications as a routine occurrence, participants reported numerous concerns about modifications including: inaccurate dosing, altered drug absorption or effectiveness, potential interactions with food vehicles used for administration, possible cross-contamination issues, occupational hazards for nurses due to exposure to powdered drugs and the unlicensed nature of the modified medicines,

Sometimes I question it because… you crush all the tablets, they are all kind of going into one, you know, one dust…so are you modifying you know… the chemistry or what the tablet actually does because each tablet is made up individually… Plus, I don’t know are they getting the full dose of what they should be getting, because obviously there is going to be residue inside in the crush pouch that you can’t ever get out, and also… some in the yoghurt, or in the yoghurt tin or whatever you mix it in. So am I’d say they probably don’t always get the right dose (Nurse 13, LTC).

An additional issue identified by nurses was the time-consuming nature of modifications, which impacted on nurses’ time and work-load, on the patient receiving the modified medicine and on other patients in the ward, “It definitely affects nurse’s time…we have a resident here … it takes twenty minutes to finish only that patient because everything needs to be crushed individually and you have to give everything individually. So it takes a good bit of time from you…that will affect the other patients as well… time is everything” (Nurse 1, LTC).

Overall, it is clear that nurses view modifying ODFs as a key part of their medication administration role. While nurses are aware that modifications may not be appropriate and did express concerns about the effect of modifications on drug action, it is accepted that to meet the many individualised and varied needs of older patients, medicine modifications are a necessity, “Look it’s essential….it’s a necessary evil… I’m all for modifications because it’s necessary” (Nurse 4, LTC)

Nurses’ role as patient advocate

Medicine administration was acknowledged by participants as being a key aspect of their role and nurses viewed medicine administration as their area of expertise. However, from the interviews, it was clear that the responsibilities of nurses extended far beyond simply modifying and administering the medication. Nurses are at the frontline of healthcare provision and play a central role in every aspect of patient care related to medicine modification. Nurses: identify when patients are experiencing difficulty swallowing medications; arrange review by appropriate healthcare professionals; highlight patient’s requirements and needs to other healthcare professionals, especially doctors and pharmacists when prescribing and dispensing and communicate and liaise both with and between members of the multidisciplinary team. Therefore, the input of nursing staff is crucial in the area of medicine modification, “Very much nurse led…” (Nurse 6, LTC). The importance of nurses knowing their patients was central to this, “…one of the huge advantages of working in care of the older person in long term settings is that you really get to know the patient…” (Nurse 7, LTC). Nurses, particularly in long-term care, know the patients, and therefore their preferences and requirements, extremely well, “the most important thing is to know the person, know each individual” (Nurse 8, LTC). Nurses are also alert to subtle changes in the patient that may suggest that the patient is experiencing difficulty, “… as their medical condition changes… they’ve become unwell and we know that, you know, they’re coughing a lot or that their swallow has changed or that they’re not able for their big medications, it’s because we know our patients so well I suppose” (Nurse 17, LTC). Participants did acknowledge that although some healthcare professionals do consider patient’s formulation requirements, particularly those who know the patient or geriatric specialists, overall there was a reliance on nurses to communicate patient’s formulation requirements. Nurses were cognisant of this responsibility and were particularly aware of highlighting this to out-of-hours doctors, “Especially [out-of-hours GP service] you have to be there on top of them saying no, this person is liquid, this person is, you know, suspension or whatever” (Nurse 6, LTC) and locum nursing staff. Nurses also shoulder responsibility for liaising between the various members of the multidisciplinary team and communicating various recommendations within the team as often the multidisciplinary team members communicate through the nursing staff rather than directly, “The pharmacist will do a review, the pharmacist leaves instructions, I communicate them to the GP” (Nurse 17, LTC).

It was evident that care provision in the area of medicine modification is very much nurse-led and nurses play a central role in this area. Nurses appeared to be confident in exercising these responsibilities and at the centre of this was their acknowledgement that knowing the patient and developing a good relationship with them is a key component of their role. This allows nurses to act as an advocate for their patients. For nurses, acting as an advocate for their patient’s, is an intrinsic component of their professional responsibility and identity “…none of them can speak for themselves, so you have to have somebody that knows them to be able to” (Nurse 8, LTC).

Modifying—we are working very much as a team

Nurses believed that decision-making around medicine modification requires the input and expertise of many different members of the multidisciplinary team. Nurses repeatedly highlighted the importance of ensuring that modifications are safe and appropriate “So we’d always make sure that if we’re crushing tablets that it’s safe to do so” (Nurse 18, AC). Nurses throughout the interviews demonstrated knowledge that certain formulations should never be modified, for example, sustained-release and enteric-coated preparations, which was based on their previous experience with such medications, “We’d know as well… the slow release, long acting, enteric coated or retard medicines… that we couldn’t be crushing them” (Nurse 14, LTC). Ultimately however, nurses acknowledged that drug formulations and modification appropriateness was not their area of expertise, “We would always seek external advice for that because that’s not our area of expertise" (Nurse 7, LTC), and that they always sought information and advice prior to modifying oral medicines, “I always say it, I’m not a pharmacist and I’m not a doctor and I think it’s something that, I’m very cautious by nature anyways, am so it’s something I always double and triple check” (Nurse 9, AC).

The main information source for nurses about the modification of oral medicines and the availability of alternative formulations was the pharmacist, “It is always the pharmacy” (Nurse 7, LTC). Nurses reported relying on information provided by the pharmacist, “If I have any concerns I always ring the pharmacist and I always go by their directions…but always check with the pharmacist” (Nurse 2, LTC), “That would be a rule that we just don’t go off modifying the tablets ourselves, we have to do it in liaison with the pharmacy department so that we know…… the patient is getting the benefit of the medication, it is not altering the effectiveness of the drug and that it’s safe for the patient” (Nurse 10, AC). In general, nurses had very positive views of pharmacists, “Our pharmacists are excellent. They are very accommodating to us” (Nurse 3, LTC) and pharmacists were seen to be the most knowledgeable member of the multidisciplinary team in relation to modifications, “On a Sunday or a bank holiday, you could discuss it with the medical team on call but often… regs [registrars] will tell you really to refer to the pharmacy department as soon as possible because I suppose, they’ve the most knowledge in relation to medication, the altering and modifying of them” (Nurse 10, AC). One nurse did express dissatisfaction with the support provided by a pharmacy in the past, “There was one pharmacy alright that were a bit slack that I worked with” (Nurse 6, LTC). However, this reliance on pharmacists did present challenges in acute-care settings when the pharmacy department is closed, “We don’t have any 24 hour pharmacy… you know so it may not be appropriate forms, it could be whatever you can get” (Nurse 15, AC).

Nurses did mention a number of reference sources, for example, British National Formulary, Monthly Index of Medical Specialities (MIMS) and Summary of Product Characteristics; however, these resources did not provide information related to medicine modification “And it’s not really in the MIMS either… it doesn’t say whether you can crush it or not” (Nurse 16, LTC). In one acute-care setting, a ward-specific guideline on medicine modification was developed by the pharmacy department, which was mentioned as a useful resource available at the moment of medication administration, “Just definitely, that do not crush book, that’s like our bible here” (Nurse 12, AC).

The attitudes of interview participants differed regarding the need for more resources and supports. Many of the participants expressed satisfaction with the supports and systems in place in their workplace. The majority of participants reported that they had very good working relationships with other members of the multidisciplinary team and they valued a collaborative approach to decision making in which their opinions were listened to and accepted, “We have a very good working relationship but generally they don’t question, they accept, you know, our judgement on it I suppose” (Nurse 5, LTC). Notwithstanding this finding, some participants did discuss a number of potential methods of improving multidisciplinary collaboration including: the multidisciplinary team meeting to review and discuss patient’s needs and greater consideration being given to patient’s formulation requirements by doctors and pharmacists when prescribing or dispensing, “I suppose, as a multidisciplinary, sitting down as a nurse, GP and pharmacist together… there isn’t enough constructive reviewing of that, it’s very much the GP does the monthly round, the script goes to the pharmacist, the pharmacist sends it up and the follow-up really is the nurse” (Nurse 7, LTC). Some participants also expressed a desire for auditing of their medication administration practices, “I suppose observing how we are doing it because again, you can’t constructively say right that’s the correct procedure unless you actually observe it yourself” (Nurse 7, LTC). A number of other suggestions were mentioned including: more education and training from pharmacists and availability of a pharmacy-developed site-specific formulary or online database on commonly encountered modifications, “I think all nurses should be given extra pharmacy education, especially in specialist areas where we are doing a lot of modifications” (Nurse 9, AC), “A pharmacy-led manual on the ward where, whatever amount of medications they can go through, whether they state whether this medication could be crushed or halved or dissolved in water or whether, you know, it is readily available in that particular hospital in liquid form” (Nurse 10, AC). Nurses also stated that increased availability of alternative formulations and increased recognition by the pharmaceutical industry of the formulation challenges encountered by older patients on a daily basis would be welcome.

Fractional dosing

Fractional dosing involves the administration of part of a dosage form, for example, half a tablet, to facilitate the administration of a lower dose. While score lines are often present on tablets, in many instances these score lines do not divide the tablet into equal doses but rather allow tablets to be split to facilitate swallowing. When participants were asked to discuss the common modifications they encountered in practice and the reasons for undertaking modifications, none of the participants volunteered fractional dosing. While splitting tablets was commonly mentioned, this was to overcome difficulty swallowing large tablets rather than for fractional dosing. However, when participants were specifically asked about modifications for fractional dosing, it was viewed as being frequently undertaken for older patients, “Yeah, daily … some of the medication that we give out on a daily basis doesn’t come in a dose that’s prescribed” (Nurse 11, AC). Fractional dosing was felt to be necessary for older adults due to a combination of increased sensitivity to higher doses and a corresponding lack of commercial formulations that meet these dosing requirements, “I see a lot more of it here [fractional dosing on a geriatric ward]…you would find that they’re constantly altering doses because some of them might be too severe, patients don’t react well and it’s always finding the fine balance to keep some of the patients on an even keel” (Nurse 9, AC), “…splitting the tablet because the form, the dosage wouldn’t be available, especially with the anti-hypertensive tablet, we always split it or quarter it” (Nurse 1, LTC). Drugs acting on the central nervous system, especially quetiapine, and the cardiovascular system were the most commonly implicated medications, “Seroquel … comes in a 25 mg tablet. That has to be split for 12.5. Yet 12.5 is the most common dose… but there is no 12.5 available” (Nurse 6, LTC). Fractionally dosed medications were often supplied presplit by the pharmacy, which seemed to account for nurses not considering this a modification as they did not physically perform the modification themselves, “The pharmacy will do the alteration if they are required, we don’t do it at floor level no” (Nurse 17, LTC). In addition, there was a general belief that scored tablets are designed to be split in two for fractional dosing, “I mean many tablets as you know are scored to be divided in two” (Nurse 5, LTC). However, some nurses did report checking with pharmacy colleagues whether fractional dosing was appropriate, even for scored tablets. While overall participants did not have many concerns about administering fractionally dosed medications, particularly if the pharmacy had split the tablets in advance or the tablets were scored, a number of concerns were raised including inaccurate dosing, wastage and difficulties splitting tablets, “How accurate is the dose?… like, as somebody said to me ‘I gave him the big half’. Yeah, that says everything” (Nurse 6, LTC). Overall, participants’ attitudes to the modification of medications for fractional dosing were distinct from attitudes to modifications due to swallowing difficulties or patient preference. This appeared to be related to lack of knowledge about the purpose of score lines on tablets and different attitudes towards modifications when tablets are presplit by the pharmacy.

Covert administration

The modification of medicines to facilitate covert administration was mentioned by a number of participants and it would be remiss not to address this as a separate theme. A number of participants acknowledged that covert administration was commonly undertaken in the past, particularly for patients with dementia or agitated patients, “Now I would admit, I’m a long time in the profession, certainly that has happened in the past” (Nurse 5, LTC). The majority of participants who discussed covert administration stated that it was not undertaken at their site of employment, “Now, it’s not actually done in this hospital” (Nurse 6, LTC) and that it is no longer commonly encountered. The ethical implications of covert administration and the importance of respecting patient’s wishes was a major factor influencing this, “Oh no, no, we would never… if a patient refuses that’s it… the law as you may know, says no means no. And no even means no from somebody who is cognitively impaired” (Nurse 5, LTC). There was an acknowledgement that very occasionally, covert administration occurs but that this is undertaken in strict adherence to detailed policies and guidelines on covert administration, following discussion with all members of the multidisciplinary team and the patient’s family and taking the importance of the medication into consideration, “We have a policy around it and I suppose it would have to be in the person’s best interest whether they need the tablet or not” (Nurse 16, LTC). The main challenge discussed by nurses relating to covert administration was the ethical dilemma that arose when trying to balance respecting patient’s wishes and providing optimal medical and pharmacological care to individual patients.