Background

There is little research on families’ experiences of suspected ADRs in children and little evidence to guide clinicians when communicating with families about problems with medicines.

Aims

To identify any unmet information and communication needs described by families following a suspected ADR in a child.

Methods

Semistructured qualitative interviews with 20 children and young people and the parents of 44 children and young people who had experienced a suspected ADR. Interviews were conducted face to face or by telephone; most were audio recorded and transcribed. Analysis was informed by the principles of the constant comparative method.

Results

Many parents described being dissatisfied with clinicians’ communication about ADRs. In contrast, the accounts of parents of children with cancer emphasised confidence in clinicians’ management of ADRs and the way clinicians communicated about medicines. The accounts of children and young people largely reflected parents’ accounts. Families were positive about the Yellow Card Scheme and felt that recording and reporting ADRs was important. Parents, children and young people linked symptoms to medicines using a similar reasoning as clinicians use to evaluate the possibility of an ADR.

Conclusions

Most parents felt that clinicians’ communication about ADRs was poor, suggesting that improvements are needed. The accounts of parents of children with cancer indicate that prospective explanation about ADRs can be effective. Convergence between parents and clinicians in their reasoning for linking children’s symptoms to medicines could be a starting point for improved communication.

Clinical communication with families about adverse drug reactions

The literature on communicating about medicines indicates the advantages of involving patients in open discussions about the benefits and risks of medicines in order to support informed consent and decision-making. However, patients have generally been found to be poorly informed about medicines.^12,27 A great deal of work on communication about medicines has been motivated by a concern to promote treatment adherence, rather than on enhancing communication about medicines as an important goal in its own right.²¹⁷ Although optimising adherence is an important objective, concern with promoting treatment adherence has, arguably, meant that little attention has been given to examining the experiences of patients following a suspected ADR.²⁸

Even less attention has been given to investigating the particular experiences and needs of child patients and their parents following a suspected ADR. Their situation is likely to be complicated by the frequent prescribing of OLUL drugs in paediatrics^218–220 and by parents’ distinctive role in caring for their children.²²¹ Evidence that members of the public are particularly concerned about the risks of medicines to children comes from a study comparing laypeople’s responses to hypothetical scenarios involving medicines for child or adult patients. Respondents perceived the risks of ADRs to be more severe and reported that they would be less likely to take (or give) a medicine when the recipient was a child rather than an adult.²²²

Families’ involvement in pharmacovigilance

The MHRA is responsible for monitoring medicines in the UK. One way they do this is by collecting spontaneous reports of suspected ADRs submitted via the Yellow Card Scheme.²²³ Given the frequent use of OLUL medicines in paediatrics,²¹⁸ health practitioners are strongly recommended to submit Yellow Cards for suspected ADRs in children.¹⁷ However, there is considerable concern about under-reporting of ADRs,^40,224,225 and partly in response to such concerns, the Yellow Card Scheme was extended to patients and their families in 2005.²²³

Adult patients who use the Yellow Card Scheme or its international equivalents have been found to provide more detailed reports of ADRs than clinical practitioners and to value the opportunity to contribute to pharmacovigilance.^12,226–232 These patients have spoken of having altruistic motives for reporting ADRs, as do clinicians,^226,233 and being motivated by the severity of the ADR and a concern that certain ADRs were not listed on the medicine patient information leaflet.²³³ However, public awareness and participation in the Yellow Card Scheme is low^12,27,28 and studies of patients who have managed to access the Yellow Card Scheme are, therefore, likely to be of limited use in identifying strategies to promote wider participation. Research with patients who have experienced an ADR but have not used the Yellow Card Scheme is limited. A recent study of adult patients who had been hospitalised because of a suspected ADR but had not used the Yellow Card Scheme indicated that they considered the scheme to be remote and impersonal, and they felt that it was not a patient’s responsibility to report ADRs to the MHRA.²⁸

Exploring the particular motives of parents for using the Yellow Card Scheme and the barriers they encounter is important for several reasons. Previous research has focused primarily on adult patients, yet the need for parental confidence in pharmacovigilance is particularly pressing owing to the widespread use of OLUL medicines in children^218,234 and public concern about the safety of children’s medicines.^{219,235–240} Also, the perspectives of parents may differ from those of other lay users of spontaneous reporting pharmacovigilance schemes because of parents’ distinctive caring and protective role.^221,241 Moreover, previous research has largely focused on the experiences of people who have used the Yellow Card Scheme, which as we note above, is likely to be of limited use in enhancing participation. It is important to test those assumptions by examining the views of parents who have witnessed ADRs in their children but have not previously used the Yellow Card Scheme, as well as those who have used the Yellow Card Scheme.

Aims

We designed our qualitative study to explore all aspects of participants’ experiences and views, from their accounts of communication at the point at which medicines were prescribed to their views about the implications of ADRs for future health, and their views and experiences of reporting ADRs using the Yellow Card Scheme.

Sampling, setting and recruitment

The methods used have been detailed elsewhere,^29,96 so only a brief outline is provided here. As recommended in qualitative research when there has been little previous research on a topic, we sampled for maximum variation^242,243 using three sampling routes to ensure participant diversity, particularly in terms of clinical specialty and the nature of the suspected ADRs. Route 1 comprised the two cohort studies (see Chapters 2 and 3 ) that were part of the ADRIC programme. ‘ADRIC families’ were eligible for the study if they could be approached before discharge. Treating clinicians initially introduced the study to families. The interviewers subsequently provided the parents, children and young people who expressed an interest in participating with more detailed information and then arranged the interview. We used route 2, the Yellow Card Scheme,²²³ to access parents with experience of reporting ADRs to the MHRA.^242,243 The MHRA sent invitation letters to all parents who had submitted a Yellow Card on behalf of a child of < 17 years of age, outlining the study and inviting parents to return a reply slip to the study team if they wished to participate. Qualitative interviewers telephoned parents to further explain the study and arrange an interview.

As we recruited few children via route 1 and none via route 2, we used a third sampling route to extend the sample of children in the study. For this extended sample, clinical teams identified children who had experienced a suspected ADR while receiving inpatient care at Alder Hey. ADRIC researchers facilitated this process by publicising the study, regularly visiting wards and clinics to prompt staff to identify eligible participants, and checking nursing notes via the hospital computerised records system.

Sampling to all routes ran in parallel with data analysis and was discontinued when saturation on the main analytical categories was reached.²⁴⁴ A UK NHS research ethics committee approved the study (Northwest 3 Research Ethics Committee 08/H1002/7). All participants gave written informed consent or assent.

Interviews

Interviewers (JA, HH and ES) explained their independence from clinical teams and the MHRA before all interviews. Face-to-face interviews were conducted with participants, with the exception of Yellow Card parents, who we interviewed by telephone as they resided across all parts of the UK. Interviews were semistructured and informed by a topic guide that contained prompts about families’ experiences of children’s signs and symptoms and how they linked these to a medicine; awareness of suspected ADRs; written and verbal communication with clinicians and views about the implications of ADRs for children, and views and experiences of the Yellow Card Scheme. Interviewers tailored their approach and questions to ensure that interviews were conversational and suited to the needs of both parent and child participants. Interviews were audio-recorded and transcribed. Transcripts were checked by the interviewer, who removed all identifying details before analysis.

Analysis

The analysis drew on the constant comparative approach^244–250 and was broadly interpretive. JA led the analysis reading transcripts several times to develop analytic categories. BY and MT supported this process by reading a sample of the transcripts and by ‘testing’ and developing the analysis through periodic discussion with JA. All three analysts compared within and between transcripts, and iterated between developing analytical categories and new data.^{245,247–253} We used a number of methods that are recommended to help ensure rigour in the analysis of qualitative data including respondent validation,^245,252 attending to exceptional or ‘outlier’ cases^{247–250,252,253} and scrutinising the quality of the developing analysis for its coherence and potential to influence practice. The latter was also assisted by discussion among the wider ADRIC team^252,254 to support multidisciplinary investigator triangulation.^255,256 Excerpts from interviews are presented to evidence the analysis; in these omitted speech is indicated by [. . .], explanatory text by [text] and excerpts are coded ‘AP’ (ADRIC parents), ‘AC’ (ADRIC children) ‘YCP’ (Yellow Card parents) or ‘EC’ (extended child sample).

Participants

We conducted audio-recorded interviews with a total of 45 parents (41 mothers, 4 fathers) and 19 children. Of these, 27 parents and 11 children were recruited via the ADRIC cohort studies (route 1), 17 parents were recruited via the Yellow Card Scheme (route 2) and eight children were recruited via route 3 (the extended children’s sample).

Interviews lasted approximately 60 minutes (range 17 to 138 minutes) and were conducted between 1 and 56 weeks after the suspected ADR. Four participants were interviewed in a private setting in the hospital. The remainder were interviewed in their homes. Appendix 5 shows the characteristics of participants, including child age range, gender, ranked Index of Multiple Deprivation (IMD), type of drug associated with the suspected ADR and the body system affected by the ADR.

The findings from the interviews are presented in two parts: Part 1 focuses on participants’ perspectives on communication about ADRs; Part 2 focuses on participants’ perspectives on contributing to pharmacovigilance through the UK’s spontaneous reporting scheme.

Little explanation of the risks of medicines at the time they were prescribed

Although some of the children reported receiving general advice about potential ADRs before a medicine was given, most children and parents indicated that clinicians did not explain the risks of medicines when the medicines were prescribed: ‘No side-effects were made known to me’ (YCP5); ‘I didn’t know codeine would make me constipated’ (AC07); ‘They didn’t really tell me about anything about being sick or being itchy. They never really said anything about that’ (EC13). Parents explained how clinicians focused on other issues, such as explaining their child’s condition and the importance of medicines or surgery in treating the condition: ‘They [the surgeons] don’t discuss the drugs; they discuss the surgery itself’ (AP23). If the risks of medicines were discussed, it was often at a time when parents struggled to absorb information, such as shortly before a child was due to be anaesthetised: ‘On the day your child is being operated on or when the anaesthetist comes up you are not thinking of anything other than [. . .] what’s going to happen in the operation’ (AP16). Participants also reported difficulties with written information about medicines and potential ADRs. They either did not receive these documents or found them hard to engage with: ‘I did a carefree glance [at the patient information leaflet] and chucked it’ (YCP13).

A key exception to these accounts was the parents of children with cancer, who described how clinicians provided comprehensive information about the types of reactions that medicines could cause and emphasised how clinicians carefully timed and paced their explanations so that parents could absorb the information: ‘They explained things in little bits so it sinks in [. . .] they did say he would become neutropenic’ (AP6).

How participants become aware of adverse drug reactions

Parents usually described an initial period in which they began to suspect something was wrong based on a wide collection of physical symptoms and changes in their child’s behaviour that were ‘out of the ordinary’. With the exception of patients whose suspected ADR had first been identified by clinicians or those who had cancer, participants initially tended to attribute symptoms to trivial causes, such as minor illness, injury, or changes in lifestyle or environment. It was only when symptoms worsened that participants became concerned: ‘His colour dropped and his breathing went a bit funny and he started to panic, that worried me’ (AP25) and they started to consider possible links to medicines.

Participants reported how they started to link symptoms to a medicine when they noticed patterns, such as temporal associations between a medicine being given and the onset of symptoms: ‘It just seems strange to me that she had it [the medicine] and then straight away like she got that temperature’ (AP10); ‘When I went on the ketamine I wasn’t being sick at all. Then when I went on the morphine I was being sick. So, it was quite obvious that it was the morphine that was making me sick’ (AC09). Some also noticed how symptoms receded between doses and then returned following another dose: ‘I noticed a difference [. . .] when she was having it [the medicine] and when she wasn’t having it [. . .] she started on it again and then we noticed the symptoms within a few days again of having it’ (YCP7). The absence of an alternative explanation for the symptoms also influenced participants’ attributions: ‘[The medicine] is the only thing she’s had and she hadn’t had a cold or been ill before it’ (YCP10); ‘I was like, well, the only reason this would have happened would probably have been the medication’ (AC08).

With few exceptions, parents were critical about adverse drug reaction management and communication

Parents indicated that clinicians’ communication about suspected ADRs was often poorly matched to their needs. They described receiving contradictory information and a lack of communication that might help them understand what was happening to their child while his/her symptoms were being assessed: ‘No-one actually ever said why it [the hallucination] was happening, the nurses thought it was a bit funny, they all kept coming over to see him and laughing with him sort of thing’ (AP14). The way in which clinicians managed and communicated uncertainty surrounding an ADR’s identification did little to reassure parents ‘I was saying “well, when she goes home, can I give her paracetamol? Can she never have paracetamol or can she never have a drug that might affect her liver?” And they were going “well [. . .] it should be fine” but no-one was saying “well you can, I’ll write it down and you can have it” ’ (AP12). Parents also described receiving detailed information at times when they were anxious (e.g. when a child was critically unwell or immediately prior to surgery). At these times parents found it hard to absorb information. They reported receiving little or no information at times when they were less anxious and better able to absorb information. Children voiced fewer concerns in communicating with practitioners than parents, perhaps because most children relied on their parents for information about medicines ‘Sometimes I can’t understand them [the doctors] so I just ask my dad’ (AC01); ‘My mum deals, is the information box and if I have any questions I just ask her’ (AC10).

Some parents were intensely critical of how practitioners communicated about ADRs. One parent was frustrated during a visit to outpatients when clinicians could not explain what was happening to his/her child and spoke of feeling that he/she was being lied to by clinicians: ‘They were fobbing me off [. . .] I felt like they were lying to us’ (AP5). More commonly, parents emphasized how their concerns had been ignored or dismissed by clinicians: ‘Dismissive and wasn’t taking me very seriously’ (AP10). Yellow Card and ADRIC parents both voiced criticisms of clinicians’ communication, although Yellow Card parents were particularly emphatic in their criticisms. This was prominent when they felt clinicians had ruled out the possibility that a child’s symptoms could be related to a medicine with seemingly little exploration of parents’ concerns or explanation of the reasons for ruling out an ADR: ‘She [general practitioner] literally said word for word “what would you like me to do?” And I just felt that was really dismissive’ (YCP14). Parents who felt clinicians had ignored or dismissed their concerns described a sense of abandonment: ‘I just, just felt like nobody cared, nobody was interested and they just wanted me to go away’ (YCP5).

A striking exception to the highly critical accounts of these parents came from the parents of children with cancer. These parents were almost uniformly highly positive in their accounts of how clinicians communicated about ADRs.

Parents of children with cancer were positive about adverse drug reaction communication

Despite the life-threatening nature of the illness and the risks of cancer treatment, parents of children with cancer felt well supported by how clinicians communicated with them about medicines. There was a sense from these parents that clinicians took ADRs seriously, were adept in communicating about them and had well-developed systems in place for the management of ADRs: ‘It’s quite scary when you first go home with this big bag of drugs [. . .] they said [. . .] you can ring any time, and I rang nearly every day’ (AP7). Parents pointed to how clinicians discussed possible ADR symptoms and how to respond before an ADR happened, so that parents were clear about what to look out for and what action to take in the event of a suspected ADR. Consequently, parents felt that clinicians communicated about medicines and ADRs in a way that was ordered, timely and reassuring.

Implications of poor communication about suspected adverse drug reactions

Parents who were dissatisfied with how practitioners had communicated reflected on the implications. They commented on how a lack of information about potential ADRs at the time of prescription had prevented them from being involved in decisions about their child’s care. In one case, a lack of information at the time of prescription had resulted in a parent continuing to give morphine to alleviate their child’s agitation, only to subsequently discover that agitation could be a result of itchiness caused by morphine: ‘As she kept getting more and more agitated we kept boosting it [the morphine] [. . .] and the more we pressed the booster [. . .] the itchier she got’ (AP16). A few parents remarked on how they blamed themselves for what had happened because they felt ‘responsible for what goes into’ their child (YCP10) and pointed to the distress this had caused: ‘I was devastated [. . .] I just felt like crying all the time’ (AP8). Parents also spoke of fearing a repetition of the ADR: ‘Will it happen again? [. . .] could it happen to him, to the baby?’ (AP8) and of their uncertainty about the implications of ADRs for their child’s future health and use of medicines. Parents were also confused about whose responsibility it was to prevent a recurrence of the ADR: ‘I don’t know if it would be down to me to turn round and say something or whether they have actually put something in their notes’ (AP14). Some assumed that the responsibility was theirs alone: ‘It’s something that I [. . .] have to ask to make sure he never gets given that again’ (AP18). By contrast, children tended to focus on their experience of the symptoms of the suspected ADR. One child emphasised how he had not been perturbed because the hallucinations that he experienced had ‘distracted’ (AC04) him from the pain that he was feeling. However, most children described the experience as unpleasant or frightening: ‘It was really scary. I wasn’t bothered about pain [. . .] I just felt so scared’ (AC10).

In the context of poor communication, the experience of a suspected ADR sometimes coloured parents’ views about medicines and some expressed reluctance to give certain medicines to their child in the future. For example, one parent became convinced that her child’s ADR was a reaction to morphine and that her child could never have morphine again: ‘She’s due for this big operation and she can’t have morphine’ (AP11). However, clinical review of this particular case suggested that the suspected ADR was linked to an avoidable over-dosage and that, rather than avoiding morphine altogether in future, it might be in the child’s best interests to personalise the dose. Another parent refused to allow her child to have the final course of her vaccine: ‘I will categorically say that [. . .] I will definitely not let her have the third [human papilloma virus] vaccine’ (YCP3). One child said he would refuse a medicine again: ‘I don’t want to have that medicine ever again because [. . .] it just makes you go all angry’ (AC09), although most children reported they would take the medicine again if it was likely to help them.

How participants thought communication about suspected adverse drug reactions should be handled

Reflecting their accounts of poor communication about ADRs and the resulting implications as described above, parents wanted clinicians to help them to understand what had happened to their child. Children similarly described a need to understand their experience ‘I would have liked to have known that the floppiness wasn’t just me and I would have liked to have known that I would have felt sick after’ [. . .] all I want to know is what is going to happen, when is it going to happen, how is it going to happen and am I going to be in pain’ (EC17). As one parent explained, the need to understand the ADR seemed to be intrinsic rather than motivated by ulterior considerations: ‘[It’s] not necessarily the case that everyone’s going to jump and say, “Right, I’m going to sue the drug company” and all of these sorts of things. I think parents genuinely, who are concerned about their child’s health, want to know what it was’ (YCP8). Participants wanted discussions about ADRs to be paced and timed in a way that would help them to absorb the information: ‘You just don’t think straight when you’re there [. . .] doctors have got to understand that [. . .] and maybe spend a little more time to try and explain a little bit more than they do’ (AP11); ‘Because when you are in hospital and they ask have you got any questions, you can’t really think of it because you are drugged up [. . .] and your mind goes blank. And when you get home and then you do a bit of revising and stuff like you think “oh, I should have asked that question” and stuff like that’ (EC12).

Parents particularly wanted to understand what the suspected ADR meant for their child’s future health care, to know what steps would be taken to help prevent their child suffering further ADRs and to ensure he/she would receive appropriate medicines in the future. Without exception, parents accepted that a certain level of risk came with medicines and most appreciated that clinicians faced uncertainty in identifying ADRs: ‘I think it was the antibiotics. The doctors think it is that but they can never say it is that, because there is a possibility that it’s not that’ (AP1); ‘It’s just something that, you know, just happens [. . .] I’m sort of accepting about it’ (YCP13). Many parents were critical of how clinicians communicated about ADRs and some of them got the impression that clinicians were unwilling to discuss ADRs. However, none of the parents blamed clinicians for their child’s ADR or said they intended to formally complain. Only one parent expressed a slight ‘loss of trust’ (YCP8) in clinicians. However, as we note above, a few participants explained that their trust in medicines had diminished. Alongside their wish for dialogue with clinicians about ADRs, several participants also wanted accessible and reliable written information about ADRs: ‘They should give you a little pamphlet or something to say [. . .] look this is what she’s got’ (AP12).

Awareness of the Yellow Card Scheme

Most Yellow Card parents remarked that they had found out about the Yellow Card Scheme through their training or work as a health practitioner: ‘The only reason I knew about it was because of the course that I’d done’ (YCP7), or through friends or relatives who were health practitioners. In contrast, only two ADRIC parents had heard of the Yellow Card Scheme before we interviewed them and both were nurses. None of the children had previously heard of the Yellow Card Scheme. None of the ADRIC or Yellow Card participants knew for certain whether or not the practitioners had submitted a Yellow Card reporting the suspected ADR: ‘I don’t know if one was filled in or not’ (AP20), but some remarked that they would appreciate being informed if a practitioner had done so: ‘Yeah, I think they should tell you’ (AC02).

Motivations, views and experiences of parents who submitted Yellow Cards

Most Yellow Card parents emphasised how they had submitted a Yellow Card because they wanted to help prevent other children experiencing the sorts of ADRs that their child had suffered. They also hoped that their report would contribute to the review of certain medicines ‘if they look into things, and [. . .] if there is too many incidents, they might have to relook at the tablet or relabel the information leaflet’ (YCP7). Parents did not usually think their reports would directly help their own child: ‘I didn’t think it would help me at all. I didn’t have any expectation for us’ (YCP10) and none of them wanted a medicine to be withdrawn from the market solely because of the difficulties their child had experienced. Linked to their altruistic motivations, Yellow Card parents also described a sense, albeit nebulous, of ‘achieving something positive from that experience rather than just sort of happening’ (YCP14). Those Yellow Card parents who had professional knowledge of the Yellow Card Scheme added that they were motivated to submit a report by a sense of professional obligation. Those who were not health practitioners expressed a preference for reports about suspected ADRs to come from health practitioners rather than themselves: ‘I wished it [Yellow Card] had come from the doctor first’ (YCP10).

Some Yellow Card parents seemed to understand that a certain number of reports would be needed in order to trigger action by the MHRA: ‘if enough people say something about this then something should and probably will get done’ (YCP16). Others were unsure about what happened to the data after they had submitted it. Most parents did not report expecting to receive feedback from the MHRA in response to their Yellow Card but those that had received a response were pleased: ‘What I’m delighted about is the response it makes you feel very pleased, glad that I followed it up’ (YCP3). As noted in Part 1, many Yellow Card parents emphasised how the health practitioners they consulted had not taken their concerns about their child’s ADRs seriously. In this context, the opportunity the Yellow Card Scheme offered a welcome opportunity for parents to voice their concerns about medicines in a way that was not filtered or influenced by practitioners: ‘I felt very pleased that I could [. . .] take control of it really and let someone know regardless of whether the doctor thought’ (YCP8). Other parents spoke of how submitting a Yellow Card provided a form of redress: ‘It’s kind of restorative justice in a way’ (YCP6) or helped to resolve their feelings of guilt about what had happened to their child: ‘It felt that I might have failed [my child] so that’s what I am doing it all for, really, to try and offload that information’ (YCP10).

Views and experiences of participants who had not submitted Yellow Cards

As we note above, the children we interviewed and most ADRIC parents knew nothing of the Yellow Card Scheme prior to participating in this study. When we explained the Yellow Card Scheme to them during the interviews, like the Yellow Card parents, most of the children and ADRIC parents were generally positive about the Scheme ‘I think that is a good idea as patients might think [an ADR] is important and doctors don’t’ (EC16) or spoke of the need for more to be done to publicise the Yellow Card Scheme: ‘We should be told about things like this [the Yellow Card Scheme] [. . .] if anyone has a reaction to a drug then they need to know that something is going to happen about it. It should be recorded’ (AC10). All but one parent said they would consider using the Yellow Card Scheme in future: ‘Now that I know about it, yeah, I would do. I’ll tell my friends about this actually’ (AP23). Despite this positivity, none of the ADRIC parents said that they would like to complete a Yellow Card for the particular ADR that we had discussed during the interview. Parents’ reluctance may be linked to their experiences of their child’s ADR. As described above, both ADRIC and Yellow Card parents had been dissatisfied with how health practitioners had communicated about ADRs, but ADRIC parents also described confusion and uncertainty about roles and responsibilities for recording and reporting a suspected ADR. Some assumed this was a practitioner’s role: ‘[I] just assume the doctor would sort it out’ (AP14), or expected that practitioners would submit Yellow Cards as a matter of course: ‘I would more than likely think that the doctors would do it [. . .] if the child has had a reaction they would automatically’ (AP13). Others implied that practitioners might disapprove of parents who submitted Yellow Cards and regard such parents as stepping beyond their role: ‘they might think that you are trying to do their job for them’ (AP20).

Some ADRIC parents were also reluctant to submit a Yellow Card on this occasion because they were uncertain about whether an ADR had occurred: ‘I don’t think they linked it to an adverse reaction at the time’ (AP25) or they felt that they or other members of the public were not equipped to decide if an ADR had occurred: ‘I’m not medical so I wouldn’t know what a reaction would be’ (AP18); it [the side effect] may not be from the drug, and [a parent] might think it is and go onto the internet and say that on a Yellow Card’ (AP22).

Perspectives on communication about adverse drug reactions

Parents were generally disappointed with how clinicians communicated about suspected ADRs. Although children focused on the concern or distress the ADR had caused them, they voiced fewer problems with clinicians’ communication. Children pointed to how their parents acted as intermediaries or conduits for communication about medicines and ADRs and this parental role may explain why children voiced fewer problems in communication compared with parents. The majority of parents reported receiving little or no advance explanation about the problems that might be associated with medicines. When information was provided, it was in ways that parents found hard to absorb. As a result, parents were taken by surprise when their child experienced a suspected ADR. This turned into frustration and confusion when clinicians were unresponsive to parents’ concerns and some parents felt dismissed or abandoned as a result. In the absence of explanation about what steps could be taken to prevent further ADRs, a few parents were reluctant to give their children medicines in the future. The key exception to these negative parental accounts was parents of children with cancer, who, despite their intense fears about the illness and treatment, were generally highly satisfied with how clinicians communicated about ADRs.

As well as being a source of avoidable distress, poor clinician–parent communication about suspected ADRs will impact on what parents communicate to their children about the ADR, challenge parents’ and children’s confidence in medicine, and contribute to negative perceptions and misunderstandings of medicines.^257,258 This could lead to poor adherence in the future. We found considerable convergence among participants about the nature of helpful communication. Their suggestions, which are similar to those reported elsewhere, included the importance of the timing and pacing of information, as well as the need for clinicians to explicitly acknowledge what had happened and help families to understand events that they perceived to be significant, even if the event is not significant from the perspective of clinicians.^258–260 The accounts of parents of children being treated for cancer indicated that, despite the complexities involved in prospectively explaining about ADRs while not raising undue alarm about medicines, communication about ADRs can be conducted in ways that parents find informative, understandable and reassuring.

One important challenge facing clinicians who communicate about ADRs is the uncertainty involved in attributing symptoms to medicines. We found that families’ accounts of how they linked symptoms to a medicine resembled the logic that underpins tools for assessing ADRs^53,188 in research and clinical practice. Participants noted temporal associations between a medicine’s administration and the onset of symptoms, the receding of symptoms between doses and the absence of alternative explanations for symptoms. This common ground could be a starting point for improving communication about ADRs. Alongside our other findings – parents accepted that all medicines come with risks, appreciated the uncertainty in attributing symptoms to medicines and did not blame clinicians for suspected ADRs – we think there is reason to be optimistic about the potential to improve clinician–family communication about medicines. However, this needs to be confirmed by investigating clinicians’ perspectives on communicating with parents about suspected ADRs.

Perspectives on spontaneous reporting of suspected adverse drug reactions

To our knowledge, this is the first study to specifically investigate how parents and children view the opportunity to report suspected ADRs directly to the MHRA. All participants saw value in direct reporting and those who had submitted Yellow Cards were satisfied with the Yellow Card Scheme. However, our key findings come from the ADRIC parents, none of whom had previously submitted a Yellow Card. These parents were generally supportive of the aims of the Yellow Card Scheme after it had been explained. Although they were positive about using the Scheme in the future, they were reluctant to use the Scheme to report the ADR discussed in their interviews. Comparing the settings, roles and perceptions of the Yellow Card and ADRIC parents helps to shed light on these findings. The Yellow Card parents generally reported events that had happened in the community, and linked to their professional roles, many were confident about using the Yellow Card Scheme. In contrast, the children of ADRIC parents had received hospital care for their ADR or were hospital inpatients at the time the ADR occurred. As such, these parents either expected that it was the responsibility of the practitioners looking after their child to submit a Yellow Card, or they were uncertain about whether it was legitimate for parents to report the ADR. Moreover, only a few ADRIC parents had personal links to health practitioners or were themselves health practitioners.

Parents who submitted a Yellow Card reported multiple motivations. Altruistic motivations, such as a desire to contribute to the improving the safety of medicines at a population level, were particularly prominent in their accounts. This is similar to findings on other patient groups who have reported ADRs, to clinicians’ motivations for submitting Yellow Cards^12,261,262 and it is also consistent with the goals of the MHRA.²²³ Linked to their dissatisfaction with practitioners for not taking their concerns about suspected ADRs seriously, some parents experienced reporting as providing a form of redress or felt reassured, as others have also described,^12,261,262 by the availability of an independent vehicle for ‘officially’ recording ADRs. A few parents pointed to how submitting a Yellow Card had helped to resolve feelings of guilt (about the medicines they had given or allowed their child to take), a motivation that has not been previously described and may be unique to parents and others who care for vulnerable patients. In this way, the Yellow Card Scheme seemed to enable parents to take action that seemed psychologically important following their child’s ADR, even if it would not directly benefit their child.

Consistent with previous research on adult patient reporters,^12,27,28 our findings indicate that awareness of the Yellow Card Scheme is limited and that further work is needed to promote the Yellow Card Scheme. Our study provides insight into the perspectives of parents and children who had not used the Yellow Card Scheme but were ‘eligible’ to do so. As we note above, participants supported the aims of the Yellow Card Scheme but they were reluctant to use it to report the ADR that we interviewed them about. The reasons for their reluctance may help inform strategies to widen participation in pharmacovigilance. The parents we interviewed were concerned that, because they lacked medical knowledge, their reports would be inaccurate or of little value. Emphasising that reports from members of the public can make a valuable contribution to drug safety would help to overcome such barriers, as would emphasising that people do not need to be certain that a medicine definitely caused a reaction in order to submit a report. Some parents expected that their child’s practitioners would report the ADR, yet practitioner participation in spontaneous reporting and other forms of pharmacovigilance is poor.⁴⁰ Informing the public that their reports are an adjunct to practitioner reporting may help to motivate them to participate in pharmacovigilance. Parents also worried that their reports might be perceived as undermining practitioners. These concerns could be addressed by emphasising that the Yellow Card Scheme is confidential and that information will not be shared with practitioners without a reporter’s consent.

Limitations

Our study had some limitations. First, we relied on clinical teams for access to children and ADRIC families. Clinical teams may have filtered out participants with whom their relationships were strained. To address this we sampled Yellow Card parents, as we could access them without consulting with clinicians. However, many Yellow Card parents were health professionals themselves, or had contacts who were, and their views on communication about ADRs and pharmacovigilance may be distinctive. Previous studies of patients’ perspectives on spontaneous reporting pharmacovigilance schemes share similar limitations. This arises from the limited public awareness of the Yellow Card Scheme. In this context, our sampling of participants with experience of a suspected ADR but who had not used the Yellow Card Scheme is particularly important. The views of such groups have rarely been investigated, yet they are crucial in identifying how public participation in pharmacovigilance may be promoted. Moreover, the accounts of both ADRIC and Yellow Card parents triangulate in pointing to the difficulties parents experience in communication about ADRs. Finally, the interviews were conducted sometime after the suspected ADR, which may have shaped participants’ accounts in certain ways. However, understanding the meanings that parents and children take away from their experiences of ADRs is crucial in learning how to enhance their experiences and it is these meanings that were the focus of our study.