Despite the delays and increasing attention in the prevalence of polypharmacy in the pediatric context due to the rising number of pediatric complex conditions [25, 26] the impact on caregivers’ life of a complex drug administration and their daily management has not been deeply investigated. This is the reason why we wanted to collect the experiences of caregivers of patients of our PPC Center, regarding the manipulation, preparation, and administration of pharmacological therapy, including any administration errors, and the associated expectations on therapy.
CMR are difficult to manage for clinicians because of the multiple possible interactions but also for caregivers that need specific and personalized training. To date there are few dedicated tools to help clinicians and pharmacists to identify and measure the various aspects of the burden associated with medication complexity in the adult population [27, 28]. In our panel of patients, only about half (59%) reported having had training in the use of their child's drug therapy and among them only one family had the possibility of being referred to a pharmacist. The implementation of parental training on this topic is mandatory not only at the beginning of their taking charge but should be renewed regularly in order to minimize error of preparation or administration. The lack of many child-friendly formulations impacts negatively on the time invested for medicine preparation with a reduction of quality of life for caregivers. Most of the caregivers, indeed, are investing around 3 hours/week in preparing medicaments where half of them (43%) report difficulties in maintaining the correct interval and to do some manipulation (55%) mixing the medications up with some food or beverages. It could lead to an unpredictable modification of the medication bioavailability [29] with a possible increase of adverse drug effect and, if administered via feeding tubes, obstruction and malfunctioning of them. All of these therapeutic schemes must be re-evaluated individually in order to understand the appropriateness and efficacy of the manipulations in relation to the pharmaceutical form, as well as whether it is possible to lighten or bundle the administration strategy in order to facilitate the caregiver's role. As suggested by Burlo et al. galenic compounds could help caregivers to simplify therapy administration, improving quality of life for patients and their families and possibly reducing administration error [30].
It's also worth noting that 14% of parents acknowledge making mistakes in preparation or administration in the recent three months, implying that the true number of cases of failure when the caregiver was unaware might be greater. The major reasons cited were tiredness and load during therapy administration, as well as the complexities of the therapeutic regimens. A post-hoc analysis was carried out trying to identify the items that could correlate with the risk of error. We identified the items and developed a score (SCARES score) that correlates in a statistically significant manner with the risk of error. This score will need to be validated on a larger sample but this result can certainly indicate possible corrective intervention to reduce the risk of error, such as: medication review, deprescribing (when possible), using child-friendly drugs and improving caregiver training and support.
Another important point is the caregiver's perception about the medication regimen: 62% of them report that their children are taking too many medications and 23% are not completely satisfied with the symptoms. These data should be analyzed carefully through a medication review process in order to optimize these therapies in terms of formulation and characteristics but also trying to understand possibly the psychological and social reasons at the base of this discontent, considering not only in the clinical perspective.
To note, 73% of caregivers responded positively to the possibility of having direct counseling with the clinical pharmacist to discuss their doubt about the therapy preparation or administration.
To date, there is no literature specifically addressing patients in PPC. However, from studies conducted in the general pediatric population, it appears that pharmacist-led intervention can significantly reduce therapeutic errors, as reported in this review [31]. In this RCT was reported a reduction of length of stay (LOS) of pediatric patients with respiratory system disease and an improving compliance rate through discharge education [32].
If confirmed also in the PPC population these results would be of considerable importance given the fragility of this population, the risk of medication error and the importance of ensuring proper adherence to therapies to control symptoms and guarantee the best quality of life.
We believe that the involvement of the clinical pharmacist, given the evidence in the literature and the favorable opinion of the caregivers we interviewed, can lead to a substantial improvement in quality even in a pediatric palliative care team in order to take care of patients and families in a more holistic way.
This study has some limitations. First, this is a cross-sectional, non-prospective, monocentric study. Side effects or adverse reactions related to CMR and off-label drug use have not been investigated. The possibility to repeat a more extended assessment will be the subject of future studies that will provide a more exhaustive characterization of medicine management among the PPC cohort.
Figure 4 (TITLE: The improvement strategies) describes the three action points have been activated after this survey in our center: first to offer via tele-consultation the possibility for the caregivers to have a direct contact with a clinical pharmacist in order to discuss further all the specificities of their medication regimen and secondly a systematic review of all the medication regimen highlighted as difficult to managed by parents in a multidisciplinary team of clinicians and pharmacists on regular basis. Eventually we implemented parental training done by our nurses on medication regimen with a pamphlet dedicated to the most common “daily challenges” in drug preparation as a reminder available in paper and in our center website [33].
The identification and characterization of patients with CMR in an effective way is going to be a starting point of discussion for systematic medication reviews in order to contain and reduce the risk of adverse effects, interaction and their care burden.