Data of literature [13] and our own clinical experience show that the needs of children and their parents should be more carefully considered in practical drug administration. Therefore, we explored the main causes of problems in drug handling by children and their parents. The ideas of children and their parents about how a medicine should best be administered was of particular interest in this survey. For this purpose, we performed a prospective observational study on children’s and their parents’ experiences of drug administration and their expectations of the ideal pediatric drug. A high proportion of children and parents reported having experienced drug-handling problems. Concerning preferred characteristics of an ideal pediatric drug, most answers were highly heterogeneous and often differed between children and their parents.
Experiences of drug-handling problems (Part A)
A high proportion of children and parents reported previous drug-handling problems in the context of pediatric drug therapy. The described problems were in the context of preparation of the drug formulation, dosing accuracy, compliance with the time interval between two administrations, and the children’s acceptance of the drug.
Many parents reported problems with the preparation of oral antibiotic suspensions. They described for example that the powder clumped, that they experienced extensive foam formation, and that the fill mark for water was difficult to see due to foam. Since antibiotics are almost exclusively used for acute treatment, parents are usually not familiar with their handling. In an earlier study, a pharmacist’s verbal education supported by photographic education material was much more effective in providing information on correct preparation of oral antibiotic suspensions to caregivers than the sole provision of package leaflets or education sheets [7].
A high proportion of parents reported problems in dosing liquids, especially due to dosing devices they experienced as inappropriate. This is in line with data from literature that show that more than 40% of parents made dosing errors preparing liquid medications. With advanced counseling and provision of dosing aids, those errors could be reduced [23]. However, different dosing aids show different accuracy. In particular, medicine cups that parents like to use have a reduced accuracy [17,20]. Thus, parents should be educated on the correct use of devices with a higher accuracy such as syringes. Besides, the examples provided by the parents in our study show that many devices are inappropriate with scales difficult to read, spoons too big for the child’s mouth, or dosing pipettes not fitting to the bottle adapter. Those problems have to be addressed by pharmaceutical companies.
The participants of our study also described problems concerning the splitting of tablets. This is in accordance with data from literature. For example, it was shown that in spite of functional break lines, the quartering of 10 mg hydrocortisone tablets caused unacceptable dose variations. Thus, the authors of the study favor mini-tablets in adequate dosages for children [9].
Participants of our study also reported difficulties in adherence to the time intervals for medication intake due to periods of sleep or missing compatibility of the intervals with daily routines. To increase adherence as well as quality of life, physicians, parents, and their children should aim at finding time intervals that are compatible with the families’ daily lives.
The participants of our study described reduced acceptance of medicines due to taste or odor issues or difficulties in swallowability. The preferences of children concerning those issues should be considered. Children’s preferences about their medication are very individual. This, however, makes it difficult to achieve the goals that have been set to improve drug handling in this population.
To ensure the safety and effectiveness of a drug therapy, drug-handling problems should be addressed and, whenever possible, prevented. Studies have shown that pharmacist intervention reduces medication errors in drug administration [2,4,11,12]. The instructions should be explained in a precise, simple, and understandable way. Placebo medicinal products and pictograms can increase comprehensibility. Children’s adherence can also be improved if they are actively involved in their medication process as early as possible [3].
Expectations of the ideal pediatric drug (Part B)
The peroral route of drug administration was preferred by most participants. This is in accordance with earlier studies that describe barriers to administering non-peroral formulations to children [21]. Thus, in drug development and prescription, the focus should be on peroral drug formulations.
The children’s favored characteristics of drug formulations were highly individual. Only when asked about the favored taste of peroral dosage forms, an age-dependent effect could be shown. Sweet flavors were preferred by younger children while older children tended to prefer neutral flavors. This is in accordance with findings of earlier studies that infants and children showed an elevated preference for sweet flavors [5]. Considering the individual expectations of children and adolescents, ideally different formulations of an active ingredient should be available to meet the children’s preferences as much as possible. Through an increased collaboration between physicians, pharmacists, and parents and their children, the choice of the most suitable drug formulation can be supported [1]. Even if not every administration problem leads to severe clinical consequences, it should be considered that drug-handling problems are closely related to a negative impact on adherence [8]. Therefore, resolving drug-handling problems can not only eliminate direct consequences of the problems themselves, but also reduce indirect consequences of decreased adherence. In the present study, we aimed at identifying problems from the perspectives of children and their parents and to elaborate their proposed solutions for future activities.
Preferences of children and parents concerning drug formulations differed in around half of the reports. Our findings are in line with earlier studies that have shown that children are indeed well able to express experiences and expectations concerning their drug therapy [10,22]. Nevertheless, physicians tend to talk to the parents when they aim at exploring the children’s needs. As each child, however, has individual desires and needs, pediatricians should communicate directly with children about their drug therapy and disease management at an appropriate cognitive level. While it takes more time and empathy compared to the communication with parents, children have sophisticated information needs concerning health issues [6,18]. In addition, when it comes to the appropriate drug formulation, children need to be actively involved in the decision-making process to reach optimal acceptance and adherence with the prescribed drug therapy. As we could show, parents were not always able to properly assess their children’s needs.
A particularly interesting finding of our study were single reports on proposed ideal drugs from children and parents. The suggested dosage forms ranged from the smallest possible tablets, to transdermal systems, to nasal spray, or even to mist and to utopian transmission by means of (sound) waves via headphones. The onset of action should be fast and the ideal taste ranges from neutral to pleasantly flavored, e.g. lemon or strawberry, up to savory flavors like mashed potatoes or pizza. Free choice of taste and the possibility of mixing the medicine into food were also preferred as far as taste was concerned. Red color, animal shapes, and smiley faces were mentioned visual preferences on tablets, particularly but not only mentioned by children. Parents would like to see more easy-to-read instructions for use on the package or an included anesthesia for auto-injectors.
In summary, we found a high variability in preferences that are reflected in the responses to the open question about the ideal pediatric drug. The answers were very individual and did not reveal a clear pattern. The children and their parents addressed not only practical aspects such as instructions for drug handling printed on the package, but also futuristic technological drug formulations such as the communication of effects via headphones.
Limitations
We were only able to directly address the perspective of children who had the maturity and intellectual capacity to answer the questions. In the case of younger children, only the parents’ perspective could be directly explored.