The use of Pillglide® in Children: A pilot study
Mamta Jagani1, Hélène Legay1,2, Sejal Ranmal2, Kuan Ooi1, Catherine Tuleu2Great Ormond Street Hospital for Children NHS Foundation Trust; 2UCL School of Pharmacy, London, UK
As paediatric pharmacists, we are constantly faced with the challenges of supporting parents in managing children who are struggling totake their medicines. This is not helped by the reality that the majority of medicines (>70%) are available as either tablet or capsule which areunsuitable for children to swallow. And for the small proportion of medicines available as liquid there is the additional issue with their palatability. Pillglide® came to our attention when it was made available in the UK in 2009 as a licensed medical device for adults with swallowing difficulties.The aim of the study is to investigate if Pillglide® would benefit children aged 3 years and older to comply with their medicines (tablet, capsule or liquid preparations) compared to standard behavioural approach alone.
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Prescribing for children – taste and palatability affect adherence to antibiotics: a review.
(Arch Dis Child 2012;97:293–297. doi:10.1136/archdischild-2011-300909)
- The taste of an antibiotic is often not taken into account by practitioners, although there is significant evidence to show palatability correlates strongly with adherence.
- A patient-centered approach involves effective communication and partnership between the child, parents and professionals. Open discussions around issues such as taste, formulation and dosing schedule can influence the selection of an appropriate antibiotic and the success of the treatment.
Palatability of liquid anti-infectives: clinician and student perceptions and practice outcomes.
(J Pediatr Pharmacol Ther. 2007 Oct;12(4):216-23. doi: 10.5863/1551-6776-12.4.216)
- For children, the smell and taste of the product can be major factors in their acceptance and willingness to comply with the prescribed therapy.
- It can be a struggle to administer a medication to a child when the child finds the taste of the product unpalatable.
Promoting medication adherence in children.
(Am Fam Physician. 2006 Sep 1;74(5):793-8)
- The problem of getting children to follow a treatment regimen is widespread and is frustrating for physicians.
- Having the child participate in devising the plan improves adherence.
Assessing the palatability of medications in children.
(Paediatric and Perinatal Drug Therapy, Volume 8, Number 2, September 2007 , pp. 55-60(6)
- After efficacy and safety, taste or palatability was ranked highest among the antibiotic features that were most important to parents.
- Many have faced the daunting task of forcing a sick struggling child to take an antibiotic that he or she is refusing. The result is often spitting out or vomiting of the medication resulting in the child receiving only a portion of the therapeutic dose.
- Take into account factors such as taste that may affect the ease with which parents are able to administer medications to their children.
Formulation of medicines for children.
(Br J Clin Pharmacol 59 :6 674–676 674 © 2005 Blackwell Publishing Ltd British Journal of Clinical Pharmacology).
- Liquid medicines are usually recommended for infants and younger children so the ability to mask unpleasant taste with sweeteners and flavors is crucial.
Optimizing Oral Medications for Children.
(Clin Ther. 2008 November ; 30(11): 2120–2132. doi:10.1016/j.clinthera.2008.11.018)
- Effective methods of avoiding unpleasant tastes for adults (eg, encapsulating the medicine in pill, capsule, or tablet form) are problematic because many children cannot or will not swallow these.
- The unpleasant flavor of the medicine can thwart the benefits of even the most powerful drug, and failure to consume medication may do the child harm, and in some cases, may be life threatening.
How Do You Improve Compliance?
Pediatrics Vol. 115 No. 6 June 1, 2005 pp. e718 -e724 (doi: 10.1542/peds.2004-1133)
- Poor compliance places children at risk for problems such as continued disease, complicates the physician-patient relationship, and prevents accurate assessment of the quality of care provided.
- Reliability of data on compliance is subject to question, and it is likely that compliance is significantly lower than reported in many publications. For example, parent reporting of compliance has been documented to be grossly overrated. Elliott et al4 reported that mothers claimed 60% compliance with obtaining prescribed refills, but pharmacy records indicated that only 12% adhered to the schedule.
- There is a paucity of studies of crushed tablets (a common practice in pediatrics) that may affect potency and compliance. Furthermore, ingesting a volume of fruit juice to mask the taste of a drug has potential to alter the bioavailability of the drug. Therefore, flavoring can play a major role in pediatric medication.
Challenges of Developing Palatable Oral Paediatric Formulations.
(International Journal of Pharmaceutics 365 (2009) 1–3)
- Compliance of pediatric patients can also be improved by taking into account individual taste preferences of the child.
- The PIP guidelines list taste masking and palatability as proposed studies of particular relevance to the development of pediatric products.
Formulations of Antibiotics for Children in Primary Care.
(Pediatr Drugs 2002; 4 (5): 323-333)
- Compliance and completion of therapy in young pediatric patients primarily depends on the taste of suspension medications.
- For children, smell and taste are major determinants in acceptance, and preparations that taste good improve the chances of these patients successfully completing prescribed medications.
- Every parent knows that bitter products result in a daily struggle with his or her infants. This influences their preferences for therapy to the point that many parents prefer injectable antibiotics.
Challenges Associated with Developing Medicines for Children- An Industry Perspective.
(European Pediatric Formulation Initiative (EUPFI)
- “Voice of the customer” intelligence is absolutely critical to developing medicines for children.
- Children are far less tolerant than adults. If a child tries something once and doesn’t like it there often is no going back.
A Report from the Pediatric Formulations Task Force: Perspectives on the State of Child-Friendly Oral Dosage Forms.
(Pediatric Formulations Task Force)
- Clinicians, patients and their care-givers, as well as society as a whole, place high value on pediatric clinical care.
- It necessarily follows that the availability of suitable pediatric dosage forms is of vital importance, as the availability of innovative, convenient and high-quality pediatric products can spell the difference between successful treatment of a pediatric patient or failure.
3.9 Acceptability and palatability -methods available for assessment.
(European Medicines Agency)
- Compliance rates in children range from 11-93%, with major factors attributed to formulation and palatability.
- Patient acceptability is likely to have a significant impact on the patient’s adherence and consequently on the safety and efficacy of the medicine.
A Palatability Study of a Flavored Dexamethasone Preparation Versis Prednisolone Liquid in Children with Asthma Exacerbation in a Pediatric Emergency Department.
(Department of Pediatrics, Children’s Hospital of Western Ontario, Children’s Health Research Institute and Department of Medicine, University of Western Ontario, London, Canada)
- In a pediatric population, the acceptability of a liquid medication, and hence its ease of administration, is important to consider to maximize patient compliance.
- Isa et al demonstrated that at least when parental preference was examined, taste was more important than volume in terms of preference of medication for their child.