Compounded glycopyrrolate is a compelling choice for drooling children: five years of facility experience

Abstract

Background Describe the efficacy of a galenic glycopyrrolate formulation and its impact on patients with sialorrhea Quality of Life (QoL), including costs analysis. Methods We performed a retrospective observational study on 21 patients who received a custom-formulated galenic glycopyrrolate syrup for sialorrhea for an average period of 14.3 months. We analyzed the telephone interviews with elaborated and validated questionnaires and the therapy costs comparing the brand marketed drug with the galenic formulation. Results Overall, 16 out of 21 patients (76.2%) reported a significant improvement in sialorrhea and QoL. In 14 subjects (66.7%), there was a remarkable decrease in the drooling severity; 10 individuals (47.6%) reported a reduction in drooling frequency. Nine patients experienced at least one adverse effect of glycopyrrolate therapy, and three of them stopped the treatment. No severe side effects were observed. The galenic drug significantly reduced costs for patients. Conclusions An oral glycopyrrolate solution easily administered to children with brain injuries is not commercially available in many European countries. This study demonstrates the efficacy of a compounded glycopyrrolate syrup on drooling severity, frequency and ensures a better QoL in patients and their caregivers.

Impact of compounded drugs on the caregivers’ burden of home therapy management in pediatric palliative care: A descriptive study

“…For example, the costs of a 1 mg of glycopyrrolate are 5.28 € and 0.34 € respectively for the industrial product and the galenic syrup compounded at the hospital pharmacy of the Institute for Maternal and Child Health Burlo Garofolo in Trieste, Italy. 15 Finally, the introduction of telemedicine and the use of a computerized therapy schedule may help caregivers in administering the right therapy at the right time and reducing the risk of errors. From a broader perspective, the use of telemedicine in pediatric palliative care has recently started to be investigated and its advantages are still scarce.…”

“…In fact, they are prepared ad hoc according to each patient's needs and characteristics, either in terms of type and flavor of formulations (e.g., syrup, oral suspension) or of dosage. Moreover, galenic preparations may overcome the difficulties in finding effective products on the market 15 or may cut down the costs of their purchase.…”

Current Aspects of Treatment Options of Chronic Sialorrhea in Children

“…Salivary production is normal in newborn, finishes around the 15-18th months of age and is pathological at age 4 [ 1 , 3 , 5 , 6 , 9 , 14 ]. Different subjective scales show different extents of chronic drooling [ 23 , 31 , 34 , 44 ]. Risks of chronic drooling in childhood are macerated facial skin, respiratory involvement with aspiration and pneumonia and water imbalance with dehydratation in the child in excessive forms of hypersalivation.…”

“…Non-pharmacological therapy options are speech-, physio- and orofacial therapy. Pharmacological options to treat sialorrhea are botulinum A/B intra-glandular injections (level A evidence) and anticholinergic treatment like glycopyrronium bromide or transdermal patch therapy with scopolamine (level B evidence) [ 9 , 13 , 15 , 18 - 20 , 28 , 29 , 31 , 32 , 34 , 35 , 38 , 39 , 43 , 44 , 47 ]. Useful drug therapies for acute hypersalivation include various application forms of glycopyrrolate, of which glycopyrronium bromide received a pan-European pediatric use authorization (PUMA) in 2017 for the symptomatic treatment of hypersalivation in children and adolescents [ 5 ].…”

“…Useful drug therapies for acute hypersalivation include various application forms of glycopyrrolate, of which glycopyrronium bromide received a pan-European pediatric use authorization (PUMA) in 2017 for the symptomatic treatment of hypersalivation in children and adolescents [ 5 ]. In recent years, botulinum toxin injections into the major salivary glands have been shown to be an effective and safe treatment modality with long-lasting saliva reduction [ 9 , 13 , 15 , 18 - 20 , 28 , 29 , 31 , 32 , 34 , 35 , 38 , 39 , 43 , 44 , 47 ]. All anticholinergic medications induce typical side effects like dry mouth, constipation, urinary retention and reduced bronchial secretion.…”