Tw de Vries

Lack of appropriate formulations of medicines for children in the community

Aim: Appropriate formulations are essential in pharmacotherapy. This study surveyed the use of different formulations by children in the community, and examined the reported lack of appropriate formulations (oral solutions) in relation to the licensing status of drugs. Methods: A crosssectional study based on 68 019 pharmacy dispensing records was performed in The Netherlands. For each prescription the formulation was assessed, and all prescriptions were categorized: unlicensed (no product licence), off‐label (licensed drugs used outside the licence terms) and authorized (licensed drugs used according to the licence). The types of formulation used were assessed in relation to age and licensing status. Results: In all age groups, approximately half of all prescriptions were for oral drugs. The only major age‐related trend was within oral drugs: younger children were more likely to be prescribed oral solutions. For authorized drugs the proportion of tablet/capsules exceeded oral solutions at the age of 7 y, whereas for off‐label drugs this occurred at 3 y of age. For those medicines prepared by the pharmacy, tablets and capsules were more likely to be prescribed from the age of 9 y.

Antiepileptic drug utilization in children from 1997-2005--a study from the Netherlands.

ObjectiveTo investigate the utilization of antiepileptic drugs (AEDs) in Dutch children and compare this with guidelines on the treatment of epilepsy in children.MethodFrom the Dutch Interaction Database (IADB.nl) we selected children aged 0–19 years who received at least one prescription for an AED (ATC-code beginning with N03A) between 1997 and 2005. We calculated cumulative incidences and prevalences per 1000 children per year, stratified by age-category, sex and type of AED, and the total number of months each patient received at least one prescription of AEDs, and we counted the number of person-months and AEDs prescribed. For each AED, proportions of person-months were calculated for mono- and combination therapy. Kaplan-Meier survival analysis was used to analyse the duration of AED use, stratified by sex.ResultsThe overall prevalence of the prescription of AEDs to children was constant at approximately 4.0 per 1000 children during the years of the study. The overall cumulative incidence from 1997–2005 was 0.67 per 1000 children. When stratified by age category or sex, there were no relevant differences in incidence or prevalence. Valproic acid was the most frequently prescribed drug, followed by carbamazepine and lamotrigine. In 20.3% of all person-months, patients received combination therapy; of these, 34.2% received combination therapy for 3 person-months or less. The older AEDs were prescribed more often as monotherapy than combination therapy, in contrast with the newer AEDs, for which the opposite was true. The 50% survival probability (= time period when 50% of children had stopped using AEDs) was around 2 years, with a significantly lower discontinuation of treatment for girls than boys (P = 0.04).ConclusionThe overall cumulative incidence of AEDs was determined to be 0.67 per 1000 children, and the prevalence 4.0 per 1000 children. The most frequently prescribed drug is valproic acid, followed by carbamazepine and lamotrigine. The prescribing of AEDs seems to be in conformity with the overall recommendations of the guidelines on the treatment of epilepsy in children.

Reported adverse drug reactions during the use of inhaled steroids in children with asthma in the Netherlands.

ObjectivesInhaled corticosteroids (ICS) are widely used in the treatment of asthma. We studied the suspected adverse drug reactions (sADRs) reported during the use of ICS in the Netherlands.MethodsIn the Netherlands, health professionals and patients can report suspected ADRs to the Pharmacovigilance Centre Lareb. All reported sADRs on ICS were categorised and assessed as to whether these were likely to be associated with use of the steroid. Age and gender adjusted Reported Odds Ratios (RORs) and Naranjo Scores (NS) were computed for sADRs reported more than 3 times.ResultsSince 1984, sADRs of ICS were reported in 89 children (mean age 6 years), 48 (54%) were boys. Suspected drugs were fluticasone in 46 children (52%), budesonide in 21 (24%), and beclomethasone in 22 cases (24%). Psychiatric symptoms were reported in 19 children (21%; ROR 3.8, NS 3.6), growth retardation in 6 children (7%; ROR 47.8, NS 3.0) and rashes in 6 cases (7%; ROR 0.7, NS 2.4). There were 7 reports (8%; ROR 2.1, NS 3.4) concerning abnormalities of the teeth, 4 reports of alopecia (4%; ROR 3.3, NS 3.5), and 3 reports of hirsutism and hypertrichosis (NS 4.0). Non-fatal adrenal insufficiency was reported once.ConclusionsAlteration of behaviour was the most frequently reported sADR. There are more indications that alterations of behaviour could be a real sADR of ICS. Non-fatal adrenal insufficiency was the only reported possible life threatening sADR. The association of hypertrichosis and teeth abnormalities after ICS in children has not been reported in the literature before.

Salbutamol for hyperkalaemia in children

Hyperkalaemia is a potentially fatal disorder that demands direct treatment. The efficacy of traditional medical treatment is unpredictable, limited, of short duration or carries the risk of serious adverse events. The administration of salbutamol for hyperkalaemia in children is described in several clinical trials and case reports.

Inhaled corticosteroids do not affect behaviour

Aim: To determine whether children with asthma and on inhaled corticosteroids have more behavioural problems, such as aggressiveness and hyperactivity, as compared with healthy controls and with children under medical care because of other disorders.

Effect of a minimal pharmacy intervention on improvement of adherence to asthma guidelines

Objective To study the effectiveness of a minimal intervention strategy to improve adherence to paediatric asthma guidelines. Design and setting A group of pharmacists was encouraged to discuss essential elements of asthma care with the general practitioners they normally worked with. Adherence to guidelines was evaluated by studying prescriptions for children with asthma. We compared the treatment of children registered at pharmacies which participated in the study (intervention group) with a control group of children registered at other, non-participating pharmacies (reference group) and with the results of an earlier study. Main outcome measures The numbers of children who had no short-acting betamimetics, no inhaled corticosteroids while on long-acting betamimetics, and more than one type of inhaler. Results The number of children who had no shortacting betamimetics was significantly lower in the intervention group (176/1447 vs 534/3527; p<0.01) and fewer children had no inhaled corticosteroid although on long-acting betamimetics (6/219 vs 41/477; p=0.03). The number of children who had more than one type of inhaler was equal in both groups (5.1%), but this was significantly lower compared with the earlier study (119/2311 vs 239/3217; p<0.01). Conclusions The assistance of pharmacists with adherence to paediatric asthma guidelines is beneficial. Pharmacists should be involved actively in the care of children with asthma.

Progressive facial hemiatrophy : a complex disorder not only affecting the face. A report in a monozygotic male twin pair

Progressive facial hemiatrophy (PFH) is a ubiquitous disease, characterized by hyperpigmentation of the skin followed by unilateral craniofacial atrophy of subcutaneous tissues, including fat, muscle and bone. Hereditary factors have been postulated to be involved in the aetiology of PFH. Yet, the occurrence of PFH in one of two identical male twins reported here makes this possibility unlikely. PFH usually occurs in the first two decades of life, and the clinical presentation resembles linear scleroderma. PFH may be complicated by autoimmune, neurological, ocular and dental disorders. Management of PFH comprises a long term follow‐up of somatic disorders, and prevention of psychological problems. Treatment of PFH is symptomatic and consists of plastic surgery after the disease activity has stopped.