The response rate was good: Table 1 gives the number of questionnaires mailed and returned at each age. The majority of questionnaires were completed at or close to the intended age. For example, 90% of the returned month 54 questionnaires had been completed by 55 months and 99% by 58 months, so all data from the 54–91 month questionnaires have been included. However, as the purpose of the question at 4 weeks was to ascertain what medicinal products were used on the study children as very young babies, a cut-off was applied so that only questionnaires completed before the child was 8 weeks old were included. Using this criterion, at least one questionnaire was completed for 12,525 study children and all 4 were completed for 6,635 children.
For most of the defined categories, the number of tick box responses not supported with a text response giving the name of the product increased between the ages of 54 and 91 months (at 4 weeks, responses to the medication question were all collected as free text).
The week 4 questionnaire was completed before the child was 8 weeks of age in 10,897 cases (80% of those sent, 88% of those returned). Around three-quarters of study children were exposed to some form of medicinal product before 8 weeks of age. At this age, dermatological products were most commonly reported, mainly those for treatment and protection against nappy rash, such as ‘Sudocrem’, a proprietary product containing zinc oxide used in 29% of babies, and zinc and castor oil cream used in 22%. Simeticone (activated dimeticone) in products for treatment of colic and flatulence, such as ‘Infacol’, was given to 16% of babies. Gripe water (terpeneless dill seed oil and sodium bicarbonate) was used in 13% of the cohort. Other commonly reported products included oral and topical antifungals and ophthalmic antibiotics (mostly chloramphenicol). A few babies (2.3%) were given vitamin drops. Some were given herbal drinks (2.2%), homeopathic products (1.2%) and a variety of topical complementary and alternative medicine products, such as calendula and camomile creams (3.3%).
Several OTC products not licensed for use in this age group were reported. For example, inhalant decongestant products not licensed for children under 3 months of age—Snuffle-babe Vapour Rub (eucalyptus oil, menthol and thyme oil), Karvol Decongestant Capsules for inhalation (levomenthol with chlorobutanol, pine oils, terpineol and thymol) and Vicks Vaporub (levomenthol, camphor, eucalyptus oil and turpentine oil)— were used in over 6% of the cohort, and xylometazoline nasal spray was used on 0.6%. Calpol (paracetamol), which is licensed from 2 months, was given to over 1% when they were under 8 weeks old.
At the older ages, 54, 78 and 91 months, 9,728 (78% of those mailed), 8,578 (78%) and 8,269 (73%) questionnaires were completed and returned, respectively. In these latter questionnaires, relatively few children were reported not to have used any medicinal products in the preceding 12–18 months. At 54 months (4.5 years), only 129 children (1.3% of those returning the questionnaire) were not reported as having used a medicinal product since the age of 3. At 78 and 91 months, the figures were 339 (4.0%) and 329 (4.0%), respectively. Table 1 shows the number of products reported per child at each age.
Table 2 shows the frequency of use of medicinal products, by ATC code, at each data collection time. The data are presented as the total number of drugs reported in an ATC class per number of children in which any products within this class were used (i.e. more than one product in a class may have been reported per child). The pattern of use of different categories of medicinal product varied with age. Usage of several product categories was higher at 54 months than at 78 or 91 months. For example, at 54 months, 1,052 children (10.2%) were reported to have used topical steroids (mostly hydrocortisone) compared with 7.4% at 78 months and 4.9% at 91 months. Paracetamol (as a single ingredient) was recorded for 9,211 children (94.7%) at 54 months, 7,595 (88.5%) at 78 months and 7,247 (87.6%) at 91 months. In addition, systemic antibiotics (mainly amoxicillin), laxatives (mostly lactulose), treatments for diarrhoea (mainly rehydration salts), various cough and cold products, emollient and protective skin preparations (mostly paraffin-based proprietary products), topical antipruritics, antihistamines and local anaesthetic products were all greater at 54 months than at the older ages. Conversely, use of other categories, such as throat preparations (sprays and lozenges), and anti-inflammatory products, increased with increasing age. Use of ‘asthma’ medication (mainly salbutamol and beclomethasone) also increased with increasing age; at 54 months, 6.8% of the cohort reported use of anti-asthmatics, by 78 months this had increased to 12.0% and to 14.2% at 91 months. Of the 1,174 children reported as having used asthma medication at 91 months, 1,038 (88%) had previously had a diagnosis of ‘asthma’ from a doctor and 907 (77%) reported having asthma in the past 12 months.
Treatments for less common conditions were also reported by this community sample. By 91 months, 6 children were using insulin, 17 reported methylphenidate (for attention deficit hyperactivity disorder) and 2 reported thyroid therapy. At 54 months, 28 children reported antiepileptic medication but this had reduced to 15 children by 91 months.
Between 54 and 91 months, a very small number of children were reported to have been given an OTC medicine, whilst they were younger than the age specified on the Patient Information Leaflet or Summary Product Characteristics, for example, aspirin, ‘Dequadin’ lozenges (dequalinium chloride), ‘Night Nurse Liquid’ (paracetamol, pomethazine hydrochloride, dextromethorphan hydrobromide) and ‘Diocalm’ (morphine hydrochloride and attapulgite).