Introduction 13 6 7 7 12 11 2 8 9 3 This study describes the patterns of parentally-reported use of all types of medicinal products in a large community sample of young children, at four data collection times between the ages of 4 weeks and 7.5 years. Methods 5 http://www.alspac.bris.ac.uk 5 The primary source of data collection is via postal questionnaires about the health, development and home environment of the study children completed by each child’s main carer, usually the mother. This paper presents data obtained from four such questionnaires administered when the study children were 4 weeks, 54, 78 and 91 months old. Each of these asked questions, designed by the ALSPAC study team, about the use of medicinal products. The 4-week questionnaire (sent out between 1991 and 1993), asked the baby’s mother to: “Please list all the ointments, pills and medicines that have been given to your baby while he/she has been at home. Check: have you included ointments to prevent nappy rash, eyedrops, herbal remedies, etc.” Cough medicine Antibiotics/penicillin Throat medicine Vitamins Paracetamol/calpol Ointment for skin Eye ointment Diarrhoea mixture/pills Dimotapp/decongestant Ear drops Eye drops Iron Laxatives Homeopathic medicine Herbal medicine Other For each category, the carer was asked to tick whether the response was ‘Never’, ‘Yes, for one episode only’ or ‘Yes, for 2 or more episodes’; and ‘If yes, please give full names of substances if you can’. Are there any pills, ointments or medicines that he/she has taken every day or nearly every day for the last 3 months? (Include vitamins, skin cream, inhaler, laxatives as well as antibiotics, homeopathic and herbal remedies, etc.) If yes, please describe. Cough medicine Antibiotics/penicillin Throat medicine Vitamins Paracetamol/calpol Ointment for skin Eye ointment Diarrhoea mixture/pills Dimotapp*/decongestant Ear drops Eye drops Iron Laxatives Homeopathic medicine Herbal medicine Asthma medication Vaporiser Other (*active ingredients: brompheniramine, phenylephrine and phenylpropanolamine) The tick box response options, the request for full name of the product, and the second question were the same as at 54 months. After a questionnaire was sent out, if a response was not received within 3 weeks, a reminder letter was sent. If the questionnaire had still not been received after a further 2 weeks, a second reminder letter was sent. Finally, if no response had been received after 3 months, a member of the study team either rang the mother or visited her home, and encouraged or helped her to complete the questionnaire. The date of completion is included on each questionnaire, so whilst all returned questionnaires are added to the database and included in the overall response rate, those that were completed after a defined cut-off date can be excluded from individual analyses. Most of the self-completion responses on the questionnaires are self-coding—the ticked reply box contains a printed number that can be directly keyed. However, the actual names of medicinal products used (including vitamins and supplements, herbal products, homeopathic remedies, over-the-counter and prescription products) were collected as free text responses. http://www.whocc.no/atcddd/ In cases where a category of medicinal product was ticked as having been used but no further details were provided, a non-specific code for that category has been added to the database of text responses. For the purposes of this report, all responses indicating that a product in the defined category had been used have been included, thus indicating ‘ever use’ of these categories of medicinal products rather than taking into account frequency of use. Results 1 Table 1 Total number of medicinal products recorded per child at each age   4 weeks (<8 weeks) 54 months 78 months 91 months No. of questionnaires sent out 13,659 12,374 10,914 11,251 No. of completed questionnaires a 9,725 8,578 8,269 Total no. products recorded per child 0 2,573 129 339 410 1 3,029 557 1,010 1,139 2 2,594 1,400 1,746 1,911 3 1,502 2,020 1,715 1,759 4 687 1,834 1,370 1,317 5 320 1,382 1,001 771 6 130 939 590 451 7 39 578 346 227 8 13 352 179 133 9 10 205 139 77 10  103 51 43 11  74 33 32 12  49 24 12 13  30 13 7 14  25 6 7 15  16 10 6 16  19 1 9 17  10 1 32 18  1 2 5 19  0 0 2 20  2 1  21  1 0  22   0  23   1  a 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. 1 2 Table 2 Frequency of use of medicinal products, by ATC code, at each age. Total number of drugs reported in a class/number of children in which this class of product was used (individual children may have used more than one product in a class). ATC level 1 (in bold) includes all reported cases. ATC level 2 is given where 10 or more children reported a product in this category in at least one questionnaire ATC code   <8 weeks 54 months 3–4.5 years 78 months 5.5–6.5 years 91 months 6.5–7.5 years No. of questionnaires returned with data 10,897 9,725 8,578 8,269   ATC text         A Gastrointestinal preparations 4,470/3,416 6,733/4,188 4,747/3,130 4,262/2,973 A01 Stomatological preparations 691/649 114/94 57/46 35/30 A02 Antacids, drugs for peptic ulcer and flatulence 3,422/2,690 31/27 25/23 15/13 A03 Antispasmodics, anticholinergics and propulsives 29/29 13/12 13/11 9/9 A06 Laxatives 41/41 528/421 277/200 328/262 A07 Antidiarrhoeals, intestinal anti-inflammatories and anti-infectives 39/38 693/682 196/191 227/224 A11 Vitamins 247/247 5,169/3,567 3,143/2,121 3,748/2,692 A12 Mineral supplements 1/1 170/155 40/27 158/149 B Blood and blood forming organs 61/47 57/50 28/21 32/25 B03 Antianaemic preparations 46/32 48/41 28/21 31/24 C Cardiovascular system 13/11 6/5 8/7 4/3 D Dermatologicals 9,618/6,397 5,105/3,269 3,538/2,653 2,988/2,441 D Dermatologicals unspecified 25/24 1,015/1,010 915/907 1,376/1,373 D01 Antifungals for dermatological use 584/557 173/163 185/173 125/118 D02 Emollients and protectives 7,908/5,655 1,954/1,453 12,18/928 690/519 D04 Antipruritics, including antihistamines, anaesthetics  6/6 158/151 91/89 59/57 D06 Antibiotics and chemotherapeutics, topical 98/95 169/161 154/142 107/99 D07 Corticosteroids, topical 125/121 1,358/1,052 790/631 507/408 D08 Antiseptics and disinfectants 843/785 246/223 161/154 114/110 D11 Other dermatological preparations 25/25 16/14 11/11 3/3 G Genito-urinary system and sex hormones 1/1 17/15 18/16 9/8 H Systemic hormones, excl sex hormones 3/3 69/59 63/56 49/40 H01 Pituitary, hypothalamic hormones and analogues 0 2/2 12/8 14/11 H02 Corticosteroids for systemic use 1/1 64/55 48/46 34/28 J General anti-infectives for systemic use 354/341 6,505/5,976 3,322/3,151 2,434/2,358 J01 Antibacterials for systemic use 346/335 6,498/5,973 3,309/3,146 2,419/2,349 L Antineoplastic and immunomodulating agents 0 0 1/1 2/1 M Musculo-skeletal system 0 63/62 111/107 119/118 M01 Anti-inflammatory and antirheumatic products 0 62/61 105/103 117/116 N Nervous system 163/159 9,561/9,184 7,857/7,620 7,400/7,261 N02 Analgesics 157/154 9,510/9,181 7,802/7,616 7,344/7,256 N03 Anti-epileptics 1/1 39/28 38/21 25/15 N06 Psychoanaleptics (antidepressants/stimulants) 1/1 4/2 5/5 24/17 P Antiparasitics, insecticides and repellents 0 87/80 90/84 58/54 P02 Anthelmintics 0 66/65 62/59 37/36 P03 Ectoparasiticides, scabicides, insecticides, repellents 0 14/13 22/22 17/16 R Respiratory system 1,168/1,032 9,609/6,995 8,615/5,492 7,796/5,131 R01 Nasal preparations 468/456 705/655 437/391 403/382 R02 Throat preparations 0 471/471 514/511 649/646 R03 Anti-asthmatics 0 1,178/658 2,422/1,029 1,920/1,174  R05 Cough and cold preparations 697/643 7,839/6,434 5,058/4,678 4,684/4,391  R06 Antihistamines for systemic use 3/3 216/186 184/163 140/127 S Sensory organs 1496/1411 2954/2213 1051/884 1090/861  S01 Ophthalmologicals 1,316/1,257 1,852/1,444 536/438 633/499  S02 Otologicals 3/3 737/728 426/416 405/403  S03 Ophthalmological and otological preparations 177/177 365/314 89/84 52/49 V Various 855/705 1,082/745 955/705 1,139/796  V03 All other therapeutic products (including CAM) 587/504 1,079/744 954/704 1,138/795  V07 All other non-therapeutic products (eg baby toiletries) 295/214 0 1/1 0 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). Discussion The advantage of collecting data on children’s use of medicinal products from their parents/carers, as opposed to from medical records and prescription databases, is that the former are in a position to know what was actually given to their children, rather than what may have been prescribed but not collected or taken by the child. In addition, the data potentially includes medication obtained from all sources—GP’s, pharmacies, supermarkets, CAM practitioners, friends, relatives and neighbours. However, potential issues include the accuracy of recall (especially over long periods of 12–18 months, as used at the older ages in this study) and parental knowledge and understanding about the medicines given to their child. 12 14 10 12 12 12 Therefore, as the questionnaire data on use of prescribed antibiotics and anti-asthmatics in this study is in the range expected from prescription data, parentally-reported use of non-prescription medication in this cohort is also likely to be reasonably reliable. 1 9 4