National Poisons Information Service

A service commissioned by Public Health England

 

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Members of the public

seeking specific

information on poisons

should contact:

 

In England and Wales:

NHS 111 - dial 111

 

In Scotland:

NHS 24 - dial 111

 

In N Ireland:

Contact your local GP or

pharmacist during

normal hours; click here

(www.gpoutofhours

.hscni.net/) for GP

services Out-of-Hours.

 

In Republic of Ireland:

01 809 2166

 

Healthcare

professionals seeking

poisons information

should consult:

www.toxbase.org

UKTIS

The UK Teratology Information Service (www.uktis.org) is commissioned by Public Health England to provide evidence-based information and advice to UK health professionals and to conduct surveillance on the foetal effects of maternal exposure to medicines and other chemicals during pregnancy. The service was established in London in 1983 and subsequently transferred to be part of the NPIS (Newcastle Unit) in 1995.

 

Initially, almost all enquiries to the service were made by telephone, but in recent years UKTIS has concentrated on the provision of online information because this is usually more efficient and cost-effective, allowing telephone enquiries to be reserved for more complex cases. For registered health professionals, detailed, fully referenced, clinically focused scientific monographs on the potential foetal effects of maternal exposure to over 400 medications and chemicals are available via TOXBASE. There is also open access to the summaries of these monographs via the UKTIS website (www.uktis.org). More recently, UKTIS has developed information leaflets designed for use by the general public and hosted on our public-facing website, bumps – best use of medicines in pregnancy (www.medicinesinpregnancy.org), which was launched in April 2014.

 

Why is drug and chemical exposure during pregnancy important?
Since the thalidomide tragedy in the 1960s there has been increased public awareness of the risks that some medicines, when taken during pregnancy, may harm the developing baby (i.e. act as teratogens). However, most women still take medicines during pregnancy, in many instances, before they realise they are pregnant.

 

In a recent survey in the UK, about 35% of women were found to have taken medicines at least once during pregnancy, and 6% took medicines during the first 3 months, excluding iron and vitamin supplements.

 

Although the majority of babies are normal at birth, about 1 in 40 has a congenital malformation (‘birth defect’). In most cases, it is not known why these malformations occur. Therefore, if treatment is required during pregnancy, it is important that doctors are able to give accurate evidence based advice to women about the risks, if any, of the medicines prescribed or for chemical or occupational exposure.

 


Information provision

Delivery of the national UKTIS advisory telephone line during weekday core hours was maintained during 2016/17. Call numbers continued to decrease, although to a lesser degree than in previous years, suggesting that initiatives to direct service users to online information in the first instance have been effective and have freed up the phone advisory line for more complex cases. There has also been a reduction in online accesses to the detailed, fully referenced, clinically focused scientific UKTIS monographs available to registered healthcare professionals via TOXBASE, although access numbers remain higher than in 2010/11. In contrast, accesses to review summaries through the open-access UKTIS website (www.uktis.org) have increased year on year since 2012, with a dramatic increase observed in 2016/17. This trend suggests increasing use and awareness of information provided by UKTIS, but a possible reluctance by users to have to register or log-in to access detailed information where a quick overview of risk is all that is required. It is also likely that healthcare professionals such as general practitioners only need information sporadically and are therefore a fluid user group, and that information is sought in the context of a time pressured consultation (Table 1).

 

Taking telephone enquiries and online accesses together, UKTIS information was accessed almost 1.8 million times during 2016/17. Trends in enquiry numbers by year are shown in Table 1, demonstrating the movement of information provision from telephone enquiries to online information sources.

 

Table 1. Telephone enquiries, full monograph (toxbase.org), monograph summary (uktis.org) and bumps leaflets page loads (medicinesinpregnancy.org) showing the evolution of UKTIS information provision and user access over the past 7 years as absolute figures and as the percentage of enquiries for each year

 

What written information is available?
To assist with enquiry answering, summary information has been developed for a number of drugs and chemicals to assist in the provision of risk assessments following exposure during pregnancy. The UKTIS now has 410 summaries available and of these, 350 are available directly to health professionals on TOXBASE. Since November 2011, monograph summaries were made freely available on the UKTIS website.

 

How is follow up done?
Prospective data collection using standardised procedures occurs by contacting an appropriate health professional, usually the patient’s general practitioner. This happens on two occasions:

  • Around the time of the enquiry;
  • Approximately four weeks after the expected date of delivery (EDD).

What information is collected and held?

Information collected by the UKTIS includes:

  • Details about the original enquirer, including their name, contact details; and the referring Unit and department;
  • Details about the mother, including her name and date of birth or age, past medical history and any medications taken therapeutically, obstetric history (how many previous pregnancies, any history of miscarriage or malformations), and her expected date of delivery;
  • Details about the suspected exposure, including the agent(s) involved, route of exposure, estimated dose, date, time and duration of exposure, indication for treatment (if appropriate), use of protective equipment (if appropriate, e.g. for occupational exposures), and maternal symptoms, investigation results and treatment so far.

What services does the UKTIS provide?

The UKTIS (www.uktis.org) provides a national service on all aspects of the toxicity of drugs and chemicals in pregnancy for health professionals. Information is provided via the telephone information service and also on-line via TOXBASE.

 

These services include:

  • Pre-conception advice for men and women concerning drug and chemical exposures;
  • Provision and interpretation of background risks as well as specific information on drugs and chemicals for healthcare personnel;   
  • Proactive monitoring of specific hazards and risk assessment;
  • Prospective follow up of selected cases to expand data for use in future enquiries;
  • Support for the National Poisons Information Service within the UK.

The UKTIS also provides advice on request about drug and chemical exposure during pregnancy to official organisations such as the Medicines and Healthcare products Regulatory Agency, the Commission for Human Medicines, the European Medicines Agency, the British National Formulary and the Neonatal Formulary.

 

In April 2014 a new public facing website was launched 'bumps' - best use of medicines in pregnancy (www.medicinesinpregnancy.org). This new website enables the online provision of openly accessible information that is consistent with that in UKTIS scientific monographs but summaried in a format suitable for members of the public.

 

When are the services available?
The UKTIS telephone service is available during normal working hours. Urgent advice can be obtained out of hours via the National Poisons Information Service.

 


UKTIS bumps

The introduction of scientifically credible and openly accessible patient-focussed information has proven extremely popular and an expanding library is held on our public facing website, bumps – best use of medicines in pregnancy (www.medicinesinpregnancy.org), which was launched in April 2014. During 2016/17 one or more patient information pages was added or updated every week and the 136 information pages on bumps attracted almost 1.5 million page views. bumps website daily views and information page accesses have risen steadily since launch, increasing from 4,040 in March 2016 to 5,245 in March 2017. Spontaneous feedback suggests that users of the bumps website include both pregnant women and healthcare professionals, with both groups valuing the unrestricted access to this information.

 

Several key national organisations and guidelines now preferentially refer readers to UKTIS for advice on medicines use in pregnancy or included links to www.UKTIS.org and/or bumps (www.medicinesinpregnancy.org) as a recommended source of information. These organisations include:

  • Cochrane Reviews
  • NHS choices
  • NICE Clinical Knowledge Summaries
  • NICE Guidelines
  • Royal College of General Practitioners
  • Royal College of Obstetrics and Gynaecology

UKTIS surveillance and research

The analysis and publication of surveillance data collected by UKTIS remains an essential function of the service. In the past five years UKTIS staff have co-authored eight collaborative international teratology service studies that included prospective pregnancy outcome data collected by UKTIS.1,2,3,4,5,6,7,8 Of these, two were completed during 2016/17 with one study, led by UKTIS, finding no increased risk of fetal malformation amongst offspring exposed to the smoking cessation medication varenicline early in the first trimester.8 The second study identified a signal for pregabalin as a possible teratogen.5

 

Other collaborations involving UKTIS data and/or staff, included an NIHR HTA funded systematic review of treatments for hyperemesis gravidarum,9,10 and an Epilepsy Research UK funded analysis assessing use of the UK Clinical Practice Research Datalink to study neurodevelopmental outcome following in-utero exposure to anticonvulsant medications.11

 

In early 2017, a UKTIS senior information scientist completed and submitted their PhD thesis which analysed teratology information service and patient self-reporting methods of teratogen surveillance. This work helped establish valuable research collaborations and has significantly strengthened in-house expertise in advanced statistical techniques specific to the analysis of pregnancy exposure data for the purpose of teratogen signal detection. Importantly, this work involved a critical review of teratogen surveillance systems. It is clear that prospective cohort studies based on data collected by teratology information services around the world make an important contribution to teratogen surveillance but that there is scope for modernisation of the data collection methodologies employed and an urgent need to extend existing infrastructures to capture longer term outcomes of prenatal exposures, in particular offspring neurodevelopment.

 


References

  1. Hoeltzenbein M, Elefant E, Vial T, Finkel-Pekarsky V, Stephens S, Clementi M, et al. Teratogenicity of mycophenolate confirmed in a prospective study of the European Network of Teratology Information Services. Am J Med Genet A 2012;158A: 588-96.
  2. Einarson A, Smart K, Vial T, Diav-Citrin O, Yates L, Stephens S, et al. Rates of major malformations in infants following exposure to duloxetine during pregnancy: a preliminary report. J Clin Psychiatr 2012; 73: 1471.
  3. Winterfeld U, Allignol A, Panchaud A, Rothuizen LE, Merlob P, Cuppers-Maarschalkerweerd B, et al. Pregnancy outcome following maternal exposure to statins: a multicentre prospective study. BJOG 2013; 120: 463-71.
  4. Winterfeld U, Klinger G, Panchaud A, Stephens S, Arnon J, Malm H, et al. Pregnancy outcome following maternal exposure to mirtazapine: a multicenter, prospective study. J Clin Psychopharmacol 2015; 35: 250-9.
  5. Winterfeld U, Merlob P, Baud D, Rousson V, Panchaud A, Rothuizen LE, et al. Pregnancy outcome following maternal exposure to pregabalin may call for concern. Neurology 2016; 86: 2251-7.
  6. Weber-Schoendorfer C, Oppermann M, Wacker E, Bernard N, network of French pharmacovigilance centres, Beghin D, et al. Pregnancy outcome after TNF-alpha inhibitor therapy during the first trimester: a prospective multicentre cohort study. Br J Clin Pharm 2015; 80: 727-39.
  7. Fujii H, Goel A, Bernard N, Pistelli A, Yates LM, Stephens S, et al. Pregnancy outcomes following gabapentin use: results of a prospective comparative cohort study. Neurology 2013; 80: 1565-70.
  8. Richardson JL, Stephens S, Yates LM, Diav-Citrin O, Arnon J, Beghin D, et al. Pregnancy outcomes after maternal varenicline use; analysis of surveillance data collected by the European Network of Teratology Information Services. Reprod Toxicol 2017; 67: 26-34.
  9. McParlin C, O'Donnell A, Robson SC, Beyer F, Moloney E, Bryant A, et al. Treatments for hyperemesis gravidarum and nausea and vomiting in pregnancy: a systematic review. JAMA 2016; 316: 1392-401.
  10. O'Donnell A, McParlin C, Robson SC, Beyer F, Moloney E, Bryant A, et al. Treatments for hyperemesis gravidarum and nausea and vomiting in pregnancy: a systematic review and economic assessment. Health Technol Assess 2016; 20: 1-268.
  11. Charlton RA, McGrogan A, Snowball J, Yates LM, Wood A, Clayton-Smith J, et al. Sensitivity of the UK Clinical Practice Research Datalink to detect neurodevelopmental effects of medicine exposure in utero: comparative analysis of an antiepileptic drug-exposed cohort. Drug Saf 2017; 40: 387-97.

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