NTIS is funded by the Health Protection Agency (HPA) to provide a national service on all aspects of reproductive toxicity of drugs and chemicals in pregnancy and prior to pregnancy throughout the United Kingdom. NTIS was established as part of the National Poisons Information Service (Newcastle Unit) in 1995.

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.

What services does NTIS provide?

NTIS 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

NTIS 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.

When are the services available?

The NTIS telephone service is available during normal working hours. Urgent advice can be obtained out of hours via the National Poisons Information Service.

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 NTIS now has 410 summaries available and of these, 200 are available directly to health professionals on TOXBASE. The remainder can be obtained by contacting NTIS.

Who are the staff involved in providing the service?

NTIS is staffed by a multidisciplinary team of clinicians, graduate medical information scientists, nurses, pharmacists and a teratologist.

The knowledge and experience of the staff of the centre is supported by access to a wide range of pharmaceutical and biomedical information, including computer databases, reference texts, medical and pharmaceutical periodicals, and in-house files

What routine surveillance activity does NTIS do?

Selected enquiries are followed up to obtain information on the outcome of pregnancy.

Follow up is attempted where possible for

• all cases of poisoning during pregnancy
• all occupational and environmental exposures during pregnancy
• Exposure to drugs under intensive surveillance by the Commission for Human Medicines
• Exposure to known or suspected human teratogens
• Exposure to drugs for which there are few safety data available relevant to use in pregnancy.

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 NTIS includes

• Details about the original enquirer
  • Name and contact details
  • Referring unit and department
• Details about the mother
  • 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)
  • Expected date of delivery
• Details about the suspected exposure
  • 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)
  • Maternal symptoms, investigation results and treatment so far

How are data protection aspects handled?

The data protection aspects of this surveillance activity are covered by the HPA Section 60 approval, but health professionals are asked, where possible, to ensure that the women involved are aware that their personal information is being reviewed in this way and that they are happy for it to be used in this way.

What is the data used for?

The confidential outcome information provides valuable prospective data which is used to base our advice for subsequent enquiries. This follow up data can also be used to generate hypotheses that can be tested in epidemiological studies.

Examples of important information obtained include the effects of ecstasy in pregnancy; the safety of new antidepressants; the safety of the use of antidotes in pregnant women who take iron or paracetamol overdoses during pregnancy and the potential reproductive hazards associated with exposure to carbon monoxide, CS gas or dry cleaning fluids.

What information is available?

To date, follow-up information has been obtained on the outcome of approximately 10,000 exposed pregnancies. These include exposures to medicines in therapeutic dose (6000 cases) or in overdose (2000) and chemical exposures, either environmental (900) or occupational (600).