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Dr Karen Dalby and Helen Goodwin of the MDU make some suggestions to try to help GPs avoid some of the complaints that arise from the care of children

The recent publication of a 'Strategy of Medicines for Children' by the Department of Health and the Medicines and Healthcare Products Regulatory Agency recognised that doctors, carers and patients needed more information on safe prescribing of drugs to children1. The strategy also stated that because most medicines have only been tested on adults, doctors often have no option but to prescribe unlicensed and off-label medication which can lead to medication errors.

The strategy included the welcome news that a new children's BNF is due to be published by the middle of next year which will bring together information on paediatric prescribing in a single source.

A new Medical Defence Union analysis reveals 20 per cent of all cases alleging medication errors notified to them over a recent seven-year period involved children under 15. There were 399 cases in all. While this analysis is of all cases notified to the MDU, previous analyses of only settled claims involving MDU GP members show that medication errors account for a quarter of all those cases.

While many of these cases may not result in settlement of the claim, and may not be as result of any negligence on the GP's part, the fact these cases have been notified by MDU members gives an indication of issues that can lead to adverse events and complaints. In this feature we explain the reasons for the allegations, the drugs involved and the costs. We also make some risk management suggestions to help GPs try to avoid some of these incidents.

Costs and reasons for claims

The costs of the settled claims awards to children ranged from £19,000 after a failure to monitor long-term topical steroid treatment to £150 following stocks of a vaccine not being available on the NHS. The commonest reasons for allegations of paediatric medication error being made against GP members were:

·Adverse drug reactions which accounted for 20 per cent of the cases notified (78), eg allegation of developmental delay following MMR

·Wrong dose/drug which accounted for 12 per cent of allegations (47), eg child given adult dose of metaclopramide

·Parental consent not obtained was alleged in 12 per cent of cases (41), eg MMR given without parental consent

Other reasons for allegations being made included the same vaccine being administered twice, out-of-date drugs being given, failures or delays in giving a prescription when indicated, the wrong preparation of a drug being given (eg tablets to very young children) and drugs prescribed to children with known allergies.

Drugs involved

The drugs most frequently involved in cases were:

·Vaccines ­ 60 per cent of cases (244)

·Antibiotic/antifungal/antiviral drugs ­ 12 per cent of cases (48)

·Analgesics ­ 4 per cent of cases (15)

·Steroids ­ 3.5 per cent of cases (14)

Other drugs involved included anticonvulsants, CNS stimulants, antihistamines, sympathomimetic, selective ?2 agonists, NSAIDs and antiemetics.

Case histories

Here are some examples of the type of paediatric medication issues notified to the MDU. While based on real cases, some of the details have been changed to protect confidentiality.

Wrong dose A call was received in the practice from a distressed parent. His baby, aged eight weeks, was hot and distressed. On examination a viral illness was diagnosed. Paracetamol suspension was prescribed, with the direction to give one 5ml spoonful up to four times daily. After giving several doses, the baby's mother read the directions on the bottle. This gave the dosage for an eight-week baby as a 2.5ml spoonful up to a maximum of four times daily. The baby had received twice the recommended dose for a 24-hour period.

A complaint was later received by the practice.

Additional MMR vaccination A mother brought her baby in for an MMR vaccination, having received notification of a recall via the Child Health Computer System. The practice nurse took the MMR vaccination from the fridge and checked that it was the correct vaccine with another nurse. Before giving the vaccination, the nurse discussed the injection and checked that the mother was happy for her to proceed. The practice nurse checked the baby's identity and the recall card.

The nurse did not check the patient's notes, where details of a previous MMR vaccination were recorded in the computerised record. As the batch number had not been recorded on the practice computer, the fact that the baby had received the MMR vaccine already was not recorded by the health authority. As a result, the baby was given the vaccination twice in error. When the error was realised an explanation and apology was given immediately.

Givig MMR without parental consent

One of the most common allegations relating to vaccines is administration without the consent of the parents. This often relates to the combined MMR vaccine where parents have expressed a prior wish that the vaccine not be given. Many of these cases relate to vaccinations to be given at the pre-school booster stage. There are a number of consistent themes within the cases reported:

·Failure to record that parents have withheld consent to a specific vaccine.

·A failure to check the records prior to administration of the vaccine, relying only on the standardised initiation letter.

·The status of the accompanying adult. There is a general trend for members of the family or other carers who do not have parental responsibility to accompany the child for vaccination. It is important that valid consent is sought from an appropriate adult who has parental responsibility.

General risk management suggestions

Many of the issues revealed in this analysis of paediatric medication are similar to those highlighted in past analyses of primary care medication errors in general, for example, wrong drug or dosage and prescribing to patients with known allergies.

But some different themes have emerged in incidents involving prescribing to children, such as adverse drug reactions and lack of parental consent. In addition, a number of groups of drugs are different to those in the analysis of medication errors involving adults as well.

When prescribing or administering drugs to children, it is important to:

·Remember children are not 'mini adults' in terms of dosages or drug handling; use age ranges or weight and paediatric dosage references

·Discuss known side-effects of prescribed medication with parents

·Ensure valid consent is sought prior to administration

·Review any restricted consent before administering vaccines

·Ensure all vaccines are recorded accurately, including the date, time, vaccine and batch number, as well as site and mode of injection.

·Check all relevant records, including the patient's medical records (manual and electronic) prior to administration of a drug.

General medication issues

·If prescribing drugs you are unfamiliar with, check contraindications and side-effects

·Check the past clinical history and concurrent medication before prescribing any new drug

·Check for known allergies or hypersensitivities

·Take special precautions when prescribing medications with similar names

·Review all medication on regular repeats, paying particular attention to topical steroid preparations.


1 Medicines and Healthcare Products Regulatory Agency/ Department of Health Strategy on Medicines for Children, August 17, 2004

Karen Dalby and Helen Goodwin are MDU clinical risk managers

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