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admin December 12th, 2007

The use of medicines in children is a dangerous activity. Physical and physiological differences between children and adults, and the comparative lack of data for drug use in children makes decisions about dosing complex. Often specifically licensed childrens preparations are not available, further increasing the dangers of dosing errors due to calculation errors. Conroy et al have published a systematic review of interventions to reduce the risk of dosing errors in children.

What they studied
The authors searched mainstream literature databases, and databases such as Pharmline up to October 2006, as well as hand searches of specific drug safety journals from 1995 to 2006. Criteria for selection were that the articles should report an intervention, and that the intervention should be related to dose calculations. Non-specific interventions, such as computerised physician order entry (CPOE), were also included.

What they found
From an initial 3302 articles, they found 28 relevant articles. Lack of hetoerogenity study methodology and outcomes did not allow the researchers to perform a statistical summary of the articles. Most studies used a reduction in error rates as an outcome, and most studies gave positive results. The most common intervention was related to CPOE (electronic prescribing), used in 14 studies.

• Electronic prescribing
• Other computer aids
• Unit dose dispensing systems
• Education/risk management programmes
• Smart pumps

Electronic prescribing had a variable rates of reduction of errors, which the authors suggest could be due to differing outcome measures (e.g. reductions in calculation errors compared to more general reductions in prescribing errors), and the settings of studies (small specialised settings such as neonatal units versus larger hospital populations). Differences in electronic prescribing systems, such as the level of decision support for prescribers, were also hard to determine. One study CPOE study even demonstrated an increase in the mortality rate following intervention.

Limitations
The authors note that non-beneficial, or negative, interventions were unlikely to be published, and noted several methodological issues related to the study of medication errors. However, they did not critically analyse the studies or attempt comparison of the results.

What the study adds
This review is a useful summary of the current evidence base for reducing medication errors in paediatrics. It highlights the difficulties in designing interventional studies in this area, and the lack of research in this field. Although error reductions were reported in some studies, some interventions may carry risks. The authors argue that further research is required to demonstrate the effectiveness of medication error reduction interventions on clinical outcomes and mortality. Care should be taken when interventions are implemented in different healthcare settings from that they were originally studied in.

1. Conroy S, Sweis D, Planner C, Yeung V, Collier J, Haines L, Wong ICK. Interventions ro reduce dosing errors in children. Drug Safety 2007; 30(12): 111-1125. [abstract]

• Patient Safety
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admin December 11th, 2007

The NPSA have issued two booklets about the safe dispensing of medicines.

1. A guide to the design of the dispensing environment.

2. A guide to the design of dispensed medicines.

A BMJ news report summerises the key points as:

• Designing dispensaries that encourage a safe and effective flow of work
• Patients’ waiting areas that allow for confidential discussions about their drugs
• Using bar codes on drug packs to aid accuracy checking
• Ensuring that dispensing labels are clearly laid out, with text in a size that patients can read easily
• Placing labels on packaging in a way that does not obscure important information or, where this is not possible, on smaller packets and tubes, using “flag” labels, and
• Directly labelling containers rather than outer packaging.

• Patient Safety
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admin December 11th, 2007

The UK’s NPC have issued guidance on the use of NSAIDs, and specifically have singled out diclofenac prescribing for attention. Pulse Magazine reports:

GPs should review use of the most widely prescribed NSAID diclofenac and switch to ibuprofen or naproxen, says an NHS review into the safety profile of anti-inflammatory treatments.

Diclofenac accounts for 46% of all NSAID prescriptions in primary care.

But the National Prescribing Centre’s review of cardiovascular risks associated with traditional NSAIDs and cox-2 inhibitors has said this high level of prescribing should be ‘reconsidered’.

The report claims as many as 2,000 additional or premature cardiovascular events per year could be caused by diclofenac prescribing.

It goes on to say patients on diclofenac should be reviewed and switched to low-dose ibuprofen or naproxen if possible, to reduce their CV thrombotic risk.

Background to this story can be found at MEREC 30 and the NPC blog, and additional support materials are available from the NPC.

Currently the MHRA are conducting a consultation on an application for the reclassification of a low dose diclofenac preparation from prescription only medicine status to an over-the-counter medicine for sale in pharmacies. Comments should be submitted by 4 January 2008.

• MHRA , Patient Safety
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admin July 13th, 2007

The BMJ has published the WISDOM Trial of HRT in postmenopausal women aged 50 to 69 years-of-age (mean age 62.8 SD 4.8).

Key points:

Combined hormone therapy (n=2196) was compared with placebo (n=2189):

• significant increase in the number of major cardiovascular events (7 v 0, P=0.016)
• significant increase in venous thromboembolisms (22 v 3, hazard ratio 7.36 (95% CI 2.20 to 24.60))
• no statistically significant differences in numbers of breast or other cancers (22 v 25, hazard ratio 0.88 (0.49 to 1.56)), cerebrovascular events (14 v 19, 0.73 (0.37 to 1.46)), fractures (40 v 58, 0.69 (0.46 to 1.03)), and overall deaths (8 v 5, 1.60 (0.52 to 4.89)).

Comparison of combined hormone therapy (n=815) versus oestrogen therapy (n=826) outcomes:

• no significant differences.

The study authors argue that this trial is consistent with the Womens’ Health Initiative trial, showing increased risks associated with HRT when used in older post-menopausal women. It is less useful in casting light on the risk to women who are younger and who are using HRT to deal with menopausal symptoms. An accompanying editorial argues that:

So postmenopausal hormone therapy has come full circle.9 It was originally used to treat menopausal symptoms, and now the indications for use are again hot flushes, night sweats, and vaginal dryness. It is the best treatment we have at present for these symptoms. Hot flushes and night sweats are mostly self limiting, and current advice recommends short term use with the lowest dose needed for relief of symptoms. Healthy women in early menopause are at a low absolute risk whether they take hormones or not, and they are unlikely to face substantially increased risks when using hormones for a few years.

Long term use of hormone replacement therapy to prevent chronic disease is no longer recommended, because available randomised evidence shows that the negative outcomes outweigh the positive benefits.

• ADRs , Patient Safety
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admin May 9th, 2007

The WHO have launched their nine steps to safety to combat healthcare-related injuries.

1. Look-alike, sound-alike medication names;
2. patient identification;
3. communication during patient hand-overs;
4. performance of correct procedure at correct body site;
5. control of concentrated electrolyte solutions;
6. assuring medication accuracy at transitions in care;
7. avoiding catheter and tubing misconnections;
8. single use of injection devices; and
9. improved hand hygiene to prevent health care-associated infection.

Press release here.

• Medication error , Patient Safety , WHO
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