Pharmacovigilance

Shifted from the shelf

In light of the withdrawal of diclofenac from OTC sale in UK pharmacies over concerns about cardiovascular safety, it may be time to reconsider the role of the drug altogether.

Diclofenac withdrawn from over-the-counter (OTC) sales in UK pharmacies due to concerns about cardiovascular safety

Source: istockphoto.com

Another commonly used pharmacy medicine has been removed from over-the-counter (OTC) sale in the UK, with the reclassification of oral diclofenac to prescription-only. The decision came suddenly on 14 January 2015 and pharmacies were given just 48 hours to prepare for the change.

The non-steroidal anti-inflammatory drug (NSAID) has been reclassified by the UK Medicines and Healthcare products Regulatory Agency (MHRA) because of cardiac safety concerns, the second medicine to suffer this fate in the past year: the antiemetic domperidone had its OTC licence revoked in September 2014.

The justification for removing these medicines from OTC sale is that pharmacists are not equipped to assess patients for cardiovascular safety.

But the Proprietary Association of Great Britain claims that pharmacists are well placed to advise people on whether such products are safe and appropriate. Indeed, this chimes with the position in some other European countries, whose medicines regulators have not reclassified either medicine. For example, domperidone remains available over the counter in the Republic of Ireland and diclofenac is sold in pharmacies in many countries worldwide.

There are means of strengthening the checks that pharmacists can have on medicines sold over the counter. In the UK, for instance, sales of the weight loss drug orlistat require direct pharmacist input to ensure that it is given to patients with a qualifying body mass index of 28kg/m2 or greater. And the emergency hormonal contraception product Levonelle should only be sold in UK pharmacies over the counter once the pharmacist has conducted a consultation with the patient to ensure it is appropriate and will work effectively.

This kind of approach could be taken with diclofenac sales. Having a ‘pharmacist only’ legal category for medicines as there is in, for example, Australia, would help to facilitate this. Such sales mandate labelling in the dispensary under the pharmacist’s supervision.

Concerns about the cardiovascular safety of diclofenac were raised by medicines regulators in 2005 following the withdrawal of the next-generation anti-inflammatory rofecoxib (Vioxx) from worldwide markets the previous year. Doctors have since reduced their prescribing of diclofenac substantially. In England, around 2.2 million oral diclofenac sodium prescriptions were dispensed in 2013, down from 6.9 million items in 2004 (the total number of dispensed items rose by 344 million in that time).

Conversely, the NSAID naproxen — found to be associated with lower cardiovascular risk — saw an increase in the number of items dispensed from 1 million in 2004 to over 6.5 million in 2013. Perhaps consideration should be given to extending the OTC licence of naproxen beyond that of period pain so that patients have better access to this safer alternative.

The decision to pull diclofenac away from UK pharmacy counters might not be the major issue. Instead, with other effective, safer NSAIDs available, it might be time for a rethink about whether there is a place for oral diclofenac in clinicians’ arsenal at all.

Citation: The Salvadore DOI: 10.1211/PJ.2015.20067625

Readers' comments (2)

  • I fully endorse the calls to expand the OTC licence for Naproxen. Naproxen is (or certainly was on my last visit) available to purchase from the supermarket shelf in the USA. It's a safe, effective and rational choice for P availability in the UK.

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  • I tend to be influenced by what happens in the UK - it makes me think about an issue a lot more. I work in a hospital, and appreciate a reminder to rethink how we use a medicine. Medicine use is very complicated, and the general public don't understand, or remember important facts as pharmacists do. Example, a family friends mother (>60y) had a sore back out of the blue, and took some of her husbands diclofenac slow release 100mg/day, given to him for his gout. Well, the back pain was fixed, however she got more and more generally unwell, collapsed and was carried into the GP with severe kidney infection! IV antibiotics were required. It could have gone badly indeed. Medicines are complicated, the public are not health professionals, and human beings forget information, especially when they get sick.

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