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MHRA to act on Pharmacy Voice ranitidine concerns

The medicines watchdog will investigate if the drug's packaging can be improved to reduce dispensing errors among children

The Medicines and Healthcare products Regulatory Authority (MHRA) has pledged to act on a Pharmacy Voice report on the risks of dispensing ranitidine liquid.

The MHRA said it will review the packaging of licensed liquid ranitidine medicines, in response to a Pharmacy Voice audit that suggested around 60 children under the age of 12 receive an incorrect dosage every year.

Pharmacy Voice said last month that “greater prominence” should be given to the strength on packs of the ulcer treatment, and the MHRA confirmed to C+D last Friday (August 7) that it will see if “any improvements could be made to the current packaging”.

Alongside last month’s audit results, from almost 7,000 pharmacies in 2013 and 2014, Pharmacy Voice produced guidance for pharmacy teams to increase safety when dispensing the product. It called on teams to discuss any use of the medication outside the recommended age range with the prescriber and clarify the exact dose in millilitres with a parent or carer.

The MHRA agreed with Pharmacy Voice that ensuring the correct dose for children is "very important", and praised the pharmacy organisation's initiative to "improve communication all the way through the dispensing chain". 

Commenting on Pharmacy Voice’s report, a practice manager posting on the C+D website as Trying Harderthan Ever said it is “almost impossible” to get prescribers to clarify the intended dose of ranitidine. “In the absence of this information path, a robust dose/weight chart would be extremely helpful,” they said.

Pharmacy Voice’s ranitidine guidance for children
 

  • Always check the date of birth on a prescription and consider this when completing all clinical checks. If the prescription is for a patient under 12, this should be highlighted by the branch colleague who receives the prescription, or with a sticker containing their age
  • Any medication which has been prescribed outside the recommended age range should be discussed with the prescriber
  • Consider the suitability of the prescribed medication for the patient. If the product contains alcohol, consider whether this is a suitable product and whether there is any risk of harm
  • Dosage calculations that take account of a patient’s body weight should be double checked by another pharmacist if possible
  • Pharmacists should clarify with parents or carers the exact volume in millilitres needed to give the intended dose in milligrams
  •  All pharmacies should ensure they have small syringes in stock and that these are supplied with the prescription for the measurement of prescribed doses. Parents and carers should be taught how to use these syringes correctly

Source: Pharmacy Voice rantidine audit


Have you ever made a dispensing error involving a child?

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