Medicines regulator introduces age restrictions on OTC laxatives following safety review

New rules are coming into effect for over-the-counter laxatives for adolescents, as well as the size of packs of stimulant laxatives that can be sold to adults.

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Over-the-counter laxatives for adolescents aged 12 to 17 years can now only be supplied under the supervision of a pharmacist, following the results of a four-year review by the Medicines and Healthcare products Regulatory Agency (MHRA) into their safety.

The Drug Safety Update, published on 18 August 2020, also means large packs of stimulant laxatives can no longer be bought from general retail stores, with those on the general sales list to only be sold in packs of 20 standard-strength or 10 maximum-strength tablets to patients aged 18 years and older.

Liquids may only be sold in bottles of up to 100ml. The MHRA said this was to “reflect that these medicines should be used for only short-term, occasional constipation”.

Pharmacies can sell larger packs of up to 100 tablets, which may be provided for use by people aged 12 or over — but only under the supervision of a pharmacist — and children aged under 12 years with constipation should be referred to a prescriber, the update said.

The MHRA said the updated packs are now becoming available in general sale outlets and pharmacies, but larger packs already on the shelf can continue to be sold until “early autumn of 2020”.

The new rules follow a safety review intended to address concerns about inappropriate use of stimulant laxatives, particularly, people using them in the erroneous belief that they help with weight loss. All packs will now feature more prominent warnings that stimulant laxatives do not aid weight loss.

The Royal Pharmaceutical Society (RPS) has worked with the MHRA to produce guidance for pharmacy teams around the new measures.

Pharmacy teams should, the guidance says, implement and explain the risk minimisation measures to people buying the products, and be alert to signs that could indicate potential abuse of stimulant laxatives.

The guidance includes advice, and case studies, on how to engage with people who are suspected to be using the products inappropriately. This includes people who may show signs of an eating disorder, but also older patients who may be self-medicating for long-term constipation brought on by a chronic condition.

Anja St. Clair Jones, a consultant pharmacist in gastroenterology at Brighton and Sussex University Hospitals NHS Trust, said that long-term misuse of stimulant laxatives could lead to electrolyte imbalances, renal and cardiovascular problems.

“Long-term use can also affect the gut biota,” she said. “If you keep using laxatives, you strip away the bacteria we need to help us with digestion. And there is a lot of research now to show that gut biota has an effect on our mood.”

St. Clair Jones said that community pharmacists were well-placed to identify potential misuse of stimulant laxatives. She added that long-term misuse amongst elderly patients may be easier to address in a pharmacy setting than patients with eating disorders.

“Elderly people will, generally, see pharmacists on a regular basis anyway, and can be advised about diet and drinking enough … intervention might be able to prevent them ending up in hospital.

“But, for those with eating disorders, it depends on what kind of patient relationship you have. If you have a good relationship you might be able to make a difference, but these patients will need to be referred to appropriate psychological support.”

Sarah Branch, director of the MHRA’s Vigilance and Risk Management of Medicines Division, said that patient safety was its “highest priority”.

“We believe these new measures are necessary to address the risks associated with misuse, while continuing to allow safe and appropriate access to these medicines without prescription to treat short-term constipation.”

Sandra Gidley, president of the RPS, said that the RPS was “pleased” to have worked with the MHRA on new guidance for community pharmacists and their teams, enabling them to give patients the best advice.

“As experts in medicines, pharmacists are well placed to help ensure patients do not overuse stimulant laxatives. If a patient has a question about different laxative products or are unsure about what they are currently taking, the pharmacy team will be able to help and signpost on if necessary.”

Last updated
The Pharmaceutical Journal, Medicines regulator introduces age restrictions on OTC laxatives following safety review;Online:DOI:10.1211/PJ.2020.20208273

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