Clinical developments

Tirzepatide for managing overweight and obesity

NICE issued guidance on the use of tirzepatide in type 2 diabetes in 2023 and followed this in 2024 with guidance on the same medication for managing overweight and obesity. It was initially recommended as an option for managing overweight and obesity, alongside a reduced-calorie diet and increased physical activity, in adults with an initial BMI of at least 35kg/m² and at least one weight-related comorbidity.

NICE advised using lower BMI thresholds (usually reduced by 2.5kg/m²) for people from South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean ethnic backgrounds, as some ethnicities are at an equivalent risk of the consequences of obesity at a lower BMI than people from White ethnicities.

Different models of community-based services and digital technologies are being developed by NHS England for the use of tirzepatide (Mounjaro) with accompanying evaluation over the next three years as part of a phased roll-out. In October it proposed that people would be eligible to receive tirzepatide if they have a BMI of more than 40kg/m² and at least three of the specified weight-related health problems (hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease).

The medicine would be part of a wraparound package including diet and exercise support, and could be offered in either primary or secondary care with a multidisciplinary team.

In addition, seven digital technologies were approved by NICE in late 2023 to prescribe and monitor weight management medicines and deliver multidisciplinary weight management programmes: CheqUp, Gro Health W8Buddy, Juniper, Liva, Oviva, Roczen and Second Nature. These developments are part of a bigger picture of increasing NHS efforts to reduce obesity as a means of decreasing disability and death from diabetes, heart disease and stroke.

Codeine linctus

Codeine linctus was reclassified from a pharmacy-only medicine (P) to a POM due to the risk of abuse, dependency and overdose.

Tranexamic acid and naproxen OTC

Heavy menstrual bleeding and period pain were highlighted this year with the launch of OTC tranexamic acid (Evana) and naproxen (Ultravana) products. RPS guidance on tranexamic acid OTC supply can be found at rpharms.com.

The impact of primary dysmenorrhoea on girls’ and women’s daily life is often underestimated. Dysmenorrhoea is the main reason for girls and young women to miss days at school or work but is frequently and wrongly dismissed as being a ‘normal’ part of growing up.

Non-steroidal anti-inflammatory drugs (NSAIDs) are known to work in over 80 per cent of cases of primary dysmenorrhoea. They work by reversibly inhibiting the COX-1 and COX-2 enzymes involved in prostaglandin production. NICE guidance recommends NSAIDs, such as naproxen or ibuprofen, as first-line treatments for period pain. As mentioned, a new naproxen 250mg OTC product was launched in 2024.

Ultravana is a gastro-resistant tablet (which should not be crushed) that aims to reduce GI side-effects by disintegrating after it has left the stomach. The dose is two tablets initially and then one tablet after six to eight hours if required, up to a maximum of three a day. As for any OTC NSAID, it is important to ask about previous use of aspirin or NSAIDs and any sensitivity to the drug, as well as mentioning asthma (around 7 per cent of people with asthma, rising to 15 per cent in severe asthma, experience what is now referred to as aspirin-exacerbated respiratory disease with cross-sensitivity with NSAIDs).

The use of NSAIDs more generally in dysmenorrhoea has been shown to be affected when side-effects are experienced – so for standard tablet formulations, advice and reinforcement of the need to avoid taking the medicine on an empty stomach is particularly important, with more explanation in practical terms as some people interpret “take with food” as only taking the medicine after a full meal. A smaller snack or glass of milk or juice may be enough to avoid irritating the stomach.