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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Drug Safety Update - April 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for April 2023 (PDF).

This issue gives advance notice that new safety measures will be introduced in the coming months to strengthen the safety of isotretinoin treatment. These new measures include:

  • addition of new warnings for the risk of sexual dysfunction, including the possibility of persistence after treatment discontinuation
  • development of consistent monitoring requirements for potential psychiatric and sexual side effects in all patients throughout treatment
  • initiation of treatment in patients younger than 18 years will require two prescribers to agree a patient’s acne is severe and that there is no other effective treatment

It is recommended that prescribers to fully discuss the risks with patients considering isotretinoin.

This issue also introduces new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality in patients using Janus kinase (JAK) inhibitors. It is recommended that JAK inhibitors are avoided where alternatives exist in patients age 65 years and over, current or past long-time smoking and anyone with risk factors for cardiovascular disease or malignancy. Caution is also advised in patients with additional risk factors for VTE. And due to an increased risk of non-melanoma skin cancer associated with tofacitinib, periodic skin examinations are now advised.

Additionally, this issue contains a reminder to be vigilant for pulmonary and hepatic adverse drug reactions associated with use of nitrofurantoin. Patients and caregivers should be advised to be vigilant for, and report, any new or worsening respiratory symptoms. This can occure with short and long term use of nitrofurantoin. If such symptoms occur, the nitrofurantoin must be stopped immediately. Clinicians are also advised to periodically monitor for changes in biochemical tests that would indicate hepatitis or liver injury, especially in patients using nitrofurantoin for longer durations.

Lastly in this issue is a summary of letters to healthcare professionals in March. These generally related to supply issues and recalls. Of particular note, a letter noted continued intermittent shortages of Ozempic▼, which are expected to continue throughout 2023.

Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.

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CKS Updates - March 2023

During March 2023 Clinical Knowledge Summaries were published or updated in the following areas.

The Pressure Ulcers topic is new. All of the topics have been reviewed and updated with minor structural and layout changes. The Erectile dysfunction topic has been updated to include detail about phosphodiesterase-5 (PDE-5) inhibitor dose escalation if initial treatment is ineffective or unsatisfactory in the Follow-up section.

Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.

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Prescription Charge Changes for 2023

The Department of Health and Social Care has announced changes to the NHS Prescription Charges that take effect from the 1st April 2023.

The prescription charge has increased by 30 pence from £9.35 to £9.65 for each item dispensed. In line with this increase, the price of the 3 and 12 month Pre-Payment certificates has also increased, to £31.25 and £111.60 respectively.

This year also see the introduction of the promised HRT Pre-payment certificate. At a cost of £19.30 it will cover all medicines that are licensed to treat the menopause in the UK. A new area has been added in section 10 of the Drug Tariff listing the covered medicines.

A guidance document advises that prescribers must complete a separate FP10 prescription for products covered by the HRT PPC to allow patients to claim the exemption correctly. Since the certificates can be purchased at a later date and back-dated this change to practice is advised regardless of whether the patient has an HRT PPC at the time of prescribing. It is hoped that digital solutions will be introduced as soon as possible to automate this process.

Action: Clinicians should be aware of the current prescription charge and also the value for money represented by pre-payment certificates, including the new HRT pre-payment certificate.

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