The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Bismuth subcitrate potassium / metronidazole / tetracycline (Pylera®) has been accepted for restricted use in combination with omeprazole, for the eradication of Helicobacter pylori and prevention of relapse of peptic ulcers in patients with active or a history of H. pylori associated ulcers. The restriction limits use on the basis that it is in accordance with clinical guidelines for the eradication of H. pylori.
Linzagolix (Yselty®) has been accepted for restricted use in the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. The restriction limits use to patients when conventional first-line treatments (such as tranexamic acid, hormonal contraceptives and intrauterine devices) have failed or are considered unsuitable. It should be noted that NICE Guidance has been published for this medication
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for November 2024 (PDF).
This issue reminds clinicians that this week is MedSafetyWeek. This is an annual social media campaign and the theme this year stresses the "importance of using medicines in the right way to prevent side effects, and to report side effects when they do occur". Healthcare professionals are encouraged to support the campaign, report suspected adverse drug reactions and talk to their patients and colleagues about side effects and how to report suspected safety concerns to the Yellow Card scheme.
Lastly, this issue contains a summary of letters to healthcare professionals in October. These generally related to supply issues and recalls but included a letter regarding the small increase in risk of developing meningioma with high doses (injectable and ≥100 mg oral formulations) of medroxyprogesterone acetate and measures to minimise this risk.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
During October 2024 Clinical Knowledge Summaries were published or updated in the following areas.
All of the topics have been reviewed and updated with minor structural and layout changes. The Epistaxis (nosebleeds) topic includes a recommendation to consider tranexamic acid for people presenting after a major haemorrhage and there is a new section highlighting potential differential diagnoses. The Premenstrual syndrome topic now includes diagnostic criteria for premenstrual dysphoric disorder and the management section is now structured based on individual tailored management focusing on individual symptoms and goals based on shared decision making. The Teething topic includes the latest recommendations and manufacturers' information on lidocaine-containing teething products. The Varicose veins topic contains three new recommendations regarding assessment. These included asking about red flag symptoms which may be indicative of rare but severe causes of varicose veins, examining the varicose veins for the presence of superficial vein thrombosis, and performing an abdominal examination to assess for an abdominal or pelvic mass.
Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for October 2024 (PDF).
This issue reminds clinicians of the potential side effects of glucagon-like peptide-1 receptor agonists (GLP-1RAs) including gastrointestinal side effects and hypoglycaemia that can occur in non-diabetic patients when used for weight management. Patients are also warned of the risks posed by falsified medicines when obtaining a private prescription and are advised to use registered pharmacies when getting the prescription dispensed.
Also in this issue, the MHRA are asking healthcare professionals to support new guidance for users of diabetes management equipment. It is recognised that insulin pumps and continuous glucose monitoring (CGM) devices are complex devices with the potential to result in serious harm in the event of error. Guidance has been published that explains to users how they can report safety concerns to the MHRA using the Yellow Card scheme. It is hoped that user reporting will improve the quality of information the MHRA receives and healthcare professionals are asked to highlight the guidance to appropriate patients and their families, carers and representatives.
This issue also advises clinicians of the need to monitor blood pressure when prescribing bromocriptine for prevention or inhibition of post-partum physiological lactation. It is noted that bromocriptine should only be prescribed to suppress post-partum physiological lactation, where it is medically indicated such as intrapartum loss, neonatal death, or in some cases of HIV infection of the mother. Non-pharmacological interventions are recommended for routine lactation suppression and for relieving symptoms of postpartum breast pain and engorgement. Where bromocriptine is still medically indicated, it remains contraindicated in uncontrolled hypertension, hypertensive disorders of pregnancy, hypertension post-partum, a history of coronary artery disease or other severe cardiovascular conditions. During treatment, blood pressure should be monitored, especially early in treatment and after dose increases. Treatment should be discontinued immediately if the patient develops any signs or symptoms of hypertension.
Lastly, this issue contains a summary of letters to healthcare professionals in September. These generally related to supply issues and recalls but included a letter regarding the potential risk of neurodevelopmental disorders in children of fathers treated with valproate in the 3 months prior to conception.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The National Institute for Health and Care Excellence (NICE) have published new or updated guidance for the month of October 2024. This month there is one technology appraisal, one guideline and one diagnostics guidance that impact upon primary care.
The Latanoprost–netarsudil for previously treated primary open-angle glaucoma or ocular hypertension technology appraisal has been published. This treatment is recommended as an option for reducing intraocular pressure (IOP) in adults with primary open-angle glaucoma or ocular hypertension when a prostaglandin analogue alone has not reduced IOP enough, only if:
- they have then tried a fixed-dose combination treatment and it has not reduced IOP enough, or
- a fixed-dose combination treatment containing beta-blockers is unsuitable.
The Acute kidney injury: prevention, detection and management guideline has been updated. It covers preventing, detecting and managing acute kidney injury in children, young people and adults. The update include new and updated recommendations on assessing risk factors for acute kidney injury in adults having iodine-based contrast media.
The Technologies for the assessment of attention deficit hyperactivity disorder (ADHD) diagnostics guidance has been published. It makes recommendations that QbTest is an option to help diagnose ADHD in people aged 6 to 17 years. It should only be used with standard clinical assessment by a healthcare professional. Additional research is recommended before other tests can be recommended for use or the age limits widened.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
