The National Institute for Health and Care Excellence (NICE) have published new or updated guidance for the month of February 2021. This month is one technology appraisal that impacts upon primary care.
The Dapagliflozin for treating chronic heart failure with reduced ejection fraction technology appraisal has been published. This treatment is recommended as an option for treating symptomatic chronic heart failure with reduced ejection fraction in adults, only if it is used as an add-on to optimised standard care with:
- angiotensin-converting enzyme (ACE) inhibitors or angiotensin‑2 receptor blockers (ARBs), with beta blockers and, if tolerated, mineralocorticoid receptor antagonists (MRAs), or
- sacubitril valsartan, with beta blockers and, if tolerated, MRAs
It is also noted that this treatment should only be started on the advice of a heart failure specialist.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for February 2021 (PDF).
This month readers are advised of further restrictions on the use of ulipristal acetate (Esmya®) for uterine fibroids due to the risk of serious liver injury. The temporary suspension has been lifted but it is recommended that this medicine should only be used for intermittent treatment of moderate to severe symptoms before the menopause and when surgical procedures (including uterine fibroid embolisation) are not suitable or have failed.
Readers are also notified that pregabalin (Lyrica®) has been linked with infrequent reports of severe respiratory depression, including some cases without the presence of concomitant opioid medicines. Patients considered at higher risk of this complication include those with respiratory disease, neurological disease, renal impairment, those using concomitant CNS depressants and people older than 65 years. In such patients a more cautious introduction to this medication may be prudent and adjustments in dose or dosing regimen may be necessary.
An increased risk of acute adrenal insufficiency in children has also been identified when switching from hydrocortisone tablet formulations to granules (Alkindi®). During such switches, parents or carers should be informed of the need to be extra vigilant for symptoms of adrenal insufficiency.
This issue also contains information about the newly launched Safer Medicines in Pregnancy and Breastfeeding Consortium. This is a partnership of 16 leading organisations working together to improve the health information available to women who are thinking about becoming pregnant, are pregnant, or are breastfeeding, especially relating to the medicines they take. To support this work healthcare professionals are being asked to report inconsistencies in UK advice on use of individual or classes of medicines used in pregnancy or breastfeeding via the address on the consortium's webpage.
Finally in this issue is a summary of advice recently issued by the MHRA relating to coronavirus (COVID-19) vaccines and medicines as well as the summary of letters to healthcare professionals sent in January.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Formoterol / glycopyrronium / budesonide aerosol inhaler (Trixeo Aerosphere®) has been accepted for restricted use as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist. The restriction limits use to patients with severe COPD (FEV1 less than 50% predicted normal).
Leuprorelin acetate (Prostap®) has been accepted for use as adjuvant treatment in combination with tamoxifen or an aromatase inhibitor, of endocrine responsive early stage breast cancer in pre- and perimenopausal women at higher risk of disease recurrence. It is expected treatment would continue in primary care at the recommendation of a specialist.
Leuprorelin acetate (Prostap®) has been accepted for use as treatment in pre- and perimenopausal women with advanced breast cancer suitable for hormonal manipulation.. It is expected treatment would continue in primary care at the recommendation of a specialist.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
During January 2021 Clinical Knowledge Summaries were published or updated in the following areas.
The Mental health in students topic is new. All of the other topics have been reviewed and updated in keeping with current NICE guidance with minor layout changes. The Anticoagulation - oral topic now includes a section on monitoring people taking anticoagulants during the COVID-19 pandemic in line with MHRA recommendations.
Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.
