The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for February 2013 (PDF).
This update contains drug safety advice reminding clinicians of an increased risk of atypical femoral fractures have been reported rarely in patients with postmenopausal osteoporosis receiving long-term (longer than 2.5 years) treatment with denosumab 60mg (Prolia®). This debug is a human monoclonal antibody administered by injection every six months. It is recommended that:
- Patients are advised to report new or unusual thigh, hip, or groin pain and such patients should be investigated for an incomplete fracture
- The contralateral femur should be examined in denosumab-treated patients who have sustained a femoral shaft fracture
- Discontinuation of denosumab treatment should be considered if an atypical femur fracture is suspected and the risks and benefits of continued treatment assessed
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.
The National Institute of Health and Clinical Excellence (NICE) has published new guidance for the month of February 2013. This month there is one clinical guideline and one technology appraisal that impact upon primary care.
The Fertility guideline offers evidence-based advice on the care and treatment of people with fertility problems and is an update to original guidance from 2004. This update recommends IVF treatment for eligible women who have been unable to conceive after two years of regular vaginal intercourse. The previous guideline recommended three years. This update also extends to women aged 40-42 provided IVF has not been used before, there is no evidence of low ovarian reserve and there has bee discussion of the additional implications of IVF and pregnancy at this age.
Other changes include no longer routinely offering intrauterine insemination for couples with unexplained infertility, mild endometriosis or 'mild male factor infertility' and not offering oral ovarian stimulation agents (such as clomifene) to women with unexplained infertility.
The Stroke and systemic embolism - apixaban technology appraisal recommends that Apixaban is an option for preventing stroke and systemic embolism within its marketing authorisation, that is, in people with nonvalvular atrial fibrillation with 1 or more risk factors such as:
- prior stroke or transient ischaemic attack
- age 75 years or older
- diabetes mellitus
- symptomatic heart failure
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
Details of the apixaban guideline were added 5th March 2013
The Department of Health has written to colleagues advising that there are supply issues with all normal release isosorbide mononitrate due to a problem with the availability of raw materials.
This issue is affecting normal release 10mg, 20mg and 40mg tablets and may continue for several months but modified release products are unaffected. Limited stock is entering the supply chain and some companies are obtaining unlicensed product from abroad on an individual patient basis.
Clinicians are being advised to consider changing patients affected by this shortage to an equivalent dose of a modified release product. Data regarding switching is limited but a mg for mg switch is suggested thus maintaining the same total daily dose initially. Further dose adjustments may be necessary based on clinical response.
Pharmacists who are presented with a prescription for which they are unable to obtain stock should contact, or refer the patient back to, the prescriber to discuss alternative solutions.
Action: Clinicians and Pharmacists should be aware of this shortage and work together to ensure continuity of an appropriate treatment.
The manufacturer of insulin degludec (Tresiba®) has written to healthcare professionals to pre-emptively warn about the potential risk of medication errors with this new product.
The new insulin will be available in two strengths, 100 units/ml and 200 units/ml, and as such there is a risk of incorrect does administration should the wrong strength product be supplied. The manufacturer has visually differentiated the two strengths with the lower strength pen being bright green and in boxes of five whereas the higher strength is dark green and in boxes or three. The higher strength also contains a prominent indication of the strength in a red box on both the packaging and the pen. Finally, there are tactile differences on the injector button for visually impaired patients.
The manufacturer advises that:
- The dose counter indicates the exact dose to be injected in units. As such there is no need to dose adjust when changing pen strength for an individual patient
- Strength must be specified on prescriptions
- Pharmacists must contact the prescriber where the strength is unclear
- Pharmacists must ask patients to visually identify the strength at the time of dispensing
- Patients should be provided with a patient brochure and trained in use of the pen
- Patients who self-administer their insulin must be able to read the dose counter
- Patients should check they have the correct product at the time of dispensing
- Patients must seek medical advice is the wrong dose is administered
Action: Clinicians who initiate or prescribe insulin should be aware of the differences in these products. Great care should be taken when prescribing, dispensing and using this product.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Apixaban (Eliquis®) has been accepted for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF) with one or more risk factors. The risk factors include prior stroke or transient ischaemic attack (TIA), age 75 years or above, hypertension, diabetes mellitus and symptomatic heart failure (NYHA class II or above).
Colecalciferol (Desunin®) has been accepted for the prevention and treatment of vitamin D deficiency in adults and adolescents.
Inhaled mannitol (Bronchitol®) has been rejected for treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care. The manufacturer failed to make a sufficiently robust economic case.
Linagliptin (Trajenta®) has been accepted for restricted use in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults. The restriction limits use as monotherapy to patients for whom both metformin and sulphonylureas are inappropriate due to contraindications or intolerance and in combination with a sulphonylurea and metformin when glycaemic control remains inadequate despite diet and exercise plus dual therapy.
Linagliptin and Metformin (Jentadueto®) has been accepted for restricted use in the treatment of type 2 diabetes mellitus in adults. It can be used alone in patients who are already treated with both of these medicines or who are inadequately controlled on their maximal tolerated dose of metformin. It can be used in combination with a sulphonylurea as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. The restriction limits use of this product to patients for whom a fixed dose combination of metformin and linagliptin is considered appropriate.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.