The manufacturer of Insulin Glulisine (Apidra®) has written to healthcare professionals warning of a supply interruption that will affect several presentations in the Apidra range until the end of the year.
A technical issue on the production site is cited as the cause of this problem and the letter reassures that there are no concerns regarding the quality of this or any other insulin products supplied by the same manufacturer.
The supply status is as follows:
- Apidra SoloStar prefilled pens - limited supplies at wholesalers that are expected to be exhausted by the end of September 2011. Anticipated to back in stock in December 2011.
- Apidra Optiset prefilled pens - limited supplies at wholesalers that are expected to be exhausted by the end of September 2011. Unlikely to be back in stock before planned withdrawal of this product at the end of 2011.
- Apidra ClikStar cartridges - limited supplies at wholesalers that are expected to be exhausted by the end of September or early October 2011. Anticipated to back in stock in December 2011.
- Apidra OptiClik cartridges - unaffected and in stock with sufficient supply to last until the planned withdrawal of this product at the end of 2011.
- Apidra vials - unaffected and in stock.
More information regarding currently supply status is available from the manufacturer on customer services on 0800 854 430 (Monday to Thursday - 9am to 5:15pm, Friday - 9am to 4pm). Patient enquiries can be directed to the Insulin Support Line 0845 606 688 (open 24 hours).
The manufacturer has access to some stock that will be made available on a named patient basis when alternative products are unsuitable. Pharmacies can place orders by calling 01483 505 515.
Action: Clinicians should be aware of the imminent shortage. Patients currently using the affected products will need to be assessed individually. Some people may have sufficient stock at home to last until supply is resumed. Others may need alternative products, presentations or access to the reserved stocks.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on new medicines.
Dabigatran (Pradaxa®) has been accepted for use in the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation. Such individuals must have at least one of the following risk factors:
- Previous stroke, transient ischaemic attack, or systemic embolism
- Left ventricular ejection fraction < 40%
- Symptomatic heart failure, ≥ New York Heart Association (NYHA) Class 2
- Age ≥ 75 years
- Age ≥ 65 years associated with one of the following: diabetes mellitus, coronary artery disease or hypertension
Abatacept (Orencia®) has been rejected for use in combination with methotrexate, for the treatment of moderate to severe active rheumatoid arthritis in adult patients who responded inadequately to previous therapy. The justification of the treatment’s cost in relation to its health benefits was not sufficient to gain acceptance.
Tenofovir (Viread®) has been accepted for the treatment of chronic hepatitis B in adults with decompensated liver disease.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
Diabetes Care has published the results of an experiment that aimed to assess the impact of changes in ambient air pressure on insulin delivery via a pump.
This study was entirely conducted without patient involvement but as a consequence of patient reported hypoglycaemia during air travel.
It was noted that in low air pressure situations air bubbles can form or enlarge in the insulin cartridges and force additional insulin out of the cartridge. Plunger movement was only observed when the air pressure environment was made to mimic a catastrophic plane depressurisation.
The authors conclude that, "atmospheric pressure reduction causes predictable, unintended insulin delivery in pumps by bubble formation and expansion of existing bubbles".
Action: Clinicians should be aware of this recent finding. Patients who are using insulin pumps should be warned of the risk of additional insulin delivery at low air pressures.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for September 2011 (PDF).
This issue contains drug safety information advising clinicians that use of systemic fuscidic acid concurrently with statins can lead to fatal rhabdomyolysis. Where systemic fuscidic acid treatment is necessary, statin treatment should be stopped and only restarted seven days after the last dose of fuscidic acid.
Clinicians are also informed that a Europe wide review has identified a risk of extrapyramidal effects or withdrawal symptoms in newborns to mothers who used antipsychotic medication in the third trimester of pregnancy. It is recommended that pregnant women taking such medication are advised of the risk and that newborns are monitored for symptoms which may include agitation, hypertonia, tremor, somnolence, feeding problems, and respiratory distress.
The hot topic section informs readers that a recent risk-benefit review for reboxetine (Edronax®) has concluded that the balance of evidence remains positive for the licensed indication. UK use of this product is already low and in line with national recommendations.
This section also provides an update on the impact of sales restrictions on pseudoephedrine and ephedrine. Data collected between July 2010 and July 2011 appears to show that current strategies are helping to manage the risk of misuse.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.
The Faculty of Sexual and Reproductive Healthcare has issued updated advice on emergency contraception (EC).
The document aims to summarise the available evidence and provide recommendations for the use of copper-bearing intrauterine devices (Cu-IUD), levonorgestrel and, for the first time, ulipristal acetate (ellaOne®). It provides individual advice about each of the treatments and also specific advice regarding future contraception, drug interactions, side effects, multiple use in one cycle and advance provision.
Action: The advice and recommendations will be of value to any clinician who provides emergency contraception.