MHRA Guidance Drug Safety Updates
Please note that the information in this newsletter is correct at the time of publication. Clinicians should always refer to the most up to date information.
In this ISSUE:
Prescribing information
MHRA guidance – Drug Safety Updates
Products in short supply and product discontinuations
Products with significant cost changes
1
To contact the Medicines Optimisation Team please phone 01772 214302
Please note that the information in this newsletter is correct at the time of publication. Clinicians should always refer to the most up to date information.
Prescribing information
- New Yellow Card app for reporting suspected side effects
A Yellow Card smart phone app was launched on the 14th July 2015, for people to report problems with medicines. The free mobile app is available for all healthcare professionals and patients to access.You can download the app from theiTunes App Store and/or Google Playfor your IOS or Android device.
- Cardiovascular warning for high-dose ibuprofen
The MHRA and other EU medicines regulators have reviewed the safety of high-dose ibuprofen. This is following the publication of
a meta-analysis of clinical trial data. This meta-analysis showed that people taking ≥2400 mg of ibuprofen per day were at a higher risk of arterial thrombotic events (heart attack, stroke) than people taking placebo. The review confirmed that this higher risk is similar to that seen with COX-2 inhibitors and diclofenac.
- Patient safety failures in asthma care: the scale of unsafe prescribing in the UK
A report from Asthma UK, published one year on from the National Review of Asthma Deaths, found that around 127,617 people with asthma in the UK may have been put at risk of a potentially life-threatening asthma attack due to unsafe prescribing. For further details the report can be downloaded here
1
To contact the Medicines Optimisation Team please phone 01772 214302
Please note that the information in this newsletter is correct at the time of publication. Clinicians should always refer to the most up to date information.
- Edoxaban drug safety letter
1
To contact the Medicines Optimisation Team please phone 01772 214302
Please note that the information in this newsletter is correct at the time of publication. Clinicians should always refer to the most up to date information.
Daiichi Sankyo UK Ltd has recently sent out a letter to healthcare professionals informing them of their new NOAC product Edoxaban, an oral anticoagulant which acts by direct selective inhibition of factor Xa. Please click here for a copy of the full letter.
1
To contact the Medicines Optimisation Team please phone 01772 214302
Please note that the information in this newsletter is correct at the time of publication. Clinicians should always refer to the most up to date information.
MHRA guidance – Drug Safety UpdatesSeptember 2015
1
To contact the Medicines Optimisation Team please phone 01772 214302
Please note that the information in this newsletter is correct at the time of publication. Clinicians should always refer to the most up to date information.
Proton pump inhibitors (PPIs) are associated with very infrequent cases of subacute cutaneous lupus erythematosus (SCLE), a non-scarring dermatosis that can develop in sun-exposed areas. If a patient treated with a proton pump inhibitor (PPI) develops lesions—especially in sun-exposed areas of the skin—and it is accompanied by arthralgia:
- advise them to avoid exposing the skin to sunlight
- consider subacute cutaneous lupus erythematosus (SCLE) as a possible diagnosis
- consider stopping use of the PPI unless it is imperative for a serious acid-related condition; a patient who develops SCLE with a particular PPI may be at risk of the same reaction with another
- in most cases, symptoms resolve on PPI withdrawal; topical or systemic steroids might be necessary for treatment of SCLE only if there are no signs of remission after a few weeks or months
- report any suspected side effect with PPIs, or to any medicine, on a Yellow Card
Patient reminder cards about the risk of osteonecrosis of the jaw are being introduced for Denosumab (Prolia®, Xgeva®) and intravenous bisphosphonates. Additionally, Denosumab 120mg (Xgeva®) is now contraindicated in patients with unhealed lesions from dental or oral surgery.
The Xalatan formulation of latanoprost has recently been changed such that the pH is now 6.0 compared to 6.7 previously. This change allows for longer term storage at room temperature; however it has also been associated with an increase in reporting of eye irritation. Patients as advised to tell their health professional promptly (within a week) if they have eye irritation (e.g. excessive watering) severe enough to make them consider stopping treatment.
1
To contact the Medicines Optimisation Team please phone 01772 214302
Please note that the information in this newsletter is correct at the time of publication. Clinicians should always refer to the most up to date information.
Products in short supply and discontinuations
The following links provide prescribers with up to date information on commonly prescribed products which are currently in short supply from the manufacturers
Please note there are continued stock availability issues for the following items:
- Fenbid Forte®
- Zantac®
- Vensir®
- Scheriproct® ointment
- Ferrous fumarate 210mg tablets
1
To contact the Medicines Optimisation Team please phone 01772 214302
Please note that the information in this newsletter is correct at the time of publication. Clinicians should always refer to the most up to date information.
Discontinued products
- The manufacturer of NovoPen® 4 has written to healthcare professionals advising that this device is being phased out and replaced by NovoPen® 5. It is expected that supplies of the NovoPen® 4 will run out in September 2015. The new device will be available in the same colours (blue and silver) and has a memory function which displays the number of units last injected and gives an indication of the amount of time that has passed since the last injection.
- The manufacturer of tripotassium dicitratobismuthate (De-noltab®) has written to healthcare professionals advising that the product will be discontinued with effect from the end of December 2015.No reason for the decision to discontinue this product is provided in the letter. It is recommended that appropriate alternatives are discussed with any patient who is currently taking this medication as a long term treatment.
1
To contact the Medicines Optimisation Team please phone 01772 214302
Please note that the information in this newsletter is correct at the time of publication. Clinicians should always refer to the most up to date information.
1
To contact the Medicines Optimisation Team please phone 01772 214302
Please note that the information in this newsletter is correct at the time of publication. Clinicians should always refer to the most up to date information.
Significant cost changes
- A licensed version of Midodrine is now available. Bramox (midodrine) tablets have been launched for treatment of severe orthostatic hypotension due to autonomic dysfunction in adults when corrective factors have been ruled out and other forms of treatment are inadequate. Bramox is the first licensed midodrine preparation in the UK – previously midodrine was available as an unlicensed imported costly special. Cost for 100 Bramox tablets: 2.5mg, £55.05; 5mg, £75.05.
- The current drug tariff price for Co-amoxiclav 250mg/62mg/5 ml oral suspension sugar free x 100 ml is £1.89. Prescribers are alerted to the use of non-sugar free version of the suspension which has recently been dispensed at the cost of£76 x 100 ml.
- Dicycloverine tablets and liquid have been subject to a huge increase in cost over the past 6 months. Current costs are :
Dicycloverine tablets 10mg - £146.61 for 100 tabs
Dicycloverine tablets 20mg - £155.09 for 84 tabs
Dicycloverine liquid 10mg/5ml - £143.84 for 120ml
Prescribers are advised to consider a possible switch to hyoscinebutylbromide or mebeverine.
- The current drug tariff price for generic isosorbide mononitrate tablets 60mg is £10.50 for 28 tablets. Practices may wish to consider switching to an alternative cost effective branded preparation such as Monomil (£3.49 for 28 tablets)or Chemydur (£3.49 for 28 tablets).
- The current drug tariff price for salbutamol 2mg and 4mg tablets are £104.95 and £107.43 for 28 tablets respectively. Significant cost savings for practices could be realised by reviewing the ongoing need for the medication and where appropriate consider switching to salbutamol 2mg/5ml oral solution (sugar free) which currently costs 72p for 150ml.
- Abbott nutrition have announced that from the 1st September 2015 there will be a number of price changes affecting their range of enteral feeds. In particular there has been a significant reduction in the costs of their range of oral nutritional supplements (Ensure compact and Ensure plus) which should realise cost savings across both CCG’s. A full list of the product price changes can be found here.(left click once on the PDF icon then double click on one of the pointers)
1
To contact the Medicines Optimisation Team please phone 01772 214302
Please note that the information in this newsletter is correct at the time of publication. Clinicians should always refer to the most up to date information.
Top 10 monthly price reductions and increases as of August 2015
1
To contact the Medicines Optimisation Team please phone 01772 214302