The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for March 2014 (PDF).
This issue contains drug safety advice informing clinicians of a theoretical interaction between orlistat and antiretroviral HIV medicines. Orlistat may reduce the absorption of these medicines and as such reduce efficacy. It is recommended that orlistat is only used in patients taking antiretroviral HIV medicines after careful consideration. It is also recommended that individuals interested in purchasing orlistat (Alli®) over the counter should consult their doctor before starting treatment.
This section also reminds clinicians that St John’s wort interacts with hormonal contraceptives. Two Yellow Card reports have been submitted recently regarding women using the etonogestrel implant (Implanon® or Nexplanon®) who used St John’s wort and subsequently had an unplanned pregnancy. Clinicians are advised to tell women taking hormonal contraceptives for pregnancy prevention not to take herbal products containing St John’s wort.
The stop press section contains additional information about the recently announced restricted indications and new monitoring requirements for strontium ranelate in light of increased cardiovascular risks and also the new restricted use and monitoring requirements for methysergide in light of serious fibrotic reactions. Methysergide is currently only available in the UK via unlicensed imports. The stop press section also advises that the updated packaging design for dorzolamide/timolol (Cosopt®) preservative-free eye drops, which aims to prevent inadvertent eye injuries, is now available.
Finally, in other information, advice disseminated via the NHS Central Alerting System in January regarding combined hormonal contraception is clarified. Annexes sent with this alert recommend that women at higher risk of VTE use "a non-hormonal form of contraception" when it ought to have stated "that a different form of contraception should be used". This change indicates that progestogen-only contraceptives as well as non-hormonal methods are suitable options.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.
MTRAC issued two new Commissioning Support reviews in March 2014. The reviews cover denosumab and rifaximin.
The denosumab (Prolia®) summary advises that this drug is suitable for restricted prescribing in primary care, following secondary care initiation and stabilisation of treatment. The review notes that this medicine has relatively strong evidence but a lower place in therapy as recommended by NICE guidance.
The rifaximin (Targaxan®) summary advises that this drug is suitable for restricted prescribing in primary care, following secondary care initiation and stabilisation and with the guidance of a shared care agreement. The review notes that this medicine has relatively strong evidence but a lower place in therapy after existing treatment options were inadequate or inappropriate.
Action: Clinicians should be aware of these reviews and use the recommendations to guide appropriate use of these medicines in current practice.
The Department of Health has announced that the price for an NHS prescription in England will increase by 20p to £8.05 with effect from April 2014. It is also intended that an additional 20p increase will be added in April 2015 bring the price per item to £8.25.
The prices for 3 and 12 month pre-payment certificates has remained the same at £29.10 and £104 respectively. For anyone requiring more than 4 items in 3 months or more than 13 in a year these certificates can provide significant savings.
Other NHS charges such as for dental work, wigs and fabric supports are also being increased.
Action: Clinicians should be aware of the current prescription charge and also the value for money represented by pre-payment certificates.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Alogliptin (Vipidia®) has been rejected for use in adults with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control. The manufacturer did not present sufficiently robust clinical and economic analysis to gain acceptance.
Dapagliflozin (Forxiga®) has been accepted for restricted use in adults with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control. The restriction limits use to combination with insulin, when insulin with diet and exercise, does not provide adequate glycaemic control.
Insulin degludec (Tresiba®) has been rejected for the treatment of diabetes mellitus in adults. The manufacturer did not present a sufficiently robust economic analysis to gain acceptance
Saxagliptin (Onglyza®) has been rejected for use as monotherapy in adult patients with type 2 diabetes mellitus to improve glycaemic control inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. The manufacturer failed to make a submission.
Solifenacin and tamsulosin (Vesomni®) has been accepted for the treatment of moderate to severe storage symptoms (urgency, increased micturition frequency) and voiding symptoms associated with benign prostatic hyperplasia in men who are not adequately responding to treatment with monotherapy.
Zonisamide (Zonegran®) has been accepted for restricted use as adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adolescents and children aged 6 years and above. The restriction limits use only when advised by specialists (paediatric neurologists or paediatricians with an expertise in epilepsy).
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 issued a press release noting that updated advice will be distributed to healthcare professionals regarding strontium ranelate (Protelos®) which is used to treat severe osteoporosis in post-menopausal women and men with a high risk of fracture.
A review was conducted by the European Medicines Agency recently because of study data which suggested an increased risk of heart problems. The review concluded there is no increased risk in individuals who have no history of heart or circulatory problems. However, in individuals who do have a history of heart or circulatory problems strontium is now only recommended if they are unable to take alternative medicines.
This advice will be disseminated to healthcare professionals via letter and will also be included in the March edition of the Drug Safety Update.
Action: Clinicians should be aware of this new advice. This change in advice would make a good topic for an audit.