Duloxetine (Cymbalta®) is an antidepressant that has been the subject of several previous postings. Some of this information is now in need of an update.
To clarify the current situation:
- The Scottish Medicines Consortium have restricted use of duloxetine in Scotland
- Lancashire Care Trust have restrictions in place on duloxetine
- The Summary of Product Characteristics recommends that patients (and carers) are made aware of the need to monitor for suicidal ideation/behaviour and that there is "close supervision of high-risk patients"
- The MHRA publication Current Problems in Pharmacovigilance recommends "careful and frequent patient monitoring during treatment is recommended, particularly for high risk groups."
- [Update] Leeds NHS Health Community (PCT, Acute and Care Trusts) have recommended restricted use of duloxetine
Action: The existing advice remains unchanged at this time; duloxetine should not be used as an antidepressant in a Primary Care Setting.
Previously, this site has advised the use of metformin as a first line therapy in all patients with type II diabetes.
This advice was based upon the reductions in risk of myocardial infarction seen in obese patients taking metformin in UKPDS1 however some recommendations suggest that sulphonylureas should be used in type II diabetics who are not obese.
A study in Diabetes Care has compared metformin therapy in normal, overweight and obese individuals. The abstract concludes that "metformin is at least as efficacious in normal and overweight individuals as it is in those who are obese" after the results demonstrated that HbA1c was not different in the three groups and that there were no statistically significant differences in diabetes-related complications.
Action: This study provides evidential support for metformin use in non-obese individuals with type II diabetes. Metformin is the first line agent for all patients with type II diabetes.
- United Kingdom Prospective Diabetes Study
The National Institute of Health and Clinical Excellence (NICE) has published a guideline on the management of urinary incontinence in women.
The guideline is available as:
The guideline contains information on:
- assessment and diagnosis
- conservative, pharmacological and surgical management
- non-therapeutic interventions
- indications for referral
In a press release accompanying the release of this guideline it is estimated that 5 million women in England and Wales are affected by urinary incontinence.
Action: Clinicians should be aware of the contents of this guideline; it has the potential to improve the management of urinary incontinence in large numbers of women.
In September it was reported that the European Medicines Agency (EMEA) announced that they would be updating their review of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). The review is now complete according to this press release.
The EMEA have found that NSAIDs retain a positive benefit risk balance if used appropriately and following assessment of an individual patient's cardiovascular, gastrointestinal and renal risk factors.
The Medicines and Healthcare products Regulatory Agency (MHRA) have also issued a press release. The MHRA have also issued:
The main point of interest from the review is contained in the MHRA letter to health professionals. The review has found that diclofenac (particularly at 150mg/day) and ibuprofen (at high dose - 2400mg/day) may carry a small thrombotic risk. This same risk has not been established for naproxen.
- Where possible use Paracetamol based analgesia as first line with a ladder approach if initial analgesia fails.
- Review the patient for the overall risks involved with NSAID treatment - this should include an assessment of gastro-intestinal, cardio-vascular and renal risk as well as pre-treatment assessment of blood pressure and renal function.
- Where the overall risks are low or NSAID treatment is absolutely necessary despite moderate to high risk, the NSAID of lowest risk should be used at the lowest possible dose and for the shortest possible duration. This will usually mean that Ibuprofen is the first line NSAID.
- If Ibuprofen therapy fails or is not tolerated, re-assess the patient for an NSAID before trying an alternative. Suitable alternatives would include naproxen and perhaps diclofenac.
Action: This review provides clinicians with the latest information on NSAID safety. Clinicians should compare their current practice to this latest advice and make any necessary changes.
The Department of Health has recently published two new documents regarding the safer management of controlled drugs.
The first of these is the final guidance on the changes to record keeping requirements. The document clarifies, among other things, the current legal situation surrounding running balances and computerised registers.
The second document is the interim guidance on the destruction and disposal of controlled drugs. This document details the requirements for destruction of both stock and patient returned controlled drugs as well as detailing who can witness the destruction.
Action: These documents are a useful (and official) summary of the legal changes that are affecting management of controlled drugs.