The National Prescribing Centre has published a Guide to Good Practice in the Management of Controlled Drugs in Primary Care.
The Guide incorporates the changes that were announced on November 14th 2005. It covers many aspects of the management of controlled drugs including:
- Purchase and Supply
Action: All clinicians who prescribe, supply or administer controlled drugs should obtain a copy of this guide and familiarise themselves with the changes in legislation and good practice.
The Medicines and Healthcare products Regulatory Authority has published a leaflet for patients titled Taking Medicines - some questions and answers about side effects.
The leaflet answers some common questions about taking medicines and side effects, it also details the descriptions used to quantify the risk of side effects in information leaflets. The categories are as follows:
- Very Common - affects more than 1 in 10 who take the medicine
- Common - affects between 1 in 10 and 1 in 100 who take the medicine
- Uncommon - affects between 1 in 100 and 1 in 1,000 who take the medicine
- Rare - affects between 1 in 1,000 and 1 in 10,000 who take the medicine
- Very Rare - affects less than 1 in 10,000 who take the medicine
For example, if a side effect occurred at a rate of 1 in 1,000; if 1,000 people took the medication only 1 would get the that particular side effect and 999 patient would be unaffected.
Action: Clinicians should be aware of the leaflet and the descriptors used in information leaflets. Keeping a stock of the leaflets may be useful when explaining the likelihood of side effects.
A new Cox-II selective non-steroidal anti-inflammatory (Cox-II NSAID) has been launched by Novartis. Lumiracoxib (Prexige) is available in 100mg and 400mg tablets and is licensed for symptomatic relief of osteo-arthritis and short term relief of moderate to severe acute pain associated with primary dysmenorrhea, dental surgery or orthopaedic surgery.
The Summary of Product Characteristics draws attention to the cardiovascular effects of Cox-II NSAIDs by warning that the risk of thrombotic events is raised in comparison to placebo and other NSAIDs.
Clinicians are advised to use lumiracoxib for the shortest duration and at the lowest effective dose in order to minimise these risks.
The SPC wording is as follows:
Clinical trials suggest that the selective COX-2 inhibitor class of drugs may be associated with a risk of thrombotic events (especially MI and stroke), relative to placebo and some NSAID's. As the cardiovascular risks of lumiracoxib may increase with dose and duration of exposure, the shortest duration and the lowest effective daily dose should be used. The patients need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis.
The SPC also states:
The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks.
Overall risk includes assessment of cardiovascular, gastrointestinal and renal risk.
A stepped approach to analgesia has already been reported that recommends paracetamol based analgesics first with NSAIDs used where risk is low or use of additional pain killers is necessary. Use of the NSAID of lowest risk is recommended, usually Ibuprofen. Gastrointestinal risks can be lowered by concurrent use of omeprazole.
Action: At this time it is therefore difficult to foresee a place in therapy for lumiracoxib.
Wyeth has decided to discontinue Microval, a progestogen-only contraceptive pill containing levonorgestrel 30 micrograms. This decision follows a period of supply difficulties and the withdrawal will allow Wyeth to rationalise their current hormone-based portfolio.
The withdrawal should not cause a great deal of disruption because an identical product is available from Schering Health. Norgeston contains levonorgestrel 30 micrograms per tablet and the pack size is the same as Microval (35 tablets).
Action: Clinicians will need to identify any patient who is currently using Microval and ensure that future prescriptions are for Norgeston if this choice of contraceptive is still appropriate.
Glucotide test strips, manufactured by Bayer, will be blacklisted in the Drug Tariff from January 2006.
Prescribing of these blood glucose reagent strips has been declining for several years as newer strips and devices come to market. Patients with diabetes are required to purchase their own blood glucose testing machines. The National Health Service provides testing strips.
Action: Clinicians will need to ensure that any patients currently being prescribing Glucotide strips are identified and offered a suitable alternative, however they may need to purchase a new device.