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Microsoft word - august 2008 newsletter.doc
DONCASTER PCT PRESCRIBING NEWSLETTER AUGUST 2008 Stronger warnings recommended for etoricoxib
Following a review conducted as part of a licence
Etoricoxib must not be used
extension application, the European Medicines
whose blood pressure is persistently above
Agency has recommended that the warnings and
contraindications for etoricoxib are strengthened.
must be controlled
The review assessed the risks and benefits of
etoricoxib 90mg per day for rheumatoid arthritis
Blood pressure should be monitored
and ankylosing spondylitis. It was concluded that
two weeks after the start of treatment and
the benefits outweigh the risks but that several
measures are added to prescribing information to
: Clinicians should be aware of these new
recommendations. As with all non-steroidal anti-
These recommendations are detailed in a Q&A
document (available from www.emea.europa.eu).
gastrointestinal and renal risks should be assessed
before starting treatment. Source: www.prescriber.org
Varenicline: suicidal thoughts and behaviour
Suicidal thoughts and behaviour have been
• Varenicline should be stopped immediately if
reported in users of varenicline who have no
agitation, depressed mood, or changes in
known pre-existing psychiatric conditions, and
behaviour are observed that are of concern to
while they continue to smoke. Anyone taking
varenicline who develops depression or suicidal
• The safety and efficacy of varenicline in people
thoughts should stop their treatment and contact
with serious psychiatric illness have not been
established. Patients who have a history of
Advice for healthcare professionals:
psychiatric illness should be monitored closely
• Patients should be told to stop treatment and
contact their doctor immediately if they develop
Source: Drug Safety Update 2008; 1(12)
NPSA guidance: Reducing Dosing Errors with
NPSA/2008/RRR05 issues guidance which applies when the following
opioid medicines are prescribed, dispensed or administered: buprenorphine,
diamorphine, dipipanone, fentanyl, hydromorphone, meptazinol, methadone,
morphine, oxycodone, papaveretum, pethidine.
In anything other than acute emergencies, the healthcare practitioner
concerned, or their clinical supervisor, should:
• Confirm any recent opioid dose, formulation, frequency of administration
and any other analgesic medicines prescribed for the patient. This may be
done for example through discussion with the patient or their representative
(although not in the case of treatment for addiction), the prescriber or
through medication records.
• Ensure where a dose increase is intended, that the calculated dose is safe
for the patient (e.g. for oral morphine or oxycodone in adult patients, not
normally more than 50% higher than the previous dose).
• Ensure they are familiar with the following characteristics of
that medicine and formulation: usual starting dose, frequency of
administration, standard dosing increments, symptoms of
Deadline for action complete is 30 January 2009.
Medicines Management Team • White Rose House • Ten Pound Walk • DN4 5DJ
NICE CG 66 – The management of type 2 diabetes
Oral glucose control (1): metformin, insulin secretagogues and acarbose
• Start metformin in a person who is overweight or obese1 and whose blood glucose is inadequately
controlled2 by lifestyle interventions (nutrition and exercise) alone.
• Step up metformin over several weeks to minimise risk of gastrointestinal (GI) side effects.
• Consider trial of extended-absorption metformin if GI tolerability prevents the person continuing
• Continue with metformin if blood glucose control remains or becomes inadequate2 and another oral
glucose-lowering medication (usually a sulfonylurea) is added.
• Review metformin dose if serum creatinine > 130 µmol/litre or estimated glomerular filtration rate
Stop metformin if serum creatinine > 150 µmol/litre or the eGFR < 30 ml/minute/1.73-m2. Prescribe metformin with caution for those at risk of a sudden deterioration in kidney
function, and those at risk of eGFR falling to < 45 ml/minute/1.73-m2.
• If the person has mild to moderate liver dysfunction or cardiac impairment, discuss benefits of
due consideration can be given to the cardiovascular-protective effects of the drug an informed decision can be made on whether to continue or stop the metformin.
• Consider a SU as an option for first-line glucose-lowering therapy if:
the person is not overweight1 the person does not tolerate metformin (or it is contraindicated) or a rapid response to therapy is required because of hyperglycaemic symptoms.
• Prescribe a SU with a low acquisition cost (not glibenclamide) when an insulin secretagogue is
• Educate the person about the risk of hypoglycaemia, particularly if he or she has renal impairment.
• When drug concordance is a problem, offer a once-daily, long-acting SU. Rapid-acting insulin secretagogues
• Consider offering a rapid-acting insulin secretagogue to a person with an erratic lifestyle.
• Consider acarbose for a person unable to use other oral glucose-lowering medications.
Oral glucose control (2): other oral agents and exenatide
• If glucose concentrations are not adequately controlled4, consider, after discussion with the person,
the combination of metformin + SU if human insulin is likely to be unacceptable or
ineffective because of employment, social or recreational issues related to putative hypoglycaemia, injection anxieties, other personal issues, or obesity/metabolic syndrome
a SU if metformin is not tolerated metformin as an alternative to a SU where the person’s job or other issues make the risk of
hypoglycaemia with SU particularly significant.
• If prescribing a thiazolidinedione, warn about significant oedema and tell the person what to do if it
• Do not start or continue a thiazolidinedione if the person has evidence of heart failure or is at
• When selecting a thiazolidinedione, take into account the most up-to-date advice from regulatory
Gliptins5 – GLP-1 enhancers: not covered by the guideline. Exenatide6 – GLP-1 mimetic: not recommended for routine use in T2DM Source: www.nice.org.uk 1 Tailor the assessment of body-weight-associated risk according to ethnic group: see NICE CG 43 2 General HbA1c target level 6.5%: discuss individial HbA1c target level with the person 3 Doncaster APC classification – rosiglitazone: Amber-G, pioglitazone: Green-G 4 HbA1c < 7.5% or other higher level agreed with the individual 5 Doncaster APC classification–sitagliptin: Amber-G, sitagliptin/metformin: Red, vildaglptin +/- metformin: Red 6
Doncaster APC classify exenatide Amber–G
Medicines Management Team • Sovereign House • Ten Pound Walk • DN4 5DJ
SUMMARY OF PRODUCT CHARACTERISTICS NAME OF THE MEDICINAL PRODUCT Januvia 100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL Film-coated tablet (tablet) Round, beige film-coated tablet with “27
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