Updated Controlled Drugs Regulations from 1st April 2013

28th February 2013

Controlled Drugs (Supervision of Management and Use) Regulations 2013 (SI2103/373) for England and Scotland will come into force on 1^st April 2013. These deal with governance arrangements, in particular the role and functions of Controlled Drugs Accountable Officers (CDAO), and also reflect the new architecture for the NHS in England from April 2013. 

These regulations supersede the Controlled Drugs (Supervision of Management and Use) Regulations 2006 (“the 2006 Regulations”) which came into force in 2007, and follow a consultation process by the Department of Health (DH) in September 2012 (see our article 28-09-2012). 

The DH has published information about the 2013 Regulations which can be downloaded below, along with the official Regulations and the summary of responses to the consultation.

Information about the controlled drugs regulations 2013 

Controlled Drugs (Supervision of Management and Use) Regulations 2013 

Consultation responses

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Dexamfetamine sulphate 5mg caution in use alert

27th February 2013

The MHRA have issued a caution in use alert for Dexamfetamine sulphate 5mg (Auden McKenzie; pack size x 28, batch number 12123/A) first distributed on 10-01-2013. A very small number of packs from the above batch may contain three blister strips instead of two. Pharmacists are asked to check the contents of packs from this batch and contact Auden McKenzie (01895 627420) if extra blister strips are found.

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NPA resources on controlled drugs

26th February 2013

The UK National Pharmacy Association (NPA) has produced resources for controlled drugs including Standard Operating Procedures (SOPs) and guidance sheets for its members.

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Two strengths of insulin now available in UK

21st February 2013

Insulin degludec (Tresiba; Novo Nordisk) has been launched in two strengths in the UK as 100units/mL and 200units/mL. This 200units/mL is higher than any other strength in the UK. Both strengths are available as pre-filled pen devices with distinct labeling to differentiate between the two strengths.

The pre-filled pen devices both have a dose counter window and deliver the dose in units, regardless of the strength, therefore dose conversion is not required if swapping patients from one strength to another.

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Denosumab rare cases of atypical femoral fracture with long-term use

21st February 2013

The Medicines and Healthcare products Regulatory Agency (MHRA) have reported on rare cases of atypical femoral fracture in patients receiving denosumab 60mg (Prolia^®) for post-menopausal osteoporosis for more than 2.5 years.

They advise:

• During denosumab treatment, patients should report new or unusual thigh, hip, or groin pain which should be evaluated for an incomplete femoral fracture
• Atypical femoral fractures may occur with little or no trauma in the subtrochanteric and diaphyseal regions of the femur
• The contralateral femur should be examined in denosumab-treated patients who have sustained a femoral shaft fracture, as atypical femoral fractures are often bilateral
• Consider discontinuing denosumab treatment if an atypical femur fracture is suspected, while the patient is evaluated. An individual assessment of the benefits and risks should be performed.

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Routine hepatic monitoring recommended for lenalidomide

14th February 2013

The latest Medicines and Healthcare products Regulatory Agency (MHRA) Drug Safety Update recommends routine monitoring of hepatic function at baseline, every week for the first 8 weeks and then monthly, for patients being treated with lenalidomide (Revlimid). This follows reports of elevations of hepatic enzymes occurring in 1−10 patients out of every 100 treated with lenalidomide for multiple myeloma in clinical trials; the majority of these were non-serious. Serious (potentially fatal) hepatic injuries such as acute hepatic failure, toxic hepatitis, hepatocellular hepatitis, and cholestatic hepatitis have been reported overall in

MHRA advise that impaired hepatic function generally resolves when lenalidomide is stopped and that once abnormal hepatic parameters return to baseline, treatment with lenalidomide at a lower dose can be considered.

Lenalidomide is excreted predominantly renally. The dose of lenalidomide should be adjusted in patients with renal impairment to avoid high plasma levels which may increase the risk of severe hepatotoxicity, as well as haematological undesirable effects.

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Oxymorphone new crush resistant strengths in US

12th February 2013

Oxymorphone modified release, crush resistant tablets (Opana ER; Endo pharmaceuticals, US) are now available in 7.5mg and 15mg strengths joining the rest of the strength range (5mg, 10mg, 20mg, 30mg, and 40mg).

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SMC accepts palonosetron capsules

11th February 2013

The Scottish Medicines Consortium (SMC) has accepted palonosetron 500microgram soft capsules (Aloxi^®) for use within NHS Scotland for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults.

At recommended authorized doses the soft capsule formulation has been shown to be clinically non-inferior to the intravenous formulation and is cost neutral. SMC has previously accepted palonosetron intravenous injection for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

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