Selected items from the News and Latest Additions sections of www.palliativedrugs.com, the world’s leading palliative care website.

Hot topics

Free access to the on-line Palliative Care Formulary in Scotland

From April 2013, NHS Education for Scotland has subscribed to the on-line Palliative Care Formulary (PCF4+). The content is continually updated and represents the most current version. It is hosted on the Palliative Care Portal of the Knowledge Network website. It is available free of charge to those with an NHS Education Scotland ATHENS username and password.

Drug updates

Asilone discontinued in UK

Asilone^® oral suspension (Thornton & Ross) an antacid containing simeticone 135mg, aluminium hydroxide 420mg and magnesium oxide 70mg/5mL has been discontinued in the UK. Alternative simeticone-containing antacid preparations are:

Maalox Plus^® (Sanofi Aventis)
Oral suspension (sugar-free) simeticone 25mg, dried aluminium hydroxide 220mg, magnesium hydroxide 195mg/5mL, 28days @ 5mL q.d.s =.£3; low Na⁺.

Altacite plus^® (Peckforton)

Oral suspension (sugar-free) co-simalcite 125/500 (simeticone 125mg, hydrotalcite 500mg)/5mL 28days @ 10mL q.d.s =.£7.50; low Na⁺.

See PCF Simeticone monograph

Latest additions

 PCF updated monographs

The online Palliative Care Formulary (PCF) is being continually updated. The following monographs have been updated during March 2013 and supersede those in the publication of the 4^th edition of the Palliative Care formulary (PCF4). They can be accessed from the formulary section of the website:

Chapter 5: Fentanyl (transmucosal)

Chapter 7: Octreotide

For a full list of all the monographs updated since the publication of PCF4, click here.

The oral morphine equivalent of buprenorphine TD patches – What conversion ratio do you use?

Results from this www.palliativedrugs.com  survey (November 2012 – January 2013) can be downloaded from here.

Die Januar/Februar Ausgabe des APM Newsletter ist fertig

The January/February issue of the APM Newsletter for German-speaking users of www.palliativedrugs.com is available.

Der neue APM-Newsletter Jahrgang ist in der Ausgabe Januar/Februar erschienen. Über die aktuelle Ausgaben des Newsletters wird Sie das Bulletin Board informieren.

Prepared by Sarah Charlesworth and Andrew Wilcock

Selected items from the News and Latest Additions sections of www.palliativedrugs.com, the world’s leading palliative care website.

Drug updates

Two strengths of insulin now available in UK

Insulin degludec (Tresiba^®; Novo Nordisk, Crawley, UK) has been launched in two strengths in the UK as 100 units/mL and 200 units/mL. This 200 units/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. For more information click here.

Dexamfetamine sulphate 5mg caution in use alert

The Medicines and Healthcare products Regulatory Agency (MHRA) have issued a caution in use alert for dexamfetamine sulphate 5mg (Auden McKenzie; pack size 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. Contact Auden McKenzie (01895 627420) if packs with extra blister strips are found. For more information click here.

Oxymorphone new crush resistant strengths in USA

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

SMC accepts palonosetron capsules

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

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. For more information click here. 

Prepared by Sarah Charlesworth and Andrew Wilcock

Selected items from the News and Latest Additions sections of www.palliativedrugs.com, the world’s leading palliative care website.

Safety updates

Routine hepatic monitoring recommended for lenalidomide

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^®; Celgene, Uxbridge, UK). This follows reports of elevations of hepatic enzymes occurring in up to 10% of patients treated with lenalidomide for multiple myeloma in clinical trials. This is mostly without serious consequence and resolves when lenalidomide is stopped, at which point reintroduction of lenalidomide at a lower dose can be considered. However, in <1% of treated patients, acute hepatic failure, toxic hepatitis, hepatocellular hepatitis and cholestatic hepatitis have been reported.

Because lenalidomide is excreted predominantly renally, the dose 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. For more information click here.

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

The Medicines and Healthcare products Regulatory Agency (MHRA) have reported rare cases of atypical femoral fracture in patients receiving denosumab 60mg (Prolia^®; Amgen, Cambridge, UK) for post-menopausal osteoporosis for >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; these may occur with little/no trauma in the subtrochanteric and diaphyseal regions of the femur
• the contralateral femur should be examined carefully, as atypical femoral fractures are often bilateral
• consider discontinuing treatment while the patient is evaluated; benefits and risks should be assessed on an individual basis.

For more information click here.

Prepared by Sarah Charlesworth and Andrew Wilcock

Selected items from the News and Latest Additions sections of www.palliativedrugs.com, the world’s leading palliative care website.

Hot topics

Updated Controlled Drugs Regulations (Supervision of Management and Use) from 1^st April 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 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, along with the official Regulations 2013 and the summary of consultation responses.

NPA resources on controlled drugs

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

Prepared by Sarah Charlesworth and Andrew Wilcock

Selected items from the News and Latest Additions sections of www.palliativedrugs.com, the world’s leading palliative care website.

Latest additions

PCF updated monographs

The online Palliative Care Formulary (PCF) is being continually updated. The following monographs have been updated during December 2012 and January 2013 and supersede those in the publication of the 4^th edition of the Palliative Care formulary (PCF4). They can be accessed from the formulary section of the website:

Chapter 1: PPI

Chapter 1: H₂-receptor antagonists

Chapter 5: Opioid antagonists

Chapter 5: Naltrexone

Chapter 7: Desmopressin

Chapter 11: Mouthwashes

For a full list of all the monographs updated click here.

Die November/Dezember Ausgabe des APM Newsletter ist fertig

The November/December issue of the APM Newsletter for German-speaking users of www.palliativedrugs.com is available.

Die November/Dezember Ausgabe des APM Newsletter ist fertig. Über die aktuelle Ausgaben des Newsletters wird Sie das Bulletin Board informieren.

Prepared by Sarah Charlesworth and Andrew Wilcock

Selected items from the News and Latest Additions sections of www.palliativedrugs.com, the world’s leading palliative care website.

Latest additions

PCF updated monographs

The online Palliative Care Formulary (PCF) is being continually updated. The following monographs have been updated during November 2012 and supersede those in the publication of the 4^th edition of the Palliative Care formulary (PCF4). They can be accessed from the formulary section of the website:

Chapter 7: Demeclocycline hydrochloride

Chapter 7: Systemic corticosteroids

Chapter 9: Ascorbic acid

Chapter 9: Zinc

For a full list of all the monographs updated since the publication of PCF4, click here.

Website satisfaction survey winners and results

Results from this www.palliativedrugs.com website satisfaction survey (September–October 2012) can be downloaded from here. For details of the five winners to receive a free copy of the pdf version of PCF4+ click here. Congratulations and thank you for your support. Please continue to let us know of anything you think we could improve by sending an e-mail to hq@palliativedrugs.com.

Die September/Oktober Ausgabe des APM Newsletter ist fertig

The September/October issue of APM Newsletter for German-speaking users of http://www.palliativedrugs.com is available.

Die September/Oktober Ausgabe des APM Newsletters ist fertig. Über die aktuelle Ausgaben des Newsletters wird Sie das Bulletin Board informieren.

Prepared by Sarah Charlesworth and Andrew Wilcock

Selected items from the News and Latest Additions sections of www.palliativedrugs.com, the world’s leading palliative care website.

Drug updates

Suboxone SL tablets replaced by SL film in US

Sublingual (SL) combination tablets containing buprenorphine and naloxone (Suboxone^®; Reckitt Benckiser, Warren, NJ, USA), are being replaced by a sublingual film in the US. The tablet formulation, authorized for maintenance treatment in opioid dependence, is now off-patent and available as a generic product. The manufacturer states that the sublingual film has a faster dissolving rate, a more favourable taste and improved child-safety packaging. For the SPC click here.

Pecfent in use expiry extended to 60 days

The UK SPC for Pecfent (fentanyl citrate) nasal spray 100microgram/spray and 400microgram/spray has been updated. The in-use expiry of the product has been extended from 14 days to 60 days i.e. the SPC now reads:

“If the product has not been used for 5 days, re-prime by spraying once. Discard bottle 60 days after first opening.”

Prepared by Sarah Charlesworth and Andrew Wilcock

Selected items from the News and Latest Additions sections of www.palliativedrugs.com, the world’s leading palliative care website.

Hot topics

EMA review of cardiovascular safety of NSAIDs

The European Medicines Agency (EMA) has finalised a review of recently published information on the cardiovascular safety of non-steroidal anti-inflammatory drugs (NSAIDs). The review confirms the findings from previous reviews which concluded that the overall benefit-risk balance of NSAIDs remained positive, but that a small increased cardiovascular risk could not be excluded.

Most of the data related to diclofenac, ibuprofen and naproxen. The latest evidence continues to find a small increase in the risk of cardiovascular undesirable effects for diclofenac compared with other non-selective NSAIDs, similar to the risks of COX-2 inhibitors, particularly with long-term use of high doses and in patients already at high risk. Warnings are already included in the SPC. However, the EMA will now assess all available data on diclofenac (both published and unpublished) to consider the need for updated treatment advice. In relation to naproxen and ibuprofen, the current treatment advice adequately reflects the knowledge regarding the safety and efficacy of these medicines. For more information click here.

Denosumab; fatal cases of severe symptomatic hypocalcaemia

The UK Medicines and Healthcare products Regulatory Agency (MHRA) have highlighted cases of severe symptomatic hypocalcaemia that have occurred in patients receiving denosumab 120mg (Xgeva^®; authorized for use in prevention of skeletal related events in adults with bone metastases from solid tumours) or 60mg (Prolia^®; authorized for use in osteoporosis).

Hypocalcaemia is a known risk with denosumab use, especially in patients with severe renal impairment (creatinine clearance <30 mL/min) or receiving dialysis. Severe symptomatic hypocalcaemia, including three fatal cases, has been reported in patients receiving denosumab 120mg. Although hypocalcaemia with denosumab most commonly occurs within the first 6 months of dosing, it can occur at any time during treatment.

Pre-existing hypocalcaemia must be corrected prior to initiating denosumab, and supplementation of calcium and vitamin D is required in all patients receiving the 120mg dose unless hypercalcaemia is present. Periodic monitoring of calcium levels (at the discretion of the prescriber) is recommended after use of denosumab in patients predisposed to hypocalcaemia, including those with severe renal impairment. For more information, click here.

LCP independent review

Following a round table discussion, Norman Lamb (Minister for Care and Support) is to appoint an independent chair to understand what lies behind the reports of poor quality care associated with the implementation of the Liverpool Care Pathway (LCP) in the UK media and oversee and validate the review work initiated by the National End of Life Care Programme, the Association for Palliative Medicine and Dying Matters. The results of the independent review will be reported next year. For more information click here.

MHRA Medicines Device Alert for Inadine dressings

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Medicines Device Alert for Inadine^® PVP-I non adherent dressing (9.5cm x 9.5cm) manufactured by Systagenix Wound Management (Product code: P0149; Lot numbers: 1227/1228/1229). There is a possible risk of infection due to compromised sterility, and the affected batches should not be used. For further information click here.

 Prepared by Sarah Charlesworth and Andrew Wilcock

Selected items from the News and Latest Additions sections of www.palliativedrugs.com, the world’s leading palliative care website.

Latest additions

PDF version of PCF4+ now available!

An e-book PDF version containing the latest content of the on-line Palliative Care Formulary as of September 2012 (designated PCF4+) is now available to purchase and download from the website. PCF4+ contains 17 updated monographs and 1 appendix, which supersede the printed PCF4 version. We anticipate publishing a PDF version annually, with the fifth edition of the book (PCF5) in 2014. Special launch price, until end of 2012, only £24.99 (usual price £29.99). For more details click here.

Lidocaine 5% medicated plasters – What is your experience?

Results from this www.palliativedrugs.com survey (July- August 2012) can be downloaded from here.

 Prepared by Sarah Charlesworth and Andrew Wilcock

Selected items from the News and Latest Additions sections of www.palliativedrugs.com, the world’s leading palliative care website.

Drug updates

Hydromorphone ER 32mg launched in US

A once daily modified-release hydromorphone 32mg tablet (Exalgo; Mallinckrodt, Hazelwood, MO) has been added to the existing product range of 8mg, 12mg and 16mg modified-release tablets for opioid-tolerant adult patients with moderate to severe chronic pain in the US. For full prescribing information click here.

Epistatus product description change

There has been a change made to the product description of the unauthorized (unlicensed) midazolam product Epistatus (Special Products Limited; 01932 690325 Weybridge, Surrey, UK) as follows:

Midazolam (Epistatus) 10mg in 1mL Buccal Liquid x 5mL

has been replaced with

Midazolam (Epistatus) 10mg in 1mL Oromucosal Solution x 5mL.

Change of supplier for Epanutin (phenytoin) capsules

Flynn Pharma has taken over the manufacture and distribution of Epanutin (phenytoin) capsules in the UK, with the product now marketed as Phenytoin sodium Flynn hard capsules (a generic). Phenytoin sodium Flynn hard capsules are bioequivalent to Epanutin and the capsules have markings and colourings exactly like Epanutin capsules, including still having the marking ‘Epanutin’.

Prescribers are advised to specify the Flynn Pharma product when ordering as pharmacies cannot give the Flynn Pharma product against a prescription for Epanutin and will need to get the prescription amended.

Concern has been raised in the media regarding the significant cost increase from £0.66 for a pack of 28 x 25mg capsules to £15.74. For more information click here.

Metolazone discontinued

Metolazone tablets (Sanofi Aventis) have been discontinued by the manufacturer in the UK and supplies are almost exhausted. There is currently no other supplier of metolazone tablets in the UK. The British Society for Heart Failure (BSH) has advised switching patients from metolazone to bendroflumethiazide when a patient’s supplies run out, at a dose of 2.5 mg, increasing to 5mg, if indicated.

It is thought that generic manufacturers may step into the breach, and metolazone may become available again in the UK in the future. For more information click here.

Prepared by Sarah Charlesworth and Andrew Wilcock