June 2017
Selected items from the News and Latest Additions sections of www.palliativedrugs.com, the world’s leading palliative care website with over 30,000 members from 169 Countries.
Safety updates
FDA restricts codeine and tramadol in children and adolescents
As part of an on-going safety review, the FDA have further restricted the use of codeine and tramadol:
- codeine is contra-indicated for the treatment of pain or cough in children <12 years
- tramadol is contra-indicated for the treatment of pain in children <12 years
- codeine and tramadol are contra-indicated in children <18 years to treat pain after surgery to remove the tonsils and/or adenoids
- it is recommended that codeine and tramadol are not used in adolescents 12−18 years whoare obese, or have conditions such as obstructive sleep apnoea or severe lung disease, which may increase the risk of serious breathing problems
- it is recommended that codeine and tramadol are not used by breastfeeding mothers.
For more information, click here.
Editor’s note: The restrictions for codeine reflect those issued in the UK by the MHRA in April 2015 (for cough) and July 2013 (for pain). The MHRA have not specifically highlighted any restrictions in
the UK for tramadol, which is unauthorized for use in children <12 years.
Drug updates
Acetylcysteine oral powder launched in UK
A new oral acetylcysteine powder is now available in the UK, authorized as a mucolytic adjuvant for respiratory disorders associated with thick, viscous, mucus hypersecretion. The dose is 200mg
(1 sachet, dissolved in a little water) three times a day. The cost for 28 days@ 1 sachet t.d.s. = £315. For more information, click here.
Nystatin dose changes in the BNF and SPC
The dose for oral candidosis in the BNF and all the SPCs for nystatin 100,000units/mL oral suspension, is now 1mL PO q.d.s.. There has been recent confusion over the authorized dose with generic and proprietary SPCs including differing dose schedules. The dose in the Nystan (Sqibb) SPC was increased in September 2016 from 1mL to 4−6mL q.d.s., but has now been changed back to 1mL q.d.s. This was after further discussion with the MHRA who re-assessed the evidence and did not find it robust enough to support the dose increase. For more information, click here.
Editor’s note: PCF has always recommended a higher dose of nystatin oral suspension 100,000units/mL of 5mL PO q.d.s. for oral candidosis. Nystatin is a topical treatment and few people have the oral dexterity to cover the relevant areas with just 1mL, i.e. it is an issue of volume and not the dose itself. The authorized dose in the USA is 4−6mL q.d.s.
Fentanyl lozenges (Actiq) risk minimization guides
As part of the terms of the Marketing Authorization for Actiq (fentanyl lozenges; Teva), the company have published the following educational guides to minimize risk of misuse/dependence, abuse, medication errors, drug diversion, accidental exposure, overdose, off-label use, respiratory depression and dental decay in patients on opioids.
Prescription guide
Patient guide
Patient treatment diary
Latest additions
Restructured and updated PCF Part 2 live on the website
We are delighted to announce the launch of the new format for Part 2 of PCF on the www.palliativedrugs.com website in anticipation of PCF6 print publication in late 2017. This work has been completed separately over the last 3 months. In addition, several updates to Part 1 monographs have also been completed. The changes include:
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- a more user-friendly order for the chapters and appendices; most chapters/appendices have been renumbered
- splitting of long chapters, e.g. Chapter 14 into shorter more specific chapters, e.g. a new fully revised chapter on renal impairment
- new chapters, in both Part 2 e.g. Transdermal patches and Part 1, e.g. Opioid antagonists (peripheral)
- a total of 26 updated chapters/monographs (including 9 in Part 1 / Prelims)
- a new Part 3 section for routes of administration.
For full details, see the link below. We will now be focusing on completing updates to Part 1 monographs which will be subsequently added to the website. Follow us on twitter@palliativedrugs for the latest updates.
List of changes and restructure Jan-April 2017
Survey results
Results are available from our latest survey, ‘SSRIs for pruritus – Do you use them?’. For more information, click here.
Prepared by Sarah Charlesworth and Andrew Wilcock.