1 / 48

A service commissioned by the HPA

A service commissioned by the HPA. The role of medicines regulation in prevention of serious poisoning. Nick Bateman Professor in Clinical Toxicology & Consultant Physician RIE Director, NPIS Edinburgh. NPIS Edinburgh. CONTENT. Medicines Regulation Prescription and OTC products

sasson
Download Presentation

A service commissioned by the HPA

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. A service commissioned by the HPA The role of medicines regulation in prevention of serious poisoning Nick Bateman Professor in Clinical Toxicology & Consultant Physician RIE Director, NPIS Edinburgh NPIS Edinburgh

  2. CONTENT • Medicines Regulation • Prescription and OTC products • 2. Prevention strategies • What works- and perhaps doesn’t • 3. Some ideas for the future

  3. Medicines Regulation • European licensing structure • EMEA www.emea.europa.eu/ • 2. Member states actions • May take note of local circumstances • Prescription only • Pharmacy sale • General sale products (OTC)

  4. REGULATORY ACTIONS • Changes to package/ presentation/ labelling (eg specific warnings) • Changes to category (eg drugs of potential abuse, prescription only, pharmacy supply, general sale) • Changes to indication (may limit supply, reduce hazard in “at risk” groups) via SPC, doctors letter etc • Licence revocation

  5. WHAT THEY CANNOT DO Insist on entirely new formulations (eg antidote inclusion) if efficacy and safety in routine use demonstrated Withdraw products just because of problems in overdose if normal use acceptably safe

  6. AVAILABILITY AND OVERDOSE • If it is not available you cannot take it: • EXAMPLES OF “INCIDENTAL” BENEFIT • Reye’s syndrome and aspirin (1963) • 1980s limitation on aspirin availability • Thioridazine withdrawal for arrhythmia risk autumn 2000

  7. PROPORTION OF POISONING ADMISSIONS 1981-2000 ROYAL INFIRMARY EDINBURGH

  8. PROPORTION OF ADMISSIONS PER ANNUM1981-2000 ROYAL INFIRMARY EDINBURGH

  9. PRESCRIBING OF ANTIPSYCHOTIC DRUGS PER QUARTER, 2000-2001 EXPRESSED AS % OF TOTAL ANTIPSYCHOTICS - ENGLAND

  10. TOXBASE accesses per quarter, 2000-2001 expressed as % of total antipsychotics - England Bateman et al 2003 BJCP 55: 596-03

  11. AVAILABILITY AND OVERDOSE If it is is available can you make it safer? Child resistant containers Mode of supply Volume of purchase- generally for non prescription items (Opioid programmes)

  12. CHILD RESISTANT CONTAINERS • Ingestion rate for all substances requiringCRCs declined from 5.7/1,000 children in 1973 to 3.4/1,000 children in 1978. • Reduction in exposures by 200,000 over 5 yr • 20 yr decline in deaths by poisoning 2.0/100,000 children to 0.5/100,000 National Injury Surveillance SystemandNational Center for Health Statistics(USA) Walton WW 1982 Pediatrics 69:363-70

  13. Effectiveness of child-resistant packaging(Alabama)< 5 y-of-age 168 patients. Mean age 26 mo • 71% original container • 29% transferred to another container or found outside of its container • 33% involved a child-resistant closure Lembersky et al 1996 Vet Hum Tox 38:380-3

  14. Effectiveness of child-resistant packaging(Alabama) • 20% of exposures opening properly closed child-resistant closure • 18.5% by opening a properly closed non-child-resistant closure. Child-resistance did not ensure child impenetrability Lembersky et al 1996 Vet Hum Tox 38:380-3

  15. AVAILABILITY AND OVERDOSE • If it is is available can you make it safer? • Child resistant containers • Mode of supply • Volume of purchase

  16. IRON OVERDOSE IN CHILDREN USA pre 1978 CRC for >500mg elemental iron After 1978 CRC for >250 mg elemental iron 1998 strip packs for >30 mg elemental iron

  17. Unit-dose packaging of iron supplements >30mg Tenenbein, 2005 Arch Ped Adol Med 159: 557-60

  18. AVAILABILITY AND OVERDOSE If it is is available can you make it safer? Child resistant containers Mode of supply Volume of purchase

  19. Legislation

  20. Legislation

  21. Legislation

  22. Proportion of overdose deaths (95% CI) (censored) related to paracetamol Scotland 1995-2003 Ratio Post/Pre: 1.347 (1.076-1.639) p= 0.013 British Journal of Clinical Pharmacology 2006: 62: 573-581.

  23. ADD THE ANTIDOTE? Methionine ?? (UK Paradote product) • Problems 1. How to prove efficacy in man 2. Mass medication 3. Increase in homocysteine in long term administration 4. Cost

  24. ADD THE ANTIDOTE? • Acetylcysteine? <200mg/tablet (Andrus et al) “The efficacy should be tested” Andrus JP et al 2001 BMJ 323:634

  25. AVAILABILITY AND OVERDOSE If it is is available can you make it safer? IF NOT : WITHDRAWAL?

  26. WHAT REGULATORS CANNOT DO Withdraw products just because of danger in overdose without good reason

  27. Deaths mentioning paracetamol 1995-2003

  28. Scotland • Deaths in 3 categories Paracetamol (± ethanol) ONLY Paracetamol and other drugs Co-proxamol Paracetamol 325 mg Dextropropoxyphene 32.5 mg (opioid with Na+ channel blocking effects)

  29. Paracetamol deaths by category 1995-2003

  30. Out of hospital deaths 1995-2003

  31. Estimated Fatal Toxicity Scotland per million prescription (95%CI)

  32. Coproxamol efficacy Clinical data very weak- No evidence that better than paracetamol alone acutely and no chronic studies Sold to a Generic manufacturer in UK

  33. WHAT UK REGULATOR DID Withdrew Coproxamol over a 2 year period

  34. Analgesic prescribing, Items/quarter Scotland 2002-7 UK Legislation DEC 2004

  35. Coproxamol deaths as % overdose deaths Scotland 2000-06 Legislation DEC 2004

  36. Overdose opioid analgesic deaths : Scotland 2000-06 Legislation DEC 2004 Sandilands et al BJCP 2008 in press

  37. AVAILABILITY AND OVERDOSE IDENTIFYING OTHER TARGETS ?? A new role for poisons centres

  38. Studies on prescribing data and mortality in England + Wales 1980s and 90s FTI= deaths per million scripts

  39. Prescription data, fatal poisonings and fatal toxicity index for individual antidepressants in Scotland, 2002-5 *** significantly different at 0.1% level (p<0.001)

  40. Wheeler et al. BMJ 2008;336:542-5.

  41. Wheeler et al. BMJ 2008;336:542-5.

  42. Biddle et al. BMJ 2008;336:539-42.

  43. ACTIONS • Changes to package/ presentation/ labelling (eg specific warnings) • Changes to category (eg drugs of potential abuse, prescription only, pharmacy supply, general sale ) • Changes to indication (? limit supply, reduce hazard in “at risk” groups) • Licence revocation

  44. Biddle et al. BMJ 2008;336:539-42.

More Related