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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

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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


A service commissioned by the hpa

CONTENT

  • Medicines Regulation

  • Prescription and OTC products

  • 2. Prevention strategies

  • What works- and perhaps doesn’t

  • 3. Some ideas for the future


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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)


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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


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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


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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


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PROPORTION OF POISONING ADMISSIONS 1981-2000 ROYAL INFIRMARY EDINBURGH


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PROPORTION OF ADMISSIONS PER ANNUM1981-2000 ROYAL INFIRMARY EDINBURGH


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


Toxbase accesses per quarter 2000 2001 expressed as of total antipsychotics england

TOXBASE accesses per quarter, 2000-2001 expressed as % of total antipsychotics - England

Bateman et al 2003 BJCP 55: 596-03


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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)


Child resistant containers

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


Effectiveness of child resistant packaging alabama 5 y of age 168 patients mean age 26 mo

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


Effectiveness of child resistant packaging alabama

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


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AVAILABILITY AND OVERDOSE

  • If it is is available can you make it safer?

  • Child resistant containers

  • Mode of supply

    • Volume of purchase


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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


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Unit-dose packaging of iron supplements >30mg

Tenenbein, 2005 Arch Ped Adol Med 159: 557-60


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AVAILABILITY AND OVERDOSE

If it is is available can you make it safer?

Child resistant containers

Mode of supply

Volume of purchase


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Legislation


A service commissioned by the hpa

Legislation


A service commissioned by the hpa

Legislation


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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.


Add the antidote

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


Add the antidote1

ADD THE ANTIDOTE?

  • Acetylcysteine?

    <200mg/tablet (Andrus et al)

    “The efficacy should be tested”

Andrus JP et al 2001 BMJ 323:634


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AVAILABILITY AND OVERDOSE

If it is is available can you make it safer?

IF NOT :

WITHDRAWAL?


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WHAT REGULATORS CANNOT DO

Withdraw products just because of danger in overdose without good reason


Deaths mentioning paracetamol 1995 2003

Deaths mentioning paracetamol 1995-2003


Scotland

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)


Paracetamol deaths by category 1995 2003

Paracetamol deaths by category 1995-2003


Out of hospital deaths 1995 2003

Out of hospital deaths 1995-2003


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


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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


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WHAT UK REGULATOR DID

Withdrew Coproxamol over a 2 year period


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Analgesic prescribing, Items/quarter Scotland 2002-7

UK Legislation

DEC 2004


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Coproxamol deaths as % overdose deaths

Scotland 2000-06

Legislation

DEC 2004


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Overdose opioid analgesic deaths :

Scotland 2000-06

Legislation DEC 2004

Sandilands et al BJCP 2008 in press


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AVAILABILITY AND OVERDOSE

IDENTIFYING OTHER TARGETS

?? A new role for poisons centres


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


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Prescription data, fatal poisonings and fatal toxicity index for individual antidepressants in Scotland, 2002-5

*** significantly different at 0.1% level (p<0.001)


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


A service commissioned by the hpa

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


A service commissioned by the hpa

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


A service commissioned by the hpa

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


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


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