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Mind Your Step : identifying risk with unlicensed medicines

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Simon Letellier
Simon Letellier

IDIS symposium 13th EAHP congress Maastricht The Netherlands February 27-29th 2008

Health & MedicineBusiness
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Mind your step: Identifying risk with unlicensed medicines Dr Simon Letellier Deputy hospital pharmacist Niort general hospital France EAHP ICT groups Satellite Symposium Navigating Risk Management 28 february 2008
1- Introduction Risk : “ The uncertainty of an event / hazard occurring that could have an impact on the achievement of objectives. Risk is measured in terms of consequences and likelihood . ”
1- Introduction ,[object Object],[object Object],[object Object],[object Object]
2 – Risks for prescribing and handling : the specific risks
2 – Risks for prescribing and handling : Appropriate formulation and dosing ,[object Object],[object Object],[object Object],[object Object],FDA, EU, EMEA expand cooperation to pediatrics, orphan drugs http://www.forbes.com/home/feeds/afx/2007/06/18/afx3830518.html
2 – Risks for prescribing and handling Administration and monitoring ,[object Object],[object Object],Stabilis : the international database of stabilities and compatibilities of injectable drugs, translated into 24 languages. http://www.stabilis.org
2 - Types of Risk: Supply Product information ,[object Object],[object Object],A complete listing of labels for approved prescription drugs http://dailymed.nlm.nih.gov Risk evaluation on medication ... for patients http://www.iguard.org American Clinical trials around the world http://www.clinicaltrials.gov Need information sources: - Martindale - USA : Drugs@FDA http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ - France : Thériaque http://www.theriaque.org
2 - Types of Risk: Supply Regulatory Compliance ,[object Object],[object Object],[object Object],[object Object]
2 - Types of Risk: Supply Quality of the supply chain ,[object Object],[object Object],International Pharmaceutical Federatrion – Counterfeit medicines page http://www.fip.org/www2/subsections/index.php?page=menu_counterfeitmedicines
Possible risks areas of drugs product development and distribution Substitution (counterfeit) Fraud Disguise Drug theft Diversion Deception Fraud Sell drug to grey market Drug counterfeits Product diversion/theft Fraudulent labels label switching repackaging Cutting product with counterfeits
3 - Pharmacist’s role Risk Assessment Quality Assurance Risk reduction What can pharmacists do to help minimise risk?
3- Hospital Pharmacy Assessing Risk ,[object Object],[object Object],[object Object]
3 - Quality Improvement ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
4 - European collaboration ,[object Object],[object Object],[object Object],[object Object],Development of Cross boarder information exchange
4 – The future remains uncertain ,[object Object],[object Object],[object Object],[object Object],[object Object],Pharma 2020: The vision: Which path will you take? , Pricewaterhousecoopers, June 2007

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Mind Your Step : identifying risk with unlicensed medicines

  • 1. Mind your step: Identifying risk with unlicensed medicines Dr Simon Letellier Deputy hospital pharmacist Niort general hospital France EAHP ICT groups Satellite Symposium Navigating Risk Management 28 february 2008
  • 2. 1- Introduction Risk : “ The uncertainty of an event / hazard occurring that could have an impact on the achievement of objectives. Risk is measured in terms of consequences and likelihood . ”
  • 3.
  • 4. 2 – Risks for prescribing and handling : the specific risks
  • 5.
  • 6.
  • 7.
  • 8.
  • 9.
  • 10. Possible risks areas of drugs product development and distribution Substitution (counterfeit) Fraud Disguise Drug theft Diversion Deception Fraud Sell drug to grey market Drug counterfeits Product diversion/theft Fraudulent labels label switching repackaging Cutting product with counterfeits
  • 11. 3 - Pharmacist’s role Risk Assessment Quality Assurance Risk reduction What can pharmacists do to help minimise risk?
  • 12.
  • 13.
  • 14.
  • 15.

Editor's Notes

  1. Thank you very Much Alan ! Now we know all on what are unlicensed medicines. So … now my presentation is all about risk .