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Mind Your Step : identifying risk with unlicensed medicines
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Mind Your Step : identifying risk with unlicensed medicines

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IDIS symposium

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

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  • Here is a good source of further info regarding unlicensed medicines www.specialslab.co.uk/
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  • Thank you very Much Alan ! Now we know all on what are unlicensed medicines. So … now my presentation is all about risk .

Mind Your Step : identifying risk with unlicensed medicines Mind Your Step : identifying risk with unlicensed medicines Presentation Transcript

  • 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
    • Attended benefits for the patient :
    • If an unlicensed medicine is imported, in most of the cases, the aim is:
      • To avoid an interruption or a brutal change of treatment
      • To allow the patient for a quick benefit of a therapeutic innovation
  • 2 – Risks for prescribing and handling : the specific risks
  • 2 – Risks for prescribing and handling : Appropriate formulation and dosing
    • Lack of medicines for use in paediatrics
      • Formulations difficult to realize
      • Dosing paediatric medicines is difficult to measure : digoxine, acenocoumarol, fluindione ...
    • With a new unlicensed drug : how to dose or control ?
    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
    • In a lot of cases, mixing non compatible fluids may occur. So how to deal with a new drug ?
    • Administration risks in the nurse’s work.
    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
    • With unlicensed drugs, leaflets are often in a foreign language
    •  Japanese diazepam
    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
    • A medicine has been supplied by an intermediary without appropriate license in place.
    • A story of trust and confidence, but not only …
    • Risks are : deception, repackaging, cutting product with counterfeits .
    •  Use intermediaries approved by your national medicine agency.
  • 2 - Types of Risk: Supply Quality of the supply chain
    • If the supply chain cannot be trusted, the quality of the product is unknown.
    •  Which one is authentic ?
    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
    • What is known about adverse events, interactions and cautions regarding its use ?
    • How will the product be sourced ?
    • Is the supplier trusted , with a robust supply chain and with appropriate licenses in place ?
  • 3 - Quality Improvement
    • Only in specific cases :
      • a new supplier is being used
      • there are known problems with the product
      • product only available from high risk source
    • Keypoints are in the CRM (Customer Relationship Management) :
      • reliability of supplier
      • quality of supply chain
      • regulatory compliance
  • 4 - European collaboration
      • Governmental level : Medicines agencies collaboration
      • Non governmental level : PGEU, EAHP ...
      • Individual level with Internet : Pharmacy (on the Web) 2.0
      • Software communication level : e-Pharmacy : IHE initiative
    Development of Cross boarder information exchange
  • 4 – The future remains uncertain
    • With new technologies : new types of risks
    • Neurosciences (Cognitive technology)
    • ICT (Information & Communication Technology)
    • Biotechnology
    • Nanotechnology
    Pharma 2020: The vision: Which path will you take? , Pricewaterhousecoopers, June 2007