Mind your step:  Identifying risk  with unlicensed medicines Dr Simon Letellier   Deputy hospital pharmacist Niort general...
1- Introduction Risk :  “ The  uncertainty of an event / hazard   occurring that could have  an  impact   on the achieveme...
1- Introduction <ul><li>Attended  benefits  for the patient : </li></ul><ul><li>If an unlicensed medicine is imported,  in...
2 – Risks for prescribing and handling :  the specific risks
2 – Risks for prescribing and handling :  Appropriate formulation and dosing <ul><li>Lack of medicines for use in paediatr...
2 – Risks for prescribing and handling  Administration and monitoring <ul><li>In a lot of cases, mixing non compatible flu...
2 - Types of Risk: Supply Product information <ul><li>With unlicensed drugs, leaflets are often  in a foreign language </l...
2 - Types of Risk: Supply Regulatory Compliance <ul><li>A medicine has been supplied by  an intermediary  without appropri...
2 - Types of Risk: Supply  Quality of the supply chain <ul><li>If the supply chain cannot be trusted, the quality of the p...
Possible  risks areas  of drugs product development and distribution Substitution (counterfeit) Fraud Disguise Drug theft ...
3 - Pharmacist’s role   Risk Assessment   Quality   Assurance   Risk reduction What can pharmacists do  to help minimise r...
3- Hospital Pharmacy Assessing Risk <ul><li>What is known  about adverse events, interactions and cautions  regarding its ...
3 - Quality Improvement <ul><li>Only in specific cases : </li></ul><ul><ul><li>a new supplier is being used </li></ul></ul...
4 - European collaboration <ul><ul><li>Governmental level : Medicines agencies collaboration </li></ul></ul><ul><ul><li>No...
4 – The future remains uncertain <ul><li>With new technologies : new types of risks  </li></ul><ul><li>Neurosciences (Cogn...
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Mind Your Step : identifying risk with unlicensed medicines

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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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  • hey can u please give me access to download this presentation.
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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

    1. 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. 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. 3. 1- Introduction <ul><li>Attended benefits for the patient : </li></ul><ul><li>If an unlicensed medicine is imported, in most of the cases, the aim is: </li></ul><ul><ul><li>To avoid an interruption or a brutal change of treatment </li></ul></ul><ul><ul><li>To allow the patient for a quick benefit of a therapeutic innovation </li></ul></ul>
    4. 4. 2 – Risks for prescribing and handling : the specific risks
    5. 5. 2 – Risks for prescribing and handling : Appropriate formulation and dosing <ul><li>Lack of medicines for use in paediatrics </li></ul><ul><ul><li>Formulations difficult to realize </li></ul></ul><ul><ul><li>Dosing paediatric medicines is difficult to measure : digoxine, acenocoumarol, fluindione ... </li></ul></ul><ul><li>With a new unlicensed drug : how to dose or control ? </li></ul>FDA, EU, EMEA expand cooperation to pediatrics, orphan drugs http://www.forbes.com/home/feeds/afx/2007/06/18/afx3830518.html
    6. 6. 2 – Risks for prescribing and handling Administration and monitoring <ul><li>In a lot of cases, mixing non compatible fluids may occur. So how to deal with a new drug ? </li></ul><ul><li>Administration risks in the nurse’s work. </li></ul>Stabilis : the international database of stabilities and compatibilities of injectable drugs, translated into 24 languages. http://www.stabilis.org
    7. 7. 2 - Types of Risk: Supply Product information <ul><li>With unlicensed drugs, leaflets are often in a foreign language </li></ul><ul><li> Japanese diazepam </li></ul>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
    8. 8. 2 - Types of Risk: Supply Regulatory Compliance <ul><li>A medicine has been supplied by an intermediary without appropriate license in place. </li></ul><ul><li>A story of trust and confidence, but not only … </li></ul><ul><li>Risks are : deception, repackaging, cutting product with counterfeits . </li></ul><ul><li> Use intermediaries approved by your national medicine agency. </li></ul>
    9. 9. 2 - Types of Risk: Supply Quality of the supply chain <ul><li>If the supply chain cannot be trusted, the quality of the product is unknown. </li></ul><ul><li> Which one is authentic ? </li></ul>International Pharmaceutical Federatrion – Counterfeit medicines page http://www.fip.org/www2/subsections/index.php?page=menu_counterfeitmedicines
    10. 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. 11. 3 - Pharmacist’s role Risk Assessment Quality Assurance Risk reduction What can pharmacists do to help minimise risk?
    12. 12. 3- Hospital Pharmacy Assessing Risk <ul><li>What is known about adverse events, interactions and cautions regarding its use ? </li></ul><ul><li>How will the product be sourced ? </li></ul><ul><li>Is the supplier trusted , with a robust supply chain and with appropriate licenses in place ? </li></ul>
    13. 13. 3 - Quality Improvement <ul><li>Only in specific cases : </li></ul><ul><ul><li>a new supplier is being used </li></ul></ul><ul><ul><li>there are known problems with the product </li></ul></ul><ul><ul><li>product only available from high risk source </li></ul></ul><ul><li>Keypoints are in the CRM (Customer Relationship Management) : </li></ul><ul><ul><li>reliability of supplier </li></ul></ul><ul><ul><li>quality of supply chain </li></ul></ul><ul><ul><li>regulatory compliance </li></ul></ul>
    14. 14. 4 - European collaboration <ul><ul><li>Governmental level : Medicines agencies collaboration </li></ul></ul><ul><ul><li>Non governmental level : PGEU, EAHP ... </li></ul></ul><ul><ul><li>Individual level with Internet : Pharmacy (on the Web) 2.0 </li></ul></ul><ul><ul><li>Software communication level : e-Pharmacy : IHE initiative </li></ul></ul>Development of Cross boarder information exchange
    15. 15. 4 – The future remains uncertain <ul><li>With new technologies : new types of risks </li></ul><ul><li>Neurosciences (Cognitive technology) </li></ul><ul><li>ICT (Information & Communication Technology) </li></ul><ul><li>Biotechnology </li></ul><ul><li>Nanotechnology </li></ul>Pharma 2020: The vision: Which path will you take? , Pricewaterhousecoopers, June 2007

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