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

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

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 ?

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

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.

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

With unlicensed drugs, leaflets are often in a foreign language

 Japanese diazepam

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.

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

If the supply chain cannot be trusted, the quality of the product is unknown.

 Which one is authentic ?

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 ?

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

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

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

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

With new technologies : new types of risks

Neurosciences (Cognitive technology)

ICT (Information & Communication Technology)

Biotechnology

Nanotechnology