Case Study: how reports of falsified medicinal products can impact wholesale distributors

Transcription

1 Case Study: how reports of falsified medicinal products can impact wholesale distributors Amy Kelly Ph.D. Wholesale Distribution Conference 11 th November 2014

2 Overview Legal basis Falsified medicine issues as quality defects Overview of recent falsified medicines issues affecting Member States HPRA communications to wholesalers and requests for checks and actions Wholesaler controls to prevent receipt of falsified product 11th November

3 Falsified medicinal product - definition Any medicinal product with a false representation of: (a) its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients; (b) its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or (c) its history, including the records and documents relating to the distribution channels used. Directive 2011/62/EU, Directive 2001/83/EC Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/343/01) 11th November

4 Medicinal Products (Control of Placing on the Market) Regulations 2007, as amended (SI 162 of 2013) PART 8: Prohibitions in relation to falsified medicinal products A person shall not a) place a medicinal product on the market b) place a medicinal product into circulation c) introduce a medicinal product into the State, or d) sell or supply, or offer for sale or supply a medicinal product, including from a distance by means of information society services, if he or she knows, or there are sufficient grounds to suspect, that it is a falsified medicinal product 11th November

5 Medicinal Products (Control of Placing on the Market) Regulations 2007, as amended (SI 162 of 2013) PART 9: System to prevent medicinal products, suspected of presenting a danger to health, reaching patients requires HPRA to operate a system which provides for: a) the receipt and handling of notifications of suspected falsified medicinal products and suspected quality defects of medicinal products, b) the recall of a medicinal product by holders of a Community marketing authorisations, marketing authorisations, certificates of registration or certificates of traditional-use registration c) the withdrawal from the market of medicinal products from all relevant actors in the supply chain both during and outside normal working hours, d) the recall from the market, where necessary with the assistance of health professionals, of medicinal products from patients who have received such products. 11th November

6 Medicinal Products (Control of Placing on the Market) Regulations 2007, as amended (SI 162 of 2013) SI 162 of 2013 Part 9 requires the HPRA, where it identifies a medicinal product which is suspected of presenting a serious risk to public health, to, where necessary and without delay, rapidly transmit a notification to all EEA States and all actors in the supply chain who are located in the State and who may hold stocks of the relevant medicinal product 11th November

7 Falsified Medicines Issues as Quality Defects Falsified medicines issues are investigated by HPRA as Quality Defect cases (QDRs) by Market Compliance We work closely on these issues with colleagues including: HPD Enforcement Pharmacovigilance Other Competent Authorities 11th November

8 Falsified Medicines Issues as Quality Defects All falsified medicines cases are treated as critical, high-risk, quality defects, i.e. highest priority Falsified medicines issues typically notified to HPRA by other Agency or by MAH for genuine product A number of falsified medicines cases are investigated annually as QDRs, e.g. 5 in th November

9 Falsified Medicines Issues in 2014 Case 1 April 2014: Confirmed falsified product, labelled originally as Herceptin 150mg Powder for Concentrate for Solution for Infusion identified in three European markets (UK, Germany and Finland) The packs featured genuine batch numbers and were in Italian livery The units had been stolen from an Italian hospital and re-introduced to the legitimate supply chain 11th November

10 Actions requested by HPRA communication from HPRA to RPs outlining the issue and requesting RPs to indicate if the impacted batches had ever been received into their wholesale facility advising vigilance when ordering and receiving the concerned product in the future 11th November

11 Falsified Medicines Issues in 2014 Case 1 May 2014: HPRA received further information that unauthorised wholesalers were channelling falsified product into the legitimate supply chain via authorised Italian wholesalers Affected products deemed falsified as the supply chain could not be verified 11th November

12 Falsified Medicines Issues in 2014 Case 1 May 2014 Complete listing of affected products unavailable Listings provided by Italian colleagues of 1. Unauthorised wholesalers in several MS (Cyprus, Hungary, Latvia, Romania, Slovak Republic and Slovenia) who supplied falsified product to 2. Authorised Italian wholesalers 11th November

13 Requested actions communication from HPRA to Stakeholders Providing two lists: 1. Unauthorised wholesalers 2. Authorised Italian wholesalers Requesting check of list of suppliers and related records for preceding 5 years to determine if any medicinal product received from these operators Requesting immediate quarantine of any stock from the unauthorised wholesalers If units identified, to contact HPRA immediately 11th November

14 Falsified Medicines Issues in 2014 Case 1 Further updates in 1. July 2014: To identify an additional unauthorised wholesaler, in Romania, and an additional authorised wholesaler, in Malta, impacted by the issue 2. Aug 2014: To identify an additional unauthorised wholesaler, in Greece 11th November

15 Requested actions As before, from HPRA to Stakeholders Providing updated listings Requesting check of list of suppliers and related records for the last 5 years to determine if any medicinal product received from any of the listed wholesalers Requesting immediate quarantine of any stock from the unauthorised wholesalers If units identified, to contact HPRA immediately 11th November

16 Falsified Medicines Issues in 2014 Case 2 Separate communication from Romanian colleagues regarding identification of illegal supply by an authorised wholesaler The authorised wholesaler acquired products from pharmacies, i.e. not an authorised supply chain, and distributed these onwards Connection between this issue and latter issue not confirmed at this time 11th November

17 Requested actions communication from HPRA to Stakeholders Outlining the issue Requesting a check of list of suppliers and related records for the last 5 years to determine if any medicinal product received from this wholesaler If supplies identified, to contact HPRA immediately 11th November

18 Falsified Medicines Issues in 2014 Expect further correspondence of this nature from HPRA Be prepared to check approved supplier lists and other related records Exercise vigilance 11th November

19 Controls that should be in place to prevent receipt of falsified products Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01) HPRA Guide to Good Distribution Practice of Medicinal Products for Human Use (IA-G0046-2) 11th November

20 Chapter 5 OPERATIONS EU GDP Guidelines C Principle All actions taken by wholesale distributors should ensure that the identity of the medicinal product is not lost and that the wholesale distribution of medicinal products is performed according to the information on the outer packaging 11th November

21 Chapter 5 OPERATIONS HPRA Guide to GDP IA-G Supplier approval Prior to purchase and receipt of any medicinal product, wholesalers must verify compliance of the supplying wholesale distributor or manufacturer with GDP e.g. verifying WDA and current GDP Cert The wholesaler is responsible for establishing the authority of the supplier to supply medicinal products and for obtaining appropriate documentary evidence Periodic checks on existing suppliers should be performed to ensure that they maintain an authorised status and that any changes in sourcing arrangements are evaluated 11th November

22 Approving suppliers 5.10 Supplier approval/new suppliers A robust system for approval of new medicinal product suppliers is a key component in the prevention of falsified medicines entering the supply chain In addition to establishing the authority of the supplier, wholesalers should reasonably assure themselves that previous stages in the supply chain are considered to be sufficiently robust to ensure the legitimacy of the medicinal products concerned The RP should be involved in the approval of new suppliers 11th November

23 Approving suppliers 5.10 Supplier approval The system of supplier approval should be described in a procedure and all relevant steps documented Wholesalers are requested to report to the HPRA any issues they consider suspicious or unusual with respect to sourcing of medicinal products 11th November

24 Chapter 5 OPERATIONS 5.23 Falsified medicinal products Wholesalers must: Have an SOP detailing processes to be followed in event of suspected falsified medicines Ensure that the goods-in SOP involves a detailed inspection of products received which is capable of identifying changes or unusual appearance indicative of falsified units Train staff to be aware of falsified products and what to look out for 11th November

25 5.23 Falsified medicinal products Wholesalers must: Maintain a list of approved suppliers and ensure that products are only sourced directly from these Have robust systems for ensuring legitimacy of suppliers and ensure that this is regularly reviewed Be familiar with the history of the supply chain 11th November

26 5.23 Falsified medicinal products Wholesalers must Be aware of possibility of falsified product entering the supply chain through legitimate sources, i.e. other authorised wholesalers or returns Never allow their WDA to be used by third parties to source or supply product Be suspicious of low-cost offers and be familiar with normal/expected market price 11th November

27 5.23 Falsified medicinal products A wholesaler in possession of a product that is found to be (or suspected of being) falsified is responsible for removal and quarantine of the product from saleable stock. The MAH and HPRA should be informed immediately of any suspected falsified product Suspected falsified product should never be returned to the supplier without the consent of HPRA Any suspicious approaches or activities noticed by a wholesaler should be notified to HPRA without delay 11th November

28 Summary Falsified medicine issues as quality defects Overview of recent falsified medicines issues affecting Member States HPRA communications to wholesalers and requests for checks and actions Wholesaler controls to prevent receipt of falsified product 11th November

29 Contacting Quality Defects and Recalls Breda Gleeson (Market Compliance Inspector) Rob Smyth (Market Compliance Technical Officer) Amy Kelly (Quality Defects & Recall Manager) Kevin O Donnell (Market Compliance Manager) Louise Bright (Market Compliance Administrator) 11th November

30 Thank you 11th November