Wholesalers face additional procedural challenges in their path to integration of the FMD (Falsified Medicines Directive) into their processes. Here we list some of the main questions arising for wholesalers which have come up so far.
Where in my workflow am I most likely to use ezFMD?
Consider the arrival of goods first and foremost:
- Arrival from a supplier – Optionally verifying a sample pack of each batch received may reflect best practice if supplies are received from primary wholesalers or manufacturers (MAHs). If not, you must verify each pack received from any wholesaler which is not a primary wholesaler.
- Returned packs from a customer – verify each pack.
- Destined for destruction – you will need to mark each pack as destined for destruction by scanning it.
- Recall – verify each pack on receipt as a result of a recall (optional).
Then consider supply to certain bona-fide customers.
Then consider supply to a customer who is not expected to have FMD capability, such as a medical or dentistry practice. You will be expected to decommission (mark as supplied) for such recipients. This may or not apply in your business now but no harm to provide for it when planning. Other points of use of FMD may be relevant for your organisation – get your team engaged in thinking this through.
How and when do I start to plan for FMD?
The somewhat obvious answer for When is now. Given you are reading this, FMD has come onto your horizon and there is a limited time left – see the clock on the home page.
Onto the trickier bit – the How: Take the points where goods arrive into your organisation (see answer above) and see what you need to do for each type of arrival. Write down who is currently managing each of these tasks (Mary does returns, Joe manages Goods In, etc.), at what stage will the packs be verified in each process (e.g. will packs be marked for destruction when the RP says they are not suitable for supply, or when they are being packed up for destruction? Who will actually do the FMD scanning, using what PC? Is the needed time provided for in their day?) and so continue around the flow of product around your organisation. You already have a starting point – great! Next consider if you supply to an entity that cannot decommission (mark as supplied) themselves, such as doctors’ or dentists’ practices? Then you need to plan on decommissioning (mark as supplied) these packs before you dispatch. Who in your organisation will decide which goods on orders dispatched need to be marked as supplied?
Having written down this list, start thinking of revision of SOPs, rollout and training in your organisation. Start thinking of the IT tools you will need to complete these tasks. (We would say that, wouldn’t we?) Apart from IT, are there other parties in the organisation you need to engage in the changes?
What are the main SOPs I should be planning changes for at this stage?
Having written down your considerations of the above, the SOPs involving the processes you identified are bound to need a review and revision to reflect the FMD steps. E.g. a recall procedure will need to have the added step of scanning each returned pack to validate it is a valid pack and serial number (if not, you have detected a falsified medicine in the course of a recall!). It may be prudent to provide a print-out of the scanning validation for the RP to review, sign and date to include in the recall record. So, in most wholesalers, the minimum SOPs to consider will likely include:
- Goods in procedures (optional, only if your exclusive source is a manufacturer or their primary wholesaler in your jurisdiction)
- Returns procedure
- Procedure related to destruction of medicines
- Supply of medicines (optional, depending on your customer profile – required if your customers cannot decommission packs)
- Recall procedure, if you choose to include this in your recall process (remember to send a copy of the revised SOP to your regulatory authority if required in your jurisdiction.)
Remember – this cannot be an exhaustive list – it will depend on your firm’s business model and workflow.
Will my Regulatory Authority be inspecting any aspect of FMD during their inspections? If so, which aspects?
It is reasonable to imagine FMD compliance will be included in inspections, as compliance with the FMD (Falsified Medicines Directive) is a statutory requirement and an element of GDP. Aspects which may well be inspected include a request for evidence that returned (or recalled packs if included in your SOPs) were scanned and found to be valid. Where a WDA holder supplies certain types of customers such as doctors and dentists, evidence of decommissioning (marked as supplied) in the course of such supply may also be required. Evidence of satisfactory scanning of any packs marked for destruction may also be requested. Look out for further guidance from the Regulatory Authority in your jurisdiction on the specific requirements they may have, as details evolve. One simple rule is to ensure all records of scans are retained for a suitable period, and that records of any scans of note are reviewed and signed off and dated by your RP or their deputy in a timely fashion, with a record of same retained for later inspection.
If our firm processes orders and returns, but contracts out the actual handling of the medicines to a third-party logistics provider, do we need to have FMD validation facilities within our firm?
Unlikely. Your RP should consider the business steps in which your firm engages and the FMD legislation in your jurisdiction and make the final decision in your firm. It may be helpful for your RP to consult with the your primary wholesalers and the NMVO or your regulator authority.
Technical Agreements (TA) – what impact will FMD have?
As wholesalers, if you operate with another party under the terms of a TA, you will need to consider how the FMD steps need to be reflected in that agreement. To some extent it will depend on the level of detail your current technical agreement sets out. In the example of a manufacturer (or their local subsidiary) being the Contract Giver and a local logistics partner / primary wholesaler being the Contract Acceptor, it may be appropriate to record that the responsibility for the various identified steps to achieve compliance with the FMD fall on the Contract Acceptor, with effect from February 2019 for such packs that incorporate the safety features. For other Technical Agreements which are defined with less granularity, there may be no change required.
Once a pack has been marked by our firm as destined for destruction or stolen, can that be reversed?
No. Not even if you made a mistake. Just No! (Sorry – not our rules.)