Posts Tagged ‘serialization’
Date: sometime in 2017
To: CEO, Pharmacorp Inc.
From: COO / Chief Compliance Officer / Head of Regulatory / SVP Manufacturing / Head of Supply Chain / Head of Technical Operations / whatever
Dear BossThanks for the copy of the Drug Supply Chain Security Act / Falsified Medicines Directive and your refreshingly to-the-point enquiry about our current readiness status for “the [expletive deleted] pack coding deadlines which are only months away”. As of today, I have to admit that I don’t know if our production people will be able to get everything ready in time.
We thought it was a bluffTo your point, we have certainly been aware since 2013 (and in fact years before) of the requirement to mark packs and I agree that three years of preparation seems like an adequate amount of time to get things done. However, we were hoping that either Congress / the EU was kidding or that delays and enforcement holidays would kick this can a long way down the road. I suppose with the benefit of hindsight this may indeed look somewhat “incompetent”.
We need more cashWe have now contacted all the suitable technology vendors and serialisation consultants but it seems that their lead times may be longer than we had hoped. Apparently there is a finite availability of expert resources and the first choice partners are all maxed out with existing customers who are further down the track in preparing for the deadline. Our calculation that we could save money by waiting as long as possible and letting other people make all the mistakes now looks like it may have been wrong. We may have to revisit our budget request to ask for emergency funds to get this done.
We may not be able to sell productYou asked whether missing the deadline would have an impact on our commercial operations. After enquiring with the sales division (thanks for the introduction, by the way) it turns out that the USA and EU are our largest markets – who knew? As I understand it, we can’t sell product there if we don’t meet the legal criteria, so I guess this will have an impact on the financials at some stage. I would recommend holding a slot on the agenda at the next earnings call. If it helps at all, the delay in initiating our program means that some of the capex for equipment spend might be pushed into the next financial year. We hope to be fully compliant again as soon as we get all the process mapping done, user requirement specifications written, vendors selected and contracts finalised, necessary pilots completed, equipment installed on all lines, errors minimised and OEE brought back into line, supply chain partners up to speed, serialised and aggregated inventory flushed through distribution channels etc.
It’s everywhereFYI, I am also hearing that the DSCSA and FMD may have parallels in other geographies. This may have some other impacts on our Rest of World operations. Our contract manufacturers are in various states of readiness and we may need to revisit key supply arrangements. As soon as I get to grips with what the requirement for serialisation and tamper-evidence means for our global manufacturing strategy I will report back.
I’ll get my coat…Apologies once again for being caught out by this deadline creeping up on us so suddenly – after all this time. Thanks for your understanding and good luck with explaining the situation at the Board meeting.
Don’t be that person. Make sure you plan for serialisation, aggregation and tamper-evidence. If you are planning pack changes, bear in mind that all unit-of-sale packs will need to be tamper-evident in the EU by February 2019. Make allowance for strategic advice and implementation consultancy. Don’t try to wing it. This really is the last chance to get things done right and in time. Whether you are just starting, well advanced but need some help along the way, or almost done but just need a little extra resource for fine tuning, we can help. Contact us: [email protected]Continue Reading
Pharmaceutical serialization (and/or epedigree) has been on its way for a long time. The uncertainty has been in the timing and the exact compliance requirements. Manufacturers didn’t know where or when serialization would turn up first, but they assumed that it was going to be scary. Sometimes the uncertainty and hyperbole that surrounded the subject reminded me of the chorus of the hit song by UK band The Automatic:”What’s that coming over the hill? Is it a monster?”
Now, at last, the apparition coming towards us is resolving into something we can see and start to deal with. The technical details of how drug traceability could work have been thought through. The European Federation of Pharmaceutical Industry Associations (EFPIA) has piloted its ideas in Sweden with apparent success – albeit in a limited geographical frame. They are now in the first stages of procuring the services and IT infrastructure to roll out their proposed European Medicines Verification System (EMVS) across the European Union. The German securPharm consortium is carrying out another pilot project with multiple stakeholders. The European Directorate for the Quality of Medicines (EDQM) has scoped out its eTACT project and intends to pursue it further. For a discussion of these three projects in more detail, download Blue Sphere Health’s free new white paper from www.securingpharma.com
The problem of how to code and trace drugs reliably and securely is a tough one, but progress has been made. The format wars of the last decade are now behind us at least. We know that datamatrix codes, not RFID, will be the predominant data carrier. The consensus (with some outliers, e.g. China) is that the international code format will use the GS1 standard rather than proprietary or local systems. Diverse groups have put aside their differences to propose collective solutions. In Europe, the stakeholder-led group includes EFPIA, the wholesalers organisation GIRP, repackagers EAEPC and pharmacists group PGEU. The US has seen similar activity with the Pharmaceutical Distribution Security Alliance putting forward a united and constructive front to US legislators.
The Technical Uncertainty Monster has been, if not killed, then at least stunned into temporary submission. But this is no time to be complacent. Now we have to watch out for his angry brother, the Cost Monster. The estimated running costs of the EMVS system, as released by EFPIA recently, are 1.3 – 2.2 Euro cents per pack. Since generics are typically five-fold cheaper than the branded equivalents, if applied equally the burden would fall disproportionately on cheaper medicines. A compromise will probably need to be worked out that takes pack price into consideration when setting the levy on manufacturers.
Grossed up for pack volumes in the EU, this cost range implies an annual running cost of 130 – 220 million Euros. The implementation costs in the first couple of years are likely to be a multiple of this figure. Let’s break these costs down and look at some of the more vulnerable areas where the Cost Monster might strike:
The suppression of various industry stakeholders’ vested interests in the name of a bigger cause has been impressive so far. To keep things as streamlined as possible all sides should continue to build trust and share infrastructure whenever possible. There is an argument for keeping pharmacy transaction data for pharmacists’ eyes only and away from manufacturers and to be fair the drug makers are not seeking access to point of sale information. However, physically separated dual database systems, such as securPharm seems to advocate are not the answer and would cause unnecessary complexity if rolled out across Europe. Database providers can design access rules that allow clear and secure segregation of data without the I/O movement and synchronising of information that multi-instance designs might require.
The EU has 27 member states. The more we can do to minimise the diversity of national systems the cheaper the overall cost will be. The EFPIA model will provide a national system blueprint that will be available as a pre-configured starting point to those states that don’t want to develop their own infrastructure. The same approach needs to be taken for pharmacy implementation and training elements of the roll-out. Re-using and adapting existing materials and processes will be critical to keeping costs under control.
Some countries (Belgium, Greece, Italy, possibly France although this is controversial) are granted a multi-year opt-out under the Falsified Medicines Directive, meaning they can continue with national traceability systems. In the interests of the greater good and of cost minimisation for manufacturers, it would be helpful if these states worked to harmonise with the EU framework as swiftly as feasible rather than delaying.
The IT consultancy and services element of rolling out any pan-European or federal US system will be huge. Even small process improvements and simplifications will add up to big savings over time. For this reason, the initial implementation should be as simple as possible – involving only those stakeholders and processes that are needed to get the traceability system started. Trying to implement epedigree will be hugely more expensive than starting with serialization. The lot-level approaches as advocated by PDSA are an even simpler first step.
The pharmacist is the key control point for drug traceability systems, so the rapid and efficient integration of pharmacies into any wide scale approach is critical. In focusing on the big-ticket IT components like databases, routing systems etc, we should not underestimate the complexity of getting tens of thousands of drugstores on board. Just ask Aegate who have spent years adding pharmacies to their systems in Belgium, Greece and Italy and still have nowhere near full penetration. Pharmacy point-of-sale software is a highly fragmented market making the IT integration task harder. Many stores use barcode scanners which are not compatible with datamatrix codes and will need to be replaced. Some rural pharmacies don’t have the reliable broadband internet connection needed for real-time authentication. Collectively these issues represent a vulnerable soft underbelly for the Cost Monster.
Things will not go right all the time, even when teething troubles have been solved. Providing transaction support in the pharmacist’s native tongue (the EU has 23 official languages) will require creative approaches. These issues have been solved in other industries (e.g. financial services) so pharma should look outside itself and not fall into its habitual trap of reinventing the wheel.
Most of the patient safety aims of pharmaceutical serialization will be solved with a relatively simple, uniformly applied and globally interoperable traceability system in each major region. This will be secure, with multiple separate access rights. Pharmacies will be integrated efficiently and quickly, recognising the network effect that comes with rapid and widespread participation. Design, installation, operation and support costs will be reasonable, using best practice from other industries to avoid unnecessary cost burdens on patients and taxpayers.
Alternatively, we can hide behind the sofa while the Cost Monster runs amok.
Contact me at mark(dot)davison(at)bluespherehealth(dot)com to discuss these issues in more detail and in confidence.
Photo: Silus from flickrContinue Reading
- Get a project sponsor quickly – at least at Vice-President level and preferably higher. You will need “top cover” to drive through any necessary changes.
- Appoint a project champion with sufficient time and influence to get things done. I suggest at least 0.5 full time equivalent (FTE) and if you’re starting from zero you may need 1-2 FTEs to get the job done this year. This can be internal or external resource.
- Move quickly to establish an inter-disciplinary project team. Involve supply chain, manufacturing, quality, marketing, legal as a minimum. Don’t forget to talk to your third party manufacturers, marketing partners, key distributors etc.
- Organise a management workshop to explain to senior management the key compliance obligations and business benefits.
- Present an initial options analysis to stimulate discussion and guide the next stages.
- Develop a draft strategy that fits with corporate goals and external obligations
- Decide whether you have sufficient resources and expertise in-house or whether you need interim management or external consultancy support to do the activities listed below.
- Conduct (or commission) a scoping study: go round the manufacturing sites and figure out what needs to be done and by whom.
- Check whether any commercial data processes or contracts need to be changed. Plan ahead or these administrative issues will return to bite you just when you thought you’d solved the technical puzzle.
- Contact equipment and IT vendors for guidance on costs and timing of your preferred option(s). The quicker you get in the queue the better.
- Make sure you develop an appropriate Request-For-Proposal that gives vendors sufficient information to be able to help you.
- Based on your analysis, form an implementation plan.
- Write a business case.
- Present the case to the board (or whatever your approval process involves).
- Make sure you have the activities listed above covered.
- Perform (or commission) a gap analysis to look for any remaining weaknesses, disconnects, process misalignments etc.
- Audit existing equipment to check that it is sufficiently future-proof. For example if you installed printers and vision systems for CIP13 batch-level coding for France, make sure they are also capable of the (much harder) task of serializing every pack.
- Keep abreast of new legislative developments.
- Benchmark your progress against your peers. Get external perspectives if necessary.
- Look for business intelligence outputs from pack coding that can help you improve your business