The hospitals rebelion against serialization
The current Falsified Medicines Directive (FMD) begins its history in 2011 and wants to replace the previous directive, issued in 2001. The culmination took place, after several extensions, in February 2019 with the entry into force of the obligation of serialization of drugs. It would seem, therefore, that the actors involved have had all the time necessary to prepare. Yet this event had enormous impacts and not all drug manufacturers, despite being at the beginning of the distribution chain, were able to meet the deadline. Let alone hospitals. A few months after the serialization obligation came into force, there was a great stir in the German hospital environment and strong criticism of FMD rained down. And the question is still not fully clarified. Two years later, even if we are not in Germany, it is useful, with a view to the next Italian obligation, to retrace those events, analyze in detail the main disputes and understand the decisions and agreements made to reduce negative impacts while trying to comply with the legislation.
WHAT DOES THE SERIALIZATION LAW PROVIDE?
Before reviewing what happened, it is necessary to briefly summarize what the legislation consists of.
|§ 10 (1c)
|The second amendment to the German National Helth Codex (AMG)
|Delegated Regulation (EU) 2016/161
|Drug Supply Chain Security Act | DSCSA FDA
|Regulation (EU) 2017/745
The FMD requires that in all distribution points (even in hospitals) all medicines subject to prescription are identified through a unique code (generated randomly at the time of manufacture) and checked for the presence of this identifier in a dedicated database.
This event is called "Decommissioning" and represents the end of the life cycle, the consumption of the single pack of the medicine. A second decommissioning of the same code, in fact, indicates an attempt to introduce a falsified medicine into the supply chain.
THE CAUSE OF THE DISPUTES
The costs of serialization
The directive attempts to give an indication of who should bear the burden of serialization.
But while on the generation and conservation of serial numbers it is quite clear, on the identification (consumption) of these there is a lot of room for interpretation.
According to the rapporto on the analysis of the impacts of the directive, it would seem that the cost that each hospital will have to bear is around € 750.
Obligations of persons authorised or entitled to supply medicinal products to the public
1. Persons authorised or entitled to supply medicinal products to the public shall verify the safety features and decommission the unique identifier of any medicinal product bearing the safety features they supply to the public at the time of supplying it to the public.
And here we already perceive a possible problem. The operational flow of hospital dispensers is very different from that of public pharmacies. Not only that, each hospital can adopt its own process, different from the others. For example, the handling of cytotoxic preparations must take place in special cleanrooms, and the introduction of a new element, such as DataMatrix scanning, in this critical process poses a health risk to the operators.
Fortunately, however, the second point of article 25 comes in handy and, as we will see later, will be decisive.
2. ...persons authorised or entitled to supply medicinal products to the public operating within a healthcare institution may carry out that verification and decommissioning at any time the medicinal product is in the physical possession of the healthcare institution...
In other words, there is no obligation to decommission the medicine at any precise moment, but it is possible to do so at any time. Even after administration?
In any case, if the medicine has to be decommissioned close to its physical consumption, the action cannot be done either by the manufacturing pharmaceutical company or at the distributor. Let's try, therefore, to imagine the costs of the personnel assigned to this activity, taking as an example the data from a study done at UMCF (UNIVERSITY MEDICAL CENTER FREIBURG):
In plain language, an average hospital has to hire 1-2 people who do just that: scan every single package. Every day, every day.
We can, therefore, understand the concern of hospitals when they understand what awaits them. But let's see exactly how they reacted.
APPROACH TO THE PROBLEM
1) Identify the cause of drug counterfeiting.
In the case of drugs stolen in Italy, numerous re-importers recall the lots. Based on current information from the Italian health authority AIFA, it cannot be ruled out that single packs have been placed on the market, the companies say. Some preparations are already certain that they have been delivered to pharmacies.
Un importatore parallelo segnala un'altra manipolazione per un prodotto Janssen-Cilag. Velcade 3,5 mg polvere è influenzato da manipolazioni non autorizzate che sono state identificate come contraffatte - attualmente sono interessati due lotti.
Almost two years have passed since pharmacies found counterfeit medicines in their warehouses almost every week. The preparations that had previously been stolen in Italy had entered the legal supply chain through intermediaries and re-importers. The next big wave could now threaten Germany: according to information from APOTHEKE ADHOC, significant quantities of expensive pharmaceuticals have been stolen from a hospital pharmacy in Italy.
Da "Mio caro diario" di Peter Ditzel, Editore della Deutsche Apotheker Zeitung:"Sarebbe troppo bello per essere vero: finalmente solo canali di vendita diretti dal produttore all'ingrosso alla farmacia... Questo è quanto dichiara l'Associazione Federale Tedesca Farmacisti ospedalieri (ADKA) su farmaci contraffatti e rubati. Un canale di distribuzione a tre stadi sarebbe la soluzione sufficiente per garantire una maggiore sicurezza nell'approvvigionamento dei farmaci... Se il canale di distribuzione diretto venisse adottato, il problema della contraffazione sarebbe stato già risolto. Invece, dobbiamo rivolgerci alla securPharm, un costoso sistema di sicurezza da installare."
And so on..
2) Eliminate the cause, distribute the effort
Finally, DKG and ADKA ask to exclude direct purchases for healthcare facilities from the FMD regulation, that is, those purchases that require a single validated wholesaler.
This claim is based on the idea that manufacturers do not produce and market counterfeit medicines.
And since, in the event of direct delivery, the distribution chain would become secure, they try to delegate the decommissioning of medicines to the distributors themselves.
The ABDA (Federal Union of German Associations of Pharmacists) has now taken a position on this project ... Wholesalers, for example, should be obliged to decommission serials in certain cases. "We are aware that hospital operators, hospital pharmacies and pharmacies supplying hospitals are currently discussing the correct implementation of the requirements that will apply from February 2019 in view of the particular volume issue in the supply of medicines to hospitals."
Counterfeit medicines are a global problem.
Reasonable counterfeiting protection measures are needed.
FMD and securPharm are generally to be welcomed.
Direct purchase is safe!
With direct delivery, securPharm brings no added value.
a disproportionate human, technical and intellectual effort is needed to solve a problem that doesn't even exist!
The ADKA requirements therefore remain:
exclude direct delivery from FMD's obligations on serialization
in case of direct delivery the decommissioning must be done by the supplier (distributor)
the use of aggregate codes is requiredThis requirement cannot be met as aggregation is not mandatory and is applied at source by pharmaceutical companies on a voluntary basis. In any case, neither EMVO (EMVS) nor securPharm has been designed to be able to process aggregate codes (decommissioning per box or per pallet).
Delivery of serialization data together with the goods
The objective of the last point is clear: to allow hospitals, having access to data in digital form, to perform manual decommissioning, avoiding the expensive procedure of scanning the boxes. But this introduces a double risk!
The transmission of serialization data via parallel channels (e-mail, USB) rather than secure and certified channels increases the likelihood of this data being stolen (and then used for the serialization of counterfeit drugs).
The manual deactivation of the serial, instead of by scanning the DataMatrix printed on the packages, decouples the drug from the identification code that represents it, completely depriving the serialization legislation of meaning.
In fact, the FMD autorizza manual decommissioning only if a hybrid scenario is adopted: the manually decommissioned serials must in any case come from a reading of the DataMatrix printed on the cases (not sent via e-mail, so to speak).
This is as far as the computer side is concerned. Naturally the sponsors of this change have brought many other arguments. The main one concerns the anti-tampering devices, applied to the packaging, which make the introduction of counterfeit medicines even more difficult (and therefore the serialization more useless).
We do not have official data or statistics, but we know that there is no uniformity among hospitals in approaching the problem of deactivation of serials. Below we summarize the main approaches trying to evaluate the pros and cons of each.
1) Selective identification
Since the main problem is one-to-one scanning of all serials, the simplest solution is to identify a significant sample, a statistically sufficient number of cases. Being the least expensive and generally accepted, this method is the most used. Calculating the number of packages needed is a controversial issue in itself. Who says that one case per box, or even per pallet, is enough, who instead applies a statistical formula. In any case, the printing of the datamatrix on the upper side of the case involves a considerable advantage and reduction of time.
2) Use of high definition cameras.
3) Massive decommissioning through aggregate codes.
But for forward-thinking companies that have adopted aggregation from the start, or rather, for their partners such as hospitals and distributors, massive decommissioning is the simplest solution since lo stesso sistema usato per la serializzazione, aggregation and commissioning of serials can also be used by hospitals for decommissioning. Obviously, these systems must guarantee the segregation of roles: only authorized users (hospital or distributor personnel) must be able to perform the decommissioning. And since it is necessary to allow access from different locations, they can only be of the SaaS type, that is, take advantage of Cloud technologies.
QUESTIONS AND ANSWERS - VERSION 18:
Alternatively, aggregation data can be transmitted to distributors and hospitals and used by them to complete the drug lifecycle via their serialization tool.
As we have seen, not everyone welcomed serialization with open arms. Paradoxically, hospitals, which are in direct contact with patients, have not accepted having to solve a problem for which they do not feel responsible. But since counterfeiting is a common problem, they've probably just been caught off guard and looked for a way to get help.
Another aspect to consider is that the patient, the true beneficiary of FMD, knows very little about drug serialization and traceability. It expects the authorities and the supply chain to guarantee their quality and authenticity. And as long as consumers remain within the official Supply Chain, this will surely be the case. But how aware of the risks are those users who turn to the market not reached by serialization, such as food supplements or illegal medicines? A public awareness campaign on serialization could deal a further blow to drug counterfeiting.
Finally, on several occasions, we have seen the importance of aggregate codes emphasized. The hospitals themselves, when they realized the impacts, pretended to jump from distribution without serialization to, practically, a complete Track & Trace with all levels of aggregation. We often hear that serialization without aggregation has more disadvantages than good. But now that we are aware that the journey towards Full Track & Trace (whose objectives go far beyond the fight against counterfeiting) is long and complex, we can say that serialization has brought an advantage that beats all problems: we took courage and made the first step.