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.

Really??

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.

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. 

1) Identify the cause of drug counterfeiting.

Altri produttori stanno richiamando merci italiane

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.

"Velcade contraffatto dal reimportatore"

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.

"La prossima ondata di contraffazione incombe?"

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. 

• Counterfeit medicines are a global problem.

• Reasonable counterfeiting protection measures are needed.

• FMD and securPharm are generally to be welcomed.
  

BUT

• 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 required
  

  This 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!

1. 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).

2. 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.

Definitely our favorite method. The basic principle is the same as the previous method: acquire all the serial numbers contained within a box (or pallet) and transmit them massively for deactivation. Of course, the main prerequisite is to have access to batch aggregation data, which is not always possible as aggregation is not mandatory at the moment and most pharmaceutical companies have only applied serialization. 

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.