Machine vision, artificial intelligence, and the limitations within

A recent article studied the issues deep learning vision algorithms have at classifying images. The major finding was that these neural networks emphasize surface texture over edge detection, i.e. object shapes. The underlying reason is that these textures contain an order of magnitude more information than the edges, thus the texture data dominates the learning algorithms. The result gives a lot of leeway for camouflage: the outline of an aircraft painted with overlapping clock faces was mislabeled as a clock, as a cat painted with elephant skin texture was mislabeled as an elephant.

For classifying images, deep learning vision algorithms are trained with thousands of images that either contain or do not contain the sought elements, such as a cat. The algorithm learns to find patterns, which it then uses to label images it has never seen before. The researchers then improved the learning algorithms by splitting the images into patches which were analyzed individually.

“Neural network architecture allows for integration of different features for decision-making. It doesn’t automatically happen, however. Removing unwanted deep-rooted biases is possible, if not easy.”

This brings to my mind how the human visual system works. Leaving out the differences in photosensors and the image processing happening there, our brains do not work as a single neural network analyzing the images provided by the two eyes. The data is split and the image is analyzed in different regions of the brain for different features: motion detection, edge detection leading to shape recognition, color hue recognition, etc. All this information is also compared and merged with visual memory. Most of what we think we see is actually recalled from memory, our vision is sharp (as we feel it) only in the fovea of the retina — sensing the target spot we are focusing at. There may be good reasons that evolution has split the process to different blocks.

Texture has, of course, an effect also on humans. Camouflage painting and clothing has been used to break up the shape of ships or soldiers to make them visually more difficult to spot. For simpler visual systems of the insects, simpler means seem to work: the striped texture of zebras has been found to disrupt the eyesight of the horseflies. When they get close enough to on a zebra, they cannot find the surface and either fly past or bump to the surface, not able to land. This has been proven by dressing humans and horses with zebra stripes.

Checker shadow illusion

The checker shadow illusion. Although square A appears a darker shade of grey than square B, in the image the two have exactly the same luminance. Source: Wikipedia. Original: Edward H. Adelson, vectorized by Pbroks13. 


The complex operation of the human visual system has caused some problems to the display manufacturing industry. About twenty years ago, the industry moved from CRT displays to flat panels, such as LCDs or OLEDs. The quality control of CRT display surface was relatively simple, whereas, in flat panels, all the pixels are basically individual entities. As the human vision actively and effectively adapts to changes in color hue (see the checker shadow illusion above), a human quality controller could not easily see if the color of a large display was uniform from corner to corner. Using emerging digital photography technologies had issues, too, as possible quality issues such as optical illusions were not recorded with standard visual inspection cameras. The cameras and image processing software had to simulate the human visual system to be able to see quality problems (such as Grid Illusion) that could cause headache to humans.

Most of the visual inspection processes required by quality control are of simpler nature, however. In the pharmaceutical industry, examples would be inspecting the number of pills in blister stripes, quality of the printed serialization codes in carton packages or bottles, and readability of human-readable expiry date information. Medical devices have also codes, numbers, and scales whose readability must be inspected. As the context is well-specified, the machine vision system is only required to measure, if the print quality is consistent with the required standards. One can, however, find more use for the visual inspection data, such as using the noise intrinsic to the printing process as a unique fingerprint, adding robustness against falsification and malicious QR code attacks.

Servicepoint offers services of an experienced full-service device assembly and packaging, machine vision & quality inspection, robotics, and serialization & traceability automation integration company. Call us, we can help you!

Servicepoint Oy — the reliable partner for the manufacturing industry

Product diversion in the medicinal supply chain

Recent news about problems at a Finnish nursing home for the elderly has brought to the public, among others, the issue of diversion of drugs from the legal supply chain. The issue are medicines classified as narcotics which have become unaccounted for. While this may just be a just case of forgot documentation in lawful disposal of medicines via pharmacies, the lack of documentation makes it extremely difficult to investigate. This should not be the case. I would recommend implementing the simple and already available barcode and serialization technologies:

  1. Serialized product packages enabling well-controlled and up-to-date inventory.
  2. Smart medicine cabinets only dispensing medicines to authorized and identified personnel.
  3. Standard operating procedures with simple barcode readers and background databases to link the dispensed medicines to identified patients via identified personnel in identified rooms.

The investigation regarding the contents of a single medicine package would then be greatly simplified with a quick database query by quality assurance personnel.

The gray and black markets of diverted medicines

This reminds me of when I first heard of this problem field ten years ago. While I was still a doctoral student working on mobile-phone-based health applications, I had a meeting with an executive from a company providing security services (access control) for hospitals in a 3rd world country. The main problem he discussed on was hospital staff stealing medicines to sell them in the black market: under-the-table in local pharmacies or street market.

In poorer countries, the issue may be any drug, but in developed countries, the opioids seem to be a major issue. Healthcare personnel developing an addiction to opioids is nothing new, but the lure of some “easy” extra money to augment one’s salary is also a traditional issue.

With serialized codes, the medicine packages found from illegal or gray sources, such as internet pharmacies operating where regulation is lax, can be back-tracked to the original source. This can be used to find the manufacturer, warehouses, logistics, and hospitals or pharmacies involved — exposing the culprits responsible for diversion. For the Marketing Authorization Holder (MAH), being able to prevent the flow of its products to the gray market is an important issue: the correct storage, e.g. cold chain, is not guaranteed and the MAH — the name of which is clearly printed in the package — may well be publicly blamed for any problems.

This does not, however, remove the responsibility of the consumer. If one resorts to shady sources and non-authenticable medicines, one is not only endangering one’s own health but financing criminal activity.

Rivotlin medicine bottle

Photo: Helsinki Police Department, Finland

For the pharmaceutical industry, the need for supply chain control and easy authentication of genuine products from fake are of paramount importance. No brand owner wants its logo and name in public police warnings of diverted or fake products.

Automation helping the healthcare personnel

Automated medicine cabinets and barcode readers can also help the overstretched hospital and nursing home personnel by preventing wrong medicines being applied or wrong patients being treated. Reducing possibilities of human error reduces also the stress of the personnel, just think of a nurse in night shift trying to keep track of medicines with similar-looking names, patients being shifted from room or hospital to another, and calculations of correct doses. Automation is available to help people do their work better and with less stress and strain.

Servicepoint offers services of an experienced full-service packaging, device assembly, machine vision, robotics, and serialization and track & trace automation integration company. In the last few years, Servicepoint has implemented serialization to more than a dozen sites for several manufacturers, our implemented or started projects at customers ranging from Russia to Spain, from Finland to Cyprus. Call us, we can help you!

Servicepoint Oy — the reliable partner for the manufacturing industry

The Messy FMD Deadline

This is, finally, the week of the grand deadline of the EU FMD (Falsified Medicines Directive). Considering the amount of work required from all stakeholders, the ecosystem has fared fairly well. The full test of the system is about to come when: pharma manufacturers (MAH and CMO) begin communicating the codes with each other and reporting the codes to the repositories; wholesalers and 3PL begin checking the codes in suspect cases and decommissioning the codes of products shipped to mass users, and pharmacies begin authenticating the products and decommissioning the codes.

Stabilization Period

As is well known, a lot of MAHs have begun the system setup late. Reasons are many: there may be too little resources in the company or other projects, such as a concurrent factory upgrade, have consumed the personnel and monetary resources. Some of the smaller MAHs have studied their product repertoire, made some calculations, and found that the few Rx products that they act as a MAH for (using a CMO as a manufacturer), are not worth the investment. Thus, they have reoriented themselves as MAH to OTC products only and just an importer/wholesaler for Rx products. This is understandable as for some generic drugs there is a multitude of both manufacturers and MAHs available and thus very heavy competition based on price or brand recognition.

A safe bet is that a vast majority of the code verification problems stem from other sources:

  1. export codes from India, indistinguishable from the EU FMD codes
  2. EU FMD codes printed in product batches released to market before the 9.2.2019 deadline without uploading the codes to EMVS due to EMVS or level 4 software not available

For these cases, we have different local guidance in e.g. Finland and Denmark. Dirk Rodgers discussed the Danish solution in a recent blog post.

 Danish Medicines Agency Lægemiddelstyrelsen (Denmark):

“Because the safety feature provisions do not enter into force before 9 February 2019, medicinal products manufactured before this date may not necessarily be uploaded to the repositories system. Attempts to verify these products will appear in the system as ‘unknown’. As medicinal products may have a shelf life of up to five years, it may take up to five years before all medicinal product packs covered by the safety feature provisions are uploaded in the repositories system. The Danish Medicines Agency finds that during this period, no action should be taken in response to medicinal products returned as “unknown” by the repositories system in connection with a verification attempt. The suppression of packs returned as ‘unknown’ by the system has to do with the product’s authorised shelf life. It remains important, however, to report it to the Danish Medicines Agency if a medicinal product pack looks suspicious or if there are visible signs of falsification.” (link)

 Finnish Medicines Agency Fimea (Finland)

Reporting to Fimea is not required, however, when reading the 2D barcode, according to the procedures agreed in cooperation among wholesaler and retail logistics chain parties, it is unequivocal that they have been freed to free traffic in the EU region before 9.2.2019. It must also be unequivocal that the question is not of an suspected falsified medicinal product. In these cases, if the aforementioned conditions are met, and there is no basis for suspecting a falsified medicinal product, the product can be dispensed to the customers.” (unofficial transl. by Iiro Jantunen, org. link)

These questions have also been noted by the EMVO, which has proposed a ‘Stabilisation Period‘ with “flexible alert handling” and an increase of EMVS stability and performance. The Stabilisation Period is expected to run for roughly 8 months until September 2019. The Stabilisation Period is not, however, for delaying serialization of medicines at the production lines.

National Legislation Processes

I have not looked too much into the other countries implementing EU FMD, but in Finland, at least, we are on a deadline-licking schedule. Due to the concurrent healthcare and social services reform that has overloaded the Finnish Ministry of Social Affairs and Health with legislative work, the Finnish government was able to give the implementation proposed legislation to the Parliament of Finland on 29.11.2018, and after a speedy hearing and approval process (including the equally overloaded Social Affairs and Health Committee of the Parliament), the legislation was approved on 5.2.2019. There is thus just a couple of days left for the President of Finland to sign the law before the EU FMD deadline.

Have other countries had similarly delayed legislative processes?

Brexit Mess

The possible Hard Brexit would cause a lot of trouble to the pharmaceutical industry in general (in addition to other industries, of course). Importing drugs from the UK would work similarly as from other 3rd countries, with the MAH responsible for the upload of the serialized codes to the EMVS. What may cause trouble, however, are the medicinal packages made for the UK market and uploaded to the EMVS before the day of Brexit. As the case of uncontrolled Hard Brexit would sever the link between the SecurMed (UKMVO), there may be code verification or decommissioning problems, resulting in e.g. ghost codes lingering in the EMVS even after the medicines have been used.

In any case, the British are left with a discussion about delaying the authentication at the point of dispense requirements for the case of GPs. This would require the wholesalers to decommission the serial codes before shipping the drugs to the GP surgeries. Another minor headache in the UK EU FMD case is the crown dependency of Gibraltar as well as Sovereign Base Areas on Cyprus, which are deemed out of scope for EU FMD and, thus, medicines shipped to them from areas governed by EU FMD, including UK, Spain, and the Republic of Cyprus, would have to be decommissioned in the EMVS. In the case of no Hard Brexit, however, it has been clearly stated that the EU FMD will apply to the UK unless “specifically revoked”. We’ll see.

Servicepoint offers services of an experienced full-service packaging, device assembly, machine vision, robotics, and serialization and track & trace automation integration company. In the last few years, Servicepoint has implemented serialization to more than a dozen sites for several manufacturers, our implemented or started projects at customers ranging from Russia to Spain, from Finland to Cyprus. Call us, we can help you!

Merry FMD deadline to you all!

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Printing Russian Pharma Codes

The US DSCSA delayed deadline has just passed. The EU FMD deadline is just two months ahead. The complex Russian pharmaceutical serialization requirements have been published last summer, causing disruption on pharma packaging lines.

Servicepoint has been working in pharma manufacturing and packaging lines in Russia as well as for exporting to Russia from abroad.  We have worked to help our international client to implement Russian serialization in addition to the European one. As the requirements were specified last year with no knowledge on the finalized form of the Russian serialization, we have been working to implement the changes to the system being already installed and validated.

The major issue in Russian pharma serialization is the large amount of data being required in the Data Matrix, leading to large dimensions of the matrix or small dot size. As the standard ink-jet printer head size creates an upper limit on the physical size, getting a GS1-compliant quality printing result with small dot sizes is paramount.

We were able to demonstrate printing a 36×36 Data Matrix with 300 dpi and one printer head and sufficient print quality for further processes, such as pack-by-layer, at a pharma manufacturing line of the client. Developing and implementing a solution was challenging, requiring the top skills and extensive experience of Servicepoint engineers. The data included was (GS1 Application Identifiers) GTIN (01), serial number (21), key (91), and signature (92) —  as required by the Russian draft regulation.

This demonstration was of paramount importance, as the use of existing and already implemented EU FMD or US DSCSA compliant serialization solutions facilitates rapid deployment of  Russian serialization into pharmaceutical manufacturing. We at Servicepoint are well experienced in updating and upgrading existing pharma serialization systems for new products, markets, new package sizes, or higher capacity.

Servicepoint offers services of an experienced full-service packaging, device assembly, machine vision, robotics, and serialization and track & trace automation integration company. In the last few years Servicepoint has implemented serialization to more than a dozen sites for several manufacturers, our implemented or started projects at customers ranging from Russia to Spain, from Finland to Cyprus. Call us, we can help you!

Servicepoint Oy — the reliable partner for the manufacturing industry

Pharma serialization — challenging months ahead

When the EU Delegated Act (2016/161) on safety features of medicinal products was published in Feb 9, 2016, one would have assumed the industry to be already in full work to get ready by the deadline. This was actually true for the big pharma. Companies having 100+ pharma packaging lines just had to begin work well in advance to have any chance to meet the deadline. The small and medium-sized (SME) manufacturers have been another story.

In August 2018, European Medicines Verification Organization (EMVO) announced that only 841 pharma companies had at least initiated the process to connect to the European Medicines Verification System (EMVS) by signing the agreement with EMVO. This was up only from 500 companies last February, so for most of the about 2240 marketing authorization holders there is a lot left to do. Everyone won’t meet the deadline.

With the big pharma in line as also most of the middle-sized companies, a great majority of the production capacity will be serialized and connected to EMVS in time, thus most drug production will not experience regulatory problems. Some of the small manufacturers producing essential and difficult to replace special medicines may not compliant by the deadline, resulting in a danger of medicine shortages. On the other side, small pharma manufacturers of generics will be in serious trouble if not compliant in time.

I am not a lawyer, but to me it seems that the Falsified Medicines Directive (2011/62/EU, “FMD”) leaves overseeing the compliance of the pharma manufacturers to the member states. The penalties for non-compliance should be “effective, proportionate and dissuasive” and “not be inferior to those applicable to infringements of national law of similar nature and importance.”

It looks to me that this will make many a lawyer happy in the following years.

As an automation integrator with special skills in implementing pharmaceutical serialization, Servicepoint has seen the surge of requests for quotation from SME pharma manufacturers. To respond to the rapidly rising demand we have been recruiting and training more personnel for the specialist tasks. We are happy to help new clients, too. With the current high demand, spending time in tender processes is not a priority, however.

Russian regulatory developments

The Russian pharmaceutical traceability law is going forward with a deadline just eleven months after the EU FMD deadline. The technical specs are still evolving, but case-level aggregation is required by the law for the full traceability service. This should be noted by European manufacturers who, in addition to supplying the European market, export medicines to Russia.

On technical level, the tentative Russian specification spells some trouble for packaging lines. The requirement (see post by Dirk Rodgers) to include a 4-character key (Application Identifier 91) and 88-character encrypted signature (AI 92) to the data matrix, in addition to the (possibly) standard 14-digit GTIN-14 (AI 01) and 13-character serial number (AI 21), results in 122 characters (includes field termination characters). This is considerably more than the 60 digits enough for the EU FMD -compliant data matrix (about 70 with national reimbursement number), resulting in quite a large data matrix (36×36).

Why would this be trouble at the packaging line? As the standard, easy, way to print the data matrix and human readable information is a 12,7 mm wide inkjet printer head, there is a limit how large a square data matrix one can easily print. Making the dot size smaller is possible, but the smaller the dot size, the more difficult (i.e., expensive) it is to reach the required print quality.

Summed up, it sure looks we are going to have an interesting working year ahead, with lots of work needed for the pharma industry to be compliant. Following the regulatory developments is of paramount importance, especially as the Brexit is looming early next year, too.

Servicepoint offers services of an experienced full-service packaging, device assembly, machine vision, robotics, and serialization and track & trace automation integration company. In the last few years Servicepoint has implemented serialization to more than a dozen sites for several manufacturers, our implemented or started projects at customers ranging from Russia to Spain, from Finland to Cyprus. Call us, we can help you!

Servicepoint Oy — the reliable partner for the manufacturing industry

Serialization and data integrity in pharma production

With the US, European, and Russian pharmaceutical serialization deadlines looming, the industry is busy implementing these new technologies to their production lines.

Serialization, in effect, expands the digital dimension to production data. Instead of just master and batch data, there will be individual package-related data in cloud and ERP systems. Even the small-scale production sites that have been able to rely on paper-based reporting have to adopt digital reporting.

Of obvious importance is the need to reconcile data, not just materials, after the production run before the batch is released. The approved batch should not have serial numbers hanging loose, nor packages without serial numbers, nor serialized packages not accounted for. All the rejected packages with serial numbers must be accounted for.

Digital accounting makes the control of data integrity both easier and harder. On the other hand, the data systems can be made to provide audit trail every data read, write, and change, require digital identification of persons responsible and provide backups. On the other hand, people are prone to looking for shortcuts, especially during incidents. For example, if the person having the access rights to production line stop mitigation is not always close, the personnel may find a shortcut, e.g., having access keys are available at the production line to make quick changes and repairs. This results in obvious data integrity risks.

Data integrity might look like a simple issue with a modern computerized production control systems, but it is hardly so. There are interfaces between the systems: within the organization, between trading parties such as API manufacturers or CMOs and MAHs, and between the MAHs and cloud systems or government repositories, such as the European Hub in the EMVS, and MDLP in Russia.

Each data transfer contains a possibility of unintentional data changes. Guaranteeing the data integrity between ISA levels 2 (production line) and 3 (site/factory level) may well be troublesome if the software solutions on these levels are from different vendors. An example of an unintentional change of data was with HIV testing at a blood service years ago, where the transferred testing data was truncated and critical information lost — leading to people being given contaminated blood.

Compromising data integrity compromises also patient safety.

Data integrity is also related to the data being safe. The serialization data is particularly sensitive as a data security breach may result in counterfeit manufacturers copying the genuine codes to the counterfeit products. The MES and ERP systems should thus be safe from external hacking, even in case the criminals get inside help.

One such case where the serial number data was compromised was at a software manufacturer which, in essence, sold serial codes packed in carton packages,  the software being freely downloadable but requiring the license keys. In this case, counterfeits quickly emerged in the market with perfectly genuine, but copied, serial codes. After an investigation, it was found that the issue was not computer system hacking nor an inside job, but the CD-ROMs containing the serial codes were thrown into normal garbage cans after use, and were thus available to somebody outside the factory looking through the garbage for CDs or other data-containing media.

Web links on machine-readable QR or DataMatrix codes create novel data integrity threats. An obvious problem is that the actual content of the web link is not visible, but attack links can also look similar to genuine ones. A malicious link may lead to a fake website made to look exactly like the genuine one and thus lead to a compromised test of product authenticity — it may even contain a trojan/virus attack to the mobile phone reading the code! If web links are added to QR or DataMatrix codes, one should add a layer of security, such as Systech UniSecure.

Servicepoint offers services of an experienced full-service packaging, device assembly, machine vision, robotics, and serialization and track & trace automation integration company. In the last few years, Servicepoint has implemented serialization to more than a dozen sites for several manufacturers, our implemented or started projects at customers ranging from Russia to Spain, from Finland to Greece. Call us, we can help you!

Servicepoint Oy — the reliable partner for the manufacturing industry

Countdown to Russian pharma serialization

Servicepoint has been closely watching the developments of the Russian pharmaceutical serialization. As the Federal law on the circulation of medicines has now been approved, signed by the president, and published Dec 29, 2017, it is time to wrap up the developments so far.

I have been covering the development during the design and pilot phases of lawmaking with articles and blog posts, as well as an interview last December.

Summed up, the law is about quite normal serialization, but with a boosted track & trace with extra functionality for the government. The government wants to use the system to watch at pricing and availability of drugs around Russia and provide the consumers a possibility to use a mobile app to search which pharmacists have the drug they are looking for and check the prices, too.

The data matrix should contain, in addition to the normal GTIN (Application Identifier AI=01), serial number (21), batch number (10), and expiry date (17); imported medicines require also a TH-number (240), which is the four first digits of the TN VED (ТН ВЭД), namely 3001 (e.g. blood products such as heparin), 3002 (blood or serum), 3003 (medicines not packaged in dosage forms), or 3004 (dosage forms).

Aggregation is thus required. Official deadline is Jan 1, 2020, but earlier deadlines for the seven high-spending disease classes (7 ВЗН, such as treatment of haemophilia) and medicines on the list of vital and essential medicines (ЖНВЛП, comprising about 40% of medicine packages or 35% of value), are most probably getting earlier deadlines that will be (soon?) decided by Roszdravnadzor (Federal Service for Surveillance in Healthcare). Tamper evidence is still in the air, depending on later acts.

The government also wants to have some visibility to the industry readiness. They are going to set up a working group to monitor the implementation and is going to call for hearings in July 2018 to review the progress. I would assume there will be further reviews as the deadline draws closer.

Several of the European manufacturers who have done minimal implementation of serialization just to comply with the EU FMD needs (serialization, tamper evidence, and data upload to repository), have now found out that they need to do further investment to aggregation. This is all well if the original system has been purchased and implemented so that adding aggregation is feasible and cost-efficient.

Servicepoint has collected a wide experience in packaging automation projects as well as machine vision and inspection systems. We offer services of an experienced full-service packaging, device assembly, and serialization and track & trace automation integration company. In the last few years, Servicepoint has implemented serialization to more than a dozen sites for several manufacturers, our implemented or started projects at customers ranging from Russia to Spain, from Finland to Greece.

As we are a Finnish service provider located near the Russian border, we are able to travel to Russian customer sites easily, most of our field engineers have long-term visas. We can also travel on short notice, as in addition to flying to Russia, we have easy train connections to e.g. St. Petersburg and Moscow area. We have Russian-speaking personnel, too. Call us for professional help!

Servicepoint Oy — the reliable partner for the manufacturing industry

The many faces of traceability

In common discussion on pharmaceutical serialization, track & trace means traceability of medicines from the manufacturer to the patient to ensure product authenticity.

On the other hand, the companies employ ERP systems for traceability of products and their components from sources through the logistics to gain supply chain visibility. This is very useful in case there is a defect in a sourced component: broken semiconductor components for electronics, spoiled food sources. Traceability makes product recalls easier and more precise.

This is also the case when products in the supply chain take a diversion. Let’s discuss the European pharmaceutical market under the Falsified Medicines Directive (FMD). This diversion could be an acceptable one, like a wholesaler selling a shipment of products to another wholesaler or a parallel importer (“grey imports”). In a the more complicated supply chain the purchaser of a shipment is required to verify the unique identifiers of the products. Repackaging products breaks the visibility, but the repackager is required both to decommission the unique identifiers of the original product and commission new unique identifiers to be tracked.

An unacceptable diversion would be when a product shipment, e.g. a delivery truck, is stolen. This breach must be detected and the unique identifiers reported to the EMVO as stolen ones to prevent re-entry of the unique identifiers to the supply chain. Why so? The contents of the stolen packages may have changed or new packages might have been produced with copied codes but unsafe contents – or the cold chain may have been broken.

Traceability is about protecting the consumer

For food products, traceability is also viewed the other way round: the consumer wants to know and be sure where the ingredients of his food product originate from. Thus, producer-identifying timestamps on eggs, names of farms in meat products. This process is for the end customer to identify the sources of food products, but not for authentication. The data can be easily copied or falsified.

Some pharmaceutical track & trace plans include a similar possibility for the patients: e.g. the Russian concept includes a phone app that the patient can use to trace back the logistics chain of the specific product to the manufacturer.

In comparison to the agricultural products, the pharma track & trace models do not include information before the manufacturer of the final product, or marketing authorization holder. There is some discussion about visibility to the APIs and excipients included in the medicines, though.

For the pharmaceutical industry, we offer services of an experienced full-service packaging, device assembly, and serialization and track & trace automation integration company. With experience from 30 years in the pharmaceutical industry, and of a thousand production & packaging line upgrades or new installations, Servicepoint can help you throughout the whole serialization projects. Call us for professional help!

Servicepoint Oy — the reliable partner for the manufacturing industry


The patient as the last node of a secure pharma supply chain

One of last week’s news in Finland was the police warning about street sales of Rivotril, a benzodiazepine illegally used recreationally for narcotic purposes. At least one of the purchasers has been taken to hospital for losing consciousness. The sellers have been reported to be “beggars on the street”.

Fake drugs are a grave threat to health: they may contain, instead of the suggested medicinal ingredient, other harmful or even poisonous substances. Also, authentic drugs that have been diverted from the legitimate supply chain may be a health hazard: the criminals do not care for the proper storage conditions: cold chain may have been breached and even durable medicines may lose potency if left in an overheated car in the sun. Medicinal packages may also have their contents exchanged to similar looking, but totally different pills.

To protect the public, health regulators have taken action around the world, such as serialization and addition of tamper-evidence packaging. With these measures, e.g. the European patients should have their prescription medicines authenticated by the pharmacy in the sales process. The protection given by serialization is not perfect but gives a good final safeguard.

All the investment to pharma supply chain security is in vain if the people take the shortcut to shady sellers of illegal drugs.

Illegal internet pharmacies, masquerading as operating from credible countries and with professionally made websites, give an impression to people to be a shortcut to prescription medicines. Some men, for example, who are too shy to ask their doctor to get erectile dysfunction pill prescription, see direct internet sales as an easy and discreet option. The websites are easy to find. The problem is, they do not check one’s prescription and thus the precautions for existing health conditions or medications are not taken. The other problem is that they do not usually care to sell authentic products as fakes are cheaper.

If the customers ever find out that the drugs are fake, they are shy to report to police as they should not have been purchasing the drugs illegally in the first place. Another problem for the police is that finding the perpetrators is notoriously difficult online.

In illegal online sales of prescription medicines, the risk to the customer comes in two ways: the health risks of digesting fakes, and giving one’s credit card details directly to criminals.

The pharmaceutical industry is investing heavily to implement serialization and track & trace technologies to their production lines. So are the pharmacies and the logistics companies. All this investment is in vain if the people take the shortcut to shady sellers of illegal drugs, for shame or to get medicines that are not appropriate to them.

Another issue is authenticating the medicines bought from internet pharmacies, as the patient has no visibility to the point-of-sale verification; a case for a mobile app with connectivity to the data repositories.

Photo: Helsinki Police Department, Finland

Securing pharma supply chain for the patients

recent simulation pilot — by St. James’s Hospital (Dublin, Ireland), Systech International, and Sharp Packaging Solutions — tested the logistics of medicines from the manufacturer to a hospital with test “fake” products mixed in. The simulation consisted of three batches of cancer medicines each secured by different means: one using the European Stakeholder Model (ESM), another using the US Drug Supply Chain Security Act (DSCSA) model e-Pedigree, and the third using the proprietary Systech UniSecure solution. 50 “fake” products with unique identifiers copied from the authentic ones were randomly mixed into batches of 500 products each, simulating a breach of logistics security. It was found out that of 50 “fake” products, 18 got dispensed to the patient before warning signs in the ESM model, and 10 in the e-Pedigree model. This was because in a case the counterfeiters have genuine codes to copy, either because of an information system breach or by copying the codes from authentic products (e.g. in a warehouse), the first product with an authentic serial number will get passed to the patient, even if it is fake.


A fake drug with a copied unique identifier reaches the patient, if it passes the logistics chain before the authentic drug.


Systech UniSecure adds a very efficient layer of security by detecting specific measurable characteristic patterns within the printing noise, harnessing these variations to generate an electronic signature. This electronic signature is unique to a given instance of a product and can be utilized on either a serialized or non-serialized product. These variations are both random and unique, producing e-Fingerprint that is impossible to replicate. As UniSecure does not interfere with the serialization track and trace regulations, it can be readily applied whenever the industry has the need. The logistics partners, pharmacists or even the patient can then authenticate the product with a phone app, which uses the camera existing in virtually all smartphones.

This brings us to another example of problems with the ESM or e-Pedigree: the internet pharmacies. Authentication at the point-of-dispense is all well in traditional pharmacies as the patient can see the verification to happen. In internet pharmacies, this is not the case. The patients should, thus, have a means to authenticate the products themselves, but the government-regulated systems do not allow that, the incoming Russian drug traceability system as an exception. One must remember, that an unscrupulous villain can fake the point-of-dispense application, too, to sell fake products at a criminal-run pharmacy. Systech UniSecure provides for these cases, too, as the industry can opt for extra protection: enter a “pharma brand app”. This functionality can readily be a part of mobile health app providing also other functions, such as assistance for medication adherence.

Another group that is not yet covered by the government-regulated anti-counterfeiting method nor have a system of reliable pharmacy network are people of the undeveloped countries. A prime example are antimalarial medications: a recent study found 1/3 of antimalarials in sale in Africa were fake. Another survey by WHO in Nigeria in 2011 found that 64 % of the antimalarials were fake (mPedigree). Smartphones are becoming ubiquitous in undeveloped countries. The pharma manufacturers could, then, provide protection for the poor patients, too.

For the pharmaceutical industry, we offer services of an experienced full-service packaging, device assembly, and serialization and track & trace automation integration company. With experience from 30 years in the pharmaceutical industry, and of 800 production & packaging line upgrades or new installations, Servicepoint can help you throughout the whole serialization projects. Call us for professional help!