INTRODUCTION OF TRACK AND TRACE SYSTEM
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One of the essential requirements for a drug is the assurance of its quality, together with its efficacy and safety. In the pharmaceutical industry, professionals try to develop and improve analytical methods to assure prescribed treatment will improve patient life quality. On the other side, the patients have to trust in pharmaceutical company’s integrity and acknowledge their concern regarding drugs safety. To achieve this ideal, quality of medicine, it is the most challenging mission in the drug development field. A collective joint effort between authorities from all over the world was made to ensure the patient’s safety in the 21 century. World Health Organization (WHO), Food and Drug Administration (FDA), European Union (EU) and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) gathered in their guidelines a common purpose. The goal is to help future research projects to find what their background was when they assure the quality of drugs and what can be used for developing new methodological decisions in upgrading the pharmaceutical industry. Every country applies general practices for drug assurance quality based on the submitted regulations. Essentially, there is a national compendium of good manufacturing practices (GMP) with specific chapters and annexes that maintain regulatory obligations.
One of the recent requirements to improve drugs quality is their traceability. Drug serialization is a practice that assures a unique recognition number for every drug unit. The given number may be used for product tracking and authentication in the distribution chain, allowing counterfeits identification. It requires support and collaboration from all partners involved in medicine’s marketing. There are several essential elements to be introduced in a serial number: a product code capable of giving essential characteristics like name, pharmaceutical form, concentration, package, batch number, expiration date, and a serial number obtained by a computerized algorithm. This serial number has to be unique and cannot be repeated for at least five years since its introduction on the market.
Technologies have a significant impact in combating counterfeiting drugs process. Nowadays, it is straightforward to manufacture a product which may pass at first glance as an original. Also, the online drugs market (known as a grey market) is very accessible. Accelerated growth of the online pharmacies number could put people’s lives in danger. Consequently, serialization process becomes a universal tool as a primary procedure in combatting counterfeiting.
Pharmaceutical serialization emerged as a challenge to improve the traceability of drugs. It became an urgent necessity in a global effort to combat selling counterfeit medicines, a growing and dangerous phenomenon for patients ‘health.
The specific goals are to outline the emerged modern methods to improve the serialization, the existing legislative regulation and the steps forward to global harmonization and the active mechanisms of serialization against counterfeiting medicines. Health care professionals are primarily targeted, along with specialists in the pharmaceutical industry. However, there is a lot of new ground in the area of supply chain management and serialization/ traceability.
The range of counterfeit products reaching markets has also broadened with the increased commercial use of the Internet to provide a dizzying array of both branded and generic drugs. In more than 50% of cases, medicines purchased over the Internet from illegal sites that conceal their physical address have been found to be counterfeit, according to WHO.
“In a shocking development, it was discovered relatively recently that counterfeit versions of lifesaving prescription medicines for cancer and serious cardiovascular diseases are also being sold to consumers online,” the European Alliance for Access to Safe Medicines reports.
Developing countries are an obvious target for counterfeiters, because the cost of legitimate drugs may be beyond the reach of much of the population and legal controls are often weak, analysts say.
Counterfeit (or fake) medicines
Counterfeit medicines are medicines which do not respect intellectual property rights and/or violate trademark laws. Counterfeiting can be related to product mislabelling to reproduce an authentic medicine. Another more dangerous method is to supply drugs without or with a lower/higher amount of active pharmaceutical ingredients (API). Also, a serious situation is when medicines contain non-labelled harmful toxic substances.
Fake drugs, as their name tells us, are those counterfeit drugs that are designed to mimic original medicines. Vital drugs such as those for the treatment of malaria, tuberculosis, HIV/AIDS and even anticancer drugs have not escaped forgery
The most common counterfeit drugs
Recently, published data revealed a variety of percentages of falsified drugs based on the geographic areas: 10.5% of medicines are falsified or under dosed, according to WHO worldwide, about 10-30% according to CDC in developing countries versus almost 1% in the U.S. or 13% in Europe industrialized countries. The magnitude of this problem makes it harder to achieve universal access to safe and effective global medicines and the need for further investigation of well-designed prevalence studies are required to reflect the actual prevalence.
IN THE BEGINNING: A BRIEF HISTORY
While companies have been discussing the need to identify and verify medicines to protect patient safety for some time, the pharmaceutical industry has been slow to adopt new technologies.
In 1999, following a report by the US institute of Medicine, President Bill Clinton placed patient safety (including preventing errors at the point of dispensing medicines) on the agenda of federal government and continued to lobby for changes after his presidency.
In 2003, the US Food and Drug Administration (FDA) mandated barcoding on unit doses and in the same year, the World Health Organisation (WHO) published a report recognising the scale of the counterfeit medicine challenge stating that 10% of medication worldwide was counterfeit.
A step change took place in serialisation around 2005 and a number of countries began to set deadlines for implementation. However, after making some strides towards securing the supply chain, the challenge became less of a priority during the financial crisis in 2008.
As the global economy has improved, slowly the momentum has shifted. Turkey introduced serialisation requirements in 2010 and other markets such as China, South Korea and India have regulations in place. With the EU Falsified Medicines Directive (FMD) came into effect in February 2019 and the US introduced legislation in November 2017, as part of the Drug Supply Chain Security Act (DSCSA), it’s expected that more than 75% of global medicines will be covered by some form of track and trace regulations by 2019.
While the EU FMD is limited to the verification of medicines at the dispensing point and, therefore, does not allow for the tracing of drug products throughout the whole pharmaceutical supply chain, it is a positive step towards establishing a more secure system.
BASIC CONCEPT OF TRACK AND TRACE SYSTEM
why is Track & Trace becoming increasingly important for businesses?
Product piracy is an increasing problem for businesses in the broadest range of industries. A growing number of companies are forced to confront piracy with measures such as serialization and Tracking & Tracing. Results from surveys show that nearly every second consumer considers counterfeiting as a serious problem, and nearly the same amount reported falling victim to counterfeiting. However, Track & Trace offers businesses far more than assurances against counterfeiting and piracy. The decision to serialize and track products on item level opens up a whole new range of options and can provide real value added for the business. For example, the transparency that is gained as a result can facilitate better control of recalls, loss reduction and the optimization of supply chain, marketing and sales strategies.
What does Track & Trace mean?
‘Tracking’ means monitoring forward movement of finished goods through the supply chain and ensuring that all taxes and duties have been paid and volumes verified (i.e., manufacturer to end user).
‘Tracing’ means working backwards through the supply chain to establish where any genuine product was diverted out of the legitimate supply chain (i.e., end user to manufacturer for history, recall etc.)
Tracking & Tracing: Provide visibility to specific information (e.g., batch, lot, date, origin, ingredients, safety, or recall status).
why is this useful?
The information can quickly tell the person querying the package or product on: what it is, where it came from, whether it is subject to a recall or other security issue, when and where it was packed or manufactured and in some cases, where the product was supposed to be shipped to (and therefore, whether it‘s in the correct location).
From serialization over aggregation to Track & Trace
To achieve full Track & Trace the typical approach is to start with serialization. Serialization means to make each single product unique by placing an item identifier on every single product. Typically, the item identifier is a Data Matrix-Code containing at least the product related GTIN paired with a serial number. This way the product becomes the vehicle for carrying the information needed for Track and Trace and can be identified individually. It is also then possible to store further product related information in a database linked to this unique ID. Serialization takes place directly at the production lines and requires in most cases new printing and scanning technologies and software.
The next big step after serialization is achieved is typically the aggregation. Aggregation is the process of building packaging hierarchies and storing this relationship in a database. If, for example single products get packed in a carton and these cartons get packed on a pallet, this relationship has to be recognized and stored in a database using scanning processes. Each new packing level, e.g., cartons or pallets, also requires a unique (serialized) identifier. Aggregation is a major step towards Track & Trace and the big advantage is that; once the packaging hierarchy is built and stored in a database, only the highest-level identifier (e.g., pallet) has to be scanned (identified) and all associated packed items in the hierarchy will automatically be known. This makes it much easier to follow the items through the supply chain, as not every single item needs to be scanned at different intervals in the supply chain. Aggregation can take place directly at production/packaging lines or, for example, in distribution centres during re-packing. In most instances new or additional scanning technology and software is required to capture the building of hierarchies and the movement of product through the supply chain.
Once serialization and aggregation are achieved, everything is in place in order to completely Track & Trace products through the supply chain. The final step is to define points in the supply chain where the products or, the highest packaging level (due to aggregation) has to be scanned. As a result, the state (e.g., produced, shipped, packed, dispensed, etc.) of all packed items can be changed in the database where the Track & Trace data is stored (e.g., EPCIS). While serialization and aggregation take place in production and packaging lines or in distribution centers, Tracking & Tracing mostly takes place in the supply chain.
The combination of having a unique identifier and capturing the information relating to the movement of these aggregated products (when, where, what and why) is the best way to achieve a safe, secure and transparent supply chain.
How does Track & Trace work?
The key to implement Track & Trace is the ability to put variable data on item, case and/or pallet level (depending on the granularity to which items need to be tracked) and to trace these items through the supply chain. Radio-frequency identification and barcodes are two common technology methods used to deliver traceability.
Typically, a barcode or RFID transponder usually containing a combination of GTIN and serial number will be applied to items on the production line. In some cases, there will be an aggregation of the products, related to the packaging hierarchy (e.g., item to case and case to pallet). Aggregation makes it easier to trace a bundle of items through the supply chain as only the ID of the pallet has to be scanned and therefore identifying all cases and items contained on the pallet.
Once the IDs are applied to the products; all product related events such as ‘produced’, ‘shipped’, ‘received’, ‘dispensed’ will be captured along the supply chain via scanning of these IDs with mobile devices. This captured information will be stored in a database (EPCIS) together with product related information from production such as ‘batch’, ‘manufacturing date’, ‘expiration date’ etc.
Why traceability?
Traceability can help in providing the visibility and intelligence of both global market opportunity as well as risk, in an effective and speedy manner. Speed and availability of data is often a necessity to mitigate risk and to identify and exploit new opportunities.
Different ways of Traceability
Track and Trace or Tracking and Tracing, concerns a process of determining the current and past locations (and other information) of a unique item or property.
Traceability Types
when looking at traceability one can distinguish different types of traceability
· Traceability of a product genealogy
ü Batch- or serial number component level
Product supply chain traceability
ü Serialized
ü Item serialized.
ü Batch level
ü GTIN or part number level
· Product provenance and pedigree
· Logistical Track & Trace
ü Parcel traceability
ü Sea-freight container traceability
ü Pallet level traceability
· Process traceability
ü Procure-to-pay or order-to-cash
· Traceability for sustainability and product footprint data recording
IMPORTANCE OF TRACK AND TRACE SYSTEM
Increasing Productivity
With track and trace systems, there is an environment that supports competition for drug manufacturers. With the information obtained by the systems, it is possible to carry out studies that will increase sales and productivity in pharmaceutical production.
Ensuring Serialization and Traceability
In the US and EU, Companies have gone one step further than serialization and have started to develop track and trace solutions using Data Matrix, RFID and QR code. Drug flow between production and sales channels can be monitored with these systems. All the manufacturers have to implement some kind of track and trace solution to their production line until the 2019.
War with the Counterfeit and Illicit Drugs
Drug manufacturers cannot fight the counterfeit and illicit drugs alone. With investments of government and companies in track and trace solutions, counterfeit and illicit drugs can be identified. Market penetration of counterfeit drugs will be prevented from the beginning.
Although drug track and trace systems have been able to provide traceability and increase productivity with the information registered in these systems, they have not been able to be used everywhere in the world because of the obstacles that are present today.
OBSTACLES
No Common Standards
At the very least, the inability to establish a national standard is the greatest obstacle to serialization and the implementation of drug track and trace solutions.
In the US, the Food and Drug Administration (FDA) has asked the pharmaceutical industry to set a general standard for track and trace all drugs. The idea of establishing a common standard has arisen from the desire to assemble all the industry leaders under a common roof, facilitating their adaptation.
Safety Concerns
Some drug companies argue that the barcode system is not secure and is easily changeable. Apart from this, due to the presence of important personal information, there is concern that the track and trace system will be used by unauthorized people to access the information.
Slowing the Production Lines
Manufacturer thinks that the barcoding systems which is a part of the track and trace system, will slow down the production line and have increasing costs. This belief has made the implementation process difficult.
To resolve these concerns, track and trace systems should be studied in detail and every country should establish their standards according to their processes.