What is drug serialization? #

Do you know what the code on some medication boxes is for? This device called drug serialization is an innovation with an essential role in protecting patient health.
In reality, this system allows verification of whether a medication is authentic, between its distribution and dispensing by the pharmacist. Since February 9, this procedure has been mandatory in the European Union to fight against falsified medicines (European Directive 2011/62 of June 8, 2011 EU Directive 2011/62/EU).

What is a falsified medicine? #

A falsified medicine is fraudulently presented as authentic when it is not. It can be:

• counterfeit medicines, which imitate the appearance and labeling of a real medicine. However, they do not contain the same active ingredients or contain them in different dosages.
• altered medicines that have been modified after manufacturing, for example by changing the expiration date, repackaging them, or mixing them with other substances.
  Falsified medicines represent a real danger to health. Indeed, by taking these products, patients are exposed to risks such as:
• treatment ineffectiveness;
• serious adverse effects;
• toxic reactions.
  This is why the fight against falsified medicines is a priority in public health.

A global scourge #

Medicine falsification is a global scourge and involves organized criminal networks. These networks exploit weaknesses in control systems that exist in some countries. According to the World Health Organization (WHO), one in ten medicines is falsified in low- or middle-income countries. Counterfeit medicines often affect highly demanded treatments or treatments for serious diseases, such as:

• antimalarials;
• antibiotics;
• antiretrovirals;
• anticancer drugs;
• vaccines.
  These falsified products can be a real danger to patients and may not effectively treat the diseases they are supposed to target. Furthermore, they contribute to drug resistance, which is a growing problem in the health field.

Medicines sold online #

Online sales also favor the spread of counterfeit medicines, as it is more difficult to verify their origin and quality. According to the WHO, one in two medicines sold on the web would be falsified.
In France, the pharmaceutical circuit is highly controlled and guarantees quality and safety of medicines distributed to patients. However, despite these rigorous controls, falsified products can be imported or sold online on unauthorized sites. Pharmaceutical companies (Leem) indicate that French customs seize approximately 2 million boxes of fake medicines each year.

How does drug serialization work? #

Drug serialization relies on three essential elements:

• A unique identifier (in the form of a DataMatrix code) that contains the product code, serial number, batch number, and expiration date of the medicine. The pharmaceutical laboratory affixes it to each box. These are mainly prescription-only medicines.
• An anti-tampering device that allows detection of whether the packaging has been opened or altered.
• A central database (or European hub) that records all unique identifiers of medicines put into distribution in the European Union. It is managed by the EMVO organization (European Medicines Verification Organisation).

Serialization in France #

At the national level, France MVO (France Medicines Verification Organisation) manages the central database. This organization groups the identifiers of all serialized pharmaceutical products put on the French market.
When dispensing the medicine to the patient, in a community pharmacy or internal use pharmacy (PUI), the healthcare professional scans the unique identifier and compares it to those recorded in the database:

• if the identifier is recognized and valid, the medicine is authentic and can then be dispensed;
• on the other hand, if the DataMatrix code is unknown, invalid, or already used, the medicine is suspected of being falsified and is placed in quarantine.
  Healthcare professionals use an application certified by France MVO, such as PharmaliZr, to perform verification and deactivation of unique identifiers. This application allows pharmacists:
• to easily and quickly scan Datamatrix codes of boxes;
• to check information in the national database through a dedicated web portal.
  If necessary, they can also consult European databases (EMVS, European Medicines Verification System) of other countries involved in distribution.

The anti-tampering device #

Each serialized medication box also has an anti-tampering device. Thus, this secure system allows control that the packaging has not been opened or altered since its manufacturing. It can take different forms, such as a seal, a tamper-evident label, or a specific plastic film.
Before dispensing the medicine to the patient, the pharmacist verifies the integrity of the device. If it is damaged or missing, the medicine may have been falsified. In this case, the box is placed in quarantine and will not be dispensed to the patient.

Read also: “The Challenge of Drug Serialization”

What are the advantages of drug serialization? #

Drug serialization offers many advantages for public health and the pharmaceutical sector:

• It strengthens the security and traceability of medicines. Indeed, it allows detection and elimination of falsified or expired products, which can be ineffective or dangerous. Medicines are therefore compliant with quality standards, as well as manufacturer specifications.
• Serialization improves the quality and effectiveness of treatments. Indeed, it guarantees that patients receive authentic and certified medicines.
• It optimizes stock management by facilitating tracking of medicines throughout the supply chain. Thanks to unique identification and the central database, it is easier to manage stocks, forecast needs, or reduce storage costs.
• Serialization also promotes cooperation and transparency between different actors in the medicine supply chain, such as manufacturers, pharmacists, or health authorities. The device allows fighting against fraud and medicine trafficking through identification of falsified products.

PharmaliZr, a simple and effective solution for drug serialization #

PharmaliZr is a certified application by France MVO, the organization responsible for managing the national medicines verification system. It allows healthcare professionals, whether practicing in community pharmacies or PUIs, to benefit from many features:

• easily and quickly scan Datamatrix codes of medication boxes;
• have access to information control in the national database, as well as European databases of other countries, if necessary.

PharmaliZr offers many advantages for users:

• patient safety, as it guarantees the authenticity and quality of dispensed medicines.
• detection and removal of falsified medicines from the supply chain, which can be ineffective, dangerous, or counterfeit.
• traceability of medicines throughout the supply chain, which facilitates tracking or stock management.
• fighting against fraud and medicine trafficking, which represent a health and economic risk.
• compliance with European regulation on drug serialization, in force since February 9, 2019.
• development of the application with and for pharmacists, to best meet their needs and practices.
• ease of use and installation that requires no complex training.

To contact PharmaliZr, feel free to fill out the online form. Our team will respond to you as soon as possible.
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