Current legislative and regulatory infrastructure - in the context of pharmaceutical product tracking

In present times, legislative and regulatory measures are of great importance in the pharmaceutical industry. We always take it for granted that pharmaceutical products around us are appropriately manufactured, properly labelled and safe for consumption. This trust is due to the fact that we believe these pharmaceutical products are manufactured and tested under strict regulations and laws formed by the government. It is only this way they can reach the patient or the end user. However, this view is quite far from the real truth. The real legislative and regulatory infrastructure was first given proper shape in 1927 when the FDA (Food & Drug Administration) was formed. These days one of the most important aspects concerning pharmaceutical industry is pharmaceutical product tracking and the laws and regulations dealing with this aspect. A good and efficient system meant for tracking and tracing pharmaceutical products will eventually help in detecting the counterfeit medicines. Moreover, this system also helps in a better control of supply chain and also the proper identification of pharmaceutical products even if recalls are required. However, counterfeit medicines are by and large still the biggest challenge to be dealt with. It is to be noted that fraud and counterfeiting are the most risky factors when we are talking about the safety of pharmaceuticals.

Developments in pharmaceutical product tracking in the USA

In the year 2004, the FDA, in its first report dealing with the problem of counterfeit drugs, emphasised the importance of electronic track & trace technology to ensure the safety of the supply of medicines. The FDA implemented the use of RFID (Radio Frequency Identification) technology to be the standard technology in tracking and tracing pharmaceutical products in 2007. RFID is a kind of technology which by using radio frequencies allows the automatic identification & data capture of a product. Under this technology, usually a unique or an exclusive type of identifier and some additional information is attached with the product using a device called as microchip.

This information can be read and interpreted by using a wireless device called an RFID reader, which uses radio frequencies to read an electronic tag attached to the product and identifies this unique identifier. However, implementing such a system in the pharmaceutical industry, some basic industry standards, as well as the necessary IT infrastructure first had to be set up. The RFID system will now be implemented under the Prescription Drug Marketing Act (1987). Although strongly favoured by the FDA and the US pharmaceutical industry, there are some issues involved with using RFID technology. First of all, it is quite costly and another issue is regarding the patient’s privacy. Further, in the USA, some medicines are packed in smaller packs by the pharmacists and in these cases a bar code system and RFID does not allow total control of the product. In Europe, there is a unit of use pack which allows the total control of the supply chain. Moreover, most companies are still hesitant in attaching the RFID tags to pharmaceutical products as they are still waiting for maturing of technical standards. The war against the counterfeit medicines is slowly shifting into full gear in the USA, as the government has also formed a new law making this counterfeit medicines issue a criminal offence with the offender facing punishment of up to life imprisonment, depending on the severity of patient suffering.

Product tracking for supply chain efficiency and protection

In present times, pharmaceutical companies and regulatory agencies are very concerned about fraud and counterfeiting issues in the whole supply chain network especially when the medicines are getting expensive. The government plays a very important role in protecting people from counterfeit drugs by introducing regulations and laws covering the whole pharmaceuticals supply chain which puts a check at each and every stage, starting right from the production facility. In the last five years, the technology used for tracking pharmaceutical products has been developed and upgraded many times due to technological advancements. This has led to many possibilities like tracing and tracking these products down to an item level. RFID technology, scanning technology, 2D matrix codes and sophisticated databases have enormously helped in offering more accountability all over the supply chain.

Therefore, the emergence of track & trace systems for drugs is becoming a necessity and due to this reason this has become a legal requirement in many countries. Different methods are given importance in different countries depending on the requirements and packaging standards of drugs. While in Europe 2D data matrix codes are given preference, in the USA, RFID technology is the preferred one. It is to be noted that RFID is considered to have more advantages than the other technologies as it can also monitor other conditions like temperature when drugs are transported from one place to another. So in order for the supply chain to be robust, these tracking and tracing technologies have to be in place.

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Current legislative and regulatory infrastructure - in the context of pharmaceutical product tracking
Depending upon the various types of drug packs and formats, there are various problems associated with the tracking and tracing of pharmaceutical products especially when tracking a single item. In Europe, blister packs are used, while in the USA containers of tablets are used and the information is coded on the container, not on a per item kind of basis.