E-traceability: Digital way to control counterfeit drugs

While Bangladesh pharmaceutical industries export drugs to as many as 52 countries worldwide, recent investigations reveal an estimated US $150 million worth of spurious medicines is posing a risk to public health at home. Bangladesh pharmaceutical supply chain is considered one of the world’s most vulnerable one, and the distribution system is poorly regulated. The deficiencies and gaps persisting in the supply chain allow unsafe medicines to be intentionally introduced into legitimate channels of commerce. These illegal activities include: creating counterfeit pharmaceuticals with inactive or harmful ingredients and replacing a drug with a lower-dose product resulting in disease complex and difficult to cure and many patients die because of kidney failure, liver damage, and organ disability with a variety of complexities.
In addition to pharmaceutical sector corruption, covetous commissions offered to doctors, law enforcement laxity, lack of administrative monitoring, weak judicial systems, technical inability are the main reasons of marketing adulterated medicines.
According to the World Health Organization, 15 percent of the world’s drugs are counterfeited and adulterated. India alone produces 35 percent among them and Nigeria 23 percent--representing 41 percent of the country's drugs in its own markets.
The sole effective way to fight these problems associated with counterfeit and substandard medicines is to involve the supply chain from the start, regulate it and be able to implement traceability system on each medicine that is sold in the markets. Traceability is the ability to track any food, feed, medicine, medical device. etc. through all stages of production, processing and distribution (including importation and at retail). Traceability is implemented with a record keeping system at all stages of production, processing and distribution which can be paper-based, electronic data-based or the combination of both. In comparison with the paper-based system, electronic traceability (e-traceability) system establishes an information chain which is easier to access, copy and exchange; more scalable; and can be (semi) automated.
E-traceability in healthcare uniquely identifies  a “traceable item” of each pharmaceutical product to allow its traceability all along the distribution chain (pharmaceutical industries, logistic operators, drug wholesa­lers, pharma­cies, health­care institutions and patients), describes the establishment of appropriate and effec­tive records of events, and provides  accurate communi­cation about the traceable items between trading or traceability partners. At each step of the process, the product data is confirmed in real-time through a central database, thus allowing the concerned to see the movement of medicines or medical devices across the supply chain. In this way, one can trace backwards to identify the history of the transfers and locations of a product, from the point of manufacture onwards and can track forwards to see the intended route of the product towards the point of healthcare. Within this system, a comprehensive supply chain security is built by pharmaceutical manufacturers, wholesalers and dispensers working together to deliver high-quality pharmaceutical products that have never been abandoned the legal trail of production and distribution, enhancing visibility of pharmaceuti­cal product during distribution and ensuring patients have the medicines they need-- the security and authenticity of the drug is therefore ensured and guarantees.
With the proper implementation of the e-traceability system, the following objectives can be achieved:
•    Prevent the distribution of counterfeit drugs
•    Discourage theft and adulteration of products
•    Minimise wrong supply of products
•    Facilitate effective product recalls from the market
•    Regularise the distribution of drugs at country level
•    Improve efficiency and reduce the costs of the healthcare systems
•    Evaluate in real time the consumption of each type of drug
•    Encourage the rational use of drugs

Bangladesh has already experien­ced implementing traceability for fish and fishery products exported to the EU countries which requires that ‘Food business operators shall be able to identify any person from whom they have been supplied with a food or any  substance intended to be, or expected to be, incorporated into a food’ (Regulation (EC) N° 178/2002). Traceability procedures are also required by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) of the USA. To comply with the EU Regulation and Bioterrorism Act, a paper-based traceability system for fish and fishery products of Bangladesh is in place which is now gradually turning to e-traceability involving computer, bar code and RFID technology with the help of Department of Fisheries (DoF) and various NGOs such as Bangladesh Shrimp and Fish Foundation.
The pre-requisites of implementing traceability in the supply chain depends on legislation which lays down the minimum traceability require­ments, official controls to compli­ance with legislation and businesses operators taking measures and adop­ting practices to achieve an approp­riate system of traceability. Bangla­desh promulg­ted specific requirement for traceability in the fishery sector in Fish Inspection and Quality Rules in 2008 and since then, shrimp business operators have adopted traceability procedures that is verified by DoF regulatory authority in a timely manner.
Counterfeit drugs have become an increasing national and global threat over the last few decades and more and more regulatory authorities have adopted or will adopt requirements for the use of globally unique drug identifiers and serialisation in order to protect the supply chain. The U.S. Drug Quality and Security Act (DQSA) was signed into law on 27 November 2013. It outlines critical steps to build an electronic, interoperable system for identification and traceability of prescription drugs as they are distributed in the U.S. A growing number of countries enacted some form of drug traceability. Italy was the first countries to pass such a law; Italy enacted the ‘Bollini’ law in 2000, requiring drug serialization and tracking to the point of sale. Turkey has a similar system that has in place since 2012.  In 2011, the European Union established a directive that would require all member states to enact their own drug serialization and “track and trace” regulation
by 2014.
A voluntary traceability system at the first step can be implemented in Bangladesh with a wide list of costly critical drugs used to treat conditions such as cancer, haemophilia, rheumatoid arthritis and cystic fibrosis. It can then also be applied to drugs treating illnesses such as asthma, acromegaly, wet macular degeneration and anaemia associated to the chronic renal disease. In addition, it can also be applied to various sedative drugs, antihypertensive and cough medicines, and analgesics for central action, psychoactive drugs and other substances which can cause addiction.
As pharmaceutical companies are expanding their business with the aim to expand the export markets, it is high time the government took initiative to secure and warrant the drug supply chain control with the help of creating a legislative framework to implement traceability system to combat digitally with counterfeit and substandard medicines involving sufficient health risk and severity. As a former UNIDO Consultant on Traceability and Quality Assurance, the writer has gathered experiences in implementing traceability in the shrimp supply chain from the beginning and would like to conclude that implementing it in pharmaceut­ical supply chain would be easier and bring more benefit to both manufacturers and consumers and would facilitate the risk-based approach of control system applied by the regulatory authority along the pharmaceutical supply chain.  

The writer is a Team Leader, e-Traceabilty Project, Bangladesh Shrimp and Fish Foundation, Dhaka; [email protected]

E-traceability: Digital way to control counterfeit drugs

While Bangladesh pharmaceutical industries export drugs to as many as 52 countries worldwide, recent investigations reveal an estimated US $150 million worth of spurious medicines is posing a risk to public health at home. Bangladesh pharmaceutical supply chain is considered one of the worlds most vulnerable one, and the distribution system is poorly regulated. The deficiencies and gaps persisting in the supply chain allow unsafe medicines to be intentionally introduced into legitimate channels of commerce. These illegal activities include: creating counterfeit pharmaceuticals with inactive or harmful ingredients and replacing a drug with a lower-dose product resulting in disease complex and difficult to cure and many patients die because of kidney failure, liver damage, and organ disability with a variety of complexities. In addition to pharmaceutical sector corruption, covetous commissions offered to doctors, law enforcement laxity, lack of administrative monitoring, weak judicial systems, technical inability are the main reasons of marketing adulterated medicines. According to the World Health Organization, 15 percent of the worlds drugs are counterfeited and adulterated. India alone produces 35 percent among them and Nigeria 23 percent--representing 41 percent of the countrys drugs in its own markets. The sole effective way to fight these problems associated with counterfeit and substandard medicines is to involve the supply chain from the start, regulate it and be able to implement traceability system on each medicine that is sold in the markets. Traceability is the ability to track any food, feed, medicine, medical device. etc. through all stages of production, processing and distribution (including importation and at retail). Traceability is implemented with a record keeping system at all stages of production, processing and distribution which can be paper-based, electronic data-based or the combination of both. In comparison with the paper-based system, electronic traceability (e-traceability) system establishes an information chain which is easier to access, copy and exchange; more scalable; and can be (semi) automated. E-traceability in healthcare uniquely identifies a traceable item of each pharmaceutical product to allow its traceability all along the distribution chain (pharmaceutical industries, logistic operators, drug wholesalers, pharmacies, healthcare institutions and patients), describes the establishment of appropriate and effective records of events, and provides accurate communication about the traceable items between trading or traceability partners. At each step of the process, the product data is confirmed in real-time through a central database, thus allowing the concerned to see the movement of medicines or medical devices across the supply chain. In this way, one can trace backwards to identify the history of the transfers and locations of a product, from the point of manufacture onwards and can track forwards to see the intended route of the product towards the point of healthcare. Within this system, a comprehensive supply chain security is built by pharmaceutical manufacturers, wholesalers and dispensers working together to deliver high-quality pharmaceutical products that have never been abandoned the legal trail of production and distribution, enhancing visibility of pharmaceutical product during distribution and ensuring patients have the medicines they need-- the security and authenticity of the drug is therefore ensured and guarantees. With the proper implementation of the e-traceability system, the following objectives can be achieved: Prevent the distribution of counterfeit drugs Discourage theft and adulteration of products Minimise wrong supply of products Facilitate effective product recalls from the market Regularise the distribution of drugs at country level Improve efficiency and reduce the costs of the healthcare systems Evaluate in real time the consumption of each type of drug Encourage the rational use of drugs Bangladesh has already experienced implementing traceability for fish and fishery products exported to the EU countries which requires that Food business operators shall be able to identify any person from whom they have been supplied with a food or any substance intended to be, or expected to be, incorporated into a food (Regulation (EC) N 178/2002). Traceability procedures are also required by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) of the USA. To comply with the EU Regulation and Bioterrorism Act, a paper-based traceability system for fish and fishery products of Bangladesh is in place which is now gradually turning to e-traceability involving computer, bar code and RFID technology with the help of Department of Fisheries (DoF) and various NGOs such as Bangladesh Shrimp and Fish Foundation. The pre-requisites of implementing traceability in the supply chain depends on legislation which lays down the minimum traceability requirements, official controls to compliance with legislation and businesses operators taking measures and adopting practices to achieve an appropriate system of traceability. Bangladesh promulgted specific requirement for traceability in the fishery sector in Fish Inspection and Quality Rules in 2008 and since then, shrimp business operators have adopted traceability procedures that is verified by DoF regulatory authority in a timely manner. Counterfeit drugs have become an increasing national and global threat over the last few decades and more and more regulatory authorities have adopted or will adopt requirements for the use of globally unique drug identifiers and serialisation in order to protect the supply chain. The U.S. Drug Quality and Security Act (DQSA) was signed into law on 27 November 2013. It outlines critical steps to build an electronic, interoperable system for identification and traceability of prescription drugs as they are distributed in the U.S. A growing number of countries enacted some form of drug traceability. Italy was the first countries to pass such a law; Italy enacted the Bollini law in 2000, requiring drug serialization and tracking to the point of sale. Turkey has a similar system that has in place since 2012. In 2011, the European Union established a directive that would require all member states to enact their own drug serialization and track and trace regulation by 2014. A voluntary traceability system at the first step can be implemented in Bangladesh with a wide list of costly critical drugs used to treat conditions such as cancer, haemophilia, rheumatoid arthritis and cystic fibrosis. It can then also be applied to drugs treating illnesses such as asthma, acromegaly, wet macular degeneration and anaemia associated to the chronic renal disease. In addition, it can also be applied to various sedative drugs, antihypertensive and cough medicines, and analgesics for central action, psychoactive drugs and other substances which can cause addiction. As pharmaceutical companies are expanding their business with the aim to expand the export markets, it is high time the government took initiative to secure and warrant the drug supply chain control with the help of creating a legislative framework to implement traceability system to combat digitally with counterfeit and substandard medicines involving sufficient health risk and severity. As a former UNIDO Consultant on Traceability and Quality Assurance, the writer has gathered experiences in implementing traceability in the shrimp supply chain from the beginning and would like to conclude that implementing it in pharmaceutical supply chain would be easier and bring more benefit to both manufacturers and consumers and would facilitate the risk-based approach of control system applied by the regulatory authority along the pharmaceutical supply chain. The writer is a Team Leader, e-Traceabilty Project, Bangladesh Shrimp and Fish Foundation, Dhaka; [email protected]