Maximiliano Derecho is a lawyer and acts as a legal assessor for the Department of Health Product Monitoring at the National Administration of Medications, Foods and Medical Technologies (ANMAT). He was part of the team that drove the implementation of traceability in Argentina.
After the incorporation of Rio Negro, the final province to join the National Traceability System, E-Health Reporter Latin America spoke to the lawyer about how the National System of Traceability works, how it was built and the next steps that need to be followed.
What is the role of the National Medication Traceability System?
The System makes it possible to check and monitor the path of a medication from the moment it leaves the laboratory that owns the registration – whether the product is made nationally or is imported – until it is dispensed or administered to the patient. The principal goal is to provide security to the patient with regard to the legitimacy and quality of the product they are receiving.
How did the idea of implementing it in Argentina arise?
We have been talking about traceability at different levels for many years from different perspectives. At the end of 2007 there was a scandalous public situation: the mafia of medications. Basically, the problem was the adulteration of high-cost, low-use products such as oncological, anti-retroviral and anti-hemophiliac products – these would later become incorporated in the first stage of traceability.
The critical point was the re-entry into the chain via intermediaries. Although there had been some private initiatives by laboratories and drug makers that applied traceability for each unit of the products they sold, that information was split up because each controlled its own system and it wasn’t standardized.
We wanted to do something at the public level throughout the chain and for every establishment, so we started to work on regulations. The first set was discussed for two years and in April 2011 the framework resolution was published to launch the system. Then, in May 2011, the first regulatory provision was published which defined the technical aspects and the first products to be affected.
Does the provision regulate only monitoring of medications or other medical products as well?
In 2011 it started with the traceability of medicinal specialties, i.e.: just medications. Gradually more goods have been incorporated via the identification of active products rather than commercial brands. So, any new medicinal specialty that is registered with those active products, and this is indicated in the pharmaceutical forms made compulsory by the regulations, must meet traceability regulations.
So far, four regulatory provisions have been published which gradually included new products. In addition to this, a framework resolution on the traceability of medical products was published in January 2014 where progress was made in a similar way but also took into account the differences that exist between the distribution chain and the medication supply chain. After that, in April 2014 provision 2303 was published which defines the first list of traceable medical products: coronary stents, breast prostheses, intra-ocular lenses, cardio-defibrillators, cardio-verters, cardiac pacemakers, hip and spine prostheses and electrical stimulators for hearing in the cochlea.
How is administration of medications to hospitalized patients identified?
Today the system functions at the level of the final packaging and also covers hospital products, or products in hospital packaging that have more units. We don’t provide traceability of the primary package (blister or capsule) or the dosage (pill). That kind of requirement would be too much for our current situation in public and private institutions.
In fact, no country in the world has a system like that. There are experiences in Argentina: the Hospital Garrahan and the Hospital Alemán, among others, are working on thetraceability of internal doses as part of the quality policies at those establishments, but they do not report to the National Traceability System (SNT). They do report when a box has been emptied, i.e. when a package from which doses have been taken is empty.
Is there a project for tracing doses and medications that are for sale to the public?
For the moment we are not planning to trace doses; that’s quite a lot harder. In addition, it would be rational for products in hospital packaging to be sold more cheaply. If we were to implement single identification per pill, the production costs would be much higher and this would affect the final price of the product. Today, the situation does not justify that. With regard to medications that are free for sale to the public it is probable that the pharmaceutical colleges want to include them: it all depends on how we develop, but we haven’t discarded the possibility of including them.
How was the technological infrastructure for the Traceability System created?
The software was developed by IT PAMI through an inter-institutional cooperation agreement with ANMAT; we made use of PAMI’s knowhow and their technological capacity, which was really very good.
The added value that Argentina has had on a global level has allowed us to advance very quickly in a short period of time. Laboratories and pharmacies, for example, can work for free via the web page. The other option, which is the ideal and most practical one, is to use the web service, connecting the company software with ANMAT and sharing information that way.
Has it been difficult to empower professionals in each sector to use the System?
The first resistance we experienced was the cultural barrier of pharmacists who weren’t used to using computers and new technologies; it is a very new issue in professional training. This is why, together with the ANMAT Observatory, we are working on a project to incorporate traceability content within the curricular programs and regular pharmaceutical courses so students can be taught about Traceability.
There isn’t much academic material around and the idea is to be able to provide the best available information to students and teachers, as well as to cooperate with classes on that theme.
Who is in charge of inspections?
Argentina is a federal country, so all the activities that take place in the Ciudad Autónoma de Buenos Aires and those in federal transit, the products that move between provinces, fall under national jurisdiction and are governed by ANMAT regulations. Then each province is autonomous in its regulations, although we also seek to have common healthcare policies. In particular, in regulatory terms, we need the provinces to adhere. All of them have signed up to the first provision; thirteen, fifty percent, have signed up to thesecond one; the third, which covers psychotropic substances, has been signed up to by fourteen provinces and only two have signed up to the fourth so far.
What is the relationship between the Traceability System and the new National Vademecum of Medications?
The catalogue of traceable products is fed by Vademecum. The medications are registered in the Vademecum, then they appear in the Traceability System. After that they can be reported on.
Are there projects to expand the System in any way?
The idea is to cover all medications, but also to implement it in stages. It is a very large cultural and regulatory change for the distribution chain so it takes time to adapt and evolve. The idea is to expand it gradually.
What is Argentina’s relative position in this field in global terms?
In November 2012 a Traceability Forum was held in which the FDA from the United States, the NHS from Great Britain, Turkey – the most advanced country in terms of Traceability from where we took our model – and Argentina all took part. You might not believe it, but Turkey and Argentina were teaching the United States and the United Kingdom about Traceability. We’ve also gone to countries such as Chile, Ecuador, Colombia, and Peru, among others, to provide training. The region is looking hard at what we’re doing.
Will the Traceability System replace the stamp system?
Today the stamp system continues to exist even though it was associated with the mafia of medications. There was also falsification of secondary packages and the alteration of the contents of products; various fraudulent practices occurred such as the falsification and the presentation of stamps to justify prescriptions that never existed.
There were a lot of occurrences of this kind. Care providers started to pay more attention and realized that they were receiving a lot of suspicious stamps and in many cases it was confirmed that they were fake. At the time the Administration of Special Programs, today known as the Single Reintegration System, reimbursed care providers for some of the cost of more expensive medications. This system continues to require the stamp to reimburse the sum the care provider paid for the product.
The idea is for the Traceability System to replace this mechanism with something much more specific: the single traceability code. The auditing of these systems would then be computerized rather than on paper. Care providers would be able to see inside the system with their user ID and check who dispensed each medication unit to each of the providers. Each box of medications has a code, which is like a National ID, a series number linked to the GTIN (Global Trade Item Number) of the product meaning that it is the only one that exists. It is much more specific than the stamp and the idea is for the mechanism to replace the stamp system in the future.
The Traceability System in numbers
• Including the latest provision, more than 400 active pharmaceutical ingredients are covered.
• More than 2500 commercial presentations have been traced.
• Over 600 million transactions have been reported – logistical movements – corresponding to over 15 million single medications reported at the points of supply.
• 13,377 agents – healthcare establishments – have been registered in the System and are ready to report.
• All the provinces in the country are signed up to the first provision of the System.
