Tracking the Supply Chain - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Tracking the Supply Chain
As the battle against counterfeits gains momentum, PharmTech speaks to Mark Davison, CEO of Blue Sphere Health, and Craig Stobie, global life sciences sector manager at Domino Printing Sciences, about the challenges involved with coding and tracking drugs through the global supply chain. Potential solutions are discussed, including fingerprinting technologies and end-user verification.


Pharmaceutical Technology
Volume 36, Issue 12

PharmTech: In your opinion, how successful has the industry been in fighting drug counterfeiting over the past few years? How would you describe the prevalence of the problem today?

Davison: The situation is totally different depending on where in the world you look. In the EU and US, one would be unlucky to come across a counterfeit medicine. However, as the recent Avastin case (1) showed, even these relatively well-controlled supply chains are vulnerable. In many developing countries, counterfeit drugs constitute a lethal epidemic that is killing thousands of people every year. Most fake drugs are ineffective rather than toxic, and patients still die needlessly from a disease that modern medicine could cure or control because they are taking counterfeits unknowingly. There are no easy answers but there are more things that we could do to help. We need to help these countries to build regulatory capacity, invest in monitoring equipment, educate and involve the end user in the verification process.

Stobie: The problem seems to becoming more prevalent because anticipating where counterfeiting will hit, both geographically and in terms of brand and medicine area, adds to the difficulty. Some have the view that big pharmaceutical companies are more concerned with developing new products and dealing with regulatory issues, and thus, their supply chains are being overlooked. The struggle to encourage a balanced investment in both drug development and supply-chain management can also escalate the problem of counterfeiting.

PharmTech: The globalisation of pharmaceutical supply and manufacturing has contributed to the rise in counterfeit medicines. What are some best practices that the industry can apply to secure their supply chains, especially for products coming from emerging markets such as China and India?

Davison: The key is to examine processes first and then look at security technologies. At Blue Sphere, we use a simple mnemonic called DRASTIC: Define goals, do a Reality check, collate and Analyse data, draw up a Strategy, develop Tactics, plan Implementation, ensure Communication. Many companies make the mistake of jumping to tactics and then getting hung up on technology choice and pack features. Technology bolted on to insecure processes does not add anything except cost. Look at all of your supply chain processes from a counterfeiter’s viewpoint. The right question is not ‘could a criminal copy what we do?’ but ‘could they disrupt, negate, or subvert our processes so that counterfeiting is made possible?’ As a minimum, you should audit all your suppliers for their security processes, as well as the usual product quality parameters. When you are ready to add security features, there are often many free or low cost approaches that you can take. Seek advice and always have a backup plan. Even the best security approaches will eventually be compromised so planned upgrades are a good idea.

Stobie: There are several practices the industry can apply to secure its supply chains. The key ones are:


    ADVERTISEMENT

    blog comments powered by Disqus
    LCGC E-mail Newsletters

    Subscribe: Click to learn more about the newsletter
    | Weekly
    | Monthly
    |Monthly
    | Weekly

    Survey
    What role should the US government play in the current Ebola outbreak?
    Finance development of drugs to treat/prevent disease.
    Oversee medical treatment of patients in the US.
    Provide treatment for patients globally.
    All of the above.
    No government involvement in patient treatment or drug development.
    Finance development of drugs to treat/prevent disease.
    26%
    Oversee medical treatment of patients in the US.
    12%
    Provide treatment for patients globally.
    10%
    All of the above.
    43%
    No government involvement in patient treatment or drug development.
    10%
    Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
    Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
    Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
    Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
    Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
    FDA Reorganization to Promote Drug Quality
    FDA Readies Quality Metrics Measures
    New FDA Team to Spur Modern Drug Manufacturing
    From Generics to Supergenerics
    CMOs and the Track-and-Trace Race: Are You Engaged Yet?
    Source: Pharmaceutical Technology,
    Click here