Pharmaceutical fraud is a glaring problem in the United States. In the last 15 years, it is estimated that there is been close to $200 billion in pharmaceutical counterfeiting, theft, and drug tampering. According to the U.S. Chamber of Commerce, the black market pharmaceutical industry costs legitimate pharmaceutical businesses about $32 billion in damages and lost revenue every single year. Beyond the monetary burden that this puts on pharmaceutical companies, the tampering and contamination of medication is dangerous to patients taking them.
Because risk imposed by pharmaceutical fraud is so great, the Federal Drug Administration (FDA) has proposed regulations on the documentation of pharmaceuticals, called “epedigree solutions.” Epedigree solutions involve end-to-end documentation of pharmaceutical processing: from analytical and research services, to manufacture and packaging services, to distribution, and retail.
Because there are so many moving pieces in the development and distribution of drugs, and so many hands on them, having a documented process that enables track and trace serialisation on each blister card or bottle containing medication ensures the safety of patients taking them. This is the primary goal of the regulations for epedigree solutions.
Currently, regulations that dictate the extent of epedigree solutions vary from one state to the next. California and Florida have the strictest epedigree laws; as of legislation and 2006 and 2009 respectively, companies within the pharmaceutical industry are expected to have an epedigree solution in place to track the entire life cycle of their drugs. Although the other states do not have as comprehensive of regulations in place yet, the trend is going in that direction nation-wide, giving every pharmaceutical business the need for a rigorous epedigree solution in the near future. Companies who provide products or services within the pharmaceutical supply chain should look for epedigree solutions that encompasses the following five qualities:
- Ease of deployment.
Pharmaceutical companies can develop their own software for epedigree solutions and manage it in-house. However, this is costly and time-consuming, will be difficult to maintain as regulations adjust in the future. Instead, it is advisable to adopt in an epedigree solution that can be plugged in straight from the box. In addition to this leading to easier deployment, it is more likely to incorporate industry best practices, and play well with other entities within the pharmaceutical supply chain. - Provide visibility and accessibility from beginning to end.
Since any weakness in the supply chain recording process is an opportunity for tampering or contamination of the drugs, it is important to use an epedigree solution that is trackable and visible from beginning to end, and preferable one that integrates well into the systems of other entities in the supply chain. - Flexible to change.
Good epedigree solutions utilize an established system platform with strong security protocols already in place. By using an established system as the foundation of the tracking software, changes to it have less of an impact on the business, and it is able to grow as the pharmaceutical business grows, and as regulations become more rigorous. - Beginning-to-end automation.
The epedigree regulations can put a strain on a pharmaceutical businesses resources if they are completed manually. A good epedigree solution will manage each step in the supply chain automatically, and identify any digression from the process, to minimize errors. - “Future proofs” epedigree.
Epedigree regulations stand a definite chance of fluctuating in the future, and so epedigree solutions should be capable to fluctuate with them. In addition to being able to scale as needed, a good epedigree solution should oversee compliance changes and be able to adjust to meet them. Staying in-tuned to regulation changes and updating tracking software accordingly is another reason that using an established a system that takes care of compliance changes on the pharmaceutical company’s behalf is a good idea.
Whether or not to use in epedigree solution is no longer question, it is a necessity for all businesses in the pharmaceutical supply chain. Identifying an epedigree solution that is comprehensive and meets both current and new regulations is critical for every pharmaceutical business. A good epedigree solution improves operations, reduces errors, potentially increases revenue, and avoids the risk of fines from lack of compliance. Identifying for a tracking system that has the five qualities mentioned above will ensure that the epedigree solution is effective.