Many medical treatments today include the use of prescription drugs. More than 75% of all doctors’ visits result in a prescription being written. Almost 3 million prescriptions were written in 2010 and almost half of all Americans (48.5%) have used a prescription medication over the last 30 days. With all of these prescriptions being written, it is critical for drug companies to develop pharmaceutical and medical packaging products to ensure the medication is protected from the elements and can prevent counterfeiting. Newer serialization pharmaceutical regulations and standards have been developed.
Serialization pharmaceutical regulations are essential to preventing counterfeiting but while the standards have been set, regulatory agencies have left the process of how to meet those standards up to the pharmaceutical packaging companies.
Tips for finding the best serialization pharmaceutical solutions:
- Know the regulations. This is never going to be a job that you really finish. As new challenges emerge, new standard and regulations for serialization and pharma track and trace will be written. You will need to have someone either in house or an analytical and research services consultant to maintain a watchful eye on what new regulations are developed.
- Investigate what technology your company will need. Compliance with all of the serialization pharmaceutical regulations will most likely require you to upgrade your hardware and software. You will also need to train your employees on the newer systems that they will use.
- What can you do in house and what will you need to outsource? You may find as you look into your current medical packaging techniques that you will need to outsource some the work needed to comply with all serialization pharmaceutical regulations. Given the all of the recalls that are prevented by better packaging, these expenses will be offset by savings in other areas. More than 40% of recalls are due to problems with labeling.
- Set a timeline for implementation of the new policies. After you have reviewed your techniques and situation, draft a plan with a firm timeline for when the new procedures can be implemented and then do what you have to do to stick with that. Any change to systems that are this complicated, you have to collect and synthesize a lot of data, it is a challenge. If you are installing software that is very different from what you are using now, you should build in some training time.
- Consider your partners and how you will work with them on this. Determine what data you will need to share with your trading partners. Work with them to identify the best ways you can do that while complying with all of the regulations for serialization pharmaceutical products.
Pharmaceutical and medical packaging products serve a number of purposes. They protect the product from tampering and prevent fraudulent medications from reaching stores and consumers. If a recall is every ordered, it is much easier to conduct that recall if a track and trace packaging system has been used and that saves pharmaceutical companies a lot.
While the regulations that govern the packaging for prescription and over the counter medications will change and evolve over time, having them in place provides a way to protect patients from drugs that are counterfeits or have been tampered with.