The next phase of the Drug Supply Chain Security Act (DSCSA) is approaching, and it is approaching quickly. This is an especially crucial year as manufacturers face the November deadline that requires packages to be marked with a product identifier, serial number, lot number, and expiration. From there, the remaining deadlines for other stakeholders in the life sciences supply chain are staggered throughout the remaining six years of the regulation’s 10-year plan. By 2023, the goal is to have achieved item-level traceability from end to end that will allow detection and/or tracking of suspicious or dangerous products in the pharma supply chain.
The pharmaceutical supply chain has been in a state of evolution ever since it began. At varying points along the timeline, mini revolutions occurred. Around the turn of the century, apothecaries and the makers of dyes and textiles merged sciences and efforts to take advantage of unique discoveries on both sides. Companies such as Bayer, Schering, Sandoz, Abbott, Pfizer, Smith Kline, Eli Lilly, Squibb, and Upjohn emerged as apothecaries and drug suppliers between the early 1830s and late 1890s. Their production had a profound effect on human health. In 1900, one third of all deaths were from pneumonia, diarrhea, and tuberculosis. Today, only pneumonia remains on the top ten killer list (mainly as a side effect of cardiovascular disease and cancer).
Foil packaging, plain and simple, is the most effective means of immediate shelf differentiation and lift in sales. A high-end looking foil package conveys several things to the consumer: New, Better, Advanced Formula, Superior Product, High Quality, Classy. It also suggests that the other products on the shelf are inferior in some way, of a lesser quality, value or class. “Bling” remains King… When given the choice between two products that otherwise seem the same, consumers overwhelmingly chose the better looking and more visible package.
Choosing the right packager for your products can be a daunting task and one that should not be taken lightly. There are numerous companies that claim to be expert packagers. However, when entrusting an outsource party to serve your supply chain, it is imperative to choose a partner that has a similar culture and shares a similar vision. Additionally, one that employs values and integrity instilling these traits within their associates is invaluable. The following eight elements are a guide to selecting a qualified outsource partner.
Let’s face it, not all pharmaceutical drug launches are blockbusters. Even after carefully modeling the market to forecast potential sales, the underlying data used may prove to have some challenges. Many sales forecasts are based on the idea that the market can be represented as a continuous variable, but this may not be the case for a generic product whose fate may be determined by a single decision on the part of a drug wholesale company.
As the industry continues its move toward biologics, innovative solutions and technologies will be needed to ensure a safe and reliable approach to the manufacturing and delivery of these drugs. One option is to leverage the advanced aseptic manufacturing of blow-fill-seal (B/F/S) technology, which has the potential to address the challenges of traditional glass filling as well as the global distribution of biologics.
Research shows that half of all patients in the United States and the European Union do not take their medicines as prescribed. Poor patient compliance, or medication adherence can lead to worsening of disease, serious and avoidable health risks, increased hospitalization, and even death. In fact, patient non-compliance is the fourth leading cause of death in the United States, and the annual cost of non-compliance in the U.S. is estimated to be $317 billion and $125 billion in the EU, according to research group MarketWatch.