Standard Regulations & Labellings

Generally speaking, pharmaceutical distribution patterns for solid oral dosage drug pharmaceuticals (pills, capsules, and tablets) are markedly different in the US than those used in the EU. This is true even for drugs that are manufactured by the same company. That is, pharmaceutical manufacturers commonly employ different packaging and distribution practices for exactly the same product depending on where the drugs will eventually be sold.

While these differing systems have been in place for decades, powerful forces are currently in play that could alter packaging and distribution networks on both sides of the Atlantic. Indeed, over the next five to 10 years it is entirely possible that one of three scenarios will overtake current systems:

• The US pharmaceutical packaging and distribution chain may come to look more like that in the EU;
• The EU system may come to look more like the US; or
• A hybrid of the two will become a global model.

In the EU, solid oral dosage products are typically packaged by the manufacturer in a unit dose blister card, whereby each individual dosage unit is housed in a separate cavity. These packages are distributed to pharmacies and dispensed to the patient without the need for any type of repackaging other than the application of pharmacy labeling. When the patient picks up his/her prescription, therefore, they are given a product that has been in the same container since the time of manufacture. In addition, the packaging typically includes a leaflet that was also prepared by the manufacturer outlining important drug-related information.

In the US, on the other hand, most solid oral dosage drugs are shipped by the manufacturer in a bulk container, most commonly a 100-count bottle. Bulk bottles often find their way to pharmacies through a network of wholesalers such that the manufacturer's original container may have changed hands several times before it reaches the pharmacy. In the pharmacy, drug products originally placed in bulk bottles by the manufacturer must be repackaged into smaller containers by pharmacy personnel which, in turn, are dispensed to patients. If any printed information is given to US patients at all, it is usually printed in the pharmacy based on data provided by unregulated, third-party vendors.

While the US government does require that all pharmaceutical products be shipped with information intended for physicians and pharmacists, these product inserts are typically written in language that is not useful to patients. There are some classes of drugs - oral contraceptives for instance, that must be shipped with patient-oriented leaflets under US regulations. There are also a handful of drug products that the US Food and Drug Administration (FDA) deems so potentially dangerous if they are not taken properly that it requires manufacturers to provide patient-oriented literature. Otherwise, the vast majority of pharmaceutical products dispensed in the US are given to patients with no manufacturer-prepared information whatsoever.

When comparing the two systems, the EU system offers some obvious consumer advantages. EU patients, for example, receive their prescriptions in tamper-resistant packaging that:

• Protects the drugs from atmospheric exposure;
• Eliminates any possibility of dispensing error due to pharmacy repackaging;
• Allows the drugs to be stored in humid areas without fear that they will lose their efficacy; and
• Provides assurance that medications have not been handled by anyone other than the manufacturer and the patient.