Rx Medications: The Importance of Container Integrity

Article excerpt

LEGAL COMPLIANCE

Quality products promote patient safety

Pharmacies use drug containers to fill millions of prescriptions annually. Pharmacists trust that the container used to house the medication is manufactured to standards and specifications that will maintain the integrity of the drug product during the time the patient uses the medication.

Drug containers must be able to endure environmental stressors such as permeation by light and moisture. They must also prevent leaching of the material from which the container is made. If container integrity is breached, there is risk that the drug might lose its potency or that it might adsorb from the container material that is harmful to the patient.

Minimum standards

To provide guidance to container manufacturers, standard- setting organizations have established minimum thresholds for the integrity of drug containers. Beyond those minimum recommended standards, there are at present very few (if any) state laws regulating pharmacy practice that require a pharmacy to use a drug container that meets minimum quality-control standards.

As a result, there are no legal metrics in place to guard against possible patient harm resulting from an adulterated drug product caused by a "bad" container. In the end, the marketplace is left to its own discretion in determining what is safe and acceptable for a patient's use. This lack of universally agreed-upon standards results in disparity in the quality of containers.

USP Chapter 671

One well-known standard-setting organization, the United States Pharmacopeia ("USP"), sets forth standards pertaining to the quality of healthcare products manufactured or sold in the United States.

Specifically, Chapter 671 of the USP provides standards pertaining to the properties of prescription drug containers and their components. Chapter 671 defines the term "container" to mean the "entire system comprising, usually, the container itself, the liner (if used), the closure in the case of multiple-unit containers, and the lidding and blister in the case of unit- dose containers. …