Very few state laws require a pharmacy to use a drug container that meets minimum quality-control standards. Legal metrics are needed to guard against possible patient harm resulting from an adulterated drug product caused by a "bad" container.
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.
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."
Chapter 671 sets forth the tests used to determine the moisture permeability and light transmission of multiple-unit, single-unit, unit-dose, and polyethylene and polypropylene containers used for prescription drugs. In short, Chapter 671 states that a drug container meets the requirements set forth therein where such protection or resistance results from the specific properties of the material composing the drug container.
More regulation needed
If pharmacy practice laws and regulations were in place requiring pharmacies to use containers that satisfy the tests for moisture permeability and light transmission as outlined in Chapter 671 of the USP Standards, patient protection would be enhanced and the pharmacist would enjoy greater peace of mind, knowing that the patient will not suffer harm because a poorly manufactured container compromised the dispensed drug product.
A meaningful way to promote patient safety would be to move the law to require that before a drug container can be used in a pharmacy, it must meet standards set forth by a standard-setting/accrediting body that is reputable, objective, and peer-reviewed.
In the event of patient injury that results in a product liability or malpractice tort claim, meeting such a legal requirement can be useful when it is necessary to demonstrate that the pharmacy met its duty of care.
This article is not intended as legal advice and should not be used as such. When legal questions arise, pharmacists should consult with attorneys familiar with the relevant drug and pharmacy laws.
Ned Milenkovich is a member at McDonald Hopkins, LLC, and chairs its drug and pharmacy practice group. He is also a member of the Illinois State Board of Pharmacy. Contact Ned at 312-642-1480 or at email@example.com