Frequently Asked Questions
on Guidelines on EPC for Pharmaceutical Products
for U.S. Consumers
Introduction
EPCglobal, Inc. ™ is a neutral, international not-for-profit organization developing the standards for the Electronic Product Code ™ (EPC).
Radio Frequency Identification (RFID) is a technology employing radio waves to identify objects. It is now being used in everything from automobiles and toll booths, to gasoline pumps and building access cards. It can be utilized in a variety of circumstances from improving food safety by tracking foods from farm to table, to detecting the introduction of counterfeit medicines into the pharmaceutical supply chain that includes manufacturers, distributors and pharmacies that deliver pharmaceutical products to the consumer.
EPC is a numbering system for identifying a specific object in the supply chain. An EPC tag is an RFID tag that employs the EPC numbering system. The EPC tag attached to an object contains a unique identifier for the specific item and may contain product information similar to that found today on a bar code. An EPC tag does not contain any personally identifiable information. If EPC is utilized in the packaging and labeling of pharmaceutical products, its use will be governed by the U.S. Food and Drug Administration.
Background
The EPCglobal Guidelines on EPC for Consumer Products were adopted by EPCglobal as a basic framework for responsible use and deployment of EPC and are available at: http://www.epcglobalinc.org/public/ppsc_guide/. The Frequently Asked Questions (FAQs) below provide guidance on the use of EPC tags on pharmaceutical products. The questions and answers are intended to complement the Guidelines and improve understanding of their meaning and application.
These FAQs represent the general views of EPCglobal, Inc. on certain specific issues. The Guidelines and the FAQs will evolve as appropriate to keep pace with advances in the technology and new developments in the application of the EPC.
Benefits
The use of EPC can help in detecting counterfeit prescription medicines and in preventing the diversion of pharmaceutical products by enabling the tracking and tracing of items through the multiple participants in the pharmaceutical supply chain. EPC also has the potential to enhance patient safety by improving the pharmacist’s ability to identify expired or recalled products so that they can be taken off shelves more efficiently. In the future, if products are recalled, the use of EPC may facilitate the identification of the particular recalled product. Another benefit of the use of EPC is to improve the operation of the pharmaceutical supply chain so that the medicines that consumers need are available in the quantities they need when consumers need them.
Frequently Asked Questions
General
Do EPC tags contain personally identifiable information about the consumer who purchased the item which is tagged?
EPC tags do not collect or contain any personally indefinable information. The only information that is contained on the EPC tag relates to the product, not the purchaser.
What assurances exist that EPC tags on pharmaceutical products will not intrude upon patient privacy?
First, EPC tags do not collect or contain any personally identifiable information. In addition, the EPCglobal Guidelines apply to EPC tagged products, including EPC-tagged pharmaceutical items going to consumers. Finally, the privacy protections currently afforded consumers by the provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) apply, and are unaffected by the use of RFID and EPCs. More information about how HIPAA protects the privacy and security of health information is available at http://www.hhs.gov/ocr/hipaa/consumer_summary.pdf
To what extent are EPC tags now used on pharmaceutical products?
Presently, EPC tags are being used in the pharmaceutical supply chain to help ensure the safe and secure delivery of pharmaceutical products from the point of manufacture to the pharmacy. Currently only a very small number of products dispensed to consumers have EPC tags attached
Do the EPCglobal Guidelines for Consumer Products apply to pharmaceutical products?
The EPCglobal Guidelines apply to EPC-tagged products going to consumers, including EPC tagged pharmaceutical items going to consumers.
Consumer Notice
How can consumers tell if their pharmaceutical product or its packaging contains an EPC tag?
The EPCglobal Guidelines require using the EPCglobal logo or identifier on products or packaging to provide notice of the presence of an EPC tag on consumer products including pharmaceutical products. Because the FDA regulates pharmaceutical packaging and labeling, the form of notice on the packaging or labeling of pharmaceutical products must follow FDA requirements and may differ from the consumer notices contained on other consumer products.
Who is primarily responsible for consumer notice?
It is the responsibility of EPCglobal members to provide clear notice to consumers as set forth in the EPCglobal Guidelines so that consumers know that the products they are purchasing contain an EPC tag. Responsibility for achieving this objective is shared by EPCglobal members including manufacturers, distributors, and pharmacies who work together to supply pharmaceutical products to the consumer.
Consumer choice
What options regarding EPC tags must be given to consumers to comply with the Guidelines?
The EPCglobal Guidelines require that consumers be informed of the choices that are available to discard or remove, or in the future, disable EPC tags from the products they acquire in order to provide consumer control over the tag. In some cases, however, the tag may be embedded within the pharmaceutical product container, placed underneath the product label, or be attached to product packaging that contains information important to the consumer’s welfare. In these circumstances, it will be difficult to remove the tag or discard the packaging without destroying information regarding drug use, dosage, and safety information of value to the consumer. In such cases, EPCglobal members will cooperate to find ways to ensure that consumers understand prior to purchase that the pharmaceutical product’s packaging or labeling contains an embedded EPC tag and what options consumers have available to them.
EPCglobal, among other supporters of the technology, is committed to finding additional efficient, cost effective and reliable alternatives to further enable customer control over the tag after the point of purchase.
Consumer Education
Where can consumers find more information about EPC tags?
EPCglobal is committed to ongoing consumer education about EPC, including its benefits and limitations. The goal of this effort is to increase awareness and understanding of EPC so that every consumer will come to recognize the EPC logo as an indication that an EPC tag is present on a product. The EPCglobal website, www.epcglobalinc.org contains specific information about EPC systems and tags. EPCglobal anticipates that there will be other valuable sources of information and will post links to them as they are developed.
Record Use, Retention and Security
Do EPC tags contain information about consumers?
EPC tags do not collect or contain any personally identifiable information. The only information that is contained in the EPC tag relates to the specific product, not the purchaser.
Do pharmacies link prescription information with personally identifiable information?
Federal and state laws for medical and public health reasons require pharmacies to keep records of what prescription drugs they dispense including the name of the patient for whom the drug is prescribed. This linking of prescription information with personally identifiable information takes place now without using EPC tags. The addition of EPC tags to pharmaceutical packaging or labeling will not change this record keeping requirement.
What are the Guidelines regarding the retention of information about patients related to EPC use?
The EPC tags do not contain, nor collect and store, any personally identifiable information. As with the use of information contained on barcodes today, any data which is associated with the product information contained on the EPC tag will be collected, used, maintained, stored and protected by the EPCglobal member companies in compliance with applicable laws including the Health Insurance Portability and Accountability Act of 1996 (HIPAA). HIPAA provides detailed rules protecting the privacy of personally identifiable information. EPCglobal companies will publish, in compliance with all applicable laws, information on their policies regarding the retention, use and protection of any personally identifiable information associated with EPC use.
What are the rules regarding the security of information about patients related to EPC use?
Federal and state laws protect the confidentiality and security of prescription records. Pharmacies must comply with privacy and security rules issued by the federal government under HIPAA. State laws may provide additional privacy and security requirements.
For more information contact:
EPCglobal Public Policy Steering Committee
+1 202 625 4384
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