The Risks of E-Labeling
The PPLA supports the availability of electronic information, but not exclusively. Exclusive use of electronic information is high risk because: §It is contrary to law in place since 1938.
- Electronic information is not always available to patients & health care providers.
- Sometimes, electronic information is not accessible due to various disruptions.
- Internet search engines do NOT reference the official Package Insert web addresses in search results. Searches send healthcare providers, patients and caregivers to marketing information first.
The Case Against Electronic ONLY Communication
The PPLA supports the availability of electronic information – but not information available electronically EXCLUSIVELY. Our position is based on the following points:
- The FDA’s enabling statute mandates that FDA-approved printed labeling accompany prescription drugs from the manufacturer throughout the distribution chain. Labeling Content must include full prescribing information.
- The FDA’s own cost-benefit analysis showed that just the modifications to the Package Insert (PI) incorporated in its January, 2006 Package Insert regulation delivered net benefits of almost half a billion dollars, derived not only from avoiding Adverse Drug Events (ADEs) but also from saving practitioners time.
- Electronic information is not available to everyone – many U.S. citizens do not have Internet access at all. Natural disasters may preclude electronic access. And drugs, including veterinary medicines, may be administered in settings too remote for electronic access.
- Sometimes, electronic information is not available to anyone due to power outages during natural disasters – Hurricanes Katrina and Sandy provide dramatic, well-known examples.
- Internet search engines do NOT put the official Package Insert web addresses early in the search results – even IF they are included, and careful study of up to 10 pages of search results for a common drug such as Metformin fails to find the official version on the FDA’s website. Searches send healthcare providers, patients and caregivers to marketing information first.
- If the printed Package Insert is eliminated, no information regarding dosage, use, side effects, contraindications, and risk for administering medications would accompany the drug product through the distribution system, no matter how potentially dangerous the medicine.
- The existing, low-cost system of FDA-approved, manufacturer supplied Package Inserts with every drug shipment in the U.S. is working well, and offers a high degree of flexibility.
- While the Package Insert is written, and its copy approved by the FDA, with healthcare providers in mind, many patients and caregivers do ask for copies from their physician and/or pharmacist; the patients seeking out the best and the most information are those most engaged in their own healthcare. And patients have stated unequivocally that they want information in writing both now and in the future. The patients leading the way to the patient involvement model of healthcare deserve the support of not only written information for the professional (the Package Insert) but also for them, Consumer Medication Information, or CMI.
- The written information that patients in the U.S. receive is well documented to be of poor quality. And while the Package Insert is not directed at the patient, making the PI available only electronically limits caregiver access to that information. Package Inserts play a vital role in the chain of communication to patients that is so critical to the patient involvement model of healthcare.