VIPPS Inspectors Recount Experiences, Highlight Criteria

One year after the first Verified Internet Pharmacy Practice Sites™ (VIPPS™) certifications were awarded, new applications from online pharmacies continue to flow into NABP. VIPPS inspectors are actively working to evaluate applicants against the rigorous criteria of the VIPPS program as part of the certification process.

With more than 50 evaluations completed, VIPPS inspectors noted several common trends in their observations. In many cases, applicants made adjustments to their policies and operations in order to meet the program's criteria and become VIPPS certified.

Steve Hudson, a VIPPS inspector and director of inspections for the North Carolina Board of Pharmacy, says, "VIPPS criteria are patient oriented and represent safe practice standards for the public."

Though the origin of many of the criteria is based in state pharmacy practice acts, the criteria were written to provide a tier of good practice standards in concert with licensure requirements and focused on the unique challenges and demands of long distance patient/prescriber/pharmacist relationships characteristic of the Internet/interstate practice of pharmacy.

The VIPPS 17-point criteria are divided into seven categories (see VIPPS criteria below):

• licensure,
• prescription,
• patient,
• communication,
• storage and shipment,
• over-the-counter, and
• QA/QI program.

In the area of prescription processing, addressed in the second category of the VIPPS criteria, VIPPS requires a practical working method for detecting conflicts between state laws when the patient, prescriber, and the pharmacy are in different states. Generic substitution, prescriber authority, number of refills, and controlled substance prescription requirements are areas of pharmacy practice that most frequently involve a conflict of law between two jurisdictions. In such cases, the VIPPS criteria call for the more stringent law to be followed. Some critics claim that this criterion cannot always be met in interstate commerce and will only become more complex as foreign boards adopt VIPPS programs and apply the criteria to international commerce.

Another prescription matter is the need for a mechanism to prevent hard copy prescriptions from being filled by multiple online pharmacies. VIPPS inspectors found that, although most pharmacies starting to practice online address the issue of obtaining a valid prescription for their purposes, they sometimes neglect the hard copy in the patient's possession. Additionally, because online pharmacies usually employ many pharmacists and on-the-job trained customer service staff and rarely meet either prescriber or patient face-to-face, a uniform written procedure needs to be in place for detecting, investigating, and resolving cases of questionable prescription orders and personal identity.

The third category of the VIPPS criteria focuses on the patient. VIPPS inspectors verify that sufficient information is collected from patients for drug utilization review (DUR) and consultation. Information about over-the-counter (OTC) medications, prescriptions dispensed by other pharmacies, or relevant medical conditions is also included for review.

Computer-assisted DUR is another area addressed by this category. VIPPS inspectors examine Internet pharmacies' use of computer-assisted DUR and evaluate systems through functionality testing of computer systems particularly after software updates. The VIPPS review helps to alert pharmacists not to rely solely upon the computer to warn them of improper drug usage because computer software can fail, be improperly programmed, or warning flags can be turned off. Also of concern are computer systems that have not incorporated into the DUR system reported medical conditions, prescription medications dispensed by other pharmacies, or OTC medication use, and pharmacists who are unaware that the responsibility to detect such issues has been left to him or her.

Communication, addressed in category four of VIPPS criteria, is a critical area of the VIPPS program. VIPPS inspectors have found that online pharmacies are able to provide a great deal of information to patients. Direct communication between patients and pharmacists, however, tends to be challenging. Phone contact is an option, as is e-mail, a method preferred by online pharmacies. The VIPPS review works to ensure that online pharmacies are explicit when it comes to instructing online users how to reach a pharmacist, and hours of pharmacist availability, along with expected response time to an e-mail report of a suspected medication reaction.

Another key area of observation is in the shipping stage, when medications and their packaging are challenged by a wide range of ambient conditions. Temperature control is much more of a concern today because of the new biological products which are costly, labile, and in great demand from Internet and mail- order pharmacies.
"VIPPS requirements for storage, handling, and shipping of drugs are closely examined because of the impact on patient care," notes Richard Morrison, VIPPS inspector and chief investigator for the Washington State Board of Pharmacy.
NABP believes quality control (QC), quality assessment (QA), and quality improvement (QI) are important ingredients in safe patient care and these three points are incorporated into the fifth category of VIPPS criteria.

"Because of pharmacy's scope of practice, quality assessment and improvement plans are a necessity. The VIPPS QA/QI requirement is beneficial not only for VIPPS pharmacies, but for non-VIPPS pharmacies, too," states Tim Benedict, VIPPS inspector and assistant executive director of the Ohio State Board of Pharmacy.

"QA/QI plans are the cornerstone of NABP's regulating for outcomes initiative, a regulatory approach that shifts the focus of pharmacy regulation from rules related to structure and process to a system that considers the quality of care and therapeutic outcomes," adds Jerry Moore, NABP president.

VIPPS inspectors agree that online pharmacies should not be dismissed as doing a lesser job than traditional brick and mortar pharmacies.

"A pharmacy that is able to comply with VIPPS standards is more likely to be at the pinnacle of meeting regulatory requirements than any other pharmacy out there," explains Morrison. "VIPPS requirements support licensing standards. State boards of pharmacy license pharmacies and establish standards of practice, which are for the most part consistent across the United States, and provide minimum safe practice standards. VIPPS standards improve the system and ultimately patient care."

Inspectors have found that VIPPS-certified online pharmacies not only meet licensure and practice standards in their online businesses but incorporate VIPPS principles in all areas of their pharmacy practice.

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