VIPPS^TM Certification Process Combines Regulation, Criteria, Inspection

A rigorous criteria designed to certify each VIPPS^TM applicant’s legitimacy to safely dispense pharmaceuticals to the public at large over the Internet by the NABP is a crucial component of the NABP’s Verified Internet Pharmacy Practice Sites^TM (VIPPS^TM) program.

When an on-line pharmacy applies for VIPPS certification, there’s more than just paperwork to be completed. The process includes the satisfaction of the 17-point VIPPS criteria, verification of appropriate licensure, and an on-site visit from VIPPS inspectors to examine the applicant’s actual implementation of written policies and procedures. Only after successfully completing this process will the applicant be presented VIPPS certification, and be permitted to display the VIPPS seal on their site.

"We worked very hard to make sure the development process of the VIPPS criteria was open and inclusive," says Dyke Anderson, NABP President. "From the start, we knew that devising relevant criteria would be important to the program’s ultimate success, so we invited representatives of many groups, including the federal Food and Drug Administration (FDA),the American Medical Association, and other agencies to participate. I think the process we’ve come up with is exceptional."

The application process begins with the completion of the VIPPS Application, which can be downloaded from the NABP Web site under the VIPPS link. This application covers such vital information as business name, the name under which the applicant may be doing business, ownership, the applicant’s addresses and telephone numbers, Web site addresses, the name of the pharmacist-in-charge, the states and jurisdictions in which the pharmacist-in-charge and pharmacy are licensed, the states of such licensure, services provided, and verification of the VIPPS criteria.

In verifying their adherence to VIPPS criteria, the applicant must successfully answer questions in 17 general areas, including:

• Appropriate staff licensure;
• Written policies and procedures assuring the integrity and authenticity of the prescription drug order to prevent the prescription drug order from being submitted, honored, and filled by multiple pharmacies;
• Written policies and procedures covering generic substitution statutes and regulations;
• Resolving conflicts between individual state laws and/or between state law and federal regulations where the more stringent law or regulation is adhered to;
• Reasonable verification of the identity of patient prescriber and, if appropriate, caregiver;
• The process or procedure to obtain and maintain patient medication profiles and other related data in a format that facilitates consultation with prescriber, patient, or caregiver;
• Steps in conducting prospective drug use review prior to dispensing of a medication or medical device;
• Policies and procedures to assure patient confidentiality and to protect patient identity and patient-specific identity from inappropriate or non-essential access, use, or distribution;
• Requirements for pharmacists to offer interactive and meaningful consultation to the patient or caregiver;
• Mechanisms for patients to report errors and suspected drug reactions, and detailing the pharmacy’s steps of action;
• Policies and procedures to contact the patient and prescriber if an undue delay is encountered in delivering a prescribed drug/device;
• Procedures to inform and educate the patient or caregiver about drug recalls and appropriate means to dispose of expired, damaged, and unusable medications;
• Securing and tracing shipments of controlled substances;
• Procedures to assure medications are maintained within the temperature, light, and humidity standards for each medication during storage and shipment as established by the United States Pharmacopeia, Inc.;
• The applicant’s Quality Assurance/Improvement program;
• A written policy to effect compliance with applicable federal and state laws regarding the sale of over-the-counter products identified as precursors to the manufacture or compounding of illegal drugs; and
• The provision of a draft copy of a written procedure to ensure NABP is notified within 30 days of a change of pharmacist-in-charge or other data regarding the site.

Once the VIPPS Application, supporting documentation, and application fees have been sent to NABP, staff will begin the verification and evaluation process. If necessary, staff will contact the applicant for additional information or clarification.

An important part of this verification process is the site visit conducted by a VIPPS inspection team. Usually consisting of two trained inspectors, a team will visit the applicant’s headquarters and/or fulfillment centers to review and verify the applicant’s policies and procedures as set forth by the VIPPS criteria.

Based upon the site visit and other documentation received from the applicant, the inspectors will produce a report and recommendations supporting or denying certification. If certification is not recommended, the inspectors’ suggestions for bringing the applicant’s policies and procedures in line with the VIPPS criteria will be offered, and the applicant will be granted additional time to provide evidence of implementing those recommendations.

"We want to make sure the applicants know that the VIPPS inspection is separate and complimentary to a state board of pharmacy inspection," notes Anderson. "During the site inspection, we will rely on the state board inspection process and verify the policies and procedures as set forth in the VIPPS criteria are in place, are being appropriately maintained, and are being effectively utilized by the applicant’s staff. After all, that’s the whole point of the VIPPS program."

Once an on-line pharmacy becomes VIPPS-certified, an annual review and re-certification process will be conducted. Random site visits are planned for one-third of the certified Web site headquarters each year, with all being visited once every three years. Each Web site will also be checked periodically to ensure they continue to meet the criteria.

"A number of programs address some of the same criteria as the VIPPS program," concludes Anderson, "but none are as extensive or consumer-focused as VIPPS. We’re addressing pharmacy practice criteria as defined by regulators, consumers, and by the on-line pharmacies themselves. Because we certify the on-line pharmacies meet this defined criteria through on-site inspection, VIPPS is a unique program among all of them."

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