Guidance for VAWD Accreditation

Transcription

1 Helping the pharmaceutical industry navigate with confidence. Sumeet Singh, President & Lead Consultant Samuel M. Smith, Esq., In-House Counsel & Regulatory Consultant

2 Overview Overview... 2 Industry Impact... 3 Logistics... 4 Phase 1: Application... 5 Phase 2: Intake Call... 5 Phase 3: Application Review Report... 6 Phase 4: SOP Review... 6 Phase 5: On-Site Inspection... 7 Phase 6: Post-Survey Letter... 7 About Our Company... 8 pg 2

3 Industry Impact State Specific Requirements Currently, 3 states require and 24 states recognize VAWD accreditation. Many of these states recognize VAWD as a means of implementing the licensing provisions of new laws, while mitigating the fiscal and operational impact on their board. Importance of VAWD VAWD accreditation plays a pivotal role in preventing counterfeit drugs from entering the United States (US) drug supply. Through strict due diligence via the Accreditation process, VAWD helps protect the public from drugs that have been adulterated, contaminated, diverted, or counterfeited. VAWD is a registered trademark of the National Association of Boards of Pharmacy. OptumRx On August 9, 2016 OptumRx announced that it would require Network Pharmacies to exclusively purchase from VAWD Accredited sources ; if Network Pharmacies do not comply, they would be at risk of forfeiting 100% of their reimbursement claim on the specific products procured from non-vawd Accredited sources. pg 3

4 Logistics Cost The NABP requires $5,500 upfront when submitting the application. This breaks down to: a $1,500 non-refundable application fee which covers the NABP reviewing your electronically submitted materials ; a $3,000 inspection fee which covers an inspector coming out to your facility and conducting an on-site audit and interviews ; and, finally, $1,000 for the first year's Accreditation fee. Year 2 and Year 3 will also require a $1,000 fee which averages to $2,500 per year for the first 3 years of Accreditation. Moving forward, Reaccreditation does not require the $1,500 fee, only the $3,000 inspection fee and the $1,000 annual fee. Therefore, after Year 3, the average cost to maintain VAWD Accreditation is $2,000 annually. Timeline NABP suggests the process can be completed between 6 and 9 months. However, we have consistently seen it take between 12 and 15 months - likely due to the recent OptumRx requirement. A key component to expediting Accreditation is to ensure your facility is not deficient in terms of operational procedures, per VAWD Standards. Reaccreditation Reaccreditation occurs every 3 years. The Reaccreditation process includes all phases of the initial application. pg 4

5 Phase 1 & 2 Phase 1: Create & Submit Application We consider the SOP's and VAWD Assessment to be 75% of the time and effort required to earn the Accreditation. The most important aspect of VAWD Accreditation is the Standard Operating Procedures (SOPs) because it is how the NABP ensures the Applicant will maintain compliance with its Standards. SOPs need to be developed/supplemented address the 250+ Standards. The VAWD Assessment is a 26- page document that requires the applicant to "map" each of the Standards to their SOPs. Other than the SOP & Assessment, the Application requires 5 attachments (Business Model Description, Ownership, List of Licenses, List of Customers and List of Sources. Phase 2: Intake Call The Intake Call is a friendly 15 to 30 minute phone call that serves as an introduction of your Company to the NABP and vice-versa. During the call, the a member of the NABP will ask you questions to better understand your company - expect questions regarding business model, revenue streams and future aspirations. pg 5

6 Phase 3 & 4 Phase 3: Application Review Report The Application Review Report is a an evaluation of your application materials. Common questions that are brought forth include shipping into states where the Applicant is not licensed, additional information about the company operations/leadership, and more detailed information about sourcing practices. There will also be a preliminary review of the SOPs to ensure that they are ready for a complete review. Phase 4: SOP Review This phase is often considered the "meat" of the Accreditation process. There are times when a review comes back with less than 5 deficiencies and there are times that is comes back with 75+ deficiencies. Accurately supplementing SOPs and addressing concerns directly is crucial to keeping the process moving forward. pg 6

7 Phase 5 & 6 Phase 5: On-site Inspection The On-Site Inspection is suggested to last 6 to 8 hours. There are two parts: team interview and facility tour. The team interview will involve the VAWD Inspector covering 15+ page questionnaire that addresses most VAWD standards. Additionally, the Applicant will be requested to provide documentation concerning customers, vendors, and employees. The facility tour will have the Inspector evaluate the physical operations taking place. Phase 6: Post Survey Letter In the final phase, the NABP points out concerns uncovered from the On-Site Inspection. Examples may include easy fixes such as temperatures alarms not being set properly or missing Visitor Sign-In sheets ; or, they may require more complicated process changes such as utilizing validated shipping coolers for refrigerated product. Accreditation pg 7

8 About Our Company About Five Rivers RX Since inception, Five Rivers RX has assisted over 100 companies across 8 different business models with VAWD Accreditation. Our company helps our Clients respond to industry changes and reach their compliance and commercialization objectives. We offer a wide range of strategy and consulting services for the pharmaceutical supply chain industry. Our clients range from international drug manufacturers with $10+ billion in annual revenue to family-owned pharmacies. Authors Sumeet Singh is the Founder & President of Five Rivers RX. Drawing on the relationships and knowledge he cultivated at the helm of a distribution company and a pharmaceutical distribution start-up, Sumeet is able to bring a unique "boots on the ground" understanding of the industry. Samuel M. Smith, Esq. serves as a In-House Counsel and Consultant for Five Rivers RX. He is a licensed attorney in the Commonwealth of Pennsylvania. Mr. Smith earned his J.D. from the University of Kentucky. P & F: (800) E: hello@fiveriversrx.com A: King of Prussia, PA pg 8