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LINKS

week of: August 25, 2017

• Directors of FDA’s three medical product centers applaud the U.S. Congress for passing the FDA Reauthorization Act of 2017 (FDARA).
   
• The International Quality and Productivity Center released the final report of a survey they conducted to determine whether pharmaceutical manufacturers would be ready to meet DSCSA deadlines. Approximately one quarter of participants responded that they are going to miss deadlines in both the U.S and the E.U.
   
• The Alliance for Safe Online Pharmacies conducted a survey to determine consumer behavior and perceptions of online pharmacies. 95% of participants said they were not aware of the tools available to verify the safety of online pharmacies. This is a concern as there are roughly 33,000 illegal online pharmacies at any given time.
   
• LogistiVIEW presents technology at NACDS Total Store Expo that “will enable a pharmaceutical supply chain workforce to be both efficient and compliant with Drug Quality Security Act (DQSA) regulations from production facility to the pharmacy”. 
   
• FDA releases new draft guidance entitled "Identifying Trading Partners Under the Drug Supply Chain Security Act”
   
• Bob Celeste, director of the Center for Supply Chain Studies, and other professionals speak at the NACDS Total Store Expo.
   
• Manufacturers are working to improve pharmaceutical labeling in order to meet the demands of the Drug Supply Chain Security Act.

2017-08-18 Links:

• At least 17 states have enacted rules to curb the number of opioid analgesics doctors can prescribe.
   
• China Food and Drug Administration (CFDA) submitted its membership application to the International Council for Harmonisation, which was established to facilitate international collaboration, and has been successful in standardizing and elevating drug development practices throughout the world.
   
• GS1 US publishes The GTIN Adoption and Usage Model, which helps “healthcare companies improve patient safety and supply chain efficiency by better leveraging unique product identification”
   
• NACDS endorsed the Every Prescription Conveyed Securely Act, which requires electronic prescribing for controlled substance medications in Medicare Part D. NACDS supports the use of electronic prescriptions because they are electronically trackable, cannot be copied or altered, reduce the likelihood of fraudulent prescriptions, etc.
   
• Second annual blockchain conference tailored for the healthcare industry to take place September 25-26, 2017. Conference will provide insight into how blockchains are currently being used to fix problems in healthcare and what more can be done in the future.
   
• RXTrace red light green light article about the DSCSA verification requests. I scrolled down to the bottom to read the comments andrealized the first comment was from our very own, Bob Celeste.
   
• NACDS presents “Vision 2028”- emerging technology in the future of retail and pharmacy. Expo will be held August 19-22.
   
• Conference at Johns Hopkins suggests that while blockchain is very promising, it is still years away from being established.
   
• Illegitimate online pharmaceuticals continue to be a problem. The Alliance for Safe Online Pharmacies conducted a survey- most participants could not differentiate between a legitimate and illegitimate online pharmacy. FDA runs Pangea program, an annual event to shut down and arrest illegitimate or outright-illegal online pharmacies, but they keep popping up.

September 6, 2017 links:

• Biotechnology Innovation Organization (BIO) comments on the FDA’s Draft Guidance: Product Identifier Requirements Under the Drug Supply Chain Security Act-Compliance Policy
• RFID opportunity analysis in the pharmaceutical industry
• Track & trace solutions market is expected to experience a period of high growth from 2016 to 2025
• Weak supply chains and drug importation create more opportunities for counterfeit drugs
• World Health Organization (WHO) to conduct a study to quantify the market in substandard and falsified medicines
• Manufacturers must manage risks to supply chain integrity such as regulatory and quality violations and capacity challenges
• Blockchain technology has the potential to streamline supply chain management systems and provide assurance of traceability
• As technology improves and more biologics are created cold-chain storage will become more important and complicated

August 25, 2017 links:

• At least 17 states have enacted rules to curb the number of opioid analgesics doctors can prescribe.
• China Food and Drug Administration (CFDA) submitted its membership application to the International Council for Harmonisation, which was established to facilitate international collaboration, and has been successful in standardizing and elevating drug development practices throughout the world.
• GS1 US publishes The GTIN Adoption and Usage Model, which helps “healthcare companies improve patient safety and supply chain efficiency by better leveraging unique product identification”
• NACDS endorsed the Every Prescription Conveyed Securely Act, which requires electronic prescribing for controlled substance medications in Medicare Part D. NACDS supports the use of electronic prescriptions because they are electronically trackable, cannot be copied or altered, reduce the likelihood of fraudulent prescriptions, etc.
• Second annual blockchain conference tailored for the healthcare industry to take place September 25-26, 2017. Conference will provide insight into how blockchains are currently being used to fix problems in healthcare and what more can be done in the future.
• RXTrace red light green light article about the DSCSA verification requests. I scrolled down to the bottom to read the comments andrealized the first comment was from our very own, Bob Celeste.
• NACDS presents “Vision 2028”- emerging technology in the future of retail and pharmacy. Expo will be held August 19-22.
• Conference at Johns Hopkins suggests that while blockchain is very promising, it is still years away from being established.
• Illegitimate online pharmaceuticals continue to be a problem. The Alliance for Safe Online Pharmacies conducted a survey- most participants could not differentiate between a legitimate and illegitimate online pharmacy. FDA runs Pangea program, an annual event to shut down and arrest illegitimate or outright-illegal online pharmacies, but they keep popping up.