Regulations

Drug Supply Chain Security Act in Pharmacy: Today and Tomorrow

The Drug Supply Chain Security Act (DSCSA) has been with us for almost nine years as part of the FDA’s Plan to protect the U.S. drug supply chain. The culmination of the Drug Supply Chain Security Act will reach its final implementation goal in November 2023. On 11/27/2023, all trading partners (Manufacturers, Wholesalers, and Dispensers (including Pharmacies) will need to begin using an “Enhanced Drug Distribution Security System.” However, before we talk about that, let’s talk about what you need…

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Red Flags and Controlled Drugs

The vast majority of Pharmacies are dispensing controlled substances in compliance with the DEA and State Regulations. However, we regularly hear about a Pharmacy, prescriber, wholesaler, or manufacturer in the news breaking those regulations and trying to circumvent public safety for profit. Now that the COVID-19 pandemic is winding down [fingers crossed], we are once again starting to see a focus on the public health emergency of drug addiction and abuse. Here at PRS, we get questions from Pharmacy Owners…

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pharmacy compliance, pharmacy cyber security

Things to Think About When It Comes to Protecting Your Pharmacy Infrastructure

You cannot go more than a day or two without hearing about another cyber attack in the United States. More importantly for pharmacy owners, Health Care has become a frequent target for phishing and ransomware attacks.  These can devastate an organization, so protecting your pharmacy infrastructure is critical, but have you ever stopped to think about what that protection encompasses?   In this blog, we want to cover some essential areas that need to be addressed to ensure your compliance with…

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pharmacy compliance, HIPAA, patient access to pharmacy records

HIPAA Access to Records

In this blog, we will discuss one of the “rights” that HIPAA gives individuals concerning their medical records. HIPAA provides the individual with the right to access their records in a “timely” fashion.  While not the most cumbersome act in many Pharmacies, the request from patients to access their records is something Pharmacies must respond to in a quick and timely fashion. The Officer of Civil Rights (OCR), the agency responsible for the enforcement of HIPAA, believes that a Patient…

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How to prevent a PBM taking back money

Pharmacy Self-Audits: Preventing PBMs From Taking Back Monies

How do you prevent a PBM auditor from clawing back monies? Pharmacies deal with the threat of PBMs clawing back money daily.  Fortunately, many audits resulting in the clawback of monies can be prevented by proactive activities, training, and overall employee understanding.  These activities start before the prescription is filled and dispensed and continue after the patient walks out the door. These activities mean more work, but it is work that you and your employees need to be considering as…

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