Supply Chain Logistics
Your supply chain may not be as ironclad as you think.
If you manufacture, distribute — or even reverse distribute — controlled substances, you shouldn’t underestimate your risk for drug diversion and abuse. The journey of the pill can be a long and winding one, with unsavory characters waiting in the shadows to do bad things with good shipments.
Today’s DEA rules and regulations are so complex, business owners and practitioners struggle to understand what they should be doing. Plus, the opioid crisis has resulted in more federal and state resources being put toward preventing drug diversion. And, the pressure is on investigators to step up controlled-substance compliance programs and conduct even tougher oversight.
The World Health Organization estimates that the counterfeit and grey markets were worth $75 billion dollars in 2010.
Source: Growing threat from counterfeit medicines. Bull World Health Organ. 2010 Apr; 88(4): 247-8. [PubMed]96%
of online pharmacies do not comply with applicable laws and standards put in place to protect patients
Source: Alliance for Safe Online Pharmacies. Key data about online sales of prescription medicines. Last updated February 2016.Manufacturers, repackagers, wholesalers and dispensers must provide transaction information, transaction history, and a transaction statement to each subsequent owner of the drug product.
Source: www.ncbi.nlm.nih.gov/pmc/articles/PMC4911992Hefty civil fines are being levied against non-compliant individuals and businesses across the healthcare industry, including pharmacies. Inspections conducted by the DEA and state agencies are typically unannounced, and the current federal fine per infraction is $15,691. But, it’s not uncommon for fines to exceed $1 million.
Most common violations cited by the DEA:
Lack of Physical Security
Registration Issues
Failure to Prevent Diversion
Poor Record-Keeping
It can happen to you.
Whether it’s a trusted employee, long-time client or even a relative, pharmaceutical practices are at risk for drug diversion. It’s imperative that you be prepared. Now is the time to investigate, identify, correct and strengthen your pharmacy against the most common vulnerabilities you face today. Keeping up with changing standards, best practices, new requirements and growing threats are the most effective ways to protect your business. But failing to adapt to these new realities may not only cost you financially, it can also cause irreparable harm to your personal and professional reputation.
Don’t worry. We can help.