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Last Updated on: 27th July 2023, 04:34 pm
The opioid epidemic has placed pharmacists under intense scrutiny. Regulators are aggressively investigating opioid dispensing and potential diversion. Pharmacies face audits, complaints, license actions, civil penalties and even criminal charges.
Defending against drug diversion allegations requires specialized legal guidance. A misstep can lead to severe consequences for your pharmacy license, business, finances and reputation. Here is what pharmacists need to know when facing opioid-related investigations.
State boards of pharmacy and the Drug Enforcement Administration (DEA) are tasked with combating opioid misuse. By targeting pharmacies, they aim to cut off sources feeding addiction and overdoses.
Investigators look for patterns and practices that facilitate diversion and abuse, such as:
Even well-meaning pharmacies can get caught up in questionable dispensing if they aren’t vigilant. Investigators paint well-intentioned mistakes as willful blindness. Substantial fines and license sanctions quickly follow.
When facing an audit or investigation, you need experienced counsel to demonstrate diligence and statutory compliance. Skilled lawyers lay the foundation to defeat allegations.
The moment you become aware of a drug diversion investigation, consult specialized counsel. Here’s why:
In short, waiting to engage counsel squanders valuable prep time and puts you on the defensive. Retaining counsel promptly lets you get out in front of the inquiry.
Partnering with experienced pharmacy regulatory attorneys allows you to mount a robust defense by:
Demonstrating diligence – Gather documentation showcasing your dispensing safeguards, prescription-vetting procedures, PMP checks, patient counseling, and diversion vigilance. This evidence refutes claims you enabled abuse.
Attacking allegations – Skilled counsel pokes holes in charges. For example, highlighting that you dispensed a tiny fraction of the prescriber’s total opioid volume undercuts over-dispensing allegations.
Leveraging public records – Counsel can obtain documents from regulators to understand the scope of their probe. This allows for a targeted defense.
Deploying experts – Experts can strengthen defenses by attesting to the validity of your practices. Specialists in areas like pharmacy workflows, recordkeeping, security controls and data analysis can offer invaluable favorable testimony.
Presenting mitigating factors – For example, you implemented prescriber education programs demonstrating a commitment to curtailing misuse. Documenting good faith efforts like this helps overcome accusations.
Negotiating resolutely – Experienced counsel may be able to negotiate an advantageous settlement if fighting allegations completely proves unrealistic. Skilled lawyers are shrewd negotiators.
With meticulous attention to detail and assertive advocacy, pharmacy law experts build formidable defenses against diversion charges.
These specialized cases demand attorneys intensely focused on pharmacy law. Seek these top traits:
The pharmacy law team at Spodek Law Group offers the right blend of qualities to overcome diversion allegations. Their seasoned attorneys couple deep knowledge of pharmacy operations with equally deep knowledge of pharmacy laws and regulators. Clients nationwide turn to them for strong, strategic legal guidance throughout the audit and investigative process.
Don’t leave your livelihood and reputation vulnerable. At the first sign of a drug diversion investigation, contact respected pharmacy counsel to protect your interests. With an experienced legal team on your side, you can confidently navigate the probe.
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