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.

Understanding Regulators’ Concerns

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:

• Unusually high opioid dispensing rates
• Filling illegitimate or forged prescriptions
• Filling scripts that don’t have legitimate medical need
• Ignoring red flags of diversion or doctor shopping
• Making opioids easily accessible for street sales
• Sloppy inventory control and record keeping

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.

Getting Legal Help Immediately

The moment you become aware of a drug diversion investigation, consult specialized counsel. Here’s why:

• Investigations evolve rapidly, so early intervention is key.
• An attorney ensures you don’t make damaging missteps in responding.
• Counsel can work to keep the probe focused, protecting your interests.
• Experienced lawyers immediately begin building defenses, preparing counterarguments to expected allegations.
• Pharmacy regulators get around 95% of investigations referred to prosecution. You need strong advocates in your corner fighting for a favorable outcome.

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.

Building a Strong Defense Strategy

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.

Choosing the Right Pharmacy Investigation Counsel

These specialized cases demand attorneys intensely focused on pharmacy law. Seek these top traits:

• Comprehensive pharmacy defense experience – Thorough knowledge of specific regulations, pharmacy operations, records, regulators and defenses is essential. There is no room for learning on the job.
• Past successes defending pharmacists – Look for a proven track record getting positive outcomes in DEA and board investigations. Does counsel routinely secure dismissals or mitigate penalties?
• Regulatory sophistication – Lawyers should know regulators’ tactics in and out. They must be adept at countering regulators’ moves at each turn. Look for aggressive but strategic advocacy.
• Willingness to fight charges – Some lawyers are too quick to settle. You want counsel willing to bring well-founded cases to hearing and win. But they recognize when negotiating a resolution makes sense.
• Appeals acumen – If you lose at the initial hearing, experienced representation during appeals is critical. Verify counsel has expertise reversing adverse pharmacy board and DEA rulings.
• Resources to match regulators – This is no place for underfunded legal teams. Choose lawyers with ample resources to research charges, develop strong defenses and litigate tenaciously.
• Meticulous and organized – Winning these complex cases hinges on close scrutiny of records, audits, dispensing data, allegations and defense options. Meticulous, organized counsel excel.

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.