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Fighting Allegations of Illegal Philadelphia Pill Distribution

Fighting Allegations of Illegal Philadelphia Pill Distribution

The opioid epidemic has hit Philadelphia hard, with thousands of residents struggling with addiction. In response, law enforcement has cracked down on illegal distribution of prescription painkillers. But some doctors and pharmacists claim they’re being unfairly targeted, fighting allegations that they contributed to the crisis. This article looks at the legal landscape around pill distribution in Philadelphia, and strategies for doctors and pharmacists to defend themselves.

Federal prosecutors have brought charges against numerous Philadelphia doctors and pharmacists in recent years. Most cases involve “pill mill” operations, where providers prescribed opioids for no legitimate medical purpose. But some in the medical community feel prosecutors have gone too far, targeting doctors just for having patients who misused medications. They argue the line between responsible prescribing and illegal distribution isn’t always clear.

So how can doctors and pharmacists fight back if they come under investigation? Here are some key legal considerations and defense strategies:

Prescription Monitoring Programs

A core defense is having diligently used Pennsylvania’s prescription drug monitoring program (PDMP). This database tracks controlled substance prescriptions, alerting to possible misuse. Doctors can point to checking the PDMP as proof they monitored for “red flags” like overlapping prescriptions. But merely accessing the data isn’t enough. You must show it meaningfully informed prescribing decisions. Thorough PDMP documentation is crucial.

Pharmacists too should check the PDMP for every controlled substance dispensing. While not mandatory in Pennsylvania, it shows responsible monitoring. Be sure to record PDMP lookups in patient profiles. Consider refusing to fill prescriptions that seem clinically unwarranted. This protects patients and demonstrates you weren’t complicit in diversion.

Documentation and Patient Screening

Meticulous record-keeping also helps defeat distribution charges. Documenting diagnosis and treatment rationale shows prescriptions were clinically justified. Require imaging or diagnostic tests confirming conditions warranting opioids. Screen patients for risk factors like past addiction. Have them sign “pain contracts” on using medications responsibly. This shows you worked to prevent misuse upfront.

Pharmacists too should document red flags like patients using multiple doctors or pharmacies. Keep notes on consultations about opioid risks. Report concerning patterns to prescribing doctors. Show you counseled patients but had limited power to stop determined abusers.

Prescription Quantities and Monitoring

Critically examine if your prescription quantities were truly needed for patients’ conditions. Restrict early fills and require regular visits to reevaluate dosing. Consider weaning and discontinuing opioids for patients showing signs of misuse. This demonstrates you actively managed dependencies rather than fueling them.

Pharmacists should look for unusual prescription sizes, large quantities, or early refills. Verify with doctors that doses aren’t excessive. You can legally refuse to fill prescriptions completely lacking medical purpose. But understand doctors may resent interventions they perceive as questioning their judgment.

Peer Comparison

Contextualizing prescribing patterns is also helpful. Request data on peer doctors’ opioid prescription rates for similar patients. Numbers higher than colleagues doesn’t automatically prove wrongdoing. But it flags where your clinical standards may have been lacking. You can then explain why your patients legitimately required more opioids.

Pharmacies can similarly benchmark against peers dispensing controlled substances. Higher volumes don’t mean the prescriptions you filled were invalid. But it suggests potentially looser oversight than competitors. Be ready to justify your dispensing decisions.

Law Enforcement Cooperation

If you suspect patients of diversion, contact law enforcement and assist investigations. Reporting suspicious activity shows you weren’t turning a blind eye. You can also refer at-risk patients to addiction treatment resources instead of refilling opioids endlessly. Just be sure to document steps taken.

Pharmacists should inform the DEA of questionable prescribers. You’re required to help guard against diversion. But avoid overstepping boundaries with doctors’ medical judgment. Focus reports on objective red flags like unusual prescription volumes. And don’t take enforcement into your own hands by refusing to fill legitimate scripts.

Controlled Substance Licenses

Scrutinize employees who handle opioids in your practice or pharmacy. Check backgrounds for prior diversion offenses before hiring. Ensure staff registration with the DEA and state boards. Restrict controlled substance access only to those requiring it. Oversee inventory management closely. Sloppy controls allow drugs to “walk out the door”, exposing you to liability.

Separately register locations where you dispense or store controlled substances. Update registrations promptly when moving offices. Doing otherwise is an automatic violation, even if just an administrative oversight. Keep registrations current and posted conspicuously in facilities.

Medical Necessity Defense

For doctors facing charges, a key defense is establishing you acted in “good faith”. Demonstrate your honest belief that prescriptions were medically necessary for patients. Explain the clinical reasoning behind your opioid prescribing. Have expert witnesses review records and attest treatment aligned with professional standards.

Pharmacists can also argue “good faith” dispensing. Detail how you verified legitimacy of prescriptions before filling them. Have pharmacy experts testify you acted responsibly given information available at the time.

But understand prosecutors may allege you deliberately ignored “red flags”. So thoroughly document your clinical decision-making process. You must prove you weren’t blindly filling prescriptions where no medical need existed.

Avoiding Criminal Charges

Many pill distribution cases carry heavy criminal penalties – even jail time. So avoiding criminal prosecution is critical. Quickly retaining experienced legal counsel at investigation outset is key. They can negotiate with prosecutors before charges get filed.

An immediate step is convincing investigators you weren’t intentionally diverting drugs. Admit any prescribing errors showing you weren’t fully aware of risks. Emphasize you were trying to treat patients’ pain, not recklessly supply opioids.

If charges do get filed, your recordkeeping becomes vital. It provides evidence you weren’t “deliberately ignorant” of diversion occurring. Meticulous documentation shows lawful clinical intent, not criminal mens rea.

For pharmacists, verify you performed due diligence in filling scripts. Flag how you lacked definitive proof a prescription was forged or invalid. Demonstrate you consulted prescribers about any concerns. This shows you weren’t knowingly complicit in illegal distribution.

Administrative Sanctions

Even avoiding criminal charges, you still face professional discipline by state licensing boards. They may allege you violated practice standards, acting negligently towards public health. Expect license restrictions, mandated training, or suspension.

Cooperate fully with board investigations to mitigate sanctions. Don’t reflexively reject proposed discipline, but negotiate reasonable terms. Seek informal settlements where possible. Be sure to report any actions to DEA, which can trigger separate scrutiny of your controlled substance authority.

Pharmacists also risk state board discipline and DEA registration revocation. Tying sanctions to remedial steps shows you’re addressing deficiencies. Proactively enroll in continuing education before being ordered. Document improved practices implemented.

Medical Malpractice Exposure

Doctors face another threat – lawsuits by patients harmed from overprescribing. Plaintiffs allege providers should have known opioids were fueling addiction. It’s critical to have robust informed consent processes discussing addiction risks. Require signed consent forms outlining risks/benefits before prescribing.

Pharmacists too may be sued for not preventing diversion. But courts have held pharmacies legally can’t override doctors’ prescribing discretion. You likely can’t be liable for filling facially valid scripts. But failing to notify doctors of misuse patterns could expose you. So keep diligent records of all consultations.

Avoiding Problems Proactively

The best defense is avoiding problems proactively. Doctors should regularly review opioid practices for needed improvements. Update prescribing policies to align with CDC guidelines. Consider non-opioid and alternative treatments first. Prescribe immediate-release opioids at lowest effective doses. Closely monitor patients and discontinue opioids promptly when risks outweigh benefits.

Pharmacists should implement robust procedures for dispensing controlled substances. Frequently audit inventories to detect potential diversion. Train staff on how to identify and report suspicious prescribing patterns. Proactively reach out to local doctors about enhancing patient monitoring.

Doctors and pharmacists should also document diligent responses to any patient overdoses. Review cases to see if different opioid management may have prevented deaths. Show regulators you’re learning from tragedies, not ignoring them.

A Complex Environment

Prescribers undoubtedly contributed to the opioid crisis through aggressive marketing and loose oversight. But law enforcement responses create dilemmas for doctors and pharmacists trying to balance obligations. They must treat pain humanely while preventing misuse. It’s a complex environment with unclear regulatory lines and risks of over-correction.

Providers facing allegations should get experienced legal counsel early. Thoughtful defense strategies can demonstrate your practice wasn’t outside the standard of care. Document, document, document. And emphasize willingness to strengthen prescribing policies moving forward. With smart navigation, doctors and pharmacists can defend their practice while being part of the solution.

References:

DEA Pharmacist’s Manual

CDC Opioid Prescribing Guidelines

Pennsylvania Prescription Drug Monitoring Program

DEA Pharmacist’s Manual on Suspicious Orders

How Pharmacists Can Help Prevent Opioid Diversion

Pharmacists’ Role in Opioid Overdose: Policy, Practice, and Research Needs

How To Strengthen Medical-Legal Partnerships Addressing The Opioid Crisis