Operating a pharmacy or serving as a pharmacist entails a complex regulatory environment. Even minor errors can trigger serious consequences, both in terms of patient safety and professional licensing. If you’re facing a complaint or an investigation by a state board or federal regulatory agency, timely action is critical.
Having a strong grasp of pharmacy license defense measures is essential in this high-risk field. This guide outlines common pharmacy law violations and explains how you can respond to protect your license.
Pharmacy Regulations and Regulatory Enforcement Explained
Pharmacists must comply with both federal and state laws. For example, the federal Controlled Substances Act is one of the most sweeping and complex laws governing pharmacies. State boards of pharmacy can impose additional regulations and take disciplinary action for violations.
If you’re facing such an accusation, it’s imperative to mount a strong pharmacy license defense to protect your reputation and right to work.
Possessing a valid license is the key to practicing in your profession. As such, your defense must be focused and sound. A strong pharmacy license defense strategy will address the following:
- Whether a violation occurred
- What harm occurred, if any
- How you responded
- What steps you took to mitigate the risk
Some mistakes, such as dispensing too few doses of the right medication, are relatively easy to remedy. On the other hand, dispensing the incorrect medication could potentially result in severe patient harm.
During an investigation, the pharmacy board will consider the severity of the violation, whether there was intent, and whether patient harm occurred, among other things, especially in cases involving regulatory enforcement.
Common Pharmacy Law Violations
The following are some of the most frequent issues that state boards and regulators encounter:
Incorrect Dosages and Dispensing Incorrect Drugs
Dispensing errors or an incorrect dosage could jeopardize patient safety and trigger disciplinary action. Misleading or missing instructions can also be a major issue.
Fortunately, many of these processes are now automated, which helps reduce the risk of drug errors. Still, as a pharmacist, it’s vital to do your due diligence before putting medications in the hands of patients.
Prescription Fraud
Diversion of controlled substances and prescription fraud are among the most egregious offenses pharmacists can commit due to the intent involved.
Pharmacists are entrusted with potentially harmful and addictive controlled substances. When they abuse this trust by performing unauthorized refills or inadequately tracking controlled medications, their actions can have serious repercussions.
Operating Outside Your Scope
Engaging in pharmacy activities without proper credentials can trigger swift regulatory action. Similarly, issuing prescriptions without proper approval can lead to license suspension or revocation.
Record-Keeping Failures
As a pharmacist, you’re responsible for documenting every single pill that enters and exits the facility. Inaccurate logs or missing records can lead to professional discipline. Modern automation software drastically reduces the risk of these types of violations by enforcing redundancies. Still, it’s up to you to be diligent and focused.
Violations of State or Federal Regulations
Non-compliance with state board rules or federal laws can be a source of severe consequences for pharmacists. Violating HIPAA or state privacy laws is also a major concern. You must ensure that you’re respecting patient privacy and doing everything by the book.
How to Respond When Your Pharmacy License Is at Risk
If you’ve been accused of a violation or are staring down a board inquiry notice, here’s a step-by-step response plan for effective pharmacy license defense:
Take the Notice Seriously and Act Quickly
The moment you find out about a complaint, you must respond appropriately. Review the document or message carefully to find out what the allegations are and pay close attention to any deadlines or response requirements.
If you fail to follow up in a timely manner, the regulatory board could take default action against your license. That’s the last thing you want. After all, you’ve spent countless hours working to obtain it.
Preserve Evidence
If you have any records or messages relevant to the complaint, save them. Make copies for your lawyer if you’re legally allowed to do so. The more information you can provide, the more effectively they can evaluate your case.
Don’t get rid of anything, even if you’re worried that it could hurt your case. Destroying evidence can result in even harsher penalties. A skilled attorney will be able to formulate a plan for addressing any concerning evidence.
Hire an Experienced Pharmacy License Defense Lawyer
Pharmacy regulations are technical and complex. A lawyer who focuses on pharmacy license defense can guide you through the process and manage communications with regulators. They’ll handle everything, including gathering evidence and keeping track of important filing deadlines.
Let your lawyer focus on protecting your license, ensuring pharmacy compliance, and safeguarding your reputation. That way, you can keep your attention on conducting yourself in a safe and professional manner.
Conduct an Internal Review and Audit
Identify how the incident occurred and whether it was a one-off or part of a pattern. Determine what corrective actions you’ve taken or will take to prevent future problems.
Demonstrating proactive, good-faith remediation will show the board that you’re passionate about doing things the right way and are willing to make necessary changes to keep patients safe.
Implement Corrective Measures
Document any corrective actions you take, which may include:
- Staff retraining
- Updating standard operating procedures
- Improving controlled substance tracking
- Conducting more frequent audits
The goal is to show the board how you’re making your processes better. A few simple changes can go a long way in minimizing the disciplinary actions you face.
Cooperate (but Don’t Self-Incriminate)
As a pharmacy license holder, you’re required to cooperate with the board’s investigation. However, you should be careful not to incriminate yourself when giving testimony or agreeing to interviews.
Consult with your attorney before providing any statements or documents to regulators. They’ll ensure that your rights are protected.
Turn to Unlock Legal Today
Are you facing disciplinary action as a pharmacist? Unlock Legal can create a strong pharmacy license defense plan and represent you at every critical junction.
Don’t face this career-threatening challenge on your own. Contact us to schedule a free consultation.
