Making pharmaceutical errors can have a significant detrimental impact on a pharmacy owner or pharmacist. The Illinois Board of Pharmacy and the Drug Enforcement Administration (DEA) can take harsh action, classifying a pharmaceutical error that results in serious injury or death as malpractice. In addition to the civil legal ramifications brought forth by the alleged victim and/or their family, a pharmacist and the facility that employs them can also lose their licenses.

Incorrect Medication to the Patient

If a patient is given the wrong medication, it can cause serious or even fatal side effects. Unfortunately, these mistakes do occur, especially in pharmacies that have a large volume of prescription medications they fill on a daily basis. This can happen for any of the following reasons:

• The medication has a similar name as the name of the medication the patient was supposed to be given. Take, for example, Catapres® (clonidine) and Klonopin® (clonazepam). The generic names for both of these medications are very similar, but if the drugs are mixed up, the patient can experience loss of seizure control, hypotension, and other dangerous side effects.  

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Pharmacists, just like many other professionals, are required to complete necessary education and training related to their field, and then obtain their license through the state of Illinois. The agency that is in charge of licensing and regulation over the state’s approximately 20,000 pharmacists and pharmacy technicians is the Illinois Board of Pharmacy, which is part of the Illinois Department of Financial and Professional Regulation (IDFPR).

Part of the oversight the pharmacy board has is handling all complaints and investigations, as well as taking any appropriate disciplinary actions. If you have received notification from the board that they are investigating a complaint against you or conducting an investigation for any other reason, it is important to contact an Illinois professional license defense attorney right away.

Reasons for an Illinois Board of Pharmacy Disciplinary Action

The Illinois Board of Pharmacy can place a pharmacist on probation, or they may even revoke the pharmacist’s license if they feel the pharmacist has committed a violation. For example, a pharmacist who has been convicted of a felony level offense or has been convicted of a crime of moral turpitude may lose their pharmacist’s license. Crimes of moral turpitude include sexual misconduct, assault, and DUI.

Pharmacists need to have detailed knowledge of a wide variety of pharmaceutical issues, as well as the practices followed in their profession and the legal issues related to the products and services they provide to patients. To ensure that a person will be able to meet all of their ongoing requirements as a pharmacist, they will need to complete examinations demonstrating their knowledge and competency. The Multistate Pharmacy Jurisprudence Examination (MPJE) is one of the two exams that students must pass, and if they fail this exam three times, they must complete certain requirements for remediation before they can retake the exam.

What Does the MPJE Cover?

The MPJE will consist of 120 questions, and a person will have 2.5 hours to complete the exam. These questions will cover:

• Pharmacy practice (around 83 percent of the test) - Subjects addressed will include the legal responsibilities of pharmacy staff, procedures followed when acquiring and distributing pharmaceutical products, legal requirements for issuing prescriptions, proper procedures for dispensing controlled substances and other products, patient counseling requirements, requirements when distributing or dispensing non-prescription products or medications, record-keeping procedures, and requirements for handling hazardous materials.

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Pharmacies provide a variety of products and services to patients, and they will need to maintain the proper licensing and accreditation to ensure that they can continue operating. Some pharmacies offer products that fall under the category of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS), and to receive payments through Medicare for these products, they will be required to maintain accreditation. Pharmacy owners will need to be sure to understand the requirements that they will need to meet to receive DMEPOS accreditation.

Eligibility Requirements

Pharmacies will be required to complete the DMEPOS accreditation process through the National Association of Boards of Pharmacy (NABP). To qualify for accreditation, a pharmacy will need to meet the following basic eligibility requirements:

• A pharmacy must have the proper licenses and be in good standing in all areas where it conducts business.
• A pharmacy must be in a commercial location rather than a personal residence, and it must have been in operation for at least 30 days while complying with all applicable state laws and regulations.
• A pharmacy must have a licensed pharmacist-in-charge who manages pharmacy operations and staff members.
• A pharmacy must predominantly serve human customers (as opposed to prescriptions for veterinary medicine), and it must fill prescriptions for at least 10 human patients.

Quality Standards

The Centers for Medicare & Medicaid Services (CMS) also maintains standards for quality that pharmacies will be required to meet to obtain accreditation as a supplier of DMEPOS. These standards address:

Medical providers that prescribe, dispense, or handle controlled substances are required to follow all applicable laws and regulations related to these drugs. The Drug Enforcement Administration (DEA) monitors providers to ensure that controlled substances are being used correctly, and it may take action to address any potential violations of the law. As part of its ongoing efforts, the DEA often conducts audits and inspections, and providers who have received a Notice of Inspection from the DEA will want to understand their rights and how they can protect themselves from consequences that could affect their DEA registration or their professional license.

Understanding DEA Inspections

The DEA performs regular, routine audits of medical providers that have a controlled substance registration. Inspections may also be performed as part of a larger investigation related to possible drug diversion, including in cases involving reports or claims of unlawful prescribing, unlawful dispensing, or conspiracy to possess or distribute controlled substances.

While the DEA may obtain a search warrant before performing an inspection, in most cases, a provider will receive a Notice of Inspection. This notice will follow a standard form (DEA Form 82), and it will include the name and address of the premises being inspected, the name and title of the owner or operator in charge of the premises, the date and time when the inspection will be performed, and the signature of the person performing the inspection. Typically, a registrant must provide informed consent before an inspection can be performed, and they have the constitutional right to refuse an inspection. Informed consent is given by signing a written statement in which a provider will verify that they understand that the results of an inspection could be used as evidence if the DEA or other law enforcement officials decide to pursue criminal drug charges.