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oak brook license defense lawyerPharmacists, 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.

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Il MPJE Remediation LawyerPharmacists 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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IL pharmacy lawyerPharmacies 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:

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Il license defense lawyerMedical 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.

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IL license defense lawyerIn the healthcare industry, there are many safeguards put in place to protect patients. When it comes to medication and pharmacies, it is no different. PBM pharmacy audits are conducted both for the sake of the pharmacy benefit manager (PMB) and for you, the pharmacy owner. A PBM audit can be a stressful experience for a pharmacy, especially a small, independent one, but many pharmacies cannot operate at desired capacity without also working with a PBM. If you have an upcoming PBM pharmacy audit, proper preparation is key to success.

Documentation is Extremely Important

For many pharmacies, but especially independent pharmacies, documentation is often an area that needs attention. When your PBM auditor comes to your pharmacy, they may request to see certain documentation that could be from months or even years ago. This documentation could be anything to do with things such as supply changes, such as going from a 30-day supply to a 60-day supply, or early refills. Having your documentation completed, thorough, and organized will save you much stress during the audit.

Consistency Is Expected

Part of the job of a PBM auditor is to make sure that each patient receives the same standard of care when they use your pharmacy. This is accomplished by making sure that all employees are following the same rules and policies while they perform their job. When your PBM auditor is at your pharmacy, they will be looking for any errors made by your staff, such as checking the amount of medication dispensed or ensuring all of the proper forms and documentation are filled out. It is a good idea to have an official standard operating procedure (SOP) written out and distributed to all of your employees so that they understand what is expected of them every time they fill a prescription.

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