Three Pillars of Pharmacy Compliance

Maintaining compliance in hospitals, health centers, and other clinically based pharmacies goes beyond the handling, dispensing, and prescribing of drugs. Pharmacy compliance rules require staff to properly manage electronic prescriptions, maintain mandatory licenses, and complete continuing education (CE) courses.

These three compliance pillars, among many others, support ongoing compliance, safety, and integrity of clinical pharmacies and the employees behind the counters. In this article, I’ll discuss how pharmacies should focus compliance efforts on electronic prescribing, licensure, and CE. I’ll also share how compliance software helps streamline pharmacy document and policy management.

What Is Pharmacy Compliance?

Pharmacy compliance is adhering to laws, regulations, and professional standards governing pharmacy practice. This includes ensuring that pharmacies operate within the legal framework set by federal, state, and local authorities and complying with industry standards and best practices.

Pharmacies are governed by federal agencies, including the Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA). Drugs are separated by class, with controlled dangerous substances categorized in schedules under the Controlled Substances Act. Pharmacies must also comply with laws and state pharmacy board regulations of each state in which they operate.

As I outlined earlier, federal and state regulations cover various compliance requirements. Let’s examine three pillars to which pharmacies must pay particular attention.

Pillar One: Electronic Prescribing Requirements

Electronic prescription services (EPS) are significant in pharmacy compliance programs. Healthcare providers digitally enter prescription information and securely transmit it to pharmacies using special software programs. Providers can view a patient’s prescription history, allergy information, and drug interactions to make informed clinical decisions before approving medications.

EPS reduces the need for paper prescriptions, which have a higher potential for misinterpretations that can lead to errors. Along with reducing errors, EPS offers enhanced patient safety, reduced costs, and improved efficiency in the prescription process.

On the surface, using EPS seems simple. However, proper electronic prescription compliance is complex, especially for controlled substances. For example, if a provider prescribes Schedule I and II controlled substances, the EPS must contain inputs for:

Authentication: The pharmacy must confirm the identity of the provider signing for the prescription without direct communication and prove that the provider’s identity was properly verified.
Nonrepudiation: The EPS must contain strong and substantial evidence of the provider’s identity, sufficient enough to prevent the provider from successfully denying having sent the data. This includes the ability of a third party to verify the origin of the electronic documentation.
Message Integrity: The EPS must have functions that ensure the recipient or a third party can determine whether the document’s contents were altered during transmission or after receipt.

Pillar Two: Pharmacy Licensure Requirements

A Doctor of Pharmacy degree (PharmD) from a school or college of pharmacy accredited by the Accreditation Council for Pharmacy Education is required to become a licensed pharmacist. You also must pass The North American Pharmacist Licensure Examination (NAPLEX) to practice in every state.

With a degree and passing NAPLEX grade, a pharmacist must obtain a license in any state where they dispense pharmaceuticals. Typically, once licensed in their home state, the pharmacist may apply for a license in another state through reciprocity, making them eligible to waive specific requirements concerning the licensing process.

Requirements for pharmacist licensure vary depending on the states where the pharmacy is located and intends to operate and if the pharmacist is in charge of the facility. Most states require license renewal every two years, but regulations vary by location.

Beginning June 2023, pharmacists applying for or renewing a DEA license to dispense controlled substances must complete a one-time, eight-hour Medication Access and Training Expansion (MATE) Act training requirement. If training was completed before June 27, 2023, pharmacists are not required to complete another eight hours of training to satisfy the MATE Act.

Along with a PharmD from an accredited institution, 46 states require pharmacists to pass the Multistate Pharmacy Jurisprudence Examination (MPJE) to practice medicine. Unlike the NAPLEX, pharmacists must take this exam again if they decide to practice in another state or jurisdiction unless the board of pharmacy says otherwise. California and Arkansas have exams that cover laws specific to those states and do not require pharmacy graduates to take the MPJE. Alaska, Idaho, Michigan, and Vermont do not require jurisprudence exams to practice.

Pillar Three: Continuing Education Requirements

Like licensure, CE requirements for pharmacists vary by state. It’s a huge benefit to practitioners when the employer provides CE credits since they can be expensive. Continuing education is typically between 15-40 hours of CE credit required every two years. Some states require in-person or “live” training. It’s important to verify CE mandates for each state your organization operates in.

The National Pharmacy Technician Association (NPTA) requires certified pharmacy technicians to complete a CE course every two years to renew their certifications with the Pharmacy Technician Certification Board (PTCB) and National Healthcareer Association (NHA). Both require a minimum of 20 hours of CE, including one hour each of pharmacy law and patient safety CE.

Healthcare organizations with pharmacies must also administer initial training and refresher courses for numerous Occupational Safety and Health Administration (OSHA) standards, including blood-borne pathogens, disaster preparedness, preventing needlesticks, and identification of regulated medical waste.

Digital Support For Pharmacy Compliance

Maintaining these three pharmacy compliance pillars involves effective document tracking, record-keeping, and attention to detail. Paper files, spreadsheets, emails, and phone calls may get the job done, but I’ve found that they take up a lot of valuable time and expose your pharmacies to human error.

Compliance software best supports document tracking, exclusions monitoring, continuing education course assignment and completion reports, and provider profile updates by bringing them together in a central location. It is especially useful for:

Automated Exclusions Monitoring: Software continually cross-references provider and entity information against a network of multiple states and federal exclusionary databases and accurately identifies excluded parties.
License Verification: Automated license verifications are incomplete until someone within your organization verifies the information. The software can open license verification websites to check the data or allow you to view the verification document already in your database. Making any needed updates can be done within the platform and manual verification is automatically tracked with the verifier’s name and the date the person completed the verification.
Manage CEs and Continuing Medical Education (CME) Training: Healthcare compliance and HR pros can manage required courses using a learning management system (LMS) as part of the compliance process. Pharmacists can access a wide range of relevant, up-to-date courses available anytime, anywhere. Staff can self-assign courses that automatically save to their training profiles, allowing for easy reporting and fulfilling CE or CME license requirements.

Healthcare organizations looking to streamline and improve their pharmacy compliance processes should choose a software solution that saves time, reduces risk, and improves staff and patient safety. Ready to learn more? Contact MedTrainer for a demo.

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