Even among the most conscientious individuals in one of the most regulated professions, mistakes happen. Our health care system has numerous layers of compliance and accountability to prevent errors in the administration of pharmaceuticals. However, all systems have flaws, which can cause mistakes.
When a pharmacist makes a mistake in administering a patient’s prescription, it can have a wide range of consequences for the patient taking the medication and the pharmacist that provided it.
Who Regulates Pharmacists in Texas?
The Texas State Board of Pharmacy (TSBP) oversees all pharmacists licensed in Texas. The TSBP is tasked with adopting rules in compliance with state and federal law for all pharmacists, processing and adjudicating complaints, setting educational standards, and issuing licenses.
What Happens When the Texas State Board of Pharmacy Discovers a Pharmacist Made a Mistake Involving a Patient’s Medication?
Under the Texas State Board of Pharmacy’s procedures, insurance companies with professional liability policies for pharmacists must report specific actions of policyholders to the Board within a particular timeframe of their occurrence. This includes reporting dispensing errors resulting in injury. In addition, individual patients may also report dispensing mistakes directly to the Board.
If the TSBP becomes aware of a dispensing error through the report of an insurance company or via a complaint from a patient, the Board will first determine whether it has jurisdiction over the claim (the Board has jurisdiction over all dispensing errors) and commence administrative action against the pharmacist alleged to have caused the error.
What Are TSBP’s Procedures for Dispensing Errors?
Once the TSBP determines it has jurisdiction over an allegation of misconduct (like a dispensing error), it will first charge an investigator to collect evidence regarding the claim. The investigator may contact the pharmacist subject of the allegation, the person or entity that made the complaint, and other related parties.
After all the evidence has been collected, the TSBP will evaluate the evidence and determine how to proceed. Usually, the Board will set an informal hearing or informal settlement conference (ISC) to resolve the matter. The license holder may elect to have legal counsel represent their interests at this hearing or conference. Once the Board renders a final decision, it may elect dismissal or recommend discipline. After most hearings before the Board, the pharmacist usually walks away with a written or verbal warning of their actions. However, the Board may also decide the pharmacist’s actions require discipline.
Discipline can include a temporary suspension of a license, restriction of practice, payment of a fine, revocation of a license, or retirement of the pharmacist from the profession. License holders also have a right to appeal any decision made by the Board in state court.
Is the Decision that Is Made at a Board Hearing or Informal Settlement Conference Meant to Discipline the Pharmacist?
When the Board decides to discipline a pharmacist, it renders this decision at the informal settlement conference. At the conference, the pharmacist will be provided a date, time, and location of the meeting. During the meeting, the pharmacist and/or their legal counsel will discuss the evidence presented before the Board and have an opportunity to show compliance with applicable Board rules and the provisions of the Texas Pharmacy Act before a panel of Board staff and, usually, two Board members.
After the conference, the panel will render a decision, including a verbal/written reprimand, dismissal, or discipline. If the proposed action is a sanction or discipline, the panel will draft a proposed Agreed Board Order (ABO), which will be presented at the next Board meeting for discussion and adoption. If neither the panel nor the license holder can agree to the proposed ABO, then the case will go before an evidentiary hearing in front of an Administrative Law Judge (ALJ) with the State Office of Administrative Hearings (SOAH).
Once the public hearing concludes, the ALJ will draft a Proposal for Decision (PFD), including a statement of facts in the case, a summary of the law, and a proposal for dismissal or discipline. The Board will then review the PFD at the next Board meeting and decide whether to accept and ratify the order. The license holder may then appeal an adverse order according to Texas law.
Has the Texas State Board of Pharmacy Taken Other Positions on Mistakes Involving the Issuance of Medication to Patients?
Yes. Research conducted in recent years has shed new light on the issue of dispensing errors in the medical profession. Before, it was commonly accepted that dispensing errors were caused by mistakes made by individuals within a group of professionals charged with prescribing, preparing, or administering medication. So, for example, if a patient received the wrong medication or a prescription was coded incorrectly in a database, the blame lay with the prescribing doctor, dispensing pharmacist, pharmacist-in-charge or even the pharmacist tech.
However, the Board has started evaluating dispensing errors using a three-factor test to provide a more comprehensive view of this issue. When reviewing dispensing errors, the Board will look at the following elements:
- The knowledge of the individual professional
- Resources at the professional’s disposal
- The design of systems, including inherent problems and failures in that system
Based on this, the Board has emphasized that health care systems and organizations should address dispensing errors amongst staff and focus on the public welfare when dispensing medication.
What Constitutes a Medication Mistake?
Under the most recent iteration of the TSBP Board Rules, a medication mistake is referred to as a “dispensing error.” Under Subchapter B, §291.31(16), a dispensing error is
An action committed by a pharmacist or other pharmacy personnel that causes the patient or patient’s agent to take possession of a dispensed prescription drug and an individual subsequently discovers that the patient has received an incorrect drug product, which includes incorrect strength, incorrect dosage form, and/or incorrect directions for use.
Under §291.34, records of dispensing errors cannot be deleted or altered and must be maintained under the Board’s record compliance procedures. Dispensing errors can include incorrect data being inputted into an electronic system and must be recorded and corrected in compliance with the Board’s policies.
Contact Us Today for Assistance
If you have been accused of a dispensing error, our experienced licensed pharmacist defense attorneys can help with your case. Call our Austin office or visit us online.