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Pharmacies must post a sign notifying patients how they can file complaints with _____.
1. TSBP
**rule also allows for an electronic messaging system
***if a pharmacy delivers prescriptions to patients, a written notification must be provided with the delivery
Pharmacies that maintain internet sites must include what information on the pharmacy's initial home page and on the page where a sale of a prescription drug occurs?
- information on the ownership of the pharmacy
- internet address and toll-free telephone number that a consumer may use to report medication/device problems to the pharmacy and to report business compliance problems
- information about each pharmacy that dispenses scripts for the website, including the pharmacy name, address, telephone number; the name of the pharmacist responsible for the operation of the pharmacy; the Texas pharmacy license number; a link to the internet site of the TSBP; names of all other states in which the pharmacy is located, including the license number in that state and a link to the internet site of the entity that regulates pharmacies in that state if available
***pharmacies whose internet site has been verified by the NABP to be in compliance with the laws of Texas, as well as all other states the pharmacy is licensed in, are considered compliant with the notification requirements
True or False: a pharmacist not working in a pharmacy must provide the TSBP complaint notice to patients, either by posting a sign in the practice location or providing written notice to each patient when services are provided.
True
Complaints and Confidentiality
the identity of any person who files a complaint with the Board is considered confidential information and is not subject to the Texas Open Records Act
Complaints and Immunity
a person who files a complaint in good faith to the Board is immune from civil liability
Before entering a facility for an inspection, the person authorized to represent the Board must do what?
- state the purpose for the inspection
- provide the owner, pharmacist, or agent the appropriate credentials and a written notice of inspection authority
True or False: for inspections and investigations, a search warrant is not required.
True
What may the Board do during an inspection or investigation?
- inspect and copy documents
- inspect a facility's storage, equipment, security, prescription drugs or devices, components used in compounding, finished and unfinished products, and records
- perform an inventory and take samples of products
***may inspect financial records only in relation to a specific complaint
True or False: any financial data, sales data, or pricing data obtained by the Board during an inspection or investigation is confidential and not subject to the Texas Open Records Act.
True
True or False: DEA has the authority to inspect financial, sales, or pricing records.
False - unless the pharmacy consents to the inspection
As a result of a compliance inspection, an agent of the Board may issue a written warning notice listing specific violations and providing a reasonable amount of time to comply with the laws and rules. What does TSBP consider to be a reasonable amount of time?
no fewer than 10 days unless there is an imminent danger to the public health and safety
When may a compliance officer recommend the institution of disciplinary action against a licensee?
- previously cited violations are continuing to occur
- violations observed are of a nature that a written warning notice would not be in the best interest of the public
Grounds for Discipline: Applicant for or Holder of a Pharmacist License
1. Violation of the TPA or any TSBP rule
2. Unprofessional Conduct
3. Gross Immorality
4. Incapacity
5. Fraud, Deceit, or Misrepresentation (***e.g., providing inaccurate information on an application for a license or renewal of a license)
6. Convicted or placed on deferred adjudication community supervision or deferred disposition or the applicable federal equivalent for a misdemeanor involving moral turpitude or a misdemeanor under the Texas Dangerous Drugs Act, Texas or Federal Controlled Substances Act, or any felony
7. Used alcohol or drugs in an intemperate manner
8. Failed to keep and maintain records
9. Violated the Controlled Substances Act or rules and Dangerous Drug Act or rules
10. Aided or abetted an unlicensed individual to practice pharmacy
11. Refused entry into a pharmacy for an authorized inspection
12. Violated pharmacy or drug laws of this state or any other state
13. Been negligent in the practice of pharmacy
14. Failed to submit to a mental or physical exam as required
15. Dispensed prescription drugs outside the usual course of professional practice
16. Been disciplined by the regulatory board of another state
17. Violated a disciplinary order including a confidential order or contract under the program to aid impaired pharmacists and pharmacy students
18. Failed to adequately supervise a task delegated to a pharmacy technician
19. Inappropriately delegated a task to a pharmacy technician
20. Been responsible for a drug audit shortage
21. Been convicted or adjudicated of a criminal offense that requires registration as a sex offender
Grounds for Discipline for Applicant for or Holder of a Pharmacist License: "Unprofessional Conduct"
1. Dispensing fraudulent scripts or scripts based on orders not issued for a legitimate medical purpose
2. Delivering or offering to deliver a prescription drug in violation of the law
3. Sharing or offering to share with a practitioner compensation received from an individual who was provided pharmacy services as a pharmacist
4. Refusing an inspection
5. Engaging in conduct that subverts or attempts to subvert any examination (NAPLEX, MPJE) required for a license to practice pharmacy
6. Failing to practice pharmacy in an acceptable manner consistent with the public health and welfare
7. Obstructing a Board employee in the lawful performance of their duties
8. Demonstrating abusive, intimidating, or threatening behavior toward a Board member or employee during the performance of such person's lawful duties
9. Failing to maintain effective controls to prevent the diversion or loss of controlled substances or dangerous drugs
10. Dispensing a prescription drug while not acting in the usual course of professional pharmacy practice
11. Failing to correct the issues identified in a warning notice by the specified time
Grounds for Discipline for Applicant for or Holder of a Pharmacist License: "Gross Immorality"
1. Demonstrating conduct which is willful, flagrant, and shameless and which shows moral indifference to community standards
2. Engaging in an act which is a felony
3. Engaging in an act that constitutes sexually deviant behavior
4. Being required to register as a sex offender
Grounds for Discipline for Applicant for or Holder of a Pharmacist License: "Incapacity"
the practicing pharmacist has a mental or physical condition that may cause harm to the public if they continue to practice
Grounds for Discipline of Pharmacy Technicians and Tech Trainees
grounds are similar to those for pharmacists; an additional ground is performing duties that only a pharmacist may perform
Grounds for Discipline of an Applicant for or Holder of a Pharmacy License
1. Been convicted of or placed on deferred adjudication for a misdemeanor involving moral turpitude or a violation of the FCSA or any felony
2. Advertised prescription drugs or devices in a deceitful, misleading, or fraudulent manner
3. Sold prescription drugs without legal authorization
4. Allowed an employee who is not a pharmacist to practice pharmacy
5. Sold an adulterated or misbranded drug
6. Failed to engage in the business described in the application for license within 6 months of the date of issuance of the license
7. Ceased to engage in the business described in the application for a license for a period of 30 days or longer. Upon discovery that a pharmacy has ceased to operate for 30 days, the Board must notify the pharmacy that the pharmacy license will be revoked.
Grounds for Discipline of a Pharmacy License
1. Failed to establish and maintain adequate controls to prevent diversion of prescription drugs
2. Employed a pharmacist, intern, or technician whose license has been revoked, cancelled, retired, surrendered, denied, or suspended
3. Possessed or engaged in the sale of prescription drug samples
4. Waived, discounted, or reduced a patient copay or deductible for a compounded drug in the absence of a legitimate documented financial hardship of the patient or evidence of a good faith effort to collect the copayment or deductible from the patient
Penalties (Discipline authorized): "Reprimand"
Public and formal censure of license
Penalties (Discipline authorized): "Restriction"
Limit, confine, or restrain a license with certain terms or conditions
Penalties (Discipline authorized): "Suspension"
License not in effect for a specified amount of time
Penalties (Discipline authorized): "Probation"
Placing a license under a period of supervision by the Board for a term and under conditions as determined by the Board, including a probation fee
Penalties (Discipline authorized): "Revocation"
License is void and no longer in effect
Penalties (Discipline authorized): "Retire"
License is withdrawn and no longer in effect
Penalties (Discipline authorized): "Administrative Penalty"
- cannot exceed $5,000 per violation, but every day a violation occurs is a separate violation
- civil penalties for license violations and unlawful practice can be as much as $1,000 per day
TSBP Rules of Procedure: Preliminary Notice Letter
- when TSBP initiates disciplinary action against an applicant or licensee
- if Letter is ignored, it could result in a default judgment against the licensee
- Letter will offer an opportunity for the licensee/registrant to attend a nonpublic, informal conference
TSBP Rules of Procedure: Informal Conference (Nonpublic)
- voluntary settlement conference where the licensee or applicant and their attorney meet with a TSBP panel consisting of one Board member, the Executive Director, and the Director of Enforcement
- TSBP is represented at the informal conference by the Board's general counsel
- The Board's attorney presents the allegations from the Prelim Notice Letter, and the licensee and their attorney are given an opportunity to show compliance with the law. If compliance with the law can be demonstrated, the charges are dismissed
- If the charges are not dismissed, the Board panel then deliberates and makes a recommendation to resolve the case by proposing an Agreed Board Order (ABO)
- The licensee can accept or reject the ABO. If it is accepted, it is presented to the full Board for approval. If it is rejected, the matter goes through the formal disciplinary process.
TSBP Rules of Procedure: Formal Conference (Public hearing)
- A hearing is conducted in front of an Administrative Law Judge (ALJ)
- The ALJ issues findings of facts and conclusions of law and recommends sanctions to the Board in a Board Order (BO)
- The Board accepts, denies, or modifies the Board Order
- A Board Order can be appealed to a Texas district court, but a motion for a rehearing must first be filed with TSBP
Before requesting the reissuing of a license that has been revoked or removing a restriction that has been placed on a license, the licensee must wait a minimum of _____ month(s).
12 months
Subpoena Authority
The Board may issue subpoenas to compel attendance of witnesses or to compel the production of documents or records.
Temporary Suspension
A 3 member disciplinary panel appointed by Board president can temporarily suspend or restrict a license if continued practice or operation of a pharmacy would constitute a continuing threat to public welfare; can take place immediately without notice if a hearing is scheduled not later than 14 days after the suspension or restriction.
Remedial Plan
The Board may enter into a remedial plan to resolve a complaint unless the complaint involves a death, hospitalization, commission of a felony, unlicensed practice, audit shortages, diversion of controls, impairment, unauthorized dispensing, gross immorality, fraud, deceit, misrepresentation, or disciplinary action by a board of pharmacy in another state
***not considered formal disciplinary action but are public documents; removed from licensee's record after 5 years
Alternative Dispute Resolution
The Board and a licensee can agree to mediate a disciplinary case through this process following an informal conference (when an agreement could not be reached) and before a formal disciplinary hearing is conducted
Mental or Physical Exam
The Board may request or require an applicant, licensee, or registrant to submit to a mental or physical exam upon a finding of probable cause that identifies a mental or physical incapacity that would prevent them from practicing with a level of skill and competence that ensures the public health, safety, and welfare
Automatic Denial or Revocation
The Board shall deny an application for licensure as a pharmacist or immediately revoke a pharmacist license of a person who is required to register as a sex offender or who has been previously convicted of or placed on adjudication involving the use or threat of force; or has been previously convicted or placed on deferred adjudication community supervision of an offense committed while a licensed pharmacist in the course of providing services to a person who was a patient of the applicant or pharmacist