Notifications, Complaints, And Inspections Flashcards
Notifications of Complaint Options
Pharmacies must post a sign notified patient’s how they can file a complaint with TSBP
If the pharmacies delivers, there must be a written notice
If the pharmacy has an internet site, there must be general information on how to file a complaint on their initial home page where refills occur and must provide specific information on how to file a complaints no more than 2 links away
If not in a Pharmacy, there still must be a posted sign at their practice location or written notice
Compliant Policies
1) Confidentiality - confidential information and not a part of Texas Open Records Act
2) Immunity - A person who files a complaint in good faith to the Board is immune from civil liability
Board Inspections
1) Before entering the facility, the person authorized to represent the Board must state the purpose for the inspection and provide the appropriate credentials AND a written notice
2) Search warrants are not required
3) May inspect documents, storage, equipment, security, prescription drugs or devices, compounding components, finished and unfinished products, and records
4) May preform an inventory and take a sample of products
5) May inspect financial records only in relation to a specific complaint (DEA cannot inspect financial, sales or pricing records unless Pharmacy consents)
6) before filing a complaint for a violation as a result of a written warning notice issued during an inspection, TSBP gives the license holding a reasonable time (no fewer than 10 days) to comply
Define Unprofessional Consuct
Dispensing fraudulent prescriptions or prescriptions based on orders not issued for a legitimate medical purpose
Delivering or offering to deliver a prescription in a violation of law
Sharing or offering to share with a practitioner compensation received from an individual who was provided pharmacy services by a pharmacist
Refusing inspection or failing to respond to warning notice
Engaging in conduct that subverts or attempts to subvert any exam required for a license to practice
Failing to practice pharmacy in an acceptable manner consistent with pupils health and welfare
Obstructing a Board employee in the lawful performance of his duties
Failing to maintain effective controls to prevent the diversion or loss of controlled substance is or dangerous drugs
Failing to repay guaranteed student loan
Failing to respond within the time specified on the warning notice issued as a result of a compliance inspection
Responding to an inspection warning notice in a manner that is false or misleading
Define Gross Immorality
Conduct which is willful, flagrant, and shameless and which shows moral indifference to community standards
Engaging in an act which is a felony
Engaging in an act that constitute sexual deviant behavior
Being required to register as a sex offender
Grounds for Discipline for Applicants or License Holders
- Violation of any act or rule
- Unprofessional conduct
- Gross immorality
- Incapacity (mental or physical condition that may cause harm to the public if the pharmacist continues to work)
- Fraud, deceit, or misrepresentation (inaccurate information on license or renewal application)
- Deferred adjudication, misdemeanor involving moral turpitude
- Alcohol or drugs
- Failure to keep or maintain records
- Violation of controlled substances act or rules and dangerous drug act or rules
- Aiding or abetting an unlicensed individual to practice pharmacy
- Refused entry for an authorized inspection
- Violated pharmacy or drug laws of the state
- Been negligent in the practice of pharmacy
- Failure to submit to mental or physical exam as required
- Dispensed prescription drugs outside the usual course of professional practice
- Been disciplined by the regulatory board of another state
- Violated a disciplinary order including a confidentiality order or contract under the program to aid impaired Pharmacy or pharmacy students
- Failed to adequately supervise a test delegate it to a technician or inappropriately delegated the task to a technician
- Been responsible for a drug audit shortage
- Been convicted or adjudicated of a criminal offense that requires registration as a sex offender
Grounds for discipline for pharmacy technicians
Similar to the grounds for discipline of a pharmacist
An additional group for discipline of pharmacy technician who is performing duties are only a pharmacist may perform
Grounds for discipline for an applicant or pharmacy license holder
- Been convicted or placed on deferred adjudication for a misdemeanor involving moral turpitude or any felony
- Advertising prescription drugs in a deceitful, misleading, or fraudulent manner
- Sold prescription drugs without legal authorization
- Allowed an employee who is not a pharmacist to practice pharmacy
- Sold an adulterated or misbranded drug
- Failure to engage in business as described in the application for license within six months of the date of issuance
- Ceased to engage in business
Grounds for discipline for pharmacy
- Failure to establish and maintain adequate controls to prevent diversion of prescription drugs
- Employing a pharmacist, in turn, or pharmacy technician her license has been revoked, canceled, retired, surrendered, denied, or suspended
- Possessing or engaging in the sell of prescription drug samples
