L7- Complaints, Inspections, Disciplinary Actions, and Procedures

What are some Notifications that Pharmacies have to give to Consumers?

- They must post a sign notifying patients how they can file complaints

- pharmacists not working in a pharmacy must provide notification (when they are and aren't in office)

- Pharmacy delivering a prescription, must include a written notice with the delivery

What are some Notifications that a pharmacy internet site must give to consumers?

include notifications and specific information

- NABP verified .pharmacy website is deemed compliant

T/F: The identity of a person filing a complaint is confidential

true

A person filing a compliant is entitled to what legally?

to immunity from liability if the filing is in "good faith"

Legal protections for reporting violations/complaints

Protection for individuals (consumers, pharmacists, health professionals, and board members) who reported violations

- they are protected from lawsuits and may recover defense costs if sued

Counterclaim or suit to recover defense costs

right to recovery attorney fees and court costs if sued for reporting violation in good faith

Who conducts pharmacy inspections?

TSBP 'agents' (compliance officers, compliance inspectors, or investigators'

What must occur before TSBP agents can enter and inspect a pharmacy?

they must meet legal requirements for entry and inspection (proper authority or consent)

What type of information is kept confidential during a pharmacy inspection?

Financial, Sales, and Pricing Data

What can TSBP agents issue if they find violations during an inspection?

they may issue a warning notice

How long does The Board typically allow to correct violations after an inspection?

30 days before filing a complaint

Are warrants required for pharmacy inspections?

yes, they can be required in certain situations if entry is denied or not permitted

- feel free to fact check me-

What are some common compliance issues found in inspected pharmacies (Class A & C)?

- CV inventories

- Technician registration

- Incomplete computer records

- Incorrect or incomplete prescription labels

- Inadequate library

- Out of date drugs in inventory

- Sterile compounding

What percentage of Class C pharmacies (Class C-S) have common compliance issues when inspected?

20%

What percentage of Class A pharmacies (Class A-S) have common compliance issues when inspected?

8%

What are some grounds for disciplinary action for pharmacists?

- Violation for Pharmacy Act or Rule

- Unprofessional conduct

- Gross immorality

- Incapacitated

- Fraud, deceit, and misrepresentation

- Conviction or deferred adjudication of certain crimes

- Intemperate use of alcohol

- Failure to maintain records

- Violations of FCSA and other laws

- Aided or abetted unlicensed practice

- Naglicence

- others: failure to pay child support

To get more information on 'Unprofessional Conduct' where would you look?

Rule 281.7.A for a list of 30 "grounds"

To get more information on 'Gross immorality' where would you look?

Rule 281.7.B

To get more information on 'Fraud, deceit, and misrepresentation' where would you look?

Rule 281.7.C

What are some grounds for disciplinary action for pharmacy license holder or applicant?

- conviction or deferred adjudication

- false advertising

- violation of law or rule

- selling without an Rx

- allowing unlicensed practice of pharmacy

- selling adulterated or misbranded products

- failure to engage in business

- failure to maintain reccords

- failure to maintain effective controls to prevent diversion

- fraud, deceit, misrepresentation

- waiving or discounting patient copay or deductible for a compounded drug

If you want to get more information on 'grounds for disciplinary action for pharmacy license holder or applicant about failure to engage in business’, where would you look?

Rule 291.11

If you want to get more information on 'grounds for disciplinary action for pharmacy license holder or applicant' about waiving or discounting patient copay or deductible for a compounded drug?

Rule 281.8.B.8

What are some grounds for disciplinary action for pharmacy technicians and trainees?

- violating a law or rule

- gross immorality

- fraud, deceit, misrepresentation

- other

If you want to find more information on 'grounds for disciplinary action for pharmacy technicians and trainees' where can you look?

Rule 281.9- similar grounds for discipline for technicians and technician trainees

What are the different types of authorized Disciplinary action?

-Reprimand

-Restriction

-Probation

-Suspension

-Administration penalty (fine)

-Refusal to issue or renew

-Revocation

-Retire

What is confidential and not subject to disclosure under the Texas Open Records Act?

Investigative information, including investigative files

What is not subject to any legal action for release like discovery or subpoena?

Investigative information

Can investigative information be disclosed to other state and federal agencies and organizations under certain circumstances?

Yes

1 multiple choice option

What is not considered a disciplinary action, but is public record?

A remedial plan to resolve investigation of a complaint

Why would someone get a temporary suspension?

a threat to the public; due process requirements

How many months must pass for reinstatement of a license or removal of a restriction?

12 months

How much are administrative penalties (fines)?

Not more than $5000 per violation, everyday is a separate violation for imposing a penalty

What are civil penalties for?

for licensure violations and unlawful practice, up to $1000 per day

What are criminal offenses going to be?

A class A misdemeanor; up to one year in county jail and/or a fine of up to $4000

What are the 4 state laws for pharmacy and rules of procedure?

-Administrative Procedures Act

-Texas Open Meetings Act

-Texas Public Information Act

-Texas Pharmacy Act and Rules

When the TSBP is going to discipline a license what is the first thing they do?

Send a preliminary Notice Letter

Should you ignore a preliminary notice letter?

NO DO NOT IGNORE it could result in a defult order

1 multiple choice option

What is the next step after a prelimanary notice?

An informal disciplinary procedures.

-Settlement in non-public conference with Board staff and one Board member

-Will offer an Agreed Board Order (ABO). If licensee agrees and Board accepts, it cannot be appealed.

What is another way that the TSBP can discipline a license?

A formal disciplinary procedure (public/formal hearing)

-Like a trial in front of Administrative Law Judge (ALJ)

-ALJ issues an opinion recommending sanction.

-Board issues a formal Board Order (BO) which can be appealed.

-Motion for rehearing must be filed within 15 days.

How are are most cases resolved?

Informal Disciplinary Procedures

What is the only board order that is not considered public information?

An impaired pharmacist order

If you want to look into general guidelines what rule should you look?

Rule 281.60

If you want to look into ‘aggravating and mitigating factors’ what rule should you look?

Rule 281.62

If you want to look into ‘criminal offenses’ what rule should you look?

281.63, it will show you crimes relating to board licensiees and registrants

If you want to look into ‘sanctions for applicants with criminal offenses’ what rule should you look?

Rule 281.64

If you want to look into ‘schedule from administrative penalties (fines)’ what rule should you look?

Rule 281.65

If you want to look into ‘out of state disciplinary actions’ what rule should you look?

Rule 281.67

If you want to look into ‘autonomic Denial or revocation’ what rule should you look?

Rule 281.69

T/F: The Texas State Board of Pharmacy (TSBP) oversees complaints, inspections, and

disciplinary actions to protect public health and ensure pharmacy compliance.

True

Who can submit complaints?

patients, healthcare professionals, or the public and are

investigated to determine if violations of pharmacy laws or rules have occurred.

What do inspections assess for?

assess compliance with state regulations, with common

deficiencies in areas such as recordkeeping, labeling, storage, and staffing.

T/F: Disciplinary procedures follow a structured process, including investigation, informal settlement conferences, and potential formal hearings, while ensuring due process rights for licensees.

True

What must pharmacists do?

apply regulatory knowledge in practice to identify risks, prevent violations, and make legally sound decisions that uphold professional standards and patient safety