Ch. 5: Complaints, Inspections, Penalities, etc. Flashcards
1
Q
Notice for Complaints
A
- TSBP requires signage of where patients can file complaint with TSBP
- Can be electronic or written and delivered with prescriptions
- Pharmacists not working in a pharmacy must also provide notice to patients with a sign or written notice if services are being provided
2
Q
Pharmacy must maintain internet site with…
A
- Info on pharmacy ownership
- Internet address and toll-free number consumer can use to report med/device/business compliance problems to pharmacy
- Information on each pharmacy that dispenses scripts for the website: name/address/phone number, PIC, license number, link to TSBP, and names of all other states where pharmacy located and that link to regulation body
- Pharmacy with NABP verified website to be compliant in Texas and any other applicable state are considered compliant with notification requirements
3
Q
Complaints
A
- TSBP must adopt policies/procedures concerning investigation of complaints
- Confidentiality: identity of person who files is considered confidential and is not subject to Open Records Act
- Person who files in good faith is immune from civil liability
4
Q
Inspections/Investigations
A
- Before entering for inspection, Board personnel must state purpose of inspection and must provide pharmacy agent/owner with appropriate credentials/written notice of inspection authority
- Search warrant isn’t necessary
- Board may inspect/make copies, inspect storage/security/equipment/drugs/devices, compounding agents, finished/unfinished products, and records
- Can perform inventory and take product samples
- Can inspect financial records in relation to a specific complaint - confidential and not Open Record
5
Q
Result of Inspection
A
- Board agent make issue a written warning regarding violations and amount of time to comply with law/rules (at least 10 days unless imminent danger present)
- Compliance officer may recommend disciplinary action if previous cited violations are still occurring OR violations observed are such that a written warning wouldn’t be in the public’s best interest
6
Q
Grounds for Discipline: Pharmacist Applicant/Holder (21)
A
- Violation of TPA or TSBP rule
- Unprofessional Conduct
- Gross Immorality
- Incapacity
- Fraud/Deceit/Misrepresentation
- Misdemeanor related to moral turpitude, Texas Dangerous Drug Act, Texas CS Act, or ANY felony
- Used alcohol/drugs in intemperate manner
- Failed to keep/maintain records
- Violated Dangerous Drug/CS Act or rules
- Aided/abetted unlicensed person to practice pharmacy
- Refused enter for authorized inspection
- Negligence in pharmacy practice
- Violated pharmacy laws in this/other states
- Failed to submit required mental/physical exams
- Dispensed Rx drugs outside of usual course of practice
- Disciplined by other state boards
- Violated disciplinary order, including confidential ones
- Failed to supervise a task delegated to tech
- Inappropriately delegated task to a tech
- Responsible for drug audit shortage
- Conviction requiring registration as sex offender
7
Q
Examples of Unprofessional Conduct (11)
A
- Dispensing fradulent scripts or illegimate medical purpose for script
- Delivering/offer to deliver script outside of law
- Sharing/offering to share compensation received from individual who received pharmacy services
- Refusing inspection
- Engaging in conduct that subverts any examination required to practice pharmacy
- Failing to practice pharmacy in acceptable manner relating to public health/welfare
- Obstructing Board employee to perform duties
- Demonstrating abusive/intimidating/ threatening behavior towards a board member
- Failing to maintain effective controls to prevent diversion/loss
- Dispensing drug while not acting in usual course of practice
- Failing to correct issues identified in a written notice by specified time
8
Q
Examples of Gross Immorality (4)
A
- Demonstrating conduct that is willful/flagrant/shameless and shows moral indifference to community standards
- Engaging in a felony
- Engaging in sexually deviant behavior
- Registered sex offender
9
Q
Grounds for Discipline: Techs/Trainees
A
- Very similar to those of a pharmacist
- Additional ground is performing a duty that only a pharmacist may perform
10
Q
Ground for Discipline: Pharmacy Applicant/Holder (7)
A
- Convict/deferred adjudication for misdemeanor involving moral turpitude, violation of FCSA, or ANY felony
- Advertised drugs/devices in deceitful/misleading/fraudulent manner
- Sold scripts without legal authorization
- Allowed non-pharmacist to practice pharmacy
- Sold adulterated/misbranded drug(s)
- Failed to engage in business described in license application within 6 months of license issuance
- Ceased to engage in business for 30 days or longer (Board will revoke pharmacy license)
11
Q
Grounds for Discipline: Pharmacy License (4)
A
- Failed to establish/maintain controls to prevent diversion of Rx drugs
- Employed pharmacist/intern/tech whose license was revoked/cancelled/retired/surrendered/etc.
- Possessed/engaged in sales of samples
- Waived/discounted/reduced patient copay or deductible for compounded drug in absence of legitimate documentation of financial hardship or good faith effort to collect copay/deductible from patient
12
Q
Penalties (8)
A
- Reprimand - public/formal censure of license
- Restriction - limit/confine/restrain a license to certain terms/conditions
- Suspension - license not in effect for specified amount of time
- Probation - placing license under Board supervision for a term/under conditions determined by board (fee)
- Refuse to issue/renew license
- Revocation - license is void/no longer effective
- Retire: license withdrawn/no longer effective
- Administrative Penalty - fine (can be included with above sanctions), max of $5,000/day (each day is new violation)
* *Civil penalties for license violations/unlawful practice can be max $1000/day**
13
Q
Preliminary Notice Letter
A
- First step in TSBP disciplinary process
- Sent when TSBP designates disciplinary action against applicant/license
- If ignored, could result in default judgement against license
- Offer opportunity for licensee/registrant to attend non-public informal conference
- Most are voluntarily settled via informal conference.. if not settled/attended then => step 3 (formal conference)
14
Q
Informal Conference
A
- Second step in TSBP disciplinary process
- Voluntary settlement conference where licensee/applicant and their attorney meet TSBP panel (Board member, Exec Dir., and Director of Enforcement)
- TSBP represented by Board’s general counsel
- Board’s attorney presents allegations from preliminary notice letter so licensee/applicant and attorney can show compliance with law (dropped if shown)
- If not dismissed, Board panel deliberates and recommends Agreed Board Order to resolve case
- Licensee can accept/reject ABO; can’t be appealed if accepted and goes to Board for approval
- Rejected => formal disciplinary process
15
Q
Formal Conference
A
- Third step in TSBP disciplinary process
- Formal, public hearing conducted in front of Administrative Law Judge
- ALJ issues findings of facts and conclusions of law/recommends sanction to Board in a Board Order
- Board accepts/denies/modifies BO
- BO can be appealed to a Texas district court, but motion for rehearing with TSBP must be filed first
