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MPJE Review
CH 5-6: Complaints/Discipline + Class A rules
| Question | Answer |
|---|---|
| What must a Texas pharmacy post so patients know how to file complaints with TSBP? Does it need to physical or can it be electronic? | TSBP-required complaint notification, which may be posted by sign or electronic messaging system. |
| : If a Texas pharmacy delivers prescriptions to patients, what complaint-related information must accompany the delivery? | Written notification explaining how the patient can file a complaint with TSBP. |
| What information must a Texas pharmacy with an internet site provide about prescription-drug complaints? | Information on the pharmacy’s *initial/home* page and on the page where prescription-drug sales occur explaining how consumers may report suspected violations or business-compliance problems. |
| What complaint contact information must a Texas pharmacy website provide? | An internet address and toll-free telephone number consumers can use to report complaints |
| What identifying information about the pharmacy itself must appear on its internet site? | Pharmacy name, address, telephone number, and name of the PIC responsible for pharmacy operations. |
| What Texas regulatory information must an internet pharmacy provide? | Its Texas pharmacy license number and a link to the TSBP website. |
| If an internet pharmacy is licensed in other states, what information must it provide? | The names of those states, license numbers in each state, and links to those states’ pharmacy-regulatory websites when available. |
| What additional representation may a NABP-verified internet pharmacy make? | It may state that it has been verified by NABP as complying with the laws of Texas and the other states in which it is licensed. |
| Does a pharmacist who practices somewhere other than a pharmacy escape the public-notice requirement? | No. The pharmacist must provide notice to patients either by posting a sign at the practice location or giving written notice to each patient when services are provided to give them TSBP complaint information |
| Is the identity of a person filing a complaint with TSBP generally confidential? | Yes, including identifying information about the complainant. The complainant is not subject to the Texas Open Records Act |
| What legal protection is given to a person who files a complaint with TSBP in good faith? | Immunity from civil liability for making the complaint and retaliation |
| Before entering a pharmacy for an inspection, what must an authorized TSBP representative do? | State the purpose of the inspection and provide the owner, pharmacist, or agent appropriate credentials and written notice of inspection authority. |
| Does TSBP generally need a search warrant to inspect a licensed pharmacy? | No |
| What pharmacy areas/items may TSBP inspect and copy during an inspection? | The facility’s storage, equipment, security, prescription drugs/devices, compounding components, finished and unfinished products, and records (including patient records) |
| May TSBP inventory pharmacy products during an inspection? | Yes |
| May TSBP take samples of products during an inspection? | Yes |
| May TSBP routinely inspect a pharmacy’s financial, sales, or pricing records simply because it is conducting an inspection? | No |
| When CAN TSBP inspect financial, sales, or pricing data? | In connection to a specific complaint relevant to financials, or if the pharmacy consents to the inspection |
| STUDY TIP: Does DEA have general authority to inspect a pharmacy’s financial, sales, or pricing records? | No, not unless the pharmacy consents to that inspection. |
| Are records obtained by TSBP during an inspection or investigation generally public under the Texas Open Records Act? | No; investigation data are confidential. |
| After a compliance inspection, may TSBP issue a written warning rather than immediately initiate formal discipline? | Yes |
| What does a TSBP written warning following an inspection typically contain? | The specific violations identified and a reasonable time for the pharmacy to comply. |
| What does TSBP generally consider a reasonable amount of time to correct violations identified in a warning? | No fewer than 10 days unless there is an imminent danger to public health and safety. |
| When may a compliance officer recommend initiation of disciplinary action rather than merely issuing a warning? | When prior cited violations continue to occur or the violations are serious enough that a written warning would not be in the public’s best interest. |
| Can unprofessional conduct be grounds for discipline of a pharmacist? | Yes. |
| Can inadequate controls against diversion or loss of controlled substances or dangerous drugs be grounds for discipline? | Yes |
| Can dispensing while not acting in the usual course of professional pharmacy practice be grounds for discipline? | Yes |
| What is “gross immorality” in the disciplinary context? | Willful, flagrant, and shameless conduct showing moral indifference to community standards. |
| What does “incapacity” mean for pharmacist discipline purposes? | A mental or physical condition that may cause harm to the public if the pharmacist continues practicing. |
| STUDY TIP: Does incapacity necessarily mean the pharmacist has already harmed someone? | No. The issue is whether the pharmacist’s mental or physical condition may cause public harm if practice continues. |
| STUDY TIP: What is a common example of fraud/deceit/misrepresentation emphasized by Dr. C? | Providing inaccurate information on a pharmacist license application or renewal application. |
| Can violation of another state’s pharmacy or drug laws be grounds for discipline in Texas? | Yes |
| Can failure to submit to a required mental or physical examination be grounds for discipline? | Yes |
| Can discipline imposed by another state’s regulatory board become grounds for Texas discipline? | Yes |
| Can inadequate supervision of a delegated technician task be grounds for pharmacist discipline? | Yes |
| Can a pharmacist be disciplined for being responsible for a drug audit shortage? | Yes |
| What extra technician-specific ground for discipline does Dr. C highlight? | Performing duties that may legally be performed only by a pharmacist. |
| Can routinely waiving or discounting patient copays/deductibles be grounds for pharmacy discipline? | Yes, unless justified by documented financial hardship or a legitimate good-faith attempt to collect the amount. |
| Can selling an adulterated or misbranded drug be grounds for pharmacy discipline? | Yes |
| What can happen if a newly licensed pharmacy does not begin operating as the type of pharmacy described in its license application within 6 months? | The pharmacy license may be subject to discipline. |
| What must a pharmacy do if it stops operating for 30 days or longer? | Notify TSBP that it has ceased pharmacy operations, or the pharmacy license may be revoked. |
| What is a reprimand? | Public and formal censure of the license. |
| What is a restriction? | Limiting, confining, or restraining a license through specified terms or conditions. |
| What is probation? | The license remains under Board supervision for a specified period and under Board-imposed conditions. |
| What is retirement of a license? | The license is withdrawn and no longer in effect. |
| May TSBP impose an administrative monetary penalty in addition to another sanction? | Yes |
| What is the maximum administrative penalty per violation listed by Dr. C? | $5000 per violation, each day of a continuing violation counts as a new violation |
| Can each day of a continuing violation count as a separate violation? | Yes |
| What CIVIL penalty may apply to license violations and unlawful pharmacy practice? | Up to $1,000 per day, usually issued by a county/city/etc |
| STUDY TIP: What should you know about reprimand, restriction, suspension, probation, revocation, and retirement? | Be able to distinguish what each disciplinary sanction actually does to the license. |
| What document begins the formal TSBP disciplinary process described by Dr. C? | A Preliminary Notice Letter. |
| What may happen if a licensee ignores a Preliminary Notice Letter? | A default judgment may be entered against the licensee. |
| What opportunity is ordinarily offered in a Preliminary Notice Letter? | An opportunity for the licensee/registrant to attend a nonpublic informal conference. |
| Are most TSBP disciplinary matters resolved through the informal conference process? | Many are voluntarily settled through that process. |
| If a disciplinary case cannot be resolved informally, through an informal conference, what may happen next? | The matter may proceed to a formal conference/hearing process. |
| What is an informal conference? | A voluntary settlement conference between the licensee/applicant and a TSBP panel. |
| Who generally represents TSBP at the informal conference? | The Board’s general counsel/attorney |
| What does the Board attorney present during the informal conference? | The allegations from the Preliminary Notice Letter. |
| What opportunity does the licensee receive at an informal conference? | To demonstrate compliance with the law or present mitigating information. |
| What may the Board panel do if charges are not dismissed at the informal conference? | Deliberate and recommend a resolution through a proposed/agreed Board Order. |
| Can the licensee accept or reject the proposed Agreed Board Order? | Yes |
| What happens if the licensee ACCEPTS the Agreed Board Order? | It is presented to the full Board for approval. |
| What happens if the licensee REJECTS the Agreed Board Order? | The matter proceeds through the formal disciplinary process. |
| Once an Agreed Board Order has been approved by the license holder, may it ordinarily be appealed? | NO |
| What occurs at a formal disciplinary hearing? | A hearing similar to a trial is conducted before an Administrative Law Judge. |
| What does the Administrative Law Judge issue after the formal hearing? | Findings of fact, conclusions of law, and recommended sanctions in a Board Order. |
| Is TSBP required to accept the ALJ’s recommendation unchanged? | No. The Board may accept, deny, or modify the Board Order. |
| Can a final Board Order be appealed? | Yes, to a Texas district court. |
| What must generally be filed before appealing a Board Order? | A motion for rehearing with TSBP. |
| Before requesting reissuance of a revoked license or removal of a license restriction, how long must the licensee generally wait? | At least 12 months |
| Does TSBP have subpoena authority during disciplinary matters? | YES, including witness testimony as well as documents/records |
| What may TSBP subpoenas compel? | Witness attendance and production of documents or records. |
| Who may impose a temporary suspension when continued practice or pharmacy operation poses a continuing threat to public welfare? | A three-member disciplinary panel appointed by the Board president. |
| Can a temporary suspension occur without prior notice? | Yes, when the statutory conditions are met |
| How quickly must a hearing be scheduled after a temporary suspension or restriction? | No later than 14 days afterward |
| What is a TSBP remedial plan? | A nonformal resolution designed to resolve certain complaints without formal disciplinary action with no public documents/records |
| How long after completion is a remedial plan removed from the internal licensee’s record? | 5 years |
| What types of complaints are NOT eligible for a remedial plan? | Complaints involving death, hospitalization, commission of a felony, unlicensed practice, audit shortages, diversion of controls, impairment, unauthorized dispensing, gross immorality, fraud/deceit, or discipline by another state’s pharmacy board. |
| What is alternative dispute resolution in the TSBP disciplinary process? | A process used AFTER an informal conference fails to reach agreement but before a formal hearing. |
| Can TSBP require a pharmacist, licensee, or registrant to undergo a mental or physical examination? | Yes, upon a finding of probable cause that a condition may impair safe and competent practice. |
| When must TSBP automatically deny or revoke a pharmacist license? | Registered sex offender, convicted of violent crimes or threat of violence, or convicted of a crime while committed while acting as an RPh |
| What additional license must a Class A pharmacy have if it compounds sterile products? | Class A-S license. |
| Does holding a Class A-S license replace the ordinary Class A rules? | No, they still have to follow all regular class A rules |
| How many PICs must each Class A pharmacy have? | Only one PIC, and the PIC must be employed full-time |
| May a pharmacist ordinarily serve as PIC of more than one Class A pharmacy? | No, except under the limited additional-PIC circumstances described by TSBP. |
| *When may a PIC serve as PIC of two Class A pharmacies? | when the two pharmacies are not open at the same time, or for emergencies when the PIC works at least 10 hours per week in each pharmacy for no more than 30 consecutive days. |
| Who is responsible for the administrative and operational functions of a Class A pharmacy? | The owner |
| If the owner is not a pharmacist, with whom must the owner consult when establishing pharmacy policies and procedures? | The PIC |
| Who supervises pharmacy technicians and trainees in a Class A pharmacy? | A pharmacist |
| May pharmacist supervision of technicians ever occur electronically rather than by constant physical proximity? | Yes, if the pharmacist can immediately communicate directly with the technician/trainee and applicable conditions are met. |
| Who is the “dispensing pharmacist”? | The pharmacist responsible for ensuring the drug is dispensed safely and accurately as prescribed UNLESS the computer system identifies each pharmacist involved in the dispensing process. |
| What is the normal pharmacist-to-technician/technician-trainee ratio in a Class A pharmacy? | 1:6, with max of 3 trainees per pharmacist |
| Does the ordinary Class A 1:6 ratio apply to a central-fill pharmacy with no patient-facing contact? | No |
| Which duties listed by Dr. C may be performed by technicians BUT NOT trainees? | Receiving verbal dangerous-drug prescriptions, transferring dangerous-drug prescription information, and contacting a prescriber for information about an existing prescription. |
| May pharmacy technicians initiate refill-authorization requests? | Yes |
| May pharmacy technicians initiate electronic transfer requests between pharmacies sharing a common database? | Yes |
| Can techs do non-sterile and sterile compounding? | Yes, but extra training is required |
| May technicians perform bulk compounding? | Yes |
| May a pharmacy technician receive a verbal prescription for a noncontrolled dangerous drug? | Yes, but NOT for controls |
| May a pharmacy technician trainee receive a verbal dangerous-drug prescription? | NO, only registered techs can do this |
| STUDY TIP: Who may receive a verbal prescription for a controlled substance? | Only a pharmacist |
| May a pharmacy technician transfer prescription information for a dangerous drug? | Yes, but not for controls |
| May a pharmacy technician trainee transfer prescription information? | No, only a registered tech can |
| May a technician trainee contact the prescriber in that circumstance? | No, only a registered tech can |
| Who is responsible for making a reasonable effort to obtain, record, and maintain patient medication records? | Pharmacist |
| Who verifies controlled substances listed on invoices when they are received? | A pharmacist, by initialing and dating the invoices as required. |
| Who may transfer controlled-substance prescription information? | Pharmacist only |
| What water supply must a Class A pharmacy have? | A sink with hot and cold running water, excluding restroom sinks. |
| If a Class A pharmacy serves the public, what privacy area must it have? | A patient-counseling area designed to maintain confidentiality. |
| Are animals generally allowed in the pharmacy? | No |
| When must the prescription department be locked? | When it is not under pharmacist control, using appropriate keys, combinations, or other mechanical/electronic security. |
| What security system must a pharmacy possessing drugs have at minimum? | A basic alarm system with off-site monitoring and motion detectors. |
| May the PIC or owner authorize certain individuals to enter the prescription department for nondispensing functions? | Yes, if required documentation and controls are maintained. |
| Must the PIC/owner maintain written documentation of authorized nonemployee access to the prescription department when a pharmacist is NOT on site? | Yes |
| What are the rules for a pharmacy with the pharmacist is temporarily absent (for breaks or meals) if the pharmacy remains open? | 1) at least one registered tech 2)Pharmacist is on premesis 3)posted notice that pharmacist is on break 4)No pharmacist only duties can be performed by techs 5)previously verified scripts can be dispensed |
| When does the temporary-absence rule apply? | When there is only one pharmacist on duty in the pharmacy. |
| May the pharmacist leave the prescription department for a break or meal without closing the prescription department? | yes |
| Must the pharmacist remain on the premises during an on-site break? | yes |
| What pharmacy support person must remain in the pharmacy during an on-site pharmacist break? | At least one pharmacy technician, not merely a trainee. |
| May technicians begin processing prescription orders while the pharmacist is on break? | Yes, as long as no pharmacist duties are needed. |
| What must the pharmacist do upon returning from the break regarding work performed by technicians? | Conduct a drug-regimen review and verify all activities performed during the absence. |
| May a patient pick up a prescription that had already been filled and checked before the pharmacist went on break? | Yes |
| STUDY TIP: If a patient picks up a previously checked prescription while the pharmacist is on break, must the patient have received counseling before the pharmacist left? | No. Counseling is provided by giving written information and notice that the patient may contact the pharmacist with questions. |
| If the pharmacist leaves the premises and the prescription department closes, may a technician remain inside the closed pharmacy department? | NO |
| Can a previously verified prescription be delivered to a patient after the pharmacist has left the premises and the prescription department has closed? | Yes, under the special Texas rule and required conditions |
| During what general period may such a previously verified prescription be delivered? | During short periods when the pharmacist is absent, not to exceed 2 consecutive hours in a 24-hour period. |
| What delivery records must be maintained when prescriptions are released after the pharmacist leaves? | Date of delivery, prescription number, patient name and telephone number, and the name of the person picking up the prescription. |
| May the pharmacy use an automated dispensing/delivery system for these after-hours deliveries? | Yes with requirements, and automated delivery systems are NOT limited by the 2 hour rule |
| Is mandatory patient counseling required for new prescription-drug orders in a Texas Class A pharmacy? | Yes, the must attempt to provide counseling, not simply ask if the patient would like to be counseled |
| For counseling purposes, can a prescription be considered “new” even if the patient has previously received the same drug? | Yes, if it has not been dispensed to the patient by that pharmacy in the same strength and dosage form within the past year. |
| Must counseling information be provided verbally? | Yes, when the pharmacist determines the information is significant. |
| May written information supplement verbal counseling? | Yes |
| May required written counseling information be sent electronically? | Yes, including by email, if the patient requested electronic communication and the request is documented. |
| How must the pharmacy document which pharmacist provided counseling? | Through the pharmacist’s initials or identification code on the prescription or in the computer system. |
| What statement must accompany a delivered prescription regarding counseling availability? | Written English and Spanish notice that prescription information has been provided and that a pharmacist is available during normal business hours to answer questions, including an insert phone number. |
| What may nonpharmacist personnel do regarding patient questions? | Techs CAN ask screening questions intended to identify or limit interactions that require the pharmacist. But they cant screen for patient couseling |
| STUDY TIP: Does Texas use an “offer to counsel” standard for new prescription-drug orders? | No, counseling is required, you cannot simply offer counseling to a patient, you must attempt to counsel, in which case the patient may refuse |
| Is a drug-regimen review required for both new prescriptions and refills? | Yes |
| What elements must be looked at during a DRR | Allergies, CIs, rational therapy, directions for use, duplicate therapies, DDIs/FDIs/disease-drug interactions, ADRs, proper utilization |
| What identifying information about the pharmacy must appear on a dispensed prescription label? | Pharmacy name, address, and telephone number. |
| How prominently must the prescription number appear? | Easily readable, in font no smaller than 10-point Times Roman or equivalent. |
| What other info must be on the Rx label? | Date dispensed, pharmacist name or ID code (unless its kept in the computer), prescribers name, patient name (or animal name, owner, and species), instructions for use, quantity, |
| What federal transfer warning is required on Rx label prescriptions when applicable? | It is usually required for schedule 2-4 drugs, must include: “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.” *not needed for dangerous drugs or C5s |
| STUDY TIP: Is the federal transfer caution legally required on Schedule V prescription labels? | No |
| What substitution statement may need to appear when generic substitution occurs? | “Substituted for Brand Prescribed” or “Substituted for Brand Name,” as applicable. |
| What identifying information must appear regarding the drug itself? | Drug name and strength unless otherwise directed by the prescriber and directions for use. |
| What disposal statement must appear on either the prescription label or accompanying written information? | Do not flush unused medications or pour down a sink or drain,” along with the applicable FDA disposal recommendation. |
| STUDY TIP: Why should pharmacists know label requirements even though computers usually print labels automatically? | Because the pharmacist remains responsible for ensuring the legally required elements are present. |
| What special patient notice is generally required when a pharmacy dispenses a Schedule II controlled substance? | Information on locations where Schedule II controlled substances are accepted for safe disposal. |
| Instead of listing individual disposal locations, what may the pharmacy provide? | An internet address of a Board-specified website containing a searchable database of safe-disposal locations. |
| May an undelivered medication remain in a manufacturer’s original container when returned to stock? | Yes when appropriate |
| What must the pharmacist assess before returning an undelivered medication to stock? | The quality and safety of the returned medication. |
| What alternative may a pharmacy provide instead of disposal-location information? | A mail-in pouch or chemicals designed to render unused controlled substances unusable or nonretrievable. |
| If an undelivered medication is no longer in its manufacturer’s original container, what must generally happen? | It must be placed into a new container when dispensed later unless otherwise permitted. |
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