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Mis/reporting
Miscellaneous, TSBP, FDA, DEA, or other
| Type of Pharmacy/Laws/Facts | Reports to/ Controlled by/Rule |
|---|---|
| 503B (Outsourcing facility) | FDA (w/in 15 days for serious adverse events); report every 6 months) *compound sterile products not based on pt-specific rx's |
| 503A (Facilities or pharmacies) | may only compound products pursuant to an individual rx or medication order; limited compounding regulated by the States, and subject to USP 797 *limits interstate distribution of compounded drugs to 5% unless the compounder is located in a state that has entered a memorandum of understanding (MOU) w/ FDA |
| Illegitimate or suspected product | FDA using form FDA 3911 and notify trading partners within 24h |
| Prescription drug advertising | FDA |
| OTC drug advertising | Federal Trade Commission (FTC) |
| Companies that manufacture and repackage medical devices | FDA *risk associated with medical devices inlcude: Class 1 (low risk such as dental floss); Class 2 (higher risk and requires greater regulatory controls (synrignes); Class 3 (highest risk devices and pose a sig. risk of illness or injjury that require premarket approval (replacement heart valves) |
| drugs intended to be used by animals | FDA |
| Hazards Communication standard | OSHA (administers and enforces this regulation but drugs in solid/final (tablets, capsules) dosage forms are exempt) |
| HITECH Act: PHI breach affecting fewer than 500 individuals, covered entities must maintain a log of these breathes and notify ____ of these breaches ______; covered entities, including pharmacies, to notify individuals of a breah of their "unsecured" PHI within __ days | HHS; annually; 60 |
| HITECH Act: If more than 500 individuals are affected, Secretary of HHS and prominent ____ ___ must be notified in addition to the affected individuals within ____ days after the breach is discovered | local media; 60 |
| Scheduling authority for controlled substances | US Attorney General as head of the DOJ who may add, delete, or reschedule substances but must obtain a scientific and medical recommendation from FDA |
| Scheduling authority for controlled substances in Texas | Commissioner of the Texas Department of State Health Services may add, delete, or reschedule substances but cannot override actions bu the legislature |
| Most supplies (wholesalers) are required to report the acquisition and disposition of Schedule II and certain Schedule III and IV controlled substances to the DEA's _________ | Automation of Reports and Consolidated Orders System (ARCOS) *supplier who reports transactions to ARCOS is not required to send a copy of the original DEA form 222 to the DEA bc this information is already reported to ARCOS *if not required to report transaction to ARCOS (supplier under 5% rule), it must submit a copy of the original DEA 222 to DEA when acting as a supplier (by the close of the month) |
| _____ technically only allows prescriptions for Schedule III, IV, and V CS to be communicated verbally in an emergency (similar to the DEA rule for Schedule II prescriptions) | TCSA; requires that the prescriber privide an E-script within 7 days |
| _____ has indicated that pharamcitsi may dispense a Schedule III-V CS purusnat to an otherwise valid verbal prescription | TSBP |
| ___ permits prescriptions for Schedule III, IV, or V CS to be communicated verbally to a pharmacist by a practitioner or the agent | DEA; *specific requirements for emergency verbal prescriptions for Schedule II CS that include obtaining a valid E-script within 7 ays |
| Faxed prescriptions are treated the same as verbal. Schedule II CS are only allowed in limited circumstances. Faxes are valid for Schedule III-V CS under _____ law. but technically must meet the emergency requirement under the _____ | Federal; TCSA *Faxed rx's must have the prescriber's original signature |
| ___ permits faxed rx's to serve as the original rx in 3 limited situations: (1 and 3 are only for narcotic C-II) ____ had indicated that pharmacits may follow the federal law in these situations. The Faxed prescriptions would need to contain the Texas Official Prescription Form | DEA; TSBP 1. faxed by provider or provider agent for C-II narcotic to be compounded for direct admin to pt by parenteral, IV, IM, SC, or intraspinal infusion 2. for a resident at a LTCF 3. pt enrolled in hospice care program certified and/or paid for by medicare or licensed by state |
| Exemptions to the use of the Official Prescription Form include | -hospital inpatient medication orders -inpatients req. an emergency quantity of a C-II drug upon discharge (limited to a 7-day supply and must be dispensed by the hospital pharmacy) -person receiving treatment from life flight helicopter medical team, emergency medical ambulance crew, or paramedic emergency medical technician) -inmate at correction's facility -animal (exotic game, wildlife park, state or Fed research) -Therapeutic optom. (topical cocaine) -Out of state provider (w/ approved TSBP plan) |
| Unauthorized access of PMP information is a violation of the ____, the Texas Pharmacy Act and ____ rules | TCSA; TSBP |
| Mandatory use of PMP: Practitioners (other than veterinarians) and pharmacists must check the PMP before prescribing or dispensing _____, ______, ______, or ________ | opioids, benzos, barbituates, carisoprodol |
| Dispensing information for controlled substances must be transmitted to ___ no later than the next business day after the date the prescription was filled. | TSBP *if partially filled, then no later than the next business day after the prescription is completely filled |
| A pharmacy that does not dispense any controlled substances during a period of 7 consecutive days must send a report to ____ indicating that the pharmacy did not dispense any CS during that period unless the pharmacy has obtained a waiver from reporting to the board | TSBP |
| Narcotic treatment centers must be registerd with the ____ and also must be certified by the Center for Substance Abuse Treatment (CSAT) within the Substance abuse and Mental Health Services (SAMHSA) of the US department of HHS. In Texas, these programs must also obtain a license issued by the _____ | DEA; Texas Department of Health and Human Services *remember that its a specific type of DEA registration that permits the administration and dispensing of Methadone; however providers working at a registered narcotic treatment program may NOT write prescriptions for methadone for treating addiction |
| The only drugs that may be dispensed by a pharmacy to treat opiate dependence are products containing buprenorphine. What are some common/combination products of this drug? | - Probuphine (Subdermal/SQ implant) - Belbuca (buccal film) - Butrans (weekly patch) - Buprenex (SQ) - Brixadi (SQ) - Sublocade (SQ) - Suboxone (buprenorphine/naloxone buccal film) - Zubsolv (buprenorphine/naloxone sublingual tab) |
| ____ allows pharmacies to implement automatic refill programs for CS in Schedules IV-V but not Schedule III | TSBP; FCSA and TCSA is not addressed |
| Emergency refills for Schedule III-V | FCSA: not addressed TCSA and TSBP allow emergency refills using pharmacist's professional judgment |
| Emergency refills for Schedule II | Not allowed by FCSA or TCSA |
| Inventories required biennially (every 2 years) w/ _____ and _____ | FCSA; TCSA |
| Inventories required annually (every year) and includes a requirement that most inventories be signed by the PIC | TSBP |
| Texas perpetual Inventory requirements: required for Schedule II CS in class ____ pharmacies | C (institutional) |
| Texas perpetual Inventory requirements: required for ALL CS in ____ , Class ____ , and class _____ pharmacies | remote; C (ASC) ambulatory surgical center; F (Freestanding Emergency Medical Care Facility) |
| TCSA has similar requirements to FCSA for security cabinet that is locked or dispersal throughout non-controlled drugs. However, TSBP requires Class _, Class ___, Class ___, and Class ___ pharmacies to have locked storeage for Schedule II CS | Class C (institutional), Class C-S, Class C-Ambulatory Surgical Centers (ASC), and Class F (Freestanding Emergency Medical Care Facility) |
| Restrictions on Opioid Prescriptions for Acute pain: ____ no specific restrictions; _____ no refills and 10-day supply limit for opioid prescriptions for acute pain | FCSA; TCSA |
| Verbal rx: FCSA? | Allowed for Schedule III-V and allowed in an emergency for Schedule II |
| Verbal rx: TCSA? | Allowed only in an emergency for all controlled substances (Schedule II-V), but pharmacist is NOT responsible for determining if all requirements for verbal prescription are met |
| Written rx: TSBP? | requires the quantity to be written as a figure and spelled as a word (i.e. #20 (twenty) |
| Methamphetamine control (Pseudophedrine) Tx law? | locked cabinet w/in 30 feet of and in direct line of sight from a pharmacy counter staffed by an employee of the establishment; *Non-pharmacy retailer myst obtain a Certificate of Authority from the Texas department of State Health Services; purchaser myst be 16 yo |
| Inspections DEA? | cannot inspect financial, sales, and pricing data w/o a pharmacist's consent |
| Inspections TSBP? | may inspect a pharmacy's financial records in the course of an investigation of a specific complaint w/o the pharmacist's consent |
| ____ ____ _____ does permit prescribing of controled substances to such individuals to meet immediate needs, which is defined as no more than a __-hour supply | Texas Medical Board; 72 |
| When a provider retires or dies: Both ______ and Texas Medical Board have agreed by poly that it is an acceptable practice for a pharmacist to provide a ___-day supply of dangerous drug and inform pt to find a new provider. If Schedule III-V, TSBP recommends using emergency refill rules to provide a ___-hour supply | TSBP; 30-day; 72-hour |
| Nurses of home and community support agencies may purchase, store, or transport the following drugs (in a portable sealed container) without being in violation of the Texas Dangerous Drug Act: | SWFI and irrigation; Sterile saline for infection and irrigation, Hep B vaccine, influenza vaccine, tuberculin purified protein derivative for TB testing |
| Nurses of home and community support agencies may purchase, store, or transport the following drugs (in a portable sealed container) without being in violation of the Texas Dangerous Drug Act: no more than 5 dosage units of? | Heparin Na+ lock flush -- 10 U/mL or 100U/mL Epinephrine 1:1000 Diphenhydramine 50 mg/mL Methylprednisolone 125 mg/mL Naloxone 1mg/mL in a 2 mL vial Promethazine 25mg/mL Glucagon injection 1mg/mL Furosemdie 10mg/mL Lidocaine 2.5% and prilocaine 2.5% in a 5gm tube Lidocaine solution 1% in a 2mL vial |
| ____ prohibits OTC sales of products containing dextromethorphan to customers under 18 years of age | Texas Health and Safety Code Chapter 488 |
| Texas legislature passed SB 14 which bans certain _____ transitioning or _______ reassignment treatments for children including the prescribing and dispensing of puberty blockers and hormones | Gender, gender |
| According to the Texas Food, Drug and Cosmetic Act Chapter 431 and 442, Pharmacies may participate as a _______ ___ ___ to provide dangerous drugs (not controlled substances) to charitable medical clinics | charitable drug donor *may also serve as a participating provider to dispense certain prepackaged donated dangerous drugs (not CS) to recipients |
| In a hospital or LTCF, prescriptive authority may be delegated to ____ and ___ through a facility protocol. | APRN; PA's *Freestanding clinics or other medical practices owned or operated by a hospital or LTCF are not considered facility-based practices *Physician may not supervise more than 7APRNS or PA's except in a medically underserved areas or in a facility-based practices in a hospital or LTCF |
| APRN's and PA's CS prescribing in Texas: Only can prescribe in a hospital-based practice under policies approved by the medical staff. Pt must be admitted to the hospital for an intended LOS of __ hours or more or receiving care in __ or have terminal illness and be under _____ care | 24h; ER; hospice *Schedule III, IV, V--> may not exceed a 90-day suply |
| Optometric Glaucoma Specialist: may administer and prescribe ____ or _____ drugs to treat glaucoma | oral; parenteral *Therapeutic optometrist may not prescribe these (only to treat the eye and adnexa meds); *For both: May not prescribe more than one 3-day suppoly of any CS in Schedule III, IV, V |
| Cocaine eye drops for diagnostic purposes: No greater than ___ solution of cocaine eye drops in prepackaged liquid form (solution cannot be compounded. However they may not dispense cocaine solutions. | 10% *Must have a DEA registration to possess and store cocaine eye drops and cannot store more than 2 vials |
| TSBP does not regulate drug wholesalers. They are regulated by the ___ ____ __ ____ ___ ____. TSBP also does not have the authority to regulate pharmaceutical manufacturer;s representatives | Texas Department of State Health Services |
| A pharmacist shall report to the Texas Department of ____ ____ _____ any unusual or increased prescription rates or trends that may be caused by bioterrorism, epidemic, or pandemic disease | State Health Services *increased abx or sales of OTC products to treat respiratory or GI complaints or fever |
| A pharmacist must report after administering Epinephrine ensure 911 is called and pt is evaluated by emergency medical personnel and report to pt's primary care physician within ___ hours from the time of administration | 72 hours |
| providers (Doctors or delated APRN or PA) may issue an order for an epinephrine auto-injector to be stored at specific types of entities. Such an order must contain? | 1. name and signature of prescriber 2. name of the entity to which the order is used 3. quantity of epinephrine auto-injectors to be obtained and maintained under the order 4. Date the order was issued *doesn't require a pt name (same can be for albuterol/levalbuterol for respiratory distress) |
| Scripts for Epinephrine auto-injectors may be dispensed by a pharmacy pursuant to a valid script without requiring the name or any other identifying info of the user for which entities? | 1. Law enforcement agencies 2. Day care centers 3. Child care centers 4. Day camps or youth camps 5. Private or independent institutions of higher education 6. Amusement parks 7. Restaurants 8. Sport venues 9. Youth centers 10: Any other entity designated by rule of the Texas Health and Human Services |
| Scripts for epi pens AND meds for respiratory distress (albuterol/levalbuterol) may be dispensed by a pharmacy pursuant to a valid script without requiring the name or any other identifying information of the user for? | 1. School district 2. Open-enrollment charter school 3. Private School |
| Administration and provision of dangerous drugs by physicians: Tx generally does not permit physician dispensing, except? | 1. physician may provide a 72h supply of dangerous drugs (no CS) to a pt in the physician's office to meet the pt's immediate therapeutic needs 2. certain rural areas w/ no pharmacy may dispense dangerous drugs to pt and be reimbursed for cost 3. Veterinarians are allowed to dispense to their own pts w/o being licensed as a pharmacy |
| Federal Hazardous Substances Act of 1966 administered and enforced by the ____ ____ ____ ____ and have written language of name, business address of manufacturer, packer, distributor and seller along with Danger, Caution, Flammable, poision that should have? | Consumer Product Safety Commission; - Danger for corrosive, extremely flammable or highly toxic - Caution or warning for all other hazardous products - Flammable, harmful if swallowed, causes burns, vapor harmful - Poision: highly toxic in addition to danger |
| Federal Hazardous Substances Act of 1966 (enforced by CPSC) does not apply to drugs regulated by ___ but may apply to other products sold in a pharmacy such as ____, ___ ___, ____, etc | FDA; bleach, cleaning fluids, antifreeze |
| Federal Hazard Communication Standard is adminstered and enforced by ______(OSHA) | Occupational and Safety Health Administration |
| Hazardous drugs such as those subject to USP 800, chemicals, or products NOT in solid, final dosage formfor administration (liquid products for compounding) are covered by what standard? | Federal Hazard Communication Standard |
| The minimum necessary standard (meaning when using and disclosing PHI, a pharmacy must make ____ _____ to limit PHI to the minimum neccesary to accomplish the intended purpose.) | reasonable effort |
| The minimum necessary standard (disclosure of PHI) does not apply to which scenarios? | - disclosure to healthcare providers for treatment purposes (rx transfers, or providing rx info to physicians; - disclosure to which the patient has signed an authorization |
| The minimum necessary standard (disclosure of PHI) does apply to which scenario? | - disclosures for payments |
| HITECH ACT: A breach is defined as _____ _____, access use, or disclosure of PHI that compromises its security or privacy. | unauthorized acquisition |
| "Texas" HIPPA broader difference to HIPPA is that TSBP rules require a pharmacy to respond to a request for confidential records by a pt within ___ days, which is stricter than HIPPA's 30-day timeline | 15 |
| DEA Dispenser license registrations (retail pharmacies, hospitals/clinics, teaching institutions, practitioners, and mid-level practitioners must be renewed every __ years | 3 |
Created by:
Xander635
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