Texas MPJE Review Questions (7/20/19)
Drug Utilization Revew
DUR is normally defined as_____________________________
Verified Accredited Wholesale Distributors (a program designed to protect the public from counterfeit drugs from entering the US drug supply
What is VAWD?
1. Nystatin Susp 100,000u/ml, 30 ml or Nystatin Powder 3 million units 2. Hydrocortisone 60mg 3. Diphenhydramine Syrup qs ad 240ml
What is the formula for Duke's Magic Mouthwash?
1:1 for pharmacist intern only.
What is the limit of supervision a preceptor can perform?
11 members: 7 pharmacists 1 technician 3 public members
What is the makeup of the board? How many pharmacists? How many public members?
2 mg/ml; not more than 200mg/100ml to be classified as C-V.
What is the maximum quantity of codeine in mg/ml to classify it as a C-V CS?
18
What is the minimum age requirement to become a licensed pharmacist?
20 contact hours of CE per renewal period
What is the pharmacy technician continuing education requirements?
1:1
What is the ratio of pharmacists to pharmacist-interns when an intern is performing pharmacy technician duties?
1:5 if pharmacy dispenses no more than 20 different prescription drugs nor produce IV or IM drugs on-site At least 4 are CPhT's and NOT trainees
What is the ratio of pharmacy technicians to pharmacists in Class A?
No rule adopted
What is the ratio of pharmacy technicians to pharmacists in Class C?
1:8, at least 7 are technicians.
What is the ratio of pharmacy technicians to pharmacists in Class G?
1:3, at least 1 is a technician
What is the ratio of pharmacy technicians to pharmacists in Satellite Pharmacy
1:4, at least 1 is a technician
What is the ratio of pharmacy technicians to pharmacists: On-site pharmacist to technicians and trainees?
1:3
What is the ratio of pharmacy technicians to pharmacists: On-site pharmacist to trainees?
3.6 gram/day 9 gram/30 days
What is the sales limit of PSE in Texas?
Texas directs the Department of Health Services to develop a standard information form for sexual assault survivors. The form must include information regarding treatment of sexually transmitted infections and pregnancy, including generally accepted medical procedures, appropriate medications, and any contraindications of the medications prescribed for treated sexually transmitted infections and preventing pregnancy.
What is the state statute on emergency contraception?
For public members and pharmacists: 6 years and limited to 2 consecutive terms
What is the term length for pharmacists and public members?
Adulterated: - has been prepared, packaged or held under unsanitary condition and/or manufactured under conditions that do not meet GMP requirements. - if it contains unapproved color additives and/or is in whole or in any part filthy, putrid, or decomposed substances
How do you classify a drug that is manufactured under conditions that do not meet the requirements of the GMP?
The quantity prescribed and dispensed is limited to treat the patient during the emergency period. The Rx must immediately be reduced to writing by the pharmacist and contain all the information required by law. The authorized prescriber must deliver the written prescription for the emergency quantity prescribed to the dispensing pharmacy within 7 DAYS after authorizing an emergency oral prescription. The prescribing practitioner may issue multiple prescriptions for up to 90 day supply for the CS as long as it follows the regulations regarding when to fill and for a clear medical necessity
How do you dispense C-II in emergency situation?
Donated drugs may be accepted and provided or administered to patients only by a charitable medical clinic, a physician's office using the drugs for patients who receive assistance, a licensed health care professional responsible for administration of drugs in a penal institution. A prescription drug provided or administered to a patient under the pilot program must be prescribed by a practitioner for use by that patient, the clinic, or physician providing or administering the drug may charge a nominal handling fee and a clinic, physician, or other licensed health care professional received donated drugs may NOT resell the drugs. The department shall establish a location to centrally store drugs donated for distribution to qualifying recipients.
How does the Prescription Drug Donation Pilot Program work?
- "dangerous drug" means a device or a drug that is unsafe for self-medication and that is not included in C-I to C-V or Penalty Groups 1 to 4 of the Texas Controlled Substances Act. - includes a device or a drug that bears or is required to bear the legend A) "CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION" or "Rx ONLY" or another legend that complies with federal law, or B) "CAUTION: FEDERAL LAW RESTRICTS THIS DRUG TO USE BY OR ON THE ORDER OF A LICENSED VETERINARIAN."
How is a "dangerous drug" defined under Texas law?
not to exceed 60 days from issue date for medical diagnosis documenting a terminal diagnosis OR patients in LTCF.
How long are C-II prescriptions valid for with patients with a medical diagnosis documenting a terminal diagnosis?
Both CS and non CS - 2 years from last refill date
How long do prescription records have to be kept?
No
Is a board hearing required to transfer a pharmacist license from another state to Texas?
yes, the PTCB's National Pharmacy Technician Certification Exam.
Is a pharmacy technician required to pass an examination?
Yes, a new prescription is required
Is a prescription for a schedule II void if presented for filling later than 21 days after issuance?
No
Is a prescription needed to buy needles and syringes?
Yes
Is an FPGEC certification required?
Yes
Is an expiration date required on a prescription vial label in a community practice?
No, you must take the MPJE for this state.
Is the MPJE licenser results from another state transferable to Texas?
Yes
Is the MPJE required for the state of Texas?
No
Is the sale of syringes or needles restricted to only a pharmacy?
Suppository or combine with any non-controlled substances such as aspirin and acetaminophen (just like amobarbital and pentobarbital)
Is there a certain dosage form of secobarbital that does not require a DEA FORM 222?
Forms may be single or multiple copy forms as provided by the board
TYPES OF FORMS
Prospective or Concurrent
A DUR which is done before dispensing medication to a patient is generally considered as a _____________________ or ________________________ DUR.QQ
Is not at the same location as the class A or class C pharmacy
A class A or class C pharmacy may provide pharmacy services through an APS in a facility that ___________________________________________.
1. It consists in whole or in part of any filthy, putrid or decomposed substance 2. It has been prepared, packed, or held under unsanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health 3. It is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current GMP to assure that such drug meets the requirements of this act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess.
A drug will be deemed adulterated if:
Automated pharmacy system
A mechanical system that dispenses prescription drugs and maintains related transaction information is known as an ________________ ___________ ____________.
It is best to reverse the claim and give the prescription back to the patient.. Otherwise, go ahead and dispense the partial quanitity and dispense the rest within 72 hours of initial dispensing.
A patient comes to the pharmacy with a prescription for Oxycontin and you don't have enough quantity to dispense the full supply. What do you do?
No. The partial filling of C-II (UNDER NO CIRCUMSTANCES) should be given after 72 hours from patient's initial fillng.
A patient comes to your pharmacy with a prescription for Ritalin and only has enough money to pay for 30 tablets. Can the patient come back to pick up the rest of the prescription the following week?
24 hours a day
A pharmacist in Texas who does compounding must be available to respond to patient's and other health care practitioner's needs for how many hours a day?
up to 60 days from date of initial filling.
A prescriber issues a prescription for Demerol 50mg for pain to a resident in LTCF on 7/15/16. How long, after the inital filling is the partial quantity on this prescription valid for?
1. Is registered, certified, or licensed by an occupational regulatory agency in the field of health care 2. Is employed by or participates in the management of a business entity or other organization regulated by or receiving funds from the Board 3. Owns or controls more than 10% interest in a business entity or other organization regulated by or received funds from the Board 4. Uses or receives a substantial amount of tangible goods, services, or funds from the Board
A public member is NOT eligible to be a Board member the the person or their spouse:
Yes. A prescription prepared for a C-II CS to be compounded for the direct administration to a patient by parenteral, IV, IM, SC or intraspinal infusion may be transmitted by the practitioner's agent to the pharmacy by fax. T The fax serves as the original written prescription.
A regis.tered institutional pharmacist receives a fax for compounding morphine sulfate with TPN. Should the pharmacist fill it?
ASA 325mg with 100mg of codeine C-III max is 90mg of codeine per dosage unit
ASA 325mg would be considered a C-II with what mg of codeine?
4. If its container is composed, in whole or in part, of any poisonous or deleterious substances which may render the contents injurious to health. 5. It bears contains, for purposes of coloring only, a color additive that is unsafe. 6. It purports to be or is representated as a drug the name of which is recognized in an official compendium, and its strength differs from or its quality or purity falls below, the standards set forth in such compendium. 7. It is a drug and any substance has been mixed or packed therewith so as to reduce its quality or strength or subsituted wholly or in part thereof.
Also, a drug is adulterated if:
a pharmacist
An APS is required to be under the continuous supervision of whom determined by board rule?
Mid-level practitioners
An individual practitioner other than a physician, dentist, podiatrist, veterinarian who is licensed or registered or otherwise permitted by law to dispense CS is known as _____________ ____________ _________
Yes
Are patient profiles required?
Yes
Are pharmacies allowed to use electronic reference materials?
Yes. They must maintain a policy and procedure manual that includes operating a continuous quality improvement program. Peer Review Committees are recommended as a process of continuous quality improvement.
Are pharmacies required to have any type of continuous quality improvement programs to keep track of and prevent quality-related issues?
On-site training
Are there any pharmacy technician requirements?
Medicaid requires all written prescriptions to be on tamper-resistant prescription pads. Prescriptions submitted via fax, e-prescribing, telephone or prescriptions in long term care facilities and hospitals are exempt from requirements.
Are there any restrictions regarding prescriptions for Medicaid patients?
Yes; Only for C-II drugs and written electronically signed prescriptions. Federal Law requires tamper proof prescriptions written for Medicaid and Medicare recipients.
Are there any special requirements for prescription pads?
The prescriber must deliver a written or electronic prescription to the pharmacist no later than 7 DAYS after an emergency oral or telephone prescription is authorized. Rx goes to the pharmacist at the pharmacy where the prescription was dispensed.
Are there any special restrictions on emergency telephone C-II prescriptions?
1. C-II must be on official prescription form 2. Quantity must be written out (ex. TWENTY) 3. Patient identification is required 4. All Rxs including CS, must have the intended use written on the CS.
Are there any unique laws regarding the actual control drug prescription? For example, unique Rx color or check boxes for quantity, or carbon copies to anyone?
Yes, but the following is applicable: Prescription drugs only in sufficient quantities for immediate therapeutic needs may be removed from the pharmacy. Only a designated licensed nurse or practitioner may remove such drugs. And the pharmacist shall verify the withdrawal and perform a drug review WITHIN 72 HOURS of such withdrawal.
As a full-time pharmacist in a health care facility can you issue a drug for administration that a practitioner orders for a patient residing in the facility if the pharmacy is closed?
Yes. A licensed pharmacist can give the price of prescription drugs to a patient who is inquiring IN PERSON or by TELEPHONE
Can a pharmacist disclose the price of medications to a patient over the phone?
Yes
Can a pharmacist dispense a dangerous drug prescription transmitted by fax?
NO, not from a fax
Can a pharmacist dispense a faxed dangerous drug or CS prescription from the Dominion of Canada or the United Mexican States?
No. Not under any circumstances. Prescriptions for C-III, C-IV or C-V can be transferred only one time.
Can you transfer a prescription for MS Contin?
Yes. It may be issued by a prescriber in another state and may be dispensed if the prescriber is authorized by the other state to prescribe the CS. The pharmacy has a plan approved by and on file with the board allowing the activity and the pharmacy processes and submits the prescription according to the reporting requirements approved in the plan.
Can a C-II be issued by a prescriber in another state?
Yes
Can a license be issued to a foreign educated pharmacist?
Yes. The petition must be in writing and a person petitioning for reinstatement or removal of a restriction has the burden of proof.
Can a person whose license has been revoked by the Board apply for the removal of restriction after the first anniversary?
Yes. If the prescriber is authorized by the other state to prescribe the substance. The pharmacy has a plan approved by and on file with the board allowing the activity and the pharmacy processes and submits the prescription to the reporting requirements approved in this plan.
Can a pharmacist dispense a prescription drug order for Demerol that was issued by a practitioner in another state?
Yes Under normal circumstances, the partial filling of the C-II should be done within 72 hours of initial filling. If the remaining portion cannot be filled within 72 hours, the pharmacist should notify the prescriber.
Can a pharmacist partially fill a prescription (is this if there is not enough supply??)
A pharmacist may exercise his professional judgement in refilling a prescription for a prescription drug (OTHER THAN C-II controlled substance, without the MD authorization if: 1. Failure to refill the prescription might result in an interruption of a therapeutic regimen or create patient suffering 2. Either: A) natural or man-made disaster occurred that prohibits the pharmacist from contacting MD B) pharmacist is unable to contact MD after reasonable effort 3. The quantity of the drug dispensed does not exceed 72 HOUR SUPPLY 4. pharmacist informs patient or agent at the time of dispensing that the refill is being provided without prescriber authorization and that authorization is needed for further refill. 5. pharmacist informs the practitioner of the emergency refill at the earliest reasonable time.
Can a pharmacist refill a prescription drug or device without obtaining authorization from the prescriber?
Yes: can be released to: 1. Patient or patient's agent 2. Practitioner or another pharmacist if the release is necessary to protect the patient's health and well-being 3. The board or to a person or another state or federal agency authorized by law to receive the confidential record 4. Law enforcement agency engaged in investigation of a suspected violation of Chapter 481 or 483, Health Safety Code or the Comprehensive Drug Abuse Prevention and Control Act of 1970. 5. A person employed by a state agency that licenses a practitioner, if the person is performing the person's official duties. 6. Insurance carrier or other 3rd party payor authorized by the patient to receive the info
Can a pharmacist release confidential records?
Yes
Can a pharmacist start, stop or change a drug therapy with a collaborative agreement?
NO. A pharmacist who worked for a health care facility may NOT return a drug that: 1. Has been compounded 2. Appears on inspection to be adulterated 3. Requires refrigeration 4. Has less than 120 days until the expiration date or end of shelf life
Can a pharmacist who also worked for a health care facility return a drug that was compounded?
Yes If the prescriber is authorized by the other state to prescribe the substance.
Can a pharmacy dispense a C-III, C-IV, or C-V issued by a prescriber in another state?
No In Texas, pharmacy permits are non-transferable
Can a pharmacy owner transfer their pharmacy permit?
NO, per the PDMA of 1987 Drug samples cannot be traded or purchased. MD can give sample to pt but RPH not allowed to have samples in the pharmacy
Can a physician trade or purchase drug samples given to them from a medical representative?
The administering or dispensing directly, but not prescribing, of narcotic drugs listed in any schedule to a narcotic drug dependent individual for "detoxification treatment" or "maintenance treatment" shall be deemed to be within the meaning of the term "in the course of his professional practice of research". If the practitioner is separately registered with the U.S. Attorney General and complies with the regulatory standards for treatment qualification, security, records and unsupervised use of drugs pursuant to the Federal Act.
Can a practitioner registered with a narcotic treatment program administer, dispense, and prescribe scheduled narcotic drugs that are approved by the FDA for the treatment of narcotic addiction?
No Not for the purpose of treating acute withdrawal symptoms if necessary wile arrangeents are being made for referral for treatment.
Can a prescriber NOT registered with the DEA administer, dispense and prescribe scheduled narcotic drugs approved by the FDA for narcotic addiction treatment?
Yes
Can a prescriber have ownership in a pharmacy?
No. A prescription may not be issued in order for an individual practitioner to obtain a supply of CS for the purpose of general dispensing to his/her pts. So, a prescription written for office stock or "medical bag" use is not valid.
Can a prescription for Ativan for "office stock" be filled by the pharmacist for the prescriber?
Yes, for up to a total of 90 day supply if: 1. Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in usual course of practice. 2. The practitioner provides written instructions on each prescription (other than 1st prescription, if the practitioner intends for that prescription to be filled immediately) indicating the earliest date on each which a pharmacy may fill each prescription. 3. The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse. 4. The issuance of multiple prescriptions as described in this section is permissible under the applicable state laws. 5. The individual practitioner complies fully with the applicable requirements under the Act and these regulations as well as any additional requirements under state law.
Can an individual practitioner issue multiple C-II prescriptions to a single patient?
An MLP nurse midwife is authorized to dispense CS.
Can certified nurse midwives write a prescription for a narcotic cold and cough prep, hormonal contraceptives, narcotic analgesic, or nonnarcotic prep?
NO.
Can faxing a prescription for a C-II serve as the original prescription?
A pharmacist may dispense nonprescription C-V which contain NO MORE THAN 15mg of opium per 29.5729ml or 28.35gm. Schedule V CS containing codeine, dihydrocodeine, or any of the salts of codeine or dihydrocodeine may not be dispensed without a prescription.
Can you buy a C-V over the counter?
If you meet qualifications, it is available for up to 2 years.
Can you get extended-internship?
Adulterated.
Ciprofloxacin pills accidentally fall on the pharmacy floor and are unknowingly dispensed by the pharmacist to a patient. What are the dispensed pills recognized as?
Theft or stolen CS
DEA 106 is for:
Purchase and transfer of CII CS
DEA 222 is for:
New pharmacy registration
DEA 224 is for:
Renewal of pharmacy registration
DEA 224a is for:
Renewal of
DEA 225a is for
Renewal of
DEA 363a is for:
Disposal or destruction of CS
DEA 41 is for:
Estimated count of C-III through C-V is allowed unless the container holds more than 1000 tablets or capsules, in which case, an exact count is needed.
Do you need an exact count of C-III to C-V?
Yes
Doe Texas issue a license to out-of-state wholesalers?
Drugs dispensed from the automated pharmacy system may be returned to the pharmacy for reuse provided the drugs are in sealed, tamper-evident packaging which has not been opened
Does Texas allow for the return and reuse of drugs?
Federal law permits OTC sales of emergency contraceptives to anyone of child-bearing age.
Does Texas allow pharmacists to dispense emergency contraceptives? Do they need a collaborative agreement?
Yes
Does Texas allow pre-printed prescription forms for a non-controlled prescription?
YES
Does Texas follow USP compounding standards?
Yes - The Prescription Drug Donation Pilot Program
Does Texas have a drug repository/donation program?
In pharmacies with 2 or more pharmacists on duty, the pharmacists shall stagger their breaks and meal periods so that the prescription department is not left without a pharmacist on duty.
Does Texas have any regulations to help with pharmacists workload if pharmacy is employed with 2 or more pharmacists on duty?
If pharmacy is staffed by 1 pharmacist, the pharmacist may leave the prescription department for short periods of time without closing the department and removing pharmacy technicians, pharmacy technician trainee, and other pharmacy personnel from the prescription department during his or her absence.
Does Texas have any regulations to help with pharmacists' workload if the pharmacy is employed with 1 pharmacist on duty?
Yes - by jurisdiction of State Dept of Health
Does Texas have any rules and regulations on prescription medical devices and medical oxygen?
1. Kept behind counter or in locked case within 30 feet or in a direct line of sight from a pharmacy counter staffed by employee of the pharmacy THE STATE LAW DOES NOT APPLY TO LIQUID, LIQUID CAPSULE, OR LIQUID-GEL CAPSULE FORMS OF THE PRODUCTS. (Federal law does?) 2. Check ID containing the person's photograph and indicating that the person is 16 or older and sign for purchase 3. Pharmacy must make a record of sale including A. name of person making the purchase B. date of the purchase C. Item and number of grams purchased 4. Record must be kept for 2 years
Does Texas have any special laws covering purchases of PSE?(
Yes. They must be destroyed in a manner to render the drugs unfit for human consumption and disposed of in compliance with all applicable state and federal requirements under Federal and Texas Controlled Substance Acts.
Does Texas have rules and regulations on how drugs are to be disposed of?
Yes, must comply with Board rules regarding centralized dispensing
Does Texas permit the use of centralized prescription filling?
Yes
Does Texas recognize electronic signatures for non-controlled drug prescriptions that are faxed?
No
Does Texas recognize the VAWD?
for all: Yes. Licensed by the Department of State Health Services
Does Texas require a license for wholesaler distributors of: 1. Prescription medical devices 2. Non-medical devices 3. Non-prescription drugs
Yes. Registered.
Does Texas require that interns be licensed or registered?
Must be licensed pharmacist and certified and licensed as preceptor.
Does Texas require that preceptors be licensed or registered?
No
Does a foreign graduate have to appear before the board before a license can be issued?
Yes. If a pharmacy routinely provides the following services: ships, mails, delivers, dispenses, and/or provides prescription drugs and/or devices to state residents.
Does a non-resident pharmacy providing prescription drugs in the state of Texas have to be licensed or registered?
Registered as pharmacy technician or pharmacy technician trainee.
Does a pharmacy technician have to be licensed? Registered? Certified?
Yes
Does the state board have the power to suspend, deny, or revoke a pharmacy technician's license?
Faxed official prescription forms will be accounted for.
FAXED FORMS
Consent to treatment with an approved narcotic drugs
FDA-2635 is for:
3 hours of ACPE approved provider within the previous 2 years.
For initial certification, how many hours of RPh preceptor training is required.
Must be filled within 72 hours of initial filling. If pharmacist is unable to fill the rest within 72 hours, he/she shall notify the physician. The physician should write a new prescription to cover the rest after a 72 hour period has passed.
How long does a pharmacist have to fill a partial supply of Amphetamine?
If unused, the form is INVALID and must be returned to the Board with an appropriate explanation no later than 30 DAYS after the date with appropriate explanation.
How long does a practitioner have to return an unused official prescription form?
Written prescription may be delivered in person or by mail. The envelope of a prescription delivered by mail most be postmarked NO LATER THAN the 7th day after the date the prescription was authorized.
How long does an authorized prescriber have to mail a written prescription pursuant to an emergency oral prescription for C-II?
within 72 hours or 3 working days of the completed initial, annual, change of ownership, and closing inventory
How long does the PIC have to get notarized their signature and date of inventory following an annual inventory?
Within 60 days of date issued
How long must a partial supply on DEA 222 order form be filled within?
If you do not score a 75%, you must wait 30 days.
How long must you wait to retake the Texas MPJE?
Must be maintained for 2 years
How long should a patient medication record be maintained in the pharmacy?
At least 2 years
How long should inventory records be maintained?
At least 2 years from date of last transaction
How long should the records of a C-V bound book be maintained?
18
How many compliance officers are there in the state of Texas?
A pharmacy may not fill a prescription for a C-II after the end of the 21st day after the prescription is issued
How many days after a C-II prescription is issued, can a pharmacy fill the prescription?
1500
How many hours of practical experience are required for FPGEC?
11
How many members are there in the Texas State Board of Pharmacy?
1 Chief Compliance Officer 3 Compliance Program Officers 2 Compliance Specialists 4 Compliance Officers 8 Compliance Inspectors
How many of each type of compliance officers are there in the state of Texas?
8 classes of Pharmacy 1. Class A - Community Pharmacy 2. Class B - Nuclear Pharmacy 3. Class C - Institutional Pharmacy 4. Class D - Clinic Pharmacy 5. Class E - Non-Resident Pharmacy 6. Class F - Pharmacy located in Freestanding Emergency Medical Care Facility 7. Class G - Central Prescription Drug or Medication Order Processing Pharmacy 8. Class H - Limited Prescription Delivery Pharmacy
How many pharmacy licensing categories are there for the state of Texas?
Once
How many times can a pharmacy transfer a C-III to C-V prescription?
every 2 years
How often does a wholesaler's license need renewed?
every year on May 1.
How often does the inventory of controlled substances need to be taken?
No later than the next business day after the prescription is completely filled
How often is the reporting to the TPMP required?
biennial, every 2 years
How often must a pharmacist renew their license?
Monthly. The PIC shall report to the board in writing any significant loss of information from the data processing system within 10 days of discovery of the loss.
How often should a pharmacy maintain a backup copy of information stored in the data processing system using disk, tape, or other electronic backup system and update this backup copy on a regular basis?
every 7 days
How often would a PIC or staff pharmacist delegated by the PIC have to verify the correctness of a perpetual dangerous drug and CS inventory record of an emergency room?
Inform the patient or the patient's agent at the time of dispensing that the refill is being provided without authorization and said authorization is needed for further refills. The pharmacist should inform the prescriber of the emergency refill at the earliest reasonable time and maintain a record of the emergency refill containing the information required to be maintained on a prescription.
How should you limit the dispensed quantity of unauthorized refills?
Misbranded. A drug shall be classified as misbranded if its labeling is false or misleading in any particular way.
How would you classify a bottle of 250mg cephalexin containing 500mg cephalexin?
Misbranded Unless it has "Federal Legend" and is properly filled.
How would you classify a drug if the label fails to bear the symbol "RX ONLY" prior to dispensing?
Codeine amount in final mixture is 1.24 gram (1000mg + 240mg (12mg/5ml = 240mg/100ml) = 1240mg or 1.24gm. If a mixture contains less than 1.8gm of codeine per 100ml, it is a C-III. Anything over 1.8gm of codeine per 100ml is a C-II
If a pharmacist adds 1000mg of pure codeine to 100ml of Tylenol w/codeine elixir (120mg/12mg/5ml), what should the resultant mixture be classified as?
Every 2 years
If a pharmacy technician has to be registered, how often do they have to renew their registration?
A person's registration as a pharmacist-intern remains in effect as long as the person meets the qualifications for an internship specified by Board rule.
If an intern has to be registered, how long does the registration last?
1. Prescribing or attending practitioner's address 2. Practitioner's DEA registration #, if the rx is for CS
If not immediately retreivable via electronic image, what shall ALSO be included on a hard-copy printout?
NO The person must be registered with the DEA to handle and dispense CS. They have only registered to import CS and therefore cannot obtain a DEA 222 form.
If you are registered to import CS, can you obtain DEA 222 forms?
FDC: Yes - (The State Dept of Heath) The Texas Food, Drug and Cosmetic Act DDL: Yes - (The Board of Pharmacy) The Texas Dangerous Drug Act CSA: Yes = (The Department of Public Safety) The Texas Controlled Substances Act
In addition to Federal Law, does Texas have its own Food, Drug, and Cosmetic Act? Dangerous Drug Law? Controlled Substances Act?
1500 hours
In regards to internship hours, how many years of practical experience do you need?
Physicians (MD or DO) Dentist (DDS) Podiatrist (DPM) Veterinarian (DVM) Optometrists Advance Practice Nurses (APN) Physician's Assistants (PA)
In the state of Texas, who can write a prescription?
1. Pt in LTCF and that is documented on Rx. 2. Pt in hospice program and " " " 3. Rx is for narcotic preparation to administered by IV infusion, IV, IM, SC or intraspinal.
In what instances may a pharmacy dispensed a C-II prescription that was faxed?
Yes. A record of such distribution shall be maintained by the pharmacy in a bound record book containing: 1. True name of the purchaser 2. Current address of the purchaser 3. Name and quantity of CS purchased 4. Date of each purchase 5. Signature or written initials of dispensing RPh
On OTC C-V is it the usual 4oz in 48hr and sign book?
SUBUTEX - buprenorphine - generally given during first few days of treatment SUBOXONE - buprenorphine/naloxone - indicated for maintenance phase of treatment Both are approved for the treatment of opiate dependence and pain relief. Can be used in a combination therapy but not taken at the same time.
Opium addiction treatment..suboxone/subutex, either or both?
A practitioner may not: 1. allow another practitioner to use the individual practitioner's official prescription form. 2. pre-sign an official prescription blank 3. post-date an official prescription blank 4. leave an official prescription blank in a location where the practitioner should reasonably believe another could steal or misuse a prescription
PROHIBITED ACTS:
Prescriptions can be partially filled up to 60 days from the original date of the prescription issued PROVIDED that for each partial filling the pharmacist shall record on the back of the prescription: The date of the partial fill The quantity dispensed The remaining quantity authorized to be dispensed The identification of the dispensing pharmacist
SO what are the partial filling rules for LTCF or terminally ill...
Yes The pharmacy may dispense a prescription for C-III to C-V issued by a practitioner in another state if the practitioner is authorized by the other state to prescribe the substance.
Someone who suffers from severe tooth pain is visiting Texas from Ohio. Upon request, his MD calls the pharmacist in Texas and asks him to dispense a 3 day supply of Tylenol #3. Should you fill the prescription?
All controlled substances Dosage forms containing nalbuphine and carisoprodol
The CS inventory taken must include what?
True
True or false. A faxed prescription is handled in the same manner as a phoned-in prescription.
True
True or false: The inventory date must not be varied more than 4 days from the specified inventory date
If the pharmacist signs a medical release
Under what circumstances can the State Board of Pharmacy obtain medical records of a pharmacist who voluntarily checks into a drug treatment program?
1. Did not establish a diagnosis through the use of acceptable medical practices for the treatment of patient's condition 2. Prescribed prescription drugs that were not necessary for the patient due to a lack of valid medical need or lack of therapeutic purpose for the prescription drugs. 3. Issued the prescriptions outside the usual course of medical practice.
Under Texas law, what are some indicators that a prescription may have been authorized in the absence of a valid patient-prescriber relationship or in violation of the practitioner's standard of practice?
Must be manually signed by the MD and not electronically signed using a system that electronically replicates the prescriber's manual signature on the Rx
Under what circumstances can a pharmacist dispense a CIII-CV rx that was faxed?
MD who practices in a RURAL area, as defined by Texas law, may maintain a supply of dangerous drugs in his office to be dispensed in treating his patients and may be reimbursed for the cost of supplying those drugs without violating the Texas Pharmacy Act.
Under what circumstances can a physician dispense or distribute drugs in quantities greater than those necessary to meet a patient's immediate needs and be reimbursed the cost of supplying those drugs?
yes, IF 1. A share of the pharmacy's business involves the dispensing and delivery or mailing of CS. 2. The Rx is issued by a prescribing practitioner in other state in usual course of practice. 3. The Rx is filled in compliance with a written plan providing the manner in which pharmacy may fill is: a. is submitted by the pharmacy to the director b. is approved by the director in consultation with the Texas State Board of Pharmacy.
Under what circumstances may a Texas pharmacy fill a C-II Rx issued by practitioner in another state?
1. The CS was dispensed under a medication order while the patient was admitted to the hospital 2. The CS is in a properly labeled container 3. The patient possesses not more than a 7-day supply of the CS
Under what circumstances may a practitioner or institutional practitioner allow a patient, upon release from the hospital to possess a CS prescribed by the practitioner?
1. A licensed HCP authorized to administer the medication is not reasonably available to administer the medication. 2. Failure to administer the medication, other than immunization or vaccine, might result in the significant delay or interruption of a critical phase of drug therapy 3. The pharmacist possesses the necessary skill, education and certification as specified by the board to administer the medication 4. Within a reasonable time after administering medication, the pharmacists notifies the licensed HCP responsible for the pt's care that the medication was adminstered 5. The pharmacist may not administer medication to a patient at the patient's residence, except at a licensed nursing home or hospital. 6. The pharmacist administers an immunization or vaccination under a physician's written protocol and meets the standards established by the board.
Under what conditions can the board specify conditions under which the pharmacist may administer medication, including immunizations or vaccines?
A practitioner must account for each voided official prescription form by sending the voided form to the board.
VOIDED
While an official prescription blank is not in immediate use, a practitioner may not maintain or store the book at a location so the book is easily accessible for theft or other misuse.
WHILE NOT IN USE
HIPPA (Health Insurance Portability and Accountability Act) issued in 1996
What act emphasizes the security and safety of health related information?
The State Board of Pharmacy
What agency in charge of disciplining a pharmacist?
heroin LSD peyote methaqualone ecstasy
What are some examples of C-I?
Nurse Practitioners Nurse Midwives Nurse Anesthetists Clinical Nurse Specialists Physicians Assistants Optometrists Ambulance Services Animal Shelters Euthanasia Technicians Nursing Homes Homeopathic Physicians
What are some examples of MLP's?
1. May contain CS if source of supply is DEA registered 2. Security safeguards for each emergency kit 3. Maintain complete and accurate records 4. Requirements on who may be authorized to administer emergency kit drugs 5. Prohibited activities may result in revocation, denial or suspension of privilege to supply.
What are some general requirements for emergency kits placed in institutional facilities?
Every inventory or other record shall be: 1. Kept by the pharmacy and be available for AT LEAST 2 YEARS from the date of inventory or record for inspecting and copying by the board or its representative and to other authorized local, state or federal law enforcement agencies. 2. Supplied by the pharmacy within 72 hours, if requested an authorized agent of the Texas State Board of Pharmacy. 3. If the pharmacy maintains records in an electronic format, the requested records must be provided in a mutually agreeable electronic format if specifically requested by the board or its representative. 4. Failure to provide the records set out in this section, either on site or within 72 hours constitutes prima facie evidence of failure to keep and maintain records in violation of the Act.
What are some guidelines with every inventory or other records required to be kept under the provisions of the Texas Administrative Code?
1. Filling medication carts 2. Distributing routine orders for stock supplies to patient care areas 3. Accessing and restocking automated medication supply systems
What are the duties of a CPhT in Class C (For facility with ongoing clinicial pharmacy program)?
1. Pt is LTCF and "LTCF" is noted on the prescription 2. Rx to be compounded for direct administration to pt by IV, IM, SC or intraspinal infusion. 3. PT w/medical diagnosis w/terminal illess or pt enrolled in hospice certified or paid by Medicare or hospice progra that is licensed and "terminally ill" or "hospice patient" is written on prescription.
What are the exceptions to the rule about faxing C-II prescriptions?
Wholesaler must obtain from the retailer: 1. Retailer's business name, address, area code and phone number 2. Name of the person making the purchase 3. Amount of the product containing ephedrine, PSE or nor PSE ordered 4. Any other information that may be required by the director Make an accurate and legible record of the transaction and maintain the record for at least 2 years after date of transaction.
What are the guidelines for a wholesaler who sells, transfers, or otherwise furnishes a product containing ephedrine, PSE, or norPSE to retailer?
1. Should only be done by a registered pharmacist 2. Cash/credit transaction/delivery by non RPh ok) 3. Purchaser must be 18 years old 4. Every purchaser not known to the pharmacist should furnish suitable identification. 5. A record of dispensing must be entered in a C-V bound book. 4. C-V containing codeine, dihydrocodeine, or any of the salts of codeine or dihydrocodeine may not be distributed without a prescription. 5. A pharmacist may distribute nonprescription C-V CS which contain no more than 15mg of opium per 29.5729ml or 28.35gm 6. Not more than 240 ml (8oz) or not more than 48 solid dosage units of any substance containing opium, may be distributed to the same purchaser in any given 48 hour period without a prescription.
What are the guidelines for dispensing C-V OTC controlled substances?
A practitioner who obtains from the board an official prescription form is accountable FOR EACH NUMBERED FORM.
What are the guidelines with prescribing practitioners using official prescription forms? ACCOUNTABILITY
1. To assure health insurance portability to help keep a person with preexisting health conditions and wants to change jobs. 2 To prevent or reduce health care related fraud and abuse. 3. To ensure the safety and security of each patient's health related information. (to help keep pt's information confidential) 4. To enforce the standard of health.
What are the major objectives of the HIPPA Act?
1. High school or equivalent diploma 2. Complete the Texas application for registration 3. Meet all requirements for Board to access criminal history record 4. Pay required fees
What are the minimum requirements to work as a pharmacy technician TRAINEE?
1. High school or equivalent diploma 2. Taken and passed the PTCB exam, the (NPTC) exam 3. Complete the Texas application for registration 4. Meet all requirements for Board to access criminal history record 5. Pay registration fees
What are the minimum requirements to work as a pharmacy technician?
1. Must be provided with each new Rx or any Rx on the request of patient or agent. 2. Shall be communicated in person unless pt or agent is not in pharmacy or communication barrier exists. 3. Shall be documented by recording the initials or identification code of the RPh providing the counseling in the rx dispensing record on either the hard-copy rx, in the pharmacy's DPS or in an electronic logbook 4. Shall be reinforced with written info relevant to the rx and provided to the pt or agent.
What are the patient counseling requirements in Texas?
30 hours must be completed during the preceding 24 months of the person's license period.
What are the pharmacist continuing education requirements in the State of Texas?
1. Must be C-III, C-IV, C-V 2. Prescription not to exceed 90 days 3. For refill, it must be authorized after consultation with the delegating physician and consultation is noted in chart. 4. For a child less than 2yo, the prescription is written after consultation with the delegating physician and consultation is noted in chart. 5. A list of the APRN's or PA's designated by the practitioner must be maintained in practitioner's usual place of business. 6. On request by a pharmacist, a practitioner shall furnish the pharmacist with a copy of the written authorization for a specific APRN or PA.
What are the prescribing limitations for APRN's and PA's?
1. Complete a course provided by ACPE approved provider A. Requires BLS documentation B. Is an evidence-based course which includes study material, hands-on training in techniques for administering immunizations or vaccines and requires testing with passing score C. Meets current CDC training guidelines and provides minimum of 20 hours of instruction and experiential training in specific area 2. Maintain documentation of: A. Completion of initial course B. 3 hours of CE every 2 years designed to maintain competency in disease states, drugs, and administration of immunizations or vaccines C. Current certification in the AHA BLS for HCPs or its equivalent
What are the requirements for a pharmacist to administer drugs or immunizations?
There is no ratio requirement for preceptors supervising intern-trainees and student-interns as a part of a Texas college/school of pharmacy program.
What is the exception to the 1:1 ratio rule?
1. Be 18 years old 2. Be of good moral character 3. Graduated and received a professional practice degree, or graduated from a foreign college of pharmacy and obtained FPGEC certfication 4. Presented to the Board proof of current or initial licensing by examination and proof that the license has not been suspended, revoked canceled, surrendered, or otherwise restricted for any reason. 5. Submit to the Board a reciprocity fee set by the Board. 6. Submit to the Board a completed application in the form prescribed by the Board given under oath 7. Passed the Texas Pharmacy Jurisprudence examination with a minimum grade of 75.
What are the requirements for transferring a license from another state to Texas?
1. Be a Texas resident 2. Have been registered as a CPhT or RPh preceding appointment 3. Be in good standing to act as an RPh/CPhT in Texas 4. Be acting as an RPh/CPhT in Texas
What are the requirements to be a pharmacist or pharmacy technician member of the Board?
Amobarbital (AMYTAL) Pentobarbital (NEMBUTAL) Secobarbital (SECONAL) Amobarbital/Secobarbital (TUINAL)
What barbiturates are C-II?
Thiamylal (SURITAL) Thiopental (PENTOTHAL) Butalbital (FIORINAL) Butabarbital (LOTUSATE) Aprobarbital (ALURATE)
What barbiturates are C-III?
Methohexital (BREVITAL) Phenobarbital (LUMINAL) Mephobarbital (MEBARAL)
What barbiturates are C-IV?
Have no currently accepted medical use for treatment in the U.S., a lack of safety for use under medical supervision, and a high potential for abuse. They may NOT be prescribed, administered, or dispensed for medical use
What classifies a C-I controlled substance?
Copy 3 is kept by the purchaser Copy 1 + 2 is sent to supplier (who records on copy 1 + 2 the # of containers furnished on each item) Copy 1 is kept by supplier Copy 2 is sent to the DEA
What copies of a DEA 222 order form must a purchaser keep for his own record?
May 31 (yearly or biennially determined by the board)
What day of the year do pharmacy permits expire?
With prior DEA approval, destruction of the CS according to the following guidelines: 1. The pharmacy shall inventory the CS to be destroyed and itemize the inventory on DEA form 41, making 3 copies. 2. The CS shall be shall be destroyed beyond reclamation and disposed of in compliance with all applicable state and federal requirements on the approved date/time/place in the presence of Federal and State law authorized witnesses. 3. DEA approval shall be obtained by submitting a registered or certified letter to the DEA AT LEAST 14 DAYS prior to the anticipated destruction date indicating the day, time and place of the anticipated destruction, and including a copy of DEA FORM 41 which lists the CS to be destroyed
What do you need to know about destroying CS according to Texas Pharmacy Law?
1. Financial data of pharmacy 2. Sales data, other than shipment data 3. Pricing data
What does not the inspection NOT include?
Tamper-resistant packaging provides protection against intentional contamination of over the counter drugs. Certain products such as aerosol, lozenges, and OTC products used in hospitals and not accessible to the general public are exempt from this act.
What does tamper-resistant packaging provide protection against?
1. All marketed drugs in the US have to be safe AND effective. 2. Gives the power to the FDA to regulate advertising of prescription drugs. 3. Provides the GMP guidelines for mfr to mfr drugs in the US.
What does the Drug Efficacy Amendment require?
It designates a substance as a CS or rescheduling or deleting a substance, the commissioner similarly shall designate, reschedule, or delete the substance, unless the commissioner objects during the period. These are the proposed and final implementing the CSA.
What does the Federal Register provide information about?
All CS in C-II, C-III, C-IV and C-V dispensed by a pharmacy or to a Texas resident from an out of state pharmacy
What drugs are reported to the Texas PMP program?
1. Sealed in the mfr's original unopened tamper-evident packaging and either individually packaged or packaged in unit dose packaging 2. Oral or parenteral medication in sealed single-dose containers approved by the FDA. 3. Topical or inhalant drugs in sealed units-of-use containers approved by the FDA. 4. Parenteral medications in sealed multiple-dose containers approved by the FDA from which doses have not been withdrawn.
What drugs can be returned?
1. Initiating and receiving refill authorization requests 2. Entering data into a data processing system 3. Taking a stock bottle from the shelf for a prescription 4. Preparing and packaging prescription drug orders. 5. Affixing prescription labels and auxiliary labels to the prescription container provided by the pharmacy technician. 6. Reconstituting medications 7. Prepackaging and labeling prepackaged drugs 8. Loading bulk unlabeled drugs into an ADS provided a pharmacist verifies that the system is properly loaded prior to use 9. Compounding non-sterile prescriptions 10. Bulk compounding (under direct supervision of pharmacist and must have special training).
What duties can a CPhT perform in Class A pharmacy?
In Class B (nuclear pharmacy) - the preparation and distribution of radio pharmaceuticals
What duties can a CPhT perform in Class B?
1. Prepacking and labeling unit and multiples dose packages 2. Bulk compounding or batch preparation 3. Loading unlabeled drugs into an automated compounding or counting device 4. Compounding medium-risk and high-risk sterile preparations pursuant to medication orders 5. Preparing, packaging or labeling prescription drugs pursuant to medication orders 6. Distributing routine orders for stock supplies to patient care areas 7. Entering medication order and drug distribution information into a data processing system 8. Accessing automated medication supply systems 9. Compounding non-sterile preparations pursuant to medication orders 10. Compounding low-risk sterile preparations pursuant to medication orders
What duties can a CPhT perform in Class C (For facilities with 100 beds or less)?
In Class C (institutional pharmacy) 1. Pre-packing and labeling unit and multiple dose packages 2. Preparing, packaging, compounding or labeling prescription drugs pursuant to medication orders 3. Bulk compounding or batch preparation distributing routine orders for stock supplies to patient care areas 4. Entering medication order and drug distribution info into data processing system. 5. Loading unlabeled drugs into an automated compounding or counting device 6. Accessing automated medication supply systems 7. Compounding non-sterile preparations pursuant to medication orders.
What duties can a CPht perform in Class C? (For facilities with 101 beds or more)
1. Enter medication order and drug distribution information into data processing system 2. Prepare, package, or label a prescription drug according to a medication order 3. Fill a medication cart used in the rural hospital 4. Distribute routine orders for stock supplies to patient care areas 5. Access and restock automated medication supply cabinets
What duties that a CPhT performs in Class C (For rural hospitals)?
the pharmacy can get it ready but the patient must present the original prescription
What happens with a C-II fax?
1. All the scientific info that company has gathered. 2. Has to state what the drug is intended to do 3. Scientific and clinical evidence for efficacy and safety 4. Details of the chemistry and manufacture of the drug 5. Controls and analysis that will ensure that it made accurate claims and that the drug is being promoted for its intended use.
What has to be submitted with the NDA?
The code which identifies the particular drug
What imprint is required on orally administered prescription drugs?
1. Name or signature of the prescriber 2. Name of the patient 3. Name of the drug 4. Date of the prescription With prescriber authorization, the pharmacist can change or add any other information (quantity, strength, directions, etc). The practitioner's authorization MUST be documented by the pharmacist on the prescription kept in the pharmacy.
What information can NOT be changed by a pharmacist on a C-II prescription?
1. Patient's name and room number or patient's facility ID number 2. Prescribing or attending practitioner's name 3. Name, strength, dosage form of drug distributed 4. Total quantity distributed to and returned to the pharmacy
What information should the hard-copy printout contain?
Abbreviated New Drug Application (ANDA): - to market a generic variation of an approved drug once its patent life has expired. - Mfr is only required to submit chemistry and mfring information, and demonstrate that the product is comparable with the product already approved.
What is ANDA?
The DEA will issue a "Blanket Authorization" for CS destruction on a very limited basis to those registrants who are associated with hospitals, clinics or institutions. This allows them to dispose used needles, syringes, CS, and other injectable objects only. This limited exception is granted because of the probability that those objects have been contaminated by hazardous body fluids. The registrant granted to destroy CS must complete DEA FORM 41.
What is a "blanket authorization" and when does the DEA issue it?
A patient med-pak is package prepared by a pharmacist for a specific patient comprising a series of containers and containing TWO OR MORE prescribed solid oral dosage forms. It is so designed or each container is labeled as to indicate the day and time, or period of time that the contents within each container are to be taken.
What is a customized patient medication package?
Prospective DUR
What is checking the therapeutic duplication by pharmacists before dispensing generally classified as?
1. Inspect and copy documents, including records or reports 2. Inspect a pharmacy's storage, equipment, security, prescription drugs, devices, or records 3. Perform an inventory of any stock of prescription drugs or devices in a pharmacy and obtain samples of those substances
What is the extent of inspection from a Board-authorized agent limited to?
1. Known allergies 2. Rational therapy-contraindication 3. Reasonable dose 4. Direction for use 5. Route of administration 6. Duplication of therapy 7. Drug-drug, drug-food, drug-disease interactions 8. Adverse drug reactions 9. Over or under-utilization of prescribed drugs
What is included on a DUR?
Alerts the government that a fraud is taking place and allows a whistle-blower to recover a percentage of the money received under the False Claims Act.
What is qui tam action?
Filling out a DEA 222. Form has 3 copies. Purchaser fills out form keeps copy 3, sends copy 1-2 in. Supplier keeps copy 1 and forwards copy 2 to DEA. A partially filled order must be filled within 60 DAYS from the date of issuance. The order form is no longer valid after 60 DAYS from the time it was executed by the purchaser.
What is required when ordering C-I and C-II?
Double-blind
What is study in which the patients and prescribers are unaware of the true nature of the drug?
An annually revised compilation of final regulations. Requires mfr to imprint special ID codes on oral dosage forms.
What is the Code of Federal Regulations?
a daily publication that lists various federal regulations, final regulations, and government notices.
What is the Federal Register?
One has the scope to eliminate error that can be harmful to patients.
What is the advantage of a prospective or concurrent DUR?
C-V
What is the classification of Phenergan w/codeine syrup?
OPTION 1: 1. file for C-II 2. file for C-III, C-IV, C-V 3. file for all non controls OPTION 2: 1. file for all C-II 2. file for noncontrols and C-III, C-IV, C-V
What is the correct filing method for controlled substances?
If a prescription is created, signed, transmitted, and received electronically, all records relating to that prescription must be retained eletronically
What is the correct filing method for electronic prescription records?
Filling out a DEA 222.
What is the correct way to transfer 30 tablets of Oxycontin 10mg?
3 days. May not be renewed or extended An MD or authorized hospital staff may administer or dispense narcotic drugs in a hospital to maintain or detoxify an individual as an incidental adjunct to medical or surgical treatment of conditions OTHER THAN addiction. Or to an individual with intractable pain in which no relief or cure is possible or none has been found after reasonable efforts.
What is the time limit for a non-DEA registered MD to treat a patient for acute withdrawal symptoms so that a referral for treatment can be made?
May not be refilled - trick question
What is the time limit for refills of C-II?
up to 1 year
What is the time limit for the state of Texas for prescription refills for dangerous drugs or nonprescription drugs?
No more than 5 refills in 6 months
What is the time limit for the state of Texas for refills for C-III to C-V?
10 days, electronically or written
What is the time limit on notifying the State Board of Pharmacy regarding name, address, and employment changes?
Retrospective
What kind of DUR occurs AFTER dispensing of the medication?
The Kefauver-Harris Amendment
What law is known as the Drug Efficacy Amendment?
On the date of closing, the PIC shall take an inventory, remove all Rx drugs from the pharmacy, transfer the Rx drug files, including refill information, and patient medication records to a licensed pharmacy, and remove all signs or notify the landlord or owner of the property that it is unlawful to use the word "PHARMACY" either in English or any other language, or any other word or combination of words of the same or similar meaning, or any graphic representation that would mislead or tend to mislead the public that a pharmacy is located at the address.
What must be done by the pharmacy permit holder before closing or ceasing a pharmacy's operation at a specific place ON CLOSING DAY?
14 days prior to closing, the PIC shall post a closing notice sign in a conspicuous place in front of the prescription department and at all public entrance doors to the pharmacy, which includes: date of closing, the name, address, phone number of the pharmacy acquiring the Rx drug orders, including refill information and patient medication records of the pharmacy.
What must be done by the pharmacy permit holder before closing or ceasing a pharmacy's operation at a specific place PRIOR TO CLOSING?
Within 10 days of closing, the PIC shall forward to the board a written notice of the closing which includes: the actual date of closing, the license issued to the pharmacy, a statement attesting that an inventory has been conducted, and the manner by which the dangerous drugs and controlled substances possesses by the pharmacy were transferred or disposed; and information was transferred.
What needs to be done by a pharmacy permit holder after closing a pharmacy?
The registrant may accept if there are minor misspellings but must contact the DEA for corrected forms.
What needs to be done if the address printed on DEA 222 is incorrect?
A registrant must notify the nearest DEA office 14 DAYS prior to the date of discontinuing of business. If a business has been transferred to another person, the registrant must return the registration certificate and unused DEA 222 forms to the DEA. The unused forms must be marked "VOID" before sending to the DEA. In the case of discontinuing a business without transferring it to another, the registrant still needs to return the certificate of registration and unused DEA 222 forms to the DEA.
What needs to be done with unused DEA 222 forms in the case of discontinuing a CS business?
The DPS shall have the capacity to produce a hard-copy printout of an audit trail of drug distribution and return for any strength and dosage form of a drug (by either brand or generic name or both) during a specific time period.
What prescription information should be present on a hard-copy printout from a data processing system?
The pharmacist is not required be physically present at the site of the APS and may supervise the system electronically. The system must meet security and record keeping requirements established by the Board.
What qualifies as continous supervision of the APS?
1. Name, address and phone number of facility 2. Date supplied 3. Name of practitioner 4. Name of patient 5. Directions for use 6. Brand name and strength of DD or CS (if no brand name, then generic name, strength and name of mfr or distributor of the DD or CS) 7. Quantity supplied 8. Unique identification number
What should a label of a medication include that is being dispensed by an emergency room?
That the data indicated on the daily hard-copy printout is correct, by dating and signing such document in the same manner as signing a check or legal document WITHIN 7 DAYS OF DISPENSING.
What should a pharmacist verify when dispensing or refilling a prescription drug order?
1. Name and description of the drug or device 2. Dosage form 3. Dosage 4. Route of administration 5. Use by the patient 6. Common severe side or adverse effects 7. Interactions and therapeutic containdications that may occur with the therapy 8. Technique for self-monitoring of drug therapy 9. Proper storage of medication 10. Refill information 11. Action to be taken in the event of a missed dose
What should be a part of the counseling?
You must prepare another form in triplicate with the statement indicating the serial number and date of lost forms. You must also notify the nearest DEA office and submit copies 1 and 2 of the second form with a statement to the supplier.
What should you do if multiple DEA 222 order forms come up missing?
You must provide an approximate date of issuance of DEA 222 forms for verification.
What should you do if you are unable to state the serial numbers of the lost DEA 222 forms?
1. Prescriber must be registered with the DEA to prescribe a C-II 2. Board is sole source of prescription forms 3. An institutional practitioner authorized by a hospital or institution to prescribe a C-II under the hospital's DEA my order official prescription forms with restrictions. 4. An APRN or PC operating under a prescriptive authority agreement may order official prescription forms if authority to prescribe has been delegated by a physician. 5. Upon withdrawal of delegating physician's authority, such forms are void and must be returned to the board.
What should you know about an official prescription form?
A pharmacy may at any time forwards CS to DEA registered reverse distributors who handle the disposal of drugs and may contact their local DEA Diversion Field Office for an updated list of those reverse distributors in their area. When a pharmacy transfers C-II substances to a reverse distributor for destruction, the distributor must issue an Official Order Form (DEA FORM 222) to the pharmacy. When a CIII-V CS are transferred to a reverse distributor for destruction, the pharmacy should document in writing the drug name, strength, quantity and date transferred. The DEA registered reverse distributor who will destroy the CS is responsible for submitting a DEA FORM 41 to the DEA when the drugs have been destroyed. A DEA FORM 41 should not be used to record the transfer of CS between the pharmacy and the registered reverse distributor.
What should you know about destruction of CS using authorized reverse distributors?
Department of State Health Services
What state agency is responsible for issuing a license to a wholesale distributor?
Upon completion of the first year of the professional sequence or upon separation from the professional sequence.
When does an intern-trainee registration expire?
The patient med-pak shall come with PPI, in the event that any drug contained in med-pak is required to be dispensed with PPI as accompanying labeling.
When is a PPI generally required?
The drug is prescribed for administration to an ultimate user who is institutionalized in a licensed health care institution (NH, hospital, hospice) No more than a 90 day supply The drug is not in possession of the ultimate user prior to administration
When is a dispensing container NOT required to bear a label?
For LTCF and hospice patients. Pharmacist must record prescription (on official prescription form)m and must indicate "LTCF patient" or "terminally ill". If those words are not on prescription, it will be found in violation. For each partial filling, the pharmacist must record: 1. date of partial filling 2. quantity dispensed 3. remaining quantity authorized 4. name of pharmacist Before filling rest of rx, pharmacist must determine that additional partial fill is necessary Partial quantities cannot exceed total quantity prescribed. Not to exceed 60 days following issue date unless rx is discontinued.
When is the partial filling of C-II permitted?
If more than 5 percent of all controlled substances dispensed by the pharmacy are distributed to other registrants within a 1 year period. A pharmacy registered to dispense controlled substances may distribute controlled substances even without being registered as a distributor provided that: 1. The pharmacy or MD to which the CS is distributed must be registered under the Act to dispense CS. 2. The distributing pharmacy must keep accurate record of distributing CS, including name, dosage form and quantity of the CS distributed. It also requires the name, address, and DEA registration number of the receiving pharmacy or MD. 3. If the transferred CS is either C-I or C-II, the transfer MUST BE MADE ON A DEA-222 form.
When must a pharmacy register as a distributor?
Within 72 hours of the date on which the prescription drug orders were dispensed. Shall be maintained in a separate file at the pharmacy. Records of CS shall be readily retrievable from records of non-CS.
When should the daily hard-copy printout be produced from date of dispensing?
Sodium Pentobarbital is the ONLY allowable method of euthanasia for dogs and cats in the custody of an animal shelter.
Which CS is authorized for humane societies and animal control agencies to use for euthanasia of injured or unwanted animals?
The State Board of Pharmacy
Which board of regulatory agency issues the pharmacist issues?
Schedule II
Which classification of drugs required an exact count when taking inventory?
Humalog (insulin lispro) is a prescription product and requires an authorized prescription. All others are OTC.
Which insulin product requires a prescription to purchase?
The governor with the concurrence of the Senate
Who appoints the members of the Texas State Board of Pharmacy?
1. Commissioned peace officer 2. An agent of the Texas State Board of Pharmacy 3. An agent of the Texas Health and Human Services Commission, authorized by the Texas SBP 4. An agent of the Texas Department of State Health Services, authorized by the Texas SBP. 5. Any 2 of the following: a. facility administrator b. director of nursing c. acting director of nursing d. licensed nurse
Who can be witnesses for destruction of CS?
Hospital Prescriber Retail Pharmacy
Who can keep drug samples?
The Commissioner of Public Health who also shall annually establish the schedule of CS. Annual schedules include the complete list of all CS from the previous schedules and modifications in the federal schedules of CS.
Who has the right to establish and modify schedule of CS under Texas Pharmacy Law?
The pharmacist
Who has to perform the counseling?
Only by an authorized U.S. Officer (by the Attorney General). Any agent designated by the Superintendent of the Department of State Police to conduct drug diversion investigations shall, for the purpose of such investigations, also be permitted access at reasonable times.
Who inspects the records of a C-V bound book?
Call police first.. Theft or loss of CS and/or dangerous drugs should be reported in writing to the Texas State Board of Pharmacy immediately upon discovery. If the theft or loss involves CS, it must also be reported to the Texas Department of Public Safety and the DEA via FORM 106.
Who is first notified of theft of CS? DEA? Police?
the PIC
Who is responsible for filling and loading the storage containers for medication stored in bulk at the facility?
Texas State Board of Pharmacy
Who makes the rules and regulations?
Mid-level practitioners (MLP's) are registered and authorized by the DEA and the state in which they practice to dispense, administer, and prescribe CS in the course of professional practice.
Who may prescribe, dispense, and administer CS in the course of professional practice?
1. Commissioned peace officer 2. An agent of the Texas State Board of Pharmacy
Who needs to witness the actual destruction of a CS in a LTCF?
The FTC (Federal Trade Commission) regulates nonprescription drug advertising under the Federal Trade Commission Act.
Who prevents misleading advertising of OTC products?
Texas Licensed Pharmacists and Pharmacy Students
Who qualifies for the Professional Recovery Network?
CFR (Code of Federal Regulations)
Who requires a mfr to imprint special ID codes oral dosage forms?
Nofify Diversion Field Office of the DEA in area. Notify in writing of the theft or significant loss of any CS within 1 BUSINESS DAY of discovery of loss or theft. The registrant shall also complete, and submit the the Diversion Field Office in his area DEA FORM 106.
Who should a registrant notify, in writing, of a theft or significant loss of any CS within 1 business day of such loss or theft?
From the Dominion of Canada or the United Mexican States - permitted with specific exceptions
Will Texas allow prescriptions from a foreign country prescriber?
Yes
Will Texas allow prescriptions from an out of state prescriber?
C-II Morphine is a C-II, regardless of the dose.
You have 100ml of morphine oral solution (20mg/5ml). You had 6.5 gm of aspirin powder to the solution. What should the resultant mixture be classified as?