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Texas Pharmacy Law Exam Already Graded
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Pure Food and Drug Act 1906 - correct answer -Purity Standards (Misbranded, Adulterated) Food, Drug, and Cosmetic Act (1938) - correct answer -Created FDA -Required drug to be SAFE when used according to labeled direction Durham-Humphrey Amendment (1951) - correct answer -Created OTC and RX distinction: Manufacturers of prescription drugs must provide a warning on the label stating, "Federal law prohibits dispensing without a prescription" -Allowed the authorization of oral prescriptions and refilling Kefauver-Harris Amendment (1962) - correct answer -Requires "PROOF-OF-EFFICACY" (passed in response to thalidomide) -Provides the authority to the FDA to regulate prescription drug advertisements, must disclose SE (Note that the FTC regulates OTC advertising, not the FDA) -Provides good manufacturing practices (GMP) guidelines for drug manufacturers Medical Device Act (1976) - correct answer -Passed to protect public from dangerous and useless devices -Sets GMP standard manufacturing for medical devices Orphan Drug Act (1983) - correct answer -Extended patent life of drugs to treat rare disorders in order to encourage pharmaceutical companies to develop drugs for diseases that have a small market Hatch-Waxman Act (1984) - correct answer -A.K.A. Drug Price Competition and Patent Restoration Act -ANDA: Abbreviated new drug application for generic drugs, generic manufacturing drug companies only have to show bioequivalence, no duplicate clinical testing -Increases the patanet term for newly dveloped drugs. Encourages innovation
Prescription Drug Marketing Act (Dingle Bill Act of 1987) - correct answer -Requires states to license wholesale distributors under federal guidelines -Provides a minimum standard for prescription drug storage, handling, and record keeping -Bans re-importation of prescription drugs produced in the US -Bans sale, trade, or purchase of drug samples -Mandates storage, handling, and recordkeeping requirements for drug samples -Prohibits the resale of prescription drugs purchased by hospitals or healthcare facilities (certain exceptions) Omnibus Reconciliation Act of 1990 (OBRA-90) - correct answer -Prospective Drug Utilization Review -Patient Counseling Standards: Dispensing pharmacist must offer counseling (In Texas required to counsel, not just offer, must document later) FDA Modernization Act (1997) - correct answer -Replaced the prescription legend "Caution: Federal law prohibits dispensing without a prescription" with "Rx Only". -Clarified when a pharmacist may compound prescription drugs FDA Rule: OTC Labeling Requirments (1999) - correct answer -Standard, easy to read format making it easier for self-administration easier and safer Define an "Adulterated" drug - correct answer -"It's dirty" -Contaminated, filthy, putrid, decomposed -The manufacturing does not comply with GMP -Unsafe color additive -Labeled as "USP" but is not -Strength differs from what the label says -If it is mixed or packed with any substance with reduces its strength or quality or the drug has been substituted wholly or in part Define a "Misbranded" drug - correct answer -"It's a lie" -Label is false or misleading
Describe a Class I drug recall - correct answer Generally issued when the drug is believed to cause serious adverse health problems including death Describe a Class II drug recall - correct answer Issued when the drug causes temporary or reversible medical consequences and adverse reactions Describe a Class III drug recall - correct answer Issued when the drug is not likely to cause any health problems Which government entity regulates prescription drug advertising? - correct answer FDA What information does the FDA require all "Direct to consumer" advertising to contain? - correct answer -Accurate and not misleading -Make claims only when supported by substantial evidence -Reflect the balance between risks and benefits -Be consistent with the FDA approved labeling Which government entity regulates OTC advertising? - correct answer FTC A "Med guide" written in lay language that includes an explanation of how to safely use a drug must be provided or the prescription is considered....? - correct answer Misbranded When may the FDA require a Medguide - correct answer -It could prevent serous adverse effects -The drug has serious risks that could influence patients' decision to use it -Patient adherence to directions is crucial Describe the different parts of the NDC - correct answer The NDC is a 10 or 11 digit code divided into 3 segements
- Labeler code--first 4 to 5 digits
- Drug product code--middle 4 digits
- Pack size code--last 2 digits
Describe pregnancy category A - correct answer Adequate and well controlled studies have failed to demonstrated a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters) Describe pregnancy category B - correct answer Animal or reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate risk to the fetus in any trimester Describe pregnancy category C - correct answer Animal reproductions studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks Describe pregnancy category D - correct answer There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks Describe pregnancy category X - correct answer Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits Poison Prevention Packaging Act - correct answer -Requires child-resistant containers for prescription and non-prescription drugs -The physician or the patient may request non-child resistant containers (the PATIENT may sign a blanket waiver to child resistant caps) -Manufacturers of OTC products may designate ONE size to be easy open for the elderly What does the acronym "HIPPAA" mean? - correct answer Health Insurance Portability and Accountability Act
-Requires use of Official Prescription Form Pure forms of codeine and hydrocodone are what Schedule? - correct answer Schedule II When mixed with other non-narcotic agents, which drugs may be classified as Schedule III, so long as they do not maximum allowable limits? - correct answer Codeine, Dihydrocodeine, Morphine, Opium, Ethymorphine, and Hydrocodone What are the maxim allowable limits for Codeine to be classified as a Schedule III? - correct answer Max concentration: 1.8gm/100ml Max dosage per unit: 90mg What are the maximum allowable limits for Dihydrocodeine to be classified as a Schedule III? - correct answer Max concentration: 1.8gm/100ml Max dosage per unit: 90mg What is the maximum allowable limit for Morphine to be classified as Schedule III? - correct answer Max concentration: 50mg/100ml What are the maximum allowable limits for Opium to be classified as Schedule III? - correct answer Max concentration: 500mg/100ml Max dosage per unit: 25mg What are the maximum allowable limits for Ethylmorphine to be classified as Schedule III? - correct answer Max concentration: 300mg/100ml Max dosage per unit: 15mg What are the maximum allowable limits for Hyrdocodone to be classified as Schedule III? - correct answer Max concentration: 300mg/100ml Max dosage per unit: 15mg
Define a Schedule IV drug - correct answer Low potential for abuse (Examples: alprazolam, diazepam, phenobarbital, and phentermine) What is the maximum allowable limit for Codeine to be classified as a Schedule V drug? - correct answer Max concentration: 200mg/100ml What is the maximum allowable limit for Dihydrocodeine to be classified as a Schedule V drug? - correct answer Max concentration: 100mg/100ml What is the maximum allowable limit for Opium to be classified as a Schedule V? - correct answer Max concentration: 100mg/100ml What is the maximum allowable limit for Ethylmorphine to be classified as a Schedule V? - correct answer Max concentration: 100mg/100ml Is a separate DEA registration required for each pharmacy location? - correct answer yes What is considered a "mid-level" practitioner? Do they have to register with the DEA? - correct answer Advanced Practice Nurse or Physician Assistant must register with the DEA to prescribe controlled substances Does a pharmacist have to register with the DEA in order to dispense controlled substances? - correct answer No What are the 3 steps to verity a DEA number? - correct answer 1) Add the 1st, 3rd, and 5th digits
- Add the 2nd, 4th, and 6th digits and multiply by 2
- Add the sum of steps 1 and 2 -The last digit of the sum should be the same as the last digit of the DEA number -The second letter should be the first initial of the prescriber's last name Are interns, residents, staff physicians, and mid-level practitioners acting as an agent of the hospital able to administer, dispense, and prescribe controlled substances using the hospital's registration? - correct
Date of the prescription Where do physicians order Schedule II prescription forms from? What is the form printed with? - correct answer DPS. The form is printed with the prescriber's name, address, DEA number, and DPS number. Each official prescription form is sequentially monitored. What must the physician complete for each Schedule II prescription? - correct answer -Date the prescription was issue -Patient name & address (the pharmacist may add this upon verification if it is omitted by the physician) -Patient age -Drug, strength and quantity -Directions for use -Signature of the physician -Physician's DPS registration number and DEA registration number How many drugs may be prescribed on each Schedule II prescription form? - correct answer Only ONE drug per prescription form How long are schedule II prescriptions valid for? - correct answer 21 days What is the law concerning the partial filling of a Schedule II prescription? - correct answer If a pharmacy does not have the full quantity the pharmacist my partially fill the prescription, but the remaining quantity must be filled within 72 hours and the pharmacist must document the partial fill on the face of the prescription. If the remaining portion is not filled within 72 hours, the prescription becomes void, the pharmacist must notify the physician, and the patient must get another prescription. What is the only exception to the law concerning partial filling of a Schedule II prescription? - correct answer Partial filling a Schedule II for a terminally ill patient or a patient in a long-term care facility:
- The prescription is valid for 60 days
- The pharmacist may fill as partial quantities as needed
- For each partial filling, the pharmacist must record on the back of the prescription: the date, quantity filled, quantity remaining, and the dispensing pharmacist's name
A FAXED COPY of the Official Prescription Form of Schedule II prescription may serve as the original prescription under what situation(s)? - correct answer -When a Schedule II narcotic is for direct administration to a patient in home infusion or IV pain management therapy -When a Schedule II substance is prescribed to a patient in a long term care facility -When a Schedule II narcotic is prescribed for a patient in hospice care What are the exemptions from the Official Schedule II prescription program? - correct answer -Hospital inpatient medication records -Upon discharge from the hospital the patient may take a schedule II drug with them if: the substance was dispensed while the patient was admitted to the hospital, the substance is in a properly labeled container, and it is not more than a 7 day dupply -A patient receiving treatment from an emergency medical ambulance, paramedic emergency medical technician, or life flight helicopter medical team -A patient receiving treatment while an inmate at a correctional facility operated by the Texas Department of Criminal Justice -Animals admitted to animal hospitals or in wildlife management programs, or state or federal research facilities -Therapeutic optometrists administering topical cocaine What is the law concerning the filling of Schedule II drugs in emergency situations? - correct answer -A pharmacist may fill an oral Schedule II prescription in an emergency situation -The pharmacist must record all the information that would be required on an official prescription -The physician must deliver or mail a hard copy to the pharmacy within 7 days What information is required for Schedule III-V prescriptions? - correct answer -Date the prescription was issue -Patient name & address (pharmacist may add this upon verification if it is omitted) -Patient's DOB -Drug strength, quantity, directions for use -Intended use -Signature of the practitioner
What is required for the transfer of Schedule III-V drugs between pharmacies? - correct answer A commercial invoice How many members are on the Texas State Board of Pharmacy? Who is responsible for their appointment? How long is their term? How many pharmacists are on the Board? How many terms may a Board member serve? - correct answer 9 Members appointed by the Governor with the consent and advice of the Senate for a 6 year term (6 pharmacists and 3 public members). A member may not serve more than 2 consecutive terms. Which 2 classes of pharmacies must be represented on the Texas State Board of Pharmacy? How many members are required for a quorum? - correct answer Class A and Class C pharmacies must be represented. A majority of members is required for quorum (5 members). A majority vote of the quorum is required for official action. What are the qualifications to become a Board member of the Texas State Board of Pharmacy? - correct answer The member must be a Texas resident, licensed for 5 years preceding appointment, license must be in good standing with the Board, and must be practicing pharmacy in this state. What are the requirements for pharmacist licensing by examination? - correct answer -Must be at least 18 years old -Good moral character -Graduate of ACPE accredited school or graduate of a foreign college of pharmacy and obtained full certification from the FPGEC -Completed 1500 hours of internship -Pass NAPLEX and MPJE -Has not had license suspended or revoked in another state What are the requirements for pharmacist licensing by reciprocity? - correct answer -Must have been licensed by exam in the state you are reciprocating from, OR Must have been continually engaged in the practice of pharmacy for a period of 2 years immediately preceding application -Pass MPJE
What are the requirements for pharmacist-intern licensing? - correct answer -Enrollment in an ACPE accredited college of pharmacy -Successfully complete the first professional year and 30 credit hours What are the duties of a pharmacist-intern? - correct answer A pharmacist-intern may perform any duty of a pharmacist when under the direct supervision of a preceptor What are 3 things that a pharmacist-intern may not do? - correct answer -Present or identify himself/herself as a pharmacist -Sign or initial any document which is required to be signed or initiated by a pharmacist -Supervise technicians When does a pharmacist-intern license expire? - correct answer If the student does not take the NAPLEX and MPJE within 3 months of graduation What are the requirements in order to be a preceptor? - correct answer 1 year experience in a pharmacy setting AND 3 hours of preceptor CE within the last 2 years What must pharmacists display in their primary place of practice? - correct answer Their license and renewal certificate A pharmacist must notify the board within 10 days of what? - correct answer Changing the name, address, or place of employment Who is responsible for ensured that a pharmacy is in compliance with all state and federal laws and rules? - correct answer The Pharmacist-in-charge Pharmacists must renew their license every.....? - correct answer 2 years What are the late registration penalties for pharmacist license renewal? Is there a grace period? - correct answer -No grace period -1 to 90 days late: 1&1/2 times the renewal fee
What are the required notifications for pharmacist administration of vaccines under the written protocol of a physician? - correct answer -The pharmacist must notify the supervising physician within 24 hours of the administration of the immunization or vaccination -The pharmacist must notify the patient's primary care physician within 14 days Patients under what age must be referred to a physician for immunization? - correct answer 14 years old How long must patient immunization records be maintained by a pharmacist? - correct answer 2 years Under what conditions may a pharmacist refill an emergency 72 hour supply for a patient? - correct answer If failure to refill might result in an interruption of therapy or create patient suffering -This does not apply to CII's -The pharmacist must inform the patient at the time of dispensing that there are no refills and that authorization of the practitioner will be required for further refills -The pharmacist must inform the practitioner at the earliest reasonable time What are the provisions of the Natural or Manmade Disaster Provision (Passed in response to Hurricane Katrina)? - correct answer A pharmacist may dispense a 30 day supply without authorization of the prescriber if: -Failure to refill might result in an interruption of therapy or create patient suffering -The pharmacist is unable to contact the prescriber -The governor has declared a state of emergency -The executive director of TSBP has notified pharmacies Can a pharmacist dispense a prescription if he or she knows that the prescription was issued after an internet consultation or telephone conversation? - correct answer No. This does not apply in an emergency (Ex. When a physician is on call for another physician) How long is the registration valid for a technician trainee? - correct answer Valid for 2 years and it may not be renewed
What are the requirements for being a technician trainee? - correct answer Applicant must have a high school diploma or equivalent, or be working to achieve a high school diploma or equivalent. The applicant must also pass the criminal history check and provide fingerprint information (and pay required fee for the fingerprint service) What are the requirements for Pharmacy technician certification? - correct answer -High school diploma or equivalent -Pass the PTCB Exam What are the CE requirements for pharmacy technicicans? - correct answer Maintain 20 hours of CE during each renewal period (2 years). At least 1 hour must be pharmacy law. Not more than 10 hours may be earned at the workplace Under what conditions may a pharmacist dispense a generic medication? - correct answer -The generic costs less than the brand -The patient does not refuse -The prescriber has not prohibited substitution by a valid dispensing directive What is the definition of "generically equivalent"? - correct answer -The Orange Book designates the product as an "A" rated generic -If the drug is not listed in the Orange Book then pharmacists shall use their professional judgement What are the requirements for "dispensing directives" from prescribers? - correct answer -The practitioner must write BRAND NECESSARY or BRAND MEDICALLY NECESSARY -The directive must be in the practitioner's own handwriting. Pre-printed lines or stamps with the directed are not valid -For verbal & electronic prescriptions: If it is a Medicaid prescription, the practitioner must mail or fax a written prescription within 30 days Under what conditions may a pharmacist substitute capsules, tablets, or liquid? - correct answer -If the patient consents and the pharmacist notifies the practitioner -The dispensed form contains the identical amount of the active ingredient, it is not enteric-coated or time release, and does not alter clinical outcomes
What is the law concerning reporting of theft or significant loss of a controlled substance to the State Board? - correct answer Any theft of significant loss of any controlled substance shall be reported in writing to the board immediately on discovery What is the law concerning reporting of theft or significant loss of a dangerous drug to the State Board?
- correct answer The board must be notified of any theft or significant loss of any dangerous drug by submitting a list of the name and quantity of all dangerous drugs stolen or lost How many days prior to closing a pharmacy must the DEA be notified? - correct answer 14 days Besides notifying the DEA, what else must be done 14 days PRIOR TO CLOSING a pharmacy? - correct answer A closing notice sign must be posted informing the patients of the name, address, and telephone number of the acquiring pharmacy What must be done on CLOSING DAY of a pharmacy? - correct answer -Closing inventory (all controlled substances) -Transfer patient medication records -Remove the word "pharmacy" from all signs What must be done AFTER CLOSING of a pharmacy? - correct answer -Notify the board within 10 days -Surrender pharmacy license -Affirm that a closing inventory was conducted -Notify the Board the manner by which dangerous drugs and controlled substances were transferred or disposed -Notify the Board in writing the name and address of the pharmacy to which the records were transferred -Void and Return unused DEA 222 forms Can prescription drugs be returned after dispensing? - correct answer Medications may not be returned for the purpose of resale after the prescription or drug has been originally dispensed or sold.
*Exception: There is a program for the return of non-controlled medications from health care facilities. To be eligible for this program the medication must have never been in the possession of the person for whom it was prescribed What is the law concerning disposal of a controlled substance? - correct answer Transfer to a reverse distributor that is authorized by DEA to destroy controlled substances What must a pharmacy do upon discovering a theft or significant loss of a controlled substance? - correct answer -Report the theft or significant loss in writing to the board immediately upon discovery -Contact the police and file a police report -Fill out a DEA form 106 What are the 3 filing systems required by Texas law? - correct answer -Schedule II prescriptions -Schedule III-V prescriptions -Nonscheduled prescriptions How do pharmacists verify that controlled substances were actually received? - correct answer By recording his or her initials and the date of receipt on the invoice What is the law concerning controlled substance inventory for a new pharmacy? - correct answer An initial inventory of controlled substances must be taken for the opening day. The inventory must be signed by the PIC and notarized within 72 hours. How often must controlled substances be inventoried? - correct answer Controlled substances must be inventoried annually on May 1st. Must be signed by PIC and notarized within 72 hours. When performing inventory, which drugs require an exact count? - correct answer -An exact count is required for all CII drugs -An estimated count may be made for CIII-V drugs (if the pack size is 1000 count or more then an exact count is required) How long must records be retained in the pharmacy? - correct answer 2 years
