Pharmacy Law Final

Front 1

1. In Maryland, when the Board of Pharmacy issues a license to practice Pharmacy, the license authorizes the pharmacist to practice pharmacy:
a. In an institutional pharmacy or a retail pharmacy.
b. In a retail pharmacy, an institutional pharmacy, or a long term facility.
c. In a specialty pharmacy or a retail pharmacy.
d. All of the above.
e. None of the above.

Back 1

d. All of the above. ***

Front 2

2. Continuation education for a pharmacist requires how many education credits to be obtain as a condition of a renewal of a license:
a. 30 hours every two years.
b. 15 hours each year for two years.
c. 15 hours each year for three years.
d. 30 hours every four years.
e. 35 hours every two years.

Back 2

a. 30 hours every two years. ***

Front 3

3. Which of the following is not an offense for which a pharmacist may be disciplined by the Board of Pharmacy?
a. Providing professional services while under the influence of alcohol.
b. Submitting a false statement to obtain a fee.
c. Willfully failing to file a record or report required by a regulation of the Board of Pharmacy.
d. Providing an authorized prescriber free medication for distribution to needy patients.

Back 3

d. Providing an authorized prescriber free medication for distribution to needy patients. ***

Front 4

5. Which of the following statements is true concerning a defamatory complaint made to the Board of Pharmacy by a customer of the store against an individual pharmacist:
a. No action for defamation may be filed by the pharmacist until the Board of Pharmacy has disposed of the complaint.
b. A defamation action may not be filed by the pharmacist if the complainant acts in good faith in filing the complaint.
c. To ensure good health standards applicable to the practice of pharmacy, a defamation complaint may only be filed if the pharmacist’s conduct has been egregious.
d. No complaint for defamation may be filed.

Back 4

b. A defamation action may not be filed by the pharmacist if the complainant acts in good faith in filing the complaint. ***

Front 5

6. The Board of Pharmacy may direct a pharmacist licensee to submit to an appropriate examination by a health care provider under which of the following circumstances?
a. None
b. A verified complaint has been filed against the pharmacist containing a complete recitation of facts upon which a reasonable person would determine a health investigation is appropriate.
c. The pharmacist may injure himself/herself if he/she does not receive proper medical assistance.
d. The Board has reason to believe that the licensee may cause harm to a person affected by the licensee practicing pharmacy.

Back 5

d. The Board has reason to believe that the licensee may cause harm to a person affected by the licensee practicing pharmacy. ***

Front 6

7. Due process rights that must attend a disciplinary hearing brought by the Board of Pharmacy against a pharmacist must include:
a. Reasonably stated notice of the charges against the pharmacist.
b. The right to present witnesses at the hearing.
c. The right to have live witnesses presented at the hearing to give testimony under oath against the pharmacist.
d. The right to cross examination and to offer rebuttal to the Board’s case.
e. All of the above.

Back 6

e. All of the above. ***

Front 7

9. Which statement is true as to reciprocity of license in Maryland.
a. A Maryland statute allows it.
b. Rules and regulations passed by the Board of Pharmacy govern the process.
c. There is no reciprocity in Maryland.
d. Both a. and b. are correct.
e. None of the above are correct.

Back 7

d. Both a. and b. are correct.**

Front 8

11. Which of the following statements is accurate?
a. At the place of employment, a pharmacist shall conspicuously display his/her license to practice pharmacy.
b. Pharmacy regulations require a pharmacist to identify himself/herself to any customer seeking to know the name of the pharmacist.
c. Permit holders are required to prominently display the names of the pharmacists working in the facility during the time a particular pharmacist is working.
d. All of the above

Back 8

a. At the place of employment, a pharmacist shall conspicuously display his/her license to practice pharmacy. ***

Front 9

13. A nonresident pharmacy permit holder must:
a. Comply with the laws of the State where the pharmacy is located.
b. Disclose any change of location address to the Maryland Board within 30 days of a change of location.
c. Maintain records of prescriptions dispensed to Maryland residents.
d. Maintain a toll-free telephone service available to patients during regular hours of operation, which must be not less than 6 days a week, and for a minimum of 40 hours per week.
e. All of the above.

Back 9

e. All of the above. ***

Front 10

15. Which of the following is a correct statement.
a. A non-resident permit holder must disclose its toll-free telephone number to patients by a label affixed to each container of a prescription drug dispensed.
b. A non-resident pharmacy permit holder is required by Maryland law to have displayed in the pharmacy the current license of the pharmacist filling prescriptions.
c. While there are no specific parenteral/sterile enteral regulations in Maryland, a pharmacy must comply with the directives of the American Hospital Association requirements when performing these activities.
d. When a pharmacy permit holder closes an operation, sales of CDS drugs made to another permit holder must be filed with the Board of Pharmacy within a period of 120 days following the closing.
e. Both a. and d. are correct.

Back 10

a. A non-resident permit holder must disclose its toll-free telephone number to patients by a label affixed to each container of a prescription drug dispensed.***

Front 11

16. To obtain a permit to operate a “retail” pharmacy in the State of Maryland, which of the following is a requirement applicable to the permit holder:
a. That he/she/it not interfere with or impair the free and complete exercise of professional pharmaceutical judgment or skill by the pharmacist.
b. To maintain a current reference library that is “appropriate” to serve both the needs of any practice specialty of the pharmacy and the consumer the pharmacy serves.
c. To provide a “toll-free” or local consumer access telephone number accessible during regular hours of operation.
d. All of the above

Back 11

d. All of the above****

Front 12

17. Maryland prescription records must be maintained for what period of time.
a. 2 years.
b. 5 years.
c. 120 days for the written prescription so long as there are computer records that are maintained for 5 years
d. As long as the permit holder at the time the prescription was filed remains the permit holder.

Back 12

b. 5 years. ***

Front 13

18. As to delivery of prescriptions, which of the following is not true?
a. No prescription may be left at the store courtesy counter after the pharmacy is closed.
b. A prescription may be delivered to the patient or an “authorized” agent of the patient.
c. A prescription may only be delivered to the residence of a patient when the patient is there at the time of delivery.
d. Authorization by a patient for a delivery may be made to the pharmacist in writing or verbally.

Back 13

c. A prescription may only be delivered to the residence of a patient when the patient is there at the time of delivery. ***

Front 14

19. As to pharmacy security, which of the following statements is true:
a. A means must be provided for securing the prescription area so as to prevent and monitor unauthorized entry.
b. Proper temperature and ventilation must be maintained at levels that do not affect prescription drugs and devices.
c. Any individual is to be prevented from being in the prescription area unless a pharmacist is immediately available on the premises to provide pharmacy services.
d. All patient records must be secured to prevent unauthorized disclosure or loss.
e. All of the above.

Back 14

e. All of the above. ***

Front 15

20. Which of the following statements is not correct?
a. A pharmacist may not practice in a location under circumstances or conditions which prevent the proper exercise of his/her professional judgment.
b. It is the responsibility of a pharmacist to maintain knowledge of the “current” health and sanitation laws relative to the practice of pharmacy.
c. A pharmacist may not provide a pharmaceutical service outside the boundaries of the pharmacist’s training and education.
d. All of the above are correct.

Back 15

d. All of the above are correct. ***

Front 16

21. Which of the following statements is correct?
a. A pharmacist may accept the return of an individual unit dose of a drug only if the pharmacist determines that the drug had been handled in a manner to preserve the strength, quality, purity and identify of the drug.
b. No prescription medication may be returned to pharmacy stock after it has left the pharmacy premises unless it bears the manufacturer’s seal.
c. Sale of prescription medication not properly handled and labeled in accord with applicable law constitutes misbranding which is a crime under both federal and state law.
d. All of the above
e. a and b only

Back 16

d. All of the above ****

Front 17

22. Brand name is defined:
a. The proprietary name a manufacturer places on a drug or on its container.
b. The name of a drug designated by the FDA upon approval of sale of a drug.
c. Any name that appears on the container of a prescription drug.
d. The name of prescription medication that is labeled: “Rx only.”

Back 17

a. The proprietary name a manufacturer places on a drug or on its container. ***

Front 18

23. As to the date of a prescription, which of the following is not correct.
a. A CDS prescription is not legal unless it bears the date it is written.
b. No prescription in Maryland may be filled more than 120 days from the date it is written.
c. No prescription may be refilled in Maryland, no matter how many refills are designated, if the prescription is more than 1 year old.
d. All of the above are correct.

Back 18

c. No prescription may be refilled in Maryland, no matter how many refills are designated, if the prescription is more than 1 year old.***

Front 19

24. Before a pharmacist may refuse to fill or refill a prescription,
a. The decision of the pharmacist must be based on professional judgment, experience, knowledge, or available reference materials.
b. The pharmacist must attempt to notify the prescriber of the refusal.
c. The pharmacist must maintain a copy of the prescription.
d. None of the above are correct.

Back 19

a. The decision of the pharmacist must be based on professional judgment, experience, knowledge, or available reference materials. ***

Front 20

25. Which of the following is a correct statement?
a. Prescription drugs not bearing a manufacturer’s expiration date may be sold in Maryland.
b. Prescription drugs bearing an expired date must be removed from the shelf.
c. Prescription drugs not bearing a manufacturer’s expired date may only be distributed to institutional pharmacies.
d. Both a. and b. are correct.

Back 20

b. Prescription drugs bearing an expired date must be removed from the shelf. ***

Front 21

26. As to facsimile prescriptions, which statement is correct?
a. Prescriptions may not be faxed in Maryland.
b. A faxed prescription must contain the electronic signature of the prescriber.
c. The prescription is transmitted by a commercial intermediary, which guarantees the confidentiality and security of the transmission.
d. None of the above are correct.

Back 21

c. The prescription is transmitted by a commercial intermediary, which guarantees the confidentiality and security of the transmission. ***

Front 22

27. As to the law governing a generic equivalent dispensed prescription medication, which statement is correct?
a. Only substitutions recognized by The Yellow Book may be used.
b. The consumer is charged less for the generic product, as compared to the brand drug.
c. The prescription third party drug plan utilized by the patient does not prohibit the use of generic products.
d. The pharmacist records the brand name and notes the words “generic substitute” on the label of the prescription dispensed.

Back 22

b. The consumer is charged less for the generic product, as compared to the brand drug. ***

Front 23

28. Interns or residents in a hospital may prescribe CDS drugs under the hospital’s registration

a. True
b. False

Back 23

a. True ***

Front 24

29. A chain pharmacy must have a separate DEA registration for each store

a. True
b. False
c. True, but only if they are all in the same state

Back 24

a. True ****

Front 25

30. An oral surgeon wants to obtain a Schedule II intravenous barbiturate from the local pharmacy for office use (e.g. administration to a patient), she

a. must provide the pharmacy with a written prescription
b. must provide the pharmacy with a completed form 222
c. both of the above

Back 25

b. must provide the pharmacy with a completed form 222 ****

Front 26

31. Schedule II drugs

a. can be dispensed pursuant to a phoned-in prescription, if for a refill
b. are limited to 30 day supply
c. can be dispensed pursuant to a phoned-in prescription only in an emergency as long as the pharmacy receives the written prescription within 7 days
d. All of the above
e. both b and c are correct

Back 26

c. can be dispensed pursuant to a phoned-in prescription only in an emergency as long as the pharmacy receives the written prescription within 7 days ****

Front 27

32. Under which of the following conditions may a Schedule III prescription be faxed to the pharmacy and filled as if it were a signed original?

a. for a resident of a long term care facility
b. for a resident of a rural area
c. for mail order pharmacy dispensing
d. All of the above

Back 27

d. All of the above***

Front 28

33. Partial filling of a schedule II drug is permitted as long as the patient receives the balance within

a. 24 hours
b. 48 hours
c. 72 hours
d. 96 hours

Back 28

c. 72 hours ****

Front 29

34. Unauthorized refills of Schedule IV drugs are permitted
a. If drug is necessary to maintain life
b. If prescriber cannot be reached
c. If only a reasonable amount is dispensed
d. None of the above
e. Both a and b

Back 29

d. None of the above ****

Front 30

35. When a pharmacist conducts his or her CDS inventory, which of the following must be included?

a. drugs stored in the pharmacy
b. drugs owned by that pharmacy and stored in a warehouse for that pharmacy at a different location
c. prescriptions filled but not yet picked up
d. all of the above
e. a and b only

Back 30

e. a and b only****

Front 31

36. Which of the following are examples of schedule I substances?

a. LSD
b. Marijuana
c. Cocaine
d. All of the above
e. a and b only

Back 31

e. a and b only****

Front 32

37. A cough syrup contains 15mg. of codeine phosphate and 100mg. guaifenesin in each 10ml dose. A 4 fluid ounce bottle of this cough syrup would likely be classified as

a. Schedule II
b. Schedule III
c. Schedule IV
d. Schedule V

Back 32

d. Schedule V****

Front 33

38. An institutional pharmacy must have a USP in its library.
a. True
b. False

Back 33

b. False ****

Front 34

39. The hospital pharmacy must have a master log for all drugs that are repackaged from bulk containers. This log must include
a. manufacturer
b. lot number
c. name of repacker
d. all of the above
e. a and b only

Back 34

d. all of the above ****

Front 35

In the long term care setting,
a. a facility shall maintain a record and signed Schedule II count at the end of
each shift if the facility does not have an in-house pharmacy
b. a facility shall maintain a record and signed Schedule II count at the end of
each shift whether or not operating an in-house pharmacy.
c. a facility only needs to account for Schedule II drugs every other year.

Back 35

b. a facility shall maintain a record and signed Schedule II count at the end of
each shift whether or not operating an in-house pharmacy. ****

Front 36

41. In a long term care facility, who can administer Schedule II drugs?
a. nurse
b. medicine aide
c. either of the above

Back 36

c. either of the above ****

Front 37

42. A pharmacist must conduct drug regimen review in a comprehensive care facility at least

a. weekly
b. monthly
c. semi annually
d. annually

Back 37

b. monthly ****

Front 38

In the comprehensive care facility,

a. Two members of the nursing home staff can destroy controlled dangerous
substances II through V.
b. Division of Drug Control personnel are required to destroy CDS II through V.
c. Two members of the nursing home staff can destroy CDS III through V but
schedule II can only be destroyed by Division of Drug Control personnel.

Back 38

a. Two members of the nursing home staff can destroy controlled dangerous
substances II through V. ****

Front 39

Consider the following scenarios.

a. Chain drug store buys drums of 5,000 tablets of prescription drug X and repackages them in 100’s to send out to their pharmacies for dispensing.
b. Hospital volunteer takes from a bottle of 1,000 tables of prescription drug X and prepares prepacks of 15 tablets for use in the hospital.
c. A community pharmacist, who fills many compounded prescriptions for a particular ointment makes up, in advance, a six month supply.

Which of the above scenarios constitutes manufacturing?

a. Scenario a only
b. Scenario a and b
c. Scenario a and c
d. Scenario b and c
e. Scenario a, b, and c

Back 39

c. Scenario a and c ****

Front 40

In determining whether a pharmacy is compounding or manufacturing, the FDA will
consider, among other things, whether a pharmacy is advertising

a. Its general compounding abilities
b. Its ability to compound a particular drug
c. Neither of the above

Back 40

c. Neither of the above ****

Front 41

Under Maryland’s “OBRA 90” statute

a. a pharmacist must offer to counsel only for Medical Assistance prescriptions
b. a patient may not decline the offer
c. the offer to counsel covers both new and refill prescriptions
d. All of the above are correct
e. Both a and c are correct

Back 41

a. a pharmacist must offer to counsel only for Medical Assistance prescriptions ****

Front 42

In making the offer to counsel, which of the following can take the place of face to face
communication?

a. notation on the bag
b. a newspaper advertisement
c. communication by telephone
d. all of the above
e. a and c only

Back 42

e. a and c only ****

Front 43

49. In a pharmacist negligence case--- suppose the pharmacist received a prescription for a long acting brand name medicine for hypertension. The pharmacist subsequently dispensed another company’s generic long acting medicine but it was not deemed bioequivalent in the Orange Book. Further, suppose the patient suffered damages and sued the pharmacist.

a. The pharmacist would be automatically liable since he violated the law on dispensing generic equivalents.
b. The pharmacist would not be automatically liable but would have to overcome a presumption that he breached his professional duty by violating the law.
c. The answer would depend on the extent of the patient’s injuries

Back 43

b. The pharmacist would not be automatically liable but would have to overcome a presumption that he breached his professional duty by violating the law. ****

Front 44

50. Which of the following types of damages is/are difficult for an injured patient/plaintiff to receive from a lawsuit?

a. nominal damages
b. compensatory damages
c. punitive damages

Back 44

c. punitive damages ****

Front 45

51. Which of the following cases was not really a pharmacist duty-to-warn case?

a. Baker v Arbor Drugs
b. Happel V WalMart
c. Riff v Morgan Pharmacy

Back 45

b. Happel V WalMart****
c. Riff v Morgan Pharmacy ****

Front 46

52. In Maryland, a veterinarian can prescribe “human” prescription drugs for animal use.

a. True
b. True, but only for food producing animals
c. False

Back 46

a. True ****

Front 47

53. Consider the following: A particular drug (Drug X) is prescription only for human use. However, for animal use, Drug X is OTC. A patient comes into the pharmacy and requests Drug X for their animal. The pharmacy only stocks the Drug X for human use.

a. The pharmacist can sell the customer the Drug X he has in stock, without a prescription.
b. The pharmacist must have a prescription from the animal’s veterinarian in order to dispense the Drug X he has in stock to the customer.
c. The pharmacist may dispense the Drug X he has in stock for the customer’s animal if the customer brings in a prescription for the animal from the customer’s family doctor.
d. None of the above.

Back 47

b. The pharmacist must have a prescription from the animal’s veterinarian in order to dispense the Drug X he has in stock to the customer. ****