PA Pharmacy Act

Question 1

Describe the pharmacy act’s definition of drugs

Answer 1

i. articles recognized as drugs in the official U.S. Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary or its successor.
ii. Articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals.
iii. Articles (other than food) intended to affect the structure or any function of the body of man or other animals.
iv. articles that meet any of the above definitions but are NOT a device

Question 2

non-proprietary drug

Answer 2

a drug containing any quantity of any controlled substance or any drug which is required by any applicable Federal or State law to be dispensed only by PRESCRIPTION

Question 3

proprietary drug

Answer 3

NON-PRESCRIPTION, non-narcotic medicines or drugs which may be sold without a prescription and which are prepackaged for use by the consumer and labeled according to state & federal regulations

Question 4

PA pharmacy act’s definition of an emergency prescription

Answer 4

a refill of a Rx essential to the continuation of therapy in a chronic condition, for which the refill has not been authorized and for which the pharmacist notifies, within 72 hours, the prescriber that an emergency prescription has been dispensed.

EXAMPLE: Patient runs out of lisinopril on Friday after doctors’ office is closed for the weekend.

not to be confused with the CII emergency verbal prescription

Question 5

definition of nonresident pharmacy

Answer 5

any pharmacy located outside PA that ships, mails or delivers, in any manner, legend devices or legend drugs into this Commonwealth pursuant to a prescription order

Question 6

definition of direct and immediate personal supervision

Answer 6

• Review by the pharmacist of the prescription or drug order prior to dispensing.
• Verification by the pharmacist of the final product.
• Immediate availability of the pharmacist on the premises to direct the work of the supervised individual and to respond to questions or problems.

Question 7

To be licensed as a pharmacist by the State Board of Pharmacy, an individual must NOT be less than ___ years old & must be a U.S. citizen

Answer 7

21

Question 8

To be licensed by the State Board of Pharmacy, an individual must not have been convicted of a felony related to a controlled substance unless at least ____ years have elapsed from the date of conviction, the applicant satisfactorily demonstrates to the board that he has made significant progress in personal rehab, and the applicant otherwise satisfies all other qualifications.

Answer 8

10

Question 9

Any person enrolled or accepted as a student of pharmacy in an accredited pharmacy degree program may, after completing his ___________ year of college (undergraduate), file with the State Board of Pharmacy an application for registration as a pharmacy intern

Answer 9

second

Question 9

All individuals licensed as pharmacists or must renew their license how often?

Answer 9

biennially (every 2 years)

Question 10

All certificates issued to pharmacy interns shall be valid for a period not exceeding _____ years from the date of issue exclusive of time spent in the military service.

Answer 10

six

Question 11

If a pharmacist licensed in PA and OH was disciplined in OH, when must the pharmacist report to the PA Board this disciplinary action?

Answer 11

either on the biennial registration application or within 30 days (whichever is sooner)

NOTE: PA Pharmacy Act states biennial application or within 90 days but another PA law says differently -> go with stricter

Question 11

True or False: CII prescriptions can be transferred.

Answer 11

FALSE. To be transferred, the drug cannot be a Schedule II controlled substance & must be lawfully refillable.

Question 11

A pharmacy must keep records/files of compounded/dispensed prescriptions for how long?

Answer 11

at least 2 years

Question 12

The pharmacist TRANSFERRING the prescription must cancel the original prescription in his records and indicates on the prescription records…

Answer 12

to whom the prescription was transferred, including:

1. the name of the pharmacy
2. the date of transfer
3. the name or initials of the transferring pharmacist.

Question 13

The pharmacist receiving the transferred prescription must note on the prescription that it is a transferred prescription & record all of the following on the prescription records in addition to other information required by law:

Answer 13

• date of issuance of original prescription.
• date of original filling of prescription.
• original number of refills authorized on prescription.
• complete refill record from original prescription.
• number of valid refills remaining.

*must also note the location & file # of the original prescription
*must note the name of the pharmacy & RPh from whom the Rx was transferred

Question 14

When can a pharmacist transfer a prescription to another pharmacist without all of that documentation?

Answer 14

A pharmacist may transfer a prescription to another pharmacist employed by the same corporation without regard to the requirements of subclauses (iv) and (v), provided that both pharmacists have access to the same computerized prescription transfer system which contains the prescription and refill records and incorporates procedures to prevent unauthorized refills.

example: CVS to another CVS

Question 15

A non-resident pharmacy doing business in PA must be registered with PA (biennially) & must report discipline in state where located to the PA board in what time frame?

Answer 15

within 30 days

Question 16

An applicant for pharm tech registration must be at least ____ years of age and have high school diploma/equivalent.

Answer 16

• must be at least 17yrs of age and have high school diploma/equivalent.
• must complete a board-approved pharm tech training program.
• must submit to a criminal history record check as required by the board.

NOTE: No individual is required to register as
a pharmacy technician under section 3.3 of the act yet.

Question 17

A pharmacist’s license can be refused, revoked, or suspended for various reasons, one of which being “guilt of unprofessional conduct” which consists of many examples. One of which is accepting back and redistributing unused drug (that has left the premises) UNLESS…

Answer 17

in original sealed container with name, lot #, and expiration date

Question 18

The State Board of Pharmacy is made up of various individuals:

Answer 18

• Commissioner of Professional & Occupational Affairs (POA)
• Attorney General (AG)
• 2 public at large
• 5 pharmacists (who are NOT teachers or instructors of pharmacy)

Question 19

What are the backgrounds of the 5 pharmacists on the Board?

Answer 19

• 2 from independent
• 2 from chain (which operate five or more pharmacies licensed within PA)
• 1 from institutional setting

*All must have been registered for at least 5 years in the state, appointed by Governor with consent of Senate

Question 20

How long is a Board term?

Answer 20

6 years

Question 21

True or False: The Board makes/orders inspections of all pharmacies, including health care facilities.

Answer 21

FALSE. The Board makes/orders inspections of all pharmacies except for health care facilities which are inspected the Department of Health (DOH to use Board standards and inform of outcome which Board can act further on if needed)

Question 22

When the Board refuses to issue license/permit, they must give reasons and opportunity for hearing, which applicant must request within ____ days of notice.

Answer 22

15

Question 23

True or False: The board may initiate investigation from complaint and discipline after proceedings OR temporarily suspend if necessary.

Answer 23

TRUE
- Temporary suspensions can be used by Board when there is an immediate and clear danger to the public health and safety

Question 24

In the case of a temporary suspension: a notice must be given, a formal action started, & within ____ days preliminary hearing must be held to determine if enough evidence to continue. If yes, temporary suspension can remain in effect no longer than _____ days.

Answer 24

In the case of a temporary suspension: a notice must be given, a formal action started, & within 30 days preliminary hearing must be held to determine if enough evidence to continue. If yes, temporary suspension can remain in effect no longer than 180 days.

Question 25

When can the Board initiate an automatic suspension?

Answer 25

specific reasons such as legal commitment to an institution due to mental incompetency or felony conviction.

Question 26

The Board will not reinstate revoked license, but an individual has to apply for reinstatement after at least __ years has passed (or ___ years if for felony w/CS) and must meet all licensing requirements (e.g. exams, etc.)

Answer 26

The Board will not reinstate revoked license; individual has to apply for reinstatement after at least 5 years has passed (or 10 years if for felony w/CS) and must meet all licensing requirements (e.g. exams, etc.)

Question 27

Does the PA Pharmacy Act permit physicians to dispense medications?

Answer 27

It is unlawful to practice pharmacy without license (unless authorized to help, e.g. intern). However, a physician is permitted to dispense to their own patients after diagnosis or treatment of said patient, if done by said licensee

Question 28

What are the requirements of an emergency prescription?

Answer 28

• Rx has no refills, is not a controlled substance, & unable to obtain authorization from a prescriber
• drug is essential to maintenance of life, needed for continuation of therapy in chronic condition & interruption of the therapy could cause an undesirable health consequence, be detrimental to the patient’s welfare or cause physical or mental discomfort
• date & quantity of refill and pharmacist signature must be documented
• RPh provides only one refill & it is limited to 72-hour emergency supply (if needed, can be up to a 30-day supply).
• within 72 hours, prescriber must be notified

Question 29

No poison can be sold, delivered or furnished to any person who is less than___ years of age.

Answer 29

16

Question 30

True or False: Schedule A poisons are allowed to be sold, but Schedule B poisons cannot.

Answer 30

FALSE. Both Schedule A & B poisons can be sold but there must be a poison label with the word “poison” distinctly shown on said label, together with the name of said place of business of the seller, all printed in red ink.

No person shall sell, distribute or furnish any poisons included in Schedule “A”, or the additions thereto, without making or causing to be made at the time of selling an entry in a poison book kept solely for that purpose

Question 31

Pharmacists can enter into agreements or protocol with a physician for management of drug therapy in institutional setting. Management of drug therapy includes:

Answer 31

• adjusting a drug regimen
• adjusting drug strength, frequency of administration or route;
• administration of drugs;
• ordering laboratory tests and ordering and performing other diagnostic tests necessary in the management of drug therapy
  -monitoring the patient’s vital signs;
• providing education and training to the patient which is related to the management of drug therapy.

Question 32

In a drug therapy protocol, the Board is to establish an appropriate time frame, not to exceed _____________, within which the RPh must notify the doctor of any changes in dose, duration, or frequency of medication prescribed.

Answer 32

72 hours

Question 33

A drug therapy protocol can remain in effect for a maximum of…

Answer 33

2 years
- then, the parties shall review the agreement & determine its renewal, necessary modifications or termination.

Question 34

A pharmacist may administer influenza & COVID immunizations to people ___ years of age & older.

Answer 34

5

Question 35

After a pharmacist administers immunizations, the individual’s PCP (if known) must be notified within _______________ of administration.

Answer 35

48 hours

Question 36

What is the different between a drug therapy protocol & a collaborative practice agreement?

Answer 36

A drug therapy protocol is in the institutional setting. A collaborative practice agreement is in the outpatient setting.