Exam 1 - Lecture 4

Question 1

Durham-Humphrey Amendment info

Answer 1

1. Establish criteria for distinguishing RX vs OTC drugs
2. Legally established oral RX & Refills
3. Didn’t contemplate Electronic RX but federal/state law permits
4. Exempts pharmacy label on dispensed drugs from section 502
5. Specifies min info that dispensed RX label must contain
6. Expiration or BUD on RX label required pursuant to state laws

Question 2

Label requirements that aren’t exempt from Section 502

Answer 2

1. Label must not be misleading
2. Drug dispensed must not be imitation drug
3. Drug must not be sold under name of another drug
4. Packaging and label must confirm to official compendium standards
5. If drug subject to deterioration, must be packaged and labeled appropriately
6. packaged in conformance with PPPA

Question 3

Legend Drugs (RX only)

Answer 3

1. Unsafe for use except under the supervision of a practitioner because of the toxicity, the method of use, or the collateral measures necessary to use the drug
2. Subject to the new drug application (NDA) approval process

Question 4

Mass Law for Prescription Labels

Answer 4

M.G.L. c 94 C Section 21

Question 5

Patient Package Inserts basic info

Answer 5

1. FDA approved prescription drug labeling
2. developed by manufacture, approved by FDA
3. some PPI is voluntarily submitted by manufacturer and approved by FDA, but distribution not mandated

Question 6

Patient Package Insert - when given?

Answer 6

1. required to be dispensed with specific products or classes of products

Question 7

Medication Guides

Answer 7

1. paper handout that come with many prescriptions
2. contain FDA-approved info that can help patients avoid serious adverse events
3. developed by manufacturer, approved by FDA and required to be given to consumers each time medication is dispensed

Question 8

Medication guides required with certain prescribed drugs and biological products when FDA determines that….

Answer 8

1. certain information is necessary to prevent serious adverse effects
2. patient decision-making should be informed by information about a known serious side
3. patient adherence to directions for the use of a product are essential to its effectiveness.

Question 9

Off-label prescribing info

Answer 9

1. prescribing and dispensing is legal under FD&C Act
2. required professional eval of risk vs benefit
3. courts generally regard labeling as evidence toward the standard of care but bot as prima facie established the standard of care

Question 10

Examples of unapproved uses of approved drugs?

Answer 10

1. The drug used is for a disease or medical condition that it is not approved to treat, such as when a chemotherapy is approved to treat one type of cancer, but healthcare providers use it to treat a different type of cancer
2. The drug used is given in a different way, such as when a drug is approved as a capsule, but it is given instead in an oral solution,
3. The drug used is given in a different dose, such as when a drug is approved at a dose of one tablet every day, but a patient is told by their healthcare provider to take two tablets every day.

Question 11

Standards for Prescription Format and Security

Answer 11

105 CMR 721

1. Updates partial fill requirements for Schedule II prescriptions, consistent with federal opioid legislation (The SUPPORT Act)
2. Requires all prescriptions for controlled substances (few exceptions) and devices to be generated and transmitted through federally compliant electronic prescribing systems.

Question 12

Exceptions to Standards for Prescription Format and Security

Answer 12

1. Excludes all Schedule VI medications for Schedule VI-only prescribers;
2. Prescriptions issued in response to a declared public health emergency, diseases dangerous to public health, or other urgent public health matter.

Question 13

Required Elements of a Prescription

Answer 13

1. Reg number of practitioner
2. Date of issuance of RX
3. Name, Dosage, strength per dose unit and quantity of dose units
4. name/address of patient
5. Directions for use, inc cautionary statements
6. statement indicating number of refills
7. if Schedule 2, not saying pt can fill amount less than full quantity

Question 14

Exceptions to Name/Address requirement of prescription

Answer 14

except in a veterinary prescription or a prescription for expedited partner therapy issued in accordance with 105 CMR 700.003(J), in which case the patient, and the address may be left blank;

or in the case of a prescription for naloxone the person taking delivery of the naloxone may be used in place of the name of the patient, and the address may be left blank;

Question 15

Valid signature requirement

Answer 15

1. An electronic signature that meets the requirements of 105 CMR 721.031 shall have the full force and effect of a handwritten signature on a paper-based written prescription.
2. A paper-based written prescription must be written and signed by the practitioner in accordance with M.G.L. c. 94C, § 23 and 105 CMR 721.000.
3. 2018 Amendments- Fail Over- allows Schedule VI computer-generated fax prescriptions to be valid oral prescriptions (excludes those determined by the Commissioner to carry a bona fide potential for abuse (currently, this determination applies to gabapentin only).

Question 16

Electronic prescriptions must be validated and authenticated

Answer 16

1. Federal law leaves it up to the states to determine who may prescribe independently or in collaborative practice.
2. Scope of authority as determined by the state for prescribers who are not MDs or DOs is important for pharmacists to know.

Question 17

Prescriptive Authority issues

Answer 17

1. Federal law leaves it up to the states to determine who may prescribe independently or in collaborative practice.
2. Scope of authority as determined by the state for prescribers who are not MDs or DOs is important for pharmacists to know.

Question 18

M.G.L c94C Section 19.

Answer 18

Prescription for a controlled substance to be valid shall be issued for a legit medical purpose by a practitioner acting in usual course of professional practice.

Responsibility for proper prescribing and dispensing of controlled substances shall be upon the prescribing practitioner but a corresponding responsibility shall rest with the pharmacist who fills the prescription.

Question 19

Prescriptive Authority is…

Answer 19

ability to issue written or oral prescriptions or medication orders

Question 20

Advanced Practice RNs (APRNs)

Answer 20

1. certified nurse practitioner (CNP),
2. certified registered nurse anesthetist (CRNA),
3. psychiatric clinical nurse specialist (PCNS);
4. certified nurse-midwives (CNM)

• Clinical nurse specialists are not authorized to register for prescriptive practice *

Question 21

Do NP still need supervising in mass to prescribe?

Answer 21

NAH

Question 22

Which APRNs need to be in written guidelines with a supervising physician?

Answer 22

Certified nurse practitioners

Psychiatric clinical nurse specialists

certified registered nurse anesthetists

Question 23

Special info certified nurse midwives?

Answer 23

must practice within healthcare system and be in a clinical relationship with an OB-GYN

Question 24

How many states don’t requires NPs to practice independently?

Answer 24

23

Question 25

CDTM requirements

Answer 25

1. written agreement
2. authorized pharmacist
3. permitted practice settings

Question 26

Written agreement for CDTM

Answer 26

written and signed agreement between pharmacist with training and experience relevant to the scope of the collaborative practice and supervision physician that defines the collaborative practice.

review and renewal on a biennial basis

Question 27

Requirements to be authorized pharmacist CDTM

Answer 27

1. Hold current license
2. Have $1m in liability insurance
3. PharmD or 5 yrs experience
4. Complete 5hrs of CE dressing areas of practice related to collab practice additional to other CE req
5. Apply to participate in medical assistance program admin

Question 28

Permitted practice settings and exceptions for CDTM

Answer 28

1. Hospitals
2. Long-term care
3. Inpatient/outpatient hospice
4. Ambulatory care
5. Collaborating pharmacist in a retail drug business
   • Limited to patients that are 18+
   • Extension by 30 days of current drug therapy
   • Asthma, COPD, diabetes, HTN, Hyperlipidemia, CHF, HIV/AIDS, osteoporosis & Comorbidities
   • C6 substances only

Question 29

Limitations for CDTM in retail?

Answer 29

1. Limited to patients that are 18+
2. Extension by 30 days of current drug therapy
3. Asthma, COPD, diabetes, HTN, Hyperlipidemia, CHF, HIV/AIDS, osteoporosis & Comorbidities
4. C6 substances only

Question 30

Authority to Dispense Prescription Drugs

Answer 30

1. FD&C Act does not specify who may or may not dispense prescription drugs
2. Rest with the States
3. Massachusetts – M.G.L. c 94C §9 (b) administering and dispensing of controlled substances in course of professional practice