PHARM LAW EXAM 2

T/F: Under MA law, written or electronic Rx CII, shall become invalid 30 days after date issued; MA MD prescribed Rx

True; expires after 30 days

Out of State: 5 day expiry (CII; narcotics: contiguous state prescription, narcotics: any state

In Massachusetts, CII prescriptions can have how many refills?

0 refills

CIII/CIIII: up to 5 monthly fills

CIIV: up to one year

In MA, the RPh filling a written CII prescription shall endorse what?

Their signature on the face of the prescription

T/F: CII/CIII may be filled for a max of 90 days upon single filling for OUD

True

(90 days for CII only for stimulants (Adderall, Ritalin), OUD (buprenorphine), or implantable fusion pumps)

Under MA law, opioid CII/CIII may be filled for a max of 30 day supply of such substance upon single filling

True

T/F: Under MA law, all prescriptions for controlled substances shall be kept for 2 years by the pharmacy

True

Under MA regulations, which of the following is not required on a prescription

Time prescription was issued

MA doctors may write more than 1 drug product with the same or different dispensing instructions on the same Rx form

False

T/F: Patient requests their Rx for a CII partially filled, remaining amount of Rx needs to be filled no later than 30 days after issue date

True

T/F: If a patient requests a partial Rx CII, the remaining portion of Rx may only be filled at the same pharmacy that originally dispensed the lesser amount

True

Which of the following circumstances may written/oral Rx be issue without an electronic Rx

Prescriptions issued by veterinarians

Prescriptions issued for controlled subtances in Schedule VI

Prescriptions issued outside the jurisdiction of the Commonwealth of Massachusetts

Prescriptions for compunded drug preparations

If an oral Rx for a CII is issued, the practioner shall cause electronic Rx to be delivered within how many days?

2

If an oral Rx for a CII is issued, the practioner shall cause written Rx to be delivered within how many days?

7

T/F: an oral Rx issued by practitioner may be communicated to RPh by an expressly authorized employee or agent of practice

True

The term “practitioner” as defined by Massachusetts Law can include

Physician

Dentist

Podiatrist

Nurse Practioner

Dentist

What is required on the pharmacy label

Pharmacy name and address

Serial number of the prescription

Filling pharmacists initials

Name of Patient, unless vet prescription

Name of the controlled substance

Directions for use and cautionary statements

In MA upon request of elderly person or person visually impaired, the directions on the label affixed by RPh to vial shall be typed in print size allowing no more than how many characters per inch?

shall be typed in print size allow no more than 10 characters per inch

The first segment of the NDC number represents

Manufacturer/Distributor

The second segment of the NDC number represents

Strength/formulation of drug

The third segment of the NDC number represents

Package size

General Rule for Beyond-Use Date

One year from the date of dispensing

For generic substitution of a drug, one would look to the FDA ___ book?

Orange

For interchanging biologics and biosimilars one would look to the FDA ___ book?

Purple

T/F: Epidemiology is the scientific study of distribution and determinants health related states and events (not just disease in a specific population)

True

T/F: Immunizations are an example of primary prevention

True

T/F: Early detection and prompt treatment for a disease is secondary prevention

True

Reducing complication of established disease is an example of which level of prevention strategy?

Tertiary

Which of the following is true regarding public health?

Evolved from hygiene, environmental and health sciences

A pharmacists role in public health might include

Poison prevention counseling

Developing asthma management programs

Providing diabetes counseling

Providing immunizations

T/F: WHO’s definition of health is state of complete physical, mental, and social well-being, and not merely the absense of disease

True

T/F: Public health is defined as promoting and protecting the health of people and the communities where people live, learn, and play

True

Regulation of all drugs that is to protect consumers from adulterated, misbranded, foods, drugs, cosmetics, or devices

Food, Drug, and Cosmetic Act

Which amendement made two drug classes (prescription/OTC) and states the label must contain adequate directions and allowed oral prescriptions/refills

Durham-Humphrey Amendment

Which amendment required the components to recieve premarket approval for safety to food products?

Food Additive Amendment

Which amendment established the safety of color additives in foods, drugs, and cosmetics?

Color Additive Amendment

Which amendment strengthened the new drug approval process by requiring drugs to not only be safe, but also effective?

Kefaufer-Harris Amendment

What did the Medical Device Amendment do?

Created extensive regulations regarding the safety and efficacy of devices

Required premarket approval and establishment of performance standards

Required conformance with GMP and adhere to recording and reporting these

Required classification of devices based on their functions

How many people in the US is required to qualify to be under the Orphan Drug Act to be seen as a rare disease/ condition

< 200,000

This act was enacted to streamline the generic drug approval process while giving patent extensions to innovative drugs

Waxman-Hatch Amendment/ Drug Price Competition and Patent term Restoration Act

(same thing)

Prescription Drug Marketing Act establishes sales restrictions and record keeping requirements for ____?

Prescriptions drug samples

Which act strengthened FDA authority related to post-marketing requirements, while expediting the process?

Safe Medical Devices Act

Which amendment allows the FDA to ban individuals/firms from participating in the drug approval process if convicted of related felonies?

Generic Drug Enforcement Act

Which act requires manufacturers to pay fees for NDA applications and supplements when the FDA must review clinical studies?

Prescription Drug User Fee Act

Which act authorizes health claims on food product labeling, as long as they are made in compliance with FDA regulations?

Nutrition Labeling and Education Act

T/F: Under the Dietary Supplement Health and Education Act, FDA regulates dietary supplements more as foods than as drugs?

True

Food and Drug Administration Modernization Act is to eliminate backlogs in the approval process as well as what?

Creates a fast tract drug approval process for life threatening diseases

Establishes a databank of information on clinical trials

Authorize scientific panels to review clinical investigations

Establishes ingredient labeling requirements for inactive ingredients

Which are correct for Medical Device User Fee and Modernization Act?

Establishes user fee requirement for premarket reviews of medical devices

Inspections can be conducted at establishments by accredited third parties

Which are corect answers for Food and Drug Amendments Act?

Amended drug and medical device provisions that were set to expire

Provided the FDA with new funding and more authority over drug safety

Require postmarket clinical studies to assess risk

Require companies to implement risk evalution and mitigation strategies

*look at word doc

Which are correct answers for FDA Safety and Innovation Act

Collect fees from manufacturers seeking NDAs or medical device approvals

Contains several provisions directed at reducing drug counterfeiting

Enables the FDA to inspect foreign drug manufacturers more regularly

Contains several provisions to block the import of adulterated products

What are the two titles under the Drug Quality and Security Act of 2013?

Compounding Quality Act

Drug Supply Chain Security Act

T/F: The 21st Century Cures Act provides for billions of dollars of additional funding to NIH

True

Which act reauthorized the user fee programs and created a new category of OTC hearing aids?

FDA Reauthorization Act

A drug contaminated or manufactured, processed, etc incorrectly

Adulteration

Which statement best describes hospital accrediation?

Assesses structures, processes, and outcomes of care to improve quality and safety

Which of the following orgs sets standards for hospital care and conducts unannounced for site visits as part of accreditation?

Joint Commission

Which hospital management will you expect to see in a non-profit hospital?

Board of Trustees

Which hospital management will you expect to see in a for profit hospital?

Board of Directors

Which of the following would not be considered as a responsibility of hospital pharmacy?

Medication Administration

Which of the hospital committees are responsible for evaluating and selecting medications to be included on hospital formulary

Pharmacy and Therapeutics Committee

T/F: Medication order verification falls under a clinical pharmacist job responsibility in a hospital setting

True

Who do pharmacists routinely interact with in a hospital setting?

Nurses

T/F: Shriner’s Hospital is an example of a specialty nongovernment not-for-profit hospital

True