PharmLaw Domain 1

What does the practice of pharmacy include?

-Performing a DUR to determine appropriateness of therapy

-Interpreting and evaluating prescription orders in pts best interest (drug product selection and/or substitution)

-Compounding, mixing, and preparing drugs preparations

-Filling, packaging, and labeling of drugs

-Dispensing, selling, or distributing drugs/medicines

-Providing pt counseling

-Maintaining proper records

-Performing MTM

What is a CLIA waiver?

(Clinical Laboratory Improvement Amendments of 1988) waiver: A pharmacist may be authorized to test and treat for some of the following conditions: Influenza, Streptococcal Pharyngitis, COVID-19, RSV

What is typically NOT in the definition of Practice of Pharmacy?

• Diagnosing

• Initiating a prescription order for any/all prescription medication/drugPerforming surgery or invasive procedures

How many pharmacies may a PIC be in charge of at a time?

In general = 1

True or false: the PIC is responsible for proper staffing levels

True

True or false: the PIC is responsible for overseeing staff, and that all licenses are active and valid

True

True or false: the PIC is responsible for accurate Rx recordkeeping: C-II apart from C III, IV, V apart from non-CS prescriptions

True

True or false: the PIC is responsible for security of drugs/pharmacy, including temperatures of drug storage areas

True

True or false: the PIC is responsible for minimizing theft/diversion

True

True or false: the PIC is responsible for Notifying Board of staff violations, such as improper disclosure of PHI or HIPAA breach

True

True or false: the PIC is responsible for notifying Boards of any changes in his/her personal address, or changes to pharmacy hours

True

True or false: the PIC is responsible for implementation of a Quality Assurance Program, or Continuous Quality Improvement Program

True

True or false: the PIC is responsible for timely PMP submissions (usually required each day)

True

True or false: the PIC is responsible for responding to inspection deficiencies in a timely manner

True

Who is a CPA between?

A specifically names pharmacist, or small group of specifically named pharmacists, and a physician, or other health care practitioners if allowed in state law

What are the general minimum qualification criteria for a CPA?

• Some states require pharmacist to have a certain number of years of experience as a pharmacist (usually 1 or 2 years)

• Some states require that the pharmacist is Board-Certified or “Residency Trained”

  • Some states require a pharmacist in a CPA to obtain EXTRA CE hours for renewal, and if so, the hours must be related to the area of practice of the CPA

True or false: in general, the physician directly pays the pharmacist for services provided under a CPA

False - in general, the physician does not directly pay the pharmacist for services provided under a CPA (no “kickbacks”)

In general, a CPA does NOT allow for a pharmacist’s selection of drug products that are______________________

Not usually prescribed by the physician (unless the selection of that drug product is specifically authorized by the CPA)

True or false: in general, a CPA is NOT for a pharmacist to diagnose patients. Diagnosing is generally outside the Scope of Practice of the pharmacist.

True - note: there are some exceptions if they are doing Test and Treat

True or false: in general, a CPA is meant to be for the pharmacist listed on the CPA, and not for an intern under their supervision

True - note: immunization-based CPAs notwithstanding, in general

What are the six categories of information generally included in a CPA?

• Who is officially “party” to the agreement

• Purpose of the agreement

• Administrative policies

• Clinical Procedures authorized

• Reviewing/Revision/Renewing and Termination

  • Effective date and signature

What parts of are usually under the administrative policies of a CPA?

• Professional liability insurance

• Site or setting where the service is to take place

• Patient inclusion/exclusion

• Method for communication/documenting

  • Continuous quality improvement (CQI) or Quality Assurance (QA) or compliance

What parts are usually listed under the Clinical Procedures Authorized section of a CPA?

• Disease states to be managed

• Prescribing

• Modification, Continuation, or Discontinuation of Drug Therapy

• Ordering of laboratory tests

• Counseling and provision of education materials

• May include provision of a “patient visit summary”

• When to refer

• Override

• Follow up

Can a pharmacist prescribe CSs under a CPA?

It is state specific - some allow it in certain circumstances - if they do they must have their own DEA number

True or false: a CPA may or may not include interpreting results from a laboratory test

True - for example, an HIV positive test may require immediate referral to the physician

Does the Board of Pharmacy usually want a copy of the CPA? When do they need to be notified?

The BoP usually wants a copy of the agreement! The Board must be notified if the agreement is revised/altered/edited in any way, and if/when it is renewed

True or false: states that do not include administering vaccines in the practice of pharmacy allow pharmacists to immunize either through a statewide standing protocol or by allowing pharmacists to form CPAs with a physician

True

What are three other delegative authorities to pharmacists?

• Immunizations

• Therapeutic interchange

  • Other statewide protocols

True or false: other “restrictions” of practice include that pharmacists may only serve patients in states in which they are licensed

True

True or false: a pharmacist may be required to report another pharmacist’s impairment (“mandatory reporting”)

True

As a general rule, technicians can only perform ______________ duties delegated to them by the pharmacist.

Non-judgmental - so if a task requires professional judgment then a technician is prohibited from doing it!

What are 6 examples of what technicians are USUALLY prohibited from doing?

• Counseling patients

• Communicating with the prescriber regarding clinical information and/or prescription drug information

• Accepting a new prescription from a prescriber verbally (over the phone)

• Interpreting prescription drug orders/select drug products

• Performing DUR

• Performing the final check of the dispensed prescription before delivery to the patient

What are some gray area tasks for technicians? (varies state-to-state)

• Transfer non-CS prescriptions

• Transfer CS prescriptions

  • Tech-check-tech product verification

Interns can usually do everything a pharmacist can do, except for….?

• Supervising technicians

• CPA-related activities

What are clerks not allowed to do?

• Answer health/clinical questions about medications (OTC or Rx)

• Counsel patients

• Count medications/fill prescriptions

• Compound drugs

Usually to obtain registration as a pharmacy tech, what are the requirements?

• Be 18 years old

• Be of “good moral character”

• Have either graduated high school or have obtained a GED

What are the requirements to get a pharmacy intern license?

• Must be currently enrolled in a college of pharmacy

When do intern licenses usually expire?

Usually 1 year after graduation from a college of pharmacy

True or false: clerks are usually, but not always, “unregistered” by the Board of Pharmacy

True

Under which law is adulteration defined?

Under the Food, Drug, and Cosmetic Act Section 501

In general, adulteration refers to what?

purity, quality, or strength of the drug being inappropriate

If the methods in, or the facilities and controls used for, its manufacture, processing, packaging, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice, a drug is considered ….. what?

AdulteratedT

True or false: a drug is not considered adulterated if it bears or contains, for purposes of coloring only, a color additive which is unsafe

False - it is considered adulterated

If a drug purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from or its quality or purity falls below, the standard set forth in such compendium, it is considered what?

Adulterated - note: if it differs from the standard of strength, quality, or purity set forth in the compendium, but that difference from the standard is plainly stated on its label then it is NOT adulteration

Which law defines misbranding?

The Food, Drug, and Cosmetic Act Section 502What

What is the definition of misbranding?

In general, misbranding refers to misleading labeling or a label lacking required information. A drug is misbranded if:

• Labels fails to contain name/place of business of mfg, packer, or distributor

• Label fails to contain accurate statement of quantity of contents in terms of weight, measure, or count

• Label fails to prominently and conspicuously (easy to read) display required information

• Labeling fails to contain adequate directions for use

• purports to be a drug recognized in an official compendium, and is not packages and labeled as in the compendiu

What is the definition of a class I recall?

The most serious recall, where there is a reasonable probability that using or being exposed to the recalled drug will cause serious health consequences for a consumer. In these situations, the consequences of a patient using the drug are immediate and life threatening. A class I recall is urgent and generally involves removing the drug from the market.

Generally, class I recall notifications provide instruction with actions for ______.

Patients

Class I recalls are generally conducted at the ______ level.

Consumer

What is the definition of a class II recall?

Using the drug may cause temporary health consequences but the probability of a serious health issue is remote. These recalls are generally conducted at the retail level, and patients and consumers can continue using the medicine unless directed otherwise by the recalling company or FDA.

True or false: for Class II recalls, consumers can generally continue taking the medicine unless the recalling company provides other instructions

True

Class II recalls are generally conducted at the ________ level

Retail - pharmacies must remove drugs from inventory

What is the definition of a class III recall?

Using the drugs is NOT likely to cause health consequences. For example, a class III recall could include certain concerns about minor drug labeling errors, defective packaging or incorrect expiration date. These recalls are generally conducted at the wholesale level, and patients and consumers can continue using the medicine unless otherwise directed by the recalling company or FDA.

True or false: for Class III recalls, consumers generally have to stop taking the medication

False - consumers can generally continue taking the medicine unless the recalling company provides other instructionsC

Class III recalls are generally conducted at the ________ level

Wholesale - Pharmacies can LIKELY keep drugs they already have, unless the mfg/FDA says otherwise

What is a DEA form 41 for?

Destroying/disposal of controlled substances documentation

Why are expiration dates important for consumers to pay attention to?

Drug exp dates reflect the time period which the product is known to remain stable, which means it retains its strength, quality, and purity when it is stored according to its labeled storage conditions

What are 3 possible signs of counterfeit drugs?

• Does the drug or packaging look different than what you normally receive?

• Have you experienced a new or unusual side effect after using the drug

  • Did you buy the drug from an online pharmacy?

What is the online MedWatch Reporting Form from the FDA for?

Reporting unlawful sales of medical products on the internet

Who declares that an emergency use authorization is appropriate?

Secretary of HHS

Who may authorize emergency use of drugs/medical products?

FDA

True or false: an HHS EUA declaration from is dependent on a Public Health Emergency (PHE) declaration

False - an HHS EUA declaration is distinct from, and not dependent on, a PHE declaration

FDA may issue an EUA only if FDA concludes that the following four statutory criteria for issuance have been met:

a. serious or life-threatening disease or condition

b. evidence of effectiveness

c. risk benefit analysis

d. no alternatives

FDA recommends that a manufacturer request for an EUA include a “Fact Sheet” for HCPs or authorized dispensers that includes essential information about the product. In addition to required information, Fact Sheets should include: __________ (4 things)

• A description of the disease/condition

• Any contraindications or warnings

• Dosing information (if applicable), including any specific instructions for special populations

• Contact information for reporting adverse events and additional information about the product

Is informed consent required for administration or use of an EUA product?

No, it is not required. But, FDA does require manufacturers to ensure that recipients are informed about the MCM they receive under an EUA.

FDA “recommends” that the EUA include a ______________ for patients

Fact Sheet (difference than the one for HC providers)

For an unapproved product and for an unapproved use of an approved product, the statute requires that FDA ensure that recipients are informed to the extent practicable given the applicable circumstances of:

(4 things)

1. That FDA has authorized emergency use of the product

2. Of the significant known and potential benefits and risks associated with the emergency use of the product, and of the extent to which such benefits and risks are unknown

3. They have an option to accept/refuse EUA product

4. Of any available alternatives to the EUA product and of the risks and benefits of available alternatives

True or false: prescription requirements may be waived for EUA drug products, as well as REMS requirements (if applicable)

True

___________________ is the FDA center responsible for overseeing the drug importation program which includes OTC and prescription drugs, including biological therapeutics and generic drugs

The Center for Drug Evaluation and Research (CDER) - a part of the FDA!!!

An imported drug may be refused entry if, for example, it appears to be: (3 things)

adulterated, misbranded, or unapproved

What are the two distinct pathways provided by the FDA and HHS for importing prescription drugs from abroad, and what is the specific geographic restriction for the second pathway?

1. Final guidance for Industry pathway: commercial importation of prescription drugs (including biological products) from abroad

2. Section 804 Importation Program (SIP) Pathway: Allows states and Indian tribes to import eligible prescription drugs specifically from Canada to significantly reduce costs without posing additional public health risks - drugs that are ALREADY FDA-approved

What is DSCSA?

Drugs Supply Chain Security Act

Describe the DSCSA.

Outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the US, creating a tighter, closed supply chain to prevent, detect, and respond to counterfeit or harmful products.

True or false: Hospital and Retail pharmacies must “Confirm the Entities you do business with are licensed and registered”

True!!

Pharmacies must notify FDA, and other “trading partners” within __________ of determining a product is illegitimate

24 hours

If the FDA requests the pharmacy to provide product information (after determining a product is illegitimate), the pharmacy must do so within ____________

2 business days

The law requires drugs to be traced as they move through the supply chain, and pharmacies must store the product tracing documentation you receive for _______

6 years

True or false: if you sell a prescription drug to a trading partner, you must generate and provide all product tracing documentation with the transaction

True

What should you do with suspect prescription drugs when trying to determine if they are illegitimate?

Quarantine them!

What are some DSCSA “Red Flags” to look out for? (3)

• Is the supplier (of drugs) new to the pharmacy

• Is the price too good to be true

• Is the product missing info (NDC, lot number, exp date, etc)

What is the federal institute responsible for conducting research and making recommendations for the prevention of work-related injury and illness?

The National Institute for Occupational Safety and Health (NIOSH)N

NIOSH is part of the ____, in the Department of Health and Human Services (HHS)

CDC

Which Act established NIOSH?

Occupational Safety and Health Act of 1970

True or false: the NIOSH List of Hazardous Drugs in Healthcare Settings creates a legal obligation for employers

False - it creates no legal obligation for employers; it is advisory in nature and informational in content

How does NIOSH define a hazardous drug?

A drug that is:

1. Approved for use in humans, and

2. Not otherwise regulated by the US Nuclear Regulatory Commission, and

3. Either:

   1. Is accompanied by prescribing information in the “package insert” that includes mfg’s special handling information (MSHI) to protect workers handling the drug, or

   2. Is identified as a carcinogenic hazard, developmental hazard, reproductive hazard, genotoxic hazard, or other health hazard by exhibiting one or more of the following toxicity criteria in humans, animal models, or in vitro systems: carcinogenicity, developmental toxicity (including teratogenicity), reproductive toxicity, genotoxicity, organ toxicity at low doses, or a structure and toxicity profile that mimics existing drugs determined hazardous by exhibiting any one of the previous five toxicity types

What are the two tables in the NIOSH List of Hazardous Drugs?

1. Table 1: Drugs that have mfg’s special handling information (MSHI) in the package insert and/or meet the NIOSH definition of a hazardous drug and one of more of these criteria:

   1. Are classified as “known to be a human carcinogen”

   2. Are classified as “carcinogenic to humans” or “probably carcinogenic to humans”

   3. Many are cytotoxic, and many toxic to workers actively trying to conceive, breastfeeding

   4. Not all are antineoplastic (but many are)

2. Table 2: drugs that meet definition of hazardous drug and:

   1. Do not have MSHI

   2. Not “known human carcinogens”

   3. Not classified as “carcinogenic to humans” or “probably carcinogenic to humans”

      1. May exhibit some otxicity, may also present occupational hazard to those actively trying to conceive, pregnant, breasfeeding, etc.

OSHA’s mission

Assure America’s workers have safe and healthful working conditions free from unlawful retaliation

True or false: OSHA sets and enforces standards; enforcing anti-retaliation provisions of the OSH Act and other federal whistleblower laws; providing and supporting training, outreach, education, and assistance

TrueW

Which regulatory agency enforces requirements under Bloodborne Pathogens Standard?

OSHA

FD&C Act Section 503A describes compounding by __________ whereas Section 503B describes compounding by ____________

Pharmacies (retail and/or hosptial), outsourcing facilities

True or false: pharmacies (503A) can compound drug products for veterinarian’s “office" use”

True

A pharmacy’s compounding must be based on ____________________ for an identified individual patient, whereas an outsourcing facility (503B) may or may not obtain prescriptions for identified individual patients

Receipt of a valid prescription

A Pharmacy’s notice of privacy practices: (3)

• Must be provided to anyone that asks for it

• Must be made available on a pharmacy’s website

  • May be emailed to a patient it the patient has agreed to receive it by email

Privacy practices must contain: (4)

• How the pharmacy will use/disclose the PHI

• The individual’s rights, and the effective date of the notice

• Who the person may contact for more information

• The pharmacy’s legal duty with respect to the law

Pharmacy is required to keep “activity logs” or “audit logs” for electronic PHI (who logged in an accessed PHI) for _____

6 years

Following a breach, pharmacy must notify affected individual(s) and HHS (via online form) within __________

60 days