law exam 2

a _____ is a person under the care of any healthcare provider

patient

what is the “graying” of america?

by 2040, 20% of america will be over 65

_____ ____: care that encompasses a wide range of medical services provided to patients who do not require overnight hospitalization; what are some examples?

outpatient care

1. routine check-ups

2. specialized consults

3. urgent care

4. diagnostic testing

5. CT scans

6. blood work

_____ ____: care involves the hospitalization of patients for comprehensive medical treatment and monitoring; what are some examples?

inpatient care

1. medical and surgical procedures

2. maternity patients

3. rehabilitation

4. intensive care unit (ICU)

5. long term care facilities

compare compliance and adherence:

compliance:

• conformity to the recommendations about day-to-day treatment by the provider with respect to the timing, dosage, and frequency

• regulatory

adherence:

• extent to which patient’s behavior, taking medication, following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations from a health care provider

• collaborative

what are factors that influence adherence?

• social/economic

• condition-related

• patient-related

• therapy-related

• health system

what impacts might culture have on health?

• communication

• traditional healing practices that may conflict with western medicine

what is health literacy?

the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions

what is the patient-centered model?

holistic approach where all aspects of care are addressed taking the patient’s point of view

what is disease-centered care?

focus on the accurate diagnosis and treatment of the organic pathology until cure is not possible

when communicating with a patient, you want to speak at a ___ grade level

5th

what is the function of the durham-humphery amendment?

• establishes criteria for distinguishing prescription drugs from OTC drugs

• legally establishes oral prescriptions and refills

• specifies the minimum information that a dispensed Rx label must contain

what are the methods of switching prescription drugs to OTC?

partial switch:

• manufacturer seeks to partially switch some of the indications of use to nonprescription marketing status, while keeping other indications as prescription status;

• manufacturer submits new NDA

• drug is available OTC for some conditions and prescription for other

full switch:

• the manufacturer seeks to switch the drug product covered under the NDA to nonprescription marketing status in its entirety

• manufacturer submits an efficacy supplement to an approved NDA

• drug only available as nonprescription

what is the primary goal of the pharmacist patient care process (PPCP)?

a) to ensure medication adherence 

b) to identify side effects of medications

c) to improve patient outcomes through a patient-center approach

d) to reduce the cost of medications

c) to improve patient outcomes through a patient-center approach

which of the following best defines health literacy?

a) the degree an individual can make informed decisions

b) the ability to speak about health issues

c) the capability to read medical jargon

d) the frequency of healthcare provider visits

a) the degree an individual can make informed decisions

which question can be used to assess a patient’s health literacy?

a) “do you like your physician?”

b) “how confident are you in filling out medical forms?”

c) “have you had any surgeries recently”

d) “what is your favorite medication?”

b) “how confident are you in filling out medical forms?”

improved public health measures, technology and longer life expectancies has to?

a) increased focus on emergency care

b) greater use of technology for acute illness

c) emphasis on chronic disease management

d) decreased patient-provider communication

c) emphasis on chronic disease management

direct-to-consumer advertising of medications has led to:

a) increased reliance on physician guidance

b) patients taking fewer medications

c) patients becoming more informed consumers

d) reduction in healthcare costs

c) patients becoming more informed consumers

how is patient adherence typically measured?

a) by checking the patient’s heart rate and blood pressure

b) through patient self-report or prescription data

c) by the number of clinic visits scheduled

d) by observing patient-provider interactions

b) through patient self-report or prescription data

what does the consumer model of care emphasize?

a) physicians control over all treatment decisions

b) patient autonomy and decision-making

c) a focus on acute care setting

d) the financial relationship between patients and providers

b) patient autonomy and decision-making

what does the term “patient-centered care” emphasis?

a) minimizing patient involvement in treatment decisions

b) prioritizing cost-effective treatments over patient needs

c) tailoring healthcare to individual patient preferences and needs

d) standardizing treatments for all patients

c) tailoring healthcare to individual patient preferences and needs

according to the patient-centered model, what should be at the forefront of care?

a) disease treatment

b) accurate diagnosis

c) practioner’s expertise

d) the patient’s perspective and experience

d) the patient’s perspective and experience

which model emphasizes a collaborative relationship between patients and healthcare providers?

a) activity-passivity model

b) patient-centered model

c) consumer model

d) biopsychosocial model

b) patient-centered model

which of the following is a factor influencing patient adherence?

a) socioeconomic status

b) patient demographics

c) type of medication packaging

d) frequency of clinic visits

a) socioeconomic status

motivational interviewing is primarily used to:

a) diagnose chronic diseases

b) improve drug adherence

c) encourage behavior change

d) educate patients about side effects

c) encourage behavior change

describe the composition of the massachusetts board of pharmacy:

13 members; comprised of 8 RPhs, 1 pharmacy technician, 1 representative of the public with experience in health care service, 1 registered physician, 1 registered nurse and 1 expert in patient safety and quality

in the board of pharmacy, the pharmacists come from:

2 independent, 2 chain, 1 has at least 7 years of experience a hospital setting, 1 will be from long-term care, 1 has practice in sterile compounding, 1 from academic standing

what are the requires to becoming a Board of Pharmacy member?

at least 7 years of experience for pharmacists and technician, no displinary action against any members; need to have a clean record for 10 years before being appointed

who appoints board members?

the governer

what is the term of years that a board member can serve?

3 years; can be reappointment but cannot serve more than 2 terms

inspectors of the board need to be trained in chapters ___ and ___ of the USP.

795, 797

how do you differentiate prescription vs non-prescription drugs?

a prescription drug contains a federal legend, legend has “Rx” only

the DEA oversees schedules ___-___

I-V; to prescribed a schedule VI drug you need a mass controlled substance registration not at DEA #

what is the difference between drug class and drug schedule?

drug classes categorize medications based on their effects and therapeutic uses, while drug schedules rank substances according to their potential for abuse and legal restrictions.

a schedule II drug must be submitted _____.

electronically

in case of emergency a schedule II,III,IV,V or VI may be dispensed upon ____ or ____ prescriptions 

written or oral

what is considered an emergency situation to not send a control prescription electronically?

1. immediate administration is necessary for proper treatment of intended user and a) it is not possible to generate or transmit an electronic prescription or

b) practioner determines the electronic prescription would delay treatment of patient

when do schedule II prescriptions expire?

30 days after the date of issuance if they’re written by an in-state prescriber

if an out-of-state prescriber prescribes a schedule II when does it expire?

5 days

when does the 30 days begin?

the day after the prescription was written

what are the exceptions to filling a 90 day supply of schedule II and III drugs?

1. if the drug is used in the treatment of opioid use disorder

2. any non-opioids in schedules II and III, such as stimulants and testosterone and

3. implantable infusion pumps

(true or false) epidemiology is the study of the distribution and determinants of health related states and events, not just disease in a specified population

true

(true or false) immunizations are an example of a primary prevention

true

(true or false) early detection for treatment of a disease is secondary prevention

true

reducing complications of established disease is an example of which level of prevention strategy

tertiary prevention

what is public health?

“The science and art of preventing disease, prolonging life, and promoting health through the organized efforts and informed choices of society, organizations, public and private communities, and individuals.”

what is primary prevention?

prevents an illness or injury from occurring at all; e.g. immunizations, tobacco cessation programs

what is secondary prevention?

minimizes the severity of the disease or injury once it has occurred; e.g. pap smear, mammography

what is tertiary prevention?

minimizes disability by providing medical care and rehabilitation services; e.g. occupational and physical therapy in burn patients, cardiac rehab in post-myocardial infarction patients

what is epidemiology?

• Seeks to describe the distribution and determinants of disease, injury, mortality, and other health outcomes.

• • Is the diagnostic discipline of public health

• • Is a major part of public health’s assessment function

• • Investigates causes of diseases

• • Many diseases, especially chronic diseases have multiple causes

• • Identifies trends in disease occurrence

• • Evaluates effectiveness of medical and public health interventions

what is descriptive epidemiology/ patterns of disease occurrence?

Classifies the occurrence of disease according to variables:

• Person – who is affected?

• Place – where does the condition occur?

• Time – when and over what time period does the condition occur?

• Descriptive epidemiology study- a study concerned with characterizing the amount and distribution of health and diseases within a population

• The ultimate goal is to use this knowledge to control and prevent the spread of disease.

• Set the stage for more focused investigations

• Etiology

• Planning needed services

what are some fields of public health?

• epidemiology

• biostatistics

• social and behavioral

• environmental health

• health policy and management

what are some social determinants of health?

economic stability, neighborhood and physical environment, education, food, community and social context, health care system

how does public health relate to pharmacy practice?

• Medical care, including access to medication, is an essential determinant of health

• Vaccine distribution

• The Food and Drug Administration regulates pharmaceuticals

• Epidemiologic methods are used to study the efficacy of new drugs.

• Prescription Monitoring Program to monitor potentially sensitive prescriptions

a prescription must enable the practitioner to instruct the pharmacist to dispense a brand name drug product by indicating “___ ______”

no substitution

DAW has to do with billing of _____, it’s not a legal issue

insurance

the ____ and ____ of the practitioner shall be clearly indicated on the prescription

name and address

for schedules II-V controlled substances you need a ____ registration, for schedule VI you need a mass _____ _____ registration

DEA; controlled substance

what does NPI stand for?

National Provider Identifier

if its a prescription for an opioid schedule II it needs to have a notation that the patient may ____ ____ _____ the prescription amount less than the recommended full quantity indicated

fill upon request

a prescription issues by a certified nurse practitioner, psychiatric nurse, etc. shall also contain the ____ of the supervising qualified healthcare professional unless the nurse issuing the prescription is authorized for independent practice

name

written prescriptions must contain the practitioners signature and shall be transmitted via ____ or similar technology or written on a ____ ____ form consistent with federal requirements for medicaid

facsimile; tamper resistant

a ____ shall be considered an oral prescription and shall not require a written or electronic follow-up prescription 

failover (prescription that failed to be sent over electronically)

what is an example of an “additional drug”?

gabapentin

in massachusetts can a prescription contain more than one drug product?

no

in an emergency situation a pharmacist may dispense a controlled substance in schedule II upon receiving the written or orally transmitted authorization if the quantity prescribed and dispensed is limited to the amount ____ to ____ the patient during the emergency period

adequate to treat 

in an emergency situation, the prescribing practitioner shall cause an electronic or written prescription for the emergency quantity prescribed to be delivered to the pharmacy which must have on its face “authorization for emergency dispensing” with ___ business days

7

if you receive an oral prescription, you must receive the electronic copy within ____ days

2

a prescription for a controlled substance may be issued only by a practitioner who is:

1. authorized to prescribe controlled substances; and

2. registered pursuant to the provisions of this chapter

an oral prescription issued by a ____ may be communicated to a pharmacist by an expressly authorized employee or agent of the ____.

practitioner

(true or false) there are 13 members on the massachusetts board of pharmacy

true

which of the following statements about the massachusetts board of pharmacy is FALSE.

a) the board has 8 RPh & each have had at least 7 consecutive years of experience

b) board has 5 reps of the public w/exp in health care service delivery, admin

c) board members shall be appointed and shall serve for a term of 3 years

d) no member shall serve more than 2 consecutive terms on the board

b) board has 5 reps of the public w/exp in health care service delivery, admin

(true or false) under mass law, written or electronic Rx for a CS in schedule II, shall become invalid 30 days after date issue.

true

(true or false) mass law CS schedule II or III may filled for a max of 90 days upon single filling for tx of OUD, ie buprenorphine

true

(true or false) under mass law, opioid CII or III may be filled for a max of 30 day supply of such substance upon single filling

true

(true or false) under mass law, all prescriptions for controlled substances shall be kept for 2 years by the pharmacy

true

under mass laws and regulations, which of the following is not required on prescription.

a) names and address of the patient

b) date of issuance of the prescription

c) names, dosage and strength of the controlled substance prescribed

d) time the prescription was issued

d) time the prescription was issued

(true or false) MA MDs may write more than 1 drug product with the same or different dispensing instructions on the same Rx form

false

(true or false) pt 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

(true or false) if pt requests Rx CII, the remaining portion of Rx may only be filled at the same pharmacy that originally dispensed lesser amount.

true

SATA in mass electronic Rx are required, however under which of the following circumstances may written/oral Rx be issued

a) prescriptions issued by veterinarians

b) prescriptions issued outside the jurisdiction of the commonwealth of mass

c) prescriptions issued for controlled substances in schedule VI

d) prescriptions for compounded drug preparations

all of the above

if oral Rx is issued, and no exception, the practitioner shall cause electronic Rx to be delivered within ____ days.

2

if oral Rx is issued, and no exception, the practitioner shall cause written Rx to be delivered within ___ days

7

(true of false) mass law, an oral Rx issued by a practitioner may be communicated to RPh by an expressly authorized employee or agt of pract.

true

SATA the term practitioner as defined by massachusetts law can include:

a) physician

b) dentist

c) podiatrist

d) nurse practitioner

e) pharmacy technician

a) physician

b) dentist

c) podiatrist

d) nurse practitioner

this law prohibited the adulteration and misbranding of foods and drugs in interstate commerce.  the law fell short of providing that protection that Congress intended, because of a US Supreme Court decision held that the misbranding provision in the law did not prevent false of misleading efficacy claims.

pure food and drug act (1906)

this law along with amendments forms the nucleus of todays’ law.  it provided that no new drug could be marketed until proven safe for use under the conditions described on the label and approved by the FDA.  this law also expanded the definitions of misbranding and adulteration, requiring that labels must contain adequate direction for use and warning about the habit-forming properties of certain drugs. 

food, drug and cosmetic act (1938)

this amendment established two classes of drugs-prescription and OTC- and provided that the labels of prescription drugs need not contain “adequate directions for use” so long as they contain the legend “Caution: federal law prohibits dispensing without a prescription”.  this amendment also authorizes oral prescriptions and refill of prescription drugs.

 

durham-humphrey amendment (1951)

 

this amendment requires that components added to food products receive premarket approval for safety.  also contain in this law is the anticancer provision (Delaney Clause) which prohibits the approval of any food additive that might cause cancer.

food additives amendment (1958)

the amendment requires manufacturers to establish the safety of color additives in foods, drugs, and cosmetics.  under this amendment the FDA can approve a color for one use but not for others (e.g. external use only). 

color additive amendments (1960)

this amendment is also called the Drug Efficiency Amendment, it strengthen the new drug approval process by requiring that drugs be proved not only safe but also effective.  the efficacy requirement was made retroactive to all drugs marketed between 1938 and 1962.  In addition, the amendment also transferred jurisdiction of prescription drug advertising form the FTC to the FDA, established GMP requirements and added more extensive controls for clinical investigations by requiring the informed consent of research subjects and reporting of adverse drug reactions.

kefauver-harris amendment (1962)

this amendment requires classification of devices according to their function, premarket approval, establishes performance standards, conformance of GMP requirement and adherence to record and reporting requirements of medical devices.

medical device amendment (1976)

congress passes this Act to provide tax and exclusive licensing incentives for manufacturers to develop and market drugs or biologicals for the treatment of “rare diseases or conditions (defined as those affecting fewer than 200,000 Americans.)

 

orphan drug act (1983)

also called the Waxman-Hatch Amendment, that act was enacted to streamline the generic drug approval process while giving patent extensions, in certain cases, to innovator drugs. 

drug price competition and patent term restoration act (1984)

congress enacted this act in response to the growing alarm that a secondary or diversionary distribution system for prescription drugs was threatening the public health and safety.  further this law establishes sales restrictions and record keeping requirements for prescription drug samples and prohibits hospitals and other healthcare entities from reselling their purchases to other businesses and requires the state licensing of drug wholesalers.

prescription drug marking act (1987)

this act further strengthened the Medical Device Amendment giving the FDA additional authority especially related to post marketing requirements and premarket notification and approval, while expediting the premarket device approval process.

safe medical devices act (1990)

this act resulted from a scandal that occurred when some FDA staff accepted bribed from generic drug industry personnel in order to facilitate the approval process of certain generic drug products.  this law authorizes the FDA to ban individuals or firms from participating in the drug approval process if convicted of related felonies. 

the generic drug enforcement act (1992)

the act requires manufacturers seeking NDAs to pay fees for applications and supplements when the FDA must review clinical studies.  the fees provide the FDA with the resources to hire more reviewers to assess these clinical studies and speed up the NDA reviews.  in addition, this Act must be reauthorized every 5 years.

prescription drug user fee act (1992)

the Act mandates nutrition labeling on food products and authorizes health claims on product labeling, as long as that are made in compliance with FDA regulations.

the nutrition labeling and education act (1990)

this act defines dietary supplements and permits manufacturers to make certain claims that otherwise would be illegal under the FDCA.  under this Act FDA regulates dietary supplements more as foods than as drugs.

dietary supplement health and education act (1994)