Pharm Law Exam 1

Apothecary Era Years

2600 BC - 1700 BC

Ancient China

• 2000 BC

• Diagnosed and treated

• Utilized plants and natural materials

• Apprenticeship-based

• Educated others on herbs

Arabia and Medieval Europe

• 700 AD - 1300 AD

• Private apothecaries emerged

• Standardized instructions for preparing medications

• Separated arts of apothecaries from physician services

Separation of pharmacists and physician roles

Formalized by King Frederick II in 1240 AD

Colonial America

• 1640

• Community members filled the gap relying on folklore, herbs, minerals, and magic

Apothecary Era

• 2600 BC - 1700 AD

• Healing based on herbs, minerals, and natural remedies

• Knowledge passed through apprenticeship or family tradition

• Private practice for pharmacists / apothecaries

• Formalization of separation of pharmacy from medicine

• No standardized requirements for education, pharmacopeia, or regulation

US Pharmacopeia Year

Held in 1820, pharmacists were included in 1840

Purpose of US Pharmacopeia

• Developed list of midicinal drugs with their effects and directions for their use

• Designed to bring uniformity, promote safely and quality control

First College of Pharmacy

Philadelphia College of Pharmacy School 1821

MCPHS

Founded in 1823

Mother of Pharmacy

Elizabeth Gooking Greenleaf

Evolution of Pharmacy Education

Flexner Report

Standardized MD training

Mills Report

Recommended 6 year PharmD

Good Moral Character

those virtues of a person which are generally recognized as beneficial to the public health, safety and welfare

Good Standing

means the pharmacist’s personal registration is not currently being sanctioned by the Board

Preceptor

means a registered pharmacist in good standing who has completed at least one year of the actual practice of pharmacy and who the Board has approved to supervise and direct the training of pharmacy interns and to assist in the training of other pharmacy interns

Pharmacy Intern

the period of training under the supervision of a Board-approved registered pharmacist preceptor, which training is a prerequisite to examination for personal registration as a pharmacist in the Commonwealth of Massachusetts

 To qualify for licensure, the applicant must achieve a NAPLEX and MPJE score of higher than ___?

75%

Licensure by Reciprocity

Licensure by reciprocity means that if you hold a license in one state, you can get a similar license in another state without retaking the main exams required in that state. Taking a law exam might be required as every state has different laws.

When do Massachusetts Pharmacist licenses expire?

December 31st of every even year

When do Pharmacy store license espire?

December 31st of every odd year

How many CE contact hours are required for Massachusetts pharmacists?

20 contact hours are required by December 31st each even year.

Can these contact hours be carried over from one calendar year to the next?

No

Maximum number of contact hours per day

8 hours

Within the required contact hours per year, at least how many of them have to be live, in person

5 hours

How many contact hours are pharmacist required to have in the pharmacy law area?

2 hours

How many contact hours are required for sterile compounding?

5 hours

Do you need CE contact hours in the year of PharmD graduation?

No, as long as you meet the 20 required minimum hours

How long are pharmacists required to maintain documentation of their CEs?

A pharmacist is required to maintain documentation for at least two years starting from the date of completion.

How many hours maximum can pharmacy interns receive in a day?

12 hours of pharmacy internship credit per day

Three levels of technicians

Certified Pharm Techs (CPT), Registered Pharm Techs (PT), and Pharm Tech Trainees (PTT)

Supervisory Ratios between Pharmacy interns, CPT, and PTT

1 pharmacist maximum : 4 support personnel (1CPT, 1 Pharm Intern) or >2 CPT or Interns) - Massachusetts

1 pharmacist : 3 support personnel (>1 Pharm intern or a CPT)
1 : 2

Categories of Drugs

Prescription vs Non-Prescription drugs (OTC)

Categories of Prescription Drugs

Controlled Drugs (Schedules I-V)
Uncontrolled Drugs (Schedule VI Mass / No Schedule Fed)

Public Goods

Beneficial products that private corporations do not supply because there is no incentive to

Orphan Drug Act

provided incentive to pharmaceutical companies to develop drugs for rare diseases, which is not ideal for private companies because of the lack of demand. Therefore, this role is passed to public corporations instead

Orphan Drugs

Drugs that combat rare diseases

Example of Public Goods

Orphan Drugs, Vaccines

Externalities

• When the production or consumption of a good affects someone who does not fully consent to the effect

• When the costs of the good are not fully incorporated in the price of the good

Example of Externalities

Indiscriminate use of antibiotics result into superbugs that are viruses or bacteria that develop a resistance towards antibiotics

Natural monopolies

When the fixed costs of providing a good are high, relative to the variable costs of producing the good

Information asymmetry

When the consumer is uninformed about the true value of a good

Types of Market Failures

• Public Goods

• Externalities

• Natural Monopolies

• Information Asymmetry

Limits of the Law

• Certain human relationships

• Deminimis violations

• Protecting individual freedoms while preventing harm to others

De minimis Violations

• As long as a mistake or violation to the law is minimal and leads to no harm to the patient, it counts as a de minimis violation which would not be pursued as heavily

Sources of Law

• US Constitution

• Legislatures: Statutory Law

• State constitutions

Administrative agencies

Administrative agencies are created by legislatures to administer a body of substantive law

• DEA

• FDA

DEA

Drug Enforcement Administration

FDA

Food and Drug Administration

Board of Pharmacy Roles

• Promulgate regulations (executive branch)

• Regulations enact via notice and comment rulemaking

• Validity tests of a regulation

Regulations are published in:

Federal Register and Code of Federal Regulations (CFR)

Law made by courts

Common Law

Criminal: government v. private party

• Charged with a crime as prohibited by a statute and subject to penalties specified by statute

• Objectives: deter, punish, rehabilitate - Theft

Civil: private party v, private party

• May be based upon statute or common law legal rights

• Objective: compensation to injured party - Manslaughter

Administrative: agency v. private party

Disciplinary determination, which may include warning, fines, licensure revocation or suspension, probation

State Boards of Pharmacy (BOP)

• Purpose of the board: to administer state pharmacy practice acts and protect the public

• National Association of Boards of Pharmacy (NABP) performs several functions, including:

  • Overseeing the standardized licensure exam process

  • Forum for developing professional policies and standards

  • Developing model legislation and regulations for use by member boards

  • Administers the NAPLEX

• Board composition depends on state law but includes practicing pharmacists and often consumer members.

Licensing of pharmacists

• Requirements essentially same for each state

• Foreign pharmacy school graduates may be allows to take the equivalency exam in order to take the board.

• Citizenship requirement for licensure is unconstitutional

• NAPLEX exam administered in every state

• License transfer generally allowed by every state

• Pharmacist licenses subjected to periodic renewal

• Continuing educations (CPE credits)

Licensing pharmacies

• In an effort to free pharmacists for more professional services, some states have authorized the use of kiosks

• Many states have laws specifically prohibiting dispensing prescriptions via the internet unless prescriptions were issued pursuant to a good faith prior examination by the prescriber

Actions Against a License

• State boards have broad discretion in the discipline of pharmacists and pharmacies

• State pharmacy boards may not focus on outcomes as much as they should

• Boards must comply with administrative procedure laws in any disciplinary action

Pharmacists’ Patient Care Process

• Collect

• Assess

• Plan

• Implement

• Follow Up

What is a Patient?

Someone under the care of any healthcare provider

Patient populations requiring unique medication and care

• Pediatric

• Critically ill

• Low income

• LGBTQ

• Concurrent Disease States

• Geriatric

• Pregnancy

• Lactation

• Women

• Unhoused

Largest segment of medical care patients in America

Patients over the age of 85

Outpatient Care

Care encompasses a wide range of medical services provided to patients who do not require overnight hospitalization

Inpatient care

Care involves the hospitalization of patients for comprehensive medical treatment and monitoring

Models of Physician - Patient Relations

• Consumer model

• Patient-centered model

• Biopsychosocial model

Consumer Model

• Ready access to information

• Facilitates “self-care”

• Increase demands for goods and services

Patient-Centered Model

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

• Constrasts to disease-centered care

Compliance

The range of a patient’s conformity to the recommendations about day-to-day treatment by provider with respect to timingm dosage, and frequency

• Regulatory

Adherence

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

• Collaborative

Factors influencing adherence

• Social/Economic

  • Income, Employment and housing, cultural beliefs

• Condition-related

  • Asymptomatic conditions, co-morbidities

• Patient-related

  • Believs about treatment, fear of side effects, Forgetfulness, lack of knowledge or motivation

• Therapy-related

  • Complexity of regimen, treatment duration, side effects

• Health system

  • Provider-patient relationship. Lack of monitoring / follow up

Patient Cultures

• Shared system of values, beliefs, and learned patterns of behaviors

• Dynamic

• Influenced by an individual’s

  • Proximity to culture of origin

  • Education

  • Gender

  • Age

  • Sexual preference

Impact of Culture on Health

• Cultural perspectives influence individual’s perceptions of health, illness, and treatment choices

• Communication (verbal and nonverbal)

• Many cultures have their own tradition healing p0ractices that may compliment or conflict with Western medicine

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

Screening Questions For LowHealth Literacy

Screening questions can be a valuable tool to identify individuals
who may be at risk of low health literacy.