Introduction to Pharmacy Law

What is the Hierarchy for U.S. Laws

U.S. Constitution > Federal Law > State Constitution and Law

What are the 4 Law Implementation steps?

1. Law is passed

2. Executive branch (BoP) implement laws through regulations

3. Public comment period (15-45 days)

4. Law is effective

Law vs. REgulation

Law: Broad rules passed by Congress or by state legislatures

Regulation: More detailed rules created by agencies such as the FDA or state boards of pharmacy.

Name 3 federal executive branch agencies

DHHS: Department of health and human services

FDA: Food and Drug Administration

DEA: Drug Enforcement Administration

Name 3 California State executive branch agencies

1. HHSA: Health and Human Services Agency

2. EPA: Environmental Protection Agency

3. Business Consumer services and Housing Agency → Department on Consumer Affairs → Ca BoP

Name 3 Federal Laws affecting Pharmacy Practice

1. Food, Drug, and Cosmetic Act: Establishing the FDA

2. Controlled Substances Act: CS rules

3. HIPAA: Standards for electronic healthcare data transactions.

California Board of Pharmacy is composed of 13 appointed members: 7 _______ and 6 _________

Pharmacists, Public members

Are two interns under the same pharmacit allowed different tasks?

yes

How many interns per pharmacist at a time?

Two maximum

At intake station, what must be posted for patients to see?

Patient Rights Poster and the registered licenses of pharmacy personnel.

How many technicians can be on duty per pharmacist on duty?

3

How many technician trainees can be on duty per pharmacist on duty?

1

How many clerks or personnel not filling Rx can be on duty per pharmacist on duty?

any amount

Who may possess a key to all pharmacy inventory, cash, and personnel? What is the exception?

only the pharmacist.

An emergency key may be left in a tamper-evident container for the owner or building manager.

What is the one exception a pharmacist doesn’t have to be present?

30 minute meal breaks are required on shifts of 5 hours or more (may be waived if the shift is 6 hours or less). The staff may remain inside for customer service and non-pharmacist tasks only.

Pharmacy Practice –BPC §4050

Pharmacists are defined as health care providers,

May provide patient care services, not just products.

Advanced Practice Pharmacists may monitor and adjust drug therapy .

Scope of Service:

• Immunizations: flu and travel (CDC

guidelines)

• Smoking cessation

• Naloxone and self-administered

hormonal contraceptives

• Emergency contraception therapy

• HIV pre-and post-exposure medications

Dangerous Drugs/Device – BPC §4022

Possessing someone else’s prescription drugs is a federal offense

“Dangerous drug” or “dangerous device” means any drug or device unsafe for self-use in humans or animals, and includes the following:

Any drug that bears the legend: “Caution: federal law prohibits dispensing without prescription,” “Rx only,” or words of similar import.

Controlled Substances – BPC §4021

Any substance listed in Chapter 2 (commencing with §11053) of Division 10 of the Health and Safety Code are under tight regulations

Medication Profile Law

Who needs one Every patient whose prescriptions are filled at the pharmacy —unless the pharmacist reasonably believes the patient will not return.

It must contain: Patient and prescription

information; allergies and idiosyncrasies; prior

prescription drugs, devices and OTC medications

It must be kept at least one year from the last fill.

Prescription Requirements – BPC §4040

A prescription must require:

1. Pt name and address

2. Drug name, quantity and directions

3. Date of Issue

4. Prescriber name, address, phone, license classification, and DEA number if a controlled substance

5. Signature of the prescriber (if written)

6. Notice of prescription purpose or ondition, if the pt requests it.

E-Prescribing Requirement

Since January 1, 2022, most California prescriptions must be transmitted electronically

Exceptions:

-Technological or electrical failure prevents transmission

-The pharmacy is located outside

California

-The prescriber and the dispenser are the

same entity

-Terminal-illness prescriptions meeting

Health and Safety Code §11159.2

criteria

Written Prescription Requirements

A written prescription must contain, at minimum:

-Name and signature of the Prescriber

-Name and address of the patient

-Drug name, quantity and directions

-Date of issue

Generic Substitution

May substitute when the generic has:

-The same active chemical ingredients,

strength, quantity and dosage form

-The same generic drug name, and FDA

acceptance as having the same active

ingredients

Its not permitted if the prescriber writes “ do not substitute” or words of similar meaning

Labeling – BPC §4076 (a) (1)-(11)

Required on every label

• Drug name and directions for use

• Patient name

• Prescriber name and date filled

• Pharmacy name and address

• Prescription number

• Drug strength and quantity dispensed

• Expiration or beyond-use date

• Purpose or condition, if on the

prescription

• Physical description of the drug

Consultation

Oral consultation in all care settings:

-On the patient’s or agent’s request

-Whenever the pharmacist’s

professional judgment calls for it

Consultation is also required when:

-The drug has not previously been

dispensed to the patient

-The dose, dosage form or directions

have changed

Quality Assurance Program

Every pharmacy must establish or participate in a quality assurance program that documents and assesses medication errors, their cause and the response

Once an error is discovered —immediately, and no later than 2 business days:

1

Tell the patient about the

error and the steps needed

to mitigate it or avoid injury

2

Retrieve the medication

dispensed in error

(recommended) to aid the

investigation and prevent

harm

3

Notify the prescriber if the

patient took the wrong

medication, or the error

caused a clinically

significant delay in therapy

—unless the prescriber

called first

Medication Error Reporting - BPC 4113.1

Community pharmacies must report all medication errors to the California State Board of Pharmacy 14 days from the date of discovery.

Outpatient hospital pharmacies are exempt from this regulation.