Equivalence and Substitution

Regulations fall within the jurisdiction of the individual states.

Pharmaceutical equivalence: same active ingredient, same dosage form, same route of administration, identical in dosage strength or concentration, may contain different excipients 

Therapeutic equivalence:  pharmaceutical equivalence and bioequivalent 

Bioequivalence | ADME

A = absorption

D = distribution

M = metabolism

E = elimination 

The manufacturer must submit graphs to the FDA illustrating the two products containing the same drug have similar blood concentration vs. time curves, including: 

Time to peak

Peak concentrations

Area under the curve (AUC)

References

Approved Drug Products with Therapeutic Equivalence Evaluations aka The Orange Book

The Electronic Orange Book (internet version)

United States Pharmacopeia Dispensing Information (USP/DI) Volume III plus supplements 

Facts and Comparisons, Inc Approved Bioequivalence Codes 

FDA’s Internet Website http://www.fda.gov

Drugs marketed before 1938 are not required to be in The Orange Book.

A Rated

Bioequivalent to the innovator’s drug product 

Therapeutically equivalent to the brand name or reference product

A-rated products may be substituted for one another.

B Rated

NOT bioequivalent to the innovator’s drug product 

B-rated products may not be substituted for one another.

Generally, a tablet cannot be substituted for a capsule, an ointment for a cream.  Most sustained-release or controlled-release are not interchangeable. 

AB Rated

Previously not considered to be bioequivalent and now organized into bioequivalence groups (AB1, AB2, AB3, etc)

Must have the same number or lack of number to be bioequivalent 

Cannot substitute an AB1 product for a product designated as AB2

The Federal government has not passed regulations limiting the substitution of these products although a few states have.

Examples:

Carbamazepine

Digoxin

Levothyroxine

Lithium

Phenytoin

Theophylline

Valproic acid

Warfarin

Checkout our self-guided courses and instant download study guides on Teachable for Texas, Iowa, Maryland and federal law!

Study Tips for the MPJE

Do not waste time memorizing law citations.

The test will not refer to specific laws by citation.  Examples: Chapter 10.32.22, Regulations 10.34.22.01-.08 or Public Health Law Section 2164.  Instead, focus on learning the law material and how to apply it. 

Focus on well-established laws and regulations.

The test is not likely to ask or score questions related to recent changes in the law. The test is also not going to ask about temporary or recent exceptions such as the current COVID-19 exceptions in place.  

When a drug name is given in the question identify if it is OTC, prescription only or a controlled substance.  

Identify the regulations that may apply to the drug based on how it is classified and identify the general concept or principle the question is asking about.  Think about the question in a straightforward manner. Questions are not written to trick.

Make sure to review how state and federal laws may differ in the particular state. 

When there is a difference between federal and state laws and regulations, the strictest applies.  Some specific areas to review and compare are controlled substance schedules, methamphetamine purchase limitations and regulations related to controlled substance prescriptions such as valid types of prescriptions, refill limitations, and expiration dates.  Additionally, mid-level authority, technician ratios and authority, board licensing and renewals, collaborative practice agreements, immunizations, prescription monitoring programs, etc. vary from state to state.

Set aside a specific time to study.

It can be really easy to have good intentions of studying without ever making it happen. Plan and set aside time to study for the scheduled test date.  Add it to a digital calendar or planner if needed.  Once plans are in writing, it is easier to stick to those plans.  Try to make sure your plans don’t interfere with work, family or other obligations.  Have a regular study space that is comfortable and conducive to studying. 

Don’t try to cram all at once.  

It can be best to space studying out into more shorter sessions than one long binge session.  If you are fighting heavy eyelids, it is really hard to study! Try not to procrastinate or find excuses not to study.  There will always be other tasks to complete, material that is boring or difficult, however it’s important to stick to set study plans if at all possible. It can be best to plan for a 5-minute break every 30 to 40 minutes for longer study sessions.  If possible, take a walk around the block, grab a snack or complete a short physical task during break periods.

Eliminate ALL the distractions.  

It feels like there are SO many distractions these days.  Technology can be a big one.  Try to reduce notifications, background noises and access to mindless internet scrolling.  Find a quiet place away from family or roommates if possible.  Make sure to have good lighting, a comfortable temperature, and uncluttered workspace.

Organize notes or study material.

Group similar topics or information together.  Break it up into sections.  Look up and research any words or topics that aren’t understood to make sure notes are complete and accurate.  Re-write or re-organize information if it’s presented in a way that doesn’t work well for your learning style.  Color code, create charts, create tables or other graphics that help with learning if necessary.  Or purchase a study guide or course that does this for you – that’s what we do!!

Create a specific goal for your study session.  

Organize material that needs to be studied.  Have a goal of getting through a set number of sections, chapters or subject material.    

Mark or highlight study material you will need to revisit.  

If there is a topic that is particularly difficult, or the bulk of the test material, make sure to spend more time revisiting that material.  Be able to find it easily and review it just prior to your test time.