What is specialty pharmacy? And what do I need to study for the NAPLEX/MPJE?

 What is a specialty pharmacy? 

And what do I need to study for the NAPLEX/MPJE

As more money and time are funneled into research and development projects, many new medications for complicated disease states are entering the market. While there is no specific definition for “specialty” medications, usually a medication is deemed as such when one or all of the following are met: 

1. The medication itself is very expensive

2. The medication requires specific storage/handling precautions

3. The medication requires specific monitoring

4. The medication is used for (a) complicated disease state(s)

Specialty pharmacies focus on these medications usually because traditional community and retail pharmacies don’t have the time or resources to properly handle these medications. Many insurance companies also require patients to receive their specialty medication from a specialty pharmacy to promote better patient outcomes.

Workflow 

The general workflow of a specialty pharmacy looks something like this: 

1. A prescription is received from the doctor and billed to the patient’s insurance.

2. Usually, the medication will require a prior authorization from the insurance company, and many specialty pharmacies have technicians that work on processing these.

3. After the insurance has been billed, a pharmacist calls the patient to discuss the medication. This consultation usually lasts about 15-20 minutes and details storage, administration, side effects, monitoring, and more.

4. Specialty medications are commonly mailed directly to the patient or the patient’s local pharmacy for pick-up.

5. Patients are contacted directly by a pharmacist for their first refill, and then they are contacted by the pharmacist every 3 months to check-in. For the refills in between, technicians coordinate billing and mailing the prescriptions. Patients are offered a consultation at these refill calls but don’t always need to speak to a pharmacist. 

Licensing 

Specialty pharmacies are typically licensed in multiple states to service many patients.  For the MPJE, it is important to note the requirements for licensure across state lines. Some important key law requirements to note for pharmacies that are mailing prescriptions include: 

1. The pharmacy must be licensed in the state where the dispensing facility is located.

2. The pharmacy must disclose the location, names, and titles of pharmacists dispensing drugs to out-of-state residents.

3. The pharmacy must be compliant with all directions and requests from Boards of Pharmacy from different states.

4. The pharmacy must maintain records of drugs dispensed to out-of-state residents.

5. The pharmacy must have a toll-free telephone service available to patients at least 6 days per week for a minimum of 40 hours per week. This number must be listed on each drug container label.

Your state may have more specific requirements for mail-order pharmacies, so it will be important to review those further before taking the MPJE.

Clinical Information

When reviewing specialty medications for the NAPLEX, it is important to remember that the NAPLEX is an exam designed to focus on safety. The purpose of this exam is to ensure that pharmacists are safely dispensing medications to patients and preventing harm. When focusing on medications for this exam, focus on side effects and appropriateness of therapy. 

Autoimmune Diseases

The more common disease states covered on the NAPLEX fall under the umbrella term “autoimmune diseases.” In general, specialty medications for autoimmune diseases are rarely the first-line treatment. When faced with exam questions regarding rheumatoid arthritis, Crohn's, ulcerative colitis, and other autoimmune diseases, keep in mind that there are many oral, non-specialty medications that are preferred before the expensive injectables. Usually, these therapies involve using steroids to achieve remission, and then some oral medication to maintain remission. Focusing on treatment algorithms and where specialty medications fit in will be helpful in determining the appropriateness of therapy when presented a patient case.

The second important pearl to remember is that specialty medications for these disease states work by decreasing immune system function. It will be important to note that live vaccines cannot be administered to patients taking these medications, and patients should receive a TB test before starting these medications. You may get a patient case on the exam regarding an immunosuppressed patient presenting to the pharmacy to catch up on vaccinations. Know what immunizations are appropriate for this patient group. 

Finally, specialty medications do not usually work immediately. Often, patients are started on a high dose of steroid taper to control the disease while the specialty medication is started. It will be important to know what steroid doses are immunosuppressive. There are usually a few questions regarding immunosuppressive steroid doses on the NAPLEX, so these are easy right answers if you memorize them! 

Conclusion 

There are several other specialty disease states that I would like to cover in future blog topics, including HIV and oncology medications. Moving forward with your studying, it will be important to understand where specialty medications fit in treatment algorithms and what side effects pharmacists must be cognizant of when filling these medications for patients. Stay tuned for more study tips and information!

Free NAPLEX and MPJE practice questions:

Practice Question 1

Pharmacy X is a mail order pharmacy in Illinois that dispenses prescriptions to patients in nearly every state. What regulatory authority do the states, other than Illinois, have?

 A. The states have no authority to regulate Pharmacy X.

 B. The states can legally require that Pharmacy X be licensed and conform to the same requirements as pharmacies in that state.

 C. The states can legally require Pharmacy X to register with the state board and meet certain requirements that are not unduly burdensome.

 D. The states can impose stricter requirements on Pharmacy X than it does on in-state pharmacies.

Practice Question 2

MJ is a 32-year old female with a history of Crohn’s Disease. She is currently using Humira (adalimumab) and is injecting 40 mg under the skin every other week. She presents to the pharmacy today for vaccinations before traveling with her church group on a mission trip in 6 weeks.  When she turned 30 she was up-to-date on all of her vaccinations. Which of the following vaccines should be administered today?

A. Yellow Fever

B. Oral Typhoid

C. Seasonal influenza vaccine

D. Hepatitis A & B

Practice Question 3

BD is a 38-year old male with a history of rheumatoid arthritis. He presents to the clinic today complaining of bilateral joint pain and stiffness, especially upon waking. He currently takes meloxicam 15 mg daily which does not relieve his symptoms. Which is the most appropriate therapy to start BD on today? 

A. Prednisone 20 mg po qd 

B. Methotrexate 7.5 mg once weekly 

C. Indomethacin 50 mg tid 

D. Adalimumab 50 mg sc every other week 

*****

Answers to the MPJE/NAPLEX style questions:

Practice question 1 - Answer: C

Practice question 2 - Answer: Only C & D can be administered today.

Practice question 3 - Answer: B

Taking practice MPJE®/NAPLEX® exams is key to passing the board exams on the first try. Practice exams:

1.   Expose you to time constraints and help you build mental stamina

2.   Expose you to different questions (K-type, select all, etc.)

3.   Expose you to random topics with various difficulties

4.   Expose you to new answer choices

5.   Help demystify the exams and ease test anxiety

PassRXnow offers MPJE practice content for 15+ states and 600+ NAPLEX questions covering clinical, patient profile, calculations, and top 200 generics/brand name drugs. All NAPLEX and MPJE practice exams have answers, explanations, and references. 1000’s of questions, all updated frequently. 

You can avoid the impact of failing the NAPLEX / MPJE by doing more practice exams. Check out our offerings. For transparency, you can see the last update date for each course at the top of the course page in the links below. Content is updated regularly.

MPJE – click here for the latest States (if you don’t see your state MPJE reference below)

Washington MPJE   | Michigan MPJE  | Pennsylvania MPJE | Massachusetts MPJE| Florida MPJE | New York MPJE | Tennessee MPJE | Illinois MPJE | Ohio MPJE | Texas MPJE |  Georgia MPJE | Federal pharmacy law | Advanced MPJE covering USP <800>, Central fill, and more

New states are constantly added. Click here to see the latest MPJE for all states.

NAPLEX  - click here for the NAPLEX offerings

NAPLEX practice| NAPLEX & MPJE Essentials

About the author

Tara Airola is a recent PharmD graduate from the University of Wisconsin-Madison School of Pharmacy. She currently works at a dermatology-specialized pharmacy in Chicago, IL. Her areas of interest include autoimmune diseases, cancers, and acne treatments.