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HelixTalk - Rosalind Franklin University's College of Pharmacy Podcast

178 - Law & Order: Pharmacy Edition. A Concise Review of High-Yield Pharmacy Law Topics for the MPJE

HelixTalk - Rosalind Franklin University's College of Pharmacy Podcast

Sean P. Kane, PharmD, BCPS

Health & Fitness, Medications, Rosalindfranklin, Rfums, Pharmacy, Pharmd, Pharmacist, Medicine, Drugs

5 • 644 Ratings

🗓️ 13 February 2024

⏱️ 57 minutes

🔗️ Recording | iTunes | RSS

🧾️ Download transcript

Summary

In this episode, we speak with Janeen Winnike, the Associate Dean for Student Affairs at Rosalind Franklin and a co-course director for the Pharmacy Law course at the university. We review some of the key points regarding federal and Illinois pharmacy law – a must-listen especially for graduates preparing for their MPJE exam after graduation!

Key Concepts

  1. The FDA (via the Food, Drug, and Cosmetic Act) primarily regulates manufacturers. Most regulation for pharmacies and pharmacists is via the federal Controlled Substances Act and state-based regulations (acts and administrative codes).
  2. An IND (investigational drug application) is required to begin human clinical trials (phase I-III). An NDA (new drug application) is used for the FDA to consider whether a drug should be approved for use in the US.
  3. The Federal Controlled Substances Act outlines which drugs are scheduled I-V. State law can be more restrictive. C-II drugs have special regulations related to prescribing, ordering/distribution, refills, partial fills, etc.
  4. In Illinois, pharmacists, student pharmacists, and pharmacy technicians are permitted to vaccinate patients aged 7 years and older (or temporarily 3 years and older per the PREP act for COVID-19 and influenza vaccines). Pharmacists can order and administer COVID-19 and influenza vaccines; other vaccines require a standing order or a prescription in order prior to administration in a pharmacy.

References

  1. Illinois Pharmacy Practice Act (225 ILCS 85) https://ilga.gov/legislation/ilcs/ilcs3.asp?ActID=1318&ChapterID=24
  2. Illinois Pharmacy Practice Act Administrative Code (Part 1330):  https://www.ilga.gov/commission/jcar/admincode/068/06801330sections.html
  3. Illinois Controlled Substances Act (720 ILCS 570) https://ilga.gov/legislation/ilcs/ilcs5.asp?ActID=1941&ChapterID=53
  4. Illinois Controlled Substances Act Administrative Code (Part 3100) https://www.ilga.gov/commission/jcar/admincode/077/07703100sections.html
  5. Pharmacist’s Manual: An Informational Outline of the Controlled Substances Act. Drug Enforcement Administration. https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-046R1)(EO-DEA154R1)_Pharmacist%27s_Manual_DEA.pdf

Transcript

Click on a timestamp to play from that location

0:00.0

Welcome to Helix Talk, an educational podcast for healthcare students and providers covering real-life clinical pearls, professional pharmacy topics, and drug therapy discussions.

0:11.0

This podcast is provided by pharmacists and faculty members at Rosal Franklin University College of Pharmacy.

0:17.0

This podcast contains general information for educational purposes only. This is not professional

0:22.4

advice and should not be used in lieu of obtaining advice from a qualified health care provider.

0:27.2

And now, on to the show. Welcome to Helix Talk episode 178. I'm your co-host, Dr. Kane.

0:35.4

And I'm Dr. Patel. And the title of today's episode is

0:38.2

Law and Order, Pharmacy Edition, a concise review of high-yield pharmacy law topics for the MPJ.

0:45.2

Surprise today. We have a returning contributor guest faculty. Our professor, Janine Rennicki,

0:51.9

she's an associate dean for student affairs at our university,

0:55.1

Rosalind Franklin, and she's a co-course director where she teaches pharmacy law.

0:59.9

That's why we have her here to share the expert tips on how to be successful in taking

1:05.2

MPJ. Thanks, Dr. Cattel. Thank you for being here. And of course, for any legal podcast, we must have a legal disclaimer.

1:12.6

So a couple of things that we have to talk about is, you know, we will focus a little bit on

1:16.6

federal law, but most law that actually impacts pharmacists is at the state level.

1:20.6

So we will be covering a little bit of the state law specific to Illinois, but please recognize

1:25.6

that your state is probably different. With that

1:27.7

in mind, the questions that we're going to be asking about our individual state law

1:31.7

could be applicable to your state. So can a pharmacist and immunize it in your state? Can

1:36.2

a technician immunized in your state? Such a great comment, Dr. Kane, because that's

1:39.5

what I tell students all the time, right? Within our law course, we're going to focus on

1:43.3

the state where which we're located, which is Illinois, but I let students know right up front. Think about

1:49.5

these questions, think about these topics, and make sure you're learning those for the state you're

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