Continuing Pharmacy Education Program

Saturday, May 18, 2013

2 - 4 PM

Pre-Meeting CPE

The Compounding/Manufacturing Debate: When Is a Duck Not a Duck?

ACPE #205-0000-13-001-L03-P
(0.2 CEUs – 2 contact hours)

Target Audience: Pharmacists
Activity Type: Application-based

Learning Objectives
At the conclusion of this session participants will be able to:

1. Explain how a compounding pharmacy might be registered as a manufacturer by Food and Drug Administration (FDA).
2. Describe how states can enforce their regulations when it comes to the activities of compounding pharmacies acting as manufacturers.
3. Describe how compounding pharmacies that are acting as manufacturers may be regulated in the future.

Description
The New England Compounding Center tragedy resulted in regulators conducting in-depth investigations of compounding pharmacies. This has brought to light the realization that these types of entities may be operating in a gray area of law. During this special pre-meeting continuing pharmacy education (CPE) panel session, federal and state regulators and compounding experts will discuss the perplexities surrounding the issue of compounding pharmacies acting as manufacturers and the resultant and ongoing regulatory challenges facing the boards of pharmacy.

Sunday, May 19, 2013

8 - 11:30 AM
Joint CPE

Educational Poster Session – Sharing Responsibility for Public Protection

ACPE #205-0000-13-002-L05-P
(0.1 CEU – 1 contact hour)

Target Audience: Pharmacists
Activity Type: Knowledge-based

Learning Objectives
At the conclusion of this session participants will be able to:

1. Describe several public protection projects that boards of pharmacy and schools and colleges of pharmacy have implemented.
2. Explain several ways that sharing responsibility can increase public protection.

Description
Continuing an annual favorite, CPE credit will be awarded for those participating in the Educational Poster Session. Board of pharmacy and school and college of pharmacy representatives will present various poster displays as they relate to sharing responsibility to increase public protection. CPE is earned through interactive participation with presenters for one hour during the three and one-half hour offering and by completing a post-session test.

3:30 - 4:30 PM
Joint CPE

gTLD and LegitScript Investigations Update

ACPE #205-0000-13-003-L03-P
(0.1 CEU – 1 contact hour)

Target Audience: Pharmacists
Activity Type: Knowledge-based

Learning Objectives
At the conclusion of this session participants will be able to:

1. Describe the public health issues surrounding rogue Internet pharmacies.
2. Describe how the .PHARMACY domain will establish a worldwide, safe Internet space for consumers seeking legitimate pharmacy services.
3. Describe the current accomplishments in protecting the public by curtailing illegal entities from setting up rogue Internet drug outlets.

Description
It appears that every time a rogue Internet drug outlet is shut down, many more attempt to take its place. During this joint CPE session, meeting attendees will hear an update regarding enforcement successes, including what registrars, search engines, credit card companies, and others are doing to shut down rogue sites. Also discussed will be the issue of generic Top-Level Domains (gTLD), including NABP’s application to obtain the .PHARMACY gTLD and the current strategy for keeping the rogue players out of the game.

Monday, May 20, 2013

8:15 - 10:15 AM
Joint CPE

Veterinary Pharmacy Issues: Identifying Illegal Practices and Distinguishing Supply Chain Variations

ACPE #205-0000-13-004-L03-P
(0.2 CEUs – 2 contact hours)

Target Audience: Pharmacists
Activity Type: Knowledge-based

Learning Objectives
At the conclusion of this session participants will be able to:

1. Illustrate why pharmacists who dispense veterinary medicines should possess particular skills.
2. Describe the additional training necessary for pharmacists to practice veterinary pharmacy.
3. Explain the legal differences between the human and veterinary drug supply chain.

Description
Many pet owners think that Fido is part of the family, but who should prescribe and dispense veterinary medicines? This session’s discussion will center around what knowledge is necessary regarding drug therapy and pharmacokinetics in veterinary medicine and why a lack of such knowledge may place our animal counterparts at risk. Additionally, attendees will learn the differences between the two drug supply chains – the how and the why the veterinary drug supply chain is legally allowed to be separate and vary from the human drug supply chain.

Tuesday, May 21, 2013

8:45 - 10:15 AM
Executive Officer and Board Member CPE

Virtual Pharmacy Practice and Wholesale Distribution – Out of Thin Air

ACPE #205-0000-13-005-L03-P
(0.15 CEUs – 1.5 contact hours)

Target Audience: Pharmacists
Activity Type: Application-based

Learning Objectives
At the conclusion of this session participants will be able to:

1. Describe how some virtual manufacturers and virtual wholesale distributors are creating enforcement issues for those charged with regulating them.
2. Explain how virtual manufacturers and virtual wholesale distributors may be playing a role in creating/worsening drug shortages.
3. Describe the changes in laws and/or regulations that are necessary to assist regulatory bodies to enforce compliance of virtual manufacturers and virtual wholesalers.

Description
Do virtual manufacturers and virtual wholesale distributors play in the same realm as brick and mortar entities? How is the spectrum of wholesale distribution changing in response to regulators’ enforcement nightmares and could virtuals possibly be playing a role in the drug shortages crises? A recent NABP task force tackled these issues and some alarming trends were unveiled. Attendees will learn about how some virtuals fly under the enforcement radar and what changes are necessary to protect the public by making them visible and ensuring their compliance.

8:45 - 10:15 AM
Compliance Officer CPE

Pill Mills, Non-Therapeutic Drug Use, and Prescription Drug Monitoring: What to Look for During Investigations

ACPE #205-0000-13-006-L03-P
(0.15 CEUs – 1.5 contact hours)

Target Audience: Pharmacists
Activity Type: Knowledge-based

Learning Objectives
At the conclusion of this session participants will be able to:

1. Explain how prescription monitoring programs (PMPs) are used to detect non-therapeutic drug use.
2. Describe how PMP reports may be used during a pharmacy investigation.
3. Describe how effective PMPs are in decreasing pill mill operations.

Description
With prescription drug monitoring programs, today’s technologically advanced world provides boards of pharmacy and their compliance officers better tools in which to conduct pharmacy investigations and detect cases of diversion and abuse. During this CPE session, experienced regulators will provide attendees proven methods on using these and other tools when investigating pill mills and non-therapeutic drug use.

10:30 AM - Noon
Joint CPE

Are Biosimilars the Same as Generics? Point-Counterpoint 

ACPE #205-0000-13-007-L03-P
(0.15 CEUs – 1.5 contact hours)

Target Audience: Pharmacists
Activity Type: Application-based

Learning Objectives
At the conclusion of this session participants will be able to:

1. Explain what biologics are and how they are manufactured.
2. Describe the difference between generic substitution and biosimilar interchangeability.
3. Describe changes to drug product selection laws and regulations that may be necessary to address biosimilar interchangeability.

Description
Biosimilars are becoming a hot topic with the upcoming implementation of the Biologics Price Competition and Innovation Act of 2009. Questions have been posed as to whether they should be allowed to be interchangeable with reference products and what regulatory changes boards of pharmacy may need to address to deal with this issue. This panel of government and industry experts will provide session attendees with in-depth information on biologics and biosimilars, including the pros and cons of interchangeability and what regulatory hurdles need to be cleared.

NABP and the NABP Foundation is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education (CPE). ACPE Provider Number: 205. Participants may earn ACPE accredited CPE credit by completing a Statement of Continuing Pharmacy Education Participation online and submitting it electronically to NABP. Full attendance and completion of the program evaluation and learning assessment for each session are required to receive CPE credit and a Statement of Continuing Pharmacy Education Credit.

Continuing Legal Education (CLE) Policy: NABP staff will be available to assist attendees on an individual basis to apply for CLE credit for attending CPE sessions. To apply for CLE credit, attendees must initiate the program approval process in their own states by completing and submitting the appropriate application materials and forms. NABP will provide documentation as necessary.