Showing posts with label Education. Show all posts
Showing posts with label Education. Show all posts

Friday, August 2, 2013

University of Michigan College of Pharmacy Presents CEU Including The Changing Landscape of Pharmacy Compounding David Brushwood, RPh, JD Professor of Pharmaceutical Outcomes & Policy The University of Florida College of Pharmacy Gainesville, Florida

Annual Pharmacy Lectures
Program Schedule

Date: Friday, October 4, 2013
Location: Weber's Inn, 3050 Jackson Ave., Ann Arbor, MI 48103
Time: 8:15 AM to 4:30 PM
Cost: $95 / person
7:45 am              Registration and continental breakfast (included in registration fee)
8:15 am              Welcome and program introduction
8:30 am              Morning lectures

Managing the Fungal Outbreak: Pharmacists' View from the Front Lines
Robert Loveland, BSPharm, PharmD
Outpatient Pharmacy Manager
St. Joseph Mercy Hospital
Ann Arbor, Michigan

Nina E. West, PharmD
Clinical Pharmacy Manager
St. Joseph Mercy Hospital
Ann Arbor, Michigan

Kimberlyn M. Dang, PharmD
Generalist Pharmacist
University of Michigan Health System

Wednesday, July 3, 2013

PCCA Compounding Courses


Class Schedule

Read course descriptions here.

Introductory Compounding Lab Boot Camp

  • Status: Sold out
  • Location: Houston, Texas
  • Date: August 12-13, 2013

Advanced Compounding Training Program - Fall 2013 (10-Week Online Component and Lab)

Veterinary Compounding Training Program - Fall 2013 (10-Week Online Component and Lab)

Veterinary Compounding Training Program - Fall 2013 (10-Week Online Component ONLY)

Monday, June 3, 2013

Free CE Program For NH Pharmacists - June 5, 2013


 
A free (4 live CE credits for pharmacists) Board co-sponsored program is being offered on Wednesday, June 5, 2013 (8:30 A.M to 1:00 PM) at Concord Hospital. 

Topics/Guest Speakers Include: 
NH Pathology Report / Dr. Thomas Andrew
Primary Care Challenges in Treating Pain
Dr. Molly Rossignol 
Fraudulent Prescriptions  
Chris Shambarger R.Ph /Trooper Marc Beaudoin 
E-prescribing Control Medications/ Attorney Larry Sweeney R.Ph.
PMP Update / Jay Queenan R.Ph. MBA

View the program flyer Adobe Acrobat symbolfor more information.




Monday, May 13, 2013

Testimony before the Committee on Health, Education, Labor and Pensions United States Senate May 9, 2013 Allan Coukell, Senior Director of Drugs and Medical Devices The Pew Charitable Trusts


Testimony before the Committee on Health, Education, Labor and Pensions
United States Senate
May 9, 2013
Allan Coukell, Senior Director of Drugs and Medical Devices
The Pew Charitable Trusts
Dear Chairman Harkin, Ranking Member Alexander and members of the Committee,
Thank you for the opportunity to testify on your proposal to improve the safety of pharmaceutical compounding.
My name is Allan Coukell. I am a pharmacist and director of drug and medical device work at the Pew Charitable Trusts, an independent, nonpartisan research and public policy organization.
Pharmacists have always compounded medicines – it is the origin of the profession – but the activities you seek to address today are far removed from the traditional practice of preparing individualized medicines for one patient at a time.
Today, some compounders produce large volumes of drugs, often manufacturing them before a prescription is received, shipping many thousands of units– high-risk or sterile products – to clinics and hospitals across the country.
The regulatory framework has not kept up with this changing industry. Traditionally, states oversee pharmacy practice and the FDA oversees drug manufacturing. But compounding falls into a grey zone. In a very broad sense, FDA has the authority to regulate some compounding activities, but it is not at all clear how far that authority goes. Nor are there formalized mechanisms to divide the oversight of compounding between the states and FDA.
Examining the Risks
The epidemic caused by the New England Compounding Center is but the most recent case highlighting the risks to patients.
That outbreak has been associated with 53 deaths so far and nearly 700 serious infections. Included with my testimony is a Pew summary that describes 19 additional pharmacy compounding errors since 2001.1
The list includes 22 additional deaths, as well as serious infections – meningitis, bloodstream and at least 38 patients who suffered partial or complete loss of vision – but also patients harmed by sub-potent or super-potent doses. For example, in 2007 three people died after receiving intravenous colchicine that was eight times the labeled strength.2
Recent inspections of compounders raise further concern: Two months ago, the FDA announced a recall of all of the products manufactured by a New Jersey compounder because of potential mold contamination. The FDA press release referred to “visible particulate contaminants” in what was
supposed to be a sterile product.3 Also this year, a Georgia compounder conducted a nationwide recall of sterile products after reports of serious eye infections.4
Appropriate Oversight and Quality Standards
Congress has long grappled with these risks. The current section 503(A) of the Food, Drug and Cosmetic Act was passed in 1997. After the courts struck down parts of that provision, members of this committee tried again to create meaningful Federal oversight of certain compounding activities. But that legislation was strongly opposed by the compounding industry, and did not pass. Today, FDA’s legal authority remains unclear. Even as the Agency steps up its oversight of compounders, its ability to access records has been challenged.5
The proposal before you today offers an opportunity to finally address some, though not all, high-risk compounding activities. It has the following strengths:
 It addresses sterile products, which are particularly high risk,
 By including facilities that sell in multiple states, it will capture many of the largest operations, and
 It contains safeguards that will help prevent compounders from undermining “gold-standard,” FDA-approved drugs.
Increased Federal Oversight
The legislation creates a new category of FDA-regulated “compounding manufacturers” – compounders that produce sterile products in anticipation of a prescription and who sell product outside the state in which it is created.
The bill would require compounding manufacturers to comply with the same manufacturing quality standards, known as good manufacturing practices (GMPs), that apply to pharmaceutical companies making FDA-approved drugs.
This recognizes that the United States Pharmacopeial standards (chapter 797) used in many states are unsuited to large-scale anticipatory production. Pew recently joined with the American Hospital Association (AHA) and the American society of Health-System Pharmacists (ASHP) to co-host a pharmacy compounding summit that heard from experts who stressed this point strongly. The FDA, and not state pharmacy boards, is the appropriate agency to enforce GMPs.
Using limited resources wisely necessitates addressing the largest potential public health problems first. That means, in part, ensuring quality standards at facilities that produce large numbers of doses. While not perfect, we believe that the proposed framework for interstate sales would capture a meaningful portion of the highest-risk compounding.
However, we urge the committee to not exclude mixing and reconstituting of drugs in accordance with manufacturer label from the definition of compounding manufacturer. If these ostensibly sterile products are mixed in large volume under unsanitary conditions, it could represent a significant public health risk

continue reading here

Tuesday, December 4, 2012

University of New England pharmacy students blend custom meds for animal patients

9 hours ago — Bangor Daily News

PORTLAND, Maine - Pharmacy students at the University of New England are learning how to formulate custom medications not only for their future customers, but also for those customers pets. Doctoral students are studying how to safely compound veterinary drug prescriptions, mixing up batches of the same medications humans take ... [...]


Source found here

Monday, September 17, 2012

The CPG applies to all Compounders; Physicians, Veterinarians, and Pharmacists and There is a Great Need to Educated Those Individuals as David Miller Points Out

David G. Miller, RPh, IACP Executive Vice President & CEO recently discussed his presentation about U.S. v. Franck's Lab, Inc. at the annual convention of the American Veterinary Medical Association (AVMA). To read his comments, especially about the need for education, click here.

Wednesday, July 18, 2012

Education About Compounding is Essential


This article from the Veterinary Practice News makes excellent points about why educating veterinarians is so important and must be done.

Education is Key

By Marissa Heflin


The American Assn. of Equine Practitioners has set its own Equine Veterinary Compounding Guidelines. The organization wants to educate veterinarians on compounded drugs so they can make the best choice for patients, says Eleanor Green, DVM, Dipl. ACVIM, Dipl. ABVP.
“Veterinarians need to be aware that compounded products are not FDA-approved products and that they have not gone through the rigorous testing nor have they gone through the rigorous quality assurance process that FDA-approved drugs do,” she said.
“They also need to educate their clients when they are faced with picking a drug for their patient to weigh the benefits versus the risks.
And it is a risk because there is a larger percentage (of compounded products) that do not contain what the label says, so it can either be insufficient treatment or it can be toxic.”
Prescribing veterinarians should understand that their professional liability policy may not respond to allegations of negligence arising from the use of compounded drugs, according to the AAEP’s guidelines. The organization encourages veterinarians insured with the AVMA-Professional Liability Insurance Trust to review comments at AVMAplit.com.
In addition, veterinarians need to be aware that compounding, including formulation in a novel drug-delivery system such as transdermals may affect the absorption and depletion of a drug, according to the AVMA’s policy on compounding. This may result in drug concentrations above or below the therapeutic range and lead to an adverse drug event, including therapeutic failure.

Article found here

Sunday, July 1, 2012

More retailers offering pet prescriptions--But Are Retailers A Safe Place From Which To Buy Your Pet Medications

The recent article below points out that a number of retailers are now offering pharmacy services for sick pets. However, it may not be a good idea to buy your pet prescriptions from retailers. As the article points out: "The problem pet owners face is that pharmacists at these stores aren't trained about the medication and how it can affect the animals," Lund said. "The pharmacist or some website isn't going to help you when you're having a reaction at 10 p.m."
The author of this blog believes there is a great need for trained, specialized pharmacist in veterinary medicine. We need more colleges and universities that offer a specialized degree in veterinary pharmacy. To ensure a pet's safety and wellbeing, pet owners should check out the pharmacy and pharmacist they are doing business with. A good place for a pet owner to start their research is with the state board of pharmacy to see if the pharmacy or pharmacist has ever been disciplined or fined.  Another area to examine is whether the pharmacy and pharmacist are knowledge of veterinary medications.
More retailers offering pet prescriptions
 - SUN SENTINEL
FORT LAUDERDALE, Fla. -- Retailers are making it easier and cheaper for pet owners to get the medication they need to care for their sick cats and dogs.
Winn-Dixie is the latest chain to extend its pharmacy services to reach sick pets. The Jacksonville, Fla.-based grocery chain began offering pet prescriptions recently when it partnered with Center Pet Pharmacies, a Washington, D.C.-based company that specializes in pet medication. Target launched its pet refills program at stores with pharmacies in 2010, and Wal-Mart began in March of this year.
"We already had a nice size business of pet owners at our pharmacies who used our services to get discounted prices on antibiotics and other cross-over drugs," said Mike LeBlanc, director of pharmacy business development for Winn-Dixie. "It just seemed natural to provide drugs for pets at the same time."
Most often pet owners get their prescription medications from their veterinarian's office or online through sites like 1-800-PetMeds.com. But veterinarians like Kristy Lund at Lund Animal Hospital in Boca Raton, Fla., are seeing more patients opt to have refills sent to places like Wal-Mart or Target, where cheaper generic alternatives are offered.
"In today's economy, more people have to bargain-shop, and this provides a service for those who may be struggling with care costs," Lund said.
In 2012, American pet owners are expected to spend nearly $53 billion on their animals, according to the American Pet Products Association. Pet owners will spend more than $13 billion on medical care costs alone, which is an expected 1.3 percent increase from the total spent in 2011.
"The problem pet owners face is that pharmacists at these stores aren't trained about the medication and how it can affect the animals," Lund said. "The pharmacist or some website isn't going to help you when you're having a reaction at 10 p.m."
Most veterinarian practices have pharmacies inside their offices. Veterinarians are required to attend seminars every two years to keep their drug administering licenses active. Retailers, like Winn-Dixie, partner with pet compounding pharmacies which specialize in developing drugs in smaller dosages for animals, which does not require their employees to have special training to administer animal prescriptions.
Pet supplies chains like Petsmart and Petco do not sell prescription medications. Walgreens and CVS Pharmacy do not sell pet medicines either.
Although Publix doesn't offer pet-specific medications, "cross-over" drugs, which are treatments like antibiotics or anti-inflammatory capsules used by both pets and humans, can be picked up from its pharmacies.
Most cross-over prescriptions can be filled in the same day, LeBlanc said. Specialized pet medications take 24 to 48 hours to fill. Pet prescriptions filled by Winn-Dixie pharmacies also will include personalized instructions similar to when human prescriptions are filled and delivered. About 75 percent of all Winn-Dixie locations have pharmacies.
"These services make our shopper's lives easier," LeBlanc said. "They're already purchasing pet food inside the store, and now they have the opportunity to take care of another pet need here too."
Pet medicines can come in bacon or other flavors, and or be switched from a capsule to a gel depending on a pet owner's needs, said Kenny Kramm, owner of Center Pet Pharmacies.

Read more here: http://www.newsobserver.com/2012/06/28/2165994/more-retailers-offering-pet-prescriptions.html#storylink=cpy


Read more here: http://www.newsobserver.com/2012/06/28/2165994/more-retailers-offering-pet-prescriptions.html#storylink=cpy