CDC Launches Free App ‘Solve the Outbreak’

Affirunisa Kankudti

First Posted: Feb 20, 2013 08:47 AM EST

The recent meningitis outbreak linked to compounding pharmacy has shown how important it is to be able to locate the center of the outbreak and how people must be equipped to deal with such emergencies. Now, you may not be a disease detective, but you can play a game of disease investigation at home.

As part of its efforts to connect with people on social networks, the Centers for Disease Control and Prevention has launched a free app that lets you solve a disease outbreak.

"You'll play the role of an Epidemic Intelligence Service agent. Find clues about outbreaks and make tough decisions about what to do next: Do you quarantine the village? Talk to people who are sick? Ask for more lab results?," CDC said.

Users will be first included in the 'training staff", after which they'll have to earn points based on their ability in analyzing the data. Each answer will earn points and save lives of people affected by the "outbreak".

Players will earn badges and cracking the outbreak case will make them a Disease Detective.

CDC said that the app was designed in-house and hasn't given any development costs, The Huffington Post reported.

This isn't the first time that a federal agency has come up with a free application. Other examples of apps created to provide information to the public include "Ask Karen" launched by the Agriculture Department, and National Institutes of Health's Wireless Information For Emergency Responders, or WISER.

The Solve the Outbreak app from CDC can be found at iTunes.

Source found here

http://dockets.justia.com/docket/massachusetts/madce/1:2013cv10351/149614/

http://dockets.justia.com/docket/massachusetts/madce/1:2013cv10351/149614/

Landon et al v. New England Compounding Pharmacy Inc

Landon et al v. New England Compounding Pharmacy Inc

Fusco v. New England Compounding Pharmacy, Inc.

Fusco v. New England Compounding Pharmacy, Inc.

Baer et al v. New England Compounding Pharmacy Inc et al

Baer et al v. New England Compounding Pharmacy Inc et al

The PCMA Specialty Pharmacy Business Forum

I want to remind you about PCMA's upcoming Specialty Pharmacy Business Forum (SPBF). The event will be held at the wonderful Wynn Las Vegas on March 26-28, 2013. You should register this week, because March 4 is the cut-off date for booking room reservations at the conference rate.

The SBPF is a must-attend meeting for anyone connected to the specialty channel—manufacturers, pharmacies, payers, PBMs, wholesalers, and others. PCMA has a special LinkedIn group for attendees. You can also schedule private meeting rooms during the event. Full details from PCMA below, including information about continuing pharmacy education (CPE) credits.

I'll be attending, so please send me an email if you'd like to arrange a one-on-one meeting. See you in Vegas!

OFFICIAL DESCRIPTION FROM PCMA

Specialty Pharmacy Business Forum (SPBF) 
March 26-28, 2013
Wynn Las Vegas
Las Vegas, NV
Keynote Speaker: General Colin Powell

PCMA's Specialty Pharmacy Business Forum (SPBF) provides individuals and companies in the specialty pharmacy chain of commerce, exceptional educational and business networking opportunities. Our 1,000+ expected attendees will range from C-suite executives to mid-level professionals tasked with all aspects of the business of specialty pharmacy. The SPBF will feature outstanding conference sessions with top industry thought leader speakers discussing the most current and impactful industry topics.

We are pleased to announce that General Colin Powell will be our keynote speaker.

The conference will kick-off with a reception on Tuesday, March 26, and continue all day Wednesday and Thursday, closing with a reception on Thursday, March 28.

Registration is now open at http://www.pcmanet.org/events/27#regInfo . Room reservations can be made at the Wynn Las Vegas website. The cut-off date for making reservations is Monday, March 4, 2013. Availability and the negotiated group rate cannot be guaranteed after this date.

WHO SHOULD ATTEND

• Anyone looking to learn, network and grow their business in the SP space
• Pharma and Biotech Industry
• Managed Markets - Market Access - Managed Care
• Trade, sales, and marketing teams
• Employer, payer, and corporate account managers and directors
• Pricing, contracting, and reimbursement professionals
• Pharmacy and medical officers and directors
• Healthcare quality or innovation professionals
• PBM and PBM-owned Specialty Pharmacy Industry
• All professionals within trade/pharma relations & contracting
• Executives from all aspects of specialty pharmacy business
• Pharmacy and medical directors
• Pharma program teams
• Specialty Pharmacies
• Owners, executives, and pharmacists
• Wholesalers and distributers
• Regional pharmacy owners and executives
• Payer executives responsible for drug and specialty pharmacy management
• Managed care executives

PCMA has revamped their conference networking opportunities by offering PCMA-Connect as a LinkedIn Group and online networking community (for registered attendees of the SPBF only). This group allows attendees to see who else is going to be at the meeting and, if interested, to connect before arriving onsite. Additionally, PCMA has semi-private rooms available for anyone who would like to schedule meetings in Las Vegas.

CPE CREDITS WILL BE OFFERED

PCMA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Individuals may obtain continuing pharmacy education (CPEs) credits during PCMA’s Specialty Pharmacy Business Forum. All PCMA continuing pharmacy education (CPE) sessions are designed to be knowledge-based activities (K) for pharmacists (P).

For the most up-to-date information on the SPBF and PCMA’s other 2013 events, visit PCMA’s website at www.pcmanet.org/events.

Source found here

Pharmacist Steve Blog Reporting: State Board Reprimands, fines Allegychoices, pharmacist

Here is what Pharmacist Steve says:

State board reprimands, fines Allergychoices, pharmacist.

http://lacrossetribune.com/news/local/state-board-reprimands-fines-allergychoices-pharmacist/article_29f00ba8-7bc3-11e2-8eb9-001a4bcf887a.html
From the article:
Allergychoices was ordered to forfeit $1,000 and pay $3,500 in costs, and Kachel was ordered to pay $100 in costs, according to the pharmacy board’s Feb. 13 order.
Allergychoices is a retail pharmacy spinoff of Allergy Associates of La Crosse, also in Onalaska, that is noted for its liquid sublingual immunotherapy drops.
The pharmacy board alleged improper labeling for not listing concentrations of ingredients in each prescription, which the company has agreed to do under the order.
The state also faulted Allergychoices for delivering initial 90-day supplies of medications to the prescribing doctors’ offices instead of to the patients’ homes. The company did that so the doctors could observe the first administration of the medicine, the state board said.
Looks like the oversight of compounding pharmacies is on the upswing.. and this may be a indication of how BOP’s are going to pay for it.. Find “i’s” that aren’t dotted and “t’s” that are not crossed and fine the crap out of the pharmacy/pharmacist. IMO.. these “infractions” really put the public’s health/safety at risk … NOT!

Source found here

Texas Board of Pharmacy Considering Prohibiting Out of State Pharmacies From Mailing or Shipping Compounded Drugs Into State

http://www.tsbp.state.tx.us/files_pdf/BN/Feb13/AGENDA.pdf »

IACP's Response to the Washington Post Article - A Message from David Miller, at IACP

I wanted to make sure you were aware that the Washington Post article which appeared on Friday alleging that IACP is now supporting FDA oversight of compounding pharmacy is neither accurate nor reflective of the complete story.  In fact, IACP and our PR firm gave the reporter very specific written statements were given a spin by the journalist.

The following is the exact language we gave to the reporter: 

1.  IACP is supportive of a discussion about the creation of a category of non-traditional manufacturing. A formal position has not yet been taken by the IACP or, to our knowledge, by any other pharmacy organization. This is a concept that we believe needs to be reviewed and discussed in the public arena.

2.  For this group of non-traditional manufacturers, if they are manufacturers, we would expect that the FDA would regulate them. The FDA would have to determine if the same criteria would be applied to this category as is applied to traditional manufacturers. Any compounding pharmacy – not a manufacturer, traditional or non-traditional – should continue to be regulated and overseen by state boards of pharmacy.

In short, IACP supports a policy conversation about regulating manufacturing. We have not endorsed or supported a specific program, design, concept or anything else.  Strictly a discussion. That is consistent with IACP's statements to Congress and state regulatory authorities.

I'd sure appreciate your help in making sure that compounding pharmacists have the whole story.

David G. Miller, R.Ph. 

Many Legal Documents Available on Blog

For those who have just started reading blog or who joined late, numerous legal documents from Franck's, Apothecure and Gary Osborn, U.S. v. Barder and others are available on this blog to anyone who has the link to those documents.  If you are looking for a specific legal document and can't find it feel free to email me at stuckrichmond@gmail.com 

History of Pharmacy and Compounding: ERICA L. NOREY Duty to Fill? Threats to Pharmacists’ Professional and Business Discretion

I. INTRODUCTION
Although the origin of the word pharmacy is often attributed to the Greek
pharmakon, meaning remedy,1 the art of combining and compounding agents
existed long before the word came into use.2 Despite the many changes pharmacy
practice has gone through in its long history, the majority of which have occurred
within the last fifty years,3 those in the profession consider it an intensely personal
calling that is guided by basic human values and compassion.4 The role of
the modern-day pharmacist is not that of a mere dispenser of legal medication5—
that categorization undermines the pharmacist’s important role in the clinical
process.6

Continue reading here

IRS Guidance Favorably Modifies Voluntary Worker Classification Settlement Program Article By: David Diaz Diane M. Morgenthaler Ruth Wimer, Esq., CPA McDermott Will & Emery posted on: Tuesday, January 8, 2013 (Employee or Independent Contractor for tax purposes--for deciding how sales reps should be treated)

One year ago the Internal Revenue Service (IRS) published Announcement 2011-64, which provided a Voluntary Classification Settlement Program (VCSP) for employers to treat their workers as common law employees rather than independent contractors only on a prospective basis.  Now the IRS has issued two new announcements that favorably modify and expand the VCSP.  Because certain favorable tax relief is available only for applications filed before June 30, 2013, employers should review quickly their worker classification issues in light of this new guidance.

On December 17, 2012, the Internal Revenue Service (IRS) issued Announcements 2012-45 and 2012-46 to revise the tax relief for employers that utilize the Voluntary Classification Settlement Program (VCSP).  Originally established in December 2011, the VCSP permits eligible taxpayers to voluntarily reclassify their workers for federal employment tax purposes and obtain limited tax relief for previous nonemployee treatment. 

Background

The IRS overwhelmingly favors classification of workers as employees rather than independent contractors in part  because withholding of employment taxes is required for the former and not the latter.  Whether a worker is performing services as an employee or as an independent contractor depends upon numerous facts and circumstances, but the most important factor is whether the worker is subject to the employer’s right to direct and control the worker as to what and how services are performed.  The determination of a worker as an employee is often not self-evident.  For employers under IRS examination, the Classification Settlement Program (CSP) is available to resolve federal employment tax issues related to worker misclassification if certain requirements are met.  The CSP allows the prospective reclassification of workers as employees with reduced federal employment tax liabilities for past nonemployee treatment.  The IRS determined it also would be beneficial to offer employers a program that allows voluntary reclassification of workers as employees without paying all past employment tax liabilities and without correcting past employer quarterly federal tax returns (Form 941).  Accordingly, the IRS issued Announcement 2011-64 last year.  The tax relief available under the VCSP—only 10 percent of the employment tax liability for one year—is similar to that available under the CSP, and the VCSP has become very popular. 

Continue reading here

A “Phantom Recall” Does Not Comport with FDA’s Regulatory Practice—Or Does It?: The Need for More Stringent Mandatory Reporting in FDA Matters Eleanor G. Tennyson

ABSTRACT: This Note examines the regulatory and enforcement authority of the Food
and Drug Administration (“FDA”) in light of the recent rash of recalls of pediatric
over-the-counter medicines by The McNeil Consumer Healthcare Company (“McNeil”),
a subsidiary of Johnson & Johnson. After detailing the controversy surrounding
McNeil’s quality-control and recall procedures, the analysis focuses on proposed
legislation that would give the FDA mandatory recall authority. The analysis proposes
that, without requiring mandatory reporting of unexpected events associated with
drugs, such legislation may only equip the FDA with phantom authority. As such, it
concludes with a proposed methodology of co-reporting that would ensure the FDA has
both the knowledge and power necessary to force drug manufacturers and distributors
to comply with the FDA’s regulations.
I. INTRODUCTION .................................................................................... 1841
II. THE FDA’S RECALL POWERS AND THE MCNEIL “PHANTOM RECALL”
CONTROVERSY ...................................................................................... 1842
A. VOLUNTARY AND INVOLUNTARY RECALLS THE (IN)ABILITY OF THE
FDA TO MANDATE RECALL OF PHARMACEUTICAL AGENTS .............. 1843
B. THE HEADACHES OF TYLENOL AND MOTRIN: MCNEIL’S TWO-YEAR
BATTLE WITH SYSTEMIC RECALLS ................................................... 1845
C. A CONGRESSIONAL HEARING DISCOVERS LAPSES IN QUALITY
CONTROL AND DISTURBING REMEDIAL MEASURES UNDERTAKEN BY
MCNEIL ......................................................................................... 1848
D. THE HEADACHE CONTINUES: A SECOND CONGRESSIONAL HEARING
DETERMINED TO FULLY INVESTIGATE THE “PHANTOM RECALL” ...... 1849

III. USING THE “PHANTOM RECALL” TO ARM THE FDA WITH MORE
TANGIBLE ENFORCEMENT POWERS ...................................................... 1852
A. WHY DOESN’T THE FDA HAVE THE AUTHORITY TO MANDATE A
RECALL FOR DRUGS IN VIOLATION OF THE FDCA? ........................... 1852
B. AN ATTEMPT TO GIVE THE FDA MANDATORY RECALL POWER:
H.R. 5740 AND S. 1584 ................................................................ 1853
C. DOES THE PROPOSED LEGISLATION GIVE THE FDA PHANTOM
AUTHORITY? .................................................................................. 1856
D. ENSURING PROPER NOTICE BEGINS WITH MANDATORY FDA
NOTIFICATION................................................................................ 1858
1. Reporting Unexpected Drug Events to the FDA: The
Who, Where, How, and Why ............................................... 1859
2. The FDA Should Be Notified of All Unexpected Events
Related to Drugs and Medical Devices ............................... 1860
IV. CONCLUSION ....................................................................................... 1862

Read this law review here

Note Rethinking Off-Label Regulation in the Wake of Sorrell v. IMS Health: Can State Involvement Compensate for Waning FDA Authority to Curb Commercial Free Speech? Ashley A. Zborowsky

Off-label promotion and the U.S. Food and Drug Administration’s
(FDA, the Agency) current restrictions on commercial
“free speech” have garnered much attention in recent years
due to a district court ruling in United States v. Caronia1 and a
subsequent Supreme Court decision in Sorrell v. IMS Health.2
United States v. Caronia is currently pending review in the Second
Circuit following Sorrell—a highly anticipated ruling. The
outcome of the Caronia case could have a staggering effect on
FDA regulatory authority with respect to promotional activity,
and has been the topic of much scholarly debate. However,
First Amendment rights and commercial free speech are not
novel issues in the context of pharmaceutical and device law.
While many entities have challenged the constitutionality of
FDA’s ban on off-label promotion, in and out of the courtroom,
deference to Agency interpretations of relevant provisions of
the Food, Drug and Cosmetic Act (FDCA) has enabled FDA to
recover billions of dollars in penalties from manufacturers for
off-label promotional activities.3

Continue reading here

REGULATING THROUGH RULES: SUGGESTED CHANGES IN THE FEDERAL REGULATION OF VETERINARY COMPOUNDING

13 Hous. J. Health L. & Policy 129
Copyright © 2012 David Hrncir
Houston Journal of Health Law & Policy
I SSN 1534-7907

David Hrncir*
TABLE OF CONTENTS
INTRODUCTION .......................................................................................... 129
DEFINITION OF COMPOUNDING .................................................... 132
HISTORY OF VETERINARY COMPOUNDING AND ITS
REGULATION .................................................................................. 133
WHY THE FDA SHOULD PREFER NOTICE-AND-COMMENT
RULEMAKING ............................................................................................. 138
CHEVRON DEFERENCE ................................................................... 138
AUER DEFERENCE .......................................................................... 141
SIMILARITIES IN PROMULGATING CPGS AND RULES ................... 142
THE U.S. SUPREME COURT’S SUGGESTIONS ................................. 145
THE FDA WILL BE DRIVING THE INITIATIVE ............................... 145
BENEFITS TO THE COMPOUNDING PROFESSION ....................................... 146
THE ABILITY TO COMMENT ........................................................... 146
A MORE CERTAIN REGULATORY ENVIRONMENT ........................ 147
THE STATUTORY BASIS FOR A PROPOSED RULE ....................................... 148
POLICY BASES FOR A PROPOSED RULE AND SUGGESTED CONTENT ....... 153
SOME FINAL REBUTTALS TO FDA HESITATION OVER THE ABOVE

To read this law review article click here

Drug Shortages in the United States

 

By Rina Shah, U.S. Office of Personnel Management on National Healthcare Operations,
Washington, DC¹

Introduction
According to the American Society of Health System Pharmacists (“ASHP”), there are currently about 200 drug shortages, ranging from the Acetazolamide Injection to the Zoster Vaccine Live.² A recent study claimed that these numerous drug shortages are not as bad as they seem because they are limited to a few disease areas and generic injectables.³ Despite the purportedly limited scope, drugs that are vital to treating major diseases such as childhood leukemia and breast cancer are part of the current shortages.⁴ Due to concerns about delays in treatment, increased morbidity and mortality, and higher healthcare costs,⁵ manufacturers and the government have been attempting to remedy the issue. As government legislation is still pending and other responses are fairly recent, there has not been any reliable information to indicate whether these strategies are working.
Causes of Drug Shortages
The source of drug shortages varies from drug to drug, but the primary reasons are manufacturing problems combined with increased demand.⁶ For example, a shortage of the dopamine injection was reported by ASPH on November 17, 2011.⁷ The reasons for the shortage were listed by one manufacturer as a manufacturing delay and by another as increased demand.⁸ Another drug that is currently experiencing a shortage, the tobramycin injection, is reportedly in short supply because of manufacturing delays.⁹

Continue reading here

TimAllenMDJD: From Johns Hopkins: Compounding Pharmacies: Who is...

TimAllenMDJD: From Johns Hopkins: Compounding Pharmacies: Who is...: http://www.ncbi.nlm.nih.gov/pubmed/23350709 Pain Pract.  2013 Jan 28. doi: 10.1111/papr.12033. [Epub ahead of print] Compounding   Ph...

Compounding Pharmacists Weigh New Manufacturing Class, But Still On Fence

The International Academy of Compounding Pharmacists scrambled Friday (Feb. 22) to clear up confusion regarding the group's stance in ongoing legislative talks to address drug compounding, saying IACP is supportive of, although the group has not taken a stance on, proposals to create a new drug manufacturing category, an idea that was also separately floated by state pharmacy boards.

Subscription required here

Feb 25, 2013, 11:03am EST: Recall from Village Fertility Pharmacy--6 products over three years

Waltham, Mass.-based Village Fertility Pharmacy has issued a voluntary recall of several compounded products, after a foreign substance was detected in a small percentage of two lots of the fertility drug progesterone. The pharmacy said it contacted the Massachusetts Board of Pharmacy immediately after discovering the particulate matter.

The recall includes six different products shipped over the past three months. They include five progesterone products and one other medication, Leuprolide. More testing is being conducted and results will be released in the coming days.

Related: Compounding crackdown hurting patients (premium content).

“We are working cooperatively with all government agencies and are awaiting the results of the investigation,” Village Fertility Pharmacy president Stuart Levine said in a statement. “While no patients have reported any adverse effects, we believe the prudent course is to recall all of these medications.”

The recall includes the following products:

* Progesterone Injection Cottonseed Oil 50 MG/ML

* Progesterone Injection Olive Oil 50 MG/ML, 100 MG/ML

* Progesterone Injection Sesame Oil 50 MG/ML, 100 MG/ML

* Progesterone Injection Ethyl Oleate 50 MG/ML, 100 MG/ML

* Hydroxy Progesterone Caproate 250 MG/ML

* Compounded Leuprolide Acetate 1MG/.2ML

Progesterone is a hormone that supports pregnancy and it is compounded in different solutions to accommodate patients’ various needs. Leuprolide suppresses natural ovulation.

Village Fertility Pharmacy said that only 5 percent of its overall business comes from compounded products.

source found here

S.B. 227 Introduced in TX Relating to Dispensing Aesthetic Mediciations Directly to Patients

BILL ANALYSIS

 

 

Senate Research Center	S.B. 227
83R2570 SLB-F	By: Williams
	Health & Human Services
	2/21/2013
	As Filed

 

 

 

AUTHOR'S / SPONSOR'S STATEMENT OF INTENT

 

Certain topically applied medications prescribed to treat skin pigmentation disorders are more safely and effectively administered when supervised by a physician.  However, Texas is one of only five states that prohibit a physician's ability to dispense aesthetic medications directly to patients.  S.B. 227 enables patients to easily receive a physician's counsel to simplify what is often a complicated treatment process as well as modification of the application regimen to respond to the patient's particular response. 

 

S.B. 227 amends the Occupations Code by very narrowly expanding physician dispensing in Texas to permit physicians to dispense aesthetic prescription drugs if it makes sense for their practices and their patients.  The only aesthetic pharmaceuticals which will be allowed to be dispensed by the physician are bimatoprost, hydroquinone, tretinoin, metronidazole, and tazarotene. 

 

Physicians who do not wish to dispense will not be adversely affected by S.B. 227; they will retain the same options to provide prescription aesthetic drugs to their patients through regular pharmacies and compounding pharmacies.  Furthermore, S.B. 227 requires the physician to inform the patient that the prescription may be filled at the pharmacy or dispensed in the physician's office.

 

The Importance of Custom Compounding for Pets

Custom compounding is the preparation of a medication that is tailored to treat the specific needs of individual pets by a veterinary pharmacist. There are various reasons for using this method, the most common of which is difficulty in administering the most appropriate and effective dose of a medication that is primarily manufactured for use in human healthcare. Other reasons could include:

• Allergy to the manufactured medication
• Sensitivity to other ingredients in the medication such as the substance that is used to deliver the drug
• Difficulties administering the medication due to its taste
• The required medication has been discontinued by the manufacturer
• An exact dosage is required to effectively treat the animal
• To make it easier for the pet owner to administer multiple medications

Just about any medication can be compounded including eye drops, and there are a number of different vehicles that can be used to administer them. These can include transdermal gels, capsules, creams, solutions, suspensions and suppositories.

Safety of Compounded Medications
Compounding pharmacies are not regulated by the Food and Drug Administration; however, the state boards of pharmacy do provide quality control. When prescribed by a licensed veterinarian, and compounded by a licensed veterinary pharmacist, custom medications are very safe.

Compounded medications are only available at a compound pharmacy, but not all pharmacies provide this service. Of those that do, only a few have a veterinary pharmacist on staff. Because of this, veterinarians are very cautious when choosing a compound pharmacy. Typically, most veterinarians use one specific pharmacy on a regular basis for custom prescriptions.

About the Author
Ms. Laleh Taheri is the Pharmaceutical Director at Compoundia Pharmacy, a leading compound pharmacy in Westlake Village, California. As a compound pharmacist, Laleh and her company specialize in custom compounding, including sterile injectable s for veterinary use.

Source found here

ABC40 Alert: Drug Recalled by Mass. Compounding Pharmacy--Huge: 39 states and approximately 2100 patients affected

WALTHAM, Mass. (ABC) — Another Massachusetts pharmacy is in trouble.

Village fertility pharmacy in Waltham, Mass. is conducting a voluntary recall of compounded medications for women who are undergoing in vitro fertilization treatment.

The company issuing the recall after something was found floating in a vial. Massachusetts board of pharmacy ordered the company to cease and desist all sterile compounding on February 20.

Pharmacy officials say the medications were shipped to 39 states to approximately 2,100  patients. According to the pharmacy, none of their patients have reported any adverse effects.

 

Source found here

FDA Guidance on Labeling for Human Prescriptions and Biological Products

Guidance for Industry:

• Labeling for Human Prescription Drug and Biological Products -- Implementing the PLR Content and Format Requirements (PDF - 527KB)

2013 FDLI Annual Conference

Where the Food and Drug Law Community Comes Together

April 23-24, 2013 | The Ronald Reagan Building and International Trade Center | Washington, DC

FDLI’s Annual Conference is the largest and longest-running legal conference for FDA-regulated industry and the entire food and drug law community. This advanced two-day program will cover legal, regulatory, policy and economic issues spanning the gamut of FDA’s authority by bringing together experts from the Federal Government, industry, public sector, consulting organizations and academia. 

At this year’s 2013 conference, attendees will get the opportunity to:

• Hear FDA’s 2013 strategic priorities directly from key leadership and product Center Directors. 
• Be a part of the dialogue and join more than 750 colleagues and clients at the largest and longest-running legal and regulatory conference for food and drug law industry stakeholders.
• Network with seasoned professionals in law, regulatory, compliance, marketing/public relations and management working in or representing FDA-regulated companies.
• Build relationships during special networking events, including our signature Networking Reception on April 23.

For more information click here

Part D 2014 Draft Call Letter Addresses Automatic Rx Refills, Drug Safety Issues--added controls on compounded drugs

By Gregory Twachtman, Cathy Kelly / Email the Authors / Feb. 25, 2013 
Reimbursement / Word Count: 1315 / Article # 00130225004 / Posted: February 25 2013 12:00 AM

---

Executive Summary

CMS instructions to Part D sponsors cite elimination of waste as a reason to require plans to confirm members want a refill. Draft call letter also addresses expanding drug utilization reviews beyond opioids, added controls on compounded drugs.

Subscription required here

 

Third Annual Medical Pharmacy Trend Report Illuminates Hidden Healthcare Costs

Mon Feb 25, 2013 8:45am EST

http://pdf.reuters.com/htmlnews/8knews.asp?i=43059c3bf0e37541&u=urn:newsml:reuters.com:20130225:nBw256006a

Industry reporting on specialty pharmaceuticals has historically left out
medications covered and paid for under the medical benefit.

This is the only detailed drug trend report available for those medicines
administered by providers and billed under the medical benefit.

Specialty drug costs increased 16 percent for the top 25 therapies.
AVON, Conn.--(Business Wire)--
Today, Magellan Pharmacy Solutions, a division of Magellan Health Services
(NASDAQ: MGLN) released its third annual Medical Pharmacy Trend Report. The
report is the only industry benchmark of its kind to analyze medical drug data,
explaining the trends surrounding specialty medications such as those used to
treat complex chronic conditions like cancer, rheumatoid arthritis and multiple
sclerosis. 

"No other source exists that directly measures the trends for injectables that
are paid under a payor`s medical benefit, where top drugs, such as Neulasta,
Remicade, Avastin, Rituxan, and Tysabri are almost entirely paid," said Michael
Waterbury, President of ICORE Healthcare (a subsidiary of Magellan Pharmacy
Solutions). 

As much as 50 percent of specialty pharmaceuticals are managed and paid for
under the medical plan benefit today, a significant increase compared to
previous years. This is driven by several factors, most notably the ability of
manufacturers to maintain patent protection for the top 25 specialty drugs.
Increases in price and utilization are also key drivers of increased trend. The
year-over-year cost increase for specialty drugs was 16 percent for the top 25
therapies. 

Continue reading here

Arkansas Pharmacy Association Annual Convention June 2013 and 2012 Presentation available

Annual Convention

APA’s Annual Convention is usually held in June at a hotel in Little Rock or another city in Arkansas.  Pharmacists and others are encouraged to attend annually and take advantage of the Continuing Pharmacy Education (CPE) that is offered all in one location, as well as the opportunity to learn about innovative services from exhibitors.  The APA Annual Convention is also a great opportunity to network with colleagues from around the state. 2013 APA 131st Annual Convention: Dispensing Knowledge for Better Health The 2013 APA Annual Convention will be held June 5-8 at the Peabody (soon to be the Marriott) Hotel in Little Rock. The Conference theme is "Dispensing Knowledge for Better Health." For Exhibitors: APA invites organizations wishing to reach Arkansas pharmacists to become a sponsor.  Read about Silver, Gold, Platinum and Golf sponsor opportunities in the 2013 Exhibitor Prospectus .  Click here for 2013 Exhibitor Registration Material . WHY ATTEND? Continuing Pharmacy Education:  APA offers up to 20 hours of Continuing Pharmacy Education with highly-regarded instructors on topics ranging from pain management to pharmacy law. Comprehensive Exhibition:  Almost 30 exhibitors including pharmacy wholesalers, manufacturers, insurers, Colleges of Pharmacy, hospitals and software vendors are on hand to discuss their newest products and services that will benefit the practice of pharmacy in Arkansas. Social and Networking Events:  Connect with old friends and meet new colleagues at the annual convention.   UAMS Class Reunions:  Classes of 1953, 1958, 1963, 1968, 1973, 1983, 1988, 1993, 1998, 2003, and 2008 will be holding their reunions in conjunction with the Arkansas Pharmacists AssociationAnnual Convention, June 5-8 (Wed.-Sat.) at the Peabody Hotel in Little Rock.  The party is scheduled for Friday, June 7.  In 2013, UAMS' Alumni Association will especially honor the class of 1963 for their years of practice as graduates of UAMS.  Members of the class will be presented with 50-Year Medallions from UAMS College of Pharmacy. The reunion party is open to all alumni regardless of graduation year and their guests. 2012 APA 130th Annual ConventionReview 2012 convention presentations here.