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| About GSHP | ASHP | How You Can Join | Contact Us |
April 2012
Announcements
GSHP Membership Dues
GSHP Newsletter
Click here to pay your
Welcome to the GSHP Newsletter. We hope you will enjoy the new revised GSHP membership dues
newsletter filled with Georgia and National news and information.
web link
In this issue are:
GSHP 2012 Summer meeting, July 20-22 About GSHP
2012 Legislative Session Wrap-Up
Get more out of your GSHP membership
web link
Georgia Society of Health-
Headlines System Pharmacists (GSHP)
is a professional society of
GSHP News pharmacists and related
personnel practicing in
GSHP 2012 Summer meeting, July 20-22 organized healthcare
2012 Legislative Session Wrap-Up settings.
Get the Most Out of Your GSHP Membership
Mission Statement
ASHP News Helping our members
Renewed Focus on Tuberculosis Holds Promise for New Treatments become better practitioners.
FDA Mulls Expanded Universe of Nonprescription Drugs
Motto
ASHP and Other Concerned Organizations Call for Changes to Draft Drug
Bringing pharmacy practice
Shortages Bill
into focus.
BPS Calls for Taskforce Members for New Specialties
Pharmacy News
Hospitals Scramble on the Front Lines of Drug Shortages Georgia Society of Health-
System Pharmacists
FDA Approves Peginesatide to Treat Anemia in Adult Patients on Dialysis
3015 Shannon Lakes North
FDA, IOM Point to Need to Ramp Up Development of Abuse-Resistant
Suite 303
and Novel Nonopioid Pain Medications
Tallahassee, FL 32309
Percentage of Child Deaths by Meds Poisoning Rising
(800) 913-4747
Citalopram Hydrobromide - Drug Safety Communication: Revised
Recommendations, Potential Risk of Abnormal Heart Rhythms • e-mail link
NY Leaders Negotiate Prescribed Drugs Restrictions • web link
Kentucky Joins Program to Share Prescription Drug Dispensing Data
AMA, Pharmacist Testify at FDA Hearing on Innovative Technologies
White House and the F.D.A. Often at Odds
California, Vermont Consider Tougher Vaccine-Exemption Rules
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GSHP News
GSHP 2012 Summer meeting, July 20-22
About ASHP
ASHP is a 35,000-member
national professional
association that represents
pharmacists who practice in
hospitals, health
maintenance organizations,
Amelia Island Plantation long-term care facilities,
home care, and other
components of health care
Amelia Island Plantation Video systems. ASHP is the only
national organization of
hospital and health-system
Take a tour of Fernandina Beach (video) pharmacists and has a long
history of improving
medication use and
enhancing patient safety.
Summer meeting online registration
American Society of
Comments from last year's meeting Health-System
Pharmacists
7272 Wisconsin Avenue
GSHP has a superior program! Well worth traveling to attend. Have Bethesda, MD 20814
attended state meetings elsewhere, and Georgia rocks! Very relevant 301-657-3000
& applicable information, excellent speakers & fun, too.
• e-mail link
• web link
I thought the meeting was fantastic...the right mix of learning and
fun!
Calendar
Great facility, friendly GSHP facilitators, wonderful learning and
collaborative environment 2012 Summer Meeting
and Exhibition [ASHP]
Beautiful location, very good content, will attend again next year 6/09/12 - 6/13/12
The ASHP 2012 Summer
AGENDA as of 4/18/2012, subject to revisions Meeting is your chance to
take part in four fulfilling
days of intense intellectual
FRIDAY (6.5 hours) stimulation, in-depth
education, and hands-on
exploration. Join your peers
10:00am – 11:00am Parenteral Nutrition in Baltimore for this unique
experience designed
11:00am – 11:15am BREAK expressly for current and
future pharmacy leaders in
hospitals and health
11:15am – 12:45pm Multiple Myeloma (Lunch provided) systems.
Baltimore Convention
12:45pm – 1:00pm BREAK Center
Baltimore, Maryland
1:00pm – 2:00pm TRACK A: Stroke prevention for afib web link
TRACK B: Neonatology GSHP Summer Meeting
7/20/12 - 7/22/12
2:00 – 2:15 pm BREAK
Amelia Island Plantation, FL
2:15 – 3:15pm TRACK A: Surviving Sepsis update TRACK web link
B: TBD
2012 National
Residency Preceptors
3:15 – 4:15 pm Poster session Conference [ASHP]
8/16/12 - 8/18/12
4:15pm – 5:15pm Key Note Address- PPMI The National Residency
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Preceptors Conference
(NRPC) is the only meeting
5:15pm – 6:15pm Open Forum: purely dedicated to
pharmacy residency
training. The NRPC covers
6:30pm – 8:30pm Reception/Exhibits in Exhibit Hall timely topics important to
all program directors and
SATURDAY (3.5 hours) preceptors of ASHP-
accredited, ASHP-
application submitted, and
8:00am – 9:30am TRACK A: Managing vascular newly emerging residency
complications of new targeted chemotherapeutic agents training programs. This is a
must-attend event for
TRACK B: Informatics residency preceptors and
directors who seek quality
programming and
9:30am – 11:00am Exhibits/Breakfast in Exhibit Area networking opportunities
with other preceptors across
11:00am – 12:00pm TRACK A: Berkley testing / Am care the country.
clinic expansion TRACK B: Medication Errors Washington D.C.
web link
12:00pm – 1:00pm TRACK A: New drug update:
antibiotics TRACK B: Medication Errors GSHP Annual Meeting
10/19/12 - 10/21/12
Brasstown Valley Resort
12:00pm – 2:00pm Resident and Student Forum (box
lunch provided) Young Harris, GA
web link
SUNDAY (3 hours)
2012 Midyear Meeting
[ASHP]
8:00am – 9:00am Breakfast / Officer Installation 12/02/12 - 12/06/12
The 47th ASHP Midyear
9:00am – 10:30am New Anticoagulant reversal Clinical Meeting & Exhibition
will be held in the exciting
Las Vegas, this year.
10:30am – 12noon TRACK A: Sun, Sand, and Simplifying ASHP's Midyear Clinical
Preceptor Development: A Winning Combination for Meeting is the largest
gathering of pharmacists in
Advancing Residency Training. TRACK B: HIV Overview the world. With its focus on
improving patient care, the
Room Reservations meeting is attended by
more than 20,000
pharmacy professionals
The 2012 Summer Meeting will be held at the Omni Amelia Island Plantation, from 86 countries. For
Amelia Island, FL. GSHP has very attractive room rates that start at $173 decades, the ASHP Midyear
single/double per night for an ocean view hotel room at the Omni Amelia Clinical Meeting has
Island Inn and Beach Club. To make your reservation, click here: provided health-system
pharmacy practitioners with
http://www.omnihotels.com/FindAHotel/AmeliaIsland/MeetingFacilities/GSHSP a venue for updating their
knowledge, networking with
colleagues, enhancing their
The GSHP room rate will be honored for three days prior to group arrival and
skills, and learning about
three days after group departure. the latest products and
technologies.
The Plantation has a wide variety of rooms and villas and the link above can
help you with any of them. Las Vegas, NV
web link
Click here for villa information, rates, etc.
There is NO daily resort service fee this year. The room rate includes:
Self Parking ($10 daily value)
Unlimited high speed internet access in all accommodations ($9.95
daily value)
On-property Transportation ($4.00 daily value)
Unlimited use of health & fitness center ($20 daily value)
In Room Coffee Service ($5.00 daily service)
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Meeting Concierge & 24 Public Safety Team
Local & Toll Free Phone Access
Summer meeting cancellation policy
A full refund will be granted for refund requests received by July 1; from July
2 through July 10, a $25 administrative fee will be deducted from the
registration fee; after July 10, there will be NO refunds for cancellations.
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web link | return to headlines
2012 Legislative Session Wrap-Up
2012 Georgia General Assembly
Summary of Legislation for GSHP
S.B. 288 - Immunizations; allow pharmacists to give
immunizations with physician's protocol. This measure
passed out of the Senate 43-7, but died in House Health
and Human Services Committee.
S.B. 346 - State Board of Pharmacy; prescription drugs
by mail/other common carriers. This proposition changes
current state law to allow mail order from within the
state with the same restrictions and patient safety
precautions that Kaiser Permanente currently has. Also
allows the Board of Pharmacy to develop rules to allow
for a prescription to be filled at one pharmacy and sent
to another pharmacy, which is commonly referred to as
Central Fill. Language for the Board of Pharmacy to
regulate remote entry access for hospital pharmacies was
also added to the legislation. Passed out of the Senate
and House and is on the Governor's desk.
S.B. 370 - Controlled Substances; Schedule I and V
controlled substance; "dangerous drug." This is the
annual drug update bill. It passed the Senate and House
and has already been signed by the Governor into law.
S.B. 378 - Controlled Substances; changes definition of
written prescriptions for dangerous drugs. S.B. 378
allows prescriptions to be filled in Georgia that are
written in other states. It also brings state law into
compliance with Federal law related to drug samples.
Passed the Senate 49-0 and died in the House Judiciary
Non-Civil Committee.
S.B. 380 - Pharmacist and Pharmacies; change definition
of security paper. This measure remedies the problems
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related to prescription pads that was inadvertently
created with the passage of the Prescription Drug
Monitoring legislation from last year. This bill also
requires licensing of pharmacies from other states that
send prescriptions to Georgians. Passed the Senate, but
died on the floor of the House on the final legislative day.
S.B. 416 – Authorizes the Department of Insurance to
develop exchange standards regarding electronic prior
authorization drug requests with health care providers.
Allows for the national standards that are to be adopted
by the National Council of Prescription Drug Programs
governing electronic prior approvals of prescriptions to be
the standard followed here in Georgia. Passed the Senate
and House and is awaiting the Governor's signature.
S.B. 417 - Pharmacists and Pharmacies; electronic
transmission mechanism; provide certain requirements.
Authorizes physicians to be able to see a complete
electronic version of an insurance company's drug
formulary. Did not pass the Senate and is dead.
S.B. 445 - Secretary of State; create the position of
director of professional licensing; provide powers, duties,
and responsibilities. This is the Secretary of State's bill
to streamline the process of getting professional licenses
and renewals. This bill was withdrawn from General
Assembly consideration on February 28, 2012 and
therefore died. However, it is a certainty that the
Secretary of State will re-introduce a similar measure
during next year’s General Assembly.
H.B. 729 - Revenue and taxation; Internal Revenue and
Internal Revenue Code of 1986;. Clarifies that insulin is
exempt from taxes like all prescription drugs in Georgia.
Passed the House and Senate and is awaiting the
Governor's signature.
H.B. 878 - Pharmacists and pharmacies; use remote
order entry for hospital pharmacies under certain
conditions. This issue was ultimately added to S.B. 346.
This version of the proposal did not pass the House and
is dead.
H.B. 952 - Pharmacists and pharmacies; revises certain
definitions of specific opioid drugs. Current Georgia law
already allows for Doctors to notate that the prescription
must be “dispensed as written.” GSHP was successful in
adding language to exempt hospital systems, however
this measure did not pass the House and is dead.
H.B. 964 - The Pharmacy Audit Bill of Rights; recoupment
pursuant to an audit under certain circumstances.
Currently when a Pharmacy Benefit Manager audits a
pharmacy, they can recoup the cost of the drug for
simple clerical or record keeping errors. This legislation
would correct this problem. H.S. 964 did not pass the
House and is dead.
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H.B. 972 - Georgia Pain Management Clinic Act; This is
the Attorney General's legislation to continue regulating
pill mills in Georgia. H.B. 972 died on the last day of the
session as the House did not have time to approve the
changes made by the Senate.
H.B. 1069 - Pharmacists and pharmacies; revise
definition of security paper. Similar to S.B. 380, this
measure addresses the problems regarding prescription
pads that were inadvertently created with the passage of
the Prescription Drug Monitoring legislation from last
year. It passed the House, but died on the floor of the
Senate the last day.
H.B. 1124 - Pharmacists and pharmacies; prescription
biologic product and biosimilar product. Seeks to limit the
substitution of biologic and biosimilar products to only
other biologic or biosimilar prescriptions. Did not pass the
House and is dead.
H.B. 1125 - The Pharmacy Audit Bill of Rights;
recoupment pursuant to an audit under certain
circumstances. Does not allow PBM's to recoup the costs
of drugs in an audit if there was a technical or error such
as spelling errors, etc. Did not pass the House and is
dead.
H.B. 1130 - Georgia State Board of Pharmacy;
administratively attached to Department of Community
Health; Moves the Board of Pharmacy out from under
the Secretary of State and makes it an independent
agency like the Composite Medical Board. Did not pass
the House and is dead for this year.
H.B. 1149 - Physicians; administration of vaccines by
pharmacists or nurses pursuant to vaccine protocol
agreements; House version of SB 288 which allows
pharmacists to give any immunization. Did not pass the
House and is dead.
web link | return to headlines
Get the Most Out of Your GSHP Membership
Our goal at GSHP is to provide you with current and timely information that will
help you with your practice. In addition to the GSHP website and our email blast
system, we utilize three other methods for reaching out to members.
Facebook
GSHP has a page on Facebook. Follow us on Facebook, by clicking on the link
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below: https://www.facebook.com/pages/Georgia-Society-of-Health-System-
Pharmacists/3262
61148598
LinkedIn
We also have a group on LinkedIn. To join the group,
http://www.linkedin.com/groups?trk=hb_side_g&gid=3699702
Text messaging service
We now have the ability to send you a text message to your cellphone and would
like to ask you to join in our txt messaging service. Based on current cellphone
regulations, you have to opt in to this service which you can do by sending a txt
from your cellphone. You will need to txt gshp to 33938 from your cellphone. Your
cellphone number will not be shared with anyone and you will receive no more than
3 txt messages per month from GSHP. Remember this is an opt in service that
requires you to txt GSHP to 33938.
ASHP News
Renewed Focus on Tuberculosis Holds Promise for New Treatments
[May 1, 2012, AJHP News] Kate Traynor BETHESDA, MD 13 April 2012—FDA
approved rifampin for the treatment of tuberculosis (TB) in 1971, the same year
Intel Corporation invented the first microprocessor.
Since then, advances in computer technology have revolutionized the way people
live and work. But no additional medications have been approved by FDA for the
treatment of Mycobacterium tuberculosis infection—a problem that federal officials
and others want to fix.
"It can't take 40 years for us to get our next drug candidates for tuberculosis
developed," said Janet Woodcock, chief of FDA's Center for Drug Evaluation and
Research, during a March 19 briefing in Washington, D.C., sponsored by the Critical
Path to TB Drug Regimens partnership.
Launched in 2010, the partnership was founded by the Bill and Melinda Gates
Foundation, the Critical Path Institute, and the Global Alliance for TB Drug
Development, also known as the TB Alliance. The partnership promotes innovative
ways to speed the development of new TB drugs.
Read More
FDA Mulls Expanded Universe of Nonprescription Drugs
[May 1, 2012, AJHP News] Kate Traynor BETHESDA, MD 13 April 2012—Some
drugs that are now available only with a prescription may one day be obtained after
consulting with a pharmacist or answering a series of questions on a computer
terminal, under a new system that FDA is considering for nonprescription drug use.
Described in the February 28 Federal Register, the new system would establish
"conditions of safe use" for nonprescription sales of specific drugs that would,
absent these conditions, require a prescription.
FDA calls its outline for the expanded availability of nonprescription drugs a new
paradigm for medication use.
"I would like for us to have additional flexibility for nonprescription use and the
ability to use circumstances and technology and incorporate those into practices,"
said Janet Woodcock, chief of FDA's Center for Drug Evaluation and Research,
during a March 22–23 public hearing on the new paradigm.
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Read More
ASHP and Other Concerned Organizations Call for Changes to Draft Drug
Shortages Bill
Sign-on Letter Asks Senate Working Group to Improve Pending Legislation 4/6/2012
Bethesda, Md.— The American Society of Health-System Pharmacists (ASHP),
together with 22 other health care organizations representing patients, clinicians,
and hospitals, sent a letter today to the Senate Committee on Health, Education,
Labor and Pensions (HELP) urging improvements in draft legislation addressing the
drug shortage crisis.
The Senate HELP Committee is currently drafting language to help solve the drug
shortage crisis as part of its work to reauthorize the Prescription Drug User Fee Act.
The signers of the letter acknowledge their appreciation of the Senate’s draft
legislation; however, they are urging several improvements to ensure that the goal
of eliminating generic drug shortages can be accomplished.
Read More
BPS Calls for Taskforce Members for New Specialties
4/2/2012 The Board of Pharmacy Specialties (BPS) is accepting nominations for
taskforce members in two role delineation studies, a critical step in evaluating
proposed specialties. The studies will determine whether infectious diseases and
cardiology pharmacy are based upon a specialized knowledge of pharmaceutical
sciences, as well as specialized functions routinely performed by practitioners in
these proposed specialties, according to the BPS announcement on its website.
BPS took this action in response to requests submitted jointly by several
organizations including ASHP, the American College of Clinical Pharmacy, and the
American Pharmacists Association. The Society of Infectious Disease Pharmacists
also joined the organizations in the requests for a study of infectious disease
pharmacy. ASHP has been a long-time supporter of BPS and the development of
sound specialty credentials, serving as a petitioner or co-petitioner on requests to
recognize four of the specialties currently recognized by BPS.
The deadline for volunteering for the taskforces is May 4. For more information, go
to http://www.bpsweb.org/news/pr_040212.cfm.
Read More
Pharmacy News
Hospitals Scramble on the Front Lines of Drug Shortages
Washington Post (DC) (04/10/12) Sun, Lena H.
The scarcity of certain drugs--including those used to anesthetize surgical patients
and to alleviate pain--has been an escalating problem for several years now, finally
hitting record proportions in 2011. The phaseout of older drugs for newer ones, as
well as quality problems such as fungal contamination, are the primary reasons for
the shortages. Manufacturing shutdowns play a role as well. "Right now, anesthesia
is a big concern," points out Valerie Jensen, associate director of the Food and Drug
Administration's drug-shortage program. "These drugs are absolutely in critical
shortage." Hospitals have been forced to ration medications, use more expensive
alternatives, and even postpone critical treatments as a result. The fallout,
according to the Institute for Safe Medication Practices, has included numerous
injuries--and even some deaths--as healthcare workers make errors in dosing and
preparing substitutes. Some hospitals have resorted to mixing drugs themselves,
for their own use. Not only is this legal, say pharmacists, it reduces the chances of
a mistake. As hospital staffers struggle daily to manage shortages and avert crises,
federal regulators are fast-tracking the process for some upstart firms to produce
older drugs. Additionally, manufacturers are providing earlier notification when a
drug is in danger of going into short supply.
return to headlines
FDA Approves Peginesatide to Treat Anemia in Adult Patients on Dialysis
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FDA.gov (03/27/12)
The FDA has approved peginesatide (Omontys) for the treatment of anemia in adult
dialysis patients who have chronic kidney disease (CKD). This approval decision was
based on two randomized, active-controlled, open-label, multi-center clinical trials
including a total of 1,608 patients with hemoglobin levels initially stabilized by ESA.
These patients were assigned to receive either peginesatide or to continue their
current ESA treatment. Results showed peginesatide was as safe and effective as
the current treatment in maintaining hemoglobin levels. The most common adverse
events observed in patients treated with peginesatide included diarrhea, vomiting,
hypertension, and arthralgia. Based on this data, the drug has been approved with
a Risk Evaluation and Mitigation Strategy (REMS), which added safety measures
consisting of educational elements for health care professionals and a requirement
to assess drug use data.
return to headlines
FDA, IOM Point to Need to Ramp Up Development of Abuse-Resistant and
Novel Nonopioid Pain Medications
Genetic Engineering & Biotechnology News (04/02/12) Philippidis, Alex
FDA officials, including Center for Drug Evaluation and Research (CDER) director Dr.
Janet Woodcock, have recently said that the development of abuse-resistant opioids
and novel nonopioid pain therapies are among the agency's priorities for 2012. This
announcement follows the release of the Institute of Medicine's (IOM) "blueprint for
action" to improve pain prevention, care, education, and research by 2015. The
blueprint asks for increased coordination by government, business, and academia
on these efforts. To this end, the National Institutes of Health (NIH) awarded $386
million in research grants during the 2011 fiscal year to research to aid patients
with chronic pain conditions. While there are no comparable statistics for private
industry, anecdotal evidence suggests there is growing interest among
pharmaceutical researchers to improve abuse-resistant pain medicines.
return to headlines
Percentage of Child Deaths by Meds Poisoning Rising
CNN Health (03/20/2012)
Each day roughly about 165 young kids in the United States are seen in emergency
rooms after getting into medications, according to findings revealed in a report by
Safe Kids Worldwide, which unveiled a new initiative Tuesday called “Safe Storage,
Safe Dosing, Safe Kids." The campaign calls on caregivers, medical personnel,
pharmacists, drug makers and government groups to work to reduce accidental
poisonings of children from medications. The report, which contains poisoning data
from the Centers for Disease Control and Prevention and the American Association
of Poison Control Centers, reveals that while overall U.S. poisoning deaths among
kids plunged by half from 1979 to 2006 - the percentage of those deaths from
medications – both prescription and over-the-counter products – has nearly
doubled, jumping from 36% to 64%. The trend is blamed on several factors,
including more available and improperly stored medications in homes.
return to headlines
Citalopram Hydrobromide - Drug Safety Communication: Revised
Recommendations, Potential Risk of Abnormal Heart Rhythms
Medwatch (03/28/2012)
The FDA has issued new recommendations for citalopram hydrobromide (Celexa).
These recommendations advise that the drug not be used at doses greater than 40
mg per day because it may increase a patient's risk of QT interval prolongation and
Torsade de Pointes. The new recommendations also advise against use of
citalopram in patients already at risk of QT interval prolongation, and calls for the
use of doses not exceeding 20 mg in patients over 60 years of age. These new
recommendations are based on postmarketing data, and results of thorough QT
studies assessing the effects of doses of citalopram and its active S-isomer
escitalopram (Lexapro) on the QT interval in adults.
return to headlines
NY Leaders Negotiate Prescribed Drugs Restrictions
Wall Street Journal (04/10/12)
Spokesman for New York Governor Cuomo, Attorney General Eric Schneiderman,
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and legislative leaders have confirmed that there are ongoing talks negotiating
measures to control the black market in hydrocodone and other addictive
painkillers. Schneiderman has been advocating for "real time" online review and
reporting on each prescription written and filled for a patient by doctors and
pharmacists, as it would prevent doctor shopping by addicts and dealers. The
Senate has passed bills that reclassify hydrocodone into the same restricted group
as oxycodone, meaning that a new prescription is required each time, and a bill
that would increase the criminal penalties for those doctors and pharmacists who
illegally divert prescription drugs.
return to headlines
Kentucky Joins Program to Share Prescription Drug Dispensing Data
Surfky News Group (03/27/12)
Gov. Steve Beshear announced that the Kentucky All Schedule Prescription
Electronic Reporting (KASPER) program will join the Prescription Monitoring Program
InterConnect (PMP InterConnect). Under the agreement, Kentucky will share and
receive prescription drug dispensing data with at least 20 other states to help
monitor prescription drug abuse. PMP InterConnect aids the transfer of information
to other states by linking participating drug monitoring programs. Twenty states
already agreed to join the Interconnect program, and more may follow. "We are
very proud of the success of our KASPER program and feel it is one of the most
effective tools available for tracking drug abuse, misuse, and diversion within the
state of Kentucky," said Acting Cabinet for Health and Family Services Secretary
Eric Friedlander. "Joining the InterConnect will dramatically strengthen our ability to
monitor and detect abuse." Kentucky has the highest rate of opioid abuse in the
United States, according to the Kentucky State Epidemiological Outcomes
Workgroup. Prescription drug deaths in the state almost outnumber deaths
attributed to motor vehicle accidents. PMP InterConnect will allow Kentucky
prescribers and pharmacists to more easily identify patients with prescription drug
abuse problems.
return to headlines
AMA, Pharmacist Testify at FDA Hearing on Innovative Technologies
Modern Physician (03/22/12) Robeznieks, Andis
Both pharmacists and physicians recently testified at the Food and Drug
Administration hearing on using innovative technologies—such as interactive kiosks
where individuals could self diagnose and self medicate for certain conditions—to
expand the availability of certain drugs without a prescription. For example, Dr.
Sandra Adamson Fryhofer, expressed doubts that expanding the availability of
drugs available over the counter would significantly reduce patient visits to the
emergency room for minor ailments.
return to headlines
White House and the F.D.A. Often at Odds
New York Times (04/02/12) Harris, Gardiner
FDA staff say that politics continues to play a role in their decisions, despite some
improvements under the Obama Administration. FDA officials say that, for example,
the White House intervened when the FDA considered removing from the market
unapproved, pharmacist-compounded versions of KV Pharmaceutical's 17 alpha-
hydroxyprogesterone caproate (17P) due to cost concerns. Officials have also
indicated that politics interfered with their decisions on access to levonorgestrel
(Plan B) for some adolescents. Harvard University Prof. Daniel Carpenter has raised
concerns that these revelations could have a significant impact on the FDA. "In a
globalizing world, where trust is a huge part of what American manufacturers have
to sell, the politicization of the FDA could hurt not only consumer protection but
industry profits as well," he warned. "If this trend continues, one could easily see
major government purchasing programs in Europe, India, China and elsewhere
saying, 'We're not going to follow FDA recommendations anymore.'"
return to headlines
California, Vermont Consider Tougher Vaccine-Exemption Rules
American Medical News (04/09/12) O'Reilly, Kevin B.
Vaccine exemptions for children with physician-verified medical contraindications
area allowed in every state, while 48 states allow religious exemptions and 20
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states allow philosophical exemptions. In California, parents need only sign a form
to opt-out of immunization requirements, but proposed legislation would require
parents to get signatures from physicians, nurse practitioners, or physician
assistants indicating that they have been informed of the benefits and risks of
immunization. The measure is a response to outbreaks of vaccine-preventable
diseases, such as pertussis, which infected more than 9,000 people and resulted in
800 hospitalizations and 10 deaths statewide in 2010. The bill is supported by the
California Medical Association, whose president-elect, Dr. Paul Phinney, says: "It
just makes sure parents are fully informed and make a good decision." Meanwhile,
lawmakers in Vermont have proposed eliminating the personal-belief exemption.
Legislation to add religious or personal-belief exemptions or make them easier to
obtain is being considered in Kansas, Massachusetts, Minnesota, Mississippi, New
Jersey, New York, South Dakota, and West Virginia.
return to headlines
© 2012 American Society of Health-System Pharmacists.
News summaries © 2012 Information, Inc. [subscribe/unsubscribe]
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