Drug Topics - Legal News
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Healthcare Reform: Drug Topics readers speak out
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With the subject of healthcare reform on the front burner in Washington and across the country, Drug
Topics invited members of its Frontline editorial advisory board to share their thoughts. A selection of their
responses is presented here. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - November 4, 2009 Category: Medical Law Source Type: news
Drug prices can't depend on who's buying
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In the prescription drug market, discriminatory pricing is common for independent community pharmacies
and their patients. This fall, a Federal District Court in New York will consider a critical case: Drug Mart
Pharmacy Corp. et a. v. American Home Products Corp. et al. The outcome of the case may determine whether
discriminatory pricing techniques are illegal. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - November 3, 2009 Category: Medical Law Source Type: news
Health system pharm tech roles expand
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Hospitals and health systems have taken the lead in expanding the role of pharmacy technicians.
"The better educated techs are, the more they can support pharmacists," says Mary Mohr, RPh, MS, of
Clarian Health. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - October 8, 2009 Category: Medical Law Source Type: news
FDA-mandated REMS now in force in pharmaceutical industry
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The FDA can require risk evaluation and mitigation strategies for certain prescription drugs and
biological products, to ensure that the benefits of such products outweigh the risks. The effect of REMS ripples
down through the supply chain to affect how pharmacies dispense medication. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - October 7, 2009 Category: Medical Law Source Type: news
FDA issues guidance on REMS
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The FDA has announced the availability of the first draft guidance for industry on Risk Evaluation and
Mitigation Strategies. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - October 7, 2009 Category: Medical Law Source Type: news
Biogeneric drugs and brands: The future market share
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When manufacture of biogenerics is a legal reality, brand manufacturers will still retain a strong
market share for several years. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - October 7, 2009 Category: Medical Law Source Type: news
Pharmacy groups file lawsuits over Medicaid cuts
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Pharmacy groups have filed three lawsuits that argue that California, New York, and Washington have
not met their legal requirements to assure Medicaid patients receive access and quality care at least equal to
patients in the general public. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - September 30, 2009 Category: Medical Law Source Type: news
Controversy stirs over mail-order drugs
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Controversy is in the mix after two mail-order prescription surveys with conflicting results were
released within two days of each other. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - September 23, 2009 Category: Medical Law Source Type: news
Controversy stirs over mail order drugs
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Controversy is in the mix after two mail-order prescription surveys with conflicting results were
released within two days of each other. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - September 23, 2009 Category: Medical Law Source Type: news
Healthcare groups ask Congress to block cuts
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A coalition of healthcare industry groups has sent a letter to the bipartisan leadership in Congress
seeking to delay pending Medicaid cuts. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - September 21, 2009 Category: Medical Law Source Type: news
Joint Commission targets safety failures
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The Joint Commission is targeting patient safety failures with a new program that will directly affect
pharmacy operations. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - September 17, 2009 Category: Medical Law Source Type: news
Pharm tech sues employer
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A New Jersey pharmacy technician who claims to have been traumatized after a "masked
gunman" burst into her store is suing her employers. Find out why, keep reading. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - September 14, 2009 Category: Medical Law Source Type: news
Pro-life pharmacists win preliminary injunction
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Two Illinois pharmacy owners have gained a temporary victory in their effort to conduct their practice
according to their pro-life opinions. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - September 9, 2009 Category: Medical Law Source Type: news
FDA advisory committee recommends Cervarix
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GlaxoSmithKline has announced that the FDA's Vaccines and Related Biological Products Advisory
Committee voted that clinical data support both the efficacy and safety of Cervarix, the company's candidate
cervical cancer vaccine. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - September 8, 2009 Category: Medical Law Source Type: news
September 26 rollback of wholesale drug prices approaching fast
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With the settlement of the class-action lawsuit brought against First DataBank and McKesson by
third-party payors accusing the companies of conspiring to inflate average wholesale prices (AWP) of hundreds of
drugs, AWP values will roll back from 1.25 to 1.20 times the drugs' wholesale acquisition cost (WAC). (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - September 3, 2009 Category: Medical Law Source Type: news
Beware of fake remedies sold as "dietary supplements"
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Manufacturers, promoters, and sellers of dietary supplements are prohibited by law from making claims
to treat or cure illness or disease, or their symptoms. Pharmacists should encourage patients to check with medical
professionals before commencing use of any dietary supplement. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - September 3, 2009 Category: Medical Law Source Type: news
Iowa board of pharmacy considering medical marijuana
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The Iowa Board of Pharmacy is now one step closer to making its recommendation to the state?s
legislature regarding the use of medical marijuana in the state. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - September 2, 2009 Category: Medical Law Source Type: news
West Virginia attorney general sues pharmacies
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The West Virginia Attorney General's Office has filed a lawsuit that alleges that CVS Pharmacy, Kmart,
Kroger, Walgreen Pharmacy, and Target violated a state law designed to promote use of generic equivalents for
brand-name prescription drugs, according to media reports in the state. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - September 2, 2009 Category: Medical Law Source Type: news
West Virginia's attorney general sues pharmacies
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The West Virginia Attorney General's Office has filed a lawsuit alleging that CVS Pharmacy, Kmart,
Kroger, Walgreen Pharmacy, and Target violated a state law designed to promote use of generic equivalents for
brand-name prescription drugs, according to media reports in the state. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - September 1, 2009 Category: Medical Law Source Type: news
Kentucky bears down on prescription drug abuse
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Kentucky Attorney General Jack Conway recently announced that the National Association of Drug
Diversion Investigators (NADDI) will fund new drug diversion efforts in Eastern Kentucky and allow the task force
to expand into other areas of the state. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - September 1, 2009 Category: Medical Law Source Type: news
Court orders supplement makers to pay up
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The marketers of the dietary supplements Coral Calcium and Supreme Greens, who claimed their products
would cure ailments from cancer to heart disease, have been ordered by a federal district court to pay nearly $70
million. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - August 31, 2009 Category: Medical Law Source Type: news
Virginia's pharmacy board adopts new CE compliance process
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In what it describes as an effort to stabilize and possibly decrease costs, a significant portion of
which are associated with enforcement of laws and regulations, the Virginia Board of Pharmacy is testing new
processes to help increase the efficiency of certain noncompliance issues. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - August 28, 2009 Category: Medical Law Source Type: news
GSK advisory: Advair warehouse theft
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GlaxoSmithKline has announced that two lots of Advair Diskus medication were stolen earlier this month
from the company's distribution facility near Richmond, Virginia. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - August 27, 2009 Category: Medical Law Source Type: news
NABP convenes task force to research PMPs
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The National Association of Boards of Pharmacy will convene a two-day task force Oct. 28 and October
29 to research various prescription-drug monitoring programs and recommend standards or model rules. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - August 27, 2009 Category: Medical Law Source Type: news
GSK advisory: Warehouse theft
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GlaxoSmithKline has announced that two lots of Advair Diskus medication were stolen earlier this month
from the company's distribution facility near Richmond, Virginia. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - August 27, 2009 Category: Medical Law Source Type: news
Pharmacy associations drop Del. lawsuit
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The National Association of Chain Drug Stores (NACDS) and the National Community Pharmacists
Association (NCPA) on Aug. 26 reached a favorable agreement with the Delaware State Department of Health and Social
Services. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - August 27, 2009 Category: Medical Law Source Type: news
Pharmacy associations drop Delaware lawsuit
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On Aug. 26 the National Association of Chain Drug Stores and the National Community Pharmacists
Association reached a favorable agreement concerning Medicaid reimbursement rates with the Delaware State
Department of Health and Social Services. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - August 26, 2009 Category: Medical Law Source Type: news
Medicare prescription benefit program exceeds expectations
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The program created to provide Medicare recipients with prescription drug benefits exceeded
expectations during its first two years. Keep reading to find out how. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - August 26, 2009 Category: Medical Law Source Type: news
California pharmacies challenge Wyeth buyout
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In an antitrust lawsuit filed Aug. 21, seven California pharmacies sued in an attempt to block the
expected $68 billion buyout of Wyeth by Pfizer Inc. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - August 25, 2009 Category: Medical Law Source Type: news
Pharmacy sued by tech who mixed lethal horse supplement
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A former employee at the Ocala, Fla. pharmacy allegedly linked to the sudden deaths of 21 polo ponies
in April at the U.S. Open Polo Championship in Palm Beach has filed a lawsuit claiming she was fired for
cooperating with authorities investigating the tragedy. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - August 25, 2009 Category: Medical Law Source Type: news
Pharmacy sued by pharmacists who mixed lethal horse supplement
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A former employee at the Ocala, Fla. pharmacy allegedly linked to the sudden deaths of 21 polo horses
has filed a lawsuit claiming she was fired for cooperating with authorities investigating the tragedy in April at
the U.S. Open Polo Championship in Palm Beach County. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - August 25, 2009 Category: Medical Law Source Type: news
Calif. pharmacies challenge Wyeth buyout
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In an antitrust lawsuit filed on Aug. 21, seven California pharmacies sued in an attempt to block
Pfizer Inc.?s expected $68 billion buyout of Wyeth. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - August 25, 2009 Category: Medical Law Source Type: news
Pharmacy technicians face states' scrutiny, regulation
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Keep reading to learn about some legal roadblocks in the way of pharmacy technicians. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - August 24, 2009 Category: Medical Law Source Type: news
N.Y. pharmacists voice concern over Medicaid change
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The Pharmacists Society of the State of New York is fighting mad over the state's plan to contract
with mail-order pharmacies to deliver high-cost medications to Medicaid customers. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - August 20, 2009 Category: Medical Law Source Type: news
FDA approves Saphris to treat schizophrenia and bipolar I
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The U.S. Food and Drug Administration has approved Saphris tablets (asenapine) to treat adults with
schizophrenia, a chronic, severe and disabling brain disorder, and to treat bipolar I disorder in adults, a serious
psychiatric disorder that causes shifts in a person's mood, energy, and ability to function. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - August 19, 2009 Category: Medical Law Source Type: news
FDA issues rules for investigational drugs
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The U.S. Food and Drug Administration published two rules recently to help clarify how very ill
patients can obtain access to investigational drugs and biologics when they are not eligible to participate in a
clinical trial and have no other satisfactory treatment options. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - August 17, 2009 Category: Medical Law Source Type: news
NACDS, NCPA forge on with Medicaid lawsuit
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The National Association of Chain Drug Stores and the National Community Pharmacists Association are
moving ahead with their lawsuit against Delaware's changes to Medicaid reimbursement rates, even after Walgreen Co.
said it no longer supports the suit. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - August 13, 2009 Category: Medical Law Source Type: news
Miami prescription drug wholesaler convicted
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A Miami resident has been convicted of both conspiring to divert human growth hormones and causing the
diversion of these human growth hormones in interstate commerce. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - August 12, 2009 Category: Medical Law Source Type: news
Biologics bills duke it out in Congress
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In coming years, nearly half of all newly approved drugs could come from biotechnology. With stakes so
high, Congress is working to create a more direct pathway for the FDA to approve "biosimilars", the
generic or "follow-on" versions of biologics. Two bills before Congress approach the issues
differently. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - August 8, 2009 Category: Medical Law Source Type: news
Rogue Internet pharmacies face new penalties
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The death of a teenager led Congress to pass the Ryan Haight Online Pharmacy Consumer Protection Act
in 2008, amending the Controlled Substances Act to prohibit delivery, distribution, or dispensing of controlled
substances over the Internet without a valid prescription. Retail pharmacies should make sure that their Internet
sales procedures are in full compliance with this law. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - August 8, 2009 Category: Medical Law Source Type: news
Going, going, gone
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Over the next several years, generic versions of many best-selling drugs will become available as
patents reach their expiration dates. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - August 8, 2009 Category: Medical Law Source Type: news
Pharmacy medication errors may be ruled criminal
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Pharmacy mistakes can sometimes lead to injury or even death. Pharmacists can be held liable in a
civil suit for money damages; now a pharmacist in Ohio may be convicted of a criminal charge in the accidental
death of a two-year-old girl. It is possible that the effect of criminal liability upon professional practices will
worsen outcomes rather than improve them. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - August 7, 2009 Category: Medical Law Source Type: news
Pharmacy deadline for "Red Flags" rule extended
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The FTC has extended to November the compliance deadline for its "Red Flag" identity
theft regulation, affecting all businessess that extend credit to customers. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - August 6, 2009 Category: Medical Law Source Type: news
Iowa pharmacy board studies legalized marijuana
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Iowa proponents have sought legalization of medical marijuana for years. Now the state?s Board of
Pharmacy Examiners (IBPE) wants to learn more about the issue. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - August 5, 2009 Category: Medical Law Source Type: news
NCPA seeks to correct flex spending requirements
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The National Community Pharmacists Association (NCPA) recently wrote to a key standards-setting body
requesting action on a number of regarding a new Internal Revenue Service requirement meant to ensure flexible
spending account debit cards are used properly that is seen by the association as problematic. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - August 4, 2009 Category: Medical Law Source Type: news
California legislative committee examines pharmacy workplace issues
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The California State Assembly Committee on Labor and Employment recently held an informational hearing
on the subject of workplace conditions in retail pharmacies. Among those testifying were pharmacists, academics,
students, consumer advocates, and representatives of the California Retailers Association. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - August 4, 2009 Category: Medical Law Source Type: news
Update: Senators urge review of CVS business policies
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Two groups of U.S. Senators recently sent letters to the Federal Trade Commission (FTC) urging a
thorough review of CVS Caremark?s anti-competitive and anti-privacy business practices since their
merger. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - August 3, 2009 Category: Medical Law Source Type: news
Collaboration with physicians improves patient care, revenues
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Orlando, Fla.--Pharmacists can collaborate with physicians and other health professionals in many ways
? including through drug therapy management programs, pharmacy vaccine programs, and practice agreements ? to build
revenue streams and improve patient outcomes. (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - August 2, 2009 Category: Medical Law Source Type: news
NCPA continues fight against surety bond
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The National Community Pharmacists Association (NCPA) is still working to urge Congress to exempt
community pharmacies from the Oct. 1 accreditation and surety bond requirements needed to continue providing
Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) to Medicare patients (Source: Drug Topics - Legal News)
Source: Drug Topics - Legal News - July 30, 2009 Category: Medical Law Source Type: news
