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DEA Heads First-ever Nationwide Prescription Drug Take-back Day

The Drug Enforcement Administration (DEA) and government, community, public health and law enforcement partners today announced a nationwide prescription drug “Take-Back” initiative that seeks to prevent increased pill abuse and theft.



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CVS Pharmacy Inc. Agrees to Pay $17.5 Million to Resolve False Prescription Billing Case

CVS Pharmacy Inc., the retail pharmacy division of CVS Caremark Corporation that operates more than 7,000 retail pharmacies in 41 states and the District of Columbia, has agreed to pay the United States and 10 states $17.5 million to resolve False Claims Act allegations.



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Google Forfeits $500 Million Generated by Online Ads & Prescription Drug Sales by Canadian Online Pharmacies

Online search engine Google Inc. has agreed to forfeit $500 million for allowing online Canadian pharmacies to place advertisements through its AdWords program targeting consumers in the United States, resulting in the unlawful importation of controlled and non-controlled prescription drugs into the United States.



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Attorney General Holder, Federal and State Officials Announce Enforcement Efforts Against Illegal Prescription Drug Distributors in Florida

Federal authorities, along with state and local law enforcement partners, conducted coordinated enforcement actions today against 22 individuals and one pharmacy allegedly involved in the illegal distribution of prescription drugs.



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Walgreens Pharmacy Chain Pays $7.9 Million to Resolve False Prescription Billing Case

Walgreens, an Illinois-based corporation operating a national retail pharmacy chain, has paid the United States and participating states $7.9 million to resolve allegations that Walgreens violated the False Claims Act, the Justice Department announced today.



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Healthpoint Ltd. to Pay up to $48 Million for False Medicaid and Medicare Claims for Unapproved Prescription Drug

Healthpoint Ltd. and DFB Pharmaceuticals will pay up to $48 million to resolve allegations that Healthpoint caused false claims to be submitted to Medicare and Medicaid for an unapproved drug, Xenaderm, which was ineligible for reimbursement by those programs.



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Florida Woman Sentenced to Serve 72 Months in Prison for Conspiring to Distribute Prescription Drugs Over the Internet

Lina Rodriguez, 34, was sentenced today in the U.S. District Court for the Southern District of Florida to serve 72 months in prison, followed by 24 months of supervised release, for operating and facilitating the operation of an Internet-pharmacy business that illegally shipped over $1.5 million of pharmaceuticals since July 2007 to U.S. and overseas purchasers.



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The Department of Justice Files Suit Against Louisiana Pharmaceutical Company for Distributing Unapproved and Misbranded Prescription and Over-the-counter Drugs

Acting Assistant Attorney General Stuart F. Delery announced today that the Department of Justice, on behalf of the Food and Drug Administration (FDA), has filed suit in the U.S. District Court for the Western District of Louisiana against Sage Pharmaceuticals.



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Wyeth Pharmaceuticals Agrees to Pay $490.9 Million for Marketing the Prescription Drug Rapamune for Unapproved Uses

Wyeth Pharmaceuticals Inc., a pharmaceutical company acquired by Pfizer, Inc. in 2009, has agreed to pay $490.9 million to resolve its criminal and civil liability arising from the unlawful marketing of the prescription drug Rapamune for uses not approved as safe and effective by the U.S. Food and Drug Administration (FDA).



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CVS’ Caremark Will Pay $4.25 Million for Allegedly Denying Medicaid Claims for Reimbursement of Prescription Drug Costs

Caremark LLC, a pharmacy benefit management company (PBM), will pay the government and five states a total of $4.25 million to settle allegations that it knowingly failed to reimburse Medicaid for prescription drug costs paid on behalf of Medicaid beneficiaries, who also were eligible for drug benefits under Caremark-administered private health plans.



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Endo Pharmaceuticals and Endo Health Solutions to Pay $192.7 Million to Resolve Criminal and Civil Liability Relating to Marketing of Prescription Drug Lidoderm for Unapproved Uses

Pharmaceutical company Endo Health Solutions Inc. and its subsidiary Endo Pharmaceuticals Inc. (Endo) have agreed to pay $192.7 million to resolve criminal and civil liability arising from Endo’s marketing of the prescription drug Lidoderm for uses not approved as safe and effective by the Food and Drug Administration.



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Attorney General Holder Delivers at the ONDCP Summit on Heroin and Prescription Drugs

You know as well as anyone that the challenges we face are daunting. You’ve shown us that, as we seek to address the problem of substance abuse, it makes sense to focus on the most dangerous types of drugs. And right now, few substances are more lethal than prescription opioids and heroin.




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Attorney General Holder Announces New Drug Take-Back Effort to Help Tackle Rising Threat of Prescription Drug Addiction and Opioid Abuse

Calling prescription drug addiction an “urgent and growing threat” to our nation’s public health, Attorney General Eric Holder on Monday announced a new Drug Enforcement Administration(DEA) regulation that would allow pharmacies, hospitals, clinics, and other authorized collectors to serve as authorized drop-off sites for unused prescription drugs.



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Policy Changes Could Bolster Prescription Drug Monitoring Programs

High rates of opioid prescribing have contributed to the current U.S. opioid epidemic and the steady increase in overdose deaths across the country. Prescribers wrote an all-time high of 255 million opioid prescriptions in 2012, and though that rate has since declined.




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Just a Decade Later, DEA Reopens Comment Period for Electronic Prescriptions for Controlled Substances

By Karla L. Palmer




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High-priced drugs in Medicare Part D: Diagnosis and prescription

Drug pricing in the U.S. is a persistently vexing policy problem. High drug prices stress consumers, payers, employers and “budgeteers”. At the same time the public demands new and better treatments, and the scientific advances that make such treatments possible. The pharmaceutical industry insists, with merit, that delivering new improved treatments, and in some cases…

       




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Health policy 101: How the Trans-Pacific Partnership will impact prescription drugs


For the last several years, the US government has been negotiating a free-trade agreement known as the Trans-Pacific Partnership (TPP) with 11 other countries across the Asia-Pacific and Latin American regions, which could have major impact on the pharmaceutical market.  When finalized it will be the largest free-trade agreement in history, impacting up to one-third of world trade and roughly 40 percent of the global gross domestic product. The deal has attracted a fair share of criticism from a wide range of groups, including concerns over proposed regulations for biologic drugs in participating countries. Specifically, critics are concerned about the length of data exclusivity granted to the companies that hold the patents on these drugs. Below is a primer on biologics and how they are being addressed in the TPP.


What are biologics and biosimilars?

Biologic drugs include any therapy derived from a biological source; a group which includes vaccines, anti-toxins, proteins, and monoclonal antibodies. Because they are typically much larger and more structurally complex than traditional ‘small-molecule’ drugs, they are also more difficult—and much more costly—to develop and manufacture. Biologics are also among the most expensive drugs on the market, costing an average of 22 times more than nonbiologic drugs. Avastin, a cancer drug, can cost more than $50,000 a year, while the rheumatoid arthritis drug Remicade can cost up to $2,500 per injection.

Given these high costs, there is substantial interest in encouraging the development of biosimilars, a term used to describe follow-on versions of an original biologic. Estimates of the potential cost savings vary substantially, but some have predicted that competition from biosimilars could reduce US spending on biologics by $44 to $66 billion over the next ten years.  In the European Union, biosimilars have been on the market since 2006, and a 2013 analysis found that, for the 14 biosimilars on the market, the average price discount was about 25 percent. By 2020, the overall cost savings are projected to total $16-$43 billion.

After the Affordable Care Act (ACA) was passed in 2010, the US Food and Drug Administration (FDA) developed an accelerated approval pathway for biosimilars, modeled after the pathway used for the approval of small-molecule generics. In order to meet the criteria for biosimilarity, the drug must share the same mechanism of action for the approved condition of use, and there must be no clinically significant differences between the two drugs in terms of purity, safety, or potency. FDA recently approved its first biosimilar, Zarxio, which is a copy of the oncology drug Neupogen.

What issues are being raised over data exclusivity in the US?

Under current FDA regulations, biologic drugs are granted 12 years of data exclusivity following approval. During this period of exclusivity, the FDA may not approve a biosimilar application that relies on the data submitted as part of the original biologic application. This form of temporary monopoly is distinct from patent protection, which is granted well before approval and is not related to clinical data.  Data exclusivity does not prevent another company from generating the data independently, but drug companies are unlikely to go to the considerable (and costly) effort of replicating a full course of clinical trials for a drug that is already on the market. (Though biosimilars may need to undergo some additional clinical testing under current FDA regulations, the amount of data required to support approval would certainly be less than what is required for an original biologic approval.)

The 12-year exclusivity period for biologics was established in the ACA following intense debate, and has continued to attract criticism. (By contrast, the period of data exclusivity is just five years for small-molecule drugs.) Supporters argue that given the greater cost and difficulty of bringing a biologic to market a longer period of exclusivity is necessary to incentivize innovation. Others argue that the resulting restrictions on competition keep drug prices unnecessarily high, inevitably putting a strain on the health system and keeping potentially life-saving drugs out of reach for many patients.

How would the TPP affect data exclusivity?

For the 11 countries besides the U.S. that are involved in the TPP, current data exclusivity protections range from zero (Brunei) to eight years (Japan). Under the Obama Administration’s current proposal, participating countries would increase those periods to match the US standard of 12 years. Curiously, this proposal directly contradicts the administration’s ongoing domestic efforts to lower the period of data exclusivity. Since the ACA passed, the Obama administration has repeatedly proposed reducing it to seven, arguing that this would save Medicare $4.4 billion over the next decade. Some have noted that, once the 12-year period is enshrined in the TPP, it will become significantly more difficult to change it through the US legislative process. Furthermore, imposing US standards on the 11 member countries would inevitably restrict competition at the global level, and many patient advocacy and international humanitarian organizations have argued that doing so would undermine the efforts of US global health initiatives like the Vaccine Alliance and the Global Fund to Fight AIDS, Tuberculosis and Malaria, which rely on price competition to manage program costs.

It is unclear whether the US will be successful in its efforts. There have been reports that the issue of data exclusivity has become a significant point of contention, and the US delegation may seek to compromise on its demands. It may, for example, negotiate exceptions for the poorer countries involved in the negotiation, as the Washington Post notes. However, the details of the negotiations are largely confidential, which makes it challenging to assess the possibilities, their relative advantages, or how the US Trade Representative (which is leading the US negotiations) is balancing the need to ensure adequate incentives for innovation with the need to control drug costs and facilitate patient access to potentially life-saving therapies.

Editor's note: Elizabeth Richardson, a research associate in the Center for Health Policy, contributed to the research and writing of this post. 

       




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The medical marijuana mess: A prescription for fixing a broken policy

In 2013, Patrick and Beth Collins were desperate. Thirteen‐year‐old Jennifer, the younger of their two children, faced a life‐threatening situation. In response, the Collins family took extreme measures—sending Jennifer thousands of miles away in the company of her mother. Beth and Jennifer became refugees from a capricious government whose laws threatened Jennifer’s health, the family’s…

       




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Louisiana’s prescription drug experiment: A model for the nation?

The high cost of prescription drugs has become an increasingly pressing concern for policymakers, insurers, and families. New drugs—like those now available for hepatitis C— offer tremendous medical benefits, but at a cost that puts them out of reach for many patients. In an effort to address the affordability dilemma, the Louisiana Department of Health…

       




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Is it too late for sustainability? Not if we follow this prescription

Peter Rickaby says he has "never been more optimistic about the possibility of change," but it will require some radical action.




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Pilates, not pills: Doctors are writing exercise prescriptions

Family doctors are acknowledging that there's only so much medicine can do, and sometimes a walk in the park is just what a person needs.





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Eyeglass World Launches First Retail Collection of Prescription Lenses for Smart Glass Devices - Future of Eyewear

Eyeglass World launches first retail collection of smart glass technologies in the U.S., including specially designed prescription lens options and hardware for Recon, Vuzix and Epson wearable devices.





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Opioid Prescriptions from Dentists Linked to Youth Addiction Risk

Dental painkillers put teens and young adults at increased risk for opioid addiction in the following year, a study from the Stanford University School of Medicine has found.




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Around Half of Dental Opioid Prescriptions Exceed Guidelines

Around half of the opioids prescribed by dentists in the United States exceed the three-day supply recommended by federal dental pain-management guidelines.




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Forecasting Proper Opioid Prescriptions After Cesarean

Knowing the dose of opioids taken after cesarean delivery and before discharge can inform individualized prescriptions and reduce unnecessary, leftover




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New Jersey man, 21, charged after woman, 19, dies from night of 'rough sex, prescription medication'

Michael T. Gaffney, 21 (left), of New Jersey, was charged with reckless manslaughter, following the death of a woman in the garage of the building (right) they'd attended a Halloween party at earlier.




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New Walmart service will try to RIVAL Amazon Prime with perks like discounted fuel and prescriptions

Walmart is rolling out a new subscription service to rival Amazon Prime that could include unique perks its online competitor does not already offer, like discounts on prescriptions and fuel.




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Ted Cruz wants to work with AOC to make birth control pills available without prescriptions

The left-right duo agree birth control pills should be available over the counter and Cruz proposed that they collaborate. Republicans last proposed it in 2015; Senate Democrats blocked it




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HEALTH: The new pill-free prescription

Come spring, the first thing that patients see as they walk into the College Surgery in Cullompton, Devon, are the green shoots of a raised-bed vegetable garden beside a physic garden




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Prescriptions for PrEP increased 1,000% in 2 years in NYC

A new report by DOHMH researcher Paul Salcuni has shown things are changing in New York: with a surge of 976 percent in PrEP prescriptions between 2014 and 2016.




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Mother plied son, 15, with liquid morphine and prescription drugs before he died, inquest hears 

Holly Strawbridge, 34, of Salcombe, Devon, gave a cocktail of drugs and booze to her son Tyler Peck at their family home, causing him to overdose, an inquest found. She is currently serving ten years.




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Woman dies after 'rough sex in car and taking prescription drugs'

Michael T. Gaffney, 21, from Maywood was charged with reckless manslaughter last month over the death of Francis Victoria Garcia, 19.He allegdly posted a picture of her body on Snapchat.




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A prescription that suits the doctor!


Does the World Bank advocate development, or is it simply a money-lender pushing its loan packages? For too long, the distinction has been blurred, allowing the Bank to make self-serving recommendations. Sudhirendar Sharma notes the latest instance of this as the Bank pushes into water sector reforms in India.




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Kerala crisis prescription: unconvincing, no rigour


It is nobody’s case that there is no crisis. But when remedies are prescribed, the diagnosis and the investigation have to be beyond dispute. P N Venugopal critiques a report from the Centre for Development Studies, Thiruvananthapuram.




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PDR for nonprescription drugs, dietary supplements, and herbs




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The Rumi prescription: how an ancient mystic poet changed my modern manic life / Melody Moezzi

Online Resource




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ACSM's resource manual for guidelines for exercise testing and prescription / American College of Sports Medicine ; senior editor, David P. Swain ; section editors, Clinton A. Brawner ... [et al.]




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ACSM's guidelines for exercise testing and prescription / senior editor, Deborah Riebe, PhD, FACSM, ACSM EP-C, Associate Dean, College of Health Sciences, Professor, Department of Kinesiology, University of Rhode Island, Kingston, Rhode Island ; assoc

American College of Sports Medicine, author, issuing body




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Prescription to shed weight: Shift from pills to vegetables




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Effect of prescription opioids and prescription opioid control policies on infant health [electronic resource] / Engy Ziedan, Robert Kaestner

Cambridge, Mass. : National Bureau of Economic Research, 2020




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JAMA Internal Medicine : Analysis of Proposed Medicare Reforms on Prescription Drug Total Spending and Patient Cost-Sharing

Interview with Aaron Kesselheim, author of Analysis of Proposed Medicare Part B to Part D Shift With Associated Changes in Total Spending and Patient Cost-Sharing for Prescription Drugs, and Francis J. Crosson, M.D., author of Managing the Cost of Medicare Part B Drugs: Implications for the Program and Beneficiaries





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The Dentist's Drug and Prescription Guide, 2nd Edition


 

The updated and authoritative reference to medications used in dental practice 

The revised and updated second edition of The Dentist's Drug and Prescription Guide offers a practical and quick reference to medications commonly prescribed in dental practice.  With contributions from experts on the topic, this comprehensive book takes an accessible question-and-answer format, providing answers to common questions dentists ask about drugs. The most updated



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Association of Mental Health Disorders With Prescription Opioids and High-Risk Opioid Use in US Veterans of Iraq and Afghanistan

Interview with Karen H. Seal, MD, MPH, author of Association of Mental Health Disorders With Prescription Opioids and High-Risk Opioid Use in US Veterans of Iraq and Afghanistan






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ACSM's exercise testing and prescription / editors, Madeline Paternostro Bayles, Ann M. Swank