This document summarizes an analysis of opioid utilization among Medicare Part D beneficiaries in 2016. Some key findings:
- One in three Part D beneficiaries received an opioid prescription. Half a million received high amounts with an average daily dose over 120 mg for at least 3 months.
- Almost 90,000 beneficiaries were at serious risk of misuse or overdose due to receiving extreme amounts (over 240 mg daily for a year) or appearing to doctor shop (using multiple prescribers and pharmacies to obtain high doses).
- About 400 prescribers had questionable patterns, ordering opioids for many beneficiaries who were at serious risk. Nearly 200 each prescribed extreme amounts to over 40 beneficiaries, while over 260 each prescribed to over 20
Prescription Medicines Costs in Context November 2019PhRMA
This document discusses the costs and context of prescription medicines. It notes that while prescription drug spending is a small percentage of total healthcare spending, patients often face high out-of-pocket costs. It outlines the significant costs and risks of drug research and development. The document also describes the role of generics in reducing costs over time and how rebates and discounts do not always lower costs for patients.
Prescription Medicines Costs in Context October 2020PhRMA
This document discusses the costs and affordability of prescription medicines in the United States. It notes that while spending on prescription medicines accounts for only 14% of total health care spending, patients face high and rising out-of-pocket costs for medicines. While most medicines sold in the US are generics, brand name medicines face significant price negotiations and rebates paid to insurers and pharmacy benefit managers that often do not lower costs for patients. The document outlines reforms to make medicines more affordable and accessible for patients.
Prescription Medicines Costs in Context January 2020PhRMA
This document discusses the costs and context of prescription medicines. It notes that while prescription drug spending represents 14% of total healthcare spending and a small portion of Medicaid spending, it has enabled breakthrough treatments for chronic diseases. While brand drug prices grew by 0.3% in 2018 after rebates, spending on other healthcare services is projected to grow 5 times faster than prescription drug spending through the next decade. The document also outlines how generics have reduced costs significantly, providing $1.99 trillion in savings over 10 years, and how biosimilars are expected to reduce brand drug sales by $95 billion from 2019-2023 through increased competition.
REPORT 3 OF THE COUNCIL ON SCIENCE AND PUBLIC HEALTH (I -09)CannabisCare.Ca
Action of the AMA House of Delegates at the 2009 Interim Meeting: Council on Science and
Public Health Report 3 Recommendations Adopted as Amended and Remainder of Report Filed.
REPORT 3 OF THE COUNCIL ON SCIENCE AND PUBLIC HEALTH (I-09)
Use of Cannabis for Medicinal Purposes
(Resolutions 910, I-08; 921, I-08; and 229, A-09)
(Reference Committee K)
Prescription Medicines Costs in Context - June 2019PhRMA
We are in a new era of medicine where breakthrough science is transforming care with innovative treatment approaches and enabling us to more effectively treat chronic disease, the biggest cost driver.
Prescription Medicines - Costs In Context March 2019PhRMA
Discussions about costs are important. We recognize that many are struggling to access the medicine they need, and have important questions about their medicine costs. And we want to help find the answers.
Prescription Medicines - Costs in Context January 2019PhRMA
Discussions about costs are important. We recognize that many are struggling to access the medicine they need, and have important questions about their medicine costs. And we want to help find the answers.
MedTech Healthcare Group is the largest provider of outpatient substance abuse treatment programs in Westmoreland and Indiana counties in Pennsylvania, operating three clinics over the past decade. It has treated thousands of patients for opioid addiction and helped reduce the impact of the opioid epidemic. MedTech is on track to generate $3 million in revenue and $900,000-1 million in EBITDA in 2015, with steady growth since its founding in 2006. The behavioral healthcare industry, particularly medication-assisted treatment (MAT) for opioid addiction, represents a large and growing market opportunity.
Prescription Medicines Costs in Context November 2019PhRMA
This document discusses the costs and context of prescription medicines. It notes that while prescription drug spending is a small percentage of total healthcare spending, patients often face high out-of-pocket costs. It outlines the significant costs and risks of drug research and development. The document also describes the role of generics in reducing costs over time and how rebates and discounts do not always lower costs for patients.
Prescription Medicines Costs in Context October 2020PhRMA
This document discusses the costs and affordability of prescription medicines in the United States. It notes that while spending on prescription medicines accounts for only 14% of total health care spending, patients face high and rising out-of-pocket costs for medicines. While most medicines sold in the US are generics, brand name medicines face significant price negotiations and rebates paid to insurers and pharmacy benefit managers that often do not lower costs for patients. The document outlines reforms to make medicines more affordable and accessible for patients.
Prescription Medicines Costs in Context January 2020PhRMA
This document discusses the costs and context of prescription medicines. It notes that while prescription drug spending represents 14% of total healthcare spending and a small portion of Medicaid spending, it has enabled breakthrough treatments for chronic diseases. While brand drug prices grew by 0.3% in 2018 after rebates, spending on other healthcare services is projected to grow 5 times faster than prescription drug spending through the next decade. The document also outlines how generics have reduced costs significantly, providing $1.99 trillion in savings over 10 years, and how biosimilars are expected to reduce brand drug sales by $95 billion from 2019-2023 through increased competition.
REPORT 3 OF THE COUNCIL ON SCIENCE AND PUBLIC HEALTH (I -09)CannabisCare.Ca
Action of the AMA House of Delegates at the 2009 Interim Meeting: Council on Science and
Public Health Report 3 Recommendations Adopted as Amended and Remainder of Report Filed.
REPORT 3 OF THE COUNCIL ON SCIENCE AND PUBLIC HEALTH (I-09)
Use of Cannabis for Medicinal Purposes
(Resolutions 910, I-08; 921, I-08; and 229, A-09)
(Reference Committee K)
Prescription Medicines Costs in Context - June 2019PhRMA
We are in a new era of medicine where breakthrough science is transforming care with innovative treatment approaches and enabling us to more effectively treat chronic disease, the biggest cost driver.
Prescription Medicines - Costs In Context March 2019PhRMA
Discussions about costs are important. We recognize that many are struggling to access the medicine they need, and have important questions about their medicine costs. And we want to help find the answers.
Prescription Medicines - Costs in Context January 2019PhRMA
Discussions about costs are important. We recognize that many are struggling to access the medicine they need, and have important questions about their medicine costs. And we want to help find the answers.
MedTech Healthcare Group is the largest provider of outpatient substance abuse treatment programs in Westmoreland and Indiana counties in Pennsylvania, operating three clinics over the past decade. It has treated thousands of patients for opioid addiction and helped reduce the impact of the opioid epidemic. MedTech is on track to generate $3 million in revenue and $900,000-1 million in EBITDA in 2015, with steady growth since its founding in 2006. The behavioral healthcare industry, particularly medication-assisted treatment (MAT) for opioid addiction, represents a large and growing market opportunity.
This document summarizes a survey of Medicaid Schedule II opioid prescriptions from May 1st to July 31st, 2015. It found that hydrocodone claims made up 80.1% of all claims and patients received on average 2 prescriptions totaling 2527.2 mg of morphine equivalent. The analysis identified 3641 patients, 1734 prescribers, and 1956 pharmacies with high opioid usage. These "flagged" entities accounted for 19,376 claims totaling a high dosage. The document recommends further investigating these targets and integrating with other programs to address the opioid epidemic.
The document discusses generics medicines in India. It notes that the Indian pharmaceutical market is predominantly a branded generics market, with generics accounting for around 90% of total sales. The government of India is focused on boosting generics growth within India and for exports. However, the generics industry faces challenges from regulatory/licensing issues. The conference aims to address these challenges and find solutions to promote the generics industry in India.
Revisiting Recommendations on Drug Resistance from Past Studiescgdev
The document summarizes recommendations from various sources to address the problem of antimicrobial resistance. It outlines recommendations in three areas: health systems, behavior changes, and technology developments. For each area, it lists specific recommendations, the organizations that proposed them, and considerations around implementation such as targeted stakeholders and timeframes. Key recommendations include improving regulation and surveillance of antimicrobial use, optimizing treatment guidelines, educating providers and patients, developing new diagnostics and drugs, and providing incentives for research and development.
Prescription Medicines Costs in Context March 2022PhRMA
This document discusses trends in prescription drug costs and spending in the United States. It notes that 60 new medicines were approved by the FDA in 2021 for cancer, hemophilia, and COVID. While brand drug prices declined slightly in 2020, overall drug spending grew modestly. Most drug spending goes to health insurers, pharmacy benefit managers, and other entities rather than drug manufacturers. The majority of drugs dispensed are generics, which provide billions in savings each year. The document argues that while drug spending is projected to increase at a similar rate as overall healthcare costs, patients still face high out-of-pocket costs due to deductibles, coinsurance, and other cost-sharing policies by insurers.
A new study adds further evidence to suggest that opioid prescribing in the U.S. is skewed and concentrated among a few providers. Researchers looked at prescribing patterns in data from an unspecified national private insurer between 2003-2017.
Around 670,000 providers prescribed more than 8 million standard doses of opioid prescriptions — but more than a quarter of these prescriptions were written by only 1% of physicians. And in 2017, these physicians prescribed nearly half of all the dispensed opioids. This small group of doctors also prescribed higher doses than recommended, and for longer durations than guidelines allow.
What’s encouraging, the authors suggest, is that the vast majority of physicians do seem to follow guidelines. Some caveats: The study was based on one company’s data, and didn’t look at medical reasons behind prescriptions.
Over 30 years after the Orphan Drug Act was passed, orphan drugs continue to be a lucrative market for pharma companies. Although orphan diseases affect small populations, these treatments address a high unmet need and also benefit from commercially attractive pricing structures and additional regulatory benefits.
Full graphic: http://www.isrreports.com/free-resources/5408/
Generic Drugs having low cost. We should know about world drug scenario. In our daily life, we must concern with doctors and take drugs for cure. But we are not aware about drugs.We should know about drugs, not to become a Doctor, but for general awareness or at least to know what we are taking for our helth.
How Do Opioid Prices and the Evolving Opioid Crisis Relate to the North Ameri...with Wind
The Role of Opioid Prices in the Evolving Opioid Crisis is a publication by order of the Commander in Chief; Our 45th President, Mr. Donald J Trump.
This is an objective purview of the role pharmaceutical marketing and advertising and the one true law that is Supply and Demand have had on the current crisis North America finds itself in.
I aim to be objective - no subjective - or opinionated argument - merely share the presentation as it was originally published by < whitehouse.gov. >
I will state this - however - the opioid crisis - is real - it is not some propaganda cooked up by CDC - DEA - or the Free Masons (wholly misunderstood by today's youth - Illuminati).
It has - in some, shape, form or fashion - affected every single North American at some point over the entirety of this - ridiculous attempt at going to war - against substances.
For my opinions, feel free to connect on
< https://www.linkedin.com/in/oudcollective >
FOLLOW @oudcollective
< https://www.twitter.com/oudcollective >
or help out in pinning beginnings at
< https://www.pinterest.com/THEWINDLLC >
Best,
< linktr.ee/C.Brennan.Poole >
< https://allmylinks.com/chasing-the-wind >
Chasing the Wind, LLC DBA THE WIND LLC is licensed under a creative commons attribution share-alike (CC BY-SA) International 4.0 license. Link to license at < www.creativecommons.org/licenses/by-sa/4.0 >
Prescription Medicines - Costs in Context - May 2018PhRMA
This document discusses the costs and context of prescription medicines. It notes that while prescription drug spending is a small percentage of total healthcare spending in the US and globally, innovative new medicines are transforming care for chronic diseases. While generic drugs now make up 90% of prescriptions filled in the US, brand drug prices have grown just 1.9% after rebates and discounts are applied. The document argues that competition from generics and biosimilars will reduce brand drug sales, but innovator companies continue developing new medicines to treat diseases.
Prescription Medicines - Costs in Context - August 2018PhRMA
Discussions about the cost and affordability of medicines – and health care more broadly – are important. At the same time, it is important to look at costs across the health care system and not just the share going toward life changing medicines.
Essential medicines and counterfeit medicinesAmit Bhondve
The document discusses essential medicines and counterfeit medicines. It defines essential medicines as those that satisfy the priority health needs of a population and are selected based on disease prevalence, efficacy, safety and cost-effectiveness. The WHO publishes a Model List of Essential Medicines every two years to guide countries in developing their own lists. Counterfeit medicines pose serious risks as they may contain incorrect ingredients, too much or too little of the active ingredient, or no active ingredient at all. It is difficult to determine the full extent of counterfeiting due to varying reporting methods across countries and regions. Counterfeiting is most prevalent in areas with weak regulatory and enforcement systems for medicines.
This document is a project report submitted by Mr. Santosh Panchakshari Salgare to the Department of Management Sciences at Savitribai Phule Pune University. The project involved conducting a study to understand the prescription pattern of generic drugs at Hindustan Antibiotics Limited in Pimpri, Pune. The report includes an introduction to the pharmaceutical industry, company profile of Hindustan Antibiotics Limited, objectives, methodology, findings and analysis of the study, and conclusions and recommendations.
PHA 654 Presentation -Rx to OTC Switch, Behind the Counter Drugs & Sudafed - ...Esther Cho, PMP
This document summarizes information about the switch of Sudafed from prescription to over-the-counter status, its active ingredient (pseudoephedrine), product lines, issues of methamphetamine abuse, and regulatory actions taken. Key points include: Sudafed was switched to OTC status in 1976; pseudoephedrine is its active ingredient for nasal congestion; numerous Sudafed products exist; pseudoephedrine is a key ingredient for illegal meth production; and laws now require it be kept behind the pharmacy counter with purchase limits due to abuse issues.
Dr Paul Cornes has received salary from the UK National Health Service and honoraria from several pharmaceutical companies including Roche, Janssen, Sandoz, Lilly, European Generics Association, Teva, and Hospira. The document discusses the increasing cost of cancer drugs and argues that greater use of generics and biosimilars can help contain costs while maintaining treatment effectiveness. It provides examples showing that in the US, increased generic drug use has saved over $1 trillion in healthcare costs in the past decade through lower prices.
Prescription Medicines - Costs in Context - September 2018PhRMA
Discussions about costs are important. We recognize that many are struggling to access the medicine they need, and have important questions about their medicine costs. And we want to help find the answers.
Generic Medicine and its Future Prospects in IndiaAnkita Bharti
Its is one of the project assigned to us in Rural Marketing!!! Mine topic was Generic Medicine and its future prospects in India keeping in mind the High Expenditure an average Indian has capacity to bear.
Hope its liked and appreciated by people. I will be also sharing a slide with a small online survey I did in this context which will provide a bit more insight in this aspect to everyone.
Hope people will find this useful and informative..
This document provides an educational module on interactions between herbal and dietary supplements (HDS) and the blood thinner warfarin. It discusses how HDS are regulated, common types of HDS, and research showing that many popular HDS can interact with warfarin in ways that affect the drug's effects. A survey found that many patients on warfarin use HDS but do not report this to their doctors. The module teaches how to use three online resources to identify potential interactions and provides a case study and practice using the resources to assess interaction risks.
Prescription Medicines - Costs in Context - September 2018PhRMA
Discussions about costs are important. We recognize that many are struggling to access the medicine they need, and have important questions about their medicine costs. And we want to help find the answers.
Generic medicines promulgating growth and access rev1Balaji Ramadurai
Large population of poor people in India, find it difficult to afford the more expensive branded category of medicines. They were fired up by our PM's “Jan Aushadhi” scheme which ensures availability of quality medicines at affordable prices to all.
My students are doing their bit for the country . Appreciate if you could look through their work and encourage them for their future. In case you need to contact them, we have provided the contacts on their project material.
The document discusses the opioid epidemic and medication-assisted treatment in the United States. It provides statistics on the prevalence of opioid addiction and discusses various treatment options like buprenorphine, methadone, and naltrexone. It also examines trends like the growing use of buprenorphine treatment and shifts toward outpatient versus inpatient care. Finally, it outlines questions that consulting firm Splash 4 Partners explores around issues like third-party payment for addiction treatment and scaling medication-assisted treatment practices.
The Centers for Medicare & Medicaid Services outlines their opioid misuse strategy to address the national opioid epidemic. Their strategy includes 4 priority areas: 1) implementing more effective strategies to reduce risks of opioid use disorder, overdoses, and inappropriate prescribing; 2) expanding access to naloxone to reverse overdoses; 3) expanding screening, diagnosis, and treatment of opioid use disorder including medication-assisted treatment; and 4) increasing use of evidence-based practices for pain management. Opioid misuse has led to alarming increases in overdoses and deaths, and CMS aims to combat this through promoting safe opioid use, improving access to treatment, and alternative pain management options.
This document summarizes a survey of Medicaid Schedule II opioid prescriptions from May 1st to July 31st, 2015. It found that hydrocodone claims made up 80.1% of all claims and patients received on average 2 prescriptions totaling 2527.2 mg of morphine equivalent. The analysis identified 3641 patients, 1734 prescribers, and 1956 pharmacies with high opioid usage. These "flagged" entities accounted for 19,376 claims totaling a high dosage. The document recommends further investigating these targets and integrating with other programs to address the opioid epidemic.
The document discusses generics medicines in India. It notes that the Indian pharmaceutical market is predominantly a branded generics market, with generics accounting for around 90% of total sales. The government of India is focused on boosting generics growth within India and for exports. However, the generics industry faces challenges from regulatory/licensing issues. The conference aims to address these challenges and find solutions to promote the generics industry in India.
Revisiting Recommendations on Drug Resistance from Past Studiescgdev
The document summarizes recommendations from various sources to address the problem of antimicrobial resistance. It outlines recommendations in three areas: health systems, behavior changes, and technology developments. For each area, it lists specific recommendations, the organizations that proposed them, and considerations around implementation such as targeted stakeholders and timeframes. Key recommendations include improving regulation and surveillance of antimicrobial use, optimizing treatment guidelines, educating providers and patients, developing new diagnostics and drugs, and providing incentives for research and development.
Prescription Medicines Costs in Context March 2022PhRMA
This document discusses trends in prescription drug costs and spending in the United States. It notes that 60 new medicines were approved by the FDA in 2021 for cancer, hemophilia, and COVID. While brand drug prices declined slightly in 2020, overall drug spending grew modestly. Most drug spending goes to health insurers, pharmacy benefit managers, and other entities rather than drug manufacturers. The majority of drugs dispensed are generics, which provide billions in savings each year. The document argues that while drug spending is projected to increase at a similar rate as overall healthcare costs, patients still face high out-of-pocket costs due to deductibles, coinsurance, and other cost-sharing policies by insurers.
A new study adds further evidence to suggest that opioid prescribing in the U.S. is skewed and concentrated among a few providers. Researchers looked at prescribing patterns in data from an unspecified national private insurer between 2003-2017.
Around 670,000 providers prescribed more than 8 million standard doses of opioid prescriptions — but more than a quarter of these prescriptions were written by only 1% of physicians. And in 2017, these physicians prescribed nearly half of all the dispensed opioids. This small group of doctors also prescribed higher doses than recommended, and for longer durations than guidelines allow.
What’s encouraging, the authors suggest, is that the vast majority of physicians do seem to follow guidelines. Some caveats: The study was based on one company’s data, and didn’t look at medical reasons behind prescriptions.
Over 30 years after the Orphan Drug Act was passed, orphan drugs continue to be a lucrative market for pharma companies. Although orphan diseases affect small populations, these treatments address a high unmet need and also benefit from commercially attractive pricing structures and additional regulatory benefits.
Full graphic: http://www.isrreports.com/free-resources/5408/
Generic Drugs having low cost. We should know about world drug scenario. In our daily life, we must concern with doctors and take drugs for cure. But we are not aware about drugs.We should know about drugs, not to become a Doctor, but for general awareness or at least to know what we are taking for our helth.
How Do Opioid Prices and the Evolving Opioid Crisis Relate to the North Ameri...with Wind
The Role of Opioid Prices in the Evolving Opioid Crisis is a publication by order of the Commander in Chief; Our 45th President, Mr. Donald J Trump.
This is an objective purview of the role pharmaceutical marketing and advertising and the one true law that is Supply and Demand have had on the current crisis North America finds itself in.
I aim to be objective - no subjective - or opinionated argument - merely share the presentation as it was originally published by < whitehouse.gov. >
I will state this - however - the opioid crisis - is real - it is not some propaganda cooked up by CDC - DEA - or the Free Masons (wholly misunderstood by today's youth - Illuminati).
It has - in some, shape, form or fashion - affected every single North American at some point over the entirety of this - ridiculous attempt at going to war - against substances.
For my opinions, feel free to connect on
< https://www.linkedin.com/in/oudcollective >
FOLLOW @oudcollective
< https://www.twitter.com/oudcollective >
or help out in pinning beginnings at
< https://www.pinterest.com/THEWINDLLC >
Best,
< linktr.ee/C.Brennan.Poole >
< https://allmylinks.com/chasing-the-wind >
Chasing the Wind, LLC DBA THE WIND LLC is licensed under a creative commons attribution share-alike (CC BY-SA) International 4.0 license. Link to license at < www.creativecommons.org/licenses/by-sa/4.0 >
Prescription Medicines - Costs in Context - May 2018PhRMA
This document discusses the costs and context of prescription medicines. It notes that while prescription drug spending is a small percentage of total healthcare spending in the US and globally, innovative new medicines are transforming care for chronic diseases. While generic drugs now make up 90% of prescriptions filled in the US, brand drug prices have grown just 1.9% after rebates and discounts are applied. The document argues that competition from generics and biosimilars will reduce brand drug sales, but innovator companies continue developing new medicines to treat diseases.
Prescription Medicines - Costs in Context - August 2018PhRMA
Discussions about the cost and affordability of medicines – and health care more broadly – are important. At the same time, it is important to look at costs across the health care system and not just the share going toward life changing medicines.
Essential medicines and counterfeit medicinesAmit Bhondve
The document discusses essential medicines and counterfeit medicines. It defines essential medicines as those that satisfy the priority health needs of a population and are selected based on disease prevalence, efficacy, safety and cost-effectiveness. The WHO publishes a Model List of Essential Medicines every two years to guide countries in developing their own lists. Counterfeit medicines pose serious risks as they may contain incorrect ingredients, too much or too little of the active ingredient, or no active ingredient at all. It is difficult to determine the full extent of counterfeiting due to varying reporting methods across countries and regions. Counterfeiting is most prevalent in areas with weak regulatory and enforcement systems for medicines.
This document is a project report submitted by Mr. Santosh Panchakshari Salgare to the Department of Management Sciences at Savitribai Phule Pune University. The project involved conducting a study to understand the prescription pattern of generic drugs at Hindustan Antibiotics Limited in Pimpri, Pune. The report includes an introduction to the pharmaceutical industry, company profile of Hindustan Antibiotics Limited, objectives, methodology, findings and analysis of the study, and conclusions and recommendations.
PHA 654 Presentation -Rx to OTC Switch, Behind the Counter Drugs & Sudafed - ...Esther Cho, PMP
This document summarizes information about the switch of Sudafed from prescription to over-the-counter status, its active ingredient (pseudoephedrine), product lines, issues of methamphetamine abuse, and regulatory actions taken. Key points include: Sudafed was switched to OTC status in 1976; pseudoephedrine is its active ingredient for nasal congestion; numerous Sudafed products exist; pseudoephedrine is a key ingredient for illegal meth production; and laws now require it be kept behind the pharmacy counter with purchase limits due to abuse issues.
Dr Paul Cornes has received salary from the UK National Health Service and honoraria from several pharmaceutical companies including Roche, Janssen, Sandoz, Lilly, European Generics Association, Teva, and Hospira. The document discusses the increasing cost of cancer drugs and argues that greater use of generics and biosimilars can help contain costs while maintaining treatment effectiveness. It provides examples showing that in the US, increased generic drug use has saved over $1 trillion in healthcare costs in the past decade through lower prices.
Prescription Medicines - Costs in Context - September 2018PhRMA
Discussions about costs are important. We recognize that many are struggling to access the medicine they need, and have important questions about their medicine costs. And we want to help find the answers.
Generic Medicine and its Future Prospects in IndiaAnkita Bharti
Its is one of the project assigned to us in Rural Marketing!!! Mine topic was Generic Medicine and its future prospects in India keeping in mind the High Expenditure an average Indian has capacity to bear.
Hope its liked and appreciated by people. I will be also sharing a slide with a small online survey I did in this context which will provide a bit more insight in this aspect to everyone.
Hope people will find this useful and informative..
This document provides an educational module on interactions between herbal and dietary supplements (HDS) and the blood thinner warfarin. It discusses how HDS are regulated, common types of HDS, and research showing that many popular HDS can interact with warfarin in ways that affect the drug's effects. A survey found that many patients on warfarin use HDS but do not report this to their doctors. The module teaches how to use three online resources to identify potential interactions and provides a case study and practice using the resources to assess interaction risks.
Prescription Medicines - Costs in Context - September 2018PhRMA
Discussions about costs are important. We recognize that many are struggling to access the medicine they need, and have important questions about their medicine costs. And we want to help find the answers.
Generic medicines promulgating growth and access rev1Balaji Ramadurai
Large population of poor people in India, find it difficult to afford the more expensive branded category of medicines. They were fired up by our PM's “Jan Aushadhi” scheme which ensures availability of quality medicines at affordable prices to all.
My students are doing their bit for the country . Appreciate if you could look through their work and encourage them for their future. In case you need to contact them, we have provided the contacts on their project material.
The document discusses the opioid epidemic and medication-assisted treatment in the United States. It provides statistics on the prevalence of opioid addiction and discusses various treatment options like buprenorphine, methadone, and naltrexone. It also examines trends like the growing use of buprenorphine treatment and shifts toward outpatient versus inpatient care. Finally, it outlines questions that consulting firm Splash 4 Partners explores around issues like third-party payment for addiction treatment and scaling medication-assisted treatment practices.
The Centers for Medicare & Medicaid Services outlines their opioid misuse strategy to address the national opioid epidemic. Their strategy includes 4 priority areas: 1) implementing more effective strategies to reduce risks of opioid use disorder, overdoses, and inappropriate prescribing; 2) expanding access to naloxone to reverse overdoses; 3) expanding screening, diagnosis, and treatment of opioid use disorder including medication-assisted treatment; and 4) increasing use of evidence-based practices for pain management. Opioid misuse has led to alarming increases in overdoses and deaths, and CMS aims to combat this through promoting safe opioid use, improving access to treatment, and alternative pain management options.
Four Effective Opioid Interventions for Healthcare LeadersHealth Catalyst
The crisis of opioid abuse in the U.S. is well known. What may not be so well known are the ways for clinicians and healthcare systems to minimize misuse of these addictive drugs. This article describes the risks for patients when they are prescribed opioids and the need for opioid intervention. It offers four approaches that healthcare systems can take to tackle the crisis while still relieving pain and suffering for the patients they serve:
Use data and analytics to inform strategies that reduce opioid availability
Adopt prescription drug monitoring programs to prevent misuse
Adopt evidence-based guidelines
Consider promising state strategies for dealing with prescription opioid overdose
Opioid misuse is a public health epidemic, but treatments are available and it’s time for those involved in the delivery of healthcare to change practices.
This document discusses the opioid epidemic in America and proposes actions to address it. It summarizes that:
1) Nearly 200,000 Americans have died from prescription opioid overdoses since 1999, and up to 40% of long-term opioid therapy patients may be addicted.
2) Keeping chronic opioid therapy doses low can help reduce overdose risk. Many overdose deaths occur at doses of 50 mg or more per day, while most patients receive lower doses.
3) Immediate actions are needed to curb new inappropriate long-term opioid prescriptions, including more selective initial prescribing, checking prescription monitoring programs, and limiting initial supplies. Policies and regulations also need to be updated to reflect risks of addiction
Medical care responding_to_us_opioid_epidemic_von_korff_franklin_4-22-2016 (3)Paul Coelho, MD
This document discusses the opioid epidemic in America and proposes actions to address it. The key points are:
1) America is experiencing an unprecedented epidemic of prescription opioid addiction and overdose, with almost 200,000 deaths since 1999 mostly affecting patients prescribed opioids.
2) Proposed actions to address the epidemic include avoiding unnecessary opioid prescriptions, changing policies to reflect risks of addiction/overdose, and enhancing surveillance of opioid prescribing and patient safety.
3) Additional actions proposed are increasing clinical monitoring of patients on long-term opioid therapy, consistently offering to taper doses or discontinue opioids as an option, and ensuring treatment for addicted patients.
1. Co-prescribing opioids and benzodiazepines poses serious health risks like respiratory depression and increased risk of overdose death. Delaware has high rates of prescriptions for these drugs.
2. Delaware's PDMP collects prescription data that can help identify patients and providers with troubling patterns of co-prescribing to reduce risks. Regular screening and urine tests can also help address misuse.
3. PDMP data analysis found that in 2013 over 12% of individuals in Delaware filled prescriptions for both drug classes, putting them at risk. The PDMP is a valuable tool to improve prescribing practices and detect misuse.
The abuse of prescription painkillers and illicit opioids has become a public health concern in the United States of America. The Centers for Disease Control and Prevention (CDC) reports that more than 1,000 Americans are given treatment in emergency departments every day for misusing prescription opioids.
This document summarizes a seminar presentation on orphan drug designations and approvals. It begins with introducing rare diseases and defining orphan drugs. It then discusses the key aspects of the Orphan Drug Act of 1983 in the US that provides incentives for orphan drug development, including 7 years of market exclusivity. The document outlines the orphan drug designation process through the FDA, including the application process. It also summarizes the incentives provided through the Act, such as tax credits, grants, and fee waivers, to encourage pharmaceutical companies to develop treatments for rare diseases.
The opioid epidemic is a major problem in the United States, with approximately 128 people dying daily from opioid overdoses. The over-prescription of opioids by doctors and aggressive marketing of opioids by pharmaceutical companies has contributed significantly to increased addiction rates. While opioids are effective for managing pain in the short term, long-term usage can lead to addiction, especially as patients rely on them instead of alternative pain management methods. Public policy responses have included making the opioid overdose reversal drug naloxone more widely available, limiting initial opioid prescription amounts, and requiring electronic prescription tracking to curb misuse and falsified prescriptions.
Tackling the Opioid Problem - Analgesic Prescribing in the Emergency DepartmentSCGH ED CME
This document discusses the opioid crisis and approaches to pain management. It describes how Purdue Pharma aggressively marketed OxyContin in the 1990s, leading to widespread overprescription and misuse. This contributed significantly to the rise in opioid overdoses and deaths in the US. In response, pharmaceutical companies developed abuse-deterrent formulations of opioids like OxyContin and Targin to discourage tampering and injection. However, these formulations did not prove abuse-proof. The document advocates for careful opioid prescribing practices to limit diversion and abuse, including assessing risks, limiting durations, and involving specialist services. Non-opioid options like paracetamol, NSAIDs, and tramadol should be prioritized for mild-moderate pain
Wide variation and excessive dosage of opioid prescriptions for common genera...Paul Coelho, MD
This study examined opioid prescribing patterns for common outpatient general surgery procedures. They found wide variation in the number of opioids prescribed, from 0 to over 100 pills for the same procedures. On average, only 28% of prescribed opioids were actually taken by patients. Less than 2% of patients requested refills. The study identified an "ideal" number of pills to prescribe for each procedure that would satisfy 80% of patients' needs and significantly reduce excess prescribing - for example, prescribing 5 pills for partial mastectomies instead of the typical 20 pills. Prescribing the ideal amounts could decrease total opioids prescribed by 43%.
This report examines CMS's oversight of Medicare Part D beneficiaries who receive opioid prescriptions and providers who prescribe opioids to these beneficiaries. It finds that while CMS provides guidance to Part D plan sponsors on monitoring beneficiaries at high risk of opioid overuse, it lacks complete data on the full population of beneficiaries at risk. It also finds that CMS oversees prescribing through its contractor NBI MEDIC but does not specifically analyze opioid prescription data or require reporting on actions taken regarding inappropriate opioid prescribing. The report concludes that CMS needs more comprehensive oversight to reduce the risks of opioid misuse, overdose, and inappropriate prescribing among Medicare beneficiaries.
Third-party administrators (TPAs), employers and employees are increasingly concerned about the growing cost of specialty drugs. Relief, WellDyneRx believes, will come to those employers and TPAs that (1) encourage specific public policy changes and (2) partner with pharmacy benefit managers (PBMs) that own best-of-breed specialty pharmacies.
National Association of Attorneys Generals’ Presidential Initiative Summit Ap...CVS Health
Remarks by Thomas M. Moriarty, Executive Vice President, Chief Strategy Officer and General Counsel at the National Association of Attorneys Generals’ April 2017 Summit.
For more on the event, please visit: https://cvshealth.com/thought-leadership/making-progress-how-public-and-private-stakeholders-are-collaborating-to-improve-care
Opioid Epidemic - Causes, Impact and FutureCitiusTech
In 2017, everyday, more than 130 people died in the US after overdosing on opioids. This document talks about America's worst drug crisis ever and shares how technology can play a role to cope up with this epidemic.
The document discusses the opioid epidemic in the United States, focusing on the role of OxyContin. It describes how OxyContin became widely prescribed due to a shift in pain treatment philosophy in the 1980s, an aggressive marketing campaign by Purdue Pharma claiming the drug had a low addiction risk, and changes in physician prescribing habits. However, OxyContin proved to be highly addictive, and increased opioid prescriptions correlated with rising overdose rates. Purdue Pharma was later found to have misleadingly marketed OxyContin and paid fines, but the epidemic had already taken hold across the nation. The FDA and state governments have since implemented measures to curb inappropriate opioid prescribing and monitor distribution.
This document discusses the challenges and strategies for successful orphan drug development. It notes that despite small patient populations, orphan drug development has grown significantly due to regulatory incentives. However, orphan drug development faces challenges including difficulties designing studies due to lack of disease information, problems recruiting small patient populations, and regulatory complexities. The document recommends three strategies for overcoming these challenges: 1) partnering with experienced CROs knowledgeable in rare diseases, 2) engaging key opinion leaders to help with sites and education, and 3) allowing flexibility in protocols and budgets to address unexpected changes common in rare disease studies. Overall the document outlines the benefits and hurdles of orphan drug development and provides guidance on navigating clinical and regulatory obstacles.
The document discusses addressing the opioid epidemic through a public health lens. It provides data on the rise in opioid-related deaths in Massachusetts from 2000-2016. It also discusses prevention, intervention, treatment and recovery efforts through Governor Baker's Opioid Working Group. This includes adopting core medical competencies focused on substance use, expanding treatment beds and recovery programs, and the Chapter 55 data initiative to better understand the epidemic through linking multiple health datasets.
This document contains summaries of several research papers on topics related to chronic pain, suicide risk, and bipolar disorder:
1) One study found that tapering opioid doses for chronic pain patients was associated with increased risks of overdose and mental health crisis compared to patients who did not taper. Higher tapering speeds were linked to even greater risks.
2) Another study observed chronic pain patients undergoing opioid tapering or transition to buprenorphine treatment. Higher initial opioid doses predicted needing buprenorphine, and benzodiazepine use predicted dropout. Pain levels varied after treatment.
3) Research on combat veterans found that those exposed to combat had higher rates of PTSD, suicide attempts, strokes and chronic pain
Labeling Woefulness: The Social Construction of FibromyalgiaPaul Coelho, MD
This document discusses the social construction of fibromyalgia and how it has been established as a legitimate disease label despite a lack of clear biological or clinical evidence. It argues that fibromyalgia serves social and economic purposes for various groups, including patients, doctors, pharmaceutical companies, and the media, but poses risks by medicalizing psychosocial problems. The document proposes that widespread pain is a normal human experience for some that is best addressed by exploring psychosocial factors rather than believing the solution lies in neurobiology. Examining fibromyalgia as a social construct may be more helpful for patients than continuing to medicalize their experiences.
Outcomes in Long-term Opioid Tapering and Buprenorphine Transition: A Retrosp...Paul Coelho, MD
This study analyzed outcomes for 240 patients with chronic pain who were prescribed long-term opioid therapy above 90 mg morphine-equivalent daily doses. Patients were offered an outpatient opioid taper or transition to buprenorphine if taper was not tolerated. 44.6% successfully tapered, 18.8% transitioned to buprenorphine, and 36.6% dropped out of treatment. Higher initial opioid doses predicted needing buprenorphine, and benzodiazepine/z-drug use predicted greater dropout. Pain intensity changes after treatment were mixed, with over half of tapered patients reporting increased pain and about half of transitioned patients reporting decreased pain.
This document appears to be a questionnaire assessing symptoms of widespread pain and calculating a WPI (Widespread Pain Index) score and SS (Symptom Severity) score. It asks the respondent to indicate areas of pain on a diagram and rate the severity of symptoms like fatigue, thinking difficulties, and unrefreshed sleep. It also inquires about additional symptoms like abdominal pain, depression, and headaches. The final section rates pain-related worry and fear on a scale. Additional questions determine if the respondent has a workers compensation or disability claim related to their pain complaint.
Fibromyalgia is a condition that causes chronic aches and pains all over the body, fatigue, and often a sleep disorder. The doctor diagnosed the patient with fibromyalgia based on a score of 13 or more on the fibromyalgia questionnaire from the American College of Rheumatology, which is consistent with the syndrome. By focusing on and managing the diagnosis of fibromyalgia, the patient's other pain symptoms can decrease.
This document contains two studies related to psychological treatments for chronic conditions:
1) A study of chronic fatigue syndrome patients found that poorer outcomes were predicted by membership in a self-help group, receiving sickness benefits, and symptoms of dysphoria. Severity and duration of symptoms did not predict response.
2) A randomized controlled trial of 125 fibromyalgia patients compared operant behavioral therapy, cognitive behavioral therapy, and attention placebo. Both behavioral therapies significantly reduced pain intensity while cognitive therapy improved cognitive and affective variables and operant therapy improved physical functioning and behaviors. The attention placebo resulted in no improvement or deterioration.
This document summarizes three studies on the risks and efficacy of opioids for chronic non-cancer pain (CNP). The first study finds that while opioids were associated with small improvements in pain and physical functioning compared to placebo, they also increased the risk of vomiting. Comparisons to other medications found similar benefits to pain and functioning. The second study finds no difference in pain-related function between opioid and non-opioid groups over 12 months, and higher rates of adverse effects and pain intensity in the opioid group. The third study finds limited effectiveness of opioids for CNP, as opioid users did not report improvements in outcomes after 2 years. Regarding risks, higher opioid doses are associated with increased overdose risk across several patient groups in
1) This randomized clinical trial compared opioid vs nonopioid medication therapy over 12 months for patients with chronic back, hip, or knee pain.
2) It found no significant difference in pain-related function between the two groups, but pain intensity was significantly better in the nonopioid group. Adverse effects were significantly more common in the opioid group.
3) The study concludes that opioid therapy was not superior to nonopioid medications for improving pain-related function over 12 months, and the results do not support initiating opioids for moderate to severe chronic musculoskeletal pain.
Mortality quadrupled among opioid-driven hospitalizations notably within lowe...Paul Coelho, MD
This study analyzed national hospitalization data from 1993-2014 to examine trends in mortality and characteristics of hospitalizations related to opioids compared to other drug and non-drug hospitalizations. The key findings were:
1) Mortality among opioid-related hospitalizations quadrupled from 0.43% before 2000 to 2.02% in 2014, increasing 0.12 percentage points per year relative to other drug hospitalizations.
2) While total opioid-related hospitalizations remained stable, diagnoses shifted from opioid dependence/abuse to opioid/heroin poisoning, which have higher mortality rates. Hospitalizations for poisoning grew by 0.01 per 1,000 people annually after 2000.
3) Patients hospitalized for opioid/
Prescriptions filled following an opioid-related hospitalization.Paul Coelho, MD
This study analyzed prescription drug fills within 30 days of discharge for 36,719 patients hospitalized for opioid misuse. Only 16.7% received medications approved for opioid dependence, while 40.3% filled antidepressant prescriptions and 22.4% filled opioid pain medication prescriptions. Concurrently, 13.9% filled benzodiazepine prescriptions and 7.4% filled both benzodiazepine and opioid prescriptions, indicating a need for improved education on risks. Overall, more effort is required to ensure patients receive recommended post-hospitalization treatment and support services.
This study examined the risk of psychiatric hospitalization in the offspring (second generation) of Finns who were evacuated to Sweden without parents during World War II (first generation), compared to offspring of Finns who were not evacuated. The study found that daughters of mothers who were evacuated during childhood had an elevated risk of psychiatric hospitalization, especially for mood disorders. However, there was no increased risk found for offspring of evacuated fathers or for male offspring of evacuated mothers. This suggests that early childhood adversity experienced by the first generation, such as war-related trauma, may be associated with mental health problems that persist into the second generation.
Correlation of opioid mortality with prescriptions and social determinants -a...Paul Coelho, MD
This study analyzed Medicare Part D data from 2013-2014 to examine the relationship between opioid prescription rates, socioeconomic factors, and opioid-related mortality rates at the county level in the United States. The results showed that higher county-level opioid prescription rates, especially those from emergency medicine, family medicine, internal medicine, and physician assistants, were associated with higher opioid-related mortality rates. Higher poverty levels and proportions of white populations in counties also correlated with increased mortality. Additionally, prescribers in the highest quartile of opioid prescription rates had a disproportionate impact on mortality compared to the remaining 75% of prescribers.
This study analyzed opioid prescription trends among medical specialties in the U.S. from 2007-2012 using a national prescription database. The key findings were:
- Primary care specialties (family practice, internal medicine, general practice) accounted for nearly half of all dispensed opioid prescriptions in 2012.
- Specialties treating pain conditions like pain medicine, surgery, and physical medicine had the highest rates of opioid prescribing.
- Overall opioid prescribing rates increased from 2007-2010 but stabilized from 2010-2012 as most specialties reduced rates.
- The greatest increase in opioid prescribing was among physical medicine specialists, while the largest decreases were in emergency medicine and dentistry.
The place-of-antipsychotics-in-the-therapy-of-anxiety-disorders-and-obsessive...Paul Coelho, MD
This document summarizes a research article about the use of antipsychotic drugs in the treatment of anxiety disorders and obsessive-compulsive disorders. The review finds evidence that certain second-generation antipsychotics (SGAPs), like quetiapine, risperidone, and aripiprazole, can be effective for generalized anxiety disorder (GAD) and obsessive-compulsive disorder (OCD). Quetiapine in particular receives a recommendation as a first-line treatment for GAD. However, the review finds insufficient evidence for SGAPs in the treatment of social anxiety disorder and panic disorder. First-generation antipsychotics are not recommended for any anxiety disorders based on their side effect profiles
Structured opioid refill clinic epic smartphrases Paul Coelho, MD
#*** I explained to the patient the risks of combining opioids and benzodiazepines based on medical literature. We agreed to slowly taper the patient off benzodiazepines and trial safer alternatives for sleep and anxiety issues.
#*** I showed the patient their fibromyalgia screening questionnaire results, which were consistent with a fibromyalgia diagnosis. Fibromyalgia can amplify other painful conditions and is often the primary source of morbidity when present with other chronic pain diagnoses.
#*** We discussed the patient's high risk opioid regimen based on their dose exceeding CDC guidelines. While willing to work on a harm reduction plan, it will require a taper or switching to buprenorphine due to safety concerns.
Opioids for the Treatment of Chronic Pain: Mistakes Made, Lessons Learned, an...Paul Coelho, MD
This document summarizes the key issues regarding the use of opioids for chronic pain treatment:
1) An overreliance on opioids to treat chronic pain has contributed to the prescription opioid abuse epidemic in the US, as outpatient use allows for abuse and diversion of these addictive drugs.
2) While clinical trials show opioids effectively treat acute pain and are initially effective for chronic pain, real-world use reveals increased risks of abuse, addiction, and poor functional outcomes over the long-term.
3) The evidence supporting chronic opioid therapy was limited and observational in nature, yet convinced the medical community until larger population studies showed increased abuse rates contrary to initial assumptions.
The potential adverse influence of physicians’ words.Paul Coelho, MD
The physician's words can inadvertently amplify patients' symptoms and increase somatic distress if not carefully considered. Learning about potential side effects from medications, procedures, or test results can lead patients to experience and report those effects more frequently through psychological mechanisms like misattribution and increased attention to bodily sensations. Discussing concepts like nocebo and viscerosomatic amplification with patients can help provide reassuring explanations for symptoms and make them feel less intrusive. Physicians should thoughtfully consider their word choices and focus on benefits as well as side effects to minimize undue distress.
This document is an evidence report published by the Institute for Clinical and Economic Review (ICER) that evaluates the comparative clinical effectiveness and value of cognitive and mind-body therapies for chronic low back and neck pain. It was authored by Jeffrey Tice and others from ICER. The report assesses the clinical evidence on therapies such as cognitive behavioral therapy and mindfulness-based stress reduction and presents economic analyses of the long-term cost-effectiveness and potential budget impact of these therapies. It also incorporates input from clinical experts and stakeholders.
The conundrum of opioid tapering in long term opioid therapy for chronic pain...Paul Coelho, MD
The document discusses the challenges clinicians face when tapering patients off long-term opioid therapy for chronic pain. It explains that opioid dependence can cause worsening pain, psychiatric symptoms, and functioning during tapering due to neuroplastic changes. While tapering seems logical to address risks of high-dose opioids, it may paradoxically make a patient's issues worse due to protracted abstinence syndrome. The document provides guidance for managing these complex patients focused on both pain and opioid dependence.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
1. 1
HHS OIG Data Brief • OEI-02-17-00250
Opioids in Medicare Part D: Concerns about Extreme Use
and Questionable Prescribing
Opioid abuse and overdose deaths are at epidemic
levels in the United States. In 2015, the number of
opioid-related deaths exceeded 33,000 for the first
time.1
Nearly half of these deaths involved
prescription opioids.
Opioids include narcotics intended to manage pain
from surgery, injury, or illness. They can create a
euphoric effect, which makes them vulnerable to
abuse and misuse (i.e., taking opioids in a way
other than prescribed). Although opioids can be
appropriate under certain circumstances, the Office
of Inspector General (OIG) and others are
concerned about fraud, abuse, and misuse of
opioids, including those obtained under Medicare
Part D. Part D is the optional prescription drug
benefit for Medicare beneficiaries. In 2016, it
covered 43.6 million beneficiaries.
This data brief is part of a larger strategy by OIG to
fight the opioid crisis and address one of its top
priority outcomes—to protect Medicare
beneficiaries—and the community as a whole—from prescription drug abuse. Previous OIG
work called attention to increased spending for commonly abused opioids.2
OIG has also
highlighted the problem of drug diversion—the redirection of prescription drugs for an illegal
purpose, such as recreational use or resale.3
In addition to the risk of abuse, misuse, and diversion, opioids carry a number of health risks.
Side effects from using opioids may include respiratory depression, confusion, tolerance, and
physical dependence.4
For seniors, long-term use of prescription opioids also increases the
likelihood of falls and fractures.5
For these reasons, it is essential that Medicare Part D
beneficiaries only receive medically necessary opioids in the appropriate amounts.
Prescribers play a crucial role in ensuring that beneficiaries receive appropriate amounts of
opioids. To help inform prescribers, the Centers for Disease Control and Prevention (CDC)
Key Takeaways:
One in three Medicare Part D
beneficiaries received a
prescription opioid in 2016
About 500,000 beneficiaries
received high amounts of
opioids
Almost 90,000 beneficiaries are
at serious risk; some received
extreme amounts of opioids,
while others appeared to be
doctor shopping
About 400 prescribers had
questionable opioid prescribing
patterns for beneficiaries at
serious risk
2. 2
recently published guidelines on prescribing opioids to patients with chronic pain.6
The
guidelines recommend that prescribers use caution when ordering opioids at any dosage and
avoid dosages that are equivalent to 90 mg or more of morphine a day.7
In addition, the Centers
for Medicare & Medicaid Services (CMS) has initiated a number of projects to address opioid
misuse and inappropriate prescribing. For instance, CMS identifies Part D beneficiaries who are
potentially overutilizing opioids and who may be in need of case management.8
Despite these
efforts, concerns remain about beneficiaries receiving high amounts of opioids through Part D.
This data brief builds on OIG’s previous work and includes in-depth analysis of opioid
utilization among Medicare Part D beneficiaries.9
It provides baseline data on the extent to
which beneficiaries receive extreme amounts of opioids and appear to be “doctor shopping.”
The analysis looks at the morphine equivalent dose (MED) received by each beneficiary, which
equates all of the various opioids and strengths into one standard value. This data brief also
identifies prescribers who have questionable opioid prescribing patterns.
RESULTS
One in three Medicare Part D beneficiaries received opioids
in 2016
In 2016, one out of every three beneficiaries received at
least one prescription opioid through Medicare Part D. In
total, 14.4 million of the 43.6 million beneficiaries enrolled
in Medicare Part D received opioids. Medicare Part D paid
almost $4.1 billion for 79.4 million opioid prescriptions for
these beneficiaries. The vast majority of these opioids
(80 percent) were Schedule II or III controlled substances,
meaning they have the highest potential for abuse among
legally available drugs.10
The most commonly prescribed opioids were tramadol,
hydrocodone-acetaminophen (including the brand-name
version, Vicodin), and oxycodone-acetaminophen
(including the brand-name version, Percocet). Part D
beneficiaries received about 15 million prescriptions for
tramadol 50 mg, which is a Schedule IV drug.11
Beneficiaries also received several million prescriptions
for various strengths of hydrocodone-acetaminophen, a
Schedule II drug, and for oxycodone-acetaminophen 5 mg,
another Schedule II drug. See Exhibit 2.
Several States had higher proportions of beneficiaries receiving opioids than the Nation overall,
which was 33 percent. Alabama and Mississippi had the highest proportions, with almost half of
the State’s Part D beneficiaries receiving at least one opioid—46 percent and 45 percent,
3. 3
respectively. Arkansas had 44 percent of beneficiaries
receiving opioids, while Oklahoma, Tennessee, and
Louisiana each had 42 percent. The lowest proportions
were in Hawaii (21 percent) and New York (22 percent).
In addition, 1 in 10 Medicare Part D beneficiaries
nationwide received opioids on a regular basis.
Specifically, 5 million beneficiaries received opioids for 3
months or more in 2016. Research shows that the risk of
opioid dependence increases substantially for patients
receiving opioids continuously for 3 months.12
Of these 5
million beneficiaries, 3.6 million received opioids for
6 or more months and nearly 610,000 received opioids for
the entire year.
Half a million Part D beneficiaries received high
amounts of opioids in 2016
A total of 501,008 beneficiaries received high amounts of
opioids through Medicare Part D in 2016. This does not
include beneficiaries who had cancer or were in hospice
care. Each of the 501,008 beneficiaries received an
average morphine equivalent dose (MED) of greater than
120 mg a day for at least 3 months. MED is a measure that
equates all the various opioids and strengths into one
standard value. A daily MED of 120 mg is equivalent to
taking 12 tablets a day of Vicodin 10 mg or 16 tablets a
day of Percocet 5 mg. These dosages far exceed the amounts that the manufacturers recommend
for both of these drugs.13
They also exceed the 90 mg MED level that CDC recommends
avoiding for patients with chronic pain.14
The most commonly prescribed opioid for beneficiaries with high amounts was oxycodone
30 mg. One in five beneficiaries who received a high amount of opioids had at least one
prescription for oxycodone 30 mg. Oxycodone is one of the prescription opioids most
commonly involved in law enforcement cases.15
Although beneficiaries may receive opioids for legitimate purposes, these high amounts raise
concern. Many experts have noted that opioid dosages should not be increased over a MED of
90 mg a day without careful justification.16
Moreover, opioids carry other health risks including
respiratory depression, constipation, drowsiness, and confusion. Older adults may also be at an
increased risk of injury, as research has shown that the risk of fracture may increase as drug
dosage increases.17
4. 4
Almost 90,000 beneficiaries are at serious risk of opioid
misuse or overdose
Two groups of beneficiaries are at serious risk of
opioid misuse or overdose: (1) beneficiaries who
received extreme amounts of opioids and (2)
beneficiaries who appeared to be doctor shopping.
A total of 89,843 beneficiaries were in these two
groups in 2016. Specifically, 69,563 beneficiaries
received extreme amounts of opioids, and
22,308 beneficiaries appeared to be doctor
shopping (i.e., received high amounts of opioids
and had multiple prescribers and pharmacies). A
total of 2,028 beneficiaries were in both groups.
Other beneficiaries may also be at serious risk of
opioid misuse or overdose, but they are not the
focus of this data brief.
About 70,000 beneficiaries received extreme amounts of opioids
A total of 69,563 beneficiaries received extreme amounts
of opioids for the entire year, putting them at serious risk
of opioid misuse or overdose.18
Each of these
beneficiaries had an average daily MED that exceeded 240
mg for the entire year. This extreme amount is more than
two and a half times the dose CDC recommends avoiding
for chronic pain patients. (See Exhibit 3.) Research has
shown that patients who receive an MED at such a level
are at increased risk of overdose death.19
Of note, 678 beneficiaries received even more extreme
amounts of opioids. These beneficiaries each received an
average daily MED greater than 1,000 mg for the entire
year. In one case, a beneficiary from New Hampshire
received 134 prescriptions for opioids from one prescriber
in 2016, including 13 months of OxyContin 80 mg,
13 months of OxyContin 60 mg, 13 months of OxyContin
40 mg, 14 months of oxycodone 30 mg, and 13 months of
fentanyl patches.
Receiving extreme amounts of opioids raises concerns. It
may indicate that the beneficiary is receiving medically
unnecessary drugs, which could be diverted for resale. It
Two Groups of Beneficiaries at
Serious Risk of Opioid Misuse or
Overdose:
1. Beneficiaries who received
extreme amounts of opioids—i.e.,
an average daily MED greater than
240 mg for 12 months.
2. Beneficiaries who appeared to be
doctor shopping—i.e., received a
high amount of opioids (an average
daily MED greater than 120 mg for
3 months) and had four or more
prescribers and four or more
pharmacies.
5. 5
may also indicate that the beneficiary is addicted to opioids and at risk of overdose.
Alternatively, it may indicate that a beneficiary’s identification number has been stolen or sold.
Example of Beneficiary Receiving Extreme Amounts of Opioids
One beneficiary in New York received 62 opioid prescriptions during the year, which is
more than one prescription per week. All of the prescriptions were for fentanyl or
oxycodone. The beneficiary had an average daily MED of over 3,130 mg for the entire
year, which is almost 35 times the level that CDC recommends avoiding. All but one of
these opioids were prescribed by one family medicine physician.
About 22,000 beneficiaries appear to be doctor shopping
A second group of beneficiaries—those who appear to be doctor shopping (i.e., received high
amounts of opioids and had multiple prescribers and pharmacies)—are also at serious risk of
opioid misuse or overdose. Doctor shoppers are beneficiaries who seek medically unnecessary
prescriptions from multiple prescribers and multiple pharmacies. A total of 22,308 beneficiaries
appear to be doctor shopping. Each of these beneficiaries received a high amount of opioids—an
average daily MED that exceeded 120 mg for at least 3 months—and have four or more
prescribers and four or more pharmacies in 2016.20
Typically, beneficiaries who receive opioids
have just one prescriber and one pharmacy. 21
Although beneficiaries may receive opioids from
multiple prescribers or pharmacies for legitimate reasons, these patterns raise concern.
Notably, 162 beneficiaries each
received opioids from more than
10 prescribers and more than
10 pharmacies in 2016. One
beneficiary received opioids from
46 different prescribers and 20
different pharmacies. In August
alone, this beneficiary received 11
different opioid prescriptions from
8 prescribers in 5 different States;
this beneficiary filled these
prescriptions at 6 different
pharmacies.
Receiving high amounts of
opioids and having multiple
prescribers and pharmacies may
indicate that a beneficiary is
seeking medically unnecessary
6. 6
drugs, perhaps to use them recreationally or to divert them. It could mean that the beneficiary’s
identification number was stolen or sold. It may also signal that the beneficiary’s care is not
being monitored or coordinated properly. Furthermore, it may indicate that prescribers are not
checking the beneficiary’s opioid history before prescribing. All but one State maintain
databases, called prescription drug monitoring programs, that track prescriptions for controlled
substances. Prescribers can check these databases before ordering opioids to determine if the
beneficiary is already receiving opioids ordered by other prescribers.22
Examples of Beneficiaries Who Appear to be Doctor Shopping
A beneficiary in Washington, D.C. received prescriptions for opioids from
42 different prescribers and filled them at 37 different pharmacies in a year. In a
single month, this beneficiary received 2,330 pills from prescriptions written by just
one prescriber. These drugs included oxycodone, hydromorphone, and morphine.
A second beneficiary in Illinois received 73 prescriptions for opioids from
11 different prescribers and filled them at 20 different pharmacies in a year. On
multiple occasions, this beneficiary filled opioid prescriptions at multiple
pharmacies on the same day. For example, one day he filled two 30-day
prescriptions for fentanyl patches at two nearby pharmacies and another 30-day
prescription for morphine at a third pharmacy more than 40 miles away.
About 400 prescribers had questionable opioid prescribing
patterns for beneficiaries at serious risk
In total, 115,851 prescribers ordered opioids for at least one beneficiary at serious risk of opioid
misuse or overdose (i.e., a beneficiary who has received extreme amounts or appeared to be
doctor shopping). The vast majority of these prescribers each ordered opioids for only one or
two of these beneficiaries. Some prescribers ordered for many more. A total of 401 prescribers
stand out as having questionable prescribing patterns; these prescribers ordered opioids for the
highest numbers of beneficiaries at serious risk. The patterns of these 401 prescribers are far
outside the norm and warrant further scrutiny.
Specifically, 198 prescribers ordered opioids for a high number of beneficiaries who received
extreme amounts, while 264 prescribers ordered opioids for a high number of beneficiaries who
appeared to be doctor shopping. Sixty-one prescribers ordered opioids for high numbers from
both groups of beneficiaries at serious risk. In total, prescribers with questionable patterns wrote
256,260 opioid prescriptions for beneficiaries at serious risk, costing Part D a total of
$66.5 million.
7. 7
Nearly 200 prescribers each ordered opioids for dozens of beneficiaries who
received extreme amounts of opioids
There were 198 prescribers with questionable prescribing patterns for beneficiaries who received
extreme amounts of opioids. Each of these prescribers ordered opioids for at least
44 beneficiaries who received extreme amounts. As noted earlier, beneficiaries who receive
extreme amounts of opioids are at serious risk. They each had an average daily MED of more
than 240 mg for the entire year and did not have cancer or hospice care. CDC recommends
avoiding a daily MED of more than 90 mg, but beneficiaries with extreme amounts are receiving
more than two and a half times that amount.
Although high amounts of opioids may be necessary for some patients, questionable prescribing
patterns may indicate that the prescriber is ordering medically unnecessary drugs. These drugs
may be diverted for resale or recreational use. Furthermore, beneficiaries who receive extreme
amounts of opioids are at serious risk of misuse or overdose; therefore, it is important for
prescribers to pay close attention to the amount of these drugs that they order and the frequency
in which they order them.
Fifteen prescribers stand out. Each ordered opioids for more than 98 beneficiaries who received
extreme amounts during the year. In one case, a prescriber in Missouri wrote an average of
31 opioid prescriptions each for 112 beneficiaries. Half of these beneficiaries had an average
daily MED that exceeded 375 mg for the entire year. Another prescriber in Indiana wrote an
average of 24 opioid prescriptions each for 108 beneficiaries who received extreme amounts;
these drugs cost Part D $1.1 million.
Examples of Prescribers with Questionable Prescribing Patterns for Beneficiaries
Who Received Extreme Amounts of Opioids
One Florida physician repeatedly ordered extreme amounts of opioids for multiple
beneficiaries. For one beneficiary in a single day, this physician ordered three
opioids—oxycodone and two different forms of fentanyl—that had a daily MED of
1,239 mg. In total, this physician prescribed opioids to 125 beneficiaries who
received extreme amounts. Part D paid $1.6 million for these drugs.
A family medicine physician in Texas wrote 1,199 opioid prescriptions for
103 beneficiaries. For one beneficiary, this physician wrote 27 opioid prescriptions—
9 months each of oxycodone, methadone, and hydrocodone-acetaminophen. For
another beneficiary, this physician wrote 24 opioid prescriptions—8 months each of
oxycodone, morphine, and hydrocodone-acetaminophen. In total, Part D paid
$192,000 for opioids prescribed by this physician for beneficiaries who received
extreme amounts.
8. 8
Over 260 prescribers each ordered opioids for numerous beneficiaries who
appeared to be doctor shopping
There were 264 prescribers with questionable prescribing patterns for beneficiaries who
appeared to be doctor shopping. These beneficiaries received high amounts of opioids and had
four or more prescribers and four or more pharmacies. Each of the 264 prescribers ordered
opioids for at least 21 of these beneficiaries. Like beneficiaries who receive extreme amounts,
beneficiaries who appear to be doctor shopping are at serious risk of opioid misuse or overdose.
Questionable prescribing may indicate that beneficiaries are receiving poorly coordinated care
and could be in danger of overdose or dependence. It may also mean that prescribers are not
checking the State prescription drug monitoring databases, or that these databases do not have
current data. Another possibility is that the prescriber’s identification was sold or stolen and is
being used for illegal purposes. Questionable patterns also raise significant concern that
prescribers may be operating “pill mills.” A pill mill is a doctor’s office, clinic, or health care
facility that routinely prescribes controlled substances—such as oxycodone—outside the scope
of professional practice and without a legitimate medical purpose.
Eighteen prescribers stand out in that each ordered opioids for more than 45 beneficiaries who
appeared to be doctor shopping. Of note, four physicians in the same practice in Texas each
ordered opioids for more than 56 beneficiaries who appeared to be doctor shopping.
Example of Prescribers with Questionable Prescribing Patterns for Beneficiaries
Who Appear to be Doctor Shopping
Four practitioners from the same practice in Wisconsin—1 physician and 3 nurse
practitioners—each prescribed opioids to more than 136 beneficiaries who appeared
to be doctor shopping. Together, these practitioners wrote 2,823 opioid prescriptions
during the year for beneficiaries who appeared to be doctor shopping, costing Part D
$336,000. Two-thirds of these prescriptions—1,885—were for oxycodone, a
commonly diverted drug.
Nurse practitioners and physician assistants make up one-third of the prescribers
with questionable prescribing patterns for beneficiaries at serious risk
One-third (133 of 401) of the prescribers who had questionable prescribing patterns for
beneficiaries at serious risk were nurse practitioners or physician assistants. In total, 81 of these
prescribers were nurse practitioners and 52 were physician assistants. Most of the nurse
practitioners specialized in family or adult health and just two specialized in acute care.
9. 9
CONCLUSION
In 2016, one out of every three beneficiaries received a prescription opioid through Medicare
Part D. Half a million of them received high amounts of opioids—an average daily MED of
120 mg for at least 3 months of the year. Even more concerning, almost 90,000 beneficiaries are
at serious risk of misuse or overdose. These include beneficiaries who received extreme
amounts of opioids—more than two and a half times the level that CDC recommends avoiding—
for the entire year. They also include beneficiaries who appeared to be doctor shopping (i.e.,
received high amounts of opioids and had multiple prescribers and pharmacies). Moreover, 401
prescribers had questionable prescribing patterns for beneficiaries who are at serious risk. These
patterns are far outside the norm and warrant further scrutiny.
Ensuring the appropriate use and prescribing of opioids is essential to protecting the health and
safety of beneficiaries and the integrity of Part D. The extreme use of opioids and apparent
doctor shopping described in this study put beneficiaries at risk and may indicate that opioids are
being prescribed for medically unnecessary purposes and then diverted for resale or recreational
use. It may also indicate that beneficiaries are receiving poorly coordinated care.
Prescribers play a key role in combatting opioid misuse. They must be given the information
and tools needed to appropriately prescribe opioids when medically necessary. States’
prescription drug monitoring programs can provide invaluable information to prescribers about a
patient’s opioid prescription history. Prescribers must be vigilant about checking the State
monitoring databases to ensure that their patients are receiving appropriate doses of opioids and
to better coordinate patient care. At the same time, we must address prescribers with
questionable prescribing patterns for opioids to ensure that Medicare Part D is not paying for
unnecessary drugs that are being diverted for resale or recreational use.
But focusing on prescribers alone is not enough. A multifaceted approach is necessary. As the
Department has highlighted—strengthening public health surveillance, advancing the practice of
pain management, improving access to treatment and recovery services, targeting availability
and distribution of overdose-reversing drugs, and supporting cutting-edge research—all need to
be part of the strategy to fight the opioid crisis.23
OIG is committed to fighting the opioid crisis and protecting beneficiaries from prescription drug
abuse and misuse. It has formed a multidisciplinary team dedicated to addressing this issue. As
a part of that effort, we will work with our law enforcement partners and CMS to follow up on
the specific prescribers who we identified in this review. We will also continue to conduct
investigations and reviews that address the ongoing problems created by opioid misuse. In
addition to enforcement, we will identify other approaches to support prevention and treatment
efforts. We are also committed to conducting reviews to improve the efficiency and
effectiveness of the broader Department efforts.
In addition, we are committed to forging expanded partnerships among Federal agencies, States,
and private sector partners. We specifically call on Part D sponsors to work with OIG and CMS
to further improve efforts to combat opioid misuse in Medicare. These efforts include Part D
sponsors’ program integrity activities to address prescription drug and pharmacy fraud. We also
10. 10
specifically encourage Part D sponsors to effectively use CMS’s Overutilization Monitoring
System, which identifies beneficiaries who are potentially overutilizing opioids. We further
encourage sponsors to implement drug management programs for at-risk beneficiaries, following
additional guidance from CMS.24
In addition, we continue to support our private and public
sector partners as part of the Healthcare Fraud Prevention Partnership and our shared
commitment to reducing the harms of opioids.25
By working together and expanding our efforts
in Part D, we can help curb the opioid crisis in our Nation.
11. 11
METHODOLOGY
We based this data brief on an analysis of prescription drug event (PDE) records for Part D
drugs. This data brief includes prescriptions that beneficiaries received through Part D. It does
not include prescriptions received through other programs or through only paying cash. Part D
sponsors submit a PDE record to CMS each time a drug is dispensed to a beneficiary enrolled in
their plans. Each record contains information about the drug and beneficiary, as well as the
identification numbers for the pharmacy and the prescriber.
We matched PDE records to data from the First Databank, National Plan and Provider
Enumeration System (NPPES), National Claims History File, and Part C Encounter Data file to
obtain descriptive information about the drugs, prescribers, and beneficiaries. First Databank
contains information about each drug, such as the drug name, strength of the drug, therapeutic
class (e.g., an opioid), and controlled substance schedule (e.g., Schedule II or III). NPPES
contains information about prescribers, such as their name, address, and taxonomy (i.e.,
specialty). The National Claims History File contains claims data from Medicare Parts A and B,
including diagnoses codes. Part C Encounter Data contains medical claims data for beneficiaries
enrolled in Medicare Advantage plans. For the purposes of this study, we use the term
“prescription” to mean one PDE record.
Analysis of Opioid Utilization
We identified PDE records for opioids that beneficiaries received in 2016.26
We calculated total
Part D spending, the total number of beneficiaries, and the total number of prescriptions for all
opioids and all Schedule II and III opioids. To determine total spending, we summed four fields
on the PDE records that represent the total gross drug costs: ingredient cost, dispensing fee,
vaccine administration fee, and sales tax. Next, using PDE data and Medicare enrollment data,
we determined the proportion of Part D beneficiaries who received opioids in the Nation and in
each State. We then identified the most commonly prescribed opioids by calculating the total
number of prescriptions for each generic drug name (delineated by strength and form). Lastly,
we counted the total number of days during the year that each beneficiary received opioids.
Beneficiary Analysis
Next, we determined the amount of opioids that each beneficiary received. To do this, we
calculated each beneficiary’s average daily morphine equivalent dose (MED).27
The MED
converts opioids of different ingredients, strengths, and forms into equivalent milligrams of
morphine. It allows us to sum dosages of different opioids to determine a beneficiary’s daily
opioid level.
To calculate each beneficiary’s average daily MED, we first calculated the MED for each
prescription (i.e., PDE record).28
To do this, we used the following equation:
𝑀𝐸𝐷 =
(𝑠𝑡𝑟𝑒𝑛𝑔𝑡ℎ 𝑝𝑒𝑟 𝑢𝑛𝑖𝑡) × (𝑞𝑢𝑎𝑛𝑡𝑖𝑡𝑦 𝑑𝑖𝑠𝑝𝑒𝑛𝑠𝑒𝑑) × (𝑀𝐸𝐷 𝑐𝑜𝑛𝑣𝑒𝑟𝑠𝑖𝑜𝑛 𝑓𝑎𝑐𝑡𝑜𝑟)
(𝐷𝑎𝑦𝑠 𝑠𝑢𝑝𝑝𝑙𝑦)
12. 12
We then summed each beneficiary’s MED for each day of the year based on the dates of
service and days supply on each PDE record. We refer to this as the daily MED. We
excluded from this analysis beneficiaries with a diagnosis of cancer or a hospice stay in
2016.29
Next, we determined the extent to which beneficiaries received high amounts of opioids.
We calculated each beneficiary’s average daily MED over each 90-day period in 2016.
We determined that a beneficiary received high amounts of opioids if he or she exceeded
an average daily MED of 120 mg for any 90-day period and had received opioids for 90
or more days in the year. We used these criteria because they closely align with the
current criteria used by CMS for its Overutilization Monitoring System.30
The MED of
120 mg also exceeds the level CDC recommends avoiding for patients with chronic
pain—an MED of 90 mg.
We then determined the extent to which beneficiaries received extreme amounts of opioids. We
calculated each beneficiary’s average daily MED over the entire year. We considered a
beneficiary who exceeded an average daily MED of 240 mg for the entire year and had received
opioids for 360 days or more to have received an extreme amount of opioids.
Lastly, we determined the extent to which beneficiaries appeared to be doctor shopping. To do
this, we calculated the total number of prescribers and pharmacies from which each beneficiary
received opioids in 2016. We considered beneficiaries to have appeared to be doctor shopping if
they exceeded an average daily MED of 120 mg for any 90-day period, received opioids for 90
or more days in the year, and received opioids from four or more prescribers and four or more
pharmacies.
Prescriber Analysis
For this analysis, we identified prescribers who ordered opioids for a high number of
beneficiaries at serious risk: beneficiaries who received extreme amounts of opioids and
beneficiaries who appeared to be doctor shopping. We considered these prescribers to have
questionable prescribing patterns that warrant further scrutiny.
In total, 60,742 prescribers ordered opioids for beneficiaries who received extreme amounts and
79,175 prescribers ordered opioids for beneficiaries who appeared to be doctor shopping. For
each of these prescribers, we calculated the number of beneficiaries in each group for whom the
prescriber ordered opioids. We then identified the prescribers who ordered opioids for the
highest number of beneficiaries in each group.31
Lastly, we calculated the average number of prescriptions that each prescriber ordered for
beneficiaries in each group. We also calculated the average daily MED for beneficiaries for each
prescriber for each group.
13. 13
ACKNOWLEDGMENTS
This report was prepared under the direction of Jodi Nudelman, Regional Inspector General for
Evaluation and Inspections in the New York regional office, and Nancy Harrison and
Meridith Seife, Deputy Regional Inspectors General.
Miriam Anderson served as the team leader for this study. Other Office of Evaluation and
Inspections staff from the New York regional office who conducted the study include
Margaret Himmelright and Jason Kwong. Office of Evaluation and Inspections staff who
provided support include Nadia Chait and Meghan Kearns. We would also like to acknowledge
the contributions of other Office of Inspector General staff, including Robert Gibbons,
Lauren McNulty, and Jessica Swanstrom.
14. 14
ENDNOTES
1
CDC, “Increases in Drug and Opioid-Involved Overdose Deaths: United States, 2010–2015.” MMWR Morb
Mortal Wkly Rep, December 30, 2016, pp. 1445–52. Accessed at
https://www.cdc.gov/mmwr/volumes/65/wr/mm655051e1.htm on May 4, 2017.
2
OIG, High Part D Spending on Opioids and Substantial Growth in Compounded Drugs Raise Concerns, OEI-02-
16-00290, June 2016. Also see OIG, Questionable Billing and Geographic Hotspots Point to Potential Fraud and
Abuse in Medicare Part D, OEI-02-15-00190, June 2015.
3
Maxwell, Ann, Assistant Inspector General for Evaluations and Inspections, Office of Inspector General, U.S.
Department of Health and Human Services, “Opioid Use Among Seniors: Issues and Emerging Trends”
(Congressional testimony), February 24, 2016. Also see Cantrell, Gary, Deputy Inspector General for
Investigations, Office of Inspector General, U.S. Department of Health and Human Services, “Fraud in Medicare”
(Congressional testimony), March 24, 2015.
4
Chau, Diane L. et al. “Opiates and Elderly: Use and Side Effects.” Clinical Interventions in Aging, 2008, p. 276.
Accessed at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2546472/ on April 17, 2017. Also see CDC, “CDC
Guideline for Prescribing Opioids for Chronic Pain: United States, 2016.” MMWR Recomm Rep, March 18, 2016.
5
Saunders, Kathleen W. et al. “Relationship of Opioid Use and Dosage Levels to Fractures in Older Chronic Pain
Patients.” Journal of General Internal Medicine, 2010, pp. 310–15. Accessed at
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2842546/ on April 17, 2017.
6
CDC, “CDC Guideline for Prescribing Opioids for Chronic Pain: United States, 2016.” MMWR Recomm Rep,
March 18, 2016, pp. 1–49. Accessed at https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm on May 4, 2017.
7
Ibid, p. 16. The CDC guidelines recommend that prescribers avoid increasing opioids to morphine equivalent
dosages of 90 mg a day or more or carefully justify the decision to increase to this level.
8
CMS identifies beneficiaries who are at high risk for opioid overutilization. On a quarterly basis, CMS provides
each Part D sponsor with a list of these beneficiaries through its Overutilization Monitoring System. For more
information about CMS’s complete efforts to address opioids misuse, see CMS, CMS Opioid Misuse Strategy 2016.
Accessed at https://www.cms.gov/Outreach-and-Education/Outreach/Partnerships/Downloads/CMS-Opioid-Misuse-
Strategy-2016.pdf on April 20, 2017.
9
OIG, Ensuring the Integrity of Medicare Part D, OEI-03-15-00180, June 2015. Also see OIG, High Part D
Spending on Opioids and Substantial Growth in Compounded Drugs Raise Concerns, OEI-02-16-00290, June 2016.
10
Controlled substances are drugs regulated by the Controlled Substances Act, which established five schedules
based on the medical use and the potential for abuse. Schedule I drugs, such as heroin, have no currently accepted
medical use. Schedule II drugs, such as oxycodone, hydrocodone, and fentanyl, have a high potential for abuse and
may lead to severe psychological or physical dependence. Schedule V have the lowest potential for abuse among
controlled substances. See 21 U.S.C. § 812. In total, Part D paid $3.9 billion for Schedule II and III opioids in 2016.
11
Although tramadol is a Schedule IV drug, which means it has low potential for abuse and low risk of dependence,
recent research raised concern about a link between tramadol and long-term use of opioids. The research found that
initial treatment with tramadol increases the probability of long-term use. In addition, the Substance Abuse and
Mental Health Services Administration reports that emergency department visits associated with tramadol increased
145 percent from 2005 to 2011. See CDC, “Characteristics of Initial Prescription Episodes and Likelihood of Long-
Term Opioid Use: United States, 2006–2015.” MMWR Morb Mortal Wkly Rep, March 17, 2017, pp. 265-69.
Accessed at https://www.cdc.gov/mmwr/volumes/66/wr/mm6610a1.htm on May 4, 2017.
12
CDC, “CDC Guideline for Prescribing Opioids for Chronic Pain: United States, 2016.” MMWR Recomm Rep,
March 18, 2016, p. 25.
13
According to the manufacturer labels, the maximal daily dose for Percocet 5 mg is 12 tablets and the daily dosage
for Vicodin 10 mg should not exceed 6 tablets. For more information about Percocet, see page 2 at
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/040330s015,040341s013,040434s003lbl.pdf and for
Vicodin see page 20 at http://www.rxabbvie.com/pdf/vicodin_apap_300mg_hydrocodone_5mg-7_5mg-
10mg_PI.pdf.
14
In addition, CMS uses a daily MED of 120 mg for 90 days—as well as beneficiaries having four or more
prescribers and four or more pharmacies—to identify beneficiaries who are potentially overutilizing opioids for its
15. 15
Overutilization Monitoring System. Beginning in 2018, CMS is changing its criteria to an average daily MED of 90
mg plus four or more prescribers and four or more pharmacies or six or more prescribers, regardless of the number
of pharmacies. See CMS, Announcement of Calendar Year (CY) 2018 Medicare Advantage Capitation Rates and
Medicare Advantage and Part D Payment Policies and Final Call Letter and Request for Information. Accessed at
https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Announcement2018.pdf on
April 25, 2017. Note that the guidance uses the term “more than 3 prescribers and more than 3 pharmacies,” which
is which equivalent to “4 or more prescribers and 4 or more pharmacies.”
15
U.S. Drug Enforcement Administration, Diversion Control Division, National Forensic Laboratory Information
System: Year 2015 Annual Report, 2016. Accessed at
https://www.deadiversion.usdoj.gov/nflis/2015_annual_rpt.pdf on April 24, 2017.
16
CDC, “CDC Guideline for Prescribing Opioids for Chronic Pain: United States, 2016.” MMWR Recomm Rep,
March 18, 2016, p. 23. Accessed at https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm on May 4, 2017.
17
Ibid, p. 13, 44.
18
This does not include beneficiaries who had cancer or were in hospice care.
19
Ibid, p. 10.
20
As mentioned above, CMS uses a daily MED of 120 mg for 90 days—in addition to beneficiaries having four or
more prescribers and four or more pharmacies—to identify beneficiaries who are potentially overutilizing opioids
for its Overutilization Monitoring System.
21
Specifically, 58 percent of beneficiaries who received opioids have one prescriber and 78 percent have one
pharmacy. This does not include beneficiaries who had cancer or hospice care.
22
State requirements for checking this information vary. For more information about these programs, see
Prescription Drug Monitoring Program Training and Technical Assistance Center, Tracking PDMP Enhancement:
The Best Practice Checklist, 2017. Accessed at
http://www.pdmpassist.org/pdf/2016_Best_Practice_Checklist_Report_20170228.pdf on April 26, 2017. Also see
PEW, Prescription Drug Monitoring Programs: Evidence-based practices to optimize prescriber use, 2016.
Accessed at http://www.pewtrusts.org/~/media/assets/2016/12/prescription_drug_monitoring_programs.pdf on April
21, 2017.
23
Price, Tom, Secretary, U.S. Department of Health and Human Services, “Secretary Price Announces HHS
Strategy for Fighting Opioid Crisis.” Speech to the National Rx Drug Abuse and Heroin Summit, April 19, 2017.
Accessed at https://www.hhs.gov/about/leadership/secretary/speeches/2017-speeches/secretary-price-announces-
hhs-strategy-for-fighting-opioid-crisis/index.html on May 3, 2017.
24
The Comprehensive Addiction Recovery Act of 2016 allows Part D sponsors to establish drug management
programs for beneficiaries who are at risk for prescription drug abuse. Under these programs, sponsors may limit at-
risk beneficiaries’ coverage of frequently abused drugs to one or more selected prescribers and one or more selected
pharmacies. Comprehensive Addiction and Recovery Act of 2016, Pub. L. No. 114-198, § 704 (July 22, 2016).
25
Healthcare Fraud Prevention Partnership, Health Payer Strategies to Reduce the Harms of Opioids, January 2017.
Accessed at https://downloads.cms.gov/files/hfpp/hfpp-opioid-white-paper.pdf on March 7, 2017.
26
Using CMS’s Integrated Data Repository, we identified a total of 79,425,530 PDE records for opioids with dates
of service in 2016.
27
To calculate MED, we used CDC’s Morphine Milligram Equivalent (MME) file, which is available at
https://www.cdc.gov/drugoverdose/media/index.html. It contains MED conversion factors for each National Drug
Code. MED and MME are interchangeable terms. For more information on calculating opioid dosage, see CDC,
Calculating Total Daily Dose of Opioids for Safer Dosage. Accessed at
https://www.cdc.gov/drugoverdose/pdf/calculating_total_daily_dose-a.pdf on June 26, 2017.
28
We included PDE records dispensed in 2015 with days of use in 2016. We excluded PDE records for injection,
intravenous, and intrathecal opioids from this analysis.
29
We identified beneficiaries with a cancer diagnosis or hospice stay using CMS’s National Claims History File and
Part C Encounter data. In total, we identified 2,658,350 beneficiaries with cancer or hospice who received at least
one opioid.
30
As stated above, CMS currently uses a daily MED of 120 mg for 90 days—in addition to beneficiaries having four
or more prescribers and four or more pharmacies—to identify beneficiaries who are potentially overutilizing opioids
for its Overutilization Monitoring System.
16. 16
31
Each of these prescribers is an extreme outlier in terms of the number of beneficiaries to whom they prescribed
opioids in one of the groups at serious risk. These prescribers were more than 3 standard deviations above the mean
and in the top 0.3 percent.