Linda I. Marks, Senior Litigation Counsel, Consumer Protection Branch, U.S. Department of Justice speaks around criminal prosecutions of drug counterfeiters and diverters in the US.
Scott A. LaGanga, Executive Director Partnership for Safe Medicines (PSM) and Senior Vice President, Public Affairs -Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA), opens PSM's Interchange 2014.
This document discusses Maine's experience with LD 171, a law passed in 2013 to legalize the importation of prescription drugs from licensed pharmacies in Canada, UK, Australia and New Zealand. It describes how the Maine Pharmacy Association President ordered drugs from an online Canadian pharmacy called Canada Drug Center and found the drugs to be substandard and contaminated. The law was struck down in 2015 because it compromised federal drug regulation. Attempts by other states to import drugs from foreign pharmacies similarly found poor oversight, unsafe drugs, and an inability to regulate foreign entities.
Tim Mackey, Assistant Professor, University of California, San Diego - Department of Anesthesiology, speaks about the effect counterfeit Avastin has had on efforts to protect the American public from counterfeit medications.
A presentation by Tom T. Kubic, President and CEO, Pharmaceutical Security Institute and Treasurer, Partnership for Safe Medicines about the threat of imported counterfeit prescription drugs.
This document discusses the threats posed by counterfeit medicines. It provides several examples of counterfeit medicines breaching the US supply chain and being distributed through "Canadian" websites and social media sites. The counterfeits have been found to contain no active ingredients, toxic ingredients, or incorrect doses of active ingredients. They are manufactured under unsafe conditions but can appear virtually indistinguishable from real medicines. The document emphasizes that counterfeit medicines pose a real threat to patient health and safety.
A presentation by J. Aaron Graham, Executive Director of Brand Safety & Security at Boehringer Ingelheim Pharmaceuticals, Inc., about the threat of imported counterfeit prescription drugs.
Daniel Burke, FDA's Senior Special Agent in the Cybercrime Investigations Unit, introduces our 3rd panel at the 2014 Interchange by speaking about how fake online pharmacies can affect American citizens.
In this presentation, Director of National Outreach Shabbir Imber Safdar reviews the current state of counterfeit drugs in America today, discusses some of the myths surrounding importation, and provides tips for saving money safely on the cost of prescription drugs.
Scott A. LaGanga, Executive Director Partnership for Safe Medicines (PSM) and Senior Vice President, Public Affairs -Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA), opens PSM's Interchange 2014.
This document discusses Maine's experience with LD 171, a law passed in 2013 to legalize the importation of prescription drugs from licensed pharmacies in Canada, UK, Australia and New Zealand. It describes how the Maine Pharmacy Association President ordered drugs from an online Canadian pharmacy called Canada Drug Center and found the drugs to be substandard and contaminated. The law was struck down in 2015 because it compromised federal drug regulation. Attempts by other states to import drugs from foreign pharmacies similarly found poor oversight, unsafe drugs, and an inability to regulate foreign entities.
Tim Mackey, Assistant Professor, University of California, San Diego - Department of Anesthesiology, speaks about the effect counterfeit Avastin has had on efforts to protect the American public from counterfeit medications.
A presentation by Tom T. Kubic, President and CEO, Pharmaceutical Security Institute and Treasurer, Partnership for Safe Medicines about the threat of imported counterfeit prescription drugs.
This document discusses the threats posed by counterfeit medicines. It provides several examples of counterfeit medicines breaching the US supply chain and being distributed through "Canadian" websites and social media sites. The counterfeits have been found to contain no active ingredients, toxic ingredients, or incorrect doses of active ingredients. They are manufactured under unsafe conditions but can appear virtually indistinguishable from real medicines. The document emphasizes that counterfeit medicines pose a real threat to patient health and safety.
A presentation by J. Aaron Graham, Executive Director of Brand Safety & Security at Boehringer Ingelheim Pharmaceuticals, Inc., about the threat of imported counterfeit prescription drugs.
Daniel Burke, FDA's Senior Special Agent in the Cybercrime Investigations Unit, introduces our 3rd panel at the 2014 Interchange by speaking about how fake online pharmacies can affect American citizens.
In this presentation, Director of National Outreach Shabbir Imber Safdar reviews the current state of counterfeit drugs in America today, discusses some of the myths surrounding importation, and provides tips for saving money safely on the cost of prescription drugs.
In this webinar I provide an overview of counterfeits in America, I talk about some myths of importation, and I teach patients and patient advocates some great tips for saving money safely.
The document discusses the dangers American patients face from counterfeit medications obtained outside of the regulated US drug supply chain, such as through fake online Canadian pharmacies. It details how breaks in the secure supply chain, such as patients buying drugs online or some doctors and pharmacists obtaining drugs from unlicensed distributors, can endanger patients by exposing them to counterfeit and unsafe medications. The document aims to dispel myths about obtaining cheaper drugs from outside the US and provides tips for patients to stay safe.
Healthcare providers are increasingly breaking the secure supply chain and endangering patients. Learn about counterfeit drugs and most recent incidents involving providers.
Also learn about how you can be a part of the solution by working with the Partnership for Safe Medicines.
Counterfeit drugs pose a major global problem and public health risk. According to the World Health Organization, over half of counterfeit drug cases found no active ingredients, while others contained incorrect or dangerous ingredients. Developing countries are especially impacted, with up to 60% of reported counterfeit drugs. Counterfeiting undermines healthcare systems and can have deadly consequences. The document warns that weak drug regulation and an unsecured supply chain allow for counterfeits to proliferate. It advocates purchasing from authorized drug distributors only to help strengthen oversight of the pharmaceutical supply system.
This document discusses ethics in the pharmaceutical industry. It provides examples of unethical behavior by pharmaceutical companies, such as experiments on human subjects without proper consent and misleading drug advertisements. It also outlines ethical behaviors like integrity, transparency, and prioritizing patient care. The core issues discussed are balancing profit motives with medical research and treatment goals. International regulatory bodies aim to promote ethical standards and enforce codes of conduct.
This document discusses ethical issues with the pricing of drugs by US pharmaceutical companies. It provides examples of Valeant Pharmaceuticals and Turing Pharmaceuticals dramatically increasing prices of older drugs. While legal, these actions seem unethical given lack of investment in research. Congress is investigating if drugmakers are price gouging. There is debate around government regulation of drug prices to balance innovation and accessibility.
Ethical dilemmas concerning drug pricing-Shrinath GhadgeShrinath Ghadge
There is no straightforward solution to the proper pricing of a pharmaceutical. Numerous factors influence pricing from the company perspective such as return on investment, costs of future R&D efforts, access to federal funding, and size of the patient population, to name a few. In addition the healthcare system in the US is generally much more expensive than other countries, driving up overall costs. A public distrust of pharmaceutical companies' greed has been fueled by recent cases of exorbitant increases in drug prices without clear cause. These instances do raise questions of the ethics employed by some companies
This document discusses several ethical issues facing the pharmaceutical industry. It examines cases involving Martin Shkreli sharply increasing drug prices, Mylan acquiring EpiPen and significantly raising its price, and the role of government patent protections and lobbying contributing to pharmaceutical monopolies in the US market. It poses the question of whether it is justified or ethical for drug companies to set extremely high prices that make life-saving treatments unaffordable for most consumers.
Changing times ask for solid relationships.
Times are changing. A renewed interest from big pharma in the rare disease landscape
has awakened due to large-scale patent expirations, competition from generics &
biosimilars, anemic pipelines, escalating clinical trial costs and a global health-care
reform. This means that the traditional blockbuster model has become less viable while
the revenue-generating potential of orphan drugs has shown to be huge with a greater
return on investment than non-orphan drugs. According to EvaluatePharma, the orphan
drugs sales will grow at an annual rate of 11% and constitute 19% of the total share of
prescription drugs by 2020, totalling 176 billion dollars.
The rare disease landscape is very complex due to the large amount of stakeholders
involved. Despite their different interests they have one goal in common: getting an
orphan drug approval that will help save or improve lives. But there are many challenges
on the road to orphan drug designation:
• Complex and changing national and regional regulations
• Clinical trial design and finding & keeping patients
• The lack of a central database designed specifically to list patient registries, which
asks for close stakeholder engagement
• Partnering and establishing financing for future development
• Establishing a foundation for price that is balanced and sustainable
• Achieving an efficient and timely access to market with equal access for patients
around the world
• Achieving timely and correct diagnosis to enable higher quality of life and more time
and information for developers
More information: http://www.orphandrugssummit.com/
Online Access to Safe and Affordable Medication: Applying human rights law to...PharmacyChecker
Online Access to Safe and Affordable Medication: Applying human rights law to cyber rule-making and Internet governance
https://www.pharmacychecker.com/
Internet users are benefiting from online access to safe and affordable medications. The pharmaceutical industry views Internet access as a threat and disruptive to its profit model because consumers are paying less than the drug companies intended for them to pay. According to the UN Human Rights Council, access to affordable medication is a human right. As the Internet community seeks to infuse the principles of international human rights law into the discourse and practice of Internet governance it should help maintain the widest possible online access to safe and affordable medication.
https://www.pharmacychecker.com/
June 19, 2013: This presentation to highlight the dangers of counterfeit drugs to Maine patients was given to the Bangor Dept. of Health Public Advisory committee
Fighting black market and counterfeit drugs in America endangers patients. Any break in the regulated, closed supply chain - whether by patients buying drugs online, or medical professionals purchasing from unlicensed distributors - puts lives at risk. Counterfeit or improperly handled treatments for conditions like HIV/AIDS, osteoporosis, kidney disease, and diabetes can be ineffective or even life-threatening when patients' health depends on properly manufactured and stored medicine. Protecting the supply chain is crucial to patient safety.
Counterfeit medicines are drugs produced with the intention to deceive that contain incorrect or insufficient active ingredients which can lead to therapeutic failure or drug resistance and sometimes death. Substandard medicines are genuine drugs that do not meet quality specifications due to manufacturing problems and may contain less or more active ingredients than stated. The most frequently counterfeited drugs are expensive medicines like hormones, antibiotics, and anticancer drugs. Globally, 10% of drugs are counterfeit, rising to 25% in developing countries and 50% in some places. Counterfeiting is encouraged by the profitability, weak laws, and large price differences between identical drugs. Actions to address the problems include strong legislation, authentication markings on packages, surveillance, and education.
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/
Consumer advocacy groups are petitioning the FDA to change the labeling of the smoking cessation drug Chantix to include more detailed warnings about potential psychiatric side effects such as suicidal behavior and depression based on reports from thousands of patients. Pfizer, the manufacturer of Chantix, is attempting to remove the bold warning about psychiatric problems from the labeling and claims studies have not shown a link between Chantix and suicidal behavior. The FDA will review the risks of Chantix by considering studies, input from Pfizer, experts, and the public to determine if changes are needed to the drug's labeling.
Marv Shepherd, PSM president, Member USP Package Storage and Distribution Expert Committee, and Professor at the University of Texas at Austin speaks about updates to United States Pharmacopeia's good distribution practices.
This presentation was the main portion of a March 15th, 2012 Congressional briefing in Washington DC on the state of counterfeits in America and the details, as currently known, of the fake Avastin incident.
In this webinar I provide an overview of counterfeits in America, I talk about some myths of importation, and I teach patients and patient advocates some great tips for saving money safely.
The document discusses the dangers American patients face from counterfeit medications obtained outside of the regulated US drug supply chain, such as through fake online Canadian pharmacies. It details how breaks in the secure supply chain, such as patients buying drugs online or some doctors and pharmacists obtaining drugs from unlicensed distributors, can endanger patients by exposing them to counterfeit and unsafe medications. The document aims to dispel myths about obtaining cheaper drugs from outside the US and provides tips for patients to stay safe.
Healthcare providers are increasingly breaking the secure supply chain and endangering patients. Learn about counterfeit drugs and most recent incidents involving providers.
Also learn about how you can be a part of the solution by working with the Partnership for Safe Medicines.
Counterfeit drugs pose a major global problem and public health risk. According to the World Health Organization, over half of counterfeit drug cases found no active ingredients, while others contained incorrect or dangerous ingredients. Developing countries are especially impacted, with up to 60% of reported counterfeit drugs. Counterfeiting undermines healthcare systems and can have deadly consequences. The document warns that weak drug regulation and an unsecured supply chain allow for counterfeits to proliferate. It advocates purchasing from authorized drug distributors only to help strengthen oversight of the pharmaceutical supply system.
This document discusses ethics in the pharmaceutical industry. It provides examples of unethical behavior by pharmaceutical companies, such as experiments on human subjects without proper consent and misleading drug advertisements. It also outlines ethical behaviors like integrity, transparency, and prioritizing patient care. The core issues discussed are balancing profit motives with medical research and treatment goals. International regulatory bodies aim to promote ethical standards and enforce codes of conduct.
This document discusses ethical issues with the pricing of drugs by US pharmaceutical companies. It provides examples of Valeant Pharmaceuticals and Turing Pharmaceuticals dramatically increasing prices of older drugs. While legal, these actions seem unethical given lack of investment in research. Congress is investigating if drugmakers are price gouging. There is debate around government regulation of drug prices to balance innovation and accessibility.
Ethical dilemmas concerning drug pricing-Shrinath GhadgeShrinath Ghadge
There is no straightforward solution to the proper pricing of a pharmaceutical. Numerous factors influence pricing from the company perspective such as return on investment, costs of future R&D efforts, access to federal funding, and size of the patient population, to name a few. In addition the healthcare system in the US is generally much more expensive than other countries, driving up overall costs. A public distrust of pharmaceutical companies' greed has been fueled by recent cases of exorbitant increases in drug prices without clear cause. These instances do raise questions of the ethics employed by some companies
This document discusses several ethical issues facing the pharmaceutical industry. It examines cases involving Martin Shkreli sharply increasing drug prices, Mylan acquiring EpiPen and significantly raising its price, and the role of government patent protections and lobbying contributing to pharmaceutical monopolies in the US market. It poses the question of whether it is justified or ethical for drug companies to set extremely high prices that make life-saving treatments unaffordable for most consumers.
Changing times ask for solid relationships.
Times are changing. A renewed interest from big pharma in the rare disease landscape
has awakened due to large-scale patent expirations, competition from generics &
biosimilars, anemic pipelines, escalating clinical trial costs and a global health-care
reform. This means that the traditional blockbuster model has become less viable while
the revenue-generating potential of orphan drugs has shown to be huge with a greater
return on investment than non-orphan drugs. According to EvaluatePharma, the orphan
drugs sales will grow at an annual rate of 11% and constitute 19% of the total share of
prescription drugs by 2020, totalling 176 billion dollars.
The rare disease landscape is very complex due to the large amount of stakeholders
involved. Despite their different interests they have one goal in common: getting an
orphan drug approval that will help save or improve lives. But there are many challenges
on the road to orphan drug designation:
• Complex and changing national and regional regulations
• Clinical trial design and finding & keeping patients
• The lack of a central database designed specifically to list patient registries, which
asks for close stakeholder engagement
• Partnering and establishing financing for future development
• Establishing a foundation for price that is balanced and sustainable
• Achieving an efficient and timely access to market with equal access for patients
around the world
• Achieving timely and correct diagnosis to enable higher quality of life and more time
and information for developers
More information: http://www.orphandrugssummit.com/
Online Access to Safe and Affordable Medication: Applying human rights law to...PharmacyChecker
Online Access to Safe and Affordable Medication: Applying human rights law to cyber rule-making and Internet governance
https://www.pharmacychecker.com/
Internet users are benefiting from online access to safe and affordable medications. The pharmaceutical industry views Internet access as a threat and disruptive to its profit model because consumers are paying less than the drug companies intended for them to pay. According to the UN Human Rights Council, access to affordable medication is a human right. As the Internet community seeks to infuse the principles of international human rights law into the discourse and practice of Internet governance it should help maintain the widest possible online access to safe and affordable medication.
https://www.pharmacychecker.com/
June 19, 2013: This presentation to highlight the dangers of counterfeit drugs to Maine patients was given to the Bangor Dept. of Health Public Advisory committee
Fighting black market and counterfeit drugs in America endangers patients. Any break in the regulated, closed supply chain - whether by patients buying drugs online, or medical professionals purchasing from unlicensed distributors - puts lives at risk. Counterfeit or improperly handled treatments for conditions like HIV/AIDS, osteoporosis, kidney disease, and diabetes can be ineffective or even life-threatening when patients' health depends on properly manufactured and stored medicine. Protecting the supply chain is crucial to patient safety.
Counterfeit medicines are drugs produced with the intention to deceive that contain incorrect or insufficient active ingredients which can lead to therapeutic failure or drug resistance and sometimes death. Substandard medicines are genuine drugs that do not meet quality specifications due to manufacturing problems and may contain less or more active ingredients than stated. The most frequently counterfeited drugs are expensive medicines like hormones, antibiotics, and anticancer drugs. Globally, 10% of drugs are counterfeit, rising to 25% in developing countries and 50% in some places. Counterfeiting is encouraged by the profitability, weak laws, and large price differences between identical drugs. Actions to address the problems include strong legislation, authentication markings on packages, surveillance, and education.
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/
Consumer advocacy groups are petitioning the FDA to change the labeling of the smoking cessation drug Chantix to include more detailed warnings about potential psychiatric side effects such as suicidal behavior and depression based on reports from thousands of patients. Pfizer, the manufacturer of Chantix, is attempting to remove the bold warning about psychiatric problems from the labeling and claims studies have not shown a link between Chantix and suicidal behavior. The FDA will review the risks of Chantix by considering studies, input from Pfizer, experts, and the public to determine if changes are needed to the drug's labeling.
Marv Shepherd, PSM president, Member USP Package Storage and Distribution Expert Committee, and Professor at the University of Texas at Austin speaks about updates to United States Pharmacopeia's good distribution practices.
This presentation was the main portion of a March 15th, 2012 Congressional briefing in Washington DC on the state of counterfeits in America and the details, as currently known, of the fake Avastin incident.
1. Partnership for Safe Medicines China (PSM China) was established in Beijing in November 2012 with participation from 12 associations to ensure a safe drug supply chain and educate patients and consumers on safe medication use.
2. PSM China's members include associations representing pharmaceutical manufacturers, distributors, hospitals, and licensed pharmacists.
3. In 2014, PSM China collaborated with Partnership for Safe Medicines India, launched a website, focused education efforts on medication for the elderly and chronic diseases, and organized over 180 volunteers to support educational programs.
Tim Mackey presented on the availability of dangerous, unapproved, and recalled drugs online. Some key points:
- Research has found narrow therapeutic index drugs, drugs not approved for sale, and drugs under global recall are actively being marketed for sale without a prescription online.
- The online drug ecosystem is complex, involving affiliate networks, business-to-business sellers, and emerging technologies like the dark web.
- Moving forward, efforts should identify high-risk dangerous drugs, develop global lists of such drugs, map the entire illicit online pharmacy ecosystem, and prioritize enforcement against the worst offenders. The goal is to improve identification, surveillance and enforcement of clearly dangerous medicines available online without oversight.
Marv Shepherd conducted research exploring whether hospital pharmacies could be a source of diverted drugs. A survey of Texas hospitals found that 25% reported being contacted by "grey market" vendors weekly or daily to purchase pharmaceuticals. Additionally, over 85% of hospitals reported being contacted by such vendors in the last month to sell drugs. While the size of this illicit market is unknown, the findings suggest some hospitals may be unlawfully diverting drugs. Further analysis found no significant associations between vendor contacts and hospital size, ownership, or location. The research indicates opportunistic vendors are actively trying to obtain drugs from some hospitals in Texas.
PSM India aims to: raise awareness of spurious drugs' harm; educate consumers and practitioners on drug quality and identifying suspected spurious drugs; and collaborate with the government and WHO. PSM held an international workshop on ensuring patient safety over commercial interests and regaining consumer confidence. A study found many small manufacturers lack Good Manufacturing Practices compliance and risk producing spurious drugs. It evaluated 348 essential drugs across India to understand the spurious drug problem's full extent and compliance with regulations. PSM plans to expand detection technologies statewide and work with regulators against law-violating manufacturers.
The document summarizes a panel discussion on new developments in international cooperation to address challenges related to unapproved and counterfeit drugs. It describes problems like large quantities of prescription drugs coming from other countries and physicians ordering directly from unlicensed suppliers. Global challenges in investigations like tracing money and packages and obtaining evidence from other countries are also outlined. The panelists discuss international enforcement operations and USP programs that help strengthen quality assurance in developing countries.
The document summarizes initiatives to combat counterfeit medicines in various countries. It finds that healthcare professionals' roles are often unclear and they are not always at the forefront of counterfeiting issues. The WHPA campaign aims to strengthen advocacy for investing in healthcare professionals' education and capacity to detect, report, and prevent counterfeits. It establishes dialogue between stakeholders to share knowledge and resources and initiate cost-effective solutions. The WHPA Call to Action and toolkit provide strategies and resources to build comprehensive regional plans against counterfeiting through increasing professional capacity, regional cooperation, collaborative practice, and improved collaboration with authorities.
The document discusses how American patients have been impacted by unsafe and counterfeit medicines from 2010-2013. It describes several cases where medical professionals purchased non-FDA approved drugs and devices, exposing patients to risks. This includes expired, stolen, or improperly stored medicines. The document outlines issues with specific treatments like IUDs, Botox, osteoporosis drugs, HIV drugs, and diabetes treatments. Patients who received counterfeit versions faced potential health problems. While the full scope of the counterfeit drug problem in the US is unknown, the document argues it threatens patient safety when healthcare providers and patients cannot be certain the treatments they receive are real and effective.
The document summarizes the 2013 Interchange conference hosted by the Partnership for Safe Medicines (PSM). It lists the executive director of PSM and its many member organizations. It then describes PSM's efforts over the past year to educate over 300,000 patients, nurses, doctors and pharmacists, and nearly 1,000 at-risk clinics about counterfeit drugs through Facebook ads, printed materials, and trainings. PSM has also been working with international partners in countries like India, China, and Brazil. The conference agenda includes a new panel format and presentations on new research studies.
Non-FDA approved foreign drugs are being provided to Massachusetts patients through online pharmacies, putting their health at risk. These drugs may contain toxic fillers, expired ingredients, or lack important safety information. Several health groups and trusts in Massachusetts are directing patients to these online pharmacies to reduce costs, incentivizing the purchase of unsafe drugs. Records obtained through FOIA requests show thousands of patients across multiple regions in Massachusetts are affected. Next steps include alerting regulatory agencies to intervene.
This document summarizes a panel discussion on issues related to fake online pharmacies. The panelists included pharmacists, law enforcement agents, and policy experts. They discussed how online pharmacies are difficult to regulate due to their ability to operate across state and international lines. While organizations like the FDA and NABP have programs to verify legitimate online pharmacies, illicit sites still proliferate using search engines, social media, and other online marketing techniques. Research presented found that consumers have difficulty identifying unsafe pharmacy websites and are willing to purchase medicines from illegal online pharmacies without prescriptions, including drugs that require close medical supervision.
Tom Kubic, President and CEO of the Pharmaceutical Security Institute (PSI) and PSM board member, presents an overview of global activity in the counterfeiting of prescription medicines in 2013.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has developed a strategy to combat falsified medical products with the objective of reducing risks to patients and consumers. The strategy aims to enhance legal frameworks at the European Union and Council of Europe levels related to falsified medicines and strengthen safety features and controls for actors in the medical supply chain. It also addresses issues like internet sales of medicines and controls on active pharmaceutical ingredients.
The document thanks sponsors for supporting the 2013 Interchange conference. It provides information about materials available to attendees, including a 69-page overview of counterfeit drug policy in the conference packet and educational materials that can be co-branded or used to educate communities. A USB pen is also described that contains graphics, research, and consumer education materials from the Partnership for Safe Medicines.
The document discusses Maine laws regarding importing prescription drugs from licensed pharmacies in other countries. It states that licensed pharmacies in Canada, UK, Australia, and New Zealand can export prescription drugs by mail to Maine residents for personal use without a Maine license. It also states that entities that facilitate drug exports from these licensed foreign pharmacies to Maine residents are also exempt from needing a Maine license. The document then lists information about specific drugs' manufacturers, fill centers, and mailing addresses.
Payment Processing and Unlicensed Online Pharmacies by Damon McCoy
Presented at the 2012 Partnership for Safe Medicines Interchange on September 28, 2012
This case presentation describes a 38-year-old Hispanic man with metastatic adenocarcinoma that has spread to his lymph nodes, lungs, soft tissue, and bones. He was admitted to the hospital complaining of back pain and inability to walk. During his hospital stay he received palliative radiation, thoracentesis, abdominal biopsy confirming cancer, and orthopedic surgery. He experienced significant pain, constipation, anxiety, and distress due to his undocumented immigrant status leaving him uninsured and unable to afford treatment costs. After multiple discussions, further chemotherapy was declined and the patient was referred to hospice care.
This presentation is designed to train patient advocates in the safety issues around counterfeit drugs: how counterfeits enter our supply chain and how patients can protect themselves.
This summary provides the key information from 4 documents related to medical malpractice cases:
1) The first document describes a medical malpractice case where an infant's larynx was punctured during surgery and the doctor failed to prescribe antibiotics or keep the infant in the hospital long enough. The court reduced the $2 million jury award to a more reasonable amount.
2) The second document summarizes a wrongful death medical malpractice case where the jury award of $3.9 million was reduced to $2.6 million by the appeals court.
3) The third document describes a medical malpractice case where a man died after being misdiagnosed and sent home from a clinic with a mild antibiotic.
This document summarizes a panel discussion on avoiding liability related to prescribing controlled substances. The panelists include attorneys and medical professionals. They discuss standards of care physicians must follow, trends in more aggressive prosecution of prescribers, and recent high-profile cases where prescribers faced criminal charges for patient deaths. The panel provides guidance on steps prescribers can take to comply with legal and medical standards such as thorough patient evaluations, monitoring for signs of abuse or diversion, and avoiding defenses that blame patients.
GSK, a large British pharmaceutical company, agreed to pay a $3 billion settlement for promoting drugs for unapproved uses and failing to report safety issues. GSK promoted the antidepressant Paxil for teenagers despite risks of suicidal thoughts, and the diabetes drug Avandia despite links to heart attacks. The settlement was the largest health fraud settlement in US history but no individuals were criminally prosecuted. Critics argue that without criminal penalties for responsible executives, large fines will not change companies' behavior.
This document discusses concerns around safely implementing importation of drugs from Canada. It summarizes perspectives from experts in drug supply chain security and Canadian policy. They note that importation could undermine the Drug Supply Chain Security Act, as drugs from foreign markets don't use the same identifiers and documentation. It may also diminish Canada's drug supply and leave Americans without long-term solutions. The document outlines risks like counterfeiting and how Canadian authorities do not inspect all shipments. It questions whether importation could realistically work given these challenges to safety and oversight.
Pharmanex HCP presentation, Provo, Utah 03 Louis Cady, MD
This is the slightly trimmed version of "The Gathering Storm, The Breaking Dawn" talk I previously gave in California, dealing with the failing financial and physical health of the American public (other than the much talked about "1%") as well as the medical care system which is in danger of imploding. The Pharmanex Biophotonic scanner, its validation, and the rationale behind the LifePak supplement line is reviewed.
December 12, 2017
The Sixth Annual Health Law Year in P/Review symposium featured leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event covered hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.
For more information, visit our website at: http://petrieflom.law.harvard.edu/events/details/sixth-annual-health-law-year-in-p-review
Understanding the Endo-Cannabinoid System and Usage of Medical Cannabis in Ma...tgregoryhowcm
Overview of medical cannabis -originally written for Hospice but applicable to anyone-covers myths and stigmas, political history, the Endo-cannabinioid system , how medical cannabis actually works in the body, how to select the right strain for the symptom, side effects, methods of use, how to obtain a medical use card in Massachusetts and updated Mass regulation including the comparison of medical vs. recreational regulations. Notes are visible with download. There is one inbedded video that needs WIFI to view but link is included.
the worst Medical Errors and how to mange them.pptxhospital
This document summarizes several medical error cases that resulted in harm to patients. It begins with statistics on the prevalence and cost of medical errors. Several case studies are then described in detail, including misdiagnoses, administering the wrong medication, performing surgery on the wrong body part, and transplanting organs with the wrong blood type. Common causes of errors included miscommunication, look-alike drug names, and failure to double check vital information like blood type. The document stresses the need to prevent these avoidable errors.
NEW CLAIMS TRENDS RELATED TO THE U.S. PAIN CRISISRachel Hamilton
ACI's Medical Professional Liability Insurance Forum is the premier event on benchmarking coverage, underwriting, and claims strategies. No other event can match the practical and detailed analysis of the entire MPL Insurance landscape, including the impact of litigation, regulatory action, and market conditions in today's tumultuous environment.
A small us town scarred by a trusted doctorOther Mother
Nearly 300 patients in Munster, Indiana have sued a prominent local cardiologist, Dr. Arvind Gandhi, and his partners, claiming they performed unnecessary medical procedures. An investigation was launched after patients grew suspicious of the high number of procedures Dr. Gandhi recommended. Some doctors had previously raised concerns about Dr. Gandhi's practice but were ignored because he brought in significant revenue for the hospital. Dr. Gandhi has since retired and denies any wrongdoing.
This document summarizes a presentation on medical malpractice for advanced practice providers. It discusses the key elements of a malpractice case, common complaints and conditions that lead to malpractice claims, and analyzes data from malpractice claims involving nurse practitioners. The top claims were related to failures to diagnose conditions like cancer, breast lumps, or myocardial infarctions. Common errors involved diagnosis, treatment, medications, and follow-up of test results. Case studies illustrate examples.
AN ANALYSIS OF THE OBAMA HEALTHCARE PLANgueste31e52
The Administration's Health Care Plan is analyzed in terms of meeting certain general criteria; current claims by proponents; and, current claims by those who attack Plan critics. Charts and data are presented that support a coherent, alternate approach.
The document discusses the prescription drug price crisis in the United States. Drug prices have risen much faster than general inflation over the past decade, and millions of Americans cannot afford necessary medications as a result. The U.S. pays significantly higher prices for many drugs than other countries. Several policy solutions are proposed to lower drug costs, including allowing Medicare to negotiate drug prices, banning "pay-for-delay" deals between drug companies, and legalizing importation of lower-cost drugs from abroad. Advocacy groups are calling for stronger political action to enact reforms and lower what Americans pay for prescription medications.
Webinar 1 (Oct 9, 2020 at 12 -1 pm ET): Does Canada need an Orphan Drug Policy to incentivize drug development and submissions? What was the rationale for Orphan Drug legislation in other countries? What has been the impact of those legislations? Why did Canada develop and never implement a Canadian Rare Disease Strategy and what has been the aftermath? What is Canada’s Rare Disease Strategy and how has it influenced healthcare?
Key issues:
• Rationale and impact of Orphan Drug legislation around the world (1983 – today)
• Proposed Canadian Orphan Drug Framework and what could have resulted (2014)
• Proposed Canada’s Rare Disease Strategy and what did/did not result (2015 – today)
Given the benefits and challenges that have been raised about Orphan Drug Legislation and the current procedures for reviewing rare disease drugs across Canadian agencies (Health Canada, PMPRB, CADTH/INESSS, pCPA, provincial drug plans), should Canada still pursue a dedicated Orphan Drug Policy and, if so, what should it address? What are the opportunities for stimulating and supporting research and development for rare disease therapies in Canada and what are specific policies needed?
Presentation:
Durhane Wong-Rieger, CORD Panel Discussion
Rebecca Yu (Takeda Canada)
Nicola Worsfold (Jesse’s Journey Canada)
Sandra Anderson (Innomar Strategies)
Nahya Awada (PhD Candidate Carleton University)
The document discusses the prescription drug abuse epidemic in the United States. It provides statistics showing the rise in overdose deaths from prescription painkillers between 1999 and 2008. Certain groups are more at risk of abusing or overdosing on these drugs. "Pill mills" dispensing prescription drugs with little oversight have flourished in Florida, fueling abuse in other states. Efforts are underway to address this crisis and crack down on pill mills.
This document discusses prescription drug abuse and diversion. It notes that Schedule II substances like oxycodone and fentanyl require a written prescription with no refills, while Schedule III substances like hydrocodone are the most abused class and can be prescribed via phone. It provides statistics on the prices of abused drugs on the street and notes that many are diverted from legal sources through forged prescriptions, doctor shopping, and pharmacy theft. The document outlines HIPAA rules around disclosure of health information and state law on physician-patient privilege. It discusses trends in college student abuse of drugs like Adderall and Ritalin and warns of overdose risks of opioids like fentanyl and oxycodone.
Similar to PSM Interchange 2014 Panel 2: Linda Marks, Criminal Prosecutions: Patient Safety (20)
PSM presented a special webinar for families affected by counterfeits and fentanyl. Learn about opportunities to make your voice heard. You can watch the presentation at https://youtu.be/FmBv3Bb7ZHI
What have been the major crimes and policy developments in the space of counterfeit medicines? PSM reviews major prosecutions and legislation from the first half of 2021.
This document discusses the Partnership for Safe Medicines, an organization advocating for safe medication access. It lists over 100 member organizations and provides information on counterfeit drugs including examples during the COVID-19 pandemic of fake vaccines, testing kits, and medicines being sold. Data is presented on rising drug overdose deaths in the US driven largely by fentanyl, and examples are given of recent seizures of counterfeit pills containing fentanyl in various states and countries that are fueling the opioid crisis.
This document discusses why importing prescription drugs from Canada is not a viable solution to high drug costs in the US. It notes that previous state-level importation programs failed due to lack of savings and inability to adequately regulate foreign pharmacies. Proper testing of imported drugs is very expensive and would consume any savings. There are also safety concerns, as importation would undermine track-and-trace systems and Canada's drug supply is already limited. Law enforcement experts warn that importation could exacerbate the opioid crisis and organized crime may exploit regulatory loopholes. The document argues policymakers should focus on real solutions rather than unrealistic importation proposals.
Libby Baney, Executive Director for the Alliance for Safe Online Pharmacies talks about the current state of rogue online pharmacies and efforts to curb them.
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
- 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
Integrating Ayurveda into Parkinson’s Management: A Holistic ApproachAyurveda ForAll
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
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
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.
- Video recording of this lecture in English language: https://youtu.be/Pt1nA32sdHQ
- Video recording of this lecture in Arabic language: https://youtu.be/uFdc9F0rlP0
- 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
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
Does Over-Masturbation Contribute to Chronic Prostatitis.pptxwalterHu5
In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
1. CRIMINAL PROSECUTIONS:
PATIENT SAFETY
Partnership for Safe Medicines Interchange 2014
September 18, 2014
Newseum, Washington, D.C.
Moderator: Linda I. Marks
Senior Litigation Counsel
Consumer Protection Branch
U.S. Department of Justice
linda.marks@usdoj.gov
Views offered in this presentation are my own views, and not necessarily views of the
Department of Justice.
Views offered in this presentation are my own views, and not necessarily views of the Department of Justice.
2. PANELISTS
• Lindsay Kelly, AUSA, Eastern District of Virginia
• Jaime Peña, AUSA, District of Colorado
4. FROM TURKEY TO MISSOURI (EDMO)
2012
• MISSOURI ONCOLOGIST: DR. ABID NISAR
• CALIFORNIA WHOLESALERS: JAMES
NEWCOMB/SANDRA BEHE (BDMI)
• PACKAGE TO NISAR INCLUDED COLD CHAIN
“GOOEY MESS”
5. FROM TURKEY TO MISSOURI (EDMO)
• Blast Faxes to Target Doctors: lower costs (40-
60% typical)
6. FROM TURKEY TO MISSOURI (EDMO)
2013
• BRITISH WHOLESALER: RICHARD TAYLOR
(RICHARD’S PHARMA LTD.)
• “UNFORTUNATE EXPERIENCE” & “IMMEDIATE
BAD REACTIONS” WHERE PATIENT “STARTED TO
SHAKE”
• ALTUZAN WAS A “HIGH RISK PLAY” WITH
TURKISH LABELING
7. FROM TURKEY TO MISSOURI (EDMO)
2014
• TURKISH SUPPLIERS TO TAYLOR: OZKAN
SEMIZOGLU/SABAHADDIN AKMAN (OZAY
PHARMACEUTICAL)
• BOTH DEFENDANTS PLED GUILTY AND AWAIT
SENTENCING
8. FROM TURKEY TO MISSOURI (EDMO) . . .
and beyond
Other physicians prosecuted:
-- Isabella Martire (PG; motion to withdraw FDCA
misd guilty plea pending)
-- Joel Bernstein (PG; FDCA misd - unapproved
Mabthera)
-- Joel Bernstein, Inc. (PG; health care fraud;
bought $3.4 million oncology drugs)
9.
10. U.S. v. SANDHU (EDMO)
AND KSANDHU INDICTED 10/14
• OPERATED “ONLINEBOTOX.COM”
• SOLD BOTOX & JUVEDERM
• SISTERS KAMALDEEP AND NAVDEEP SANDHU
INDICTED: CONSPIRACY, SMUGGLING, FDCA
ADULTERATED DRUGS, OBSTRUCTION
CHARGES INCLUDE CONSPIRACY,
SMUGGLING, INTRODUCING
15. GALLANT PHARMA, EDVA
ENNNNNNNNNNNNNEXT:
U.S. v. JAMES EDWARD QUINN, WORLD
MEDICAL LTD, & ATLANTIC PHARMACEUTICALS
AG
-- UK REPACKAGERS/SHIPPERS
-- CHEMO & COSMETIC DRUGS, IUDs
16. HOSPITAL DRUG DIVERSION:
D. COLO.
• U.S. v. KRISTEN PARKER – SCRUB TECH;
STOLEN FENTANYL SYRINGES; HEP-C
• U.S. v. ASHTON DAIGLE – RN; FENTANYL
SYRINGES REPLACED WITH TAP WATER OR
SALINE SOLUTION
• UNLICENSED WHOLESALER
17. MEDICAL DEVICES:
SPECTRANETICS, D. COLO.
E WHOLESALER
• U.S. v. GEORGE JOHN SCHULTE (CEO)
• MEDICAL LASERS -- LEAD WIRES APPROVED
FOR SPECIFIC TYPES OF OCCLUSIONS
• UNAPPROVED GUIDEWIRES, CATHETER
BALLOONS, LASERS, & STENTS USED IN
SURGERIES
18. MEDICAL DEVICES:
SPECTRANETICS, D. COLO.
• UCENSED WHOLESALER
• SCHULTE CONVICTED OF MAKING FALSE
STATEMENTS TO FDA
• JANUARY 2014: 10TH CIR. UPHELD
CONVICTION
REPACKAGERS IN U.K. & CANADA
19. U.S. v. VAUGHAN CIPPERLY,
D. COLO.
• PHYSICIAN PURCHASED CHEMO DRUGS
FROM QUALITY SPECIALTY PRODUCTS (QSP),
CANADA
• UNAPPROVED, FOREIGN-MADE
• PLED GUILTY TO CONSPIRACY TO INTRODUCE
UNAPPROVED DRUGS; FORFEITED $500,000
• EPACKAGERS IN U.K. & CANADA)