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.
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.
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.
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.
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
The FDA has requested that Darvon and Darvocet/Propoxyphene be removed from the US market due to safety concerns. Patients taking these medications should not stop taking them abruptly, but should contact their doctor to discuss alternative pain management options. Propoxyphene was first approved in 1957 but has been reviewed by the FDA twice previously due to safety issues, and an advisory committee voted against its continued use in 2009. Additionally, the FDA has requested the voluntary withdrawal of the obesity drug Meridia from the US market following a clinical trial that indicated an increased risk of heart attack and stroke for patients taking the drug. Patients should stop taking Meridia and discuss alternative weight loss options with their healthcare provider.
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.
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.
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.
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
The FDA has requested that Darvon and Darvocet/Propoxyphene be removed from the US market due to safety concerns. Patients taking these medications should not stop taking them abruptly, but should contact their doctor to discuss alternative pain management options. Propoxyphene was first approved in 1957 but has been reviewed by the FDA twice previously due to safety issues, and an advisory committee voted against its continued use in 2009. Additionally, the FDA has requested the voluntary withdrawal of the obesity drug Meridia from the US market following a clinical trial that indicated an increased risk of heart attack and stroke for patients taking the drug. Patients should stop taking Meridia and discuss alternative weight loss options with their healthcare provider.
This lecture discusses health policy related to curbing abuse of controlled substances - like narcotics. This article discusses several steps Utah has made to decrease the number of opiate-related deaths.
Yankee Public Relations' latest newsletter for Octapharma USA, a subsidiary of Octapharma AG, a global human protein products manufacturer. Yankee PR is a boutique communications firm in New Jersey.
Orphan drugs are intended for the treatment of rare diseases or conditions affecting fewer than 200,000 people in the US or 5 in 10,000 people in the EU. Various acts like the Orphan Drug Act of 1983 in the US and the Rare Diseases Act of 2002 in the EU provide incentives like market exclusivity periods of 7-10 years and waivers on fees for drug approval to encourage development of treatments for rare diseases. However, developing orphan drugs remains challenging due to the small patient populations and high costs. Major pharmaceutical companies and some specialist companies are involved in orphan drug development and access to these treatments remains a priority.
RyMat Inc.: A Look At Generic vs. Brand PharmaceuticalsStuart Silverman
The document discusses generics vs brand name drugs and risks associated with generics. It notes that generics must have the same active ingredients and be within 10-25% of brand name drug concentrations to be approved. However, generics may have different inactive ingredients and manufacturing processes can vary, resulting in differences between generics. The document outlines issues found at some generic drug manufacturing plants in India and China, including falsifying data, poor quality control, and hiding failed test results. It warns that not all generics are equal and some imported from these countries may pose risks.
This document discusses drugs for rare diseases. It begins by defining rare diseases according to different organizations. Rare diseases are individually rare but collectively common, affecting around 6-8% of the global population. Developing drugs for rare diseases is challenging due to the small patient populations and high costs. Governments provide incentives like tax breaks and exclusive rights to encourage pharmaceutical companies to develop orphan drugs. Recent advances in genetics have helped identify causes of many rare diseases and accelerated drug development. While treatment options have increased in recent decades, more understanding and viable treatments are still needed for most rare diseases.
Orphan Drugs and Haemophilia by Flora PeyvandiJordan Nedevski
1) Orphan drugs are developed for rare diseases that would otherwise be unprofitable to treat. Regulations in the US, EU, Japan, and Australia provide incentives like market exclusivity to stimulate orphan drug development.
2) New long-acting drugs for hemophilia, a rare bleeding disorder, could potentially qualify for orphan drug designation and the 10 years of market exclusivity in the EU. However, ensuring wide access and competition is important.
3) While long-acting hemophilia drugs differ in structure and mechanism, their market exclusivity status is unclear. The hemophilia community wants different treatment approaches and competition to best meet patient needs long-term.
The document discusses a partial paper-based pharmacy record system at Emory Eastside Medical Center that uses some automated software. It describes an investigation by pharmacist Gail Zwicke into patient safety and workflow. Pharmacy tech Bob Deans compares clinical and retail pharmacy workflows. Various diagrams and SQL queries related to a pharmacy database are also included. The document ends with a section for questions and answers.
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.
The development & approval of Novoeight, a case studyAllen Che
The FDA approved Novoeight, a recombinant Factor VIII treatment for hemophilia A, in October 2013 based on positive results from clinical trials. Novoeight was found to effectively control and prevent bleeding episodes in adults and children with hemophilia A. The approval process involved reviewing manufacturing, clinical data, and inspections to ensure safety and efficacy. This approval expands treatment options for hemophilia A patients and represents continued innovation in the development of safer recombinant clotting factor therapies.
This document discusses orphan drugs, which treat rare diseases. It defines orphan drugs and outlines criteria used in the US and EU to designate drugs for rare diseases. Rare diseases affect fewer than 200,000 people in the US and 10,000 in the EU. The Orphan Drug Act of 1983 in the US provided incentives for orphan drug development. Similar laws exist in other countries. Developing orphan drugs is challenging due to low patient populations and high costs. Examples of orphan drugs and their manufacturers are provided. The process for obtaining orphan drug designation is also summarized.
Florida has cracked down on "pill mills" to reduce prescription drug abuse, but this has unintentionally hurt patients with legitimate pain. Strict regulations have made doctors afraid to prescribe and pharmacists afraid to fill prescriptions for pain medications. As a result, terminally ill cancer patients and others in real pain may be forced to go without needed medication. While the crackdown has reduced prescription drug deaths, many wonder if it has gone too far in denying care to people with legitimate medical needs.
This document discusses generics versus brand name anti-epileptic drugs (AEDs). It notes that generics have the same active ingredients and biological effects as brand names, but some concerns exist regarding their approval process and effects on certain populations like children and the elderly. While regulatory agencies say existing bioequivalence rules are adequate, both they and patient advocacy groups may be biased. The document concludes there is reason for concern about current generic regulations and advises doctors to track what medications patients receive and educate others to minimize risks of substituting generics.
This document contains guidance from Dr. H.K. Takvani on prescribing drugs. It advises doctors to only prescribe drugs that are necessary, effective, safe, cost-effective, and something they would give to their own family. When choosing branded drugs, Dr. Takvani recommends selecting ones from reputable companies with the lowest prices and avoiding incentives. Generic drugs are preferable if quality can be controlled, ideally through government oversight or double-blind studies conducted by medical institutions. Doctors should base their drug knowledge on peer-reviewed literature, not information from pharmaceutical companies.
This document summarizes a national dialogue on drug-impaired driving that took place in April 2012. It discusses policy goals of identifying impaired drivers and distinguishing impairment from medication use. Statistics show that in 2009, over 13,000 drivers who died in crashes tested positive for drugs. The document outlines the dangers of drug-impaired driving and different state laws addressing this issue. It also notes challenges with drug evaluation programs and drug testing. Suggestions are made to improve prevention of drug-impaired driving.
Prescription drug abuse is a rapidly growing epidemic in America. There are three main types of prescription drugs commonly abused - narcotic painkillers, sedatives and tranquilizers, and stimulants. Prescription drug abuse is on the rise due to the overwhelming availability of these drugs as more people need medication, and the misconception that prescription drugs are safe since they are prescribed. Prescription drug abuse costs society billions of dollars and has serious health risks for individuals, including death when mixed with alcohol or other drugs.
Special Challenges in Clinical Trials: Case Study: the Dying child and the ...Michael Swit
A review of a case study involving whether it would be proper to authorize the use of a drug whose approval had been withdrawn when it is believed to be the only hope for a dying child.
Understanding Georgian Pharmaceutical LawMelinda_White
According to the document, pharmaceutical law in Georgia covers issues with medications including inadequate testing, insufficient warnings, and poor prescriptions from doctors. The document discusses how deaths from prescription drug overdoses have increased dramatically in Georgia in recent years. It provides an overview of pharmaceutical law and what legal recourse victims may have, including compensatory damages, if they have been harmed by dangerous drugs prescribed negligently in Georgia.
This document discusses the ethical challenges of marketing in the healthcare industry, particularly in the pharmaceutical sector. It examines cases involving Eli Lilly, GlaxoSmithKline, 23andMe, and Par Pharmaceuticals to illustrate tensions between informing patients and the FDA's role in ensuring safety. Pharmaceutical companies aim to educate through marketing, while the FDA controls information dissemination and prohibits off-label promotion to protect public health based on rigorous testing. The document urges understanding both perspectives to balance business and patient interests.
The document discusses the complex relationship between physicians and the pharmaceutical industry. It provides an overview of industry marketing practices like gifts and promotions and their influence on physician prescribing behaviors. It also reviews studies that show that even small gifts can create a sense of obligation in physicians and influence their clinical decisions, going against principles of objectivity and benefiting patients. Guidelines aim to limit gifts and promotions to protect against conflicts of interest, but relationships still present challenges to medical professionalism.
Scope after b pharmacy, m pharmacy, pharma d, d pharmacy,Career options after...Payaamvohra1
This ppt gives an idea about the different job opportunities, different career scope after completing pharmacy courses. Do checkout other ppt and videos of Best pharmacy tips and tricks
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.
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.
This lecture discusses health policy related to curbing abuse of controlled substances - like narcotics. This article discusses several steps Utah has made to decrease the number of opiate-related deaths.
Yankee Public Relations' latest newsletter for Octapharma USA, a subsidiary of Octapharma AG, a global human protein products manufacturer. Yankee PR is a boutique communications firm in New Jersey.
Orphan drugs are intended for the treatment of rare diseases or conditions affecting fewer than 200,000 people in the US or 5 in 10,000 people in the EU. Various acts like the Orphan Drug Act of 1983 in the US and the Rare Diseases Act of 2002 in the EU provide incentives like market exclusivity periods of 7-10 years and waivers on fees for drug approval to encourage development of treatments for rare diseases. However, developing orphan drugs remains challenging due to the small patient populations and high costs. Major pharmaceutical companies and some specialist companies are involved in orphan drug development and access to these treatments remains a priority.
RyMat Inc.: A Look At Generic vs. Brand PharmaceuticalsStuart Silverman
The document discusses generics vs brand name drugs and risks associated with generics. It notes that generics must have the same active ingredients and be within 10-25% of brand name drug concentrations to be approved. However, generics may have different inactive ingredients and manufacturing processes can vary, resulting in differences between generics. The document outlines issues found at some generic drug manufacturing plants in India and China, including falsifying data, poor quality control, and hiding failed test results. It warns that not all generics are equal and some imported from these countries may pose risks.
This document discusses drugs for rare diseases. It begins by defining rare diseases according to different organizations. Rare diseases are individually rare but collectively common, affecting around 6-8% of the global population. Developing drugs for rare diseases is challenging due to the small patient populations and high costs. Governments provide incentives like tax breaks and exclusive rights to encourage pharmaceutical companies to develop orphan drugs. Recent advances in genetics have helped identify causes of many rare diseases and accelerated drug development. While treatment options have increased in recent decades, more understanding and viable treatments are still needed for most rare diseases.
Orphan Drugs and Haemophilia by Flora PeyvandiJordan Nedevski
1) Orphan drugs are developed for rare diseases that would otherwise be unprofitable to treat. Regulations in the US, EU, Japan, and Australia provide incentives like market exclusivity to stimulate orphan drug development.
2) New long-acting drugs for hemophilia, a rare bleeding disorder, could potentially qualify for orphan drug designation and the 10 years of market exclusivity in the EU. However, ensuring wide access and competition is important.
3) While long-acting hemophilia drugs differ in structure and mechanism, their market exclusivity status is unclear. The hemophilia community wants different treatment approaches and competition to best meet patient needs long-term.
The document discusses a partial paper-based pharmacy record system at Emory Eastside Medical Center that uses some automated software. It describes an investigation by pharmacist Gail Zwicke into patient safety and workflow. Pharmacy tech Bob Deans compares clinical and retail pharmacy workflows. Various diagrams and SQL queries related to a pharmacy database are also included. The document ends with a section for questions and answers.
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.
The development & approval of Novoeight, a case studyAllen Che
The FDA approved Novoeight, a recombinant Factor VIII treatment for hemophilia A, in October 2013 based on positive results from clinical trials. Novoeight was found to effectively control and prevent bleeding episodes in adults and children with hemophilia A. The approval process involved reviewing manufacturing, clinical data, and inspections to ensure safety and efficacy. This approval expands treatment options for hemophilia A patients and represents continued innovation in the development of safer recombinant clotting factor therapies.
This document discusses orphan drugs, which treat rare diseases. It defines orphan drugs and outlines criteria used in the US and EU to designate drugs for rare diseases. Rare diseases affect fewer than 200,000 people in the US and 10,000 in the EU. The Orphan Drug Act of 1983 in the US provided incentives for orphan drug development. Similar laws exist in other countries. Developing orphan drugs is challenging due to low patient populations and high costs. Examples of orphan drugs and their manufacturers are provided. The process for obtaining orphan drug designation is also summarized.
Florida has cracked down on "pill mills" to reduce prescription drug abuse, but this has unintentionally hurt patients with legitimate pain. Strict regulations have made doctors afraid to prescribe and pharmacists afraid to fill prescriptions for pain medications. As a result, terminally ill cancer patients and others in real pain may be forced to go without needed medication. While the crackdown has reduced prescription drug deaths, many wonder if it has gone too far in denying care to people with legitimate medical needs.
This document discusses generics versus brand name anti-epileptic drugs (AEDs). It notes that generics have the same active ingredients and biological effects as brand names, but some concerns exist regarding their approval process and effects on certain populations like children and the elderly. While regulatory agencies say existing bioequivalence rules are adequate, both they and patient advocacy groups may be biased. The document concludes there is reason for concern about current generic regulations and advises doctors to track what medications patients receive and educate others to minimize risks of substituting generics.
This document contains guidance from Dr. H.K. Takvani on prescribing drugs. It advises doctors to only prescribe drugs that are necessary, effective, safe, cost-effective, and something they would give to their own family. When choosing branded drugs, Dr. Takvani recommends selecting ones from reputable companies with the lowest prices and avoiding incentives. Generic drugs are preferable if quality can be controlled, ideally through government oversight or double-blind studies conducted by medical institutions. Doctors should base their drug knowledge on peer-reviewed literature, not information from pharmaceutical companies.
This document summarizes a national dialogue on drug-impaired driving that took place in April 2012. It discusses policy goals of identifying impaired drivers and distinguishing impairment from medication use. Statistics show that in 2009, over 13,000 drivers who died in crashes tested positive for drugs. The document outlines the dangers of drug-impaired driving and different state laws addressing this issue. It also notes challenges with drug evaluation programs and drug testing. Suggestions are made to improve prevention of drug-impaired driving.
Prescription drug abuse is a rapidly growing epidemic in America. There are three main types of prescription drugs commonly abused - narcotic painkillers, sedatives and tranquilizers, and stimulants. Prescription drug abuse is on the rise due to the overwhelming availability of these drugs as more people need medication, and the misconception that prescription drugs are safe since they are prescribed. Prescription drug abuse costs society billions of dollars and has serious health risks for individuals, including death when mixed with alcohol or other drugs.
Special Challenges in Clinical Trials: Case Study: the Dying child and the ...Michael Swit
A review of a case study involving whether it would be proper to authorize the use of a drug whose approval had been withdrawn when it is believed to be the only hope for a dying child.
Understanding Georgian Pharmaceutical LawMelinda_White
According to the document, pharmaceutical law in Georgia covers issues with medications including inadequate testing, insufficient warnings, and poor prescriptions from doctors. The document discusses how deaths from prescription drug overdoses have increased dramatically in Georgia in recent years. It provides an overview of pharmaceutical law and what legal recourse victims may have, including compensatory damages, if they have been harmed by dangerous drugs prescribed negligently in Georgia.
This document discusses the ethical challenges of marketing in the healthcare industry, particularly in the pharmaceutical sector. It examines cases involving Eli Lilly, GlaxoSmithKline, 23andMe, and Par Pharmaceuticals to illustrate tensions between informing patients and the FDA's role in ensuring safety. Pharmaceutical companies aim to educate through marketing, while the FDA controls information dissemination and prohibits off-label promotion to protect public health based on rigorous testing. The document urges understanding both perspectives to balance business and patient interests.
The document discusses the complex relationship between physicians and the pharmaceutical industry. It provides an overview of industry marketing practices like gifts and promotions and their influence on physician prescribing behaviors. It also reviews studies that show that even small gifts can create a sense of obligation in physicians and influence their clinical decisions, going against principles of objectivity and benefiting patients. Guidelines aim to limit gifts and promotions to protect against conflicts of interest, but relationships still present challenges to medical professionalism.
Scope after b pharmacy, m pharmacy, pharma d, d pharmacy,Career options after...Payaamvohra1
This ppt gives an idea about the different job opportunities, different career scope after completing pharmacy courses. Do checkout other ppt and videos of Best pharmacy tips and tricks
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.
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.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
This document summarizes an educational health seminar covering various topics:
1) Statistics on leading causes of death and health issues.
2) Causes of health problems like improper diet, chemicals, and lack of exercise.
3) Issues with traditional pharmaceutical-focused healthcare models and deception in the fitness industry. It promotes alternative health programs from doctors Mercola and Berg that focus on prevention and lifestyle changes.
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 the importance of patient-centered care and informed decision making when taking prescription drugs. It notes that adverse drug reactions are a leading cause of death and disability worldwide. It emphasizes that patients should question their doctors about prescribed drugs, including potential side effects, interactions, and non-drug treatment alternatives. The document encourages patients to research their medications and report any adverse reactions to help improve pharmacare outcomes and ensure treatments are safe and effective. Overall, it promotes empowering patients to make informed choices about prescription drug use through questioning, researching, sharing knowledge with others, and reporting reactions.
This paper discusses the growing problem of prescription drug abuse in the United States. It examines the roles of physicians overprescribing drugs, pharmaceutical companies aggressively marketing drugs, and individuals needing to take responsibility for their health. The paper argues that while prescription drugs can help some patients, too many are prescribed unnecessarily or dangerously. Physicians should recommend lifestyle changes before drugs, and individuals should research alternatives to newly prescribed drugs which are often pushed by pharmaceutical advertising. Overall responsibility lies with physicians to consider patient well-being over profits, pharmaceutical companies to curb misleading marketing, and individuals to make informed health decisions.
This study surveyed 36 patients in a residential addiction treatment program to understand the methods used to improperly obtain prescription medications from physicians. Key findings include:
- Patients obtained an average of 50 prescriptions over 3.8 years, seeing an average of 2 doctors in 1.2 different states and 5 pharmacies.
- The most common reasons for obtaining prescriptions from doctors rather than buying illegally were legal concerns and lower cost/increased comfort.
- The most obtained drug types were opioids (97% of patients) and sedative-hypnotics (47% of patients).
- The majority (75%) feigned symptoms to obtain prescriptions, with some using falsified medical records or
Over-the-Counter (OTC) and prescription drug abuse is a growing and dangerous problem, and as a retailer you can play a role in reducing and preventing it.
For additional info and resources on this topic visit www.helpingservices.org/otc.
Drug Safety is the science relating to collection, detection, assessment, monitoring and prevention of adverse effects with pharmaceutical products. It mainly focuses on adverse drug reactions
The use of conplementary and alternative medicine (SamboGlo
This document provides an overview of a seminar presentation on complementary and alternative medicine (CAM) and nursing practice. It defines CAM and discusses the most commonly used CAM therapies. It outlines safety concerns regarding regulatory issues and potential interactions. It also discusses nursing considerations for assessing CAM use, educating patients, and ensuring safety. Nurses need knowledge of CAM to understand their patients' health choices and provide guidance on reliable sources of information.
This document discusses medication errors that can occur in hospitals. It defines medication errors as any error in prescribing, dispensing, or administering drugs, regardless of whether harm occurs. Medication errors are a major cause of preventable patient harm. The document classifies medication errors as mistakes, slips, or lapses, depending on where the error occurs in the medication use process. It also discusses different ways medication errors have been estimated to cause deaths in other countries to highlight the significant impact of these errors.
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 document discusses the 2012 Joint Commission National Patient Safety Goals. It provides 3 goals: 1) improve patient identification, 2) improve communication among caregivers, and 3) improve safety of medication use. It also presents several case studies on medication errors and discusses root causes, prevention strategies, and recommendations to reduce errors.
This document discusses the non-prescribed use of over-the-counter (OTC) drugs by medical students. It finds that 70% of students self-medicate with cough remedies, antihistamines, and analgesics. Some also misuse broad-spectrum antibiotics and multivitamins. While OTC drugs can provide convenience, their misuse poses health risks like antibiotic resistance. The document examines the types of OTC drugs commonly used in India and their growth drivers and barriers. It also discusses debates around classifying some drugs in a new "behind-the-counter" category requiring pharmacist discussion.
Securing the Global Pharmaceutical Supply Chain against the Threat of Counter...Yasmin AbdelAziz
In 2012, counterfeit versions of the cancer drug
Avastin were found in 19 American treatment
centers. The impostor drug lacked the active
ingredient, rendering it virtually useless for
treatment purposes.
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/
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Similar to Americans patients exposed to counterfeit and black market medication (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 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.
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.
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.
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.
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.
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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.
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Co-Chairs, Val J. Lowe, MD, and Cyrus A. Raji, MD, PhD, prepared useful Practice Aids pertaining to Alzheimer’s disease for this CME/AAPA activity titled “Alzheimer’s Disease Case Conference: Gearing Up for the Expanding Role of Neuroradiology in Diagnosis and Treatment.” For the full presentation, downloadable Practice Aids, and complete CME/AAPA information, and to apply for credit, please visit us at https://bit.ly/3PvVY25. CME/AAPA credit will be available until June 28, 2025.
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LOW BIRTH WEIGHT. PRETERM BABIES OR SMALL FOR DATES BABIES
Americans patients exposed to counterfeit and black market medication
1. Fighting black market and counterfeit
drugs in America
Shabbir Imber Safdar
Director of National Outreach
Partnership for Safe Medicines
www.safemedicines.org
415-683-7526
shabbir@safemedicines.org
2. PSM Members
Academy of Managed Care Pharmacy
AIDS Drug Assistance Program
Alaska Pharmacists Association
The ALS Association
American Association for Homecare
American College Health Association
American Pharmacists Association
American Society of Health System Pharmacists
Arizona Pharmacy Alliance (AzPA)
Association of Nurses in AIDS Care
BioForward
Biotechnology Industry Organization
California Healthcare Institute
California Pharmacists Association
California Society of Health-System Pharmacists
(CSHP)
Colorado Biotechnology Association
Community Access National Network
The Council for Affordable Health Insurance
European Federation of Pharmaceutical Industries
and Associations (EFPIA)
Generic Pharmaceutical Association
Global Medicines Program
Healthcare Distribution Management Association
HealthCare Institute of New Jersey
Healthcare Leadership Council
The Hispanic Institute
Illinois Pharmacists Association
Institute of Health Law Studies
Institute for Safe Medication Practices
Interamerican College of Physicians and Surgeons North Carolina Association of Pharmacists
International Anti-Counterfeiting Coalition
Oklahoma Pharmacists Association
International Federation of Pharmaceutical
Parenteral Drug Association
Manufacturers and Associations
PDMA Alliance
Kidney Cancer Association
Pennsylvania Pharmacists Association
The Latino Coalition
Pennsylvania Society of Health-system
The Life Raft Group
Pharmacists
Maryland Pharmacists Association
Pharmaceutical Industry Labor Management
Maine Pharmacists Association
Association (PILMA)
Maine Society of Health-System Pharmacists
Pharmaceutical Security Institute
(MSHP)
Pharmacists Planning Services, Inc.
Men’s Health Network
PhRMA
Missouri Pharmacy Association
RetireSafe
National Alliance for Hispanic Health
Spina Bifida Association of America
National Alliance On Mental Illness
Texas Pharmacists Association
National Association of Chain Drug Stores
Texas Society of Health-System Pharmacists
National Association for Uniformed Services
United States Chamber of Commerce
National Association of Boards of Pharmacy
University of New England College of Pharmacy
National Association of Drug Diversion
University of Texas Pharmacy School
Investigators
Vietnam Veterans of America
National Association of Manufacturers
Virginia Pharmacists Association
National Alliance of State Pharmacy Associations Vermont Pharmacists Association
National Biopharmaceutical Security Council
West Virginia Rx
National Community Pharmacists Association
WomenHeart
National Grange of the Patrons of Husbandry
International and Governmental Organizations
National Latina Health Network
World Health Organization
NeedyMeds
Nevada Board of Pharmacy
Orange County Healthcare Agency
New York State Council of Health-system
Pharmacists (NYSCHP)
2
3. How Patients Are Protected
• Regulated, closed, licensed, secure supply chain, covering:
– Pharmacists and pharmacies
– Nurses, Physicians
– Wholesalers & Manufacturers
• FDA testing of medications
• FDA and company pharmacovigilance programs
• Pharmacist and physician supervision of medication choices and
interactions
Any break in the hand to hand regulatory chain
endangers patients. America is one of the few
countries with a closed, secure, drug supply chain.
4. How patients are endangered from
supply chain breaks
• Common: patients break it
– Buying online from unlicensed pharmacies
• Less common:
– Physicians, pharmacists, and distributors buying
from unlicensed distributors
• Uncommon:
– Manufacturing supply chain producer
5. Patients Buy Counterfeits
in Pursuit of Savings or
Magical Solutions
• Patients, too, break the supply
chain by buying from fake online
pharmacies (often claiming to be
Canadian) or other unapproved
avenues.
• Recent examples:
●
Weight loss pills
●
Flu Treatments
#fakedrugs
#PSM2013
6. Patients Buy Counterfeits in Pursuit of
Savings or Magical Solutions
• These consumers don't realize that:
●
Drugs they buy from Canadian online pharmacies are not
from Canada's legitimate drug supply.
●
Despite the assurances of drug exporters about "Tier One"
countries the FDA has never designated any country from
which it is universally safe to import medicine.
●
If it’s not FDA-approved, you can’t be assured that the
contents are safe, or what they’re supposed to be.
#fakedrugs
#PSM2013
7. 97% of more
than 10,000
websites
sampled were
out of
compliance
with laws and
pharmacy
practice
standards.
1 in 6
Americans buy
drugs on the
Internet
without a
prescription.
8. Patient story: Buying meds online isn’t
like buying socks
(where’s the cheapest price?)
• Even if it’s an over-thecounter medicine, it’s still
medicine.
• Victims purchased overthe-counter weight loss
medication from a website,
"www.2daydietshopping.co
m."
• Purchasers reported many
life-threatening side effects
including stroke.
• 2 people were convicted in
2011.
Containing sibutramine, a
prescription-only
ingredient, the pills could lead
to
• elevated blood pressure
• stroke
• heart attack
• anxiety
• nausea
• heart palpitations
• a racing heart
• insomnia
• increases in blood pressure
9. YouTube videos and
cartoons teach IUD
and implant
insertion and
removal,
despite the risk of
infection and death.
10. The Problem of
Misbranded Treatments
●
The United States has seen a rash of cases in which
medical professionals have purchased non-FDA
approved medicines and other medical devices.
●
Illegal distributors make a profit selling drugs from
sources that aren’t trustworthy -- illegally
imported, expired, stolen, damaged by bad
handling.
●
Doctors and pharmacist generate profit by billing
insurance, Medicare and patients the full price for
legitimate treatments.
#fakedrugs
#PSM2013
11. The Problem of
Misbranded Treatments
● This problem threatens a broad range of
patients who must rely on their healthcare
providers for safe treatments.
● Infused, injected and inhaled drugs are
particularly easy to counterfeit; the main
challenge is packaging.
12. Misbranded Treatments Botox
• Botox (onabotulinumtoxinA) -injected anti-wrinkle treatment, also
for repetitive neck spasms and
chronic migraines
●
Multiple cases. One false distributor sold almost
6,000 doses of unapproved, imported Botox
and Juviderm.
●
FDA warnings to over 350 medical offices,
including a Dallas area hospital, since 2012.
#fakedrugs
#PSM2013
13. Misbranded Treatments Botox
• What’s the Impact?
• 2.95 million Americans use Botox for a variety of reasons, both
cosmetic and medical.
• Since 2005, fake Botox has been found in investigations in Los
Angeles, Miami, and Kentucky.
• Patients have been disfigured and suffered
respiratory paralysis from counterfeit Botox.
14. Counterfeit Medicines
and Chronic Illness
#fakedrugs
#PSM2013
●
Patients are easily exploited while they are seeking better or
less expensive treatments.
●
Patients taking ongoing medications are at high risk because
they have longer exposure to more medicines.
●
Poor response to counterfeit or substandard medicines may be
misdiagnosed as treatment failure.
15. Misbranded Treatments
Osteoporosis Drugs
• Aclasta (zoledronate) and Prolia (denosumab) -injected medicines to treat osteoporosis.
●
Since September 2012, the FDA has warned 23 US
medical practices that they may have purchased
unapproved versions of these treatments.
• What’s the Impact?
●
40 million Americans suffer from osteoporosis or
are at high risk.
#fakedrugs
#PSM2013
16. Diverted Treatments
HIV Drugs
• MOMS Pharmacy, New York, 2012
●
4 individuals allegedly resold black market
HIV and AIDS medications that included
drugs previously dispensed to individuals,
as well as stolen and expired medications.
●
MOMS Pharmacy and its parent company,
Allion Healthcare sought reimbursement
from Medicaid.
●
The alleged scheme was a multi-state
operation that netted millions of dollars.
#fakedrugs
#PSM2013
17. Diverted Treatments
HIV Drugs
• What’s the Impact?
●
1.1 million people are living with AIDS in
the United States.
‣ (130,000 in New York State)
●
Expired or poorly handled treatments
are less effective (or ineffective).
HIV/AIDS patients rely on these
medicines to control their illness.
Ineffective treatments lead to decline
and death.
#fakedrugs
#PSM2013
18. Misbranded Drugs - Dialysis
• American Inhalation Medication Specialists, Inc.,
Tennessee, May 2013
●
Tennessee pharmacist Robert Harshbarger, Jr. substituted a
cheap Chinese import for the iron sucrose used to treat
anemia kidney dialysis patients.
●
Benefit programs paid more than $848,000 for the
misbranded iron sucrose between 2004 and 2008.
●
Several patients of Kansas Dialysis Services, L.C were
treated with the misbranded dialysis drugs.
#fakedrugs
#PSM2013
19. Misbranded Drugs - Dialysis
• What’s the Impact?
●
At the end of 2009, more than 871,000 Americans were being
treated for End Stage Renal Disease.
●
Untreated (or ineffectively treated) iron deficiency anemia
causes fatigue, shortness of breath, chest pain. Severe cases
can cause heart problems, infections and other complications.
●
Adulterated iron sucrose could cause
severe illness and death.
#fakedrugs
#PSM2013
20. Fake Drugs - Diabetes
● 2013: FDA warned diabetics to beware of illegal
“natural” remedies for the treatment of diabetes.
● Other cases around the world:
○
2011 - Fake test strips in India
○
2009 - Counterfeit insulin needles in the UK
○
2006 - Counterfeit test strips in the US
#fakedrugs
#PSM2013
21. Fake Drugs - Diabetes
• What’s the Impact?
●
As of 2011, 18.8 million Americans had been diagnosed with
diabetes.
●
Diabetes contributes to 231,404 deaths each year.
●
Ineffective treatment and poor blood sugar control
cause heart disease, stroke, blindness, kidney disease,
amputations, and poor immunity to other diseases.
#fakedrugs
#PSM2013
22. Emerging trend: black market IUDs
Two physicians in
Kentucky were
recently indicted
for purchasing IUDs
bought from an
unlicensed Chinese
manufacturer and
implanting them in
patients.
25. Misbranded Treatments
Avastin
●
McCleod Blood and Cancer Center
○
Kincaid, and his business manager
purchased misbranded drugs, and
administered them to patients.
○
Kincaid made at least $500,000 by
seeking reimbursement through the
Medicare and Medicaid/ TennCare
programs as well as other health
benefits programs.
#fakedrugs
#PSM2013
26. Misbranded Treatments
Avastin
• What’s the Impact?
• It’s difficult to know because the drugs were administered
to gravely ill patients who might have died anyway.
• "People who receive a fake medication instead of Avastin
could have lost several months of their lives.” – Dr. Nimesh
Nagarsheth, oncologist
#fakedrugs
#PSM2013
27.
28. Battleground: Maine
• Prescription drug broker in Canada facilitates
orders but not fulfillment.
• New state law passed in 2013 allows
importation of medication and prohibits board
of pharmacy from any oversight.
• Program has been going for over 8 eight years
by the Portland Employees Union and several
private Maine corporations.
29. Myths: Canadian online pharmacies are
pharmacies in Canada with a website
Unless you drive over the border into Canada to
a bricks and mortar pharmacy, when you order
from an online pharmacy you're getting a
company that pretends to sell non-Canadians
price-controlled medications for citizens.
These companies are not regulated by Health
Canada or the Provincial Pharmacy Boards.
30. Myth: Canadian pharmacists can legally
fill prescriptions from US physicians
• Pharmacists in Canada are not allowed to
legally fill a prescription written by an
American physician.
• Therefore if a “Canadian pharmacy” tells an
American to fax their prescription in, they’re
either breaking laws in their own country, or
there’s no pharmacist involved at all.
31. Myths: Canadian online pharmacies sell
price-controlled medication from Canada
Canadian citizen Andrew Strempler,
38, sentenced January 9th, 2013 to
4 years after pleading guilty to
conspiracy to commit mail fraud.
Strempler’s company, Mediplan,
fulfilled online medicine orders for
ten different online pharmacies.
FDA discovered that 90% of the drugs they seized from a Mediplan shipment were
counterfeit: Lipitor, Diovan, Actonel, Nexium, Hyzaar, Ezetrol (known as Zetia in the
US), Crestor, Celebrex, Arimidex, and Propecia.
These were not Canadian medicines, they were fakes from all over the world,
mailed from the Bahamas, with labels saying they were filled from Canada.
32. Save Money by Using FDA Approved
Generics
Not only can a generic be cheaper than a name brand, but a generic in the US
is usually cheaper than a name brand from a fake “Canadian pharmacy”. And
safer too.
33. Patient Safety: How to find discounts
The NeedyMeds Drug Discount Card
saves you up to 80% or more off
the cost of: Prescription Medicines, Overthe-Counter Drugs, Pet Prescription Drugs
The Partnership for Prescription
Assistance will help you find the program
that’s right for you, free of charge.
Buy from a VIPPS-certified online
pharmacy. Find a list at
http://www.vipps.info
34. Patient Safety: How to stay safe in the
doctor’s office
• Signs of suspicious medication in
the doctor’s office.
– Look for foreign writing
– Ask to see bottle/bag/unit with lot
number and write it down or take a
photo
• Pay attention to new or unusual
side effects or lack of therapeutic
benefit and notify your
physician/pharmacist.
35. Solving the problem
• Distribute these materials to educate the
public
• Get informed by joining our email list for
counterfeit warnings at
www.safemedicines.org
• Get our packet of handouts
• Join the Partnership for Safe Medicines
36. Efforts of the Partnership
This Year
This year we have worked with partners to reach
over 300,000 vulnerable American
patients, nurses, doctors, and pharmacists, and
nearly 1,000 at-risk clinics and doctor’s offices in six
key states.
Facebook ads
Fact pack
Patient handout
8
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40.
41.
42.
43.
44.
45.
46.
47.
48.
49.
50.
51.
52.
53.
54. Save the Date for the
2014 Interchange
September 18, 2014
Newseum
Freedom Forum
Knight Conference Center
Washington, DC
17
55. Thank you!
Please leave me your business card if you
want to receive a complete packet of our
printed materials after our next printing run in
January 2014.
We can provide large print runs of any
printed product for distribution for free to any
organization that joins PSM.
55
60. So, where do the fake pharmacies
get their medications?
These products are not made in a sterile environment. And then these fakes are sold
to American patients from “Canadian pharmacies” who ingest them.
61.
62. Misbranded Treatments
Avastin
• Kincaid and the
manager conspired
to hide the illegal
purchases from
nursing staff who
recognized that the
treatments were
counterfeit.
#fakedrugs
#PSM2013
Editor's Notes
It may seem obvious that certain medications are available illicitly on the internet, pain medications and lifestyle drugs, for example. And finding medications for recreational use can’t be so difficult because, as the NABP has determined from sampling for three years running, 97% of more than 10,000 websites analyzed were out of compliance with state and federal laws and or/NABP patient safety and pharmacy practice standards. Yet a December 2010 study by the Partnership at Drugfree.org found that 1 in 6 American obtain prescription drugs via the Internet without a valid prescription. This suggests that other medications are being purchased without doctor’s prescriptions to safeguard patient safety.
And it’s not just websites selling medications without prescriptions that promote harm. Social media sites such as Facebook, and instructional websites like YouTube are being used effectively to subvert the safety protocols of medicine. Every type of contraception is available online, including implants and IUDS complete with YouTube videos that demonstration self-implantation and insertion, despite the risk of infection and death. The health impact from a teenager purchasing and self-inserting a fake IUD is not just detrimental to the child’s health. It is symptomatic of a world-wide problem that causes the development of medicine-immune diseases and the death of many children.Fake medication given anywhere impacts health of everyone worldwide – It’s an issue that hurts everyone, especially women and children.
Cross-border jurisdiction problemsThe US case of the counterfeit cancer medications found in doctor’s clinics is a great example of how medication can move from country to country, with no authentication between sources. While the medication that ended up doctors’ offices from California to Illinois came from unauthorized distributors in the US, those people in turn purchased the medication from other unauthorized distributors from overseas where the medication wasn’t required to be inspected because it was “for export only.” Back from the UK, to Denmark, to Switzerland, to Egypt, the original signatory for the medication came froman illiterate supplier who signed his name with an “X” before traveling across three countries and through six countries.What jurisdiction did this crime occur in? Are the countries that passed the medication “for export only” through responsible? How do we protect patient safety when it’s so easy to pass the hot potato on to another party in another country?