In a recent article in USA Today - While the points in the article are related to mail out pharmacies and improved medication compliance, there are much better adherence rates when the medication is received from the clinic or physician’s office. As we look at ways to reduce the overwhelming healthcare debt facing the United States, physician dispensing is one big piece of the puzzle that can help reduce this unnecessary cost.
The document discusses orphan drugs and the need for orphan drug development. It defines orphan drugs as medicines developed to treat rare diseases affecting fewer than 5 in 10,000 people. It describes orphan drug policies in the US, EU, Japan and Australia which provide incentives like market exclusivity, tax credits and protocol assistance to encourage orphan drug development. It discusses hurdles to access orphan drugs in India like high prices and lack of formal incentives. It summarizes recent orphan drug approvals in the US and top selling orphan drugs worldwide. It highlights the need for policies and initiatives in India to encourage orphan drug development and ensure affordable access.
Orphan Drugs – the Challenges and Benefits of Navigating FDA’s Regime Governi...Michael Swit
Webinar sponsored by The Weinberg Group on Orphan Drugs, covering these topics:
The Basics of the Orphan Drug Act
Benefits of Orphan Drug status
Exclusivity
Protocol assistance, tax credits, and research grants
When is an indication is “rare”?
Orphan Drug Designation Requests – ensuring yours
robust and persuasive
Approval criteria for orphan products – how they
compare to non-orphan products
Challenges in the Orphan Drug Process
The document is a presentation about orphan drugs given by Dr. Atul Rajpara. It defines orphan drugs as those intended for the treatment of rare diseases or disorders. It discusses how rare diseases are defined in various countries and notes that over 7,000 rare diseases have been identified worldwide. The presentation outlines the Orphan Drug Act of 1983 in the US and its impact in incentivizing orphan drug development. It also discusses the orphan drug designation process and provides some examples of orphan drugs and their manufacturers. The presentation concludes by noting challenges to improving access to orphan drugs in India like affordability and a lack of incentives for drug developers.
Connecting the Dots for Fast-Track Approval for Rare Disease and Orphan DrugMedpace
This document discusses strategies for conducting clinical trials for rare diseases and orphan drugs. It begins with definitions of rare diseases and an overview of legislation related to orphan drugs. It then discusses considerations for site selection, recruitment, study execution, and monitoring that are unique to rare disease trials due to small patient populations and specialized needs. Key approaches include partnering with advocacy groups, using patient registries, minimizing patient burden, and providing tailored training and support to investigators and sites. The goal is to connect patients to trials and facilitate fast-track drug approval to meet significant unmet medical needs.
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/
The document discusses orphan drugs and regulations around them in various markets. It provides an overview of orphan drug policies in the US, EU, Australia, and Canada. The US Orphan Drug Act of 1983 was the first legislation to promote orphan drug development. It offers 7 years of market exclusivity. The EU and Canada have since established their own orphan drug frameworks that similarly aim to incentivize development of treatments for rare diseases through exclusivity periods, fee waivers, and assistance programs. However, orphan drugs regulations still face challenges around definitions of rare diseases, clinical data requirements, pricing and reimbursement.
The document discusses orphan drugs and the need for orphan drug development. It defines orphan drugs as medicines developed to treat rare diseases affecting fewer than 5 in 10,000 people. It describes orphan drug policies in the US, EU, Japan and Australia which provide incentives like market exclusivity, tax credits and protocol assistance to encourage orphan drug development. It discusses hurdles to access orphan drugs in India like high prices and lack of formal incentives. It summarizes recent orphan drug approvals in the US and top selling orphan drugs worldwide. It highlights the need for policies and initiatives in India to encourage orphan drug development and ensure affordable access.
Orphan Drugs – the Challenges and Benefits of Navigating FDA’s Regime Governi...Michael Swit
Webinar sponsored by The Weinberg Group on Orphan Drugs, covering these topics:
The Basics of the Orphan Drug Act
Benefits of Orphan Drug status
Exclusivity
Protocol assistance, tax credits, and research grants
When is an indication is “rare”?
Orphan Drug Designation Requests – ensuring yours
robust and persuasive
Approval criteria for orphan products – how they
compare to non-orphan products
Challenges in the Orphan Drug Process
The document is a presentation about orphan drugs given by Dr. Atul Rajpara. It defines orphan drugs as those intended for the treatment of rare diseases or disorders. It discusses how rare diseases are defined in various countries and notes that over 7,000 rare diseases have been identified worldwide. The presentation outlines the Orphan Drug Act of 1983 in the US and its impact in incentivizing orphan drug development. It also discusses the orphan drug designation process and provides some examples of orphan drugs and their manufacturers. The presentation concludes by noting challenges to improving access to orphan drugs in India like affordability and a lack of incentives for drug developers.
Connecting the Dots for Fast-Track Approval for Rare Disease and Orphan DrugMedpace
This document discusses strategies for conducting clinical trials for rare diseases and orphan drugs. It begins with definitions of rare diseases and an overview of legislation related to orphan drugs. It then discusses considerations for site selection, recruitment, study execution, and monitoring that are unique to rare disease trials due to small patient populations and specialized needs. Key approaches include partnering with advocacy groups, using patient registries, minimizing patient burden, and providing tailored training and support to investigators and sites. The goal is to connect patients to trials and facilitate fast-track drug approval to meet significant unmet medical needs.
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/
The document discusses orphan drugs and regulations around them in various markets. It provides an overview of orphan drug policies in the US, EU, Australia, and Canada. The US Orphan Drug Act of 1983 was the first legislation to promote orphan drug development. It offers 7 years of market exclusivity. The EU and Canada have since established their own orphan drug frameworks that similarly aim to incentivize development of treatments for rare diseases through exclusivity periods, fee waivers, and assistance programs. However, orphan drugs regulations still face challenges around definitions of rare diseases, clinical data requirements, pricing and reimbursement.
Mastering Regulatory Approval in New Orphan Drug MarketsLewis Lau
Presented at DIA 2015 Annual Meeting. A symposum titled "A Global Update on Orphan Drug" chaired by Mr Noriaki Murao
http://www.diaglobal.org/en-US/Flagship-Meetings/DIA-Annual-Meeting/Meeting-Program/Find-Sessions-and-Presentations/Event-Details.aspx?productID=3803687&eventType=Symposium&title=A%20Global%20Update%20on%20Orphan%20Drugs
This symposium addresses the current status and forthcoming activities related to orphan drugs in North America, EU and Japan. Orphan drug development is considered essential in these regions, and the various provisions to accelerate the development of orphan drugs have been implemented. However, some challenges still remain for the companies and the agencies wishing to pursue development and approval of orphan drugs in these regions.
Regulatory aspects of orphan drugs devolpmentsJITHIN K JOY
This document discusses regulatory aspects of orphan drugs and developments. It begins by defining orphan diseases and the need for orphan drug regulation to incentivize development of treatments for rare conditions. It describes orphan drug regulations in various countries like the US, Japan, Australia and challenges in developing orphan drugs. In India, around 6000-8000 rare diseases have been identified but many lack treatments. The document calls for India to introduce its own orphan drug act to define rare diseases, provide incentives for research and improve access to existing orphan drugs.
‘Orphan drugs’ future growth potential for indian pharmaceutical marketNitin Patel
This document discusses orphan drugs and their potential in the Indian pharmaceutical market. It defines orphan drugs as those developed for rare diseases affecting less than 8% of the population. The US was the first to pass orphan drug legislation in 1983 to incentivize development of these drugs. Similar laws now exist in other countries and provide benefits like 7 years of market exclusivity. While initially developed for small populations, some orphan drugs like Rituxan have become very profitable blockbusters. The global orphan drug market was worth $50 billion in 2011 and is growing faster than other drug markets. Several Indian companies are now developing or manufacturing orphan drugs for rare diseases.
This document provides information about an upcoming conference on orphan drugs that will take place on October 18-20, 2016 in London. It includes details about the interactive workshops on the first day and key sessions over the two main conference days that will discuss topics such as regulatory challenges, developing treatments for rare diseases, pediatric orphan drug development, and partnerships in the orphan drug field. Information is provided on registering for the event and sponsorship opportunities.
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
Orphan drugs have attractive attributes for development as they are potentially cheaper, faster, and less risky to develop compared to non-orphan drugs. They also have high sales potential in small distinct patient populations. Specifically, orphan drug development costs are about half that of non-orphans and their time to market is faster. They also have a higher regulatory approval success rate. This makes orphan drugs a growth opportunity, with their market forecast to reach 20% of prescription drug budgets by 2020 due to an 11.7% CAGR, higher than the 4.7% CAGR for non-orphans. Top orphan drugs are primarily in oncology and command very high prices, with the median orphan drug costing $66
The document summarizes the Orphan Drug Act of 1983 and its impact. It provides incentives like 7 years of marketing exclusivity and tax credits to stimulate development of drugs for rare diseases defined as affecting fewer than 200,000 people. Since 1983, over 1000 designations and 200 product approvals have occurred. While the Act has met its objectives, concerns around the high costs of orphan drugs and determining appropriate access and reimbursement are discussed.
This document discusses orphan diseases, orphan drugs, and regulatory aspects of orphan drugs in the US and Europe. It defines orphan diseases as those affecting fewer than 200,000 people in the US or 1 in 2000 people in Europe. Despite affecting a small percentage of the population, over 55 million people in the US and EU have orphan diseases. The document outlines regulations in the US and EU to incentivize development of orphan drugs, including market exclusivity periods. Key incentives include clinical trial cost subsidies and expedited FDA review in the US, as well as free orphan designation review by the EMA in Europe.
The document summarizes key findings from EvaluatePharma's 2014 Orphan Drug Report. It finds that worldwide orphan drug sales are forecast to reach $176 billion by 2020, almost double the growth of the overall prescription drug market. Orphan drugs are expected to account for 19.1% of worldwide prescription sales by 2020. The report also notes that Soliris, used to treat rare blood disorders, generates the highest revenue per patient of any orphan drug in the US.
The Office of Orphan Products Development (OOPD) at the FDA promotes the development of treatments for rare diseases and conditions. There are more than 6,800 known rare diseases affecting an estimated 25-30 million Americans. The Orphan Drug Act of 1983 provides financial incentives like tax credits, user fee waivers, and exclusive marketing rights for 7 years to encourage development of treatments for rare diseases. The OOPD oversees programs that grant orphan drug designation, provide funding for clinical trials and natural history studies, and award priority review vouchers for rare pediatric diseases.
The orphan drug area is relatively new but fast growing. Over the next weeks, Black Swan Consulting will summarise information on this class of drug products. Please also see http://black-swan-consulting.com/what-is-cooking/Orphan-drugs.
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.
Relationship Between Pharmacovigilance And Patient Safety[1]siddharthchachad
This document discusses challenges in pharmacovigilance and patient safety, including issues with accurate safety profiling, differences in safety reporting guidelines between countries, and limitations of only focusing on patient safety. It provides examples of drugs like thalidomide, vioxx, and celebrex that highlighted safety issues. Regulatory environments and safety reporting practices differ between countries like India, EU, and US. Standardization of terms and processes is important for effective pharmacovigilance.
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/
This document discusses the challenges and strategies for successful orphan drug development. It notes that despite small patient populations, orphan drug development has grown significantly due to regulatory incentives. However, orphan drug development faces challenges including difficulties designing studies due to lack of disease information, problems recruiting small patient populations, and regulatory complexities. The document recommends three strategies for overcoming these challenges: 1) partnering with experienced CROs knowledgeable in rare diseases, 2) engaging key opinion leaders to help with sites and education, and 3) allowing flexibility in protocols and budgets to address unexpected changes common in rare disease studies. Overall the document outlines the benefits and hurdles of orphan drug development and provides guidance on navigating clinical and regulatory obstacles.
Use of testimonials and endorsements in prescription drug advertisementsFreedom Monk
This document discusses the use of testimonials and endorsements in prescription drug advertising. It notes that while endorsements are widely used, they carry risks of being misleading if they overstate a drug's efficacy, minimize risks, or make unsupported claims. The FDA and FTC provide guidance on appropriate use of endorsements. Key points are that endorsements must be supported by substantial evidence and consistent with drug labeling. Risk information must also be adequately presented. Companies should verify endorsers' actual experience with the promoted drug. Statements cannot represent unsupported quality of life claims or overstate duration of efficacy. The FDA has taken enforcement action against misleading endorsements.
The document provides information on counterfeit drugs, including definitions, global and Indian statistics, examples of counterfeited drugs, and potential solutions. Some key points:
- The WHO defines counterfeit drugs as deliberately mislabeled regarding identity and/or source, and they may contain incorrect ingredients, insufficient active ingredients, or no active ingredients.
- India accounts for 10% of global drug production but also has high rates of counterfeiting, estimated at 20% of drugs. Globally, counterfeiting costs the legitimate pharmaceutical industry $75 billion annually.
- Many popular drugs are frequently counterfeited, such as Viagra, Lipitor, and cancer treatments. Counterfeits are found to contain
The document provides an overview of dispensing and medication counseling. It discusses the dispensing process which involves 6 steps: receiving and validating prescriptions, interpreting prescriptions, preparing and labeling items, making a final check, recording actions taken, and issuing medicine with instructions. Key aspects of each step are outlined such as selecting the proper stock, counting medications accurately, and ensuring the dispensed items match the prescription. The importance of accuracy, cleanliness and quality control throughout the dispensing process is emphasized.
Medicinal chemistry involves the discovery and design of new therapeutic chemicals and their development into medicines and drugs. It is an interdisciplinary field combining chemistry and biology. Medicinal chemists work to design new drug compounds, determine their biological effects, optimize their structures for desired effects and minimal side effects, and study how the body processes drugs. The physicochemical properties of drugs, like solubility, acidity, and reactivity influence their biological actions and interactions with targets in the body. Understanding these properties helps predict drugs' behaviors and design new candidates. A drug's solubility is key to its formulation and absorption in the body. Both lipophilic and hydrophilic structural features impact a molecule's solubility profile. Acidity and
Mastering Regulatory Approval in New Orphan Drug MarketsLewis Lau
Presented at DIA 2015 Annual Meeting. A symposum titled "A Global Update on Orphan Drug" chaired by Mr Noriaki Murao
http://www.diaglobal.org/en-US/Flagship-Meetings/DIA-Annual-Meeting/Meeting-Program/Find-Sessions-and-Presentations/Event-Details.aspx?productID=3803687&eventType=Symposium&title=A%20Global%20Update%20on%20Orphan%20Drugs
This symposium addresses the current status and forthcoming activities related to orphan drugs in North America, EU and Japan. Orphan drug development is considered essential in these regions, and the various provisions to accelerate the development of orphan drugs have been implemented. However, some challenges still remain for the companies and the agencies wishing to pursue development and approval of orphan drugs in these regions.
Regulatory aspects of orphan drugs devolpmentsJITHIN K JOY
This document discusses regulatory aspects of orphan drugs and developments. It begins by defining orphan diseases and the need for orphan drug regulation to incentivize development of treatments for rare conditions. It describes orphan drug regulations in various countries like the US, Japan, Australia and challenges in developing orphan drugs. In India, around 6000-8000 rare diseases have been identified but many lack treatments. The document calls for India to introduce its own orphan drug act to define rare diseases, provide incentives for research and improve access to existing orphan drugs.
‘Orphan drugs’ future growth potential for indian pharmaceutical marketNitin Patel
This document discusses orphan drugs and their potential in the Indian pharmaceutical market. It defines orphan drugs as those developed for rare diseases affecting less than 8% of the population. The US was the first to pass orphan drug legislation in 1983 to incentivize development of these drugs. Similar laws now exist in other countries and provide benefits like 7 years of market exclusivity. While initially developed for small populations, some orphan drugs like Rituxan have become very profitable blockbusters. The global orphan drug market was worth $50 billion in 2011 and is growing faster than other drug markets. Several Indian companies are now developing or manufacturing orphan drugs for rare diseases.
This document provides information about an upcoming conference on orphan drugs that will take place on October 18-20, 2016 in London. It includes details about the interactive workshops on the first day and key sessions over the two main conference days that will discuss topics such as regulatory challenges, developing treatments for rare diseases, pediatric orphan drug development, and partnerships in the orphan drug field. Information is provided on registering for the event and sponsorship opportunities.
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
Orphan drugs have attractive attributes for development as they are potentially cheaper, faster, and less risky to develop compared to non-orphan drugs. They also have high sales potential in small distinct patient populations. Specifically, orphan drug development costs are about half that of non-orphans and their time to market is faster. They also have a higher regulatory approval success rate. This makes orphan drugs a growth opportunity, with their market forecast to reach 20% of prescription drug budgets by 2020 due to an 11.7% CAGR, higher than the 4.7% CAGR for non-orphans. Top orphan drugs are primarily in oncology and command very high prices, with the median orphan drug costing $66
The document summarizes the Orphan Drug Act of 1983 and its impact. It provides incentives like 7 years of marketing exclusivity and tax credits to stimulate development of drugs for rare diseases defined as affecting fewer than 200,000 people. Since 1983, over 1000 designations and 200 product approvals have occurred. While the Act has met its objectives, concerns around the high costs of orphan drugs and determining appropriate access and reimbursement are discussed.
This document discusses orphan diseases, orphan drugs, and regulatory aspects of orphan drugs in the US and Europe. It defines orphan diseases as those affecting fewer than 200,000 people in the US or 1 in 2000 people in Europe. Despite affecting a small percentage of the population, over 55 million people in the US and EU have orphan diseases. The document outlines regulations in the US and EU to incentivize development of orphan drugs, including market exclusivity periods. Key incentives include clinical trial cost subsidies and expedited FDA review in the US, as well as free orphan designation review by the EMA in Europe.
The document summarizes key findings from EvaluatePharma's 2014 Orphan Drug Report. It finds that worldwide orphan drug sales are forecast to reach $176 billion by 2020, almost double the growth of the overall prescription drug market. Orphan drugs are expected to account for 19.1% of worldwide prescription sales by 2020. The report also notes that Soliris, used to treat rare blood disorders, generates the highest revenue per patient of any orphan drug in the US.
The Office of Orphan Products Development (OOPD) at the FDA promotes the development of treatments for rare diseases and conditions. There are more than 6,800 known rare diseases affecting an estimated 25-30 million Americans. The Orphan Drug Act of 1983 provides financial incentives like tax credits, user fee waivers, and exclusive marketing rights for 7 years to encourage development of treatments for rare diseases. The OOPD oversees programs that grant orphan drug designation, provide funding for clinical trials and natural history studies, and award priority review vouchers for rare pediatric diseases.
The orphan drug area is relatively new but fast growing. Over the next weeks, Black Swan Consulting will summarise information on this class of drug products. Please also see http://black-swan-consulting.com/what-is-cooking/Orphan-drugs.
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.
Relationship Between Pharmacovigilance And Patient Safety[1]siddharthchachad
This document discusses challenges in pharmacovigilance and patient safety, including issues with accurate safety profiling, differences in safety reporting guidelines between countries, and limitations of only focusing on patient safety. It provides examples of drugs like thalidomide, vioxx, and celebrex that highlighted safety issues. Regulatory environments and safety reporting practices differ between countries like India, EU, and US. Standardization of terms and processes is important for effective pharmacovigilance.
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/
This document discusses the challenges and strategies for successful orphan drug development. It notes that despite small patient populations, orphan drug development has grown significantly due to regulatory incentives. However, orphan drug development faces challenges including difficulties designing studies due to lack of disease information, problems recruiting small patient populations, and regulatory complexities. The document recommends three strategies for overcoming these challenges: 1) partnering with experienced CROs knowledgeable in rare diseases, 2) engaging key opinion leaders to help with sites and education, and 3) allowing flexibility in protocols and budgets to address unexpected changes common in rare disease studies. Overall the document outlines the benefits and hurdles of orphan drug development and provides guidance on navigating clinical and regulatory obstacles.
Use of testimonials and endorsements in prescription drug advertisementsFreedom Monk
This document discusses the use of testimonials and endorsements in prescription drug advertising. It notes that while endorsements are widely used, they carry risks of being misleading if they overstate a drug's efficacy, minimize risks, or make unsupported claims. The FDA and FTC provide guidance on appropriate use of endorsements. Key points are that endorsements must be supported by substantial evidence and consistent with drug labeling. Risk information must also be adequately presented. Companies should verify endorsers' actual experience with the promoted drug. Statements cannot represent unsupported quality of life claims or overstate duration of efficacy. The FDA has taken enforcement action against misleading endorsements.
The document provides information on counterfeit drugs, including definitions, global and Indian statistics, examples of counterfeited drugs, and potential solutions. Some key points:
- The WHO defines counterfeit drugs as deliberately mislabeled regarding identity and/or source, and they may contain incorrect ingredients, insufficient active ingredients, or no active ingredients.
- India accounts for 10% of global drug production but also has high rates of counterfeiting, estimated at 20% of drugs. Globally, counterfeiting costs the legitimate pharmaceutical industry $75 billion annually.
- Many popular drugs are frequently counterfeited, such as Viagra, Lipitor, and cancer treatments. Counterfeits are found to contain
The document provides an overview of dispensing and medication counseling. It discusses the dispensing process which involves 6 steps: receiving and validating prescriptions, interpreting prescriptions, preparing and labeling items, making a final check, recording actions taken, and issuing medicine with instructions. Key aspects of each step are outlined such as selecting the proper stock, counting medications accurately, and ensuring the dispensed items match the prescription. The importance of accuracy, cleanliness and quality control throughout the dispensing process is emphasized.
Medicinal chemistry involves the discovery and design of new therapeutic chemicals and their development into medicines and drugs. It is an interdisciplinary field combining chemistry and biology. Medicinal chemists work to design new drug compounds, determine their biological effects, optimize their structures for desired effects and minimal side effects, and study how the body processes drugs. The physicochemical properties of drugs, like solubility, acidity, and reactivity influence their biological actions and interactions with targets in the body. Understanding these properties helps predict drugs' behaviors and design new candidates. A drug's solubility is key to its formulation and absorption in the body. Both lipophilic and hydrophilic structural features impact a molecule's solubility profile. Acidity and
Pharmacognosy is "the study of the physical, chemical, biochemical and biological properties of drugs, drug substances or potential drugs or drug substances of natural origin as well as the search for new drugs from natural sources".
General Chemistry and Inorganic Pharmaceutical Chemistry Module 1 Pharmacist ...Senyora Ouf'ra
This document provides an overview of Module 1 of the pharmacist licensure exam, which covers various topics in pharmaceutical chemistry. It will be the first module administered on the first day of the exam from 8-10 AM. The module will include questions from general chemistry, inorganic and organic medicinal chemistry, analytical chemistry, and other related chemical topics. The document emphasizes that Module 1 will be the most difficult and important module to study for. It then provides examples of key topics covered, such as atomic structure, types of chemical bonds, gas laws, and thermodynamics.
Statistics for the Health Scientist: Basic Statistics IDrLukeKane
This document provides an introduction to statistics. It defines key statistical concepts like variables, data, and different types of variables. Descriptive statistics are used to summarize raw data through tables and charts. Different types of charts are described that are suitable for categorical or quantitative variables. The goals are to classify variables, choose appropriate charts and tables, and understand how to describe and communicate data.
This resource is a comprehensive inorganic chemistry workbook for first year undergraduates. It is designed as a revision resource with plenty of worked examples followed by problems to try themselves. Worked answers are given to all the problems to allow students to develop confidence in problem solving.
Pharmacology: Class Session 1 and 2 Introduction to PharmacologyMariaJose2001
This is an outline of the basics of Pharmacology. A discussion of how drugs are named, classified and its effects on the person's biochemical processes. It also included the factors influencing drug action and potential drug interactions. At the end, some commonly ysed terminologies were defined.
This document discusses the science of pharmacy and pharmacognosy. It defines pharmacy as dealing with the procurement, testing, storage, and conversion of drugs into suitable forms. Pharmacognosy is defined as the study of drugs from biological origins, including plants, animals, and minerals. The document outlines the scope of pharmacognosy, including isolation of phytochemicals, structure-activity relationships, cultivation of medicinal plants, and development of herbal formulations. Physical and chemical parameters used to evaluate crude drugs are also summarized, such as ash values, swelling factor, and extractive values.
Clinical pharmacy involves pharmacists taking a patient-centered approach to medication therapy to promote health and wellness. It requires advanced clinical knowledge and skills beyond traditional dispensing roles. Clinical pharmacists work directly with patients, physicians, and other healthcare providers to optimize medication use, identify and resolve medication-related problems, educate patients, and ensure the safe, effective, and economical use of medications. They are integral members of the healthcare team across various clinical practice settings and specialties.
Research is the systematic and objective analysis and recording of controlled observations that may lead to the development of generalizations, principles, or theories, resulting in prediction and possible control of events .
WHO guidelines on herbal drug monitoringKaustav Dey
This presentation points out the various guidelines laid out by World health organization for safe & effective way of monitoring of Herbal Medicine in a pharmacovigilance setting
Who guidelines on safety monitoring of natural medicinesPharmacy Slides
This document provides guidelines for monitoring the safety of herbal medicines. It discusses that while some see herbal medicines as inherently safe due to being natural, they can still cause adverse effects. It outlines collecting reports on adverse events from healthcare professionals, consumers, manufacturers, and others. It provides guidance on what herbal products should be monitored and how to report suspected adverse reactions, including requesting information like patient identification and descriptions of the adverse reaction. The goal is to support member states in strengthening pharmacovigilance systems to effectively monitor herbal medicine safety.
The document discusses the marketing and regulation of over-the-counter (OTC) drugs, including the differences between OTC and prescription drugs, the OTC drug review process conducted by the FDA, and the role of pharmacists in counseling patients on the safe and effective use of OTC medications. Key points covered include the benefits and risks of OTC drug use, the FDA approval pathways for OTC products, and best practices for pharmacist counseling on OTC selections and their appropriate use.
1)spontanious reporting schemes for biodrug adverse reactionsNeha Suresh
This document discusses sources of reports on adverse reactions to herbal drugs, herbal products targeted for safety monitoring, and reporting of suspected adverse drug reactions. The main sources of reports are healthcare professionals, consumers, and manufacturers. Herbal products can be categorized based on their regulatory status and marketing status. Only certain professionals can report adverse reactions, and reports should include identification information, herbal product details, adverse reaction data, other medication use, and the reporter's contact information. A single reporting form should be used to submit reports via various methods.
The document summarizes regulatory affairs for the MHRA and USFDA. It discusses the history and roles of the MHRA in regulating clinical trials, licensing products, and enforcing regulations in the UK. It then outlines the development process for new drugs from discovery through licensing. Finally, it provides an introduction to the USFDA, covering its definition, history, mission, organization, functions, and products regulated.
Hospital Formulary - presentation gives the detail idea about Hospital formulary, its advantage, disadvantage, how to prepare Hospital formulary and much more. this will be useful for Pharm.D-IV YEAR students, which was in their Hospital pharmacy subject. regards APOLLOJAMES
Pharmaceutical marketing aims to educate consumers and healthcare professionals about new treatments. While some question the value of marketing, it plays an important role in disseminating medical information. Recent changes include voluntary principles for direct-to-consumer ads and a strengthened industry code of ethics. Studies show marketing helps address underdiagnosis and undertreatment by raising disease awareness and prompting patients to see doctors. However, most physicians say clinical knowledge and patient needs strongly influence prescribing over marketing.
Pharmaceutical marketing to healthcare providers provides information on new treatment options, but it is only one of many factors that influence prescribing decisions. Surveys find clinical knowledge, patient factors, and insurance policies have greater impacts. Approximately 67% of US prescriptions are for generic drugs, much higher than other countries. While representatives provide information, prescribing is shaped more by clinical guidelines, peers, formularies, and insurers' prior authorization requirements than representative interactions.
This document summarizes a presentation given by Demetra Ashley of the DEA about regulations and efforts to address the prescription drug abuse epidemic. It discusses how most prescription drug abuse involves obtaining medications from friends and family, not through criminal means. The DEA works with various groups to educate on responsible prescribing and dispensing through initiatives like take-back events and conferences. The goal is to curb abuse while ensuring access to needed medications through enforcement as well as prevention and treatment efforts.
Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a prescription, from a healthcare professional, as compared to prescription drugs , which may be sold only to consumers possessing a valid prescription.
OTC drugs are selected by a regulatory agency to ensure that they are ingredients that are safe and effective when used without a physician's care.
Qui Tam: Off Label Drug Marketing [Data Snapshot]lawsuitlegal
When does the promotion of a pharmaceutical become illegal?
Learn what is considered off-label use for popular drugs and when it becomes unlawful in this data snapshot.
We share the most common types of off-label uses, where it happens most often, and what exceptions provide 'safe haven' protection.
Most doctors and hospitals are prescribing doctors as they should be, with the patients in mind.
However, off-label prescriptions are important when considered in relation to the False Claims Act. The issue of insurance reimbursement takes center stage when drugs are being used unlawfully and these healthcare organizations are receiving insurance payments for improper use.
So take a moment to review the data with us on Off-Label Marketing relating to qui tam actions, today.
This document provides information on best practices for prescribing opioid therapy and managing pain patients, including key facts on the pain management epidemic. It discusses definitions of chronic pain and addiction. Guidelines are provided on initial patient assessment, implementing opioid therapy if appropriate, identifying addiction risks, prescribing protocols, urine drug testing protocols, and legislation related to prescription drug monitoring programs. The goal is to provide physicians with tools and guidelines for safely and effectively managing patients with chronic pain.
Pharmacovigilance is the science of monitoring the effects of pharmaceutical products after they have been licensed for use, especially in order to identify and evaluate previously unreported adverse reactions. Herb-drug interactions can occur when herbs are taken concurrently with prescription or over-the-counter medications. Some common herb-drug interactions include garlic increasing the breakdown of antiviral drugs, green tea increasing the side effects of oral contraceptives, and liquorice decreasing the effectiveness of antihypertensives. It is important to report any suspected adverse reactions to medications to help ensure safe and effective use of drugs and herbs.
Criticism of drug promotional literature(dpl)souravpharma
This document discusses drug promotional literature and provides guidelines for its evaluation. It begins with an introduction on the large amount of drug information physicians receive. It then discusses the methods companies use to promote drugs, including detailing, literature, and gifts. Key points made are that drug promotion aims to induce prescription over educate and often includes inaccurate information. The document reviews sources physicians use, regulatory codes from WHO and India, and criteria for promotional materials. It emphasizes the need for physicians to critically evaluate promotional claims using scientific evidence.
This document discusses prescription auditing at a medical college and hospital. It defines prescription auditing and its objectives which include assessing irrational prescribing, detecting errors, and improving the quality of prescriptions. It outlines the audit process including forming a committee, setting criteria, collecting a sample of prescriptions, analyzing the data, generating a report, and creating an action plan. Key aspects of prescriptions that should be audited are completeness, legibility, rationality of medications prescribed, and adherence to treatment guidelines. The audit aims to promote rational drug use and reduce errors and costs to improve patient care.
The document discusses guidelines for developing a formulary for a 300-bed teaching hospital. It defines a hospital formulary and outlines the objectives to ensure rational drug therapy and control costs. Members of the pharmacy and therapeutics committee are involved in criteria selection, regular reviews, and managing the formulary list. The roles of pharmacists include preparing monographs with drug information and participating in the drug and therapeutics committee for policy development.
Off-label drug use refers to when a drug is used in a way that is different from its FDA-approved label, such as being given in a different dose or route, or used to treat a different disease. While doctors can legally prescribe drugs off-label, drug companies cannot market drugs for off-label uses. Off-label drug use is common in cancer treatment because some cancer drugs work against many tumor types and cancer treatment is constantly evolving. When considering off-label drug treatment, patients should ask about the evidence and risks/benefits compared to approved drugs. The FDA could better regulate off-label use by systematically collecting post-market data on harms and benefits and disseminating reports on off-label evidence
This document provides a market entry strategy for a biosimilar drug called Bevacizumab in China. It summarizes the Chinese oncology drug market, key competitors, regulatory approval process, pricing and reimbursement systems. It also provides a cost analysis and break even calculation for Bevacizumab. The total Chinese cancer drug market is worth $10.5 billion annually and colon cancer represents $1.78 billion of that market. Approval for a new drug takes 18-26 months and involves domestic clinical trials and quality testing. Pricing of oncology drugs is regulated by the government.
DCGI circular for Regulatory guidelines for sampling.pdf (1).pdfvenumadhavvurugonda
This document provides regulatory guidelines for sampling of drugs, cosmetics, and medical devices by drugs inspectors in India. It outlines procedures for sample selection based on identified risks, number of samples to collect, timelines, maintaining sampling databases, and reporting samples found to be Not of Standard Quality or spurious. The goal is to optimize limited resources and ensure effective quality surveillance across supply chains through a uniform sampling methodology. Key aspects include collecting a minimum of 10 samples per inspector per month, focusing on high-risk products and locations, and reporting test results within 10 days for public alerts.
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Health Tech Market Intelligence Prelim Questions -Gokul Rangarajan
The Ultimate Guide to Setting up Market Research in Health Tech part -1
How to effectively start market research in the health tech industry by defining objectives, crafting problem statements, selecting methods, identifying data collection sources, and setting clear timelines. This guide covers all the preliminary steps needed to lay a strong foundation for your research.
This lays foundation of scoping research project what are the
Before embarking on a research project, especially one aimed at scoping and defining parameters like the one described for health tech IT, several crucial considerations should be addressed. Here’s a comprehensive guide covering key aspects to ensure a well-structured and successful research initiative:
1. Define Research Objectives and Scope
Clear Objectives: Define specific goals such as understanding market needs, identifying new opportunities, assessing risks, or refining pricing strategies.
Scope Definition: Clearly outline the boundaries of the research in terms of geographical focus, target demographics (e.g., age, socio-economic status), and industry sectors (e.g., healthcare IT).
3. Review Existing Literature and Resources
Literature Review: Conduct a thorough review of existing research, market reports, and relevant literature to build foundational knowledge.
Gap Analysis: Identify gaps in existing knowledge or areas where further exploration is needed.
4. Select Research Methodology and Tools
Methodological Approach: Choose appropriate research methods such as surveys, interviews, focus groups, or data analytics.
Tools and Resources: Select tools like Google Forms for surveys, analytics platforms (e.g., SimilarWeb, Statista), and expert consultations.
5. Ethical Considerations and Compliance
Ethical Approval: Ensure compliance with ethical guidelines for research involving human subjects.
Data Privacy: Implement measures to protect participant confidentiality and adhere to data protection regulations (e.g., GDPR, HIPAA).
6. Budget and Resource Allocation
Resource Planning: Allocate resources including time, budget, and personnel required for each phase of the research.
Contingency Planning: Anticipate and plan for unforeseen challenges or adjustments to the research plan.
7. Develop Research Instruments
Survey Design: Create well-structured surveys using tools like Google Forms to gather quantitative data.
Interview and Focus Group Guides: Prepare detailed scripts and discussion points for qualitative data collection.
8. Sampling Strategy
Sampling Design: Define the sampling frame, size, and method (e.g., random sampling, stratified sampling) to ensure representation of target demographics.
Participant Recruitment: Plan recruitment strategies to reach and engage the intended participant groups effectively.
9. Data Collection and Analysis Plan
Data Collection: Implement methods for data gathering, ensuring consistency and validity.
Analysis Techniques: Decide on analytical approaches (e.g., statistical
Basics of Electrocardiogram
CONTENTS
●Conduction System of the Heart
●What is ECG or EKG?
●ECG Leads
●Normal waves of ECG.
●Dimensions of ECG.
● Abnormalities of ECG
CONDUCTION SYSTEM OF THE HEART
ECG:
●ECG is a graphic record of the electrical activity of the heart.
●Electrical activity precedes the mechanical activity of the heart.
●Electrical activity has two phases:
Depolarization- contraction of muscle
Repolarization- relaxation of muscle
ECG Leads:
●6 Chest leads
●6 Limb leads
1. Bipolar Limb Leads:
Lead 1- Between right arm(-ve) and left arm(+ve)
Lead 2- Between right arm(-ve) and left leg(+ve)
Lead 3- Between left arm(-ve)
and left leg(+ve)
2. Augmented unipolar Limb Leads:
AvR- Right arm
AvL- Left arm
AvF- Left leg
3.Chest Leads:
V1 : Over 4th intercostal
space near right sternal margin
V2: Over 4th intercostal space near left sternal margin
V3:In between V2 and V4
V4:Over left 5th intercostal space on the mid
clavicular line
V5:Over left 5th intercostal space on the anterior
axillary line
V6:Over left 5th intercostal space on the mid
axillary line.
Normal ECG:
Waves of ECG:
P Wave
•P Wave is a positive wave and the first wave in ECG.
•It is also called as atrial complex.
Cause: Atrial depolarisation
Duration: 0.1 sec
QRS Complex:
•QRS’ complex is also called the initial ventricular complex.
•‘Q’ wave is a small negative wave. It is continued as the tall ‘R’ wave, which is a positive wave.
‘R’ wave is followed by a small negative wave, the ‘S’ wave.
Cause:Ventricular depolarization and atrial repolarization
Duration: 0.08- 0.10 sec
T Wave:
•‘T’ wave is the final ventricular complex and is a positive wave.
Cause:Ventricular repolarization Duration: 0.2 sec
Intervals and Segments of ECG:
P-R Interval:
•‘P-R’ interval is the interval
between the onset of ‘P’wave and onset of ‘Q’ wave.
•‘P-R’ interval cause atrial depolarization and conduction of impulses through AV node.
Duration:0.18 (0.12 to 0.2) sec
Q-T Interval:
•‘Q-T’ interval is the interval between the onset of ‘Q’
wave and the end of ‘T’ wave.
•‘Q-T’ interval indicates the ventricular depolarization
and ventricular repolarization,
i.e. it signifies the
electrical activity in ventricles.
Duration:0.4-0.42sec
S-T Segment:
•‘S-T’ segment is the time interval between the end of ‘S’ wave and the onset of ‘T’ wave.
Duration: 0.08 sec
R-R Interval:
•‘R-R’ interval is the time interval between two consecutive ‘R’ waves.
•It signifies the duration of one cardiac cycle.
Duration: 0.8 sec
Dimension of ECG:
How to find heart rhytm of the heart?
Regular rhytm:
Irregular rhytm:
More than or less than 4
How to find heart rate using ECG?
If heart Rhytm is Regular :
Heart rate =
300/No.of large b/w 2 QRS complex
= 300/4
=75 beats/mins
How to find heart rate using ECG?
If heart Rhytm is irregular:
Heart rate = 10×No.of QRS complex in 6 sec 5large box = 1sec
5×6=30
10×7 = 70 Beats/min
Abnormalities of ECG:
Cardiac Arrythmias:
1.Tachycardia
Heart Rate more than 100 beats/min
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Physician Dispensing Key in Reducing Billions to US Healthcare Costs
1. EMERGING PARADIGMS: PHYSICIAN
DISPENSING
Mark A. Munger, Pharm.D., F.C.C.P., F.A.C.C.
Professor, Pharmacotherapy
Adjunct Professor, Internal Medicine
University of Utah
NABP 110th Annual Meeting 05/20/14 Phoenix, AZ Munger MA et al. Pharmacotherapy 2014 1
2. PRESENTER DISCLOSURE INFORMATION
I will not discuss off-label use or investigational use in my presentation.
I have no financial relationships to disclose.
Employee of: None
Consultant for: None
Stockholder in: None
Research support from: Utah Legislature and Department of Commerce
Honoraria from: None
NABP 110th Annual Meeting 05/20/14 Phoenix, AZ Munger MA et al. Pharmacotherapy 2014 2
3. SELF-ASSESSMENT QUESTIONS
Physician dispensing in the United
States is:
A. Rare
B. Practiced daily or weekly
C. Commonplace across all practice
settings
D. Under the direction of the Board of
Pharmacy in most states
Physicians perceive drug
dispensing as:
A. Reducing the drug cost to my patients
B. Reducing the cost of healthcare
C. Improving drug adherence
D. All of the above
NABP 110th Annual Meeting 05/20/14 Phoenix, AZ Munger MA et al. Pharmacotherapy 2014 3
4. SELF-ASSESSMENT QUESTIONS
Physician perception of the highest
burden of pharmacy practice rules on
dispensing practice is:
A. Labeling the prescription bottle
B. Keeping a medication profile system
C. Drug stock labeling and inventory
control
D. Maintaining prescription and drug
record keeping
NABP 110th Annual Meeting 05/20/14 Phoenix, AZ Munger MA et al. Pharmacotherapy 2014 4
5. UTAH PHYSICIAN DISPENSING LEGISLATION
2010 Legislative Session: SB 88 exempted physicians and clinics from pharmacist
and pharmacy licensure if dispensing a cosmetic drug or injectable weight loss drug.
2011 Legislative Session: SB 128 exempted prescribing practitioners from pharmacist
and pharmacy licensure if dispensing a cosmetic drug or injectable weight loss drug.
Prescribing practitioner: licensed physicians, APRNs, PA, and optometrists.
NABP 110th Annual Meeting 05/20/14 Phoenix, AZ Munger MA et al. Pharmacotherapy 2014 5
6. UTAH PHYSICIAN DISPENSING LEGISLATION
2012 Legislative Session: SB 161 permitted prescribing practitioners to dispense
certain oncology drugs without a license provided they meet established
requirements.
Required that prescribing practitioners qualifying for a drug dispensing exemption
relating to oncology drugs, selling contact lenses, or cosmetic or injectable weight loss
drugs notify the Division (DOPL) in writing of their intent to dispense a drug
Excluded Schedule I, II, and III drugs from the drugs that oncologists could dispense
Required the Division (DOPL) to conduct a study evaluating:
National compilation of state dispensing laws; and
Current research on non-pharmacist dispensing and patient safety
NABP 110th Annual Meeting 05/20/14 Phoenix, AZ Munger MA et al. Pharmacotherapy 2014 6
7. RESEARCH SERIES ON HEALTHCARE
PRACTITIONER DISPENSING 2012
Mark A. Munger, Pharm.D., Michael Feehan, Ph.D., Emily Rumanek, M.A., M.B.A.,
Lynsie Ranker, B.S., Kristen Vincent, Sc.B., Scott Silverstein, Pharm.D., and Jim
Ruble, Pharm.D., J.D.
Collaborative Study Team (University of Utah Health Sciences Center and
Observant, LLC. Boston, MA.)
Funding: State of Utah Legislature and Department of Commerce Grant-in-Aid
NABP 110th Annual Meeting 05/20/14 Phoenix, AZ Munger MA et al. Pharmacotherapy 2014 7
8. RESEARCH SERIES: THREE INDEPENDENT STUDIES
I. Healthcare Practitioner Prescribing in 50 State Statutes and Rules
A. Lexus Nexus: Academic Universe
1. Search Terms: Physician, dispens*, Practitioner
B. State Websites for Boards of Pharmacy
C. National Association Boards of Pharmacy Survey of Pharmacy Law 2012
II. Healthcare Practitioner Dispensing of Prescription and OTC Products
A. 379 healthcare practitioners completed a 15-minute online survey in September and October 2012.
B. Nurse practitioners, optometrists, oncologists, dermatologists, and plastic or reconstructive surgeons were selected due
to state of Utah statues.
C. Respondents were recruited by email from an pre-registered (“opt-in”) online panel to participate in market research
studies.
III.Consumer Perceptions of the Dispensing of Prescription and OTC Products by Healthcare
Practitioners
A. A total of 999 adult consumers in the USA completed a 15-minute online survey in October 2012.
B. All respondents had been dispensed a prescription and/or an OTC product, by a healthcare practitioner in the past 12
months.
C. Participants were recruited by email from an online panel of consumers pre-registered (“opt-in”) to participate in
market research studies
9. Non-Pharmacist Dispensing in the US
Allowed (44 States)
Restricted (6 States)
MA– no specific law authorizing
MT – dispensing prohibited; some exceptions
NJ – dispensing allowed; but limited to 7-day supply
NY – dispensing allowed; limited to 72 hour supply
TX – dispensing not allowed; 72 hour immediate need
UT – dispensing limited to cosmetic drugs
NABP 110th Annual Meeting 05/20/14 Phoenix, AZ
Munger MA et al. Pharmacotherapy 2014
9
10. PRACTITIONERS QUALIFIED TO DISPENSE
MD, DO, DDS, DPM, DVM, PA, NP (38 States)
Restricted to MD, DO, DDS, DPM, DVM (6 States)
NABP 110th Annual Meeting 05/20/14 Phoenix, AZ
Munger MA et al. Pharmacotherapy 2014
10
11. DISPENSING PRACTITIONER REGISTRATION
Registration Required (16 States)
No Registration Required (28 States)
States require registration with respective professional board, except:
NE – register with BoP as “delegated dispenser”
NH – register with BoP as “limited retail drug distributor”
NABP 110th Annual Meeting 05/20/14 Phoenix, AZ
Munger MA et al. Pharmacotherapy 2014
11
12. COMPLIANCE WITH PHARMACY REGULATIONS
WHEN NON-PHARMACIST DISPENSING
Some Dispensing Requirements (17 States)
No Specific Dispensing Requirements (23 States)
Must Follow All Pharmacy Requirements (4 States)
NABP 110th Annual Meeting 05/20/14 Phoenix, AZ
Munger MA et al. Pharmacotherapy 2014
12
13. HEALTHCARE PRACTITIONER DISPENSING OF
PHARMACEUTICAL RX PRODUCTS
QUALITATIVE RESEARCH
NABP 110th Annual Meeting 05/20/14 Phoenix, AZ Munger MA et al. Pharmacotherapy 2014 13
14. METHODOLOGY
Sample targets were n=80 per specialty group split evenly between dispensers (in the past 3
months) and non-dispensers.
Specialty Type Dispensers
Non-
Dispensers
Total
Nurse Practitioners 32 32 64
Dermatologists 40 39 79
Plastic and Reconstructive
Surgeons
39 38 77
Hematologist-Oncologists 27 21 48
Medical Oncologists 13 19 32
Primary Care Physicians
(Family Medicine and General Practice)
40 40 80
Psychiatrists 40 40 80
Internal Medicine Doctors 41 40 81
TOTAL 311 309 620
15. RESPONDENTS CAME FROM ACROSS THE COUNTRY
Northeast Region
100 (26%)
South Region
118 (31%)
Midwest Region
83 (22%)
West Region
78 (21%)
16. DISPENSING IS MOST COMMON AMONG
DERMATOLOGISTS OR SURGEONS
Percent
Dispensing
Nurse Practitioners
(n=96)
56%
Optometrists
(n=273)
54%
Oncologists
(n=298)
67%
Dermatologists
(n=207)
75%
Plastic and Reconstructive Surgeons
(n=185)
72%
Prevalence of Dispensing by Specialty
17. 17
Rx Dispensing is Done Very Frequently
e
48%
34%
10%
2%
6%
0%
100%
Rx Dispensers
(n=174)
Frequency of Dispensing Rx Products
(% Rx Dispensers)
1/Three Months
1/ Two Months
1/Month
Weekly
Daily
82%
dispense
daily or
weekly
18. 18
OTC Dispensing is Done Very Frequently
e
51%
32%
11%
2%4%
0%
100%
OTC Dispensers
(n=171)
Frequency of Dispensing OTC Products
(% OTC Dispensers)
1/three months
1/two months
1/month
Weekly
Daily
83%
dispense
daily or
weekly
19. 19
Patients Dispensed Medications Are As Likely
To Be Aged 65+
e
37%
33% 32%
0%
100%
General Non-Dispensed
Patients
(n=190)
Patients Dispensed
Rx products
(n=174)
Patients Dispensed
OTC Products
(n=171)
%HCPsPatientsAged65+
Patients Aged 65+
(Among Dispensers)
20. 20
HCPs are directionally more likely to dispense to
patients without prescription insurance coverage
e
54%
47% 45%
0%
100%
General Non-Dispensed
Patients
(n=190)
Patients Dispensed
Rx products
(n=174)
Patients Dispensed
OTC Products
(n=171)
%HCPsPatientsWithInsurance
CoveringRxMedication
Patients With Insurance Covering Rx
(Among Dispensers)
21. 21
3%
4%
5%
6%
7%
14%
21%
40%
25%
31%
28%
35%
61%
44%
100%
Patient Factors
Dispensers (n=190) Non-Dispensers (n=189)
Dispensers more likely than non-dispensers
to perceive patient benefits to dispensing
e
63%
50%
47%
45%
45%
32%
23%
7%
21%
16%
14%
16%
8%
10%
0% 100%
My patients are pleased that I dispense medications to them.
Dispensing by physicians in my specialty improves patient
adherence.
Dispensing by physicians in my specialty reduces the cost of
healthcare to my patients.
Dispensing by physicians in my specialty improves patient
safety.
Dispensing by physicians in my specialty reduces the cost of
healthcare to society.
My patients request that I dispense medication to them.
My patients are willing to pay a premium for the convenience
of receiving their medication at my practice, rather than at a
pharmacy.
*
*
*
*
*
*
*
*
*
*
*
*
*
*
Strongly Disagree (1-3) Strongly Agree (8-10)
22. 22
Non-dispensers have greater appreciation
for the pharmacist role
e
6%
18%
41%
49%
38%
33%
31%
70%
100%
Healthcare Providers and Pharmacists
Dispensers (n=190) Non-Dispensers (n=189)
51%
35%
20%
10%
15%
28%
29%
8%
0% 100%
Dispensing medications to my patients makes me
feel I provide a higher level of care.
Physicians in my specialty should receive training
in how to dispense medications
It is important for pharmacists to double check my
work.
Pharmacists make too many medication errors
when they dispense medications.
*
*
*
*
*
*
Strongly Disagree (1-3) Strongly Agree (8-10)
23. 23
Many procedures perceived as not highly
important and burdensome
e
78%
78%
72%
70%
64%
58%
54%
38%
32%
0% 100%
Perceived Importance
of Procedures
Highly Important (8-10)
Patient Counseling
for Dispensed Medications
Proper Drug Storage
(i.e., lighting, temperature, security)
Maintaining Prescription and
Drug Record Keeping
System Verification of Product before
Dispensing (i.e., double check)
Drug Stock Labeling and
Inventory Control
Prescription Labeling
Medication Profile System/
Medication Dispensing System
Generic Substitution
US Pharmacopeia Standard Sterile
Compounding Facility
13%
13%
27%
16%
24%
24%
33%
18%
48%
0% 100%
Perceived Burden
of Procedures
Highly Burdensome (8-10)
Among Dispensers
(n=190)
24. 24
More than a quarter intend to dispense
more in the next 2 years
e
28%
61%
11%
0%
100%
Dispensers
(n=190)
Future Dispensing Behavior
(% Dispensers)
I will dispense to
fewer patients in the
next two years.
I will dispense to the
same proportion of
patients in the next
two years.
I will dispense to
more patients in the
next two years.
Dispensing is getting to be an issue with proper
record keeping---too much time involved.
The time and effort is burdensome to our busy
practice.
It is not financially worth my time.
It is more convenient for the patients.
As more medications become available for me to
dispense, I will take advantage of the opportunity.
People like the service as it saves time and money.
They are spreading the word to others.
25. 25
More than 1-in-5 non-dispensers are likely
to dispense in the next 2 years
e
22%
39%
17%
17%
4%
1%
0%
100%
Non-Dispensers
(n=189)
Likelihood of Dispensing
in the Future
(% Non-Dispensers)
Definitely will
Very likely to
Somewhat likely to
Somewhat unlikely to
Very unlikely to
Definitely will not
22%
It makes it very convenient for the patient and this
way, I will know that they are getting the correct OTC
and RX medication.
I believe dispensing may allow patients to start
using the medication sooner and may provide some
financial benefit to the practice.
I believe there needs to continue to be a check and
balance in the healthcare system I think patient
safety is far more important that convenience.
It is not practical to stock all of the possible
medications...You may be inclined to use a specific
medication rather than the appropriate medication.
The benefit to my patients does not outweigh the
extra work involved for my staff.
26. CONSUMER PERCEPTIONS OF THE DISPENSING OF
PRESCRIPTION AND OTC PRODUCTS BY HEALTHCARE
PROFESSIONALS
QUALITATIVE RESEARCH
NABP 110th Annual Meeting 05/20/14 Phoenix, AZ Munger MA et al. Pharmacotherapy 2014 26
27. RESPONDENTS CAME FROM ACROSS THE COUNTRY
Northeast
Region
199 (20%)
South
Region
331 (33%)
Midwest
Region
258 (26%)
West Region
211 (21%)
28. Total
(n=999)
Rx
Purchasers
(n=762)
OTC Only
Purchasers
(n=237)
Consumer Age (mean) 46.6 46.7 46.3
Racial Background (%)
Caucasian 82% 81% 85%
Black or African American 10% 10% 8%
Asian or Pacific Islander 7% 7% 5%
Native American or Alaskan
Native
1% 1% 1%
Other Race 2% 2% 3%
Hispanic Background (%) 7% 7% 8%
DEMOGRAPHIC INFORMATION
Age ≥ 65 y.o.: 15.5%,
Without private insurance: 42.5%
29. 29
Two-thirds of Rx purchases are from a
local pharmacy or supermarket
e
3%
14%
16%
17%
50%
0%
100%
Total
(n=762)
Where Rx Products are Purchased
(% Rx medications purchased in last 12 months )
Local Pharmacy
Local Supermarket /
Convenience Store
Mail Order
Physician s Office
or Clinic
Other
14% of Rx purchases
are directly from the
Healthcare
Practitioner
30. 30
One quarter believe Rx products cost less
when purchased from a Healthcare Practitioner
e
23%
58%
19%
0%
100%
Total
(n=762)
Perceived Cost of
Rx Products from a Healthcare Practitioner
(% Rx Purchasers)
The cost is higher than
in a pharmacy
The cost is about the
same as in a pharmacy
The cost is lower than in
a pharmacy
31. 31
Most likely to purchase Rx from a General
Practitioner or Internal Medicine Physician;
around three times per year.
75%
50%
37%
36%
28%
25%
23%
18%
49%
0% 100%
Purchased Rx from a Given
Health Care Practitioner
Total (n=762)
General Practitioner / Family Practitioner
Internal Medicine / Internist
Mental Health Professional
Dermatologist
Obstetrician / Gynecologist
Cardiologist
Nurse / Nurse Practitioner
Oncologist
Other
Mean Times
Rx Purchased
3.02
3.03
4.02
2.00
3.42
3.21
2.87
2.50
2.99
32. 32
Pain, antibiotic, and heart medications most
likely to be purchased from Healthcare Practitioners
e
Pain Medications
(Ibuprofen or similar, Codeine or similar, Celebrex, or Skeletal Muscle Relaxants)
Antibiotics or Antiviral Medication
Heart Medications
(Blood Pressure, Heart Disease, Heart Rhythm, or Water Pills)
Central Nervous System
(Headache, Depression, Anxiety, Anti-Parkinson s, Anti-seizure, Medications for Sleep)
Drugs for the Stomach or Intestines
(Antacids, Digestants, Anti-ulcer Medication)
Eye, Ear, Nose or Throat Medications
Contraceptives
Medications for the Lungs
Blood Thinners
Other Prescription Medication
20%
18%
14%
12%
8%
8%
5%
4%
3%
8%
0% 100%
Rx Products Purchased
(% Rx Purchasers, n=762)
Other medications varied, but most
common mentions were diabetes
medications, hormone replacement
therapies and dermatological agents
33. 33
Three-quarters of Rx purchases from
Healthcare Professionals are routine purchases
e
24% 76%
Proportion of Purchased Rx Products that were
Emergency vs. Routine Refill:
(% of Rx Purchasers, n=762)
Emergency Refill (i.e., when you ran
out of a medication and were unable
to get to a pharmacy)
Routine Purchase
34. 34
10-20% of HealthCare Provider dispensed
Rx s are missing important labeling information
Name of the prescription product
The directions for use
Your name
The fill date of the prescription or its last
dispensing date
The name of the prescriber
Any cautionary statements about the
prescription product
The prescription number assigned by the
practitioner
The name, address, and telephone number
of the practitioner
93%
92%
86%
85%
85%
83%
79%
76%
0% 100%
Included on Rx Product Label
% Answering Yes
(n=762)
35. 35
At least a quarter do not get adequate
counseling and information at time of sale
e
How often to take the medication
The name of the medication
How to take the medication (e.g., with food,
certain times of the day, etc.) What are the
serious side effects to watch for
Why you were being prescribed and sold
the medication
What side effects the medication might
have
What to do in the case of any serious side
effect occurring
77%
76%
71%
65%
61%
59%
0% 100%
Often/Always Reviewed by
Healthcare Practitioner
%Often/Always
(n=762)
36. 36
93%
7%
Occurrence of Serious Side Effect on Rx
from Pharmacist:
(% of Rx purchasers, n=762)
No Yes
Primary Care Physician or pharmacist
consulted for adverse drug reaction from
pharmacist dispensed Rx
e
My Primary Care Physician
The pharmacist who sold you
the prescription
An urgent care /
Emergency room physician
Another Pharmacist
Another Healthcare
Professional
42%
30%
15%
11%
2%
0% 100%
Medical Professional First
Consulted
(% Experiencing a serious side effect, n=53)
37. 37
93%
7%
Occurrence of Serious Side Effect on Rx
from Healthcare Practitioner:
(% of Rx purchasers, n=762)
No Yes
e
64%
28%
6%
2%
0% 100%
Medical Professional First
Consulted
(% Experiencing a serious side effect, n=53)
The healthcare professional
who sold you the prescription
A pharmacist
An urgent care /
Emergency room physician
Another healthcare
Professional
Dispensing Healthcare Professional more
likely to be consulted for dispensed Rx
adverse drug reaction
9% ↓
38. 38
13%
22%
19%
20%
37%
36%
17%
27%
22%
24%
39%
42%
100%
Patient Factors
Rx Purchasers (n=762) OTC Only Purchasers (n=237)
44%
36%
36%
35%
26%
25%
37%
29%
31%
25%
17%
18%
0% 100%
It appears some purchase from Healthcare
Practitioners even if they strongly disagree
with purported benefits
e
I am pleased that my physician / nurse sells me the medication directly.
Dispensing by a healthcare professional other than a pharmacist improves
how likely I am to comply with the instructions for taking the medication
(number of doses, when to take it, etc.)
Dispensing by a healthcare professional other than a pharmacist improves
how safe it is for me to take the medication.
Dispensing by a healthcare professional other than a pharmacist reduces
the cost of my healthcare.
I am willing to pay a premium for the convenience of receiving my
medication at the physician s office or clinic, rather than at a pharmacy.
I request that my physician / nurse sell me the medication directly.
Strongly Disagree (1-3) Strongly Agree (8-10)
*
*
*
40. SELF-ASSESSMENT QUESTIONS
Physician dispensing in the United
States is:
A. Rare
B. Practiced daily or weekly
C. Commonplace across all practice
settings
D. Under the direction of the Board of
Pharmacy in most states
Physicians perceive drug
dispensing as:
A. Reducing the drug cost to my patients
B. Reducing the cost of healthcare
C. Improving drug adherence
D. All of the above
NABP 110th Annual Meeting 05/20/14 Phoenix, AZ Munger MA et al. Pharmacotherapy 2014 40
41. SELF-ASSESSMENT QUESTIONS
Physician perception of the highest
burden of pharmacy practice rules on
dispensing practice is:
A. Labeling the prescription bottle
B. Keeping a medication profile system
C. Drug stock labeling and inventory
control
D. Maintaining prescription and drug
record keeping
NABP 110th Annual Meeting 05/20/14 Phoenix, AZ Munger MA et al. Pharmacotherapy 2014 41