Herbal pharmacovigilance: India vs global outlook
Proper training for pharmacovigilance
If people had been trained on how, why, what and where to report such unwanted reactions, they would have certainly helped the regulatory authority to help themselves. Even if the National Pharmacovigilance Programme has heartened accounting of all suspected drug-related adverse events including those caused by herbal/traditional/alternative medicines, the integer of reports related to herbal drugs has been extremely bad. A great many challenges, which rule out the identification and reporting of adverse reactions to herbal drugs can be identified in terms of detection, assessment and deterrence. This includes falling short of quality assurance and control in the manufacture of herbal preparations, which in turn becomes confusing and deters the spotting of adverse reactions. However, patients get allopathic medicines at the same time, which might also be contributing to those unexpected reactions. The gist of the matter is that a person skilled in PV
The document provides an overview of drug regulation. It discusses key terms like drugs and regulation. It then summarizes the main functions of drug regulatory agencies which include product registration, manufacturing regulation, adverse reaction monitoring, and ensuring drug safety. It also lists the major drug regulatory bodies in India, the US, Japan, and the EU and provides brief descriptions of their roles and responsibilities which commonly include drug approval, quality standards, and public health and safety.
The document discusses pharmacovigilance and adverse drug reaction (ADR) reporting in India. It provides information on the national pharmacovigilance program, including who can report ADRs, how to report them, and the benefits of reporting. It describes the ADR reporting process and forms for healthcare professionals and consumers. It also discusses other vigilance programs in India related to medical devices, vaccines, blood products, and several research projects conducted with these programs.
The document discusses various aspects of interacting with the FDA, including their missions, divisions, and processes for industry communication and drug approval. It outlines the FDA's roles in inspections, legal sanctions, scientific expertise, and product safety. It also describes methods for industry liaisons such as meetings, advisory committees, and Freedom of Information Act requests. The goal is to provide knowledge on planning effective interactions and navigating the drug approval process.
The document discusses regulations for clinical trials in India. It begins by explaining that an Investigational New Drug Application (IND) provides an exemption that allows investigational drugs to be transported across state lines for clinical trials. It then describes the process of submitting an IND to the FDA, including providing animal studies data, manufacturing information, clinical protocols, and investigator information. It notes that the FDA has 30 days to review submitted INDs. Finally, it summarizes that in India, an application for clinical trials should be submitted to the DCGI along with chemistry, manufacturing, animal study data and other required documents and trial protocols, and trials can only begin after approval from the DCGI and ethics committee.
The document provides an overview of the regulatory environment for therapeutic goods in the USA, Europe, and India. It summarizes the key regulatory bodies and clinical research guidelines in each region. In the USA, the FDA regulates clinical research and ensures drug safety. In Europe, the EMEA provides scientific evaluation of medicines, while the MHRA is the regulatory authority in the UK. In India, the DCGI and CDSCO regulate clinical trials under the Drugs Controller General of India. Clinical trials must adhere to Schedule Y of the Drugs and Cosmetics Act as well as other guidelines.
Regulatory affairs is a growing field in India as the pharmaceutical industry expands globally. Regulatory authorities worldwide aim to ensure the quality, safety and efficacy of medicines through regulations. Key regulatory territories include North America, Europe, Japan and the rest of the world. Countries have regulatory authorities like the FDA in the US and EMA in Europe that enforce regulations. International harmonization efforts like ICH aim to standardize technical requirements for drug approval. Regulatory submissions to authorities include drug master files, drug dossiers and common technical documents in a standardized format. Regulatory affairs professionals play an important role in obtaining marketing approval for pharmaceutical companies.
Herbal pharmacovigilance: India vs global outlook
Proper training for pharmacovigilance
If people had been trained on how, why, what and where to report such unwanted reactions, they would have certainly helped the regulatory authority to help themselves. Even if the National Pharmacovigilance Programme has heartened accounting of all suspected drug-related adverse events including those caused by herbal/traditional/alternative medicines, the integer of reports related to herbal drugs has been extremely bad. A great many challenges, which rule out the identification and reporting of adverse reactions to herbal drugs can be identified in terms of detection, assessment and deterrence. This includes falling short of quality assurance and control in the manufacture of herbal preparations, which in turn becomes confusing and deters the spotting of adverse reactions. However, patients get allopathic medicines at the same time, which might also be contributing to those unexpected reactions. The gist of the matter is that a person skilled in PV
The document provides an overview of drug regulation. It discusses key terms like drugs and regulation. It then summarizes the main functions of drug regulatory agencies which include product registration, manufacturing regulation, adverse reaction monitoring, and ensuring drug safety. It also lists the major drug regulatory bodies in India, the US, Japan, and the EU and provides brief descriptions of their roles and responsibilities which commonly include drug approval, quality standards, and public health and safety.
The document discusses pharmacovigilance and adverse drug reaction (ADR) reporting in India. It provides information on the national pharmacovigilance program, including who can report ADRs, how to report them, and the benefits of reporting. It describes the ADR reporting process and forms for healthcare professionals and consumers. It also discusses other vigilance programs in India related to medical devices, vaccines, blood products, and several research projects conducted with these programs.
The document discusses various aspects of interacting with the FDA, including their missions, divisions, and processes for industry communication and drug approval. It outlines the FDA's roles in inspections, legal sanctions, scientific expertise, and product safety. It also describes methods for industry liaisons such as meetings, advisory committees, and Freedom of Information Act requests. The goal is to provide knowledge on planning effective interactions and navigating the drug approval process.
The document discusses regulations for clinical trials in India. It begins by explaining that an Investigational New Drug Application (IND) provides an exemption that allows investigational drugs to be transported across state lines for clinical trials. It then describes the process of submitting an IND to the FDA, including providing animal studies data, manufacturing information, clinical protocols, and investigator information. It notes that the FDA has 30 days to review submitted INDs. Finally, it summarizes that in India, an application for clinical trials should be submitted to the DCGI along with chemistry, manufacturing, animal study data and other required documents and trial protocols, and trials can only begin after approval from the DCGI and ethics committee.
The document provides an overview of the regulatory environment for therapeutic goods in the USA, Europe, and India. It summarizes the key regulatory bodies and clinical research guidelines in each region. In the USA, the FDA regulates clinical research and ensures drug safety. In Europe, the EMEA provides scientific evaluation of medicines, while the MHRA is the regulatory authority in the UK. In India, the DCGI and CDSCO regulate clinical trials under the Drugs Controller General of India. Clinical trials must adhere to Schedule Y of the Drugs and Cosmetics Act as well as other guidelines.
Regulatory affairs is a growing field in India as the pharmaceutical industry expands globally. Regulatory authorities worldwide aim to ensure the quality, safety and efficacy of medicines through regulations. Key regulatory territories include North America, Europe, Japan and the rest of the world. Countries have regulatory authorities like the FDA in the US and EMA in Europe that enforce regulations. International harmonization efforts like ICH aim to standardize technical requirements for drug approval. Regulatory submissions to authorities include drug master files, drug dossiers and common technical documents in a standardized format. Regulatory affairs professionals play an important role in obtaining marketing approval for pharmaceutical companies.
Regulatory Trends Of Pharmaceuticals I Bric Countriesshivampharma88
This document summarizes the regulatory trends of pharmaceuticals in BRIC countries. It discusses the drug regulatory frameworks and approval processes in Brazil, Russia, India, and China. It notes that BRIC countries are emerging as a significant pharmaceutical market, with expected growth rates of 12-14% annually through 2015. The document then focuses on India's regulatory system, describing the roles of the Central Drugs Standard Control Organization and various laws governing drug regulation, clinical trials, patents, and data protection in India.
ASEAN was established in 1967 by 5 countries and has since expanded to include 10 member countries. Singapore regulates pharmaceutical products under the Medicines Act and Health Products Act to ensure safety, quality and efficacy. The regulatory process for medicines involves submitting an application to the Health Sciences Authority, which evaluates the application and issues a regulatory decision of approval, approvable, non-approvable, or rejection.
Regulatory authorities (US-FDA, WHO and ICH)Sagar Savale
To promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner.
With respect to such products, protect the public health by ensuring that the food are safe, Wholesome, sanitary, and properly labelled; human and veterinary drugs are safe and effective; there is reasonable assurance of the safety and effectiveness of devices intended for human use; cosmetics are safe and properly labelled, and public health and safety are protected from the electronic product radiation.
Participates through appropriate process with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements.
The document discusses the role of cohort event monitoring under the Revised National Tuberculosis Control Programme (RNTCP) in India. It notes that cohort event monitoring is used to monitor adverse drug reactions to newer tuberculosis drugs. Adverse events and serious adverse events must be reported in standardized formats to the RNTCP program. Timely reporting of adverse events is important for patient safety monitoring of tuberculosis treatment regimens. The document outlines the process of adverse event reporting, management and data collection used for pharmacovigilance under the RNTCP.
Contract Research Organisations- CRO in Pharma FieldVINOTH R
The document provides an overview of contract research organizations (CROs). It discusses that CROs were originally formed to help pharmaceutical companies deal with capacity issues and excess demand. CROs now provide a wide range of clinical trial and drug development services to pharmaceutical sponsors. They have become an important partner for both large pharmaceutical firms and smaller biotech companies. However, the Indian CRO industry still faces challenges such as financial issues, a lack of accredited trial sites, and regulatory hurdles.
The document provides an overview of the World Health Organization (WHO) and key regulatory agencies like the Central Drugs Standard Control Organization (CDSCO) of India and the U.S. Food and Drug Administration (FDA). It discusses the roles, structures and functions of WHO in global health governance and national regulatory bodies like CDSCO and FDA in ensuring safety and efficacy of drugs, medical devices and other products. Major sections include organizational structure of WHO, priorities, achievements and challenges. For CDSCO and FDA, it summarizes their roles in approval of new drugs and devices, good manufacturing practices, and enforcement.
The document discusses several regulatory agencies that oversee medicines and medical devices. The United States Food and Drug Administration (USFDA) regulates food, drugs, cosmetics, and medical devices in the US. The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines and medical devices in the UK. The Central Drugs Standard Control Organization (CDSCO) regulates drugs and cosmetics in India under the Ministry of Health and Family Welfare. Each agency is responsible for ensuring the safety and efficacy of products under its purview.
The Medicines and Healthcare products Regulatory Agency (MHRA) is a government body which was set up in 2003 to bring together the functions of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA).
The Agency has the power to withdraw a product from the market, and in the case of medicines, to suspend production. The Agency can also prosecute a manufacturer or distributor if the law has been broken. The regulations need to be robust enough to protect the public’s health, and this costs money. The MHRA is funded largely by public monies from government for the regulation of devices, and by fees from the pharmaceutical industry for the regulation of medicines.
Regulatory affairs and Intellectual Property Rightssantoshnarla
The document provides details about Dr. Santosh Kumar Narla's academic and professional background. It states that he holds a Ph.D. in Pharmaceutical Sciences and has over 15 years of experience in formulation development and regulatory affairs. He currently works as a manager of regulatory affairs at Dr. Reddy's Laboratories in Hyderabad. It also lists his publications and presentations at national and international conferences.
Regulatory Authorities for Pharmaceuticals - TGA,MHRA,MCCSanket Shinde
The Therapeutic Goods Administration (TGA) is the regulatory body for therapeutic goods in Australia. The TGA ensures medicines and medical devices available in Australia are safe and effective by conducting pre-market assessment and post-market surveillance. It maintains the Australian Register of Therapeutic Goods which lists all approved therapeutic goods. The TGA regulates medicines and medical devices according to risk level and oversees manufacturing licensing and good practices.
Regulatory requirements for drug approval Namdeo Shinde
1. Regulatory requirements for drug approval were introduced after tragic incidents led to deaths, to ensure safety and efficacy of new drugs. Countries have different regulatory agencies that new drugs must be approved by before marketing.
2. The drug development process takes 10-12 years and involves multiple scientific disciplines working together. Non-clinical and clinical trials are conducted to characterize the drug candidate and determine safety and dosing in humans.
3. A New Drug Application contains clinical and manufacturing data submitted to regulatory agencies for review and potential approval to market a new drug. Bioequivalence studies ensure generic drugs have consistent quality, efficacy and safety compared to brand name drugs.
The Therapeutic Goods Administration (TGA) regulates therapeutic goods in Australia to ensure quality, safety and efficacy. The TGA evaluates medicines and approves their inclusion on the Australian Register of Therapeutic Goods before they can be supplied in Australia. There are multi-phase approval processes for prescription medicines, over-the-counter medicines, and complementary medicines. Prescription medicines undergo the most rigorous evaluation and require registration, while some OTC medicines and most complementary medicines only require listing on the register. The approval process involves pre-submission planning, evaluation of quality and clinical data over multiple rounds, opportunities for additional information requests, and expert review before the final registration decision.
The document discusses regulatory bodies and processes related to drugs in the United States and Canada. It provides information on the organization and functions of the US Food and Drug Administration (FDA), including the Federal Register, Code of Federal Regulations, and history of the Federal Food, Drug, and Cosmetic Act. It also discusses the Hatch-Waxman Act, Orange Book, Purple Book, and Drug Master File system in the US.
The document discusses the establishment of a national Pharmacovigillance center in Pakistan to monitor adverse drug reactions and ensure drug safety. It outlines that the center would collect voluntary reports from healthcare professionals and the public on suspected adverse reactions, lack of drug efficacy, and pharmaceutical defects. The center would work to establish standardized Pharmacovigillance processes in Pakistan and expand monitoring to areas like antibiotics resistance, medical devices, and traditional medicines.
The document discusses the potential uses and benefits of implementing a Unique Identification Number system in India's healthcare sector. It outlines how UID could be issued at birth and used on medical records, prescriptions, death certificates, and for tracking immunization and disease prevalence. This would help enable a national electronic health record system, make medical data more portable, and aid epidemiological research and response to health emergencies. Realizing UID's full potential will require coordination between various stakeholders, developing standards and security measures, and managing changes to healthcare IT systems.
The regulation of medicines in AustraliaTGA Australia
View this presentation for information on:
*the different categories of medicines
* registered (higher risk) medicines and how they are regulated
* listed (lower risk) medicines and how they are regulated
* accessing unauthorised medicines
* medicines advertising
* changing medicine technologies
Regulatory affairs professionals act as the interface between the pharmaceutical industry and drug regulatory authorities. Their main goals are to protect human health, ensure drug safety and quality, and ensure accurate product information. Key roles include liaising with regulatory agencies, preparing regulatory submissions, and advising on regulatory requirements and guidelines. An investigational new drug (IND) application is filed with regulatory agencies to legally test an experimental drug in humans after preclinical testing. A new drug application (NDA) is filed to obtain approval to market a new drug, while an abbreviated new drug application (ANDA) is filed for generic drug approval based on demonstrating bioequivalence to an existing drug. Drug master files and active substance master files provide confidential manufacturing
The document discusses the importance of regulatory affairs in the pharmaceutical industry. It describes how regulatory affairs acts as the bridge between pharmaceutical companies and government regulatory agencies by ensuring drug products meet all necessary quality, safety, and efficacy standards before and after approval. Key responsibilities of regulatory affairs include managing clinical trials and submissions, maintaining compliance with all regulations, and advising companies on regulatory requirements and strategies. Strict regulations are necessary to protect public health after past drug failures and disasters.
Pharmacist pay scales in 7th cpc proposed by ihpa Dr B Naga Raju
This document outlines a presentation made by the Indian Hospital Pharmacists' Association to the 7th Central Pay Commission regarding pay scales and allowances for pharmacists. It summarizes the current qualifications for pharmacists and argues that pharmacists should be classified as "technical" staff based on their diploma qualifications. It requests that pharmacists be granted entry level pay scales and promotions on par with other technical staff, given the technical nature of their qualifications and role. It provides evidence from previous pay commission recommendations that pharmacists deserve higher pay scales in line with their qualifications. The presentation aims to achieve pay parity and justice for pharmacists across government organizations.
1) The document outlines the revised pay structure for fresh recruits and existing employees under the 6th Central Pay Commission. It fixes entry pay levels depending on grade pay and pay bands.
2) It details rules for annual increments of 3% of total pay, and a variable 4% increment for higher achievers.
3) Examples are provided for pay fixation in cases of promotion, direct recruitment, upgraded posts, and on receiving increments. Stepping up of pay is allowed if a senior draws less than a directly recruited junior.
Regulatory Trends Of Pharmaceuticals I Bric Countriesshivampharma88
This document summarizes the regulatory trends of pharmaceuticals in BRIC countries. It discusses the drug regulatory frameworks and approval processes in Brazil, Russia, India, and China. It notes that BRIC countries are emerging as a significant pharmaceutical market, with expected growth rates of 12-14% annually through 2015. The document then focuses on India's regulatory system, describing the roles of the Central Drugs Standard Control Organization and various laws governing drug regulation, clinical trials, patents, and data protection in India.
ASEAN was established in 1967 by 5 countries and has since expanded to include 10 member countries. Singapore regulates pharmaceutical products under the Medicines Act and Health Products Act to ensure safety, quality and efficacy. The regulatory process for medicines involves submitting an application to the Health Sciences Authority, which evaluates the application and issues a regulatory decision of approval, approvable, non-approvable, or rejection.
Regulatory authorities (US-FDA, WHO and ICH)Sagar Savale
To promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner.
With respect to such products, protect the public health by ensuring that the food are safe, Wholesome, sanitary, and properly labelled; human and veterinary drugs are safe and effective; there is reasonable assurance of the safety and effectiveness of devices intended for human use; cosmetics are safe and properly labelled, and public health and safety are protected from the electronic product radiation.
Participates through appropriate process with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements.
The document discusses the role of cohort event monitoring under the Revised National Tuberculosis Control Programme (RNTCP) in India. It notes that cohort event monitoring is used to monitor adverse drug reactions to newer tuberculosis drugs. Adverse events and serious adverse events must be reported in standardized formats to the RNTCP program. Timely reporting of adverse events is important for patient safety monitoring of tuberculosis treatment regimens. The document outlines the process of adverse event reporting, management and data collection used for pharmacovigilance under the RNTCP.
Contract Research Organisations- CRO in Pharma FieldVINOTH R
The document provides an overview of contract research organizations (CROs). It discusses that CROs were originally formed to help pharmaceutical companies deal with capacity issues and excess demand. CROs now provide a wide range of clinical trial and drug development services to pharmaceutical sponsors. They have become an important partner for both large pharmaceutical firms and smaller biotech companies. However, the Indian CRO industry still faces challenges such as financial issues, a lack of accredited trial sites, and regulatory hurdles.
The document provides an overview of the World Health Organization (WHO) and key regulatory agencies like the Central Drugs Standard Control Organization (CDSCO) of India and the U.S. Food and Drug Administration (FDA). It discusses the roles, structures and functions of WHO in global health governance and national regulatory bodies like CDSCO and FDA in ensuring safety and efficacy of drugs, medical devices and other products. Major sections include organizational structure of WHO, priorities, achievements and challenges. For CDSCO and FDA, it summarizes their roles in approval of new drugs and devices, good manufacturing practices, and enforcement.
The document discusses several regulatory agencies that oversee medicines and medical devices. The United States Food and Drug Administration (USFDA) regulates food, drugs, cosmetics, and medical devices in the US. The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines and medical devices in the UK. The Central Drugs Standard Control Organization (CDSCO) regulates drugs and cosmetics in India under the Ministry of Health and Family Welfare. Each agency is responsible for ensuring the safety and efficacy of products under its purview.
The Medicines and Healthcare products Regulatory Agency (MHRA) is a government body which was set up in 2003 to bring together the functions of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA).
The Agency has the power to withdraw a product from the market, and in the case of medicines, to suspend production. The Agency can also prosecute a manufacturer or distributor if the law has been broken. The regulations need to be robust enough to protect the public’s health, and this costs money. The MHRA is funded largely by public monies from government for the regulation of devices, and by fees from the pharmaceutical industry for the regulation of medicines.
Regulatory affairs and Intellectual Property Rightssantoshnarla
The document provides details about Dr. Santosh Kumar Narla's academic and professional background. It states that he holds a Ph.D. in Pharmaceutical Sciences and has over 15 years of experience in formulation development and regulatory affairs. He currently works as a manager of regulatory affairs at Dr. Reddy's Laboratories in Hyderabad. It also lists his publications and presentations at national and international conferences.
Regulatory Authorities for Pharmaceuticals - TGA,MHRA,MCCSanket Shinde
The Therapeutic Goods Administration (TGA) is the regulatory body for therapeutic goods in Australia. The TGA ensures medicines and medical devices available in Australia are safe and effective by conducting pre-market assessment and post-market surveillance. It maintains the Australian Register of Therapeutic Goods which lists all approved therapeutic goods. The TGA regulates medicines and medical devices according to risk level and oversees manufacturing licensing and good practices.
Regulatory requirements for drug approval Namdeo Shinde
1. Regulatory requirements for drug approval were introduced after tragic incidents led to deaths, to ensure safety and efficacy of new drugs. Countries have different regulatory agencies that new drugs must be approved by before marketing.
2. The drug development process takes 10-12 years and involves multiple scientific disciplines working together. Non-clinical and clinical trials are conducted to characterize the drug candidate and determine safety and dosing in humans.
3. A New Drug Application contains clinical and manufacturing data submitted to regulatory agencies for review and potential approval to market a new drug. Bioequivalence studies ensure generic drugs have consistent quality, efficacy and safety compared to brand name drugs.
The Therapeutic Goods Administration (TGA) regulates therapeutic goods in Australia to ensure quality, safety and efficacy. The TGA evaluates medicines and approves their inclusion on the Australian Register of Therapeutic Goods before they can be supplied in Australia. There are multi-phase approval processes for prescription medicines, over-the-counter medicines, and complementary medicines. Prescription medicines undergo the most rigorous evaluation and require registration, while some OTC medicines and most complementary medicines only require listing on the register. The approval process involves pre-submission planning, evaluation of quality and clinical data over multiple rounds, opportunities for additional information requests, and expert review before the final registration decision.
The document discusses regulatory bodies and processes related to drugs in the United States and Canada. It provides information on the organization and functions of the US Food and Drug Administration (FDA), including the Federal Register, Code of Federal Regulations, and history of the Federal Food, Drug, and Cosmetic Act. It also discusses the Hatch-Waxman Act, Orange Book, Purple Book, and Drug Master File system in the US.
The document discusses the establishment of a national Pharmacovigillance center in Pakistan to monitor adverse drug reactions and ensure drug safety. It outlines that the center would collect voluntary reports from healthcare professionals and the public on suspected adverse reactions, lack of drug efficacy, and pharmaceutical defects. The center would work to establish standardized Pharmacovigillance processes in Pakistan and expand monitoring to areas like antibiotics resistance, medical devices, and traditional medicines.
The document discusses the potential uses and benefits of implementing a Unique Identification Number system in India's healthcare sector. It outlines how UID could be issued at birth and used on medical records, prescriptions, death certificates, and for tracking immunization and disease prevalence. This would help enable a national electronic health record system, make medical data more portable, and aid epidemiological research and response to health emergencies. Realizing UID's full potential will require coordination between various stakeholders, developing standards and security measures, and managing changes to healthcare IT systems.
The regulation of medicines in AustraliaTGA Australia
View this presentation for information on:
*the different categories of medicines
* registered (higher risk) medicines and how they are regulated
* listed (lower risk) medicines and how they are regulated
* accessing unauthorised medicines
* medicines advertising
* changing medicine technologies
Regulatory affairs professionals act as the interface between the pharmaceutical industry and drug regulatory authorities. Their main goals are to protect human health, ensure drug safety and quality, and ensure accurate product information. Key roles include liaising with regulatory agencies, preparing regulatory submissions, and advising on regulatory requirements and guidelines. An investigational new drug (IND) application is filed with regulatory agencies to legally test an experimental drug in humans after preclinical testing. A new drug application (NDA) is filed to obtain approval to market a new drug, while an abbreviated new drug application (ANDA) is filed for generic drug approval based on demonstrating bioequivalence to an existing drug. Drug master files and active substance master files provide confidential manufacturing
The document discusses the importance of regulatory affairs in the pharmaceutical industry. It describes how regulatory affairs acts as the bridge between pharmaceutical companies and government regulatory agencies by ensuring drug products meet all necessary quality, safety, and efficacy standards before and after approval. Key responsibilities of regulatory affairs include managing clinical trials and submissions, maintaining compliance with all regulations, and advising companies on regulatory requirements and strategies. Strict regulations are necessary to protect public health after past drug failures and disasters.
Pharmacist pay scales in 7th cpc proposed by ihpa Dr B Naga Raju
This document outlines a presentation made by the Indian Hospital Pharmacists' Association to the 7th Central Pay Commission regarding pay scales and allowances for pharmacists. It summarizes the current qualifications for pharmacists and argues that pharmacists should be classified as "technical" staff based on their diploma qualifications. It requests that pharmacists be granted entry level pay scales and promotions on par with other technical staff, given the technical nature of their qualifications and role. It provides evidence from previous pay commission recommendations that pharmacists deserve higher pay scales in line with their qualifications. The presentation aims to achieve pay parity and justice for pharmacists across government organizations.
1) The document outlines the revised pay structure for fresh recruits and existing employees under the 6th Central Pay Commission. It fixes entry pay levels depending on grade pay and pay bands.
2) It details rules for annual increments of 3% of total pay, and a variable 4% increment for higher achievers.
3) Examples are provided for pay fixation in cases of promotion, direct recruitment, upgraded posts, and on receiving increments. Stepping up of pay is allowed if a senior draws less than a directly recruited junior.
1) The document outlines the revised pay structure for fresh recruits and existing employees under the 6th Central Pay Commission. It fixes entry pay levels depending on grade pay and pay bands.
2) It details rules for annual increments of 3% of total pay, and a variable 4% increment for higher achievers.
3) Examples are provided for pay fixation in cases of promotion, direct recruitment, upgraded posts, and on receiving increments. Stepping up of pay for seniors is allowed if a junior draws higher pay.
1) The document outlines the revised pay structure for fresh recruits and existing employees under the 6th Central Pay Commission. It fixes entry pay levels depending on grade pay and pay bands.
2) It details rules for annual increments of 3% of total pay, and a variable 4% increment for higher achievers.
3) Examples are provided for pay fixation in cases of promotion, direct recruitment, upgraded posts, and on receiving increments. Stepping up of pay for seniors is allowed if a junior draws higher pay.
CNP EXPO _ Payvision Landing in Europe a regulatory approachPayvision
In his presentation Ignacio Gonzalez-Paramo, VP Global Compliance PAYVISION, will try to provide the audience with an insight on why EU regulation is strategically key for those willing to establish in the EU or to strengthen their market positioning there.
On top of that, he will also walk the attendees through the key actors in the European policy making process, as well as the most important pieces of legislation to be borne in mind by potential or existing EU CNP players. Ignacio will also underscore the regulatory issues that might imply hurdles for running a CNP business.
And, to end with, he will provide some pieces of advice on how to successfully address those issues.
• Understand why a regulatory strategy is needed.
• Get familiar with:
o Main actors in the EU Policy making process.
o Types of EU legal and regulatory instruments.
o Key pieces of legislation (for the payments business).
o Specific issues to overcome.
• Provide guidance on how to minimize regulatory business implications.
o Strategic alliances & partnerships, licensing options).
To compare filing process of NDA of different countries of India, US and Euro...Aakashdeep Raval
To compare filing process of NDA of different countries of India, US and Europe.
B) Preparation of global list documents of registration of IND and NDA as per USFDA and Europe.
Indian Railway Recruitment Board - RRB released a recruitment notification for the freshers.Interested Can apply online for the Railway recruitment from http://www.freshersworld.com/railway-job-openings and you can also get free job alert and updates related to railway job openings.
The Details of the recruitment have been uploaded you can go through it.
For more Information, refer Freshersworld
Raaj Global Pharma Regulatory Affairs Consultants Thane-mumbai profile-updat...Rajashri Survase Ojha
Raaj-GPRAC is a Thane-Mumbai (India) based agency.
Our offerings includes but not limited to making Regulatory filing strategy, Preparation of pharmaceutical product registration dossier, filing assistance, response to regulatory queries, life cycle management, regulatory compliance audit and Training.
We offer flexible and need based services to meet customer/client requirements so as to save time and cost.
This document discusses analytical method validation. It begins by explaining why method validation is important, such as ensuring consistent, reliable, and accurate data from analytical measurements. It then provides background on regulatory requirements for method validation from agencies like the FDA. The document outlines the key steps in method validation, including qualification of instruments, materials, analysts, developing validation protocols, performing validation experiments, and documenting results. It also discusses ICH and USP guidelines for method validation characteristics like accuracy, precision, specificity, linearity, range, and more. Finally, it provides details on specificity testing and criteria for different analytical procedure types.
Dossier Management and Regulatory Affairs.Naila Kanwal
The document discusses dossier management for regulatory affairs. It defines a dossier as a collection of detailed information about a subject. Effective dossier management involves planning, formatting, compilation, and review. Key aspects include understanding regulatory requirements, compiling information in a clear format, and cross-checking for errors before submission. Proficiency with software like MS Office and Adobe Acrobat is important for dossier management.
This document discusses the requirements for regulatory submissions for marketing authorization in various countries and regions.
It provides an overview of the key documents needed for marketing authorization in India, including application forms, manufacturing licenses, site documents, and product information.
It also summarizes the common ICH CTD format used for submissions to countries like the EU, US, and Japan, as well as the ASEAN CTD format used in Southeast Asian countries. The ASEAN CTD and ICH CTD formats are compared, highlighting similarities and differences in their organization.
Finally, specific documentation requirements are outlined for dossier submissions in countries like Myanmar, Vietnam, and Singapore, focusing on drug substance specifications, analytical methods, and
Regulatory affairs ensures that companies comply with government regulations regarding product safety and efficacy. Regulatory professionals are responsible for tracking legislation, advising on requirements, and submitting registration documents to regulatory agencies. They play an important role in product development by providing strategic guidance from early stages of research through marketing authorization and post-market compliance. Effective regulatory compliance requires quality management systems and manufacturing processes that adhere to good manufacturing practices.
International Journal of Drug Regulatory Affairs; 2014, 2(1), 1- 11
Abstract:
Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This article focuses on drug approval process in different countries like USA, Europe and India.
Betterment of patient to get optimal health outcomesSrinivas Bhairy
This document discusses Home Medicines Review (HMR), a service provided in Australia involving general practitioners, pharmacists, and patients to optimize medication use and health outcomes. HMR aims to identify and resolve medication-related issues through a collaborative review process. The document outlines the key components and principles of HMR, including how it is initiated, the pharmacist's home visit and assessment, reporting to the GP, and developing a medication management plan. Benefits of HMR for patients include improved medication adherence and health. The document proposes adapting the HMR model in India to improve rational medication use and save costs, which could provide employment for pharmacists and benefit patients.
DaniaRole of Advanced Practice NursingAccording to the FlorOllieShoresna
Dania
Role of Advanced Practice Nursing
According to the Florida Board of Nursing, advanced registered nurse practitioners (ARNPs) can prescribe patients with controlled substances that are listed in the schedule II, III and IV which are well described in s. 893.03 Florida Statutes. Before doing so, they are to participate in three-hour training sessions which would help them implement the right strategies (Florida Board of Nursing, 2016). For APRNs to provide the right prescriptions to their patients they are necessitate to analyze and describe patient’s health problems. They are also required to fill their patients with enough knowledge regarding the drugs side effects and how they are supposed to take them (Pigman et al., 2016). As well-known medical practitioners should ensure that after a patient receives a drug, its use is well achieved. As stated by the state requirements an APRN should also do the same to make sure that the drug given achieves the goal it it supposed to achieve (Kooienga and Wilkinson, 2017).
There are numerous barriers that inhibit APRN practitioners from carrying out their prescriptions roles as required. First, there are various programs that may be directed towards the deliverance of health care services that are of high quality. But the problem comes in when the leaders of these programs fail to equip APRNs with advanced skills for dealing with them. Lack of enough knowledge and negative perceptions towards the same may inhibit them from performing their prescription roles. Secondly, state license restrictions may limit APRNs from fully participating in their practices as required because most boards only allow they to take part in one nursing practice role depending on the concerted agreement (Reynolds et al., 2021).
When prescribing medication to patients ARNPs have a great role and responsibility. Their role depends on state laws which are associated with the prescriptive authority provided to them (Florida Board of Nursing, 2016). After and before prescribing APRNs have the role of ensuring that all the drugs are taken at the right time and that the patients know of their side effects. To be on the safer side all APRNs must be responsible while prescribing drugs as this is in all of the patients benefit.
To add on that every practitioner who needs to prescribe medication must be registered by the United States drug enforcement administration. They should also have an experience of two years in terms of the drugs they purchase, distribute, administer and dispense (Florida Board of Nursing, 2016).
References
Reynolds, A. M., Reynolds, C. J., & Craig-Rodriguez, A. (2021). APRNs' controlled substance prescribing and readiness following Florida legislative changes. The Nurse Practitioner, 46(6), 48-55.
Pigman, Campbell, and others. (2016). HB 423 – Access to Health Care Services. Retrieved from https://www.flsenate.gov/Committees/BillSummaries/2016/html/1424
Florida Board of Nursing. (2016, April). Impo ...
This document provides a sample business plan for a pharmacist-owned LLC that provides medication therapy management (MTM) services within employer pharmacies. The plan outlines qualifications for participating pharmacists, defines the standard of care for MTM services, and describes goals such as increasing patient load and billing insurance plans for services. Details are removed to protect proprietary information, but the plan provides a framework for pitching the idea to the employer and operating the MTM practice.
Retail pharmacy practice in bangladesh and abroadMD Jahidul Islam
The document discusses retail pharmacy practice in Bangladesh and abroad, outlining the types of retail pharmacies, qualifications and roles of retail pharmacists, laws regarding drugs in Bangladesh, and the drug delivery and retail pharmacy practice systems in Bangladesh and other countries. Retail pharmacies can be independent, chain, or franchise models and retail pharmacists are responsible for dispensing and advising on medications while ensuring legal and ethical guidelines are followed.
The document discusses a presentation given by Anne Burns from the American Pharmacists Association on the expanding role of pharmacists. It outlines 4 learning objectives related to describing the evolution of pharmacists providing direct patient care as part of integrated health teams, identifying challenges to full integration, reforms to laws and regulations, and the value pharmacists provide in preventing prescription drug misuse. The document also provides an overview of pharmacists' training and scope of practice under collaborative practice agreements, with examples from different states.
The document outlines proposed standards for registered pharmacies in the UK. It introduces draft standards focused on outcomes for safe and effective pharmacy practice. The standards aim to protect patients while providing flexibility for pharmacies. Responsibility for meeting the standards lies with pharmacy owners and superintendent pharmacists.
The document is a certificate stating that a student named Mr/Miss [name] with registration number [number] of the second year Diploma in Pharmacy program at Shri Sangameshwar College of Pharmacy has satisfactorily completed the required term work in Community Pharmacy & Management for the academic years [year] to [year] as prescribed in the curriculum. It is signed by the subject teacher and principal.
The Prescriptive the role of nurses and nurse Practitionersshirishgawai2
The need for prescribing has emerged alongside introduction of Nurse Practitioner Critical Care (NPCC) and Nurse Practitioner Midwifery (NPM) programs. The prescriptive role, rights and legal provision by Indian Nursing Council (INC) and MOH&FW, GoI have been deliberated in depth with the finalization of the Scope of Practice for NPMs
This document outlines the key components of developing a pharmaceutical care plan. It discusses establishing goals of therapy for each medical condition in measurable terms. Interventions should resolve any drug therapy problems, achieve the goals of therapy, and prevent future problems. Therapeutic alternatives should be considered and the preferred option discussed with the patient. A follow-up plan is made to evaluate the effectiveness of the care plan. The overall goal is to optimize patient health through individualized pharmacotherapy and monitoring.
This document discusses pharmacoeconomics in the Indian context. It begins by introducing the field of pharmacoeconomics and its growing importance in India given the large population and relatively scarce healthcare resources. It then provides an overview of how pharmacoeconomics can inform decisions regarding drug licensing, reimbursement, and formulary procedures. The role of pharmacology graduates in applying pharmacoeconomic principles to improve resource allocation in community and tertiary hospitals is also discussed.
The document provides an overview of clinical pharmacy, including its definition, development, and scope. It defines clinical pharmacy as using pharmacist knowledge and skills to improve drug safety, cost, and use in patient care. It describes how clinical pharmacy emerged in developed countries and is still developing in India. The scope of clinical pharmacy involves optimizing medication use and promoting health through advising on safe and rational drug use. Clinical pharmacists work with healthcare teams to ensure optimal and safe drug therapy for patients.
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1) Physician assistants in Ohio can now prescribe under certain conditions, including completing education requirements and practicing under the supervision of a physician.
2) Physician assistants must complete a minimum of 65 hours of education in pharmacology, clinical training, and legal implications of prescribing. They must also complete a provisional period of prescribing under physician supervision.
3) Physician assistant prescriptions are limited to drugs in an approved formulary and standards of the supervising physician. Controlled substances are further restricted.
This document discusses the role and responsibilities of hospital pharmacists. It begins by defining hospital pharmacy as the department responsible for procuring, storing, and distributing medications in a hospital setting. The scope of hospital pharmacy has expanded beyond traditional dispensing roles to include clinical services like reviewing medications for safety and providing drug information. The document outlines the organizational structure of hospital pharmacies and the professional responsibilities, qualifications, and job specifications of hospital pharmacists. It discusses standards and guidelines for good pharmacy practice from organizations like FIP, ASHP, and within India. Overall, the document provides an overview of the hospital pharmacy system and pharmacists' patient care roles within it.
Assessment of Good Pharmacy Practice (GPP) in Pharmacies of Community Setting...iosrphr_editor
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
Similar to Why Pharmacist is not allowed for Prescription drug, a thought (20)
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
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Adhd Medication Shortage Uk - trinexpharmacy.comreignlana06
The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
TEST BANK For Community and Public Health Nursing: Evidence for Practice, 3rd...Donc Test
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One health condition that is becoming more common day by day is diabetes.
According to research conducted by the National Family Health Survey of India, diabetic cases show a projection which might increase to 10.4% by 2030.
Our backs are like superheroes, holding us up and helping us move around. But sometimes, even superheroes can get hurt. That’s where slip discs come in.
2. Disclaimer
Contents of this presentation are the presenters
personal views and do not necessarily represent
any companies policies and position.
Some images are taken – freely available from the
internet for a diagrammatic representation of the
content and the source is acknowledged.
2
''Copyright(C) Raaj GPRAC,Mumbai 2011-2012. All rights reserved.''
3. Aims towards,
The implementation of
prescription rights for
registered pharmacists’
in India.
Purpose…
''Copyright(C) Raaj GPRAC,Mumbai 2011-2012. All rights reserved.''
4. Prescribing by pharmacists differs from what is currently
understood as prescribing by other health professions.
Pharmacist prescribing describes a wide range of activities. It
includes:
prescribing drugs to treat minor, self-diagnosed or self-limiting
disease conditions;
adjusting dosages and dosage forms; monitoring and refilling
prescriptions to ensure appropriate and effective care;
providing emergency supplies of previously prescribed medication;
providing comprehensive drug therapy management where the
pharmacist, working with other health professionals, takes full
responsibility for establishing and maintaining a patient’s chronic
drug therapy; and
''Copyright(C) Raaj GPRAC,Mumbai 2011-2012. All rights reserved.''
What is pharmacist prescribing?
5. 5
Substituting another drug that is expected to have
a similar therapeutic effect.
Pharmacists will assess and triage each patient
as required. If the pharmacist has the
competencies and appropriate information to
initiate drug therapy for minor, self-limiting or self-
diagnosed conditions, he or she may initiate
treatment.
Alternatively, the pharmacist may refer the patient
to another part of the health system.
What is pharmacist prescribing?
''Copyright(C) Raaj GPRAC,Mumbai 2011-2012. All rights reserved.''
6. Prescribing activities can be grouped into three general
categories:
1] Initial access prescribing—prescribing when a patient
chooses a pharmacist for advice about and treatment of
minor, self-limiting or self-diagnosed conditions, about
wellness programs, or in urgent or emergency situations.
2]prescription modification—modifying a prescription written
by another prescriber to alter dosage, formulation,
regimen or duration of the prescribed drug, or provide a
therapeutic alternative to improve drug therapy or provide
continuity of therapy
What kinds of prescribing can
pharmacists do?
''Copyright(C) Raaj GPRAC,Mumbai 2011-2012. All rights reserved.''
7. 7
3] Comprehensive drug therapy management—initiating,
maintaining, modifying or changing drug therapy based
on referral from another health provider who has made
the diagnosis or upon the request of the patient upon
receiving a diagnosis.
Comprehensive drug therapy management will occur only
in a collaborative health team environment wherein
sufficient information is available to the pharmacist for him
or her to make a recommendation for drug therapy.
What kinds of prescribing can
pharmacists do?
''Copyright(C) Raaj GPRAC,Mumbai 2011-2012. All rights reserved.''
8. This system has already been pioneered on the
international level for the better.
Such practices can be projected to validate-
i. Ample benefits for healthcare provision and
organization.
ii. Patient convenience
iii. Patient safety
iv. Harmony with clinical management plans
v. Proficiency in general practice and hospitals
vi. Professional gratification for pharmacists.
Why is this in aid of?
''Copyright(C) Raaj GPRAC,Mumbai 2011-2012. All rights reserved.''
9. Prescribing necessitates deep acquaintance of
doses, drug-drug and drug-food interactions,
adverse effects, ideal routes of administration,
pharmacokinetics, pharmacodynamics and
observation of effects.
Pharmacists are all already alive with the
knowledge of the above mentioned details.
Their prior involvement in the prescribing
process may help enhance the use of medicines.
Why is this in aid of?....continued…
''Copyright(C) Raaj GPRAC,Mumbai 2011-2012. All rights reserved.''
10. Involvement in medication management,
encompassing monitoring of therapy are well
accepted in the hospital background.
Broadening of the same by adding the permit to
prescribe early therapy and to adjust long-lasting
therapy is relatively a small step
With the overall approval of ‘prescription by
pharmacist’ on the international stage, its high
time that such an approach in India be
implemented.
Why is this in aid of?....continued…
''Copyright(C) Raaj GPRAC,Mumbai 2011-2012. All rights reserved.''
11. Only registered physicians have been prescribing
the prescriptions in India so far
As yet, this is restricted in the context of
pharmacists
If truth be told and as said earlier, prescribing
requires having subtle information of drugs and
pharmacists are full of such fine details.
That is why, there is a real need of the introduction
of ‘prescription by pharmacist’ in India, though at a
small level in the beginning to lessen the workload
in the healthcare system.
Findings…
''Copyright(C) Raaj GPRAC,Mumbai 2011-2012. All rights reserved.''
12. 1. Reliant prescribing by proper agreement
defined for it.
Such type of prescribing encompasses more
restrictions on prescription activities by dint of
formularies and/or protocols.
Is a written guideline, a clear and much detailed
document that delineates the activities that
pharmacists’ might perform in their prescriptive
boundaries.
Methodologies…
''Copyright(C) Raaj GPRAC,Mumbai 2011-2012. All rights reserved.''
13. The content of an agreement shall cover
The procedures, decision criteria or plan
that the pharmacist must follow while
prescribing
Disease types, drug-drug categories that
pharmacists may prescribe within,
for instance, anticoagulants, antiemetics,
analgesics etc…
The time limit for the agreement
Methodologies….continued…
''Copyright(C) Raaj GPRAC,Mumbai 2011-2012. All rights reserved.''
14. The responsibilities of each person
involved
Documentation and feedback
methods to the authorizing prescriber
Strategies for review and revision of
the agreement etc…
Methodologies….continued…
''Copyright(C) Raaj GPRAC,Mumbai 2011-2012. All rights reserved.''
15. 2. Reliant prescribing: Auxiliary prescribing.
Auxiliary prescribing-
Is a voluntary companionship between the independent
[doctors]and auxiliary[pharmacist] prescriber
Fulfills already decided patient –restricted plan of clinical
management with the agreement of patient.
The independent prescriber shall undertake the
preliminary assessment
The auxiliary prescriber can then write prescriptions at
public expense, working to a care management approach
that has been granted by the physician.
Methodologies….continued…
''Copyright(C) Raaj GPRAC,Mumbai 2011-2012. All rights reserved.''
16. Here the role of pharmacist will be
inclusive of contributing to clinical
management plan screening.
swapping the medicines
Finally bringing up to the independent
prescriber where applicable
Detailing clinically significant facts.
Methodologies….continued…
''Copyright(C) Raaj GPRAC,Mumbai 2011-2012. All rights reserved.''
17. 3. Mutual prescribing
This requires a cooperative practice association
linking a pharmacist and a physician with a legal
authority to prescribe medicines.
The physician first analyses and makes treatment
decisions for the patients
The pharmacist further picks, commences, screens,
alters and continues or discontinues
pharmacotherapy as suitable to achieve the agreed
patient results.
The physician and pharmacist both share the risks
and responsibilities for the patient consequences.
Methodologies….continued…
''Copyright(C) Raaj GPRAC,Mumbai 2011-2012. All rights reserved.''
18. Responsibilities ought to be taken for the whole
process of diagnosis, prescribing and follow ups
including the cognizance of boundaries of know-
how.
Surprisingly, every pharmacist might not desire to
accept such sort of liabilities.
Pharmacists are able to handle those for minor
ailments but on the contrary, expanding those
responsibilities to prescription medicines may have
an introduction of new quality assurance concerns.
Some shortcomings…
''Copyright(C) Raaj GPRAC,Mumbai 2011-2012. All rights reserved.''
19. o Episodic evaluation of pharmacists’
prescribing practices.
o This would serve as a method for
maintaining standards and ensuring best
patient outcomes.
o Having regular audits is a much fruitful
solution to examine the adherence or
compliance to prescribing rules etc…
o Proper upholding of patient records.
Conquering the shortcomings…
''Copyright(C) Raaj GPRAC,Mumbai 2011-2012. All rights reserved.''
20. All registered pharmacists in India must accept all
the intrinsic accountabilities relating to prescribing.
They need to prove their competence to do so.
However, there are also various professional,
technological, educational and legal matters that
need to be come to a decision before pharmacists
can start to prescribe.
captivatingly, the induction of mutual and/or auxiliary
prescribing methods in India would be the
appropriate steps in the best interest of patients.
Conclusion…
''Copyright(C) Raaj GPRAC,Mumbai 2011-2012. All rights reserved.''
21. Emmerton, L., Marriot, J., Bessell, T., Dean,
L., (Aug 2005), ‘pharmacist and prescribing
rights: Review of international developments’.
J Pharm pharmaceut., Vol 8{2}, page no 217-
225.
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