Recommendations on Potential Market Acceptance v. 4
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The document outlines recommendations for elements to assure safe use (ETASU) of opioids, including responsibilities for prescribers, pharmacists, and patients. It recommends regular urine drug screening for patients based on their risk level, as well as using prescription drug monitoring programs and opioid treatment agreements. The overall goal of the ETASU recommendations is to promote appropriate opioid prescribing and reduce risks of misuse.
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Objectives
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Similar to Recommendations on Potential Market Acceptance v. 4
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This document provides guidelines from the CDC for prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care. It summarizes that while opioids can provide short-term pain relief, there is little evidence for their long-term effectiveness and they present serious risks including overdose and opioid use disorder. It then outlines recommendations for clinicians on when to initiate or continue opioids, opioid selection and dosing, assessing risks, and addressing harms to improve safety and reduce risks of long-term opioid therapy.
Pharmacoepidemiology (2)
Pharmacoepidemiology is the study of the use and effects of medications in large populations. It provides estimates of drug benefits and risks in real-world populations, helping to detect adverse effects that may have been missed in pre-market clinical trials due to limited sample sizes and patient populations that do not represent those seen in practice. Pharmacoepidemiology uses epidemiological methods like cohort studies and case-control studies to understand drug effects, interactions, and outcomes in patient populations. It also includes pharmacovigilance to monitor drug safety after market approval.
Udt pdmp cme 2015
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.
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Objectives The objective of this article is to review the impact of various factors on the occurrence of Adverse Drug Reactions ADRs . Summary ADRs can be caused by several factors, including patient related, drug related, and social factors. Age is a crucial factor in the occurrence of ADRs, with both very young and very old patients being more vulnerable than other age groups. Alcohol consumption also plays a significant role in ADRs. Other factors that affect ADRs include gender, race, pregnancy, breastfeeding, kidney problems, liver function, drug dose and frequency, and many others. The medical literature has extensively documented the impact of these factors on ADRs. Taking these factors into account during medical evaluation enables healthcare professionals to choose the most appropriate medication regimen for their patients. Conclusion Various factors affect the occurrence of ADRs, some of which can be changed such as smoking or alcohol consumption while others cannot be changed such as age or genetic factors . Understanding the impact of these factors on ADRs can help healthcare professionals to select the best medication for their patients and provide them with appropriate advice. Pharmacogenomics, a new and innovative science, emphasizes the genetic predisposition of ADRs, providing a new perspective in the drug selection decision making process. B. Divya Durga "Adverse Drug Reactions- Risk Factors, Epidemiology, and Management Strategies" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-2 , April 2023, URL: https://www.ijtsrd.com.com/papers/ijtsrd56216.pdf Paper URL: https://www.ijtsrd.com.com/pharmacy/other/56216/adverse-drug-reactions-risk-factors-epidemiology-and-management-strategies/b-divya-durga
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Objectives
Our objectives are to evaluate prescription pattern and rational use of statins in a tertiary care corporate hospital.
Methodology
It was a prospective observational study conducted for a period of 6 months and included various departments of 300
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was inpatients and induvial more than 18 years of either gender who are prescribed with HMG-CoA reductase
inhibitors.
Results
In the present study 200 patients belonged to the age group of above 18 years, out of which about 65% were male
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Mellitus (DM) and cardiac events.
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The safe use of medicines is perhaps the single most important criteria that any regulatory authority within a given country has to ensure in order both to protect the public health and the integrity of its health care system. For the same purpose pharmacovigilance was established. According to WHO, Pharmacovigilance is the science and activities related to the collection, detection, and assessment of ADR’s. It promotes the systematic, rational use and assures the confidence for the safety of drugs. It improves patient care and safety. Significance of pharmacovigilance is growing as the patients or consumers have become more responsive about the advantage and hazard of medicines. Pharmacovigilance is a complex process and a robust system is essential to undertake the activity. A good pharmacovigilance system will identify the hazard aspects in the short period of time. This review article tries to explain the some basic principles, history and developments, methods and some scope of this developing field i.e. Pharmacovigilance in India.
8.1 ADR_complete.pdf
This document discusses adverse drug reactions (ADRs), including:
1) Defining ADRs and distinguishing them from adverse drug events. ADRs are unintended effects caused directly by a drug, while adverse events can have other causes.
2) Around 5-10% of hospitalized patients experience an ADR, contributing to increased costs and length of stay. ADRs can reduce quality of life and rarely cause death.
3) Pharmacovigilance aims to detect, understand, and prevent ADRs through monitoring, reporting, and research on drug safety. Pharmacists play a key role in pharmacovigilance.
Polypharmacy and medication errors
This document discusses polypharmacy and medication errors. It begins by defining polypharmacy as the use of multiple medications where more are being used than clinically indicated. Polypharmacy can increase the risk of drug interactions and adverse events. Common risk factors for polypharmacy include the elderly, multiple comorbidities, recent hospitalization, and multiple physicians or pharmacies. Medication errors are also defined as any error in the medication use process and examples are provided. Reporting systems for medication errors and the most commonly implicated drug classes and individual drugs are outlined. Risk factors for errors and recommendations to reduce polypharmacy and errors are presented.
Prescribing Opioids in the ED
1) The document discusses critical issues in prescribing opioids for adult patients in the emergency department. It provides recommendations on 4 critical questions related to opioid prescribing based on a review of the available medical literature.
2) The first critical question addresses whether prescription drug monitoring programs can help identify patients at high risk for opioid abuse. The recommendation is that PDMPs may help with this.
3) The second critical question discusses whether opioids are more effective than other medications for acute low back pain. The recommendations are to consider non-opioid options first and avoid routine opioid prescribing.
4) The third and fourth critical questions and recommendations address appropriate opioid selection and prescribing considerations on discharge for acute pain patients.
1482469439(ijcpcr)
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.
2005 DEA FAQ's
The document discusses key terms used when discussing pain medications and risk management. It defines terms like abuse, addiction, physical dependence, pseudoaddiction, and tolerance to encourage accurate use of terminology and promote better patient care and regulatory policies. Uncontrolled pain is an enormous public health problem, already costing tens of billions annually. Relieving pain is fundamental to public health, as recognized by many medical and regulatory organizations.
Final dissertation
This document discusses medication errors that can occur in hospitals. It defines medication errors as any error in prescribing, dispensing, or administering drugs, regardless of whether harm occurs. Medication errors are a major cause of preventable patient harm. The document classifies medication errors as mistakes, slips, or lapses, depending on where the error occurs in the medication use process. It also discusses different ways medication errors have been estimated to cause deaths in other countries to highlight the significant impact of these errors.
Post marketing surveillance
The document discusses post-marketing surveillance (PMS) of pharmaceutical drugs. PMS involves monitoring drug safety after market release using approaches like spontaneous reporting databases, patient registries, and record linkage between health databases. Data from PMS is important for discovering undesirable effects that were not found in pre-market clinical trials due to limited sample sizes and durations. PMS plays a key role in improving understanding of a drug's risks and benefits in real-world use.
Assignment Ethical and Legal Implications of Prescribing DrugsW.docx
This document provides guidance for an assignment on the ethical and legal implications of prescribing drugs as an advanced practice nurse. It discusses factors to consider when developing a treatment plan, such as the appropriate drug, dosage, administration schedule, and contraindications based on a patient's diagnosis and individual factors. The document emphasizes that nurses have a duty to act ethically and legally when prescribing to avoid harming patients, in accordance with their state's regulations. Students are asked to review scenarios assigned by their instructor and discuss the ethical and legal implications for all stakeholders, as well as strategies for disclosure/nondisclosure of errors and processes for minimizing medication mistakes.
introductiontopharmacoepidemiology-230613144442-c713d639.pdf
Epidemiology is the study of occurrence, distribution and determinants of health and
diseases or disorders in man and its application in controlling health problems.
Epidemiology has by tradition two major areas.
First is the study of infectious diseases that spread to large populations, i.e., epidemics.
The second is the study of chronic diseases.
Epidemiological studies help to solve such health problems and provide a basis for
improving living conditions of the people.
During its progress and development, epidemiology has made available precise and
strict methodologies for the study of diseases.
Pharmacology is the study of the effects of drugs.
Clinical Pharmacology is the study of the effects of drugs in humans, It is traditionally
divided into two basic areas namely:
1. Pharmacokinetics
2. Pharmacodynamics.
Pharmacokinetics is the study of the relationship between dose administered of a drug
and the serum or blood level achieved, it deals with absorption, distribution, metabolism
and excretion.
Epidemiology is the study of the distribution and determinants of diseases in
populations.
Epidemics is the study of chronic/ infectious diseases in large populations.
Pharmacoepidemiology is the study of the use of and the effects of drugs in large
number of people.
It involves the examination of a single individual or large groups of people followed for
many years.
It involves gathering & analysis of information in order to identify possible causation &
related factors, that can be applied in clinical practice to group of people & also to
individuals undergoing treatment.
INTRODUCTION TO PHARMACOEPIDEMIOLOGY.pptx
Pharmacoepidemiology is the one of branch deals with distribution of diseases and outcome measurement, etc.
Intro to Prevention: Psychopharmacology Guest Lecture
Current A&D Conditions in lane County: And why we need prevention. Guest lecturer: Julie Hynes, MA, RD, CPS - PreventionLane at Lane County Public Health
Pharmacoeconomics & drug compliance
This document discusses pharmacoeconomics, drug compliance, and therapeutic failure. It begins by defining pharmacoeconomics as the analysis of costs and consequences of pharmaceutical products and services. It then discusses various pharmacoeconomic methods like cost-benefit analysis and cost-effectiveness analysis. The document also explains drug compliance, adherence, and the consequences of non-compliance. It notes that non-compliance can result in therapeutic drug failure and increased costs. It concludes by discussing common interventions to improve compliance like patient education and simplifying drug regimens.
Similar to Recommendations on Potential Market Acceptance v. 4 (20)
Adverse Drug Reactions Risk Factors, Epidemiology, and Management Strategies
Adverse Drug Reactions Risk Factors, Epidemiology, and Management Strategies
A study on prescription pattern and rational use of statins in tertiary care ...
A study on prescription pattern and rational use of statins in tertiary care ...
Assignment Ethical and Legal Implications of Prescribing DrugsW.docx
Assignment Ethical and Legal Implications of Prescribing DrugsW.docx
introductiontopharmacoepidemiology-230613144442-c713d639.pdf
introductiontopharmacoepidemiology-230613144442-c713d639.pdf
Intro to Prevention: Psychopharmacology Guest Lecture
Intro to Prevention: Psychopharmacology Guest Lecture
Recommendations on Potential Market Acceptance v. 4
- 1. Recommendations on Potential Market Acceptance: Risk Evaluation & Mitigation Strategies (REMS) Medication Guide Communication Plan Elements to Assure Safe Use (ETASU) Implementation Plan References 1. Alexander, G. Caleb MD MS; Chang, Hsien-Yen PhD; Daubresse, Matthew MHS; Rutkow, Lainie JD PhD MPH; Stuart, Elizabeth A. PhD; Webster, Daniel W. ScD MPH. Effect of Florida’s Prescription Drug Monitoring Program and Pill Mill Laws on Opioid Prescribing and Use. American Medical Association. JAMA Internal Medicince. August 17, 2015 2. Cammilleri, Joseph PharmD BCACP. Opioid Monitoring. University of Florida Health Jacksonville. October 2015. 3. U.S Food and Drug Administration. A Brief Overview of Risk Evaluation & Mitigation Strategies (REMS). http://www.fda.gov/downloads/AboutFDA/Transparency/Basics/UCM328784.pdf Jessica Waetjen Regulatory, Economic, and Safety Issues of Opioid Use and Management Seminar October 17, 2015
- 2. Recommendations on Potential Market Acceptance: Elements to Assure Safe Use (ETASU) Prescribers / Pharmacists Responsibilities “A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose…” – Prescriber “…but a corresponding responsibility rest with the pharmacist who fills the prescription.” - Pharmacist Education / REMS Training Monitor and Document Pain Treatment Progress Prescription Drug Monitoring Programs (PDMP) Electronic database to voluntarily collect data Evaluate patients’ prescription drug history to recognize red flags and address problematic practices Law Enforcement Database (arrest history) References 1. Alexander, G. Caleb MD MS; Chang, Hsien-Yen PhD; Daubresse, Matthew MHS; Rutkow, Lainie JD PhD MPH; Stuart, Elizabeth A. PhD; Webster, Daniel W. ScD MPH. Effect of Florida’s Prescription Drug Monitoring Program and Pill Mill Laws on Opioid Prescribing and Use. American Medical Association. JAMA Internal Medicince. August 17, 2015 2. Cammilleri, Joseph PharmD BCACP. Opioid Monitoring. University of Florida Health Jacksonville. October 2015. 3. U.S Food and Drug Administration. A Brief Overview of Risk Evaluation & Mitigation Strategies (REMS). http://www.fda.gov/downloads/AboutFDA/Transparency/Basics/UCM328784.pdf Jessica Waetjen Regulatory, Economic, and Safety Issues of Opioid Use and Management Seminar October 17, 2015
- 3. Recommendations on Potential Market Acceptance: Patient Physical Exam and Medical / Pain History Urine Drug Screening Recommended Frequency Low risk: at least 1 per year**** Moderate risk: at least 2 per year**** High risk: at least 3-4 times per year**** Opioid Pain Treatment Agreement Risk Assessment Elements to Assure Safe Use (ETASU) References 1. Alexander, G. Caleb MD MS; Chang, Hsien-Yen PhD; Daubresse, Matthew MHS; Rutkow, Lainie JD PhD MPH; Stuart, Elizabeth A. PhD; Webster, Daniel W. ScD MPH. Effect of Florida’s Prescription Drug Monitoring Program and Pill Mill Laws on Opioid Prescribing and Use. American Medical Association. JAMA Internal Medicince. August 17, 2015 2. Cammilleri, Joseph PharmD BCACP. Opioid Monitoring. University of Florida Health Jacksonville. October 2015. 3. U.S Food and Drug Administration. A Brief Overview of Risk Evaluation & Mitigation Strategies (REMS). http://www.fda.gov/downloads/AboutFDA/Transparency/Basics/UCM328784.pdf Jessica Waetjen Regulatory, Economic, and Safety Issues of Opioid Use and Management Seminar October 17, 2015