The document outlines drug testing policies and procedures for pre-employment, random testing of employees required to have a commercial driver's license, reasonable suspicion testing, and outlines protections under the Americans with Disabilities Act. Employers are permitted to conduct drug testing if certain conditions are met to ensure a drug-free workplace while complying with state and federal regulations. The document provides guidance on testing procedures and appropriate responses to positive test results.
An overview of ICH-GCP guidelines of clinical trials.
Good clinical practice (GCP): a standard for the design , conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.
ICH-GCP is an International Conference on Harmonization Good Clinical Practice.
The guideline was developed with consideration of the current good clinical practices of the European union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the world health organization
A chronic toxicology study provides inferences about the long-term effect of a test substance in animals, and it may be extrapolated to the human safety of the test substance
This presentation is a brief overview of ICH-GCP guidelines. Although ICH-GCP is a very vast topic, still this presentation will cover almost all the points. The reader will be able to discuss about the roles and responsibilities of various personnel in clinical trials.
Toxicology testing, also known as safety assessment, or toxicity testing, is conducted to determine the degree to which a substance can damage a living or non-living organism. It is often conducted by researchers using standard test procedures to comply with governing regulations, for example for medicines and pesticides. Much toxicology is considered to be part of the field of preclinical development. Stages of in vitro and in vivo research are conducted to determine safe doses of exposure in humans before a first-in-man study. Toxicology testing may be conducted by the pharmaceutical industry, biotechnology companies or contract research organizations.
Drug development is a high-risk enterprise. The typical new drug takes 10-12 years to get to market and costs up to $500 million. Pharmaceutical companies face continually increasing challenges in drug development— shorter product life cycles, global competition, as well as daunting technical and regulatory hurdles. Meanwhile, as a result of the Human Genome Project and high throughput drug development methods, there are many more drug candidates to test. Thus, there is growing pressure on pharmaceutical and biopharmaceutical companies.
An overview of ICH-GCP guidelines of clinical trials.
Good clinical practice (GCP): a standard for the design , conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.
ICH-GCP is an International Conference on Harmonization Good Clinical Practice.
The guideline was developed with consideration of the current good clinical practices of the European union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the world health organization
A chronic toxicology study provides inferences about the long-term effect of a test substance in animals, and it may be extrapolated to the human safety of the test substance
This presentation is a brief overview of ICH-GCP guidelines. Although ICH-GCP is a very vast topic, still this presentation will cover almost all the points. The reader will be able to discuss about the roles and responsibilities of various personnel in clinical trials.
Toxicology testing, also known as safety assessment, or toxicity testing, is conducted to determine the degree to which a substance can damage a living or non-living organism. It is often conducted by researchers using standard test procedures to comply with governing regulations, for example for medicines and pesticides. Much toxicology is considered to be part of the field of preclinical development. Stages of in vitro and in vivo research are conducted to determine safe doses of exposure in humans before a first-in-man study. Toxicology testing may be conducted by the pharmaceutical industry, biotechnology companies or contract research organizations.
Drug development is a high-risk enterprise. The typical new drug takes 10-12 years to get to market and costs up to $500 million. Pharmaceutical companies face continually increasing challenges in drug development— shorter product life cycles, global competition, as well as daunting technical and regulatory hurdles. Meanwhile, as a result of the Human Genome Project and high throughput drug development methods, there are many more drug candidates to test. Thus, there is growing pressure on pharmaceutical and biopharmaceutical companies.
Part of the MaRS Best Practices Series - Pre-Clinical development workshop
http://www.marsdd.com/bestpractices/
Speaker: Mike Watson. Exec Director Drug Development Services, Ricerca BioSciences
Toxicological Approach to Drug DiscoverySuhas Reddy C
For better understanding of students. This will give you a detailed explanation of Toxicological approach. Contact me through comment section if you need any assistance in understating
The number of chemicals, poisonous household products and medicines on the Indian market it is increasing day by day which can frequently increases the risk of misuse of these products and leads to Greater incidence of intentional and unintentional poisoning.
toxicology study according to OECD guidelines, organisation for economic co-orporation and developement, jasdeep singh , maharaja ranjit singh punjab technical university bathinda
genotoxicity describes the property of chemical agents that damages the genetic information within a cell causing mutations, which may lead to cancer. While genotoxicity is often confused with mutagenicity, all mutagens are genotoxic, whereas not all genotoxic substances are mutagenic
Introduction to pre clinical screening of drugsKanthlal SK
Various Techniques and Methods for screening of new chemical entities in preclinical aspects (both invitro & invivo) for effective and safe clinical usage.
DRUG DISCOVERY & DEVELOPMENT PROCESS, it's a detail description about how drug is made available in market it's development and discovery of drug The Hole Study is given in This Topic.
Part of the MaRS Best Practices Series - Pre-Clinical development workshop
http://www.marsdd.com/bestpractices/
Speaker: Mike Watson. Exec Director Drug Development Services, Ricerca BioSciences
Toxicological Approach to Drug DiscoverySuhas Reddy C
For better understanding of students. This will give you a detailed explanation of Toxicological approach. Contact me through comment section if you need any assistance in understating
The number of chemicals, poisonous household products and medicines on the Indian market it is increasing day by day which can frequently increases the risk of misuse of these products and leads to Greater incidence of intentional and unintentional poisoning.
toxicology study according to OECD guidelines, organisation for economic co-orporation and developement, jasdeep singh , maharaja ranjit singh punjab technical university bathinda
genotoxicity describes the property of chemical agents that damages the genetic information within a cell causing mutations, which may lead to cancer. While genotoxicity is often confused with mutagenicity, all mutagens are genotoxic, whereas not all genotoxic substances are mutagenic
Introduction to pre clinical screening of drugsKanthlal SK
Various Techniques and Methods for screening of new chemical entities in preclinical aspects (both invitro & invivo) for effective and safe clinical usage.
DRUG DISCOVERY & DEVELOPMENT PROCESS, it's a detail description about how drug is made available in market it's development and discovery of drug The Hole Study is given in This Topic.
Drug testing - against my human rights?Richard Evers
Is workplace drug testing against your human rights, or can HR or health and safety enforce a drug policy? What regulations apply and what is the actual process of drug testing?
Drug testing may also be performed in schools aside from workplace. According to the study, younger generations are also using illegal drugs at an early age.-source: https://drugabusecontrol.wordpress.com/2014/12/22/drug-testing-in-schools/
Learn more about drug testing in schools,
email us @ info@drugabusecontrol.com
or call (800) 366-5029
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Welfare and Drug Testing Policy in the USAFaisal Farrukh
American Congress adopted the Anti Drug Abuse Act in 1988. In 1995 the policy was further refined and the government started implementing its drug free policy. The drug free policy enforce denial of federal benefits to users, possessors and traffickers from one to five years and the third timers permanently. This included grants, contracts, licensing, loans, but excluded welfare and public housing. In 1996 the government enacted Personal Responsibility and Work Opportunity Reconciliation Act, created Temporary Assistance for Needy Families (TANF) to make people move from welfare to work, a mandatory state run drug test.
Background Checking—The Use of Criminal Background Checks in Hiring Decisionsshrm
Approximately two-thirds (69%) of organizations reported that they conduct criminal background checks on all of their job candidates. Roughly one-half of organizations conduct criminal background checks to reduce legal liability for negligent hiring (52%) and to ensure a safe work environment for employees (49%). The top two convictions that are very influential in the decision not to extend a job offer are violent felonies (96%) and nonviolent felonies (74%). However, about three-fifths (58%) of organizations allow job candidates to explain the results of their criminal checks before the decision to hire or not to hire is made.
Sonia Gandhi and her contribution to terrorism in India for vote bank politics. There is more damning allegations on her sisters connections to ISI, her private secry Ahmed Patel connections and the way 2G licenses are sold to ISI connected companies.
THE Basic Foundation of a Successful Trucking Company...Brief Overview of the Essential Elements a Trucking Entrepreneur Must Be Knowledgeable of...and a little more!
This presentation explains the benefits of performing drug tests on your employees. It also explains when to properly administer them to your work force.
FMCSA Drug and Alcohol Testing Program RegulationsScreensoft
The FMCSA drug and alcohol testing program regulations can be confusing and complex. So, we took our internal training presentation and decided to make it public. Use this to supplement the code of federal regulations (CFR) or for training your own staff. Content includes information from Title 49 Transportation CFR Part 40 and Part 382.
Here's what to expect:
-The DOT drug and alcohol testing procedures.
-The DOT drug and alcohol tests required for truck drivers.
-Visual aids including the post-accident drug and alcohol testing criteria.
-The random drug and alcohol testing requirements for truck drivers.
-The consequences for drug and alcohol use and violations.
-The requirements and procedures for the CDL drug and alcohol clearinghouse.
On Tuesday, March 8, 2022 Kegler Brown presented its annual Managing Labor + Employee Seminar. The virtual seminar focused on timely information regarding labor and employee relations, and allowed attendees to earn CLE and SHRM credit hours.
Speaking to the Ohio Chamber of Commerce on April 5, Luis discussed several issues related to employment and medical marijuana. He detailed what the OMMCP does not do, such as how it does not require an employer to permit or accommodate an employee's use, or prohibit an employer from establishing and enforcing a drug testing policy, drug-free workplace policy, or zero-tolerance drug policy. He also highlighted other employment concerns, such as how the Worker’s Compensation Bureau will not pay for medical marijuana, and briefly reviewed the medical marijuana industry, looking at topics from sales figures to collegiate cannabis courses.
Legalization of Marijuana Webinar- Impact for Drug Testing Employers Eliassen Group
HR PROFILE TO HOST TAFT LAW:
LEGALIZED & MEDICINAL MARIJUANA’S POTENTIAL IMPACT ON THE WORKPLACE
Key Take-Aways of this Webinar Include:
1. Drug Testing for Employers- Policy, Procedure, Practice
2. Medicinal and Legalized Marijuana in the Workplace
3. Employers Best Practice to Avoid and Defend Discrimination Claims
Chapter 23
Pharmaceutical Manufacturers
Learning Objectives
Familiarity with largest drug companies and their record of fraud violations
7 elements of a mandatory compliance program
Role of the Compliance Officer
Purpose of policies and procedures on compliance
Areas of greatest drug company fraud risk
Analyze compliance program effectiveness
Questions & complaints about compliance
Introduction
Drugs constitute 10% of health care spending
Reasons for continued growth in expenditures on drugs
Few factors slowing that growth
Pharmaceutical Manufacturers & Their Fraud Violation Records
Pharmaceutical industry composed of a few very large, highly competitive companies
Top 10 pharmaceutical companies based on their revenues in 2010 and 2011
Largest federal fraud settlements with pharmaceutical companies in last five years
Active Corporate Integrity Agreements with pharmaceutical companies in early-2013
Seven Elements of Effective Compliance
Implementing written policies and procedures
Designating a Compliance Officer and Committee
Conducting effective training and education
Developing effective lines of communication
Conducting internal monitoring and auditing
Enforcing standards through disciplinary guidelines
Responding to problems & taking corrective action
Designating a Compliance Officer and Compliance Committee
Compliance Officer – focal point for compliance activities, full-time, sufficient authority, staff & resources, direct access to CEO and BOD
OIG-prescribed responsibilities of the CO
Compliance Committee – advise and assist the CO, understand company operations, integrity, judgment, assertiveness, and accessibility
Written Policies and Procedures
Code of Conduct – fundamental principles and values to provide overall direction to employee work behavior
Policies and procedures – governing employee actions in areas of operations where there is the highest risk of potential liability under federal fraud and abuse laws
Risk areas defined by OIG Program Guidance for Pharmaceutical Manufacturers
7
Integrity of Data Used to Determine Government Reimbursement
Many federal and state health care programs base their reimbursement rates for drugs on price and sales data submitted by drug firms
Failure to submit high integrity data exposes a company to liability under the False Claims Act, the Civil Monetary Penalties Statute, and the Anti-Kickback Statute
Prices reported must reflect any adjustments made to prices charged to purchasers
Kickbacks and Other Illegal Remuneration
Violations of the Anti-Kickback Statute (AKS) may result in criminal penalties
Identify paying relationships with persons able to generate federal health care revenues for the company
Examine reasons for each of the relationships
Criteria for judging legal risk of a relationship
Modify the relationship or fit it into one of the “safe harbors”
Risky Relationships:
Purchasers and Their Agents
Discounts and other remuneration to purchasers
Product supp ...
Gleamns reasonable suspicion training for supervisor
Drug testing presentation slide share
1. Drug Testing What you need to know about pre- employment and current employee testing
2. Pre-Employment Testing Testing of current employees State and Federal Regulations What to do in the event of a positive result Americans with Disabilities Act protections
3. Definition of “Drug” under VFEPA (Vermont Fair Employment Practices Act) "Drug" means a drug listed or classified by the U.S. Drug Enforcement Administration as a Schedule I drug, or its metabolites, and alcohol. 21 V.S.A. § 511(3).
4. Employers CAN require applicants to pass a drug test, if certain conditions are met. PRE-EMPLOYMENT
5.
6. Written notice is provided, outlining the testing procedure and a list of the drugs to be tested for, along with a statement that therapeutic levels of medically-prescribed drugs will not be reported
7. The drug test is administered in accordance with specified Vermont procedures for such testing, including a written policy describing the drug testing to be conductedConditions Under Which Pre-Employment Testing is Permitted in Vermont
8. Employer cannot require current employees to be tested unless the following conditions are met: Employer has probably cause to believe the employee is using or under the influence of drugs on the job Employer offers a bona fide rehabilitation program, either provided by the employer, under contract with a nonprofit hospital service corporation, or provided under a health insurance policy Drug Testing of Current Employees Under Vermont Law
9. Employer cannot require current employees to be tested unless the following conditions are met: Employee will not be terminated if the test result is positive and the employee agrees to complete the employee assistance program. The employee may be suspended for up to three months to complete the program The test is administered in accordance with specified Vermont procedures for such testing including a written policy describing the drug testing to be conducted The employee is subject to Federal Drug and Alcohol regulations as specified by the Federal Motor Carrier Safety Administration (FMCSA) Drug Testing of Current Employees Under Vermont Law (continued)
10. State law does NOT apply to CDL testing. Federal laws and regulations govern CDL drug and alcohol testing These laws and regulations REQUIRE ongoing drug and alcohol testing of CDL’s after employment. Therefore…
11. All employees whose jobs require a CDL are subject to random testing Unless an employee actually operates a commercial vehicle, he or she is not required by federal law (and thus Vermont law) to submit to random drug and alcohol testing, regardless of whether or not he or she performs safety-sensitive functions. Under FMCSA Regulations:
12. Any driver required to possess a CDL, including those employed by Federal, State, and local government agencies, owner operators, and equivalently licensed drivers from foreign countries NOT subject to ongoing testing: Drivers who only operate commercial motor vehicles (CMV’s) on private property not open to the public Drivers of authorized emergency vehicles such as law enforcement, fire department, public or private ambulance, and volunteer rescue squads, as these vehicles are NOT considered CMV’s Who Is Subject to Ongoing Testing Under Federal Law?
13. 1. Pre-Employment Also includes drivers who have been removed from a random testing pool for more than 30 days Required CDL Driver Tests
14. 2. Post-Accident Must be drug and alcohol tested whenever they are involved in a fatal accident or receive a traffic citation resulting from an injury or vehicle-disabling accident Alcohol test must occur within 8 hours Drug test must occur within 32 hours Required CDL Driver Tests
15. 3. Random Performed on an unannounced, unpredictable basis on employees whose identifying information (e.g., social security number or employee number) has been placed in a testing pool from which a scientifically arbitrary selection is made. This selection is usually computer generated to ensure that it is indeed random and that each person of the workforce population has an equal chance of being selected for testing, regardless of whether that person was recently tested or not. Because this type of testing has no advance notice, it serves as a deterrent. Refusal to test is equivalent to a positive test result Required CDL Driver Tests
16. 4. “Reasonable suspicion” If a driver exhibits signs of drug or alcohol abuse Based on observations concerning the appearance, behavior, speech or body odors of the driver Required CDL Driver Tests
17. 5. Return to Duty involves a one-time, announced test when an employee who has tested positive has completed the required treatment for substance abuse and is ready to return to the workplace Required CDL Driver Tests
18. 6. Follow-Up conducted periodically after an employee returns to the workplace upon completing rehabilitation for a drug or alcohol problem Prescribed by the substance abuse professional (SAP) who signs the return-to-duty report administered on an unannounced, unpredictable basis at least six times in the first 12 months following the return-to-duty test Can continue for up to 5 years Is in addition to random testing Required CDL Driver Tests
20. Lab provides the medical review officer with a written report of the result Dual confirmation is required for a positive result Test showing therapeutic level of tested drug must be reported as negative Medical review officer must personally contact the individual, discuss the results, and give the employee/applicant an opportunity to retest a portion of the sample at his/her own expense Employer receives confidential report with results Testing Result Process Under VT Law
21. Employer is under no obligation to employ the applicant individuals who currently engage in the illegal use of drugs are specifically excluded from the definition of an "individual with a disability" when an employer takes action on the basis of their current use If Applicant Test is Positive
22. If Employee Test is Positive The employer has an obligation under the Drug Free Workplace Act of 1988 to provide a workplace that is free of illegal drugs The employer must provide a safe work environment Consider the welfare of the employer and other employees, along with the welfare of the employee who tested positive and possible rights under ADA (Americans with Disabilities Act)
23. What to do? Employee must be given the opportunity to participate in the EAP or recognized drug/alcohol addiction treatment program The employee may be suspended for up to three months to complete the treatment program Refusal to participate is cause for termination, as is a positive test after rehabilitation is completed
24. Drug Free Workplace Act vs. Americans with Disabilities Act (ADA) Protections The Drug Free Workplace Act specifically permits employers to ensure that the workplace is free from the illegal use of drugs and the use of alcohol, and to comply with other Federal laws and regulations regarding alcohol and drug use. At the same time, the ADA provides limited protection from discrimination for recovering drug addicts and for alcoholics. ADA protects an employee with a disability, but does not give an employee the ability to bring illegal drugs on the premises If you have a “no alcohol” policy, then employees also do not have the ability to bring alcohol onto the premises
25. Current illegal users of drugs are not "individuals with disabilities" under the ADA, and are therefore not protected if the employer takes action Current alcohol users CAN be protected under the ADA, if the alcoholic can perform the essential functions of the job In either case, failure to do the job is cause for disciplinary action, even if this failure is the result of drug or alcohol abuse Is an employee who tests positive deemed to have a disability?
26. One of your drivers was driving a dump truck. The truck ran off the road. The driver was not injured, and there were no other vehicles involved, but the truck had to be towed out of a ditch. What would you do?
27. One of your supervisors has reasonable suspicion that a CDL arrived at work under the influence of drugs. A drug test was arranged. However, the employee did not show up at the testing site. He reported to work the next day, stating that he did not show up for the testing because he did not agree that he needed to be tested. What would you do?
28. A clerical employee is habitually late for work. Her supervisor at times has smelled alcohol on her breath. She’s getting her job done adequately except for the lateness. What would you do?
29. An applicant discloses to you in an interview that he is a drug addict but has undergone treatment and has been clean for several years. His drug test comes back positive. He claims he is on painkillers for a bad back. What would you do?
30. Be consistent Train your supervisors, and document your training efforts Maintain a written policy on drug testing and your commitment to a drug free workplace What you can do to protect yourself:
31. Enforcement is by private civil action State pursues violation of statute Employee may seek attorneys’ fees and court costs, damages, and injunctive relief Employer penalties include civil fine of $500-$2000, and criminal fine of $500-/$1000, imprisonment for not more than 6 months or both Enforcement and Penalties