Premium Essay

Who Drug Evaluation

In: Business and Management

Submitted By jcrrreddy
Words 17347
Pages 70


V O L U M E 10 N U M B E R 4 19 9 6










Volume 10, Number 4, 1996

World Health Organization, Geneva

WHO Drug Information
General Policy Topics
Meeting the challenge of biotechnology 175

Regulatory Matters
Acellular pertussis vaccine for infants Breath test for Helicobacter pylori Restrictions on use of anorectics Coumarin: regulatory action Laxatives: reclassification of common ingredients Is melatonin a prescription drug? NSAIDS, antimicrobials and angioedema Drug-induced liver disease Fluoxetine and hepatitis Hepatitis B vaccine and musculoskeletal reactions Pyrithyldione-diphenhydramine and agranulocytosis Roxithromycin associated with cardiac arrhythmias 187 187 187 188 189 189 189 189 190 190 190 190

Reports on Individual Drugs
Confirmation of increased chloroquine resistance in South Africa Which malaria drug for children? Post-malaria neurological syndrome and mefloquine Driving ability in cancer patients treated with morphine Hormone replacement therapy and venous thromboembolism 177 177 177 178 179

Safety Issues
Documentation requirements for approval: safety Drug safety monitoring centres 180 181

Recent Publications
WHO Expert Committee on Specifications for Pharmaceutical Preparations: Thirty-fourth report International Nonproprietary Names (INN) for pharmaceutical substances: cumulative list No. 9 Good pharmacy practice (GPP) guidelines 191 192 192

General Information
Recommendations from the ICDRA reinforce the mission of regulatory authorities The International Pharmacopoeia — how useful is it? Reference preparations for the evaluation of diagnostic kits used in blood screening 182 186 186


Similar Documents

Free Essay

Human Services Delivery

...Research design……………………………………………………………………….....6 6.0 Study Sample………………………………………………………………………….....7 7.0 Ethical considerations…………………………………………………………………....7 8.0 Measuring client progress……………………………………………………………..…8 9.0 Threats to validity…………………………………………………………………..……9 10.0 Use of data from the evaluation…………………………………………………...….9 11.0 Conclusion…………………………………………………………………………....10 References………………………………………………………………………………….…11 Human Services Program 1.0 Introduction Human services delivery refers to a broad and unique approach to meeting human needs and their respective objectives, Woodside & McClam (2002).According to Larson (2004), it requires the use of a unique interdisciplinary approach that mainly focuses on prevention and remediation of problems. The secret for a successful human services delivery is improving the quality of life by simply being committed, Gilbert (2008). This profession mainly improves service delivery systems by addressing quality, accountability, accessibility and coordination of stakeholders whose profession is services delivery, Finn (2000). Community support skills are must have prerequisites for professionals who have specialized in human services delivery. These essentials provide vivid descriptions of workers responsibilities, such responsibilities or roles are based on competencies. These include advocacy, empowerment of the participants and community networking. These skills in turn provide the trainers,......

Words: 2490 - Pages: 10

Premium Essay

Employment Law Case Study 6

...passing a preemployment drug test is required for the conditional of job offer as being constitutional. This case also discusses that a government employer is unable to demonstrate that it had a special need to drug-test a job candidate. Also whether or not drug testing should be used a determining factor in the hiring decision of a potential employee within the organization. Another important aspect to look at in the discussion of drug testing is whether or not if the job candidate can refuse drug testing without facing adverse employment consequences. There are many types of employment tests that many employers base their hiring and promotion decisions on. Employment tests are also used by employers within an organization to screen for fitness of the individual and whether or not they would be able to complete the job that would be required of them. Some of the these tests that completed by employers are designed to identify disqualifying characteristics such as illegal drug use, lack of truthfulness, intelligence, psychological, skill, and physical in order to complete any or all of the jobs that may be required of the employees in order to work for a particular organization. Not only is dug testing looked at in this case but also whether or not the Fourth Amendment is violated on the basis of unreasonable search and seizure that shows the “most significant limitation on drug testing” that is found in both the U.S. Constitution and state constitutions. Drug testing occurs......

Words: 3769 - Pages: 16

Premium Essay

Mr Kwagala

...RECORDS MAINTENANCE: Does the auditor observe that a set of records has been established with the following characteristics: 1) Secure location and access controlled to those few individuals with a need to know; 2) Information released only as appropriate; 3) Federally required tests and testing has priority and is separate from non-DOT testing; 4) Records are maintained for the proper length of time. Does the employer maintain records of its anti-drug and alcohol misuse program in a secure location with controlled access? Does the employer only release drug and alcohol testing information related to covered employees as permitted by law or in accordance with the circumstances described in Section 655.73? Are DOT tests completely separate from non-DOT tests in all respects, and do DOT tests take priority (i. e. DOT tests conducted and completed before a non-DOT test is begun, urine collected in a DOT test not used for a non-DOT test)? REGULATORY CITATION Section 655.71(a) states: “An employer shall maintain records of its anti-drug and alcohol misuse program as provided in this section. The records shall be maintained in a secure location with controlled access.” Section 655.73(a) states: “Except as required by law, or expressly authorized or required in this section, no employer may release information pertaining to a covered employee that is contained in records required to be maintained by Section 655.71 of this subpart.” 3. 4. Section 40.13(a) states: “DOT......

Words: 7626 - Pages: 31

Free Essay

Cuban Resolution to Lung Cancer

...make antibodies that are specifically targeted for EGF and are able to bind and stop it from attaching to the receptors on cancer cells. This means there is no signal telling the cancer cells to grow and divide and thus the uncontrolled growth of cancer cells is slowed down. The vaccine is usually ordered after chemotherapy and radiotherapy has already been given (CIMAVAX-EGF for Non-Small, 2014). An additional benefit of CimaVax and what makes it an important lung cancer treatment is its ability to increase the overall survival with very minimum toxicity. After performing several small trials using the vaccine, the Cancer Research UK concluded that CimaVax helps lung cancer patients live an average of four to six months longer than those who did not take or follow-up the medication (Dovey, 2015). The vaccine also decreases symptoms like coughing, breathing difficulties, and improves the overall quality of life for lung cancer patients. Side effects that may result from the medication are minor and some of them include chills, fever and nausea. Another advantage of CimaVax is that it is relatively cheap to produce and to store. Even though each shot costs about $1, the Cuban government has been offering the medicine, which must be taken one shot every month, for free to its patients (Smith, 2015). It may be obvious that the vaccine will not be distributed for free in America due to a completely different health and marketing system, but its low production and storage......

Words: 1414 - Pages: 6

Free Essay

Strategic Plan and Presentation

...Strategic Choice and Evaluation Dolores VanHorn STR/581 10/07/2015 Tugtekin Gokaydin Strategic Choice and Evaluation Abstract The purpose of this evaluation is to bring focus to the strategic choice and evaluation process. There are levels of direction involved the strategic choices that a company makes and those methods can likely determine the success of a company well in advance. This evaluation will include the value disciplines that can benefit A Life After Community Living. The generic strategies that will implemented to support the overall goal of growth for the company and the grand strategy which will include insight into the trends of the market and the individuals served by A Life After Community Living. Researchers have found empirical data that supports that organizational views reflect the characteristics of senior management, (Geletkanycz, M. A., & Hambrick, D. C. (1997). Strategic Choice and Evaluation Choosing the ideal strategic direction is paramount for long lasting growth and revenue of Life After Community Living. The residential recovery community is extremely competitive, however there is a smaller market for service providers that can offer after care residential services for the masses. This company must analyze the trends of the community and the population that it serves to make strategic choices that have value for the stakeholders. A value discipline will be identified to set a proper......

Words: 976 - Pages: 4

Free Essay

Psy 425 Week 3 Learning Team Drug-Free Workplace Evaluation Paper

...Learning Team Drug-Free Workplace Evaluation Paper To Buy This material Click below link Read the following scenario: o    The Jackdaw Company manufactures designer label clothing in several locations throughout New York and New Jersey. Over the last six years the company has grown from a handful of dedicated employees to just under 100 which include production managers, sewers, administrative assistants, and delivery truck drivers. The CEO and HR department is considering instituting a companywide drug-free workplace policy along with pre-employment drug testing for new hires.  Some at the Jackdaw Company are not fully convinced that such a policy is necessary and are concerned about the costs associated with implementing a new program.  Your team of consultants has been contacted to write the company’s policy. Your team will also provide training to employees if The Jackdaw Company decides to adopt your policy. •    Your assignment is to prepare a 2,000 – 2,500 word report for The Jackdaw Company that emphasizes the importance of a drug-free workplace and the possible cost saving benefits to the company.  When suggesting policies to help promote a drug-free workplace, include the following: o    Key benefits associated with a drug-free workplace. o    The prevalence of illicit and prescription drug users in the United States workforce. o     The possible effects of......

Words: 390 - Pages: 2

Premium Essay


...Efficacy and Cost Savings of Drug Treatment Versus Imprisonment by Doug McVay, Vincent Schiraldi, and Jason Ziedenberg January 2004 Justice Policy Institute 4455 Connecticut Avenue NW Suite B-500 Washington, DC 20008 v 202.363.7847 f 202.363.8677 POLICY REPORT J u s t i c e P o l i c y I n s t i t u t e Table of Contents Introduction: The national and local problem of drug imprisonment 3 Methodology 4 Finding 1: Treatment can be less expensive than a term of imprisonment 5 Finding 2: Treatment can be cost effective 6 Finding 3: Treatment can reduce substance abuse and recidivism while building communities 9 Finding 4: Promising treatment models exist in Maryland and around the country 11 Maryland: Break The Cycle The Correctional Options Program (COP) Drug Courts: Maryland and the National Perspective California’s Substance Abuse and Crime Prevention Act (SACPA) 11 12 13 14 Conclusion: Drug treatment can be more effective than cycling people in and out of prison 18 Endnotes 20 About the Authors Treatment or Incarceration? was primarily authored by Doug McVay, former research director for Common Sense for Drug Policy, a non-profit dedicated to expanding discussion on drug policy by educating the public about alternatives to current policies. He is the author and editor of Drug War Facts, an annual......

Words: 8236 - Pages: 33

Free Essay

Drug Courts

...first Drug Court in the United States was established in Miami- Dade County, Florida in 1989 as a response to the growing crack-cocaine problem affecting the city. Chief Judge Gerald Wetherington, Judge Herbert Klein, then State Attorney Janet Reno and Public Defender Bennett Brummer designed the court for nonviolent offenders to receive treatment. A Drug Court is a specialty court that manages drug abuse cases through comprehensive supervision, drug testing and treatment. Incarceration is an appropriate resolution for some people, but for many, society is better served by addressing the underlying causes of a person’s addiction. Montgomery County Circuit Court offers two drug court programs, one for adults and one for juveniles. Both are comprehensive treatment programs for adults and youth offenders who have serious drug/alcohol dependency problems. The drug treatment court was established in October, 2003persuant to the order of Chief Judge Robert M. Bell of the Maryland Court Appeals. The drug court was developed because of high rates of re-arrest, fragmented approaches to treatment, a focus on punishment rather than rehabilitation. The Montgomery County Circuit Court Adult Court Program is a voluntary program that offers offenders with drug/alcohol-dependency problems a new opportunity to break the chain of the cycle of drug/alcohol addiction and crime through intensive treatment and, monitoring and direct attention from the court. The purpose of the Adult Drug Court......

Words: 960 - Pages: 4

Free Essay

The Fda

...consumer protection agencies, the Food and Drug Administration (FDA) protects the public from unsafe foods, drugs, medical devices, cosmetics, and other potential hazards. As part of the department of health and human services, the FDA annually regulates over $1 trillion worth of products, which account for one-fourth of all consumer spending in the United States. It also protects the rights and safety of patients in clinical trials of new medical products, monitors the promotional activities of drug and device manufacturers, regulates the labeling of all packaged foods, and monitors the safety of the nation's blood supply. To ensure compliance with its regulations, the FDA employs over 1,000 investigators and inspectors who visit over 15,000 food-processing, drug-manufacturing, and other facilities each year. If it finds violations of law, the FDA first encourages an offending company to voluntarily correct the problem or to recall a faulty product from the market. If the firm does not voluntarily comply with the law, the FDA may take it to court and seek criminal penalties against it. The FDA may also seize faulty products, order product recalls, seek injunctive relief, impose fines, and take other types of enforcement action. Each year, the FDA declares about 3,000 products and 30,000 import shipments to be unacceptable in various ways. The FDA employs over 2,000 scientists—including 900 chemists and 300 microbiologists—who provide the scientific evidence to back up......

Words: 3299 - Pages: 14

Premium Essay


...Goodpaster, 2007, pg. 56.) There are many things that can cause an impact to the accuracy of sensory data. The three factors which can contribute to the accuracy of sensory data either positively or negatively are food, drugs and sleep. The first and the most important one is food. The human brain like other body parts needs energy in order to function properly in order to allow our senses to work well. Our brain serves as the seat of human consciousness and therefore stores our memories, helps us to feel emotions, and gives us our personalities. Eating right food with enough protein, sugars and vitamins especially starches will make our brain function very well. Without the good nutrition our brain will lack the necessary energy needed and as result will strongly affect our sensory data. “Without adequate nutrients, intellectual impairment results” (Kirby&Goodpaster,2007, p69). The second factor is the effect of drugs which has a major effect to the accuracy of the human sensory. Drugs like narcotics or pain medication and alcohol and cocaine can easily and effectively affect the function of our brain. The big problem with this kind of medicine is their ability to cause body reaction over time. In addition, some kinds of drug can cause hallucination, irritability and disturbed concentration and as result can lead to serious injuries and long term troubles (Kirby & Goodpaster, 2007). Finally, sleep as important as it is in human play a big role in......

Words: 976 - Pages: 4

Premium Essay

Clinical Trials

...PHASES OF CLINICAL TRIALS Introduction Clinical Trial Definition: “Clinical trial” means a systematic study of new drug(s) in human subject(s) to generate data for discovering and / or verifying the clinical, pharmacological (including pharmacodynamic and pharmacokinetic) and /or adverse effects with the objective of determining safety and / or efficacy of the new drug. “ Drug Development Process: The process of drug development can be broadly classified as pre-clinical and clinical Pre- clinical refers to experimentation that occurs before it is given to human subjects; whereas, clinical refers to experimentation with humans. Within the realm of clinical research, clinical trials are classified into four phases. [pic] Classification of Various phases of clinical trials: There are five different phases of clinical trials, which include: ➢ Phase 0 Trials (Micro dosing trials) ➢ Phase I Trials (Human Pharmacology/ First time in Man Studies) ➢ Phase II Trials (Pilot Trials/ Therapeutic Exploratory trials) ➢ Phase III Trials ( Expanded clinical trials/Therapeutic Confirmatory trials) ➢ Phase IV Trials ( Post Marketing trials) 1. Phase 0 Trails/Micro dosing Trials: Micro dosing, or human phase 0 clinical trials, is a technique whereby sub pharmacological doses of prospective drug candidates are administered to human volunteers. A micro dose study provides early pharmacokinetic data in humans and only requires minimal......

Words: 1463 - Pages: 6

Premium Essay


...Tuberculosis ---------- Tuberculosis (TB) is an infectious disease caused by a germ (bacterium) called Mycobacterium tuberculosis. This germ primarily affects the lungs and may infect anyone at any age. In the United States, the number of TB cases steadily decreased until 1986 when an increase was noted; TB has continued to rise since. Today, ten million individuals are infected in the U.S., as evidenced by positive skin tests, with approximately 26,000 new cases of active disease each year. The increase in TB cases is related to HIV/AIDS, homelessness, drug abuse and immigration of persons with active infections. How is TB Contracted? TB is a contagious or infectious disease that is spread from person-to- person. A person is usually infected by inhaling the germs which have been sprayed into the air by someone with the active disease who coughs. However, inhaling the germ does not usually mean you will develop active disease. A person's natural body defenses are usually able to control the infection so that it does not cause disease. In this case, the person would be infected, but not have active disease. Only about 10% of those infected will actually develop TB in their lifetimes. Active disease can occur in an infected person when the body's resistance is low or if there is a large or prolonged exposure to the germs that overcome the body's natural defenses. The body's response to active TB infection produces inflammation which can eventually damage the lungs. The......

Words: 1452 - Pages: 6

Free Essay

Case Study Analysis be successful. The new recruiter for ABC, Inc., Carl Robinson, hired 15 new trainees in the month of April and scheduled them for orientation for June 15th. They are scheduled to start working by the month of July. Monica Carrolls, the Operations supervisor, contacted Carl on May 15th to make sure everything was in order for the new trainees to begin. Carl believed everything was in order. Later that month Carl checked to see if everything was completed and ready to go; to his surprise it was not. The new hires had not completed the applications, drug screening, and there was nowhere to host the orientation. Not only was the orientation roomed booked for the entire month but the orientation training packets were also incomplete. How would Carl get all of these errors corrected before the new hires are scheduled to start training? With a designated area to hold orientation, the proper training packet, competition of files and drug test, and communication the orientation should start on the designated date. Background Upon hiring new employees, there is a proper protocol that has to take place before the employee can start working. Every company has a specific hiring process. There must be a completed job application before the potential employee can go forward with the interview process. After the interview the employer will determine if they will give a job offer. With the job offer you give information on the position, the pay, the hours, the start date and time, and......

Words: 1453 - Pages: 6

Premium Essay


...Drug-Free Workplace Evaluation Andrew Rhea, Rebecca Chiavetta, Jami Krebs, and Lisa Meier PSY 425 November 12, 2012 Dr. Elizabeth Riegner Drug-Free Workplace Evaluation Imagine an employee is returning from a lunch break, and a coworker is collaborating with this individual in an erratic manner. The coworker’s actions make this employee feel unsafe, and cause him or her to become unproductive. The coworker has an accident, and the company is shutdown to investigate the accident. The previous scenario has often occurred throughout the United States, causing companies to lose money from possible lawsuits, and decreased productivity in the workplace. Illicit, and prescription drug use is prevalent in the United States, and causes absenteeism, accidents, downtime, turnover, theft, morale issues, and decreased productivity in the workplace (University of Phoenix, 2012). This proves that companies benefit from instituting drug-free workplace policies with mandatory drug testing within the workplace. Creating a drug-free work environment is a cost-effective necessity in the workplace, and establishing a drug-free work environment will have positive effects on a company. Prevalence of illicit and prescription drug users in the United States workforce Prescription drugs are "dispensed to the public only with an order given by a properly authorized person" (The Free Dictionary, 2012, p. 1). In 1999, American's spent nearly $104.7 billion on prescription drugs, which......

Words: 1401 - Pages: 6

Free Essay

Assessing the Dare Program

...During the 1980’s the war on drugs hit hard on the United States. The D.A.R.E program which stands for Drug Abuse Resistance Education was established to instill the proper tools of living a substance free life and not caving in to peer pressure which many children are faced with. The D.A.R.E program was significant in building social skills and boosting the self-esteem of schoolchildren. D.A.R.E was established in 1983 as a collaborative venture between the Los Angeles Police Department and the Los Angeles School District. During 1996, U.S. Congress approved the Drug-Free Schools and Communities Act to endorse drug abuse training and prevention programs. Approximately 75% of school districts were utilizing the programs as well as 43 countries worldwide had also employed the D.A.R.E program. According to Rosie Cima (2015), D.A.R.E was originally intended for elementary school students, especially those entering the fifth and sixth grade. Eventually, it was integrated into the junior high schools as well as high schools. The D.A.R.E program was dedicated on reinforcing the ability teens and children had in challenging the urge to participate in substance abuse due to experimentation or peer pressure. According to Donna S. Kochis (1995), there was controversy brewing amongst scientific research and the D.A.R.E. program. The D.A.R.E program was doing everything possible to openly combat and divert the scientific cynics, they also attempted to hush......

Words: 944 - Pages: 4