Premium Essay

The Importance Of Drug Safety

Submitted By
Words 1348
Pages 6
Drug safety is of key importance in today’s climate and in the past as without it the standard of patient healthcare would be low. Drug safety or more commonly known in the pharmaceutical industry as Pharmacovigilance, refers to the detection, assessment, collection, monitoring and prevention of the adverse effects caused by pharmaceutical products. The word Pharmacovigilance is a combination of the Greek word pharmakon meaning drug and the Latin word vigilare meaning to keep watch. Pharmacovigilance focuses heavily on adverse drug reactions, which can be defined as any response to a drug which is noxious and unintended, including the lack of efficacy. Overdose, misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, …show more content…
Adverse event data received by the licence holder, normally a pharmaceutical company, has to have a prerequisite of tests sent to the local drug regulatory authority to market the medicine in most countries. The identification of hazards associated with pharmaceutical products and the minimizing of risk of any harm that may come to patients is a defining goal of pharmacovigilance. [1]
The international society of Pharmacovigilance (ISoP), previously the European Society of Pharmacovigilance (ESoP), is an international non-profit scientific organisation, which aims to foster Pharmacovigilance both scientifically and educationally, and to enhance all aspects of the safe and proper use of medicines, in all countries. [2]
Pharmacovigilance (PVG) is the on-going surveillance of product safety occurring throughout the product life cycle. It is the drug safety monitoring of pharmaceutical products and is practised in a highly regulated environment. New legislation amends the existing legislation; it is intended to further protect public health by strengthening the current European wide system for monitoring the safety of medicines. …show more content…
These include:
1. Pharmacovigilance and their quality systems.
2. Pharmacovigilance system mater file.
3. Risk management systems.
4. Management and reporting of adverse reactions to medical products.
5. Periodic safety update reports.
6. Post-authorisation studies and signal management. [4]
The safety of all medicines on the European market is strictly monitored. The inverted triangle in the product information leaflet does not mean that a medicine is unsafe but rather that the medicine is new to the market or that further data is needed. The symbol notification is there to encourage both patients and healthcare professionals to report any suspected side effects observed with the pharmaceutical product. [4]

New European Union (EU) pharmacovigilance legislation was adopted by the European Parliament and Council of Ministers in December 2010. Many of the new provisions contained in the legislation have been effective since July 2012.
The legislation is outlined in
1. Regulation (EU) No 1235/2010
2. Directive (EU)

Similar Documents

Premium Essay

Health Care Matrix

...Historical Development Matrix Complete the following matrix depicting the historical development of risk management and quality improvement. Select 8-10 historical regulatory and nonregulatory events and activities over the 20th century that contributed to the theoretical foundations of risk management. The matrix must identify the name, year, and founder of the development; the nature of the development; and its importance in the development of risk management and quality improvement. Use this table as a graphic organizer to summarize the theoretical underpinnings and historical development of risk management and quality improvement. Historical Development (Name, Year) Founder of Event Nature of Development Importance to Development of Risk Management and Quality Improvement 1. The National Health care Quality Report, 2011 Agency for Healthcare Research and Quality The nature of the development is to monitor and control nationally the quality of care in the United States. These reports measure trends in effectiveness of care, patient safety, timeliness of care, patient centeredness, and efficiency of care. In the 20th century new chapters on care coordination, health system infrastructures are put into place. The reports present, in chart form, the latest available findings on quality of and access to health care. According to Priority areas for national action: Transforming health care quality (2003), the committee decided a framework would be useful in helping to identify...

Words: 1138 - Pages: 5

Free Essay

Government Regulation

...required with the relevant legislation and regulations. In addition, pre-market approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of class III devices. Therefore, these devices require a premarket approval.   (FDA U.S. Food and Drug Administration, 2013). 2. Post-marketing control- According to "FDA U.S. Food and Drug Administration" (2013), Post-market surveillance is an assortment of processes and activities the FDA uses to screen the safety and efficiency of medical devices once they are on the market. These actions are designed to produce information to rapidly identify below par performing devices and other safety glitches, precisely characterize real-world device performance, clinical outcomes, and facilitate the development of new devices, or new uses for existing devices. 3. Consumer Education- According to "Direct-To-Consumers Prescription Drug Advertising" (March 2010), The FDA identifies three types of DTC ads: 1) reminder ads that include no reference to the drug’s purpose, benefits, or risks, and that...

Words: 474 - Pages: 2

Premium Essay

Accreditation Task 4

...needs to maintain compliance with the Joint Commission standards and provide consistent and quality care to its recipients. Compliance is a difficult task to achieve. It requires great effort on the part on the administrators and work force and requires the collaboration of interdisciplinary teams to bring about the desired effect. In order to monitor compliance, the hospital utilizes a periodic performance review (PPR) tool to assess its performance by continuous monitoring and performance improvement activities. The PPR provides the chassis for continuous standards compliance and focuses on the essential systems and practices that affect patient care and safety. The hospital self-evaluates its adherence with all Joint Commission Accreditation Participation Requirements, National Patient Safety Goals, related Elements of Performance (EPs), and develops a Plan of Action for all areas of performance identified as being non-compliant. The hospital also develops Measures of Success (MOS) for determining whether the organization is successful in resolving identified problems. Nightingale Community Hospital provides various medical, surgical, ambulatory care, laboratory, pediatric and emergency services and is thereby accountable for maintaining compliance as per accreditation policies. Areas of...

Words: 1534 - Pages: 7

Premium Essay

Asthma in Adolescents and Adults

...increase or induce an asthma attack (GINA: the Global Initiative for Asthma, Global strategy for asthma management and prevention). There are many factors that can affect any one person with this condition, such as heredity, obesity, smoke, exercise, upper respiratory tract infections, perfumes and certain occupations can trigger respiratory distress with an asthmatic episode. There are other treatment considerations that evaluate and treating other conditions may help resolve asthma management. The conditions such as gastroesophgeal reflux disease, rhinosinusitis, and nasal polyposis may improve some symptoms for asthmatic individuals if such conditions exist. Most cases of asthma are managed with drug therapy with an inhaler or oral medication. There are various drugs to reduce the inflammation that occurs with asthma and teaching is...

Words: 1291 - Pages: 6

Premium Essay

Medication Errors

...Abstract Healthcare unlike many high-risk industries has made slow progress in improving patient’s safety. The role of nursing in improving medication safety has been largely underestimated. Much of the research undertaken to date in relation to adverse medication events has neglected the impact that nurses have or could have in improving patient safety. In examining literature regarding adverse medication events one can see the urgent need for significant improvement in medication practices and processes. In addition that this health care issue will only improve with the participation of all disciplines working towards a common goal of improving the safety of those in our care. Introduction Medications play a key role in healthcare but can also be a significant key cause of medical error and of adverse patient outcomes. Nurses by the nature of their roles in medication administration can be the last line of defense in eliminating or reducing adverse medication events. The administration of medication is a common and almost routine activity in a nurse’s daily work, yet it is fraught with complexity and risk for both the patient and nurse. As a student nurse working in partnership with a registered nurse I have observed a variety of practices in medication administration that have varied from what I have been taught in class. On reflecting on these practices and questioning nurses why such practice has been adopted has illustrated to me both the flawed processes and environment...

Words: 2857 - Pages: 12

Free Essay

Glaxosmithkline Case Analysis

...of the Problem Consumers are taking advantage of price differentials for prescription drugs in other global markets by either physically crossing over to the Canadian border or ordering them from the internet. Analysis In an increasingly global environment, companies must become more aware of an empowered consumer. Information, such as pricing in other countries, is able to spread very quickly. American consumers often wish to be on an equal playing field with the rest of the world. This means that a service/good that is bought in the United State should be comparable in price/quality to the same good/service bought in another country. GSKoSmithKline (GSK) encountered numerous public relations and strategic issues with their decision to limit the supply of drugs shipped to Canada. Many American consumers chose to buy the cheaper versions of the drugs from Canadian pharmacies because of the significant price reduction. Many of these consumers, who were often low income or elderly, could not afford the United States drugs because of the expense. GSK’s Responsibility to American Patients Healthcare is a business, but it must be treated differently than other businesses. GSK has both a social and ethical commitment to produce life-saving drugs that are affordable and easily accessible to the American public. The large price differentials between drugs purchased in America and drugs purchased in Canada led many to believe that GSK was a profit-hungry corporation that...

Words: 1243 - Pages: 5

Premium Essay

Risk/Quality Management

... Risk/Quality Management There are different organizations that can be chosen to study the relationship between both risk and quality management. Risk management and quality management can be applied anywhere in the health care system. Risk management and quality management go hand in hand and have a complementary relationship. This relationship can be applied to the pharmacy organization. The pharmacy organization is the organization that definitely uses all that risk and quality management can offer. Pharmacy is the organization that was chosen using background knowledge and new information. Pharmacy is “the branch of the health sciences dealing with the preparation, dispensing, and proper utilization of drugs.” Pharmacies deal with prescription drugs and fulfilling out prescriptions to patients. Pharmacists employ the use of science and the knowledge they gained during their schooling. With this knowledge they perform tasks such as helping over physicians decide was is best for their client in terms of selection and compatibility with other prescriptions. However, they do not only help in providing information but gathering information as well though observation and communicating with the client. Through observation and communication, pharmacists can provide quality medication to clients and help them with their health in other ways. Pharmacists are not limited to just helping with prescription orders but can aid in weight loss, dieting choices and help with high...

Words: 1992 - Pages: 8

Free Essay

Accreditation Task 1

...Joint Commission compliant for the given standard. Standard | Description | Joint Commission Compliance | MM.01.01.01 | The hospital plans its medication management processes. | MetNightingale PoliciesPatient Care Polices: 1. Medication Management, Patient Specific Information 2. Medication Administration | NPSG.03.04.01 | Label all medications, medication containers (for example, syringes, medicine cups, basins), or other solutions on and off the sterile field. | MetNightingale Hospital NPSG Data: * Average Hospital-Wide Medication Labeling of Containers over the last 12 months = 99.6%. | NPSG.03.05.01 | Reduce the likelihood of patient harm associated with the use of anticoagulant therapy. | Needs ImprovementAverage Adverse Drug Events related to Anticoagulation therapy per 1000 patients days over the last 12 months = 3.4. | There is an identified risk for...

Words: 1713 - Pages: 7

Premium Essay

Hajd

...developing regions of the world.’ Duh. This settlement shows Glaxo follows similar unethical business practices in the developed world with its primary pharmaceutical products. An Australian professor wrote a revealing article about how Glaxo manipulates research evidence in medical journals. He gained this insight through internal company documents he had access to during a lawsuit. Bottom line? If you think corrupt and dishonest drug companies are being honest about vaccine safety, efficacy and adverse reactions, you have been deceived by their marketing and PR departments. Glaxo is pleading guilty and paying a criminal fine of $1 billion for misreporting efficacy data and failing to report adverse safety data from post marketing studies. ****************************************************************************************** Department of Justice Office of Public Affairs FOR IMMEDIATE RELEASE Monday, July 2, 2012 GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data Largest Health Care Fraud Settlement in U.S. History Global health care giant GlaxoSmithKline LLC (GSK) agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion...

Words: 3233 - Pages: 13

Premium Essay

Hong Leong

...JOB DESCRIPTION Job Title: Practice Manager Location: Practice Responsible to: Clinical Director/Regional Director Job Objectives/Purpose Oversee the smooth and efficient organisation of the practice administration. To ensure all company procedures as set out in Branch Procedures Manual** are carried out effectively. To ensure all financial information is reported correctly and accurately to Support Office and administrative protocols are in place. Ensure the reception area is staffed effectively and the management and efficiency/co-ordination is managed to be best needs of the business. Ensure that all employees are aware of the fact that all clients are to pay on departure and with the Clinical Director have responsibility for managing this requirement.. Main responsibilities: General Management Office Management • Be able to reconcile receipts, day sheets, income reports, bank deposits and the petty cash, and understand the essential components of any reconciling system. . • Be able to set and enforce effective credit control – to include monitoring debtors, sending regular invoices and statements, dealing with overdue account collection and the small claims court, queries on accounts, setting up payment agreements. Be able to complete pet insurance claims and deal with queries. • Be able to deal effectively with day to day banking transactions, e.g. credits, automated credits and debits, standing...

Words: 1811 - Pages: 8

Free Essay

Always a Marine Code of Ethics

...owner should lead by example never ask your employees to do something you will not do yourself. Do not be afraid to get into the job with them. Many think they should lead as a dictator. This type of behavior will not be tolerated in this company. 3. Understanding • Understand your employee’s needs. Do not shut them out. A company goes further when you have Employees you are loyal to you and not disgruntled 4. Sexual Harassment • Zero tolerance for Sexual Harassment. Sexual Harassment has more than just one victim. Sexual Harassment can actually destroy the reputation of the company. A solid investigation will be conducted and the finale judgment will be issued in accordance of the situation. 5. Safety • Safety is of utmost importance. Be careful and watch for any hazards known to you. Do not take it for granted that someone else would pick it up or fix the situation. Each person...

Words: 434 - Pages: 2

Premium Essay

Fda Approvals for Medical Trials

...problematic for enrollment, and thousands of patients are often turned down. New drugs are vitally important to improving the lives and health of Americans. Between 1986 and 2000, new drugs were responsible for 40 percent of the total increase in life expectancy. Yet, the FDA’s clinical trial process remains lengthy and expensive. It takes, on average, more than a decade to bring a new drug from the laboratory to the market. Polls show a clear majority of specialists believe the FDA clinical trial process is too slow and most report having been personally hindered in treating a patient due to the FDA approval process. The clinical trial process initiates when a drug developer submits an Investigational New Drug Application (IND) to the FDA. The IND application includes all available data on the proposed investigational drug, including the results of any animal testing. In reviewing IND applications, the FDA seeks to ensure that the proposed trial does not expose patients to “unreasonable risk of harm.” Clinical trials then move ahead in three mandatory human testing phases. Phase I consists of giving the investigational drug to a smaller group of 20 to 80 volunteers to test for toxicity and instantly apparent side effects. The major importance of Phase I testing is safety. Over 60 percent of investigational drugs in Phase I testing are considered safe enough to move on to Phase II. While safety continues to be evaluated, the main focus of Phase II is the drug’s effectiveness...

Words: 2316 - Pages: 10

Free Essay

Drug-Free Workplace

...Drug-Free Workplace Amazon.com The Drug-Free Workplace Policy enacted in 1988 to keep drug users out of the workplace and already hired employees off of drugs. At Amazon.com there is a well defined policy against illegal drugs, prescription drugs and alcoholic beverages. The writer believes that the Amazon.com policy has implemented a comprehensive drug awareness and education program. The supervisors at Amazon.com are given the proper information to reasonably suspect someone of being under the influence of drugs or alcohol. Once confirmation is made that a person is under the influence Amazon.com does offer a form of employee assistance program, to help the person, if addicted, to remove the use of drugs or alcohol from his or her professional life. This policy is well presented in its entirety let us take a closer look at keep factors. “By publishing a statement to all employees that possession, use, sales or unlawful manufacturing of controlled substances in the work place is prohibited and the actions that will be taken against violators of such statement”(National Drug-Free Workplace Alliance, n.d.). For legal purposes it is smart to abide by this statement from the Drug-Free Workforce Act of 1988, and Amazon.com has done this. Amazon.com (2005) Drug and Alcohol Abuse Policy states, “Open alcoholic beverages, illegal drugs and prescription drugs are not used while at work, in a work status or on company premises. Exceptions for prescription drugs are onsite medical provider...

Words: 1129 - Pages: 5

Premium Essay

Drug Treatment for Offenders

...Drug Treatment for Offenders Nicole Myers 20700 CRIJ 1304 Probation and Parole Abstract The addiction to drugs is a difficult thing for any individual to deal with. Often, addiction leads to the decline of a person’s well-being, financial security, and health. Drug addicts have a hard time keeping a job, their families suffer the consequences, and sometimes the addicts find themselves either in trouble with the law, or homeless on the street. There is an epidemic of almost epic proportions in this wonderful nation called the United States. However, this epidemic is not only national; it is worldwide. And because of this epidemic there are other problems in society such as an increase in crime and prison overcrowding. The epidemic is that of Substance Abuse and Addiction. The penal systems of each state house more prisoners due to drug related crimes than any other. Treatment instead of incarceration would be beneficial to the addict himself and to society as a whole. Evidence shows treatment would lower the amount of criminal activity due to substance abuse and addiction. Logic shows that if a problem is cured then the consequences of the problem disappear. There are different points of view on the subject of treatment or incarceration for those criminals who are substance abusers. And there are valid points in either argument. The viewpoint in favor of incarceration is supported by the deterrence and incapacitation theory. This theory promotes increased arrests, prosecutions...

Words: 677 - Pages: 3

Free Essay

Psychoactive Substances

...were also labeled for their hypnotics effect. This drug has a history of being used for purposes other than those recommended by the prescribing doctor. The use of this specific drug had a drastic increase during the 1960’s and early 1970’s. Although abuse and the misuse of the drug were recognized earlier, because of the low rate of prescription the problem was not considered of high importance (Wick, 2013). Benzodiazepine-type drugs (benzodiazepines and the newer non-benzodiazepines) are similar to older sedative/hypnotic drugs, such as the barbiturates, in that they act at the GABAA receptors. Unfortunately, benzodiazepine-type drugs also retain the liability for abuse and dependence associated with the earlier anxiolytics. Action at GABAA receptors likely plays a key role in both the therapeutic as well as abuse-related effects of this important class of drugs (Licatta & Rowlett, 2008) Benzodiazepines are the top prescribed drug for the treatment of anxiety disorders as well as for sedation and sleep. Because this drug reduces stress and sedates the host, they have become an ideal drug for not only anxiety, but disorders such as epilepsy and alcohol withdrawal. Benzodiazepines quickly became one of the more popular drugs used amongst psychotropics and most patients show preference towards this treatment.The risk of overdose is increased in patients with suicidal ideation. Accidental overdose can happen when the drug is combined with other depressants such as alcohol...

Words: 745 - Pages: 3