Pre & Post Marketing Analysis

| A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence?

Due to these incidents and many severe cases of drug side effects that had happened in the past including deaths, the current way drugs are developed and approved are unethical. Therefore, reform in FDA’s management as well as the guidelines is necessary to strengthen safety standards and eliminate problems regarding drug development and regulation.

The Federal Food, Drug Administration is responsible for establishing the Code of Federal Regulations which outlines the rules and regulations governing pharmaceuticals. The rules are divided into sections and include guidance based on drug categories. Due to each person having varying reactions to pharmaceutical products not all side-effects are detected during clinical testing. The Federal Food, Drug Administration is responsible for sharing the information with consumers. However, it seems a bit unethical because the large pharmaceutical companies do not have to share all of side-effect information that may assist consumers in making its choice on whether to try a product or to not try a product. Through various survey’s it was discovered that consumers are under the opinion that pharmaceutical companies need to have improved internal controls to ensure their compliance with regulations. Due to physicians and pharmaceutical companies working together and are dependent on one another there needs to be controls in place that would have an unbiased view of the regulations. The government will need to continue introducing new regulations that will aide in monitoring the relationships.

Americans must wait up to 19 years after a discovered treatment before they can participate in benefits of a new medication (Philipson & Sun, 2008). The regulatory process drug manufacturers need to endure before releasing potentially life-saving medication is an extremely expensive, time-consuming process. The Center for Drug Evaluation and Research (CDER) is the main department of the Food and Drug Administration (FDA) responsible for the safety of drugs (both prescription and over-the-counter) sold in the United States (Food and Drug Administration, 2011). This department scrutinizes the testing of new drugs and

Continue to develop new medication measures that address the detection and prevention of adverse medication-related patient safety events that can be used in future Quality Improvement Organization (QIO) Statements of Work and in CMS provider reporting programs; and

     Is a patient at liberty to diagnose his or her own affliction? If so, are they also qualified enough to know the right medication and take into consideration the drugs adverse effects? With the recent onset of direct to consumer advertising for prescription drugs, this is becoming the case. In 1994, expenditures on direct to consumer advertisements were about twenty-five-million a year. By 1998 that figure changed to about 225 million (Sasich 2). Turn on the TV, there they are. Open your favorite magazine, there they are again. Listen to the radio, congratulations, you’ve found another ad for the latest prescription drug. Rush down to your local

There are only two countries that allow advertising of prescription drugs to consumers; the United States and New Zealand. Direct to consumer advertising (DTCA) is what they call the prescription drugs advertisements that are made specifically for the consumer. Pharmaceutical companies ' survival depends upon a gullible public buying what they are selling, whether you need it or not. Prescription drug advertising is in a different category than toothpaste advertising. Because the consumer 's health is at stake, there are different rules and regulations involved. Pharmaceutical companies often do

It is important that note that even though there are a few disadvantages of using the adverse drug event alert system, the advantages definitely outweigh the bad. Patients are safer today knowing that the pharmaceutical company and physicians will receive that alert whenever there is an interaction that would occur with another drug. The pharmacists are also more comfortable dispensing the patients’ medications knowing that if there is a drug reaction, they will get an alert. As a result of adverse drug event alert system, there are a number of drug interactions that were identified. It is important that physicians and pharmacists continue to use adverse drug event alert system so as to prevent mortality rate due to adverse drug reaction or drug

After all research has been conducted including the testing of all animal and human studies associated, the New Drug application is completed by the drug developer. The results provided are used by the FDA to determine whether the drug is approved or the recommendation of further testing. Finally phase four is based on the monitoring of the drug’s risks and benefits monitored by various sponsors hired by the FDA.

The spontaneous adverse event reports are collected from patients, health care providers, lawyers, health authorities, the medical literature, and other sources. The spontaneous reporting systems provide the highest volume of information at the lowest maintenance cost and have proven their value in the early detection of patient safety issues related either to the products themselves or to their use.

Adverse events are defined by FDA as untoward medical occurrences regardless of causality to a drug. Adverse events define the drug’s toxicity profile, which serves as a

To register of any investigational product for human use the FDA or other regulatory authorities require data from acute toxicity studies. Generally the data obtained from theses preclinical studies are used to set maximum dose level for repeat dose studies in animals to support the effects of overdose in humans or any organ toxicity by comparing minimum lethal dose and maximum non-lethal dose.

Pharmacovigilance is “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine related problem.” Regulated in the US by the Food and Drug Administration (FDA) with the expectation of volunteer reporting by health care professionals (HCP) and mandatory reporting by drug developers/manufacturers, this field of study is essential in the improvement of patient outcomes and safety. Its peripheral importance lies in contributions to cost effectiveness and risk management in the public health care arena. Responsible and aggressive implementation of adverse event reporting procedures promote awareness and value to the importance of the identification of harmful effects of medication use.

The FDA has a critical role in the detection and management of safety issues that are identified after a drug is approved, including a critical role in communicating information to the public. The actions taken depend on the characteristics of the adverse events, the frequency of the reports, the seriousness of the diseases or conditions for which the drug provides a benefit, the availability of alternative therapies, and the consequences of not treating the disease. Our goal, regardless of the communication tool employed, is to make the most up-to-date drug safety information available to the public in a

Pharmacovigilance (PV or PhV) , also known as Drug Safety, is defined as the science and activities relating to the detection, collection, assessment, monitoring, understanding and prevention of adverse effects (AEs) or any other drug-related problem. World health organization (WHO) established its programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to ensure the risk-benefit profile of medicines.