Guideline On Good Pharmacovigilance Practices Essay

This report is Part 1 of assignment for Marketing MBA 565-MBOL1 to Dr. Stephen Baglione

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.

Economic: Globalization of the pharmaceutical industry is an exciting opportunity to have research and development done at cheaper prices in other countries. However, this could be a double edged sword for companies because it is easy for other countries, such as India, to produce generic versions of the drug in bulk.

According to the Food and Drug Administration (FDA 2009), the wrong route of administrating medication accounts for 1.3 million injuries each year. An article published in September issue of the Journal of Patient Safety estimates there are between 210,000 and 400,000 deaths per year associated with medical errors. This makes medical errors the third leading cause of deaths in the United States, behind that comes heart disease and cancer. To prevent medical errors always follow the Three Checks and most importantly the Rights of Medication Administration. The “Rights of Medication Administration” helps to ensure accuracy when administering medication to a patient. When administering medication the administer should ensure they have the Right Medication, Right Patient, Right Dosage, Right Route, Right Time, Right Route, Right Reason, and Right Documentation. Also remember the patient has the right to refuse, assess patient for pain, and always assess the patient for signs of effects.

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.

Outcome measures assess whether the interventions to improve medication safety practice will be successful. During the interview of the new employee, competency evaluation related to medication administration will be applied first. In addition, during the orientation for these new employees, adequate training will be provided to ensure the importance of preventing medication errors. They will be given a list of similar and look-alike medications and will focus on medications that cause the most adverse reactions when errors may occur. Then, after training and when staff start working, they will be supervised during their first few months. When they are not supervised, they will be assessed and evaluated for any errors. During this process,

One of the standards that has been implemented is Standard 4: Medication Safety. The Australian Commission implemented this standard with the intention of ensuring that competent clinicians safely prescribe, dispense and administer appropriate medicines to informed patients and monitor the effect. (Australian Commission on Safety and Quality in Health Care, 2012) In healthcare, one of the most common treatments is medication. As a result of this, there are many incidences of error, many more than any other healthcare interventions. According to the Patient Safety Network (PS Network, 2015) medication errors account for nearly 700,000 emergency department visits and 100,000 hospitalizations each year. Medication errors are often a result of the unsafe and poor quality practice of healthcare professionals or system errors. Medication errors are costly and many are avoidable. For this standard

Introduction: Since 2001, compounded drugs have caused more than 1,000 illnesses, and 87 deaths in the United States (cite 1). All of these unfortunate incidents were caused by errors during the manufacturing of compounded drugs, and in most cases, because of contamination. On the 25th of September 2013, the Drug Quality and Security Act, also known as H.R. 3204, was introduced, and three days later, was passed by the House of Representatives. On the 18th of November, this Act cleared the Senate. On the 27th of September, 2013, President Barack Obama signed the Drug Quality and Security Act into law (cite 2).

The safety of medication administration has become a universal issue and crucial for one 's wellbeing. The majority of hospitalized patients are treated with medications (Agyemang & While, 2010). The medical treatment of patients has a direct effect on the patient 's quality of life. Srinivasan declared "patients have a right to know they are receiving safe care" (as cited by Zhani, 2012, p. 1). The purpose of this paper is to identify current quality and safety issues in healthcare, share the impact the issues have on health care delivery, identify quality improvement strategies, and to reveal a plan to implement quality improvement strategies.

Medication errors in the hospital setting have significant potential to result in serious injury and even death, thus effecting patients, families, health care professionals, and hospitals. Approximately 400,000 adverse drug effects (ADE) occur each year (Institute of Medicine, 2006). Considering that not all medication errors are discovered and reported, this number is likely to be underestimated. These errors not only contribute to patient morbidity and mortality, but also cause increased length of stay and hospital expenses. It is estimated by the Institute of Medicine (IOM) that $3.5 billion is spent annually as a result of ADEs (IOM, 2006).

Medication has also become increasingly complex. There has been a massive increase in the number and variety of medications available. In addition, many medications have different routes of delivery, variable actions (long acting, short

(0/1)2.3 describe the common adverse reactions to medication, how each can be recognised and the appropriate action(s) required

Since the perception of patient safety has arisen, many medical organizations were striving to improve medication safety. Emory Healthcare, the largest and most comprehensive health care system in Georgia, was one of them who were seeking ways to prevent medication errors. In recent years, some

Liley L.L., Harrington, S., & Snyder J.S. (2011). PHARMACOLOGY for Canadian Health Care Practice 2nd Canadian Edition. Ontario, Ca: MOSBY Elsvier.

There are a number of challenges in for setting up clinical trials and performing biopharmaceutical development. In fact, China has the longest drug application timeline of all Asian countries. Language , culture, infrastructure, regulatory and quality issues are some other challenges in the emerging economies