One of the most important aspects of clinical research is ensuring the safety of new drugs, treatments, etc on patients. This is called pharmacovigilance or drug safety compliance. This safety aspect is monitored, implemented, and complied with in two ways. Firstly, the sponsor of the clinical research, usually a pharmaceutical organization, conducts drug safety tests at all the stages of the clinical trials they conduct wherever it is required by law. They also implement drug safety protocols at stages of the clinical research study voluntarily too. The other way in which pharmacovigilance compliance is ensured is by the laws and guidelines given by the regulatory authorities like the Food and Drugs Administration (FDA) in the US. SPONSOR'S PHARMACOVIGILANCE COMPLIANCE The sponsor of a clinical research study/trial has his major aim as the determination of the efficacy of a new drug on a human condition by experimenting on patients diagnosed with the condition. It is the legal, moral, and ethical responsibility of the sponsor to also ensure the experimentation is conducted in a safe manner and does not cause any adverse or fatal consequences to the patients' lives. …show more content…
This protocol is designed according to the guidelines provided by the regulatory authority. The guidelines describe in detail how sponsors can ensure that their trials or studies comply with the required pharmacovigilance regulations. Since reporting of adverse events is considered to be the most common activity performed by sponsors with respect to pharmacovigilance in clinical trials, the guidelines also explain how the reports on adverse events during the trial are to be provided by the sponsor to the regulatory
Considering that the researcher protects himself or herself and the participants, a lot of unwanted circumstances including new infections on both sides are prevented thus limiting the miscellaneous costs in the research budget. It also assures the participants that they are protected and thus will come to no harm during the study. This ensures that they are willing to cooperate and thus help the scientific community and humanity as a whole by providing the relevant data for a given investigation. Safety here also prevents errors by ensuring that the possible errors are caught on time. This then translates into results that are not only very reliable but also largely replicable onto another sample population, making them relevant in drawing a generalized
The IRB is an administrative body which has been established to make sure research participants' rights are protected. IRBs review all aspects of the researchers' project: the study design, the recruitment process, the participant population, the informed consent document and process, the risk/benefit ratio, privacy and confidentiality, data storage and protection, and safeguards for vulnerable participants (University of St. Francis, n.d.). In this way, participants' rights are protected because the effort is made even before the research begins. The review process ensures that participants are chosen fairly and informed adequately and the information collected during research is safeguarded through collection, use, and storage. Research using human participants is such an important part of medicine that it is imperative it is performed in a way that its intrigue is not compromised.
strict or they can take too long to approve a drug. But I think for the most part, the FDA is really
...s little information about the possible benefits of the study or the side effects. The side effects proved to be significant (gastrointestinal complains, headache, and an elevation of alanine aminotransferase), while the benefits were minimal. This situation emphasizes the need for a balanced approach when it comes to drug clinical trials.
Pre-clinical testing is performed to Good laboratory practice (GLP) and covers pivotal toxicology & safety pharmacology studies. In preclinical research, scientists test their ideas for new biomedical prevention strategies in laboratory experiments or in animals.
Berenson, A. (2005, October 21). Pfizer profit falls 5%. The New York Times, p. C7.
trials of investigation medical products. The FDA also has to review and approve in a
The ability to become reflective in practice has become a necessary skill for health professionals. This is to ensure that health professionals are continuing with their daily learning and improving their practice. Reflective practice plays a big part in healthcare today and is becoming increasingly noticed.
Medication compliance means; weather patient takes their medication as prescribed. Habit of medication noncompliance grow specially when patients are at home during a self-care. Behavior of taking medication is complex and it requires multiple functional strategies to improve a medication compliance. This paper is about problems and solutions for medication compliance. The solutions for medication compliance are education before medication, using reminder tools, use of compliance promoting packaging and taking help of family and friends.
Turner, B. J., Newschaffer, C. J., Zhang, D., Fanning, T., & Hauck, W. W. (1999). Translating clinical trial results into practice. Annals of Internal Medicine, 130(12), 979-986.
I believe that under this practice, the physician is conducting an experimental trial based on his own judgement. Thus, the usage of this drug in this circumstance should no longer be considered “approved.” Furthermore, if using what I consider an unapproved drug is, “good medical practice and in the best interests of the patient,” what is the role of the FDA in
Drug safety information should therefore be made easily available and accessible to the public to ensure that the patient's’ role in right medicine consumption is accordingly comprehended. The integration of pharmacovigilance to these measures would ensure public confidence on medicinal consumption (Kumar,
Medication errors are the leading cause of morbidity and preventable death in hospitals (Adams). In fact, approximately 1.5 million Americans are injured each year as a result of medication errors in hospitals (Foote). Not only are medication errors harmful to patients but medication errors are very expensive for hospitals. Medication errors cost America’s health care system 3.5 billion dollars per year (Foote).Errors in medication administration occurs when one of the five rights of medication administration is omitted. The five rights are: a) the right dose, b) the right medication, c) the right patient, d) the right route of administration, and e) the right time of delivery (Adams). Medication administration is an essential part of the nursing profession, taking up to forty percent of a nurse’s time in providing nursing care (Fowler). Consequently, nurses are commonly held accountable for medication errors. To improve the safety of a vital aspect of nursing care, bar code scanning was introduced to reduce errors in medication administration. Although bar code scanning has its advantageous aspects, there are also disadvantageous qualities.
1. What is the difference between a. and a. What is medication compliance? Medications are an important part of a patient’s life, in that without compliance or adherence to once prescribed medication, the patient’s disease will linger on and cause more complications in their body. Medication compliance is one of the most important topics discussed with the patients. Medication compliance is defined as the ability of the patient to follow correctly prescribed medication.
Computer are now a days used in pharmaceutical in industries, hospitals and in various departments for drug information, education, evaluation, analysis, medication history and for maintenance of financial records. They have become indispensable in the development of clinical pharmacy, hospital pharmacy and pharmaceutical research. Computers are also useful for patient profile monitoring, medication, database management and material management. It is useful in providing on drug interactions, drug information services and patient counseling.