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Risk Minimization Measures - Essay Example

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The paper "Risk Minimization Measures" discusses measuring the effectiveness of additional risk minimization activities in drug safety. The paper focuses on making plans and implementation of measures and determining whether or not they are effective, and in making sure that health issues…
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Risk Minimization Measures
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Risk Minimization Measures Risk Minimization Measures Risk minimization measures refer to public health interventions that are aimed at preventing the rate at which adverse reaction related to certain medicines occur. These measures also aim at reducing the severity and impact of patients using these medicines should any of the adverse reactions take place. Risk management primarily involves making plans and implementation of measures and determining whether or not they are effective. With reference to three medicines, this paper aims at discussing how to measure the effectiveness of additional risk minimization activities in Pharmacovigilance. Process indicators under Risk minimization measures refer to the measure of the level of the implementation of the original activity in accordance to how it is delivered. This part of the Risk minimization measures should act as a complementation rather than a replacement of the assessment of the goals aimed at by the measure (World Health Organization, 2007). In most cases they are always referred to as the outcome indicators. The intervention processes used to always determine the indicator process that is used. When the indicators for risk minimization involve providing guidance and information, for patients and healthcare provision professional by the use of educational tools, distribution measures of distribution should be sued to get information that can be used for the implementation of the program (Strom, Kimmel & Hennessy, 2013). Such metrics are supposed to focus on the correctness of the tool for the audience that is targeted by the process indicator. For the awareness of the audience that is targeted to be properly assessed, it is important to note that scientific survey methods are always used (Talbot, Aronson & Stephens, 2011). The surveys should include the primary standard questions that are given through telephone contacts or interviews that are conducted on the face to face basis (Plotkin, Orenstein & Offit, 2013). These approaches can be used in assessing attitude and knowledge of both the patients and the relevant healthcare service providers in general. The only way that it can be determined whether or not the minimization program is successful, healthcare professionals are always expected to check on the safety of the results that it yields. If it results in more safety in the use of the respective medicines without there being any negative outcomes or minimal outcomes it will be said that the minimization program is successful (Lorde, 1997). For instance, if a person is taking Acitretin which always prescribed for the treatment of health issues such as extensive, severe, resistant psoriasis; congenital ichthyosis; palmo-plantar pustular psoriasis; and Darier’s disease. However, one of the most known effects of this drug is that it can act as a pregnancy preventer. If in a risk minimization program enables to reduce the rate at which this drug causes this program, then it will be said that the risk minimization program was successful (Mossialos, Mrazek & Walley, 2004). For infection control, drugs such as Doxycycline which is an antibiotic used for curing of bacterial diseases such as chlamydia, urinary tract infections, and acne. The side effects of this drug can be reduced by making sure that it is not prescribed to patients having certain medical conditions (Dhillon & Raymond, 2009). The medical conditions that are supposed to be considered include liver diseases, kidney problems, or diseases such as asthma and shuffle allergy. By doing this the medical professional will be making sure that the people with the highest possibilities of being faced with these side effects do not take these drugs. The end result of such activities will be positive to the risk minimization program (In Kilcoyne, In Ambery & In OConnor, 2013). Process indicators under Risk minimization measures refer to the measure of the level of the implementation of the original activity in accordance to how it is delivered (Schmidt, 2000). This part of the Risk minimization measures should act as a complementation rather than a replacement of the assessment of the goals aimed at by the measure. In most cases they are always referred to as the outcome indicators (De Ponti, 2001). The intervention processes used to always determine the indicator process that is used. For the awareness of the audience that is targeted to be properly assessed, it is important to note that scientific survey methods are always used (Talbot, Aronson & Stephens, 2011). The surveys should include the primary standard questions that are given through telephone contacts or interviews that are conducted on the face to face basis (In Flear, In Farrell, In Hervey & In Murphy, 2013). These approaches can be used in assessing attitude and knowledge of both the patients and the relevant healthcare service providers in general. Another aspect of prescription that should be looked into when coming up with a risk management program is the proximity of there being a medication error in the process (Weston, 1997). One of the most error prone drugs is Amoxicillin (s). Amoxicillin (s) is a drug that is always used in the treatment of bacterial infections such as ear, respiratory, and dental infections. Through a medication error control program, the physician can be able to make sure that they have minimal errors when prescribing drugs to their patients (Gad, 2008). When choosing a method for measuring the effectiveness of a risk minimization measure it is always important to have it in mind that different risks have different measure. Therefore, the measure chosen should be in line with the risk that is being minimized (Orleans-Lindsay, 2012). The involved individuals should consider spontaneous reporting taking into consideration cautions that are related to the elimination of the frequently observed adverse in the population that is being treated. They should also be keen on the circumstances under which the measures that are being evaluated are supposed to be effected (Edwards, 2012). Factors used in measuring outcome frequency like incident rate of an adverse response to a drug should also be used in measuring the effectiveness of the risk management measure that the physician aim at using for a particular situation. However, the well-known biases that affect reporting of suspected adverse reactions may provide misleading results (Landesman, 2006). This will ensure that the whole process is not made ineffective by the generalization of the measures that are taken towards The purpose of patient targeted tools are supposed to be to enable the awareness of patients or their care givers on the symptoms and signs that are essential to the early recognition of specific adverse responses to certain drugs (Briggs, Freeman & Yaffe, 2011). This causes the need for more risk minimization measures and on the most favourable course of action to be taken should any of those signs occur. If needed, a patient’s educational tool could be used to provide information and to remind the patient about an important activity, for example a diary for pathology or diagnostic procedures that need to be recorded or conducted by the patient and eventually discussed with healthcare professionals, to ensure that any steps required for the effective use of the product are adhered to (Kohn, Corrigan & Donaldson, 2000). Rates of Spontaneous reporting number of expected adverse responses to these drugs reports over a fixed duration, or period. This should not be taken as a wanted estimate of the frequency of adverse occurrences in the population that underwent treatment, except in very specific situations, for example, when there is a very minimal background incidence of the adverse case in the general population and a strong relation between treatment and the adverse case Chow, 2003). In those cases when a straight measure on the risk in the pollution that underwent treatment is not feasible, spontaneous reporting can give an approximation of the frequency of the adverse reaction in the population that underwent treatment, provided that some reasonably credible information can be found for the evaluation of the reporting rate in the context of a drug use (In Young & In Michelson, 2012). However, the well known biases that influence reporting of suspected adverse effects may give misleading outcomes. For example, the introduction of a risk minimization plan in response to a safety issue detected in the post authorization phase of a medicinal product may create awareness with regard to selected adverse reactions which ultimately may lead to an increased reporting rate. In these situations an analysis of spontaneous reporting may lead to the erroneous conclusion that the intervention was not effective (In Flear, In Farrell, In Hervey & In Murphy, 2013). Decreasing reporting rates over time may also lead to the erroneous conclusion that the intervention. It is evident that risk minimization measures can effectively serve their purpose. These measures also aim at reducing the severity and impact of patients using these medicines should any of the adverse reactions take place. Risk management primarily involves making plans and implementation of measures and determining whether or not they are effective. As shown through this paper risk minimisation program can be very effective in making sure that health issues that occur as a result of medication for other health problems are reduced. References Briggs, G. G., Freeman, R. K., & Yaffe, S. J. (2011). Drugs in pregnancy and lactation: A reference guide to fetal and neonatal risk. Philadelphia: Wolters Kluwer Health/Lippincott Williams & Wilkins. Chow, S.-C. (2003). Encyclopedia of biopharmaceutical statistics. New York, NY [u.a.: Dekker. Dhillon, S., & Raymond, R. (2009). Pharmacy case studies. London: Pharmaceutical Press. De Ponti, F. (2001) Global Perspectives in Pharmacovigilance. Journal of Pharmacovigilance. Edwards, I. R. (2012). An agenda for UK clinical pharmacology: Pharmacovigilance. British journal of clinical pharmacology, 73(6), 979-982. Gad, S. C. (2008). Preclinical Development Handbook: Toxicology. Hoboken: John Wiley & Sons. In Kilcoyne, A., In Ambery, P. D., & In OConnor, D. J. (2013). Pharmaceutical medicine. In Young, D. L., & In Michelson, S. (2012). Systems biology in drug discovery and development. Hoboken, New Jersey: Wiley. In Flear, M. L., In Farrell, A.-M., In Hervey, T. K., & In Murphy, T. (2013). European law and new health technologies. Kohn, L. T., Corrigan, J., & Donaldson, M. S. (2000). To err is human: Building a safer health system. Washington, D.C: National Academy Press. Landesman, L. Y. (2006). Public health management of disasters: The pocket guide. Washington, D.C: American Public Health Association. Lorde, A. (1997). The cancer journals. San Francisco: Aunt Lute Books. Mossialos, E., Mrazek, M. F., & Walley, T. (2004). Regulating pharmaceuticals in Europe: Striving for efficiency, equity and quality. Maidenhead: Open University Press. Orleans-Lindsay, J. (2012). Pharmacovigilance medical writing: A good practice guide. Chichester, West Sussex, UK: John Wiley & Sons Inc. Plotkin, S. A., Orenstein, W. A., & Offit, P. A. (2013). Vaccines. Edinburgh: Elsevier/Saunders. Strom, B. L., Kimmel, S. E., & Hennessy, S. (2013). Textbook of pharmacoepidemiology. Chichester, West Sussex: John Wiley & Sons. Schmidt, O. (2000). Pharmaceutical quality systems. Denver, Colo: Interpharm Press. Talbot, J. C. C., Aronson, J. K., & Stephens, M. D. B. (2011). Stephens detection and evaluation of adverse drug reactions: Principles and practice. Chichester, West Sussex, UK: John Wiley & Sons. World Health Organization. (2007). Quality assurance of pharmaceuticals: A compendium of guidelines and related materials. Geneva: World Health Organization. Weston, S. E. Understanding and interpreting prescriptions. Foundation in, 97. Read More
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