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Managers are often faced with the need to make ethical decisions. Assume you are a manager working in a large Australian pharmaceutical corporation. Your team has just developed a completely new experimental vaccine that you believe can treat a virus rapidly spreading in West Africa. So far tests using your experimental vaccine on chimpanzees infected with this virus have yielded positive results. Your experimental vaccine has not been tested on humans and the Australian health authorities say it will take 10 years of human trials before your new vaccine can be approved for human use as the side-effects of this new vaccine on humans are currently unknown. You have just received a request from a health worker in Africa who wants to use your experimental vaccine to treat tens of thousands of West Africans infected with the virus.


In this unit we have discussed the role of managers as d ecision makers. Please use the 8 steps decision-making process to discuss and explain your decision on whether or not to share the experimental vaccine with the health worker in West Africa. In your discussion you must elaborate on each of the steps and the relevant factors (including ethics) that you should consider as a manager in arriving at your decision. 

Competing Priorities in Healthcare

Decision-making is a nightmare that every manager goes through in their career. Rational, sound decision-making is the primary function of any organization. Managers are charged with the responsibility of leading making decisions that may inspire the success of the organization or may break the opportunities that lie ahead (Hall, Ariss, & Todorov, 2007). Every organization and profession has a set of standards and procedures to be followed when making a decision. Health profession managers are faced with career decisions that force them to choose between saving lives and following the laid down standards within their profession. This essay applies the 8 step decision-making model to analyses a business situation for management to make decisions.

Health professionals are faced with incremental decisions of saving lives and at the same time respecting values and goals of the health profession.  The World Health Organization (2015) adds that in healthcare, there is a competing priority between existing policies that acts as barriers for  resource available and the needs of those that need to be influenced by those resources. Since healthcare is an open system, it is influenced by the environment and has recognised all the available interests that may influence anty outcome (Coulter, Fitzpatrick, & Cornwell, 2009). Therefore managers in this field make individual decisions that have a cumulative effect on the beneficiaries of healthcare.  These decisions are limited in time and need to forecast on human needs to save lives that every healthcare profession is trained to do. However, professionals are faced with situations that require them to use decide between the professional code that they believe in and the personal values that they believe in (Perneger & Agoritsas, 2011). in the pharmaceutical vaccine case, the managers is torn between respecting the established standards and saving lives of thousands of people that are on the brink in West Africa. Rational, decisions have been said to take either an intuitive or rational, approach. Intuitive decisions only require information without the need for reasoning when there no facts for the situation. On the other hand, rational, decision-making is based on an analysis of facts, steps and processes necessary to arrive at a decision. The eight-step decision-making model has steps that can guide managers when analyzing a situation for the best decisions.

Managers need to clarify the ethical conflict in the situation that they are facing to determine the next steps that will follow. Ethical conflicts present situations that urgently need decisions like saving lives but the same decisions may lead to illegality according to set laws and standards. Redman & Fry (2000) suggest that healthcare professionals are faced with ethical conflicts that force them to choose between  what their career believes in and what their minds tell them. In this situation the manager is faced with the ethical situation of going for the established professional ethics for testing the vaccine before it can be used and releasing the vaccines to be used for testing on ten people to determine their effectiveness.

Intuitive and Rational Decision-Making

According to the Australian drug regulatory system, drugs must be evaluated by the Therapeutic Goods Administration (TGA) to evaluate the quality, safety efficiency of the drugs that have been manufactured.  New chemical entities that are found in such drugs are referred to the Australian Drug Evaluation Committee (ADEC) before the drug is registered for use (Australian Government; Department of Health, 2017). This is to ensure that the drugs being released to the public can be accounted for since and the drugs balance between safety and efficacy established. Researchers have argued that there is no totally safe drug thus the need to recognize and document risks and benefits of any particular drug that is released for use (Vaughan, 2005). Therefore, the manager needs to understand the consequences of releasing the drugs for use before testing and at the same time waiting for ten years drug testing interval to end as the infected people in West Africa continue dying.

Every management decision has potential issues that are used to make a decision. Kass (2001) argues that hhealthcare professionals must exercise care when dealing with drugs since they may have effects that can affect the patient. One way to approach such issue is to identify the relevant stakeholders that are involved. Healthcare professionals who engage with stakeholders face very few obstacles when they engage stakeholders. Stakeholders may include the government, the community, health insurance groups, health professional bodies and other interested parties like the UN through WHO. Each of these stakeholders has conditions that need to be made. The issue hear will be determining whether the drug meets the conditions for stakeholders.

The manager will, therefore, consider government provisions that require production and administration of drugs and international standards that have been established since the drugs are to be supplied to a different country. On the other hand, the health regulations within West African countries need to be analyzed to determine whether their countries allow untested drugs to be used on victims. According to Marcinko (2004) drugs that are allowed to be used by patients must meet the conditions of all the stakeholders and actors within the value chain that drug operates. On the hand WHO requires member states to conduct an inclusive health policy dialogue with all players before using any drugs (DeKay & Asch, 2008). This means that even though the drugs have not been tested, individual West African states must be involved in making a decision whether to allow the drug to be used on their citizens even if it has not been tested or not. The answer for this question will be yes sync this is a desperate situation.

Ethical Conflicts in Healthcare

Ethical guidelines are standards that define the conduct of professionals that promotes dignity and preserves life in the organization. Any profession is supposed to promote the integrity and dignity of the profession to achieve well-being and safety of patients. Bastiaens (2007) suggests that since patients do not know the clinical requirements about their situation, they risks their lives in the hands of a healthcare profession. These guidelines have standards that are laid down to ensure the profession upholds the requirements. Failure to uphold these ethical standards can lead to legal implications to the practitioner. Here the manager needs to make a decision on the effects of the decision to the profession, government policy and relevant patients. Patients are in need of an urgent cure while at the same time the drug has not been tested. However, the ethical decisions revolving around the drug does not involve patients but the side effects of the drug affect them (National Medical Ethics Committe, 2012).

Under the good medical practice code, health practitioners are required to practice medicine within the contexts that are required by the law. Through the Australian code of ethics, and the declaration of Geneva and the International code of medical ethics. Relevant codes have been put in place to ensure that they meet the requirements of drugs (Beauchamp & James F. Childress, 2001). The manager needs to ask the question whether the drug meets the required standards the required ethical standards. If the drug has not been clinically tested, what could be the side effects that may be seen in the patients? And in case these side effects are revealed, who will take ethical responsibility. This is therefore an issue of making a personal decision within the profession.

Australia controls the manufacture and use of drugs within the industry. Drugs fall under therapeutic goods which are goods that may be used for therapeutic needs. The Australian community requires accessing goods in the market that are safe for human consumption. The Therapeutic Goods Act does pre-assessment, post-market monitoring, enforcement and licensing of drugs in the country (Therapuetic Goods Admnistration, 2017). Risk management strategies are based on analyzing both the benefits and risks associated with any drug. These regulations ensure that the drugs administered to patients or allowed to the public have minimal side effects to patients. Further, patients need to be aware of any side effects of a drug so that they can choose whether to use it or not. Tested and approved drugs are licensed through TGA accreditation. In this scenario we need to identify whether the drug meets the relevant regulations within the country. First of all the drug has not been tested for any side effects that may be realized on patients and at the same time the drug has not been approved for use within the country or outside the country. Lack of undefined side effects means that there may be challenges in reacting to side effects of the drug and thus lead to worse outcomes.

Identifying Relevant Stakeholders

One of the ways to make the best decisions is to carry out deep consultations before making a decision. There is need to ensure that all stakeholders are involved within the field of medicine are involved. Mahadkar, Mills, & Price (2012) stakeholder consultation allows the professional to understand the needs that of every stakeholder and the views that they have on the relevant decision. Through stakeholder analysis, strengths and views of every stakeholder are used to nsure that decisions that are reached are inclusive. Stakeholder consultation allows for the views of multiple groups toarrive at a better decision. In healthcare, patients are the beneficiaries of the drug but other stakeholders are interested in the outcomes of the decision. The manager needs to bring together all the relevant parties that may be interested in the drug to be administered and at the same time sympathise with the medical situation  under concern. Consultation will obviously lead to two potions, either to use the drug or to forego its use until it is taken to the lab for testing.

Medical outcomes must always be accounted for by any practitioner. The manager needs to way the option available and the consequences of every decision that is made. When the drug is not allowed to be used for treatment of the new infection, then the infected people will continue dyeing for the next ten years until the drug has been tested. On the other hand, allowing the drug to be used will mean going against the required standards in healthcare.

Each of the two option available has consequences that will affect any of the stakeholders. The need to use the drug before it is tested is based on the humanitarian ground of saving lives rather than the professional standards that are required. This means that if the manager fails to release the drug and instead sends the drugs to laboratories for further testing to determine any side effects, the infected people will die but there will be no legal or professional consequences to the manager. On the other hand, if the drug is released and fatal side effects are realized, then all the parties involved have to bear the consequences including legal suits from patients or punishment from relevant bodies.

The best course of action is to consult all the relevant stakeholders on the best available option for using the drug even before testing for side effects (Shamoo, 1997). The manager can engage stakeholders on the best way to get temporary certification to use the drug in the prescribed clinical settings only as actual testing continues. This will save lives and at the same time ensure that all legal and ethical requirements are met.

Importance of Ethical Guidelines in Decision-Making

Conclusion

From the eight-step decision-making model, the manager is presented with options to arrive at the best option that can lead to the best results within the required settings. The manager can arrive at a compromised decision which is regarded as the best outcome since it satisfies all the parties that are involved. The ethical puzzle of whether the drug can be used in clinical settings without prior testing for side effects can be solved and save lives of many thousands who would have been forced to continue dying as they wait for another cure to come. Therefore, managers can arrive at the best decisions using the eight-step decision-making model.

References

Bastiaens, H. (2007). Older people’s preferences for involvement in their own care: a qualitative study in primary health care in 11 Euroean countries. Patient Education and Counseling, 68(1), 33-42.

Beauchamp, T. L., & James F. Childress. (2001). Principles of Biomedical Ethics (5th ed.). Oxford Universty Press.

Coulter, A., Fitzpatrick, R., & Cornwell, J. (2009). The point of care: Measure of patients’ experience in hospital: purpose, methods, uses. London.: The Kings Fund.

DeKay, M., & Asch, D. (2008). Is the Defensive Use of Diagnostic Tests Good for Patients, or Bad? Medical Decision Making, 18(19), 19-28.

Governmnet, A., & Health, D. o. (2017, June 5). Testing of therapeutic goods. Retrieved from Australian Governmnet; Deptarment of Health; Therapeutic Goods Administration.

Hall, C. C., Ariss, L., & Todorov, A. (2007). The illusion of knowledge: when more information reduces accuracy and increases confidence. Organizational Behavior and Human Decision Processes, 103(2), 277-290.

Kass, N. E. (2001). An ethics framework for public health. American, 22(1).

Mahadkar, S., Mills, G., & Price, A. D. (2012). Stakeholder consultation practices within healthcare infrastructure planning: A conceptual approach to strategic asset management. Built Environment Project and Asset Management, 2(2), 127-145.

Marcinko, D. (2004). The Business of Medical Practice: Advanced Profit Maximization Techniques for Savvy Doctors. Springer.

National Medical Ethics Committe. (2012). Ethical Guidelines For Healthcare Professionals On Clinical Decision-Making In Collaboration With Pati. 

Organization, W. H. (2015). Health service planning and policy making, A toolkit for nurses and midwives. WHO.

Perneger, T. V., & Agoritsas, T. (2011). Doctors and patients' susceptibility to framing bias: a randomized trial. Journal of General Internal Medicine., 26(12), 1411-117.

Redman, B. K., & Fry, S. T. (2000). Nurses' ethical conflicts: what is really known about them? Nursing Ethics, 7(4), 360-366.

Shamoo, A. E. (1997). Ethics in Neurobiological Research with Human Subjects. The Baltimore Conference on Ethics. 

Therapuetic Goods Admnistration. (2017, June). Testing of therapeutic goods.

Vaughan, G. (2005). The Australian drug regulatory system. Australian Prescriber, 18(3).

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