Ethical Drug Testing Dilemmas

This assignment delves into the ethical complexities surrounding drug testing, particularly the dilemma of utilizing a potentially life-saving drug without prior side effect testing. It presents a case study and guides you through an eight-step decision-making model to analyze the situation ethically. The model helps managers weigh various factors, consider stakeholder perspectives, and arrive at a compromised decision that balances potential benefits with risks.

Running header: Application of the Eight Step Decision Making Model 1
Application of the Eight Step Decision Making Model
Student’s Name
University

Application of the Eight Step Decision Making Model 2
Application of the Eight Step Decision Making Model
Introduction
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.
Decision Making in Healthcare
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 &

Application of the Eight Step Decision Making Model 3
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.
Step one: identify the problem
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.
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

Application of the Eight Step Decision Making Model 4
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.
Step 2: Identify the potential issues involved
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

Application of the Eight Step Decision Making Model 5
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.
Step 3: Review relevant ethical guidelines
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.

Application of the Eight Step Decision Making Model 6
Step 4: Know relevant laws and regulations.
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.
Step 5: Obtain Consultation.
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

Application of the Eight Step Decision Making Model 7
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.
Step 6: Consider possible and probable courses of action.
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.
Step 7: List the consequences of the probable courses of action.
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.
Step 8: Decide on what appears to be the best course of action.
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

Application of the Eight Step Decision Making Model 8
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.
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.

Application of the Eight Step Decision Making Model 9
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.

Application of the Eight Step Decision Making Model 10
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).