Sunday, December 6, 2009

ETHICAL DECISION MAKING

1.0 Introduction
Ethical Decision making is a process of decision making accomplished of resolving problematic situation which is more debated on ethical. It is actually an ethical conflict principle involving the duties of the nurse meeting the client’s need and wishes, families concerned which will impact on decision making, while at the same time (Becker, 1991a and 1991b) said have to follow the hospital policy, the doctor’s order and taking into consideration at the legal implication of any intervention made.

It’s hard to define ethics. According to the Canadian Oxford dictionary (2001), ethics is the science of morals in human conduct: moral philosophy. Ethic is not the same as what people accepted but standard of people will deviate from the ethical standard behavior. To decide the right or wrong are moral which provide reflect on human standard and behavior where else ethics refers to how human should behave and ought to do which involves analysis of action. Chitty, (2003) said that, ethics reflected the moral statement “one should not lie” and the lying should be defined and explore when the lying might be acceptable in some circumstances.
Ethical standards include standards relating to the rights, such as the right to freedom from injury, the right to privacy and continue effort of studying our moral beliefs and moral conduct in view of reasonable and well founded reasons.

Raijah A Rahim:Dr Khatijah Lim:Prof.Madya Hjh Rohani Arshad. (2009) said that, ethics is concerned with motives and attitudes and the relationship of these attitudes to the good of the individual which may be distinguished from the law as a whole.
Can ethics be taught? I would say, Yes, because person’s growth through moral development that challenged them to look at issues that will develop moral and define right and wrong that promote the ideal of justice or human right or human welfare.

2.0Description
Registered Nurse are the best position to advocate for the patient’s right for their patient and it is frequently involved ethical issues and ethical decision making. Ethical dilemma arises daily when nurses had been confronted with the choice in which ethical reason both for and against the choice are equally desirable (Pierce, 1997).I would consider discussing on ethical issue of Informed Consent which is frequently occurred that confronting nurses currently.

2.1 Issue-Informed Consent
Informed consent is an ethical requirement that involved client’s right to be informed and to make an autonomous decision making to protect their own body towards the therapy that might affect them. From Wikipedia, “Informed consent” is said to be a legal condition whereby a person can be said to have given consent based upon a clear appreciation and understanding of the facts, implications and future consequences of an action. Informed consent obtained to promotes cooperation, safety and health of the patient which the nurse as the best position to advocate for the right of the patient to be treated fairly and equally, dignity and respects.

The patient must have the power of choice and competent in other words mental capacity to the decision making of informed consent voluntarily. It should be seen as an invitation to participate in their health care decision and should be carried out in the layman term for easy understanding. Patient should have an opportunity to ask questions pertaining to the procedure or treatment for a better understanding prior deciding to proceed or to refuse a particular course of medical treatment or any kind of intervention. AMA, (2007) suggest, informed consent must be understood by patient which consist of effective communication process which encourage patient to ask question.

In order to give informed consent, the individual concerned must have adequate information and understanding and be in possession of all relevant facts at the time consent is given. Impairments to reasoning and judgment which would make it impossible for someone to give informed consent include such factors as severe mental retardation, severe mental illness, intoxication, severe sleep deprivation, Alzheimer's disease or being in unconscious state or in a coma. At minimum, participants should have information on purpose and scope of the study the type the question that will potentially be asked, how the results will be used, and how the anonymity will be protected(Richards & Schwarts, 2002)

2.2 Scenario
I would like to discuss a scenario on administration of subcutaneous(s/c) Clexane in the patient with Acute Myocardial Infarction in this study pertaining to the informed consent. The scenario is, “Mr. Ahmad, male 42 years old, Muslim man admitted to CCU for complain of chest pain, stabbing in nature at 5.00am but went to the hospital for treatment at 6.30am after morning prayers the next day. Mr. Ahmad is married with children wish to get well very soon because he is the head of the family. His wife is not working.
In the Emergency Room, he was given Oxygen via nasal cannula,12 lead ECG was done. Noted to have ST-elevation in lead ll, lll and AVF. However, Mr.Ahmad’s. Blood sent for laboratory test. Trop I is positive. Cardiac enzymes are highly elevated. Diagnosed as Acute Inferior Myocardial Infarction. He was thrombolysed. Mr. Ahmad was given IV Morphine which relieved his chest pain.

Acute Myocardial Infarction (AMI) is the term used for clinical diagnosis caused by irreversible myocardial necrosis results from an abrupt decreased or total cessation of coronary blood flow to a specific area of myocardium (Linda D.Urden,Kathleen M.Stacy,Mary E.Lough, 2005). AMI is life threatening. The survival is better if revascularized is earlier within the first 2 hours. Immediate intervention is by fibrinolytic therapy or percutaneous coronary intervention (PCI).However, if patient does not received fibrinolytic therapy (will break down clots) or PCI, anticoagulant is required. The used of anticoagulant agent is to prevent blood clotting and prevent new clots forming. Anticoagulant does not dissolved blood clot. Anti platelet prevent platelet aggregation.

Clexane/Lovenox (Enoxaparine) is an antithrombotic agent known as Low Molecular Weight Heparin (LMWH) is used to inhibit clots formation in the arterial and venous blood vessels to prevent potential acute and chronic complication of blood vessel thrombosis.

3.0.0 Discussion: - consider the 5 steps:-
The following, I would like to discuss the issue according to the Ethical Decision Making Process which is considered a tool for resolving ethical dilemma.

3.1.1 Assessment (collection, analysis and interpretation of data)
Mr. Ahmad is a young Muslim man, married with children. Mr. Ahmad complain of chest pain and was diagnosed as having Acute Inferior MI which is life threatening. He was thrombolysed. The Doctor explained to Mr. Ahmad that he prescribed s/c Clexane due to the excellent long term clinical benefit. However, the doctor explained to Mr. Ahmad, s/c Clexane is a drug of porcine origin. Mr. Ahmad was required to sign consent if he agrees with the Clexane injection.
Mr. Ahmad was in doubt to decide whether to accept the treatment. Mr. Ahmad does not take diet offered to him and complained unable to sleep well though Mr. Ahmad looked drowsy due to IV Morphine. While in the CCU, Mr. Ahmad prays on the bed itself because he was put on Complete Rest in Bed and closely monitored. Islam strictly forbids consuming pork. The origin of the medication is giving an extreme personal and emotional conflict to Mr. Ahmad due to the religious beliefs to receive the medication. Mr. Ahmad was asked to sign consent if he agrees with the treatment.

3.1.2 The dilemma
At my point of view, although the he was thrombolysed and Clexane cause bleeding, but the origin of the medication is giving an extreme personal and emotional conflict to Mr. Ahmad due to the religious belief. Mr. Ahmad was asked to give consent prior the administration of Clexane because he is a Muslim man.

Explanations and informing Mr. Ahmad about the origin of the medicine is to avoid religious distress and possible litigation and promotes respect for his religious beliefs and may promote therapeutic alliance. Mr. Ahmad should be given a respect to get sufficient information of his condition, benefit of Clexane as antithrombotic agent and the implications of Clexane administration whereby can cause bleeding, uncommon Thrombocytopenia in a way that he can understand and enable him to exercise his right to make informed decisions which is relevant to him.
A study was done in 50 Muslim’s patient involving 18 general practioners (GP’s) shows that 42% of the patient stated won’t take any medicine if the origin is unsure.58 % stating will stop taking medicine if the origin is haram.(Sanofi-Synthelabo,2004)

When receiving medical treatment the patient should bears the responsibilities of bringing their religious belief to the clinician’s attention to respect and facilitate the controversial choices of competent individuals, subject to resource limitations, our own and others well-being autonomy. Mr. Ahmad is noted to be drowsy due to the Injection Morphine for pain relief and might impaired his judgment on making decision and therefore the clinician and doctors should assist patient to make rational choices either irrational or against a person's interests. (Ward. M, 2006).

3.1.3 Consideration choice of action
Mr. Ahmad was given time to think and make a good decision to accept the treatment for a better health in the future. According to (Bourne, R. 2007) long term studies have shown that there are clear long term benefits for patients taking the drug (Clexane) on patients with acute ST-segment elevation myocardial infarction (STEMI).

However the alternatives treatment Fondaparinux also offers the benefits and risk which is from the synthetic source. The new antithrombotic molecules which induced an inhibition of activated factor X (Fondaparinux, Arixtra) shows effectiveness and safety in prevention of acute myocardial infarction which show that new anti-Xa inhibitors also have interesting properties in antithrombotic therapy. Fondaparinux had the possibilities to offer new therapeutic which could simplify the management of patient who required anticoagulant.(Garcia Hejl C, Garcia C, Thefenne-Astier H, Servonnet A, Samson T, Foissaud V., 2008)

3.1.4 Analysis of the advantage and disadvantages for each course of action
The benefits and risks of a proposed treatment.
Clexane (Enoxaparine)is used to stop abnormal blood clots forming within the blood vessels. It can be dangerous because the clot may detach and travel in the bloodstream, where it becomes an embolus. The embolus may eventually get lodged in a blood vessel and blocked the blood supply to a vital organ such as the heart, brain or lungs. This is known as a thromboembolism. If the clots formed in a coronary artery, it reduced the blood flow to the heart and causes chest pain (angina) which results in a heart attack as what happened to Mr. Ahmad. Sanofi- aventis announced that the studies confirmed that patient with ACS will benefit from Clexane administration (Sanofi aventis, 2003).
However, Clexane cause, bleeding which is preventable.

Mr. Ahmad was given a choice to choose Fondaparinux The nature Origins of the drug and purpose of a proposed treatment. to respect his religious belief to make an ethical decision making. According to (Garcia Hejl C, Garcia C, Thefenne-Astier H, Servonnet A, Samson T, Foissaud V., 2008) recent clinical trials show that new anti-Xa inhibitors also have interesting properties in antithrombotic therapy. Fondaparinux offer new therapeutic possibilities that could simplify the management of patients under anticoagulant treatment.

However, Fondaparinux was reported can induce severe bleeding and other complication which requires close monitoring. Mr. Ahmad decision making was crucial.The efficacy of Fondaparinux is comparable, the choice between these classes relies on the risk of adverse effects, which depends on some patient’s characteristics. LMWH and Fondaparinux are contra-indicated by the patients with a renal clearance under 30 ml/min. Nevertheless, as every anticoagulant, Fondaparinux can induce major bleeding. Hubert Nielly, Aurore Bousquet , Patrick Le Garlantezec, Eric Perrier and Xavier Bohand. (2009).

Fondaparinux is administered by subcutaneous injection and is rapidly absorbed and distributed. The plasma half-life is approximately 17 hours, allowing for once daily administration. The drug is not metabolized and is eliminated unchanged by the kidneys. Other agents may be safer in patients with moderate or severe renal insufficiency. There is no known antidote or agent that reverses the anticoagulant effect of Fondaparinux. No data to support the use of plasma or prothrombin complex concentrate. Therefore, rFVIIa may be considered in the management of bleeding complications in patients receiving Fondaparinux.In a case of moderate thrombocytopenia (platelet count 50,000 to 100,000/mm3) if the platelet count falls below 100,000/mm3, the drug should be discontinued. Anthony J. Comerota and Teresa Carman (Anthony J. Comerota, Teresa Carman, 2008).

Either both medicines prescribed, to ensure positive outcome is achieved, Mr. Ahmad was informed that blood will be taken for laboratory investigation and haemodynamic status will be monitored closely while he was on treatment. Mr. Ahmad was reminded that the origins of the drug and purpose of a proposed treatment to respect his religious belief to make an ethical decision making.

3.1.5 Make a decision.
As Muslim’s man, the decision making is very crucial, either to receive the Inj Clexane from the porcine origin or Inj. Fondaparinux which the synthetic source but will cause bleeding severely. However, the both medicine is required to prevent complication due to the heart failure in future as he is still young.

Mr. Ahmad shouldn’t be influences but should be reminded, that the Quran is seen as an eternal and immutable truth, the principles of the law are seen as immutable. In some circumstances, the application and interpretation of the law changes with each age. Islamic law (syari'ah), is dynamic and flexible, exemplified by saying that "necessity renders the prohibited permissible”. Based on the prophet Mohammad's saying, "For every illness, there is a cure, except death”. (Kamyar M. Hedayat and Roya Pirzadeh, 2001) However, Mr. Ahmad has the right to refuse the treatment in view of his belief as Islam strictly forbids consuming pork.

White, C.,(2006) said, according to our Muslim’s chaplain, when there is no alternative of non porcine treatment available and there is a risk to life, it is allowable for Muslims to receive a drug of porcine origin. However, some Muslims may choose not to receive treatment or prophylaxis with heparin because of its porcine origin and patients do have the right to make the decision for themselves.

3.2.0 Plan of action

All patients have the right to get the highest standard of healthcare. According to (WMA, 2008) the patient has a right to get an appropriate information in order to make decisions and therefore:-
i) The proposed of medication explained to Mr. Ahmad.
ii) The benefit and complication of the medicine explained.
iii) Other alternative explained to Mr. Ahmad.
iv) Mr. Ahmad was given an opportunity to ask questions to elicit a better understanding of the treatment.
v) Mr. Ahmad was given the authority to make an informed decision to proceed or to refuse the treatment.
Vi) Allow religious leader for an example an Imam or Ustaz to console and the patient to make an ethical decision.

3.3.0 Implementation/consider choice of action
In order to administer s/c Clexane, the nurse should obtained consent if the patient agrees for the treatment. The indication of the medication explained. Benefit and complication should be endorsed when explained by the physician with understandable language and the conversation should be witnessed by another healthcare professional, and the substance of the conversation should be signed by both parties, the patient, physician and the witness who is could be the nurse responsible for the patient. The route, duration and dosage, sign and symptom of medication informed. Documentation of informed consent should be clear. The treatment should be stop immediately if the patient changed the decision. Refusal of treatment will be documented clearly.

3.4.0 Evaluation
i) Were the action practical? The respect for patients’ autonomy, in making decisions about their own treatment is a great beneficence in order to prevent the complication in the future even though the treatment might be unpleasant, uncomfortable or even painful but it might be the best interests of the patient.It is fair if the patient refused the treatment after the indication, complication, method and duration of treatment been explained.

The right to refuse treatment is the principle of autonomy of patient and becoming the challenged value of the health care provider. The decision making to refuse treatment ordered by physician which is known from porcine origin is ethical because Mr. Ahmad is a pious Muslim man and he belief that Clexane, the porcine origin medicine is haram even though the Muslim’s leader said it is permissive in some circumstances. The Quran states that, "you are forbidden [the consumption] of carrion, blood, swine flesh. . . . for these are unclean." (Quran 5:3, 6:145).
The alternative treatment suggested was Fondaparinux which is the synthetic medicine. Fondaparinux caused bleeding however patient will be monitored closely. The nurse veracity gave a justice to the patient who has the right to be treated equally regardless of race, sex and ethnic and religious belief.
ii) What were the consequences? The alternative treatment benefits Mr. Ahmad because it is safe, relatively cheaper and the recipients had significantly lower mortality rates. Mehta, (2008) said,the incidence of death or reinfarction at 30 days was significantly lower with Fondaparinux than with usual care (9.7% vs. 11.2%), with significant benefits also at 9 days and at final follow-up (3–6 months).

4.0.0 Conclusion
Religious patients may experience distress in accepting an animal-derived medicine product or porcine origin medicine because it may breach their personal views of the religion and therefore patients have their right to refuse treatment.

Nurses shouldn’t make an assumption about their patients' and nurses should be sensitive to a patient's individual religious beliefs, values, and cultural background as part of respecting a patient's autonomy because we live in a multicultural society.

If the patient’s religious belief ignored and neglected to explanation on porcine origin medicine, the health care provider might cause serious consequences, including patient’s distress and litigation. Religious beliefs need to be balanced against clinical need. Religious leaders and physician should work collaboratively when a patient's religious belief interferes with the treatment to find acceptable compromises in cases where suitable treatments do not exist, and the only medicine available is from porcine origin or otherwise cause death.


References:
1) WIKIPEDIA
http://en.wikipedia.org/wiki/Informed_consent
2) Kelly A.Edwards, M.(2008). Informed Consent. University of Washington School of Medicine .
3) AMA, (2009).Patient Physician Relationship Topics:Informed Consent.
http://www.ama-assn.org/ama/pub/physician-resources/legal-topics/patient-physician-relationship-topics/informed-consent.shtml
4) Manuel Velasquez, Claire Andre, Thomas Shanks, S.J., Michael J. Meyer. (2008). Can Ethics Be Taught? Makulla Centre For Applied Ethic .Online
http://www.scu.edu/ethics/practicing/decision/canethicsbetaught.html
5) Virtual Learning Commons: What is Ethics?
[1] Barber, K. (Ed.). (2001). The Canadian Oxford dictionary (pp. 478). Don Mills, Ontario: Oxford University Press. [2] Blackburn, S.W. (2003). ...
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7) Helen J Streubert Speziale, Dona Rinaldi Carpenter. (2007). Ethical Consideration In Qualitatives Research. In D. R. Helen Streubert Speziale, Qualitative research in nursing: advancing the humanistic imperative (p. 71). USA: Lippincott Willians & Wilkins.(Limited Preview)Online.

8) Rebecca A. Patronis Jones, Sharon E. Beck. (1996). Awareness Spheres For Ethical Decision Making. In S. E. Rebecca A. Patronis Jones, Decision making in nursing (pp. 98-99). Delmar Publishers. (Limited Preview)Online.
9) AMA (2007). Informed Consent. American Medical Association , Patient Physician Relationship Topics.(Online)
http://www.ama-assn.org/ama/pub/physician-resources/legal-topics/patient-physician-relationship-topics/informed-consent.shtml
10) Linda D.Urden,Kathleen M.Stacy,Mary E.Lough. (2005). Cardiovascular Disorders. In K. M. Linda D.Urden, Thelan's Critical Care Nursing (pp. 439-457). USA: Mosby Elsevier.
11) Sanofi aventis, (2003). New Study Findings confirm Clexane/Lovenox Long Term Clinical Benefit In Patient Suffering From Acute Coronary Syndrome. USA: Sanofi aventis.
Sanofi-Synthelabo,(2004).Informed Choice In Medicine Taking.England.
12) White, C. ( 2006). Venous thromboembolism Heparins are of porcine origin. BMJ , 332: 364.Online.
http://www.bmj.com.
13) WMA. (2008). Declaration Of Helsinki,Ethical Principle for Medical Research Involving Human Subject. World Medical Journal , 122.(Online)
http://www.wma.net/en/30publications/20journal/pdf/wmj20.pdf
14) Garcia Hejl C, Garcia C, Thefenne-Astier H, Servonnet A, Samson T, Foissaud V. (2008). Fondaparinux: the present and the future. Pub Med , 56(2):97-10.Online
15) Kamyar M. Hedayat, Roya Pirzadeh. (2001). Issues in Islamic Biomedical Ethics: A Primer for the Pediatrician. Official Journal of The American Academy of Pediatrics , pp. 965-971.Online.
Available: http://pediatrics.aappublications.org.( October 2001)
16) Ward, M. (Volume 20, Issue 4, December 2006). Patients who challenge. ScienceDirect Elsevier, Volume 20, Issue 4, Pages 545-563 .(Online)
17) Bourne, R. (2007). Study: Acute Coronary Syndrome Patients May Benefit from Clexane Lovenox. Associated Content , Online.
Available: http://www.associatedcontent.com/artical/ September 03, 2007.
18) Hubert Nielly, Aurore Bousquet , Patrick Le Garlantezec, Eric Perrier and Xavier Bohand. (2009). Severe bleeding secondary to misuse of fondaparinux: a case report . SpringerLink , Online.
http://www.springerlink.com/ (21thJuly, 2009)
19)Guy Maddern,Ms Easterbrook. (2008). Porcine and Bovine Surgical Products. Achieves of Surgery , 143(4):366-370.(Online)
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20) Anthony J. Comerota, Teresa Carman. (2008). Platelet Inhibition, Anticoagulants,and Thrombolitic therapy. Online.
Available: http://www.lww.com/static/docs/product/samplechapters/978-0-7817-5331-9_Chapter%205.pdf
21) Quran 5:3, 6:145.
22) Mehta, S. R. (2008). Clinical benefit and practical use of fondaparinux in the invasive management of patients with acute coronary syndromes. Canada: Oxford Journal.(Online)

2 comments:

Azlin Halim said...

Salam, I would like to give some new information about the side effects of fondaparinux vs enoxaparin from a reference "OASIS 5: Efficacy and Safety of Fondaparinux vs Enoxaparin in ACS Patients".. it does stated that fondaparinux is superior then enoxaparin in terms of safety with lower rates of bleeding in 9 days of treatment and it also decrease the risk of death and stroke.
plus- it is our duty as a muslim to ensure that the patient get the best halal treatment out there, we can't compromised about this matter even if the study shows the opposite result. this is based from the ruling of few hadith narrated by Abu Daud and Bukhari, and hv been discussed by Ibnu Al-Qayyim r.a in his book At-Tibb An Nabawi and stated in Malaysian Fatwa Society.

haYaT said...

Dear Azlin,
Thank you for the info and I agree with you that the muslims should get the halal treatment and it is our duty to inform them.