Prescribing Experimental Drugs Leads to Increased Medical Liability

1: Introduction

In USA, any drug substance that has not been passed by the Food and Drug Administration (FDA) is described as experimental in nature. Any new drug has to be passed through thorough checks by this body before they can be used for human consumption.

A lot of people are under the impression that new drugs are the best in combating the diseases and conditions that plague the human population. This includes the physicians. This might be true to some extent. But it is also a fact that there are dangers that are associated with these new drugs. These usually manifest themselves in form of side effects that are not predictable. That is the reason why most of the medical malpractice cases that ends up in the courts usually involve a physician who has prescribed an experimental drug. This research is going to test the hypothesis that prescription of experimental drugs leads to increased cases of medical malpractice.

2: Thesis Statement

The thesis that will guide the writer throughout this research is as stated below:

Prescription of experimental drugs leads to increased cases of medical malpractice

The writer will collect data that either proves or disapproves with this assertion.


Prescribing Experimental Drugs Leads to Increased Medical Liability

3: Methodology

Methodology is the section that the writer uses to explain to the reader the steps that he followed when he was collecting the data. If the data has not been collected yet, this section explains to the reader the procedures that the researcher plans to employ in collecting the same.

Unit of Observation

This is the unit that the study will be conducted upon. It is the unit that the researcher aims at collecting data about their attributes. In this research, the unit of observation in this research is doctors who are involved in treating terminal and chronic illnesses like cancer and diabetes.

Unit of Analysis

The unit of analysis in any study is the attribute of the sample group that the researcher seeks to discern. The unit of analysis in this research is prescription of experimental drugs and the effects that this practice has as far as medical malpractice is concerned.

Sample Population

This is the group that will be under study. The target population for this research is the doctors and physicians involved in managing and treating terminal and chronic conditions and diseases. However, due to the sheer number of these doctors, it is prudent to pick a sample from this


Prescribing Experimental Drugs Leads to Increased Medical Liability

group that is representative of the whole.

Sampling Procedure

The researcher will use stratified sampling. This is where he will pick the population that he is interested in, and then stratified it into different groups. He will then pick his sample from these groups. The researcher in this case will obtain data of all doctors that are involved in management of terminal illnesses and conditions. He will stratify them into those who prescribe experimental drugs and those who do not. He will then pick a study group from those who prescribes experimental drugs.

The study population will also be stratified into males and females and also further stratification based on other characteristics like their age and background.

Sample Size

Due to the delicate nature of the research, the researcher will pick a small sample so that he can be able to concentrate on them. As such, the sample size will be twenty physicians.

These twenty will be composed of ten males and ten females. This is to ensure that the research findings are not affected by lack of representation from one gender. Also, the researcher will pick physicians from all age groups. Again, this is to ensure that the findings of the research reflect the nature across all age groups.


Prescribing Experimental Drugs Leads to Increased Medical Liability

Procedure for Data Collection

This research will take the form of a survey. the physicians will be surveyed on their opinions about experimental drug prescription. They will be asked to state how often they prescribe experimental drugs and their rationale for the same. They will then be asked to state challenges that they face in these decisions and the consequences of their actions. The researcher will also ask the physicians to state if they have ever been accused of medical malpractice as a result of prescribing experimental drugs.

Tool for Data Collection

In this section, the researcher will provide the reader with the tools that were used for data collection and the rationale for using those tools. The weaknesses and strengths of these data collection instruments will be analyzed as far as this particular study is concerned.

The researcher will utilize a questionnaire to collect the information that is needed. The questionnaire will contain ten questions divided into three sections. The first section will deal with the rate of experimental drugs prescription. The second section will deal with the rationale for the prescription. The third and last section will address the consequences that this prescription has.

Data Analysis

After collecting the data, the researcher will process and present it for consumption. The data will be presented in statistics. Charts, tables and figures will also be used to analyze and present the data.


Prescribing Experimental Drugs Leads to Increased Medical Liability

4: Theoretical Framework

Every research should be grounded in theory. This is the body of knowledge that informs the direction that the research is going to assume. The theory ensures that the research is grounded in a base that can easily be referred to by others. In other words, the theoretical framework puts the research in a certain class in the field in which it is conducted.

This research will be informed by the general strain theory:

General Strain Theory

This is a theory that has been used widely by criminologists in explaining crime and criminals in the society (Callista, 2009). According to this theory, social structures that are to be found in our society sometimes do make people commit crimes. This school of thought was pioneered by sociologist Emile Durkheim. It has been popularized and refined by other scholars like Robert Merton, Agnew, and Messner among others.

There are two forms of strain in the society. The first is the structural strain. These are processes at the societal level which has a bearing on how people regard their needs (Callista, 2009). For example, if the social structures that are found within that particular society are weak, they will alter how the members of the society regard means and opportunities at their disposal. This will again be replayed if the structures are inadequately regulated, or they do not themselves provide adequate regulations to the societal members (Callista, 2009).


Prescribing Experimental Drugs Leads to Increased Medical Liability

Structure that may affect the conducts of the physicians in this study may include those of ethical committees and other professional bodies. Do the ethical committees provide enough regulation to check prescription of experimental drugs? The presence of these regulations will affect the tendency and frequency of the doctor prescribing experimental drugs.

The other form of strain in the society is the individual strain. It describes the challenges that the person experiences as he seeks to satisfy his needs (Callista, 2009). These experiences that exert a strain on the person’s conduct may include pain and friction. For example, if the person feels that the goals and expectations that the society expect him to meet are very important, he will strive to attain them regardless of the nature of the means that he uses (Callista, 2009).

For example, the doctor may feel that in a terminal illness case or a chronic condition, the society expects him to either prolong the life of the patient or to relieve the discomfort and pain of the patient. Achieving these goals may become so important to the doctor such that he takes little regard to the mean that he is going to employ. That is when the doctors feel that they have to prescribe experimental drugs in order to achieve the societal goals.

In 2000, Akers took the strain theory further to include the sources of the strain, rather than merely the type of strains as earlier depicted by Durkheim and his students (Callista, 2009). Akers was of the view that a lacuna exists between expectations that the person had and actual achievement of the goals. Some personal goals that the individual has will not be actualized. This may be because of weaknesses of the goals themselves or some hurdles that are erected by others in the society. A doctor may have a personal goal of treating a cancer patient, but this goal may be blocked by regulatory bodies which are of the view that the doctor cannot use the experimental drug, the only one available, to achieve the same.

There is also the difference between the expectations of the person as he was conducting an action and the actual results that are realized at the end of the process. This difference causes disappointment of the individual. A doctor may have the expectation of treating the cancer patient by using the experimental drug. But at the end of the day, what he achieves is negative


Prescribing Experimental Drugs Leads to Increased Medical Liability

side effects on the part of the patient and as a result, a suit of medical malpractice. This is frustrating to the doctor and may determine his likelihood of using the same medication under the same circumstances in the future.

5: Context

This section will describe the context of the research. This is where the theoretical framework highlighted above and the methodological procedures earlier explained will merge.

The research will be conducted on doctors from two hospitals in the city. The first hospital is Mount Sinai, which is known for its handling of extreme cases of terminal illnesses like cancer. The second hospital is Nazareth, from the same county. Every hospital will have ten respondents, five males and five females. The physicians were drawn from the intensive care units of the hospitals. These are the doctors who generally use experimental drugs on their patients.


Prescribing Experimental Drugs Leads to Increased Medical Liability


Prescribing Experimental Drugs Leads to Increased Medical Liability


Callista, B. O. (2009). Theoretical framework in medical research. 2nd ed. New  York:

McGraw-Hill, 345-346.


Prescribing Experimental Drugs Leads to Increased Medical Liability


Prescribing Experimental Drugs Leads to Increased Medical Liability

Personal Opinion

It is the opinion of the writer that studies need to be done on the consequences of prescribing experimental drugs on the profession of physicians. It is true that a lot of studies have been conducted around the subject of experimental drug. But these studies have confined themselves to addressing the side effects of these drugs on the patients and on the condition of the disease that is being treated. The researchers fail to acknowledge the fact that this practice of prescribing experimental drugs has effects on the life and career of the physician.

When conducting the research, the writer discovered that the prescription of experimental drugs is a moral dilemma to the doctors. There has been misunderstandings and misconception among the public that the physicians who prescribe experimental drugs do so out of recklessness and negligence. But the same public fails to realize that the expectations they have put on the doctor to treat the patient under any circumstances is a contributory factor.

It is a moral dilemma because the doctor is faced on one hand by a dying patient. The patient is dying because there is no drug for his condition. On the other hand, there is a drug that has just come from the pharmaceuticals and it is of experimental nature. But it has the potential to manage the condition at hand. The doctor is torn between seen the patient die without doing anything or risking and treating the patient who would have died anyway with an experimental drug. It is thus unfair to persecute all doctors who prescribe experimental drugs to their patients without first studying the conditions under which the prescription was done.

Appendix One: Assessment of Drug Porphyrogenicity

Source: 1


Prescribing Experimental Drugs Leads to Increased Medical Liability