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Dissertation Information for Robert Lewis Marlin

NAME:
- Robert Lewis Marlin
- (Alias) Lewis Marlin

DEGREE:
- Ph.D.

DISCIPLINE:
- Library and Information Science

SCHOOL:
- Rutgers University (USA) (1978)

ADVISORS:
- Susan Artandi

COMMITTEE MEMBERS:
- None

MPACT Status: Incomplete - Inspected

Title: RELIABILITY FACTORS IN ADVERSE DRUG REACTION REPORTING

Abstract: In the process of the utilization of marketed pharmaceutical preparations, one of the primary concerns of researchers, prescribing physicians, the pharmaceutical industry and the government regulatory agency (Food and Drug Administration), is the occurrence of adverse reactions (sometimes referred to as side effects, adverse effects, or drug experiences).

The purpose of this research was to devise and test a method of evaluating the food and drug administration’s voluntary system for collection of adverse reactions to drugs that occur during hospitalization, as a form of communication producing valid data.

The Federal government in their desire to generate data has become a large scale originator of instructions, specifications and directives for various job and/or projects within its bureaucratic structure. These descriptions of duties and responsibilities regulate the activities of all systems. “Guidelines” are the general term used for them.

The specific objectives of this study were to determine whether the guidelines established by the issuing agency (Food and Drug Administration) for voluntary hospital reporting of adverse reactions were interpreted in a uniform manner with those individuals who generate the data (hospital coordinators) and to determine if external factors to the collection system are in fact affecting the reporting.

The methodology employed three phases of investigation

1. Review of the collected data in a baseline year.
2. A survey questionnaire to participating hospital’s coordinators and FDA personnel responsible for the maintenance and monitoring of the system.
3. Interviews with a conveniently selected sample of hospital coordinators who responded to the questionnaire.

The findings showed that the operating guidelines are interpreted differently by the hospital coordinators as compared to the FDA personnel. The study also demonstrated the external factors such as, legality, “defensive medicine”, various definitions of the term “adverse drug reaction”, individual bias inherent in all participants, and FDA feedback all effect active participation in the program. The program also is affected by the poorly coordinated education and orientation programs of the FDA and generalized attitude affecting patient care.

The importance of providing participants with detailed instructions on the procedures, purposed and goals of a collection program as well as communication feedback to and from the issuing agency and the data generators are important factors in maintaining active voluntary participation.

MPACT Scores for Robert Lewis Marlin

A = 0
C = 0
A+C = 0
T = 0
G = 0
W = 0
TD = 0
TA = 0
calculated 2008-01-31 06:09:23

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