Impact of Drug Shortages - a Pharmacist Perspective

IMPACT OF DRUG SHORTAGES

FROM A PHARMACIST PERSPECTIVE

By

Troy Rehrig

A RESEARCH PROPOSAL

Submitted to

Ronald Petrilla, PhD

Misericordia University

In partial fulfillment of the requirements for

OM 515 Research Methods

2015

CERTIFICATION STATEMENT

        I hereby certify that this paper constitutes my own product, that where the language of others is set fourth, quotation marks so indicate, and that the appropriate credit is given where I have used the language, ideas, expressions, or writings of another.

Signed ________________________

                                                                 Troy Rehrig

TABLE OF CONTENTS

CHAPTER

1. INTRODUCTION                                                                           Page                          

Statement of the Problem                                                                           4

Background                                                                                             5                                                                                      

Purpose                                                                                                6

Significance                                                                                         6

Nature of the Study                                                                             6

Definition of Terms                                                                             7

1. LITERATURE REVIEW

History and Introduction                                                                     8

Causes and Trends                                                                               9

Impact                                                                                                 11

Management and Solutions                                                                 14

1. METHODOLOGY

Research Design                                                                                 17

Sample                                                                        18

Instrumentation and Materials                                        18

Research Questions                                                        19

Data Analysis                                                                20                                                                        

Appendix A

             First Letter                                                                22

            Second Letter                                                                23

        Appendix B

        Survey                                                                        24

References Cited                                                                25

Bibliography                                                                        26

i

CHAPTER I

INTRODUCTION

Drug shortages and massive price increases that can follow are having dramatic effects upon patients, health care providers and health care facilities.  This is an issue that began over ten years previously and continues to be, and will be for the foreseeable future, a major factor in jeopardizing the quality of patient care.  The lack of available medications causes direct harm to patients by forcing health care providers to ration medications or choose inferior drug treatment options.  Health care providers are stressed about the lack of choices and restrictions being forced upon them.  Patients and hospitals are being forced to pay extremely inflated costs because of some drug shortage issues but also because of the lack of competition that has been allowed to develop for many critically needed medications.  It is very important to try and understand all aspects of the causes behind drug shortages so that an effective strategy between all parties can be developed and implemented to attempt to alleviate or at least decrease the frequency, duration and severity of drug shortages.

Statement of the Problem

        Critical shortages and huge price increases of prescription medications are creating dangerous and even deadly conditions for patients and putting increased pressures and stress on hospitals, care providers and health care facilities.

Background

        Drug shortages can be caused by natural disasters, lack of raw or bulk materials, manufacturing difficulties, regulatory issues, recalls of affected or related products, or changes in product formulations.  American Society of Health-System Pharmacists (ASHP) and the Food and Drug Administration (FDA) have noted increases in drug shortages over the past ten years (Kaakeh, Sweet, Reilly, Bush, DeLoach, Higgins, Clark, & Stevenson, 2011).