17_Tutorial_Global effects of the pharmaceutical industry

HKS

Coordinator:

Dr Sharuna Verghis
sharuna.verghis@monash.edu





LEARNING OUTCOMES

After participating in this session, students should be able to:


1. Discuss the access to essential medicines.

 

2. Demonstrate an understanding of the effects of global pharmaceutical practices on the availability of medicines

 

3. Recognize the marketing practices employed by pharmaceutical companies when dealing with medical graduates and students. 


4. Have an introductory understanding of clinical drug trial and publication practices

RESOURCES


Ebook and Instructions: Global effects of the pharmaceutical industry

2023 HKS Tutorial Assignment Submission Due Dates

IATROGENENIC DISEASE

An iatrogenic disorder is the adverse effect of a therapeutic, diagnostic or prophylactic regimen which causes pathology independent of the condition for which the regimen is advised.


Iatrogenic events fall under three broad categories of being: 


1. Preventable and negligent. (e.g. malpractice errors arising from medical misconduct or lack of adherence to basic minimum standards of care) 


2. Preventable but not negligent. (e.g. nosocomial infections) 


3. Other adverse events not preventable with current knowledge & technology

REFERENCES:  

1. Krishnan & Kasthuri, 2005.

2. Goodman JC, Villarreal P, & Jones B, 2011 



SOCIOECONOMIC COSTS OF IATROGENIC EVENTS

• Extra hospital visits 

• Extra prescriptions for drugs 

• Increased visits to the emergency department 

• Increased hospitalization

REFERENCES:  

1. Weingart Wilson, & Gibberd, 2000.



FACTORS RELATED TO DRUG RELATED IATROGENES

The severity of pharmacologically mediated iatrogenic disease can range from mild to fatal. It may occur because of errors on the part of health care professionals, such as – administering the wrong drug or wrong dose, wrong method of administration, administering the drug to the wrong patient, or failure to give the prescribed drug. There is evidence that drug related iatrogenesis with regard to the healthcare provider can be influenced by drug company promotion and marketing activities, especially if such practices are unethical. 


Drug related iatrogenesis with regard to the pharmaceutical industry factors include unethical marketing practices, widening the indication of products, direct marketing to consumers without proper approval, sponsorship bias in clinical trials, and where regulation of the industry is left to voluntary codes and self-regulation systems. 


A well-known episode of iatrogenic disease is related to the drug Thalidomide. The compound was first synthesized in 1953 by Ciba but abandoned when no pharmacologic effects were found. 

Chemie Grünenthal, synthesized the drug and introduced it to the global market as a nonaddictive, relatively “risk-free” sedative vis-à-vis other more commonly used barbiturates.Initially it was promoted as an anticonvulsant for the treatment of epilepsy, for which it proved ineffective. However, owing to the sedative properties of the drug, it was marketed as a hypnotic, sedative, and tranquilizer. It was soon used for treating several other conditions including colds, flu, and nausea. In 1956, it was licensed for over the counter (OTC) sale in Germany and 46 other countries. 


It was also promoted as an – antiemetic for pregnant women. However, following a large scale reporting of fetal abnormalities, it was banned in 1962. It marked the beginning of safety and pharmacovigilance for medications, engendered ethical debates about the pharmaceutical industry’s behavior, the and the living conditions and rights of people with disabilities caused by the drug. 

 

REFERENCES:  

1. Pūras D. Human rights and the practice of medicine. Public Health Reviews.  

    2017;38(1):9. 



TUTORIAL TASK

Dear Students,

 

Download the E-Book for the tutorial from the Resources section and discuss the questions given therein.

Research, discuss and answer the following questions: 


     1. Thalidomide Case Study Watch the video: NO LIMITS | FREE FULL DOCUMENTARY | Thalidomide Disaster, True Story (https://www.youtube.com/watch?v=G0b38vpruFo)

         What was the role of the pharmaceutical industry and of regulatory authorities in this catastrophe? 

      2.Over the counter (OTC) drugs

         What is the relationship between OTC drugs and access to medicines in developing countries.  

         What are the public health risks?

        (Not more than half to three quarters of a page but ensure that the relevant points have been included).


      3. What are your thoughts about the global pharmaceutical industry in terms of equity in the distribution of

          medicines (individual reflection).


Write the answers to the questions and save the file in pdf format, naming the file as follows. Answers to be submitted by group (not individually). 

   • Group Details_Global Effects of the Pharmaceutical Industry 

   •Appoint ONE person in your group to upload the answers for the tutorial.


Answers need to be uploaded by the following Monday by 09:30 hours, 12 May (F to I) and 13 May (A to E) 2022. For any clarifications, email Dr. Sharuna Verghis at: sharuna.verghis@monash.edu.

 

See you at the tutorial! 🌿