Health and Safety Concerns of Supply Chain Management in Pharmaceutical Companies

4.2 Health and Safety Concerns

It is general knowledge that pharmaceutical companies make and provide medicines, drugs and any other related items for use of patients and consumers. Those items are directly supplied to healthcare organizations such as hospitals, pharmacies, drug stores and many others. Big organizations like hospitals will audit and screen through their pharmaceutical suppliers for health and safety reasons before approving purchase. However, pharmaceutical companies themselves must also be responsible in the area of health and safety as companies who purchase their products may have different specification and regulations.

Health and safety rules and regulation may be more stringent in some countries and some companies while others may be more relax. Supply of medicines as strategic goods in developing countries with much economic, social and political instability is faced with more uncertainties and vulnerabilities (Jaberidoost, Nikfar, Abdollahiasl and Dinarvand, 2013). That is why when any accidents, illness or death occurs, not only is the medicine or drug supplier is liable but so is the supplier. Authorities and members of the public will not hesitate to tear apart a company convicted or even suspected or having anything to do with the medical mishap.

As in all businesses, there is risk in everything. Any risks affecting the pharmaceutical supply chain not only result in resources wastage but also can threaten the patients’ life by hindering access to medicines, wrong recommended prescription, unsafe materials or ingredients used, etc.

4.2.1 General Issues or Concern

All medicines have benefits as well as risks. Any approvals by regulatory agencies such as the EMA or the FDA require medication to undergo extensive testing—usually in several thousand people. The purpose of this testing is to determine how safe and effective the medicine is—and to show that its benefits outweigh the known risks. A medicine is approved for use by appropriate patients only when its benefits have been adequately shown to outweigh the risks for its intended use in those patients.

Methodology

        There are many methods to ensure medicine safety of patients. But health and safety control begins in the research laboratory of the manufacturing company and continues for as long as the medicine is prescribed to patients anywhere in the world. Receiving regulatory approval for a medicine is a significant judgment on the safety of a medicine, but it is not the final safety checkpoint. Pre-registration clinical trials cannot detect every possible side effect, and more may become apparent because the drug is used:

1. In much larger number groups of patients
2. For longer periods of time – sometimes for months or years
3. In a more diverse patient population
4. Under ‘real-world’ circumstances rather than the more predictable and closely monitored conditions of clinical trials

After clinical trials are approved and sent for mass production, the concern will be focused on how patient react to the medication in the real world. There are many issues arising when real practice does not follow closely with expected practice. For example in the real world, patients:

1. Don’t always take their medication as recommended

b)  Don’t always adhere to dosing recommendations

c) May have underlying conditions that may affect the expected performance of a medicine

d)  May take other medication, including non-prescription medication

Data Analysis