Role of Human Resource Department in the Management of Drug Safety in Pharmaceutical Industry.. Imtiaj Hossain Chowdhury B’Pharm (Jahangirnagar University), M’Pharm (Jahangirnagar University) Master’s in Public Health (American International University Bangladesh)

1. IV
“Role of Human Resource Department in the
Management of Drug Safety in Pharmaceutical
Industry”
Imtiaj Hossain Chowdhury
B’Pharm (Jahangirnagar University), M’Pharm (Jahangirnagar University)
Master’s in Public Health (American International University Bangladesh)

2. 1
Introduction:
Drug safety is a prime concern of every pharmaceutical company. Drug safety management
introducing the activities relating to the detection, assessment, understanding and prevention of
adverse effects or any other medicine/vaccine related problem. Drug safety refers to the frequency
of adverse drug effects (i.e., physical or laboratory toxicity that could possibly be related to the
drug) that are treatment emergent—that is, they emerge during treatment and were not present
before treatment, or they become worse during treatment compared with the pretreatment state.
An adverse drug effect is distinguished from an adverse event (or experience), which refers to any
untoward experience that occurs while a patient is receiving the medication, whether or not it is
attributable to the drug. [1] For more than a century, the safety of medicines approved for use in
the United States has been one of the mission cornerstones of the Food and Drug Administration
(FDA). A key component of the FDA mission is to protect the public health by assuring the safety
of human drug products. Supporting this objective, FDA is also responsible for advancing public
health by facilitating the scientific innovations that can help make medicines safer while assuring
that the public receives clear, accurate, science-based drug safety messages. [2] Before approval
for use, FDA requires four phases of a clinical trial that determine whether a drug works in humans
and whether it is safe and effective. [3] The number of participants increases in each phase, starting
from 20 to 80 people for a phase 1 trial to up to several thousand for a phase 3 trial. [4]
Figure: Stages of drug development [3]

3. 2
Confirmation of drug safety to all stages will be successfully accomplished when the primary
concerns for the venture's success, namely quality and quantity, are properly balanced from drug
manufacturing to drug dispensing by pharmaceuticals. If drug safety cannot be properly obtained,
this circumstance has a significant impact on the distinction of care. The importance of HRDM
(Human Resources Development and Management) in the pharmaceutical healthcare system is
critical for the services of drug safety management as it maintains the overall system's effective
functioning. Inadequate consideration to develop a strong human resource management system
and failure to address its functionality are the prime barriers for the successful outcome. Whereas
strong and passionate human resource management in pharmaceuticals can lead to a productive,
motivated, and supported workforce capable of providing competent and improved services.
Background:
All drugs have side effects, but the extent
of their impact and severity varies from
mild (such as mild itching or mild
headache) to severe (such as severe rash,
damage to vital organs, primarily the liver
and kidneys, and possibly even death).
Most of the side effects are predictable and
mentioned in the leaflets for each drug.
Some drugs may not cause serious symptoms, such as certain types of antibiotics; other
medications may cause serious symptoms, such as certain cancer drugs, anti-diabetic medications,
medications to control elevated blood lipids, and many others. [5] Nonetheless, serious adverse
reactions can arise from widely used and well-known medications. For example, many people
might believe that paracetamol is very safe and would not cause serious side effects. However, this
drug can induce dangerous side effects at high doses, particularly ones affecting the liver. What
makes this worse is that the drug is found in many combinations used for cold and flu, and the
patient might be unaware of this and take extra doses, leading to a direct liver injury. [5,6]

4. 3
Objective of the study:
The purpose of this study is to find out the association of HRDM department with the issue of drug
safety in pharmaceutical industries. HRDM manages the precautions for drug safety which
required in each step of drug manufacturing.
 Balance the manpower and resources in every time for better management of drug safety.
 Provide all resources what is needed to ensure drug safety at clinical and manufacturing
stage.
 Provide all resources and qualified personnel to ensure appropriate drug dispensing for
patients.
 Arrange drug safety training/workshop for each department in pharmaceuticals.
 Periodical assessment (internal audit) of safety procedures and practices of drugs by
HRDM.
 Set up a team for drug safety monitoring.
Specific patient populations and drug safety
The type of patients using medications is a very important factor in considering drugs’ side effects.
People vary in their responses to medications according to their age. [7] Responses to drugs vary
between males and females due to the physiological differences between genders. [8] In addition,
there are patient groups that need greater attention and care when using medications, such as
pregnant women, the elderly, and children (Table-1) [3]

5. 4
Table-1: Specific category of patients for dug safety.
Type of patients Description
Pregnant and lactating
women
The danger of effects of drugs is not limited to taking drugs during
pregnancy: deleterious effects on the fetus may be experienced even if a
medication is taken within a short time period before pregnancy.
For example, the drug isotretinoin used for the treatment of acne, is
considered one of the most dangerous medications during pregnancy as it
has teratogenic effects on the fetus; therefore it is contraindicated during
pregnancy.
Children (pediatrics) Depending on age group – some medications are contraindicated in
patients less than 18 years or less than 12 years old, and also some
medications are contraindicated for use in children less than two years old.
As because children’s vital organs are not mature, and thus exposure to
certain medications may lead to toxic side effects as the body is mostly
unable to fully metabolize or excrete the drugs. This would lead to the
presence of active compounds in the body for an extended period of time
as well as an increase in their levels in the body, inducing toxic effects.
Aspirin, or “acetylsalicylic acid”, which is widely used as an analgesic
and antipyretic, is one of the drugs that are safely used in adult groups but
contraindicated in children, as it could lead to a severe adverse effect
known as “Reye’s Syndrome”. Thus, a safer alternative to be given to
children would be paracetamol and ibuprofen in the correct adjusted dose
and based on weight as well.
Old people (geriatrics) The physiological functions of many body organs decline with age,
especially important organs such as the liver and kidneys.
Older people may suffer from dementia or “impaired memory” and so
forget to take their medications.
Older people can suffer from many chronic illnesses, such as high blood
pressure, diabetes, and high blood cholesterol and lipids, possibly
necessitating the chronic use of multiple medications, which may conflict
with each other – what is known as drug–drug interaction.

6. 5
Parameters for drug safety [9]
Key parameters to be considered for safety of drug evaluation include the following:
(1) Pharmacology: Possible toxicity due to drug–target interactions, including interactions with
unintended molecular targets, or with molecular targets in unintended organs.
(2) Chemistry: Chemical scaffolding and side-chains with safety concerns.
(3) Toxicology: Toxicity in animals in vivo, and in relevant animal and human cells in culture.
(4) Drug metabolism and pharmacokinetics: Safety concerns due to toxification or detoxification,
organ distribution, clearance and pharmacokinetic drug–drug interactions.
(5) Risk factors: Physiological, environmental and genetic factors that may enhance a patient's
susceptibility.
Key Points Regarding Drug Discovery and Development: [10]
 It takes 10–15 years to develop a medicine or vaccine.
 The research-based pharmaceutical industry currently spends over USD 135 billion on
R&D per year.
 In 2011, 35 new pharmaceuticals were launched, out of more than 3,200 compounds in
development.  In 2007–2011, the number of new chemical or biological entities launched
on the world market fell to 149 from 196 a decade earlier.
 It costs an average of USD 1.38 billion to develop a single drug.
 In 2011, 5 of the 10 leading global R&D firms were pharmaceutical companies
 By the time a medicinal product reaches the market, an average of 12-13 years will have
elapsed since the first synthesis of the new active substance.
 The cost of researching and developing a new chemical or biological entity was estimated
at €1,172 million ($ 1,506 million in year 2011 dollars) in 2012
 On average, only one to two of every 10,000 substances synthesized in laboratories will
successfully pass all stages of development required to become a marketable medicine.

7. 6
International Drug Regulatory Authorities concerning for drug safety
Drug regulatory agencies and ministries of health in the Americas are collaborating to strengthen
drug safety and management in the Region,
by exchanging information on irregularities
in the manufacture of drugs and biologicals,
as well as potential supply problems, in just
one of the initiatives launched with support
from the Pan American Health Organization
/ World Health Organization (PAHO/WHO).
[11]
Regulatory agencies are usually a part of the executive branch of the government, or they have
statutory authority to perform their functions with oversight from the legislative branch. Their
actions are generally open to legal review. Regulatory authorities are commonly set up to enforce
standards and safety, or to oversee use of public goods and regulate commerce. The main
challenges of drug regulatory agencies are to guarantee safety, efficacy, and quality of
drug. [10,12]
Some International Drug Regulatory Authorities are: [10]
 International Conference on Harmonization of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH)
 European Medicines Agency (EMEA)
 Therapeutic Goods Administration (Australia) (TGA)
 U.S. Food and Drug Administration (FDA)
 Medicines and Healthcare Products Regulatory Agency (MHRA)
Drug Regulatory Authorities in Bangladesh concerning for drug safety
A regulatory agency is a public authority or government agency responsible for exercising
autonomous authority over some area of human activity in a regulatory or supervisory capacity.

8. 7
Two organizations regulate drugs and its safety in context of total healthcare system in Bangladesh
of which one is governmental and another is one semi-government.
1. The Directorate General of Drug Administration (DGDA)
2. The Pharmacy Council of Bangladesh (PCB)
The Bangladesh Pharmaceutical Society is affiliated with international organizations International
Pharmaceutical Federation and Commonwealth Pharmaceutical Association. The National Drug
Policy (2005) states that the WHO’s current Good Manufacturing Practices (GMP) should be
strictly followed and that manufacturing units will be regularly inspected by the DGDA.
The role of HRDM in Drug safety training & monitoring:
To maintain drug safety of every department from clinical trial to manufacture, HRDM arranges
training in this regard. Arrange a workshop for dispensing stage to maintain the quality of drug.
A protocol for developing and manufacturing drugs in compliance with the national and
international policy provided by HRDM to all department in pharmaceutical industry. Set up a
qualified team personnel for drug safety monitoring in pharma plant to meet the criteria of FDA
and DGDA.
Drug safety training program is the best
curriculum that covers all aspects of drug
safety and pharmacovigilance. HR have
carefully crafted the module of drug safety
training by experts.

9. 8
Employers’ responsibility:
Employer is fully responsible for the unauthorized activity. It is common observation management
using ‘Rule by Fear’ method with employees (for example- employee do what employer are told
him). This leads to a culture of fear and blame and an inability of employees to challenge and not
follow regulatory guidelines. An employee should be encouraged to take advantage of an open-
door route to organization top management when it comes to raising compliance issues and
discussing potential compliance concerns pertaining to drug safety management.
Conclusion:
Human resource management (HRM) plays a critical role in drug safety management, according
to the strategic and coherent approach HR policies, and HR practices that offer challenging
developmental opportunities and recognize employee performance. This, in turn, motivates
individuals to strive for better health through medical progress and the development of superior
pharmaceutical products.
HRDM selected qualified
personnel and provide all the
resources for safety monitoring.

10. 9
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