Pharmacovigilance - An Emerging subject in Medicines

Have you ever heard of a subject specially dealing with the adverse events and adverse reactions of the drugs? Obviously not before this decade. In traditional days, all people know is that medicines are the cure to diseases and illnesses. But with accumulation and overuse of the same drug for prolong comes the fact that drugs can also be the cause of serious health disorders.

 

This gave rise to a new subject in medical science, Pharmacovigilance. Pharmacovigilance is the subject that studies adverse drug events and adverse drug reactions related to the administration of a drug. In this blog, we will study a detailed note on Pharmacovigilance and its importance for mankind.

 

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What is Pharmacovigilance?

 

The word, Pharmacovigilance is composed of two words, Pharmakon and vigilance. Pharmakon is a Greek word that is translated as a remedy or poison. In general terms, pharmakon is described as an active pharmaceutical ingredient. 

 

That might be carrying a therapeutic action. While vigilance in general English is translated as awareness. So, generally pharmacovigilance refers to the awareness and acknowledgement of administration and side effects of drugs or any medical substance.

 

Pharmacovigilance is the branch of science that includes collecting, monitoring, researching and evaluating information from healthcare workers and patients on the adverse effects of medications, herbal drugs or any other traditional medicines. 

 

A valid case in pharmacovigilance is raised only when it is validated by an identifiable healthcare worker (that may act as a reporter), an identifiable patient (that is victim), an adverse drug event, and a suspect (drug here).

 

A pharmacovigilance case derives the casualty between the suspect drug and adverse drug event. Casualty is defined as the relationships between two or more factors, in pharmacovigilance, it is generally carried out between the drug and adverse event. 

 

The whole pharmacovigilance case is studied to check if the suspected drug is actually responsible for the adverse event or not. If the drug is actually responsible for the adverse drug event occurring, a casualty is derived between the two factors. 

 

A case is considered medically confirmed only when it has derived the casualty between two factors or if confirmed by a healthcare professional. Healthcare professionals may include physicians, nurses, pharmacists or coroners.

 

Aim of Pharmacovigilance

 

Pharmacovigilance is a subject that studies the safety data and adverse effects of a drug. The aims of pharmacovigilance are as follows:

 

1. To improve patient care and safety while using or administering medicines or any other drug product.

 

2. To research the efficacy of drugs.

 

3. To monitor the adverse effects of drugs.

 

4. To improve public health and management.

 

5. To contribute to the assessment, risk and benefits of a drug product and its administration.

 

6. To keep a record of the drastic effect of drugs.

 

7. To promote understanding and education of the individual in the subject of pharmacovigilance.

 

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Origin of Pharmacovigilance

 

Pharmacovigilance was first utilized about 170 years ago. In India, the subject is still under its infancy stage and developing further. Though, 170 years back, no one knows the term pharmacovigilance, but its first application was discovered there. 

 

In 1848 a girl in North England died after the administration of the chloroform. After the incident, chemist Sir James Simpson researched and tried to find the cause of her death.

 

Later in 1937, a drug Sulfanilamide that is used to treat streptococcal infections was responsible for 105 deaths. In 1938, it was realized the acetylsalicylic acid can be responsible for GIT infections and toxicity. Year 1957 has witnessed the severe tragedy of thalidomide.

 

Thalidomide is a drug that is used for treating morning sickness and nausea and during its clinical trials, the drug has not shown any side effects. But in later years, the drug is discovered to link with congenital abnormality phocomelia. The abnormality has lead defects in born babies of ladies who have been administered by the drug during pregnancy.

 

And it takes more than 10 years for scientists to discover the reasons and cause behind it. The incident gave rise to the importance of passive pharmacovigilance and post marketing surveillance. 

 

Post marketing surveillance is defined as the practice of monitoring the safety band of pharmaceutical drugs after it has been launched for the mankind and market. In India, the first appearance of pharmacovigilance can be traced from 1982. It was the year when India decided to join the Uppsala center of pharmacovigilance.

 

Adverse drug events and Adverse Drug Reactions

 

The whole subject of pharmacovigilance is limited to these two terms ADEs and ADRs. People from non-medical fields often consider these two terms as the same, but there is a huge difference in both. Here are the definitions.

 

1. ADE

 

ADE is expanded as an Adverse Drug Event. An adverse drug event is defined as an untoward medical condition that may be present while administration or treatment of a drug. But it is not necessary that this condition has casualty with drugs.

 

2. ADR

 

ADR is expanded as an Adverse drug reaction. It is defined as an unwanted or toxic medical condition that has occurred at any dose of drug. In simple words, ADR resembles a casualty with the drug or treatment. Thus, all ADRs are ADEs, but all ADEs are not necessary to be classified as an ADR.

 

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Importance of Drug Safety Monitoring

 

As mentioned earlier, pharmacovigilance is the subject that monitors drug safety and adverse effects of drugs. You might be wondering, what is the importance of this subject, and if it is this important why it comes so late in existence. Over time, the prolonged use of drugs and medicinal chemicals causes side effects and ill effects on the human population.

 

Drug safety monitoring is defined as a mitigation exercise that is conducted to research and explore the different adverse drug reactions caused by therapeutic drugs, biologicals or other medicinal devices. It also searches for ways by which these effects can be minimized or prevented.

 

In current scenarios, adverse drug reactions (ADRs) are the leading death factors in most of the countries. Thus, drug safety monitoring is essential for effective medicinal use. It is also responsible for a healthy population and mankind. Drug safety monitoring increases the trust of general public and healthcare professionals on a particular medicinal product.

 

Drug safety monitoring encourages the healthcare professionals to take the entire responsibility of the drugs they are using. Pharmacovigilance and drug safety monitoring guards the clinical effectiveness of a medicinal product. It enhances the integrated approach of therapeutic decision-making.

 

 

Types of Pharmacovigilance

 

Pharmacovigilance is broadly classified into two types Active Pharmacovigilance and Passive Pharmacovigilance.

 

1. Active Pharmacovigilance

 

Active pharmacovigilance is also known as proactive pharmacovigilance. It is an active safety surveillance that takes measures to detect adverse events at earliest. Adverse events are detected by asking the patients directed or by screening the hospital records. The data is managed by active follow up after the administration of drug or treatment.

 

2. Passive Pharmacovigilance

 

Passive pharmacovigilance refers to the case surveillance where no such active precautions are taken to measure the adverse effects of drugs. Any process or case where healthcare professionals send the reports mentioning an adverse drug event after the drug moiety or medicinal product has been administered to the marketing authorization or regulatory authority.

 

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Different Pharmacovigilance Authorities and Tools

 

The complex process of pharmacovigilance involves different steps and procedures. Many authorities work together to process the safety data of a drug. 

 

The quality assurance department of pharmaceutical industries, hospitals, clinics, health care professionals, patients, and National Pharmacovigilance Centers are together called as soldiers of pharmacovigilance. Here are the few national and international regulatory committees and tools that are responsible for drug safety and pharmacovigilance data.

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Different pharmacovigilance authorities in India

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1. The Uppsala Monitoring Center (UMC)

 

The Uppsala Monitoring Centre (UMC) is formed by the member countries of WHO Programme. It is an international drug monitoring company that collects and processes worldwide data of adverse drug reactions. 

 

It focuses on collecting the early symptoms of medicinal products. The prime duty of UMC is to manage the international database of ADR reports collected from different countries.

 

2. The National Pharmacovigilance Centers (NPCs)

 

National Pharmacovigilance Centers are responsible for collection of drug safety data and pharmacovigilance data at national level. Many national pharmacovigilance centers are built within hospitals and clinical institutions. It plays an important role in public awareness and is responsible for active surveillance programs.

 

3. VigiBase

 

VigiBase is an international database managed by WHO. It is a new web application that is accessible to everyone around the world. People can access the already fed information as well as report the adverse effect of any medical process. 

 

Data embedded in VigiBase is structured in a comprehensive way that is easy to analyze and can be used for the detection of adverse effects at earliest.

 

4. CDSCO

 

CDSCO is an Indian organization that is designated for the pharmacovigilance welfare in India. CDSCO is expanded as the Central Drugs Standard Control Organization; it comes under the ministry of Health and Family welfare. 

 

It is responsible for all drug regulatory affairs in India. It grants permission for issuing drugs in the Indian and international market. It is also responsible for the National Pharmacovigilance Programme in association with Indian Pharmacopoeia Association.

 

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Pharmacovigilance Program of India (PVPI)

 

The Pharmacovigilance Program of India was launched in 1986. It is a formal drug monitoring system that is used for the promotion of pharmacovigilance activity in India. There are different centers of PVPI in India, but the All India Institute of Medical Sciences is selected as the national coordinating center of the program in starting but later shifted to IPC, Ghaziabad for better functioning.

 

Different authorities which are involved in PVPI are Uppsala Monitoring Center (UMC), World Health Organization (WHO), All monitoring Centers (AMC), Ministry of Health and Family Affairs, Indian Pharmacopeia Commission (IPC), National Health Policy (NHP), and Central Drug Standard Control Organization (CDSCO).

 

Anyone including a patient, reporter or healthcare professional can report the adverse effect observed while administration of drug at peripheral, regional or zonal pharmacovigilance center. The data registered is then analyzed and processed by AMC in VigiBase. After mock drill and research, the data is verified by a regulatory committee.

 

Once any authority like CDSCO, WHO or UMC validates the data and a suspected drug is actually found as the cause of an adverse event, the drug is called back from the market. This happens in passive pharmacovigilance. Active pharmacovigilance bans a drug in the market at entry level.

 

List of drugs banned in History

 

The advent of pharmacovigilance has given the public and researchers the knowledge about the serious side effects of a drug. Many such side effects are too toxic for human health and are responsible for fatal conditions. To ensure public safety and drug efficacy many such drugs have been banned and called back from the market. The major drugs in this list includes:

 

1. Zomepirac

 

2. Phenformin

 

3. Ticrynafen

 

4. Rofecoxib

 

5. Rimonabant

 

6. Sibutramine

 

7. Rosiglitazone

 

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Pharmacovigilance is an important medicinal subject for the safety of mankind and efficacy of drugs. It is still in its infant stage in India and requires improvement and consideration. 

 

Several challenges are faced by the pharmacovigilance sector, this includes lack of awareness, less facilities, poor infrastructure, communication error, and poor management of pharmacovigilance databases. Once these challenges are covered the PV sector in India can mature to its benchmark level.