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Pharmacovigilance 101

Drugs have been a huge breakthrough in the medical field. Other than curing diseases, drugs can prevent disease, boost the immune system of a person, and also provide nutritional benefits. Despite the many benefits that drugs offer, they can have several side effects that may be harmful to the body or exacerbate the disease of the patient.

According to studies, a person taking three to four different kinds of drugs is likely to experience more adverse effects compared to a person taking just one type of medication. Some of the adverse effects of using multiple drugs are associated with the interaction of one drug with another. Due to issues such as side effects and drug-drug interactions, it has become vital for health physicians to monitor the impact of drugs on patients for safety precautions.

What is pharmacovigilance?

Pharmacovigilance is the science of monitoring, detecting, and understanding the adverse effects and drug-related problems of various licensed drugs. The role of pharmacovigilance is bestowed to a pharmacist. A pharmacist should ensure that patients benefit from the use of drugs without any significant adverse effects. Minor adverse effects such as nausea and vomiting are unavoidable in most cases, but pharmacovigilance aims at preventing significant side effects such as liver or kidney failure.

Role of pharmacovigilance in healthcare.

Pharmacovigilance has two primary roles in healthcare; to prevent patient hazard and improve public healthcare. Adverse effects and drug-related problems mainly cause patient hazards. It became essential after a healthcare hazard in the 1960s where thousands of babies were born with phocomelia, a congenital defect in which an infant has short limbs. The hazard was due to the use of thalidomide among pregnant women.

Pharmacovigilance aims are withdrawing drugs, which increase morbidity and mortality rates associated with drugs, from the market. Since the thalidomide incident, more than 10% of licensed drugs have been withdrawn from the market. It has also become essential for pharmaceutical companies to do pre-clinical tests on drugs before releasing them to the market.

There are five primary drug therapy-related problems that pharmacovigilance addresses to ensure patient and public healthcare safety; adherence, dosage, indication, safety, and effectiveness. Adherence involves the patient’s commitment to taking the drugs as prescribed by the physician, ensuring that they do not miss to take their doses. Dosage is all about the patient sticking to the drug dose and frequency as prescribed. Just as the term suggests, indication involves ensuring that the drug is appropriate for the condition of the patient.

The safety of the drug on the patient using it is a significant drug-related problem. For example, an asthmatic patient can be placed on aspirin therapy for a heart condition, but the aspirin is not safe for the patient because it triggers asthmatic attacks. The doctor will, therefore, need to look for an alternative drug. A drug is considered unsafe if it causes more harm than good, and ineffective if no improvement is seen in the patient’s condition after a certain period of use.

Safety and effectiveness of the drug are the two main areas that pharmacovigilance is based on. A patient should not be using a drug that does more harm than good to his or her health. Furthermore, taking a medication that is ineffective for the patient’s condition is no different from drug abuse. Doctors, therefore, need to make the appropriate diagnosis to avoid drug-related problems such as inappropriate indication and ineffectiveness of the drug.

Pharmacovigilance ensures that the patient is free from the above drug-related problems by asking the patient to attend further appointments or calling the patients after a few days to make inquiries on their condition. Physicians can also do some laboratory tests, and if need be, change the patient’s medications.

Healthcare professionals are advised to take the medical condition and medication history of the patient over the past years. The history helps to determine any medication allergies or adverse effects that the patient has ever experienced while using a particular drug. The process helps to prevent adverse outcomes in patients and ensure public healthcare improves.