Drugs can enter the market only when these are found safe for use. Pharmacovigilance and safety of any drug is crucial to any clinical research. It includes many aspects of well-being of the patient, trust, and confidence in the pharmaceutical industry and the field of medicine. Another important facet is the economic impact of drugs and drug safety issues.
Economic Impact on Drug Safety and Pharmacovigilance
The economic impact is the real cost of the drug that is incurred while using it for treatment. All drugs have side effects. Some drugs are potentially hazardous and have serious consequences. These can lead to huge costs incurred for the treatment of drug-induced harmful effects. In such cases, the economic impact of the drug doubles. These tremendously increase the health-care costs.
Adverse drug reactions also are known as the ADRs increase economic and clinical costs as these lead to hospital admissions, long hospital stay and emergency hospital visits.
Costs of adverse effects of drug safety
- Hospitalization for adverse effects
- Ambulance costs
- Emergency services
- Emergency visits
- A requirement of specialized nursing services
- A requirement of drugs to treat adverse effects
- Additional costs of treating new complications in existing medical conditions
- Incidence of new diseases that require complex treatments for a longer duration.
Pharmacovigilance aims to identify various drug signals as early as possible. If these are identified soon it helps to minimize the potential clinical and economic impact of ADRs.
Causes of Adverse Drug Reactions or ADRs
Here are few causes of adverse drug reactions.
- Inappropriate use of medicines
- Observation of drug effects under strict protocols and very controlled conditions.
- Lack of studies in dynamic clinical settings to check the complexity of the used drug
- Inappropriate dosage
- Inappropriate duration
- Drug interactions
- Off-label use
- Use in contraindicated circumstances
- Lack of proper knowledge and awareness in patients
The Food and Drug Administration or FDA is responsible for conducting an economic analysis of all regulations either proposed or final. This involves the assessment of costs in terms of benefits and adverse effects to know the cost-effectiveness of any drug.
At present, product development involves complex licensing. The product development begins with venture backed firms and therefore, any changes in the economics of product development due to strict safety regulations can result in a significant negative impact on investment as well as innovation.
In such scenario, a complete analysis of these elements is essential in assessing steps to improve drug safety evaluation.
An efficient strategy for identifying serious adverse effects of any drugs, we need a model to estimate and compare potential economic repercussions of any regulations that may involve preapproval of clinical testing of investigational drugs, any increase in funding due to regulations and more.
Pharmacovigilance or drug safety is primarily based on clinical trials and extensive clinical research. To bring any new drug in the market the studies and trials should be handled by professionals expertly so that the drug is safe. We know that every drug will have a side effect, but the objective of clinical studies and trials is to develop drugs that provide more benefits with fewer adverse effects. If this happens, it will help in reducing the cost of treating patients for negative side-effects and adverse effects.