Safe use of medication in clinical research

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How does the use of the drug work and how is it handled in the pharmaceutical service during clinical research?

“The patient is accompanied after the administration of the medication, giving instructions on the proper use of the product, adherence to treatment, storage conditions and recommendations to maintain immediate communication with the pharmaceutical service”.

By María Cecilia Cuesta

Pharmaceutical Chemistry

Three keys:

  • Drugs used in clinical research are studied and approved before being used in humans.
  • They are approved by the U.S. Food and Drug Administration (FDA) and in Europe by the European Medicines Agency (EMA). After being approved by the EMA, they are approved by the Spanish Agency of Medicines and Health Products (AEMPS). Before being used in Colombia, they are submitted by the sponsor to the regulatory agency INVIMA (Instituto de Vigilancia de Medicamentos y Alimentos).
  • The patient is accompanied after the administration of the drug giving instructions on the proper use of the product, adherence to treatment,

Clinical trials are carried out to determine the efficacy of a drug or vaccine, the adverse effects they may produce and whether the dose at which it is used achieves the desired effect or result.

The pharmaceutical service plays a very important role in the custody, randomization and dispensing of the drug, since when it arrives at the pharmacy, a technical reception is performed to verify that the drug arrives with all the quality specifications. 

The investigational product is stored in such a way that all specifications are preserved.

How does the safe use of the drug benefit the patient?

  1. Decreases the probability of occurrence of an adverse event or adverse reaction.
  2. It favors the effectiveness of the drug against the pathology.
  3. Guarantees the effectiveness of the mechanism of action.

Vaccine Care

In the case of vaccines, special care is taken to store them at the required temperature (2 – 8°C), and continuous monitoring is carried out by means of electronic devices that generate alerts to ensure that the product is kept within specifications. 

The pharmaceutical service is equipped with a refrigerator with temperature monitoring and backup.

Contingency procedures are in place to ensure optimal storage of the medication and electrical plant in the event of a power outage.

If the vaccines require prior adaptation before use, we have a transport procedure and a refrigerator that meets the necessary conditions for the logistics of this, guaranteeing the cold chain of the research product during transport to the central mixing plant and return to the IPS.

Assignment of medication to patients.

The assignment of the medication is done through an IXRS platform assigned by the sponsor of the study and to which only the pharmaceutical chemist of the clinical research center has access. 

The patient is accompanied after the administration of the drug, giving instructions on the proper use of the product, adherence to treatment, storage conditions and recommendations to immediately contact the pharmaceutical service in case of observing anything unusual in the appearance of the drug or its use.

Pharmacovigilance Program 

The Clinical Research Center IPS mic, performs a follow-up through the Pharmacovigilance Program to act in a timely manner in the event of an adverse reaction or any event related to the drug, thus ensuring the safety of our users.

 Conclusion

The use of the drug and how it is handled in the pharmaceutical service during clinical research is safe.

The drugs that are applied to the participants in a clinical study are of high quality and the processes previously described in this article ensure verification by the authorities and transparency in the information, custody, use and handling. The follow-up of everything that happens during a study stands out for the rigorousness of the processes for the benefit of the patient and clinical research. 

By María Cecilia Cuesta

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