Clinical trials, pharmacovigilance and verification are just some of the fields of action where pharmaceutical companies actively work to guarantee the well-being of people in their relationship with medicines.
The increased complexity in healthcare and the constant and improved evolution of personalized treatments have made it necessary for all the agents that make up the health sector to focus on patient safety, with the aim of preventing and reducing risks, errors and potential damages that people may suffer during the provision of health care.
Patient safety is essential to provide quality essential health services. In fact, there is a clear consensus that quality health services around the world must be effective, safe and people-centered. For this reason, the World Health Organization (WHO) decided last year to dedicate a day to awareness of patient safety: September 17.
The use of medicines, as well as infections related to health care, diagnostic errors or surgical complications, has been considered as one of the fields of action where there is room for improvement and surveillance plans must be strengthened to avoid unnecessary damage to the patients.
The use of medicines, as well as infections related to health care, diagnostic errors or surgical complications, has been considered one of the fields of action where there is room for improvement
In this sense, the pharmaceutical industry has been committed for years to patient safety in all areas that have to do with research, development, manufacture, marketing and proper use of medicines.
Thus, safety in the research process is fully guaranteed by an ethical and legal framework in both the European and national environment, with Directive 2001/20 / EC and RD 1090/2015, the Declaration of Helsinki on medical research in human beings, the International Guide to Good Clinical Practice or the Global Vaccine Safety Initiative (GVSI).
This regulatory framework allows the participation of healthy and sick people in any of the phases that comprise clinical trials to prove the safety and efficacy of drugs have all the guarantees and that pharmacological research is a solid and reliable process.
One of the evidence that best supports this reality is found today in the race undertaken by industry, governments and research centers to find a pharmacological solution to the SARS-CoV-2 pandemic, which is significantly reducing the times of R&D process of potential vaccines and treatments. Today it can be said that the safety of the research is not being compromised and, in no case, will the urgency to find an effective vaccine or drug against the coronavirus prevail over the safety of the people.
Nine pharmaceutical companies, leaders in vaccine research and manufacturing, stated this just a week ago through a joint manifesto in which they committed to developing vaccines in accordance with “ethical standards and sound scientific principles” that have always been characterized the research of these drugs. “The safety and efficacy of vaccines, including any potential vaccine for Covid-19, is reviewed and determined by expert regulatory agencies around the world (…). They will only be submitted for approval or authorization for emergency use when their safety and efficacy are demonstrated through a phase 3 clinical study that is designed and conducted to meet the requirements of expert regulatory authorities, ”the statement said.
According to the WHO, greater patient involvement is essential for safer health care, so, “if done right, it can reduce the burden of harm on delivery by up to 15%, saving billions of dollars every year”. In Spain, Farmaindustria has promoted this same year, in the hands of patient organizations and pharmaceutical companies, a guide of recommendations to strengthen the participation of patients in the research process, in order to provide it with even more security from the knowledge and transparency all along the way.
Likewise, the pharmaceutical industry works with one of the highest quality standards in the manufacture and production of medicines of all industrial sectors, being able to detect any possible errors or contamination in batches in short periods of time and withdrawing the product before that it reaches the market on many occasions.
In terms of patient safety, it is also worth highlighting the active role that pharmaceutical companies have in pharmacovigilance, which has been reinforced in recent years with the update in 2010 of the European Directive on the matter, as well as with the RD 577/2013. To both standards is added the guide to good practices in pharmacovigilance for the pharmaceutical industry, which includes an exhaustive control of possible adverse drug reactions, the periodic review of scientific evidence or immediate communication to the health authorities of any change in the benefit-risk balance of the drug, among many other control measures.
Finally, the innovative pharmaceutical sector is also committed to patient safety once the drug is placed on the market through the anti-counterfeiting system, a European legislative initiative that in Spain is managed through the Spanish Drug Verification System (SEVeM) , in which pharmaceutical companies, distribution and pharmaceutical associations collaborate. The entry into force of the regulation reached its first year of life last February and its ultimate goal is to further increase surveillance within the drug supply chain.
Patient safety is the main thing at this time and we believe it at Distefar. The pharmaceutical industry has always had this very present and at times like the ones we are going through, this security increases.