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What is Pharmacovigilance?

Pharmacovigilance is the science related to the detection, assessment, understanding, and prevention of adverse reactions or any health problems associated with medicines or vaccines.
Objectives of Pharmacovigilance

Understanding the Impact of Pharmacovigilance

Improve patient care and safety regarding the use of medicines and all medical interventions.
Detect issues related to the use of medicines and communicate findings in a timely manner.
Improve patient care and safety regarding the use of medicines and all medical interventions.
Promote safe, rational, and more effective (including cost-effective) use of medicines.
Contribute to risk-benefit assessment, effectiveness, and risk of medicines, leading to harm prevention and benefit maximization.

Promover la comprensión, la educación y la formación en farmacovigilancia y su comunicación efectiva al público. (Organización Panamericana de la Salud, s.f.)

Improve patient care and safety regarding the use of medicines and all medical interventions.
Detect issues related to the use of medicines and communicate findings in a timely manner.
Promote safe, rational, and more effective (including cost-effective) use of medicines.

Improve public health and safety in relation to the use of medicines.

Contribute to risk-benefit assessment, effectiveness, and risk of medicines, leading to harm prevention and benefit maximization.

Promote understanding, education, and training in pharmacovigilance and effectively communicate it to the public. 

Objectives of Pharmacovigilance

Understanding the core elements of pharmacovigilance and its relevance in public health.

Clearing Doubts

Frequently Asked Questions

Clearing Doubts

Frequently Asked Questions

A drug is a substance taken or applied to prevent or cure diseases and treat symptoms. When used correctly, it acts in our body to improve our health.

A medication is a product that cures, alleviates, prevents, or diagnoses diseases. It consists of:

  1. Active ingredient: The substance responsible for the therapeutic effect.
  2. Excipients: Substances without therapeutic function that facilitate the administration and preservation of the active ingredient.
When we take a medication, it can act in two main ways in our body. If we talk about local action, it means the medication acts directly at the site where it is applied or administered, such as a cream for a burn that concentrates its action in the application area. On the other hand, if the medication has systemic action, after being ingested or injected, it travels through the bloodstream and acts in different parts of the body where its action is needed. An example would be a pill to relieve a headache that, although taken orally and processed through the intestines into the bloodstream, acts to alleviate the headache.
The drug supply chain refers to the complete and sequential process by which a medication is developed, produced, distributed, and finally reaches patients. This process begins with research and development (R&D) in laboratories, where potential compounds to treat diseases are identified and tested. Once a promising compound is discovered, it undergoes rigorous testing and clinical trials to ensure its safety and efficacy. After obtaining necessary regulatory approvals, the medication moves to the production and marketing phase.
After manufacturing, the medication is distributed through a network of distributors and wholesalers, who are responsible for delivering it to pharmacies, hospitals, and other healthcare facilities. Here, healthcare professionals such as doctors and pharmacists play a crucial role in prescribing and dispensing the medication to patients. This entire process, from initial research to patient dispensation, is regulated and supervised by government entities to ensure medications are safe and effective for the population.

The most important link in the chain is the patient, who benefits from the medication's action. Other actors in the drug supply chain include pharmaceutical companies, responsible for research, development, and production of medications; testing laboratories and research institutions, conducting studies and tests to validate medication safety and efficacy; regulators and government entities, overseeing and approving the launch of new medications into the market; distributors and wholesalers, responsible for delivering medications to various points of sale and healthcare; and finally, healthcare professionals such as doctors and pharmacists, who prescribe and dispense medications to patients. Each of these actors plays a vital role in ensuring medications reach those who need them safely and effectively.

Animal: An example of a medication of animal origin is insulin, used to treat diabetes, which was initially obtained from the pancreas of pigs. Before biotechnology, animal insulin was the primary source administered to patients with type 1 diabetes, allowing for the regulation of blood sugar levels.

Vegetal: An example of a medication of plant origin is acetylsalicylic acid, commonly used to treat headaches and derived from the bark of the white willow tree.

Mineral: An example of a medication of mineral origin is calcium carbonate, primarily used as a supplement to treat or prevent calcium deficiency in the body. This mineral is naturally found in rocks and limestone.

Artificial Synthesis: An example of a medication produced through artificial synthesis is paracetamol or acetaminophen, a widely used analgesic and antipyretic to relieve pain and reduce fever. Artificial synthesis refers to the process of manufacturing chemical substances in laboratories through specific chemical reactions using basic raw materials. These substances are not extracted from natural sources but are created by combining and modifying molecules under controlled conditions.

Biotechnological/Biological: In the pharmaceutical context, biotechnological medications are produced using biological systems such as genetically modified cells or bacteria to produce therapeutic molecules. An example of a biotechnological medication is trastuzumab, used in the treatment of certain types of breast cancer.

Generic Medication

A generic medication is a drug created to be identical to a brand-name medication already marketed in terms of its dosage, safety, potency, route of administration, quality, performance characteristics, and intended use. The concept of a generic medication should only be used for chemically synthesized drugs.

The authorization of generic medication is based on demonstrating bioequivalence with a previously authorized medication for which the data protection or patent period has expired, if applicable.

Generic medication must meet all required quality assurances and additionally demonstrate that the active ingredient is absorbed by the body in the same manner as its corresponding original medication.

Biological Medications

Biological medications (also called biologics) can be made from sugars, proteins, living cells, tissues, or a combination thereof. They are made from natural and living sources such as animal and plant cells, and microorganisms like bacteria and yeast.

Biological medications are generally more complex than other medications. Their purification, processing, and manufacturing are often more intricate processes.

Biosimilar Medication

A biosimilar medication is a biological drug that is highly similar to another biological drug (known as the reference medication) that has already been approved by National Regulatory Authorities. While biosimilar medications and reference medications are both made from living organisms, they may be manufactured in different ways and with slightly different substances. For a medication to be called biosimilar, it must be demonstrated to be as safe, as effective, and to work in the same way as its reference medication. Additionally, it must be used in the same manner, with the same dosage, and for the same condition as the reference medication. This is demonstrated through biosimilarity studies.

In medical prescriptions, you find information about:
  • Presentation, name, and quantity of the medication
  • Route of administration and dosage (how to take the medication and in what quantity) 
  • Frequency and duration of treatment
It is important to strictly follow these instructions to ensure the effectiveness of the medications and the treatment.
  • What effects will the medication have on your body?
  • Whether the prescribed medication will interfere with other medications you are taking.
  • What unwanted or side effects you may experience while taking the medication and what you can do about them.
  • Which foods, drinks, or other medications you should avoid while undergoing treatment.
  • What to do if you forget a dose of the medication.
  • Under what circumstances you should stop taking or consuming the medication.

It is essential to purchase medications only from recognized pharmacies or authorized healthcare establishments. These places guarantee products that have passed rigorous quality controls and comply with health regulations. Avoid buying medications from informal markets, unverified websites, or unauthorized locations, as there is a risk of acquiring counterfeit, expired, or improperly stored products, which can endanger the patient's health. It is always advisable to consult a healthcare professional before purchasing or consuming any medication.

Before consuming a medication, it is vital to carefully review the information on its packaging. Check the expiration date to ensure the product is still safe for use. Additionally, confirm that the name of the medication matches the prescribed one, and review the dosage and usage instructions. It is equally important to ensure that the packaging is intact and shows no signs of tampering or damage, ensuring the medication has not been compromised. Always follow the instructions and consult any doubts with a healthcare professional. Also, ensure it has a sanitary registration number.

Drug interactions occur when two or more drugs administered simultaneously or within a close timeframe act together, modifying or altering their original effect. These interactions can enhance, reduce, or even neutralize the effect of one or both drugs. It is crucial to consider this situation as they can lead to unwanted effects or decrease the effectiveness of the treatment. In some cases, interactions can be dangerous and compromise the patient's health. Therefore, it is essential that healthcare professionals are informed about all the medications and supplements a person is taking to prevent potential adverse events.

It is essential to store medications that do not require refrigeration properly at home to ensure their effectiveness and safety. It is recommended to keep them in a cool, dry place away from direct sunlight, preferably in a closed first aid kit and out of the reach of children and pets. Avoid places with temperature changes, such as the kitchen or bathroom, as moisture and heat can alter the composition of drugs. Additionally, always keep medications in their original packaging with their respective labels for easy identification.

It is important to dispose of expired medications properly. Dispose of them in non-recyclable waste containers at home, ideally in a closed container (bag, box, bottle). Remove all personal information from the containers before placing them in the waste container.

History

Discover the history of pharmacovigilance

Pharmacovigilance is the science related to the detection, assessment, understanding, and prevention of adverse reactions or any health problems associated with medicines or vaccines.
1805
Morphine Poisoning
Morphine was commonly used for pain relief. A soothing syrup for teething, composed of morphine sulfate and alcohol, was marketed in the USA and UK. Its sale was prohibited in 1930 due to adverse effects such as addiction, coma, and death.
1805
1931 - 1932
Chloroform Poisoning
Cases of death from chloroform anesthesia procedures were collected. This event is considered the beginning of pharmacovigilance.
1931 - 1932
1935
Clioquinol Poisoning
Neurological problems were reported in people who took high doses of "Entero-Vioform," a medication for intestinal infections containing Clioquinol. Cases of blindness were recorded in children treated with this compound.
1935
1937
Diethylene Glycol Poisoning
Known for its solvent properties but not its extreme toxicity. There were mass poisonings and deaths due to cross-contamination in medications in several countries. The rapid handling of this crisis led to improvements in regulation.
1937
1938
Milestones in Drug Regulation
Multiple adverse effects caused by drugs prompted regulatory milestones. In the USA, safety demonstration of drugs before commercialization became a requirement in 1938.
1938
1957 - 1961
Thalidomide Issues
Marketed in Germany as a sedative. A year later, it was promoted as an effective and safe drug for combating vomiting and discomfort in the first trimester of pregnancy. It was withdrawn in 1961 due to the incidence of phocomelia, a congenital malformation.
1957 - 1961
1964 - 1968
Pharmacovigilance and Systematic Notification Collection Systems
Emerging in response to the thalidomide catastrophe.

The Yellow Card Scheme was created in the UK in 1964, and the WHO International Drug Monitoring Program was established in 1968, proposing the creation of an International Drug Monitoring Center.
1964 - 1968
1970
Practolol Poisoning
This medication was marketed in the UK in 1970 and caused "Practolol Syndrome," which included severe problems such as blindness and intestinal obstruction. Deaths occurred due to the delayed onset of these effects, leading to the development of a more organized method for reporting medication side effects (Prescription Event Monitoring, PEM).
1970
1978
Foundation of the World Health Organization (WHO) Collaborating Centre for Pharmacovigilance
The WHO International Drug Monitoring Program was moved to Uppsala, Sweden, becoming the WHO Collaborating Centre. Under this agreement, WHO is responsible for policy, coordination, and dissemination, while Sweden provides facilities. WHO also supports the Centre financially and promotes its findings.
1978

Regulatory Authorities

LATIN AMERICA

Argentina

ANMAT (National Administration of Drugs, Food, and Medical Technology).

Bolivia

State Agency of Medicines and Health Technology (AGEMED).

Brasil

National Health Surveillance Agency (ANVISA) and Sanitary Surveillance Center (CVS) in São Paulo.

Chile

Public Health Institute (ISP).

Colombia

National Institute of Food and Drug Surveillance (INVIMA).

Costa Rica

Ministry of Health of Costa Rica.

Ecuador

National Agency for Regulation, Control, and Sanitary Surveillance (ARCSA).

El Salvador

National Pharmacovigilance Center - Ministry of Health El Salvador.

Guatemala

Ministry of Public Health and Social Assistance of Guatemala.

Jamaica

Ministry of Health and Wellness of Jamaica.

México

Federal Commission for Protection against Sanitary Risks (COFEPRIS).

Nicaragua

Ministry of Health of Nicaragua (MINSA).

Paraguay

DINAVISA (National Directorate of Sanitary Surveillance).

Panamá

Ministry of Health of the Republic of Panama.

Perú

General Directorate of Medicines, Supplies and Drugs (DIGEMID).

República Dominicana

General Directorate of Medicines, Foods, and Health Products (DIGEMAPS).

Trinidad y Tobago

Ministry of Health of the Republic of Trinidad and Tobago.

Uruguay

MSP (Ministry of Public Health).

Venezuela

National Center for Pharmacological Surveillance (CENAVIF).

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This Pharmacovigilance site does not collect Adverse Drug Reaction Reports.
If you wish to report an adverse effect or technical complaint regarding a pharmaceutical product, please contact your healthcare provider and/or the Health Authorities in your respective country.

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