Egypt and North Africa

“To undergo treatment you have to be very healthy, because apart from your sickness you have to withstand the medicine”. Molière (French Dramatist, 1622-1673)

Although Molière was not a health care professional, but he understood very well that healthy and sickness status are too near from each others to cross from healthy to a sick person. Withstanding the medicine by that time is now referred to “Adverse Drug Reactions - ADR’s” which become very important to a continuous watch.

Pharmacovigilance is considered an important and basic concept in the pharmaceutical companies. They start to speak about adverse drug reactions and other major adverse events that could lead serious events during patients’ illness. Any patient, wants effective medicine, safe to use with no harmful side effects or sequelae, he is already suffering from his sickness.

What is Pharmacovigilance?

According to the WHO -the main reference - pharmacovigilance is :

“The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem”.

This applies throughout the life cycle of a medicine equally to the pre and post approval stages i.e. during clinical trials and marketing phase.

Pharmacovigilance is a word formed of “ Pharmaco which means medicine and Vigilare a Latin word means to watch. The complete meaning goes for alert watchfulness or watchfulness in respect of danger and caution. This necessitates a close and continuous monitoring.

The scope of pharmacovigilance is critical as it is related to patients’ life. Consequently its aim is to improve patient, public health care, and safety in relation to the use of medicines, also it contributes to the assessment of benefit, harm, effectiveness and risk of medicines. Why do we need pharmacovigilance? And do we really need it?

We do really need pharmacovigilance for the following main reasons:

Reason 1

Humanitarian concern, insufficient evidence of safety issues from clinical trials, and conducting trials on animals is not always predictable for the safety and efficacy of the drug when used on human beings.

Reason 2

Medicines of many therapeutic classes are used to treat diseases and in other critical cases to save live.

“Dying from a disease is sometimes unavoidable; dying from a medicine is unacceptable”. Lepakhin V. Geneva 2005

Reason 3

Medicines used for treating diseases are expensive, but what about treating Adverse Drug Reactions consequences….. They are more expensive!!

Reason 4 One of the main messages for pharmacovigilance is promoting rational use of medicines.

Reason 5

To ensure the public confidence for the treating medicines regarding their safety and effectiveness.

Reason 6

Ethics are main issue for pharmaceutical companies, they deal with human lives. Based on the fact that if you know of something that is harmful to another person who does not know, and not telling, is unethical.

The harmful effects of pharmaceutical product are classified into the following:

• Adverse Event (AE) – any untoward medical occurrence, that may present during treatment but which does not necessarily have a casual relationship with this treatment.

• Adverse Drug Reaction (ADR) – a response to a pharmaceutical product which is noxious and unintended, and which occurs at doses normally used in man.

Those reactions “ Serious Adverse Drug Reaction (SADR) – i.e. life threatening, causing hospitalisation, variable disabilities, and congenital anomalies. Although adverse drug reactions are documented during clinical trials, yet unexpected ADR’’s could be reported mainly during the post-marketing phase. Unexpected means events that were not previously observed and are not documented in the insert leaflet. On the other hand expected ADR’s are observed, documented during clinical trials and mentioned in the insert leaflet.

• Signal detection is report information (filled in a special format) on a possible relationship between an adverse event and a pharmaceutical product. It is the source for monitoring, detecting, and evaluating the ADR’s and focus and real safety and effectiveness of the drug once available in the market.

Reporting ADR;s could be done by: Heath Care Professional (HCP) are all persons with a relation to the health profession including physicians, pharmacists, the pharmaceutical companies by their QPPV (Qualified Persons for Pharmacovigilance), sales and marketing forces, and also by the Non-Heath Care Professional (NHCP) as the patients, and patients’ relatives.

Regulatory authorities depend on many sources of information for Drug Safety this include: Clinical trials, post-marketing data , spontaneous adverse reaction reporting (signals also know as Individual Case Reporting System ICRS), epidemiological studies, and databases of prescription.

The responsibility of the pharmaceutical companies Innovators and Generics is to collect any report for ADR’s mainly during the post-marketing phase. The concept of “ Post-Marketing Surveillance” is now as important as the clinical trial phases, even passes it.

The rational is that tests conducted on animals are insufficiently predictive of human safety; patients in clinical trials are accurately selected, limited in number and closely monitored, real use of the drug differ from those in clinical practice, duration of trials is always limited aiming for to a swift launch of the drug in the market, use in special groups such as children, the elderly or pregnant woman or drug interactions is often not available. [inlinead] Some risks are dependent on patients’ health status, kidney insufficiency (failing excretion of drugs and active metabolites), liver disease (failing drug metabolism), drug interactions, new born age (drug metabolising/enzyme systems are not fully developed), and allergies. Dosage adjustment and some special analysis are requested in these risky health status to get the maximum benefit for the a pharmaceutical product.

The pharmaceutical companies are requested according to the regulatory rules relevant to pharmacovigilance and/or ADR’s reported, to act accordingly to any reports concerning the safety of its products. Safety warnings as a “Dear Doctor Letter” dispatched thru emailing systems, labeling change/changes in the products’ insert leaflet, and finally in case of positive investigational studies proving the causal relationship between the reported ADR and the product withdrawal of the product should be done.

How pharmaceutical companies follow up the safety profile of their products in the post-marketing phase?

Periodic Safety Update Reports (PSURs) are very important pharmacovigilance documents. They provide an opportunity for the pharmaceutical companies to follow up and review the safety profile of their products at defined times, post-marketing, and ensure that the insert leaflets are up to date.

PSURs cover the following information: Dosage modification; changes in target population or indications; formulation changes; any urgent safety restrictions, restrictions on distribution; failure to obtain a marketing authorisation renewal, marketing authorisation withdrawal.

The PSURs are submitted according to certain organised schedule to ensure the regular follow up of the data presented. This schedule is: PSUR’s 6-monthly after launching the product in the market until two full years of marketing presence and usage, then yearly PSURs for the following two years; and thereafter at 3-yearly intervals. But they should be submitted immediately upon request from a Regulatory Authority.

From all the above, pharmacovigilance is considered a major tool to help in the improvement of the safety profile, ensure the effectiveness of different pharmaceutical products.

The aim should be always directed towards for the patients’ benefit, for a safe medicines and better health and life.

Egypt and North Africa

Thinking Patients’ Health, for a Safe Medicine

FIND CONTENT BY TYPE

Pharma IQ COMMUNITY

ADVERTISE WITH US

JOIN THE Pharma IQ COMMUNITY