What is Pharmacovigilance?
Pharmacovigilance and drug safety were developed to prevent another Thalidomide disaster. The present day approach to drug safety and adverse event reporting started with the Thalidomide disaster. This drug was prescribed in many countries around the world, but never in the US, to alleviate morning sickness in pregnant women. Thalidomide is a teratogen and caused horrific birth abnormalities. However these were not reported as adverse events since no such system existed at the time, and so it took a few years before people realized what was happening.
This led to the introduction of adverse event reporting and the creation of Pharmacovigilance training.
Thalidomide was sold and prescribed during the late 1950s and early 1960s to pregnant women, as an antiemetic to combat morning sickness and as an aid to help them sleep.
Inadequate tests were performed to assess the drug's safety, with catastrophic results for the children of women who had taken thalidomide during their pregnancies.
In 1962, the US enacted laws requiring tests for safety during pregnancy before a drug can receive approval for sale. Other countries enacted similar legislation, and thalidomide was not prescribed or sold for decades.
Thalidomide has since been approved for marketing for several indications including leprosy and certain cancers. It has a very restrictive risk management program which must be followed in order to obtain the drug. Patients must show proof of two methods of contraception and demonstrate an understanding of the risks of pregnancy.
1960 to around 2000: Adverse event reporting required that companies collect, assess and report adverse events (Pharmacovigilance – Pv).
- 1962: Thalidomide.
- 1968: World Health Organization Pilot Project (The WHO started to pool adverse drug reactions from multiple countries).
- 1999: Revised MedWatch 3500A, draft MedDRA.
MedWatch is the form used by companies to report adverse events to FDA. MedDRA - the Medical Dictionary for Regulatory Activities - is a medical terminology used to classify adverse event information associated with the use of biopharmaceuticals and other medical products.
- 1999: Institute of Medicine (IoM) – report on errors and risk issues.
Around the start of the 21st century, there were several high profile drug withdrawals due to safety reasons, and the IoM issued its report on errors and risk issues. This was a groundbreaking report analyzing the impact of medication errors and the risks to patients due to side effects from drugs. This report was a major factor that lead to the introduction of “Risk Management”. Prior to 2000, it was the job of regulators to assess the risks due to drugs, based on adverse event reports received. Following the IoM report, regulators started to ask drug companies to get involved in risk assessment and risk mitigation.
- 2001: Post-marketing Safety Reporting Guidelines (Guidance from FDA on how to report adverse events)
- 2002: PDUFA III
The multiple Prescription Drug User Fees Acts allowed FDA to charge companies for the drug approval process. This third act allowed FDA to use some of the money to monitor risks for up to two years post-approval. It required companies to prepare a “risk management plan” to address this two-year period, if their drug had significant risks associated
- 2003: The “Tome”
Nicknamed because of its length: 94 pages of proposed rule on adverse event reporting. The pre-marketing section was finalized in 2010. Most of the rule has not yet been finalized.
- 2004: Draft Risk Management Guidances
- 2005: Final Risk Management Guidances
The FDA risk management guidances, finalized in 2005, specified how to perform signal detection, risk assessment and risk mitigation.
- 2007: FDA Amendment Act
- 2010: New IND Reporting Rule
- 2010: European Pharmacovigilance Legislation passed
If you are involved in any aspect of pharmacovigilance, our four course modules will help you comply with European & US law. The modules are perfect for you if you are involved in drug safety, pharmacovigilance, regulatory and quality compliance.
To date we have trained over 21,000 students across 40 plus countries.
Discounts are available for multiple purchases and there is a comprehensive control panel service that enables company training managers to monitor and control groups of students.
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