Importance of drug safety to patients
 |
Report suspected side effects to medicines, vaccines, e-cigarettes, medical device incidents, defective or falsified (fake) products to the Medicines and Healthcare products Regulatory Agency. |
World Patient Safety Day
"Medication Safety" has been selected as the theme for World Patient Safety Day, 17 September 2022. The campaign is envisaged to provide the needed impetus to consolidate the efforts of the existing WHO Global Patient Safety Challenge: Medication Without Harm, emphasizing the need to adopt a systems approach and promote safe medication practices to prevent medication errors and reduce medication-related harm. Special consideration will be given to areas where most harm occurs. The key action areas are high-risk situations, transitions of care, and polypharmacy.
Find out more about the WHO global campaignWhy everyday, patient safety is important
Pharmacovigilance serves an important function in the development of a drug. It aims to “enhance patient care and patient safety in relation to the use of medicines; and to support public health programs by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines”.
Timeline
Pharmacovigilance started about 170 years ago, although it was not yet named as such at that time. It is structured activity in the professional health field, with important social and commercial implications aimed at monitoring the risk/benefit ratio of drugs, improving patient’s safety and the quality of life.
It occurs after clinical trials have been completed and a drug has been released to the general population. The aim of pharmacovigilance is to carefully monitor and report any possible adverse drug reactions (ADR) that had not previously been detected.
All these events brought to light many problems and critical issues, in particular, the reliability of animal tests, the behaviour of the industrial company, and the importance of monitoring the drugs after their marketing. In particular, the system of Pharmacovigilance of the spontaneous reporting of adverse drug reactions became systematic, organized, and regulated.
In 1968, the WHO Programme for International Drug Monitoring, was instituted and ten members participated in this program (Australia, UK, USA, Germany, Canada, Ireland, Sweden, Denmark, New Zealand, and Netherlands).
International Council for Harmonisation (ICH)
Another body relevant to mention is the International Council for Harmonisation (ICH), https://www.ich.org/, formed in 1990 and ICH works on harmonizing the requirements for the development and registration of pharmaceuticals globally via a process of scientific consensus with regulatory and industry experts working side by side.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) rejoined ICH as a fully active member and UK will have a say in the guidelines the council develops to help ensure the quality, safety and efficacy of medicines worldwide.
The ICH now has a total of 20 members, which include, among others, regulators from Brazil, China, the EU, Japan and the US, and industry associations.
In 1995, the European Medicines Agency (EMA) was set up.
In 2001, EudraVigilance was funded.
A major change in European Pharmacovigilance was observed with the new legislation (Directive 2010/84/EU), in 2012 to support its implementation, a set of guidelines for the conduct of pharmacovigilance in the EU has been developed. These are the Good Pharmacovigilance Practices (GVP) as known today.
Yellow Card Scheme
In 1964, the “Yellow card” Scheme (YCS) was structured in the UK as part of a newly introduced system that monitored the safety of medicines by a body independent of the pharmaceutical industry. Today, it is run by the Medicines and Healthcare products Regulatory Agency (MHRA). The YCS was set up to collect, collate and investigate reports of suspected adverse drug reactions.
The YCS allows the MHRA to monitor the safety of all medicines and medical devices continuously over the entire product life. Through input from pharmacists, other healthcare professionals (HCPs) and the public, the YCS acts as an early warning system for the identification of previously unrecognised or suspected adverse drug reactions (ADRs) and enables the identification and refinement of risk factors that may affect the clinical management of patients. Since its inception, Yellow Card reporting has helped to identify numerous important safety issues.
Indicative timelines for medicines and vaccines
Before a medicine or vaccine is authorised for use, evidence of its safety and efficacy is limited to the results from clinical trials, where patients are selected carefully and followed up very closely under controlled conditions.
This means that at the time of authorisation, they have been tested in a relatively small number of selected patients for a limited length of time.
After authorisation the medicine or vaccine may be used in a large number of patients, for a long period of time and with other medicines. Certain side effects may emerge in such circumstances.
The cycle of pharmacovigilance
It is therefore essential that the safety of all medicines is monitored throughout their use in healthcare practice by:
- Reporting any adverse events to your healthcare professional, Pharma Industry or MHRA (via Yellow Card Scheme).
- This information will be analysed, reviewed and assessed so a decision regarding safety of patients can be taken.
- This information is communicated to Healthcare Professionals/ Patients via Patient Information Leaflet update, Summary Product Characteristics update or sometimes via ‘Dear Healthcare Professional Letter’ or Health Programs.
- Lastly actions are monitored and more adverse events information is collected after new information available starting the safety cycle again.
Important websites for information regarding products marketed in the UK
BNF
The BNF is a joint publication of the British Medical Association and the Royal Pharmaceutical Society, which aims to provide prescribers, pharmacists, and other healthcare professionals with sound up-to-date information about the use of medicines.
https://www.bnf.org/products/bnf-online/
EMC
The electronic medicines compendium (emc) contains up to date, easily accessible information about medicines licensed for use in the UK
emc was launched in 1999 and has become an established website, trusted for reliable information about medicines. All the information on emc comes directly from pharmaceutical companies or via the medicines regulator (MHRA or EMA) and it is public information available to any Healthcare professionals, to patients and carers and general public with no need to register.
emc contains regulated and approved information on medicines available in the UK, for example:
- Summaries of Product Characteristics (known as SPCs or SmPCs)
- Patient Information Leaflets (known as PILs, Package Leaflets or PLs)
- Risk Minimisation Materials (RMMs)
- Letters to healthcare professionals
emc UK - https://www.medicines.org.uk/emc#gref
emc Northern Ireland - https://www.medicines.org.uk/emc#gref
Last modified: 20 September 2023
Last reviewed: 20 September 2023