Pharmacovigilance PDF

MIND NURTURE KRISHNA Page 1 of 6 PHARMACOVIGILANCE Pharmacovigilance, also known as drug safety pharmakon (greek) = medicinal substance vigilia (latin) = to keep watch ❖ Definition The...

MIND NURTURE KRISHNA Page 1 of 6 PHARMACOVIGILANCE Pharmacovigilance, also known as drug safety pharmakon (greek) = medicinal substance vigilia (latin) = to keep watch ❖ Definition The science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other drug related problem ❖ Aim To improve patient care and safety in relation to the use of medicines, and all medical and paramedical interventions To improve public health and safety in relation to the use of medicines To contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use To promote understanding, education and clinical training in pharmacovigilance and its effective communication to health professionals and the public. To promote rational and safe use of medicines. ❖ Goals The ultimate goals of pharmacovigilance are: The rational and safe use of medical drugs. The assessment and communication of the risks and benefits of drugs on the market. Educating and informing of patients. ❖ Why do we need pharmacovigilance ? 1. Humanitarian concern -animal toxicology is often not a good predictor for human effects. -evidence of safety from clinical trials is insufficient due to some limitations limitations (phase 1-3): limited size , narrow population (age &sex specific), narrow indications (only specific disease), Short duration 2. Safe use of medicines Medicines are supposed to save lives. Dying from a disease is sometimes unavoidable; dying from a medicine is unacceptable. It has been find that ADRs may cause 5700 deaths per year in UK. ADRs were 4th-6th commonest cause of death in the US in 1994. 3. ADRs are expensive 6.5% of admissions are due to ADR Cost £446 million per annum in US 4. promoting rational use of medicines 5. ensuring public confidence 6. to protect patients from unnecessary harm 7. ethical concern -to know of something that is harmful to another person who does not know, and not telling, is unethical.  MIND NURTURE KRISHNA Page 2 of 6 ❖ Adverse drug reactions Adverse Event (AE): Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment. Adverse Drug Reaction (ADR): Any noxious change which is suspected to be due to a drug, occurs at doses normally used in man, requires treatment or decrease in dose or indicates caution in future use of the same drug. Serious adverse event-An adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect. Thus all ADR are adverse events but all adverse events are not ADR. ❖ Classification of ADR i) Type A : ‘augmented’: on-target (too much of a good thing) - predictable. ii) Type B : ‘bizzare’: idiosyncratic, vary from patient to patient - unpredictable. iii) Type C : ‘continuous’: adverse effects which arise from long- term use of a drug. they may be perfectly safe and effective in the short term, but can become un favourable with chronic use. iv) Type D : ‘delayed’: adverse drug effects long after the drug is gone. ❖ Scope of Pharmacovigilance Adverse drug reaction Medication error In herbal medicine Counterfeit medicine Abuse and misuse of medicine Lack of efficacy Interaction of medication Blood banks Immunization and vaccination ❖ Overview of Pharmacovigilance 1. History of Pharmacovigilance Major Historical Events Led to Pharmacovigilance: In 1922, there was an enquiry into the jaundice associated with the use of Salvarsan, an organic arsenical used in the treatment of syphillis. Thalidomide Tragedy: Thalidomide was a widely used drug in the late 1950s and early 1960s for the treatment of nausea in pregnant women. It became apparent in the 1960s that thalidomide treatment resulted in severe birth defects in thousands of children Sulfanilamide Tragedy: Elixir sulfanilamide(using diethylene glycol (DEG) as the solvent or excipient) was an improperly prepared sulfonamide antibiotic that caused mass poisoning in the United States in 1937. It is believed to have killed more than 100 people. The public outcry caused by this incident and other similar disasters led to the passing of the 1938 Federal Food, Drug, and Cosmetic Act, which significantly increased the Food and Drug Administration's powers to regulate drugs  MIND NURTURE KRISHNA Page 3 of 6 Drugs that have been with drawn or restricted because of ADR Origin of Pharmacovigilance: Pharmacovigilance started about 170 years ago, although it was not yet named as such at that time. It is a structured activity in the professional health field, with aimed at monitoring the risk/benefit ratio of drugs, improving patient’s safety and quality of life. Early 20th century there were no controls over the drug development process. And its claims over-treating diseases and uncontrolled marketing. Safety, or effectiveness of the drug were NOT a concern for the government. In 1883 Dr. Harvey Wiley initiated the campaign for the Federal law for Food and Drugs Act that was finally passed in 1906, and it established that drugs must be pure and free of any contamination. The safety of the patients and the safe use of medicines are high priorities in the modern world. The first practical international cooperation in drug monitoring started in 1968; the law was further tightened following incidents such as the poisoning of children by “Sulphanilamide” and the “Thalidomide” tragedy. In 1938 Federal Food, Drug, and Cosmetic Act was implemented. After the sulfanilamide tragedy in 1937, the Federal Food, Drug, and Cosmetic Act were established in 1938; its aim was to renovate the public health system. The tragedy of Thalidomide that happened in 1961 has brought to light many problems and critical issues, in particular, the reliability of animal tests, the behavior of the industrial company, and the importance of monitoring the drugs after their marketing. In particular, this tragedy changed the system of Pharmacovigilance, because the spontaneous reporting of adverse drug reactions became systematic, organized, and regulated. Pharmacovigilance in current status: WHO drug monitoring was laid in 1971 during the 20th world health assembly, established national pharmacovigilance center with WHO collaboration. WHO collaboration center for international drug monitoring is Uppsala in Sweden, its supports and co-ordinates the WHO international drug monitoring program 2. Pharmacovigilance in India Pharmacovigilance in India was initiated in 1986 with a formal adverse drug reaction (ADR) monitoring system, under supervision of the drug controller of India. India joined the World Health Organization (WHO) Programme for International Drug Monitoring controlled by Uppsala Monitoring centre(UMC), Sweden in 1997 but was not successful. Later, the National Programme of Pharmacovigilance was launched in 2005, and was renamed as the Pharmacovigilance Programme of India (PvPI) in 2010. The Central Drugs Standard Control Organisation (CDSCO) initiated a nation-wide pharmacovigilance programme under the Ministry Of Health & Family Welfare in 2010 with AIIMS as National Coordinating Centre (NCC) for monitoring ADRs  MIND NURTURE KRISHNA Page 4 of 6 The Programme transferred to IPC as NCC in April, 2011 by a Notification issued by the MoHFW, Govt. of India. IPC-PvPI became the NCC for Materiovigilance(monitoring the safety and ensuring quality of medical devices used in the country.) Programme of India (MvPI) from July, 2015 IPC, NCC-PvPI became a WHO Collaborating Centre for Pharmacovigilance in Public Health Programmes & Regulatory services from July, 2017 The PvPI works to safeguard the health of the Indian population by ensuring that the benefit of medicines outweighs the risks associated with their use. The culture of reporting of ADRs has achieved remarkable success, with 250 PvPI-established adverse drug monitoring centres all over India and provision of training to healthcare professionals. Adverse drug Reactions are reported from all over the country to NCC-PvPI It work in collaboration with the global ADR monitoring centre (WHO-UMC), Sweden to contribute in the global ADRs data base NCC-PvPI monitors the ADRs among Indian population and helps the regulatory authority of India (CDSCO) in taking decision for safe use of medicines Goals of Pharmacovigilance program in India (PvPI) i) Short term goal Develop and implement pharmacovigilance system in India Encourage health care professionals in reporting of adverse reaction to drugs, vaccines and medical devices. Collection of adverse reaction report ii) Long term goal Expand the PvPI to all hospitals across India To develop and implement e-reporting system To make ADR reporting mandatory for health care professionals Development of Pharmacovigilance in India 3. Process of pharmacovigilance 1. Patient reports single adverse event caused by any drug on any form, adverse event form, facebook, twitter any social media, through pharma company helplines, health authorities programs etc. 2. He himself (patient) as above, or if patient reports to their pharmacist, doctor or HCP (healthcare professional) etc then they report it to manufacturer of that drug or to health authorities directly. 3. Manufacturer PV team look into triaging it, valid, invalid, serious/non serious, related/not related, expected/unexpected and enter this in their own database (controlled online environment software)  MIND NURTURE KRISHNA Page 5 of 6 4. Manufacturer reports to Health authorities, health authorities do their regulatory part. n addition per timelines to look into other similar or non similar adverse event of that drug to intimate manufacturer to change safety profile of drug and to inform in return to user and healthcare professionals about this new adverse event on their drugs box label or warning section or package inserts or any form of communication as planned and decided. 5. Simultaneously manufacturer prepares different regulatory document by combining all such single reports from all parts of word such as PBRER (Periodic benefit risk evaluation report) ASR(Annual safety report) etc. This are aggregate reports which are giving information in single document about all the adverse events that happened during the use of drug, any risks etc. Also the Manufacturer does signal detection from all this pulled adverse reports from all over world to find any potential risks the drug can be causing. 6. Any risk or events that are thought to be caused by drug are then put on labelling of that drug and communicated to public and healthcare professionals, if the adverse events are serious enough they are put in type of box warnings and communicated to physicians and healthcare professionals via communication letters as explained above. Phase-1- At first, information about adverse event collected from different sources. Below are types of reports i) Spontaneous / Voluntary report ii) Clinical trials and post marketing studies iii) Regulatory reports iv) License partner report v) Literature reports vi) Legal reports Phase-2 – Once we collect adverse events, drug safety team asses information in multiple steps i) Case validity assessment ii) Database entry iii) Event selection and coding with MedDRA iv) Product coding v) Labelling assessment vi) Writing narratives vii) Medical input  MIND NURTURE KRISHNA Page 6 of 6 Phase-3- Once the information assessed team understand why this events happened, will take necessary steps to prevent further i) Periodic report compilation ii) Signal analysis iii) Risk benefit assessment Note : Mind nurture App is available at play store now. 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