Pharmacovigilacne Net Work – PhV Net
- Background
- About PhV Net
- Training
Background
According to Article 2 of its constitution, the World Health Organization has a mandate from its Member States regarding Pharmaceutical; Biological, Herbal and Food products:
“To develop, establish, and promote international standards with respect to food, biological, pharmaceutical and similar products”
There is also provision made in Article 21 of the constitution of the World Health Assembly to adopt regulations concerning:
“Standards with respect to the safety, purity and potency of biological, pharmaceutical and similar products moving in international commerce”
Unfortunately according to the Uppsala Monitoring Centre (Austria) which is the WHO Collaborating Center supporting the WHO Medicines Safety Program; currently there is no active National Pharmacovigilance Centre in Pakistan.
Hence there is a serious communication gap of adverse drug reactions reporting; data collection and analysis between patients; health care professionals and manufacturers as well as regulatory authorities.
In recent past we have seen increasing incidence of large number of deaths due to this communication gap and unavailability of on time data to prevent a catastrophe during its initial phase. More than 250 people’s lives could be saved in last few months if we have an operational PhV Network in Pakistan.
According to the interim results of an ongoing first of its kind “Pakistan Pharmacovigilance Awareness Survey 2012” being conducted by Dimension Research among the common population, health care professionals and academia the knowledge of adverse drug reactions (commonly known as Side Effects) is quite low and even in the medical doctors and pharmacist. In addition to this if people are; unaware of where and how to report these drug reactions to sponsor and regulatory bodies. However encouraging thing is this that surveyed people like to get training and information on this and are willing to report if there is such system available. The complete PhV Awareness Survey 2012 results will be shared on its completion.
Considering its national as well as global responsibility Dimension Research which is Pakistan leading multinational Clinical Research Organization and Site Management Organization has took the initiative to address this burning issue which is affecting millions of Pakistani’s on daily basis. This un-availability of a PhV Net is resulting in:
- preventable deaths and other medical condition
- non-compliance of most of the foreign countries drug regulatory authorities pre and post registration requirements.; hence limiting the exports
- generation of epidemiological data
About PhV Net
PhV Net is the name given to the Pharmacovigilance System developed by Dimension Research. This is first of its kind voluntary initiatives taken by a private organization to address the need of Pharmacovigilance System for their country.
A dedicated site has been developed with an international standard Electronic Adverse Drug Reaction Reporting Form. The reporter of the adverse drug reactions or a person come to know about a drug reaction has three choices to enter the data:
- Register him/herself by filling a simple form and then submit the report
- His/Her Medical care provider could register and report for their patient
- Patient; Health care provider or a person who come to know about an adverse drug reaction could call Dimension research Pharmacovigilance Team and ask them to report on their behalf. However in this case they will be registered first as reporter
- In addition to above the employees of the PhV Net currently based in major cities of Pakistan i.e., Karachi, Lahore (covering Islamabad and Rawalpindi) and Multan also visit their doctors net-work on regular basis to gather any adverse drug reactions and report it in the PhV Net data base.
The reporter could also download the Adverse Drug Reaction Form and mail to PhV Net personnel by courier or through e-mail after scanning the form or could give to any visiting PhV Net employee.
Once the data is received in the data base; trained PhV Net personnel will review the details and contact the reporter for any missing details or clarification before reporting to the manufacturer of that (Pharmaceutical, Biological, Vaccine, Medical Device, Contrast media, Herbal or Food) product.
On time to time basis PHV Net team will generate reports by analyzing the data received in their network and share with relevant audience including Regulatory Authorities and over net for public awareness. This will also help in generating much needed epidemiological data required to develop health policies.
Training
It has been identified that there is a severe deficiency of knowledge relevant to Pharmacovigilacne / Drug Side effects among all walk of life in Pakistan. Hence PhV Net team of Dimension Research in collaboration with Academic Institutes; Universities; Hospitals; Pharmaceutical companies; regulatory bodies and other NGOs will be organizing on an ongoing basis training programs and certification of the participants on voluntary basis
The PhV Net team will also assist the Medical Universities; Hospitals and Private clinics to become “Pharmacovigilant Complaint Institutes/Clinics” , hence provide assurance to their patients international drug safety reporting and management standards.
These PhV Net Trainings will be announced on regular basis on the PhV Net web site, send to all the registered PhV Net reporters and to spread the word.
