CURRENT STATUS OF SAFE PHARMACEUTICAL PRACTICE IN NEPAL.

Medicine safety is one of ever debating agenda universally since history of medicine itself . In Nepal large number of population is directly under any kind of medication or medicinal product currently. strengthening of healthcare system has taken rapid progress all over the country, specifically since last ten years. in order to achieve ambitious goal of safe pharmacological practice, proper understanding of relevant subject matters is of upmost importance.

Pharmacovigilance is the branch of science that deals with detection, assessment understanding and prevention of adverse effect with pharmaceutical products. This system deals with all medications which are given as treatment, diagnosis or prophylaxis of disease and any kind of medicine safey regardless of  rational or irrational use. 

What is signal detection in pharmacovigilance;

• Signal simply means information about relationship between use of drugs and adverse event after its use. In order to be a signal any reported information should go through validation by subject matter expert based upon other relevant data and scientific analysis. 
• Individual case safety reports (ICSR) are reported through medical practitioners as spontaneous reporting system. it should be valid where detail information about patient, suspected medicinal product, suspected event and reporter should be mentioned. 
• Interpretation of future health impact, reporting to  Uppsala monitoring center (UMC) WHO. here further analysis happens and final report is acknowledged to national centers for implementation of action. for this whole activitirs UMC uses a database called "vigibase" and all member country follows is sub-part "vigiflow". 

The global pharmacovigilance system:

World heath organization has a common goal of safe use of medicine globally. for that purpose,  worldwide PV networks is expanding and currently   more than 150 countries has been actively participation and working toward it. 

• Till date, 134 countries are member of international drug monitoring and 30 associates member countries are in early stages of establishing their PV system , preparing themselves for full membership
• All member countries share a common vision of safe and more effective use of medicines, working nationally and collaborating internationally.
• Nepal is full member since 2006, responsibilities taken by Department of Drug Administration

Current status of PV  in Nepal:

• Department of drug administration (DDA) is working as national authority of pharmaceutical regulations and reporting center  of  pharmacovigilance, under which immediate directions 12 different Regional PV centers are working, Only three of them are out of Kathmandu valley.
• US$ 137 is the per capita expenditure of each Nepalese in health sector, mainly for pharmaceutical product consumption either conventional or alternative
•  According to fiscal year 2018-19 budgeting, 4.13% of total bujget is allocated for health care system, which is third highest in ranking  after education and energy. but still, percentage is lesser than previous allotment. 
• currently 23,108 of registered health practitioners are working (among them 15.671 are doctors only), for prescribing medications including all level level
• according to DDA official website, only 547 adverse reactions are reported so far. 

This data shows a major pitfall of safety concern in practitioner as well as consumer. neither number of regional centers are enough, nor total reported cases. Such condition is refereed as Underreporting in pharmacovilange (PV) science. Quality of reports will be part of another discussion. 

Postive changes for PV system in Nepal

• Release of  Reporting form by DDA: since 2018, adverse event reporting form has been released, it certainly brings quality of data provided and increase easy excess  for reporting
• Expanding number of regional centers: recently two more centers were added. 
• Increasing discourse of safe medicinal practice and consumer consciousness, 

Recommendations to strengthen the PV system in Nepal

1. Incorporation into clinical practice: Every health practitioner should make aware of spontaneous reporting system about what to report, how to report, where to report. adequate  information at academic level and through training should be provided. 
2. Expanding of reporting centers: only 12 regional centers are not enough more centers should be expanded   in each provinces and local level.
3. Consumer education : use of prescription medication, rational use of pharmaceutical products and alertness about reporting system can help to combat underreporting.
4. Design and follow proper SOP (standard operating procedure)
5. Independent pharmacovigilance unit with adequate subject matter experts eg: pharmacist, doctors, researchers, IT experts etc.
6. National guideline for Pv management should be generated from DDA to make harmonization in practice
7. National leveled program by government of Nepal only can make large difference.  For example: India was working in pharmacovigilance since 1997, but result was very unsatisfactory. Since 2004 they initiated PvPI (pharmacovigilance program of India) along with suspected adverse event reporting form and national guideline on  PV management. this program became very effective took a huge leap

                                                                                                                               Thank you !!!