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The Implementation of Pharmacovigilance in Nepal

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Phar­macy prac­tice in many emerg­ing coun­tries such as Nepal is still in the de­vel­op­ment phase. The ev­i­dence on phar­macy prac­tice tar­geted to can­cer pa­tients in Nepal is very lim­ited. There is lit­tle re­search on on­col­ogy phar­macy prac­tice af­ter Khanal et al. pub­lished an ar­ti­cle on­col­ogy phar­macy prac­tice in a teach­ing hos­pi­tal in Nepal in 2008.They high­lighted a sim­ple prag­matic model of phar­macy prac­tice or can­cer pa­tients. They high­lighted pro­vi­sion of drug in­for­ma­tion ser­vices, phar­ma­covig­i­lance, and phar­ma­cists’ par­tic­i­pa­tion in a clin­i­cal ward round with other health­care pro­fes­sion­als to study med­ica­tion-re­lated prob­lems as the ba­sic ac­tiv­i­ties which can be car­ried out in Nepalese con­text. Adding to this, Shrestha et al. ar­gues that’s there is the fi­nan­cial bur­den as­so­ci­ated with the man­age­ment of ad­verse drug re­ac­tions (ADRs( be­sides their im­pact on hu­man life.

With lim­ited hu­man and cap­i­tal re­sources, these ac­tiv­i­ties can­not be sus­tained; as such, a team of med­ical on­col­o­gists and phar­ma­cists at a Nepal Can­cer Hos­pi­tal, ini­ti­ated a can­cer hos­pi­tal-based re­gional phar­ma­covig­i­lance cen­ter, with those ac­tiv­i­ties de­scribed briefly herein. In the field of on­col­ogy and an­ti­neo­plas­tic agents, phar­ma­covig­i­lance stud­ies are im­por­tant, as it means a sig­nif­i­cant in­stru­ment to over­see drug safety. An­ti­neo­plas­tic agents usu­ally in­volves com­plex reg­i­mens. These an­ti­neo­plas­tic agents have high tox­i­c­ity and nar­row ther­a­peu­tic win­dows and there­fore ac­count the pa­tient much sus­cep­ti­bil­ity to ADRs.3 In on­col­ogy, ADRs are be­ing ac­knowl­edged as an un­avoid­able com­po­nent of treat­ment. ADRs are or­di­nary and ex­pectable.

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Con­se­quently, the idea of onco-phar­ma­covig­i­lance was de­vel­oped, which can be cat­e­go­rized as a sub­sys­tem of mon­i­tor­ing drugs which is de­rived from phar­ma­covig­i­lance to screen, as­sess, and man­age ADRs due to cy­to­toxic an­ti­neo­plas­tic drugs.

Phar­ma­cists spe­cial­ized in on­col­ogy over­see a wide va­ri­ety of func­tions of phar­ma­covig­i­lance, in­clud­ing mon­i­tor­ing, no­ti­fi­ca tion, pre­ven­tion, and man­age­ment of re­ac­tions as­so­ci­ated with chemother­apy which can be de­velop a bridge be­tween med­ical on­col­o­gists and pa­tients.6 Af­ter an es­tab­lish­ment of phar­ma­covig­i­lance in a can­cer hos­pi­tal of Nepal, few ADRs like nau­sea, vom­it­ing, di­ar­rhea, con­sti­pa­tion, skin rashes, px­ali­platin-in­duced neu­ro­pathic pain, mac­ula ery­the­ma­tous rash due to temo­zolo­mide,7 flu­o­rouracil-in­duced mu­cosi­tis, etc. are re­ported within a month, which was un­sat­is­fac­tory. The risk-ben­e­fit analy­sis was done in the man­age­ment of the ADRs by the team of clin­i­cal phar­ma­cists and med­ical on­col­o­gists. In some cases, there was a de­sen­si­ti­za­tion in the chemother­apy pro­to­col. Af­ter the iden­ti­fi­ca­tion of ADRs, ADR alert stick­ers are at­tached to the front page of a pa­tien­t’s med­ical file.

Set­ting up phar­ma­covig­i­lance is a com­plex process.

So, prac­tic­ing a mul­ti­dis­ci­pli­nary ap­proach is nec­es­sary, and one-on-one train­ing is be­ing pro­vided to nurses and phar­ma­cists. Fi­nan­cial sup­port is re­quired to fuel a phar­ma­covig­i­lance cen­ter in any or­ga­ni­za­tion, and it should have an of­fi­cially ap­proved guar­an­teed source, which is im­mune to po­lit­i­cal gov­er­nance and eco­nomic fluc­tu­a­tions, to di­rect a steady flow of funds so that the progress of work on phar­ma­covig­i­lance is not hin­dered. In Nepal, the prac­ti­cal­ity of prac­tice of na­tional phar­ma­covig­i­lance de­pends es­pe­cially on the dy­namic in­ter­est of health pro­fes­sion­als. More data on chemother­apy-in­duced ADRs will be use­ful for mak­ing a na­tional data­base. Dif­fer­ent ac­tiv­i­ties and en­deav­ors are be­ing pre­pared for sup­port­ing med­ical on­col­o­gists, doc­tors, nurses, phar­ma­cists and other health pro­fes­sion­als to re­port every an­tag­o­nis­tic re­sponse, in­clud­ing sus­pected ones, keep­ing in mind the end goal to en­hance the uti­liza­tion of med­ica­tions. Our ten­ta­tive plans are to ad­vance the idea of phar­ma­cov­ili­gance, de­tail­ing and re­port­ing of ADRs and to lead widescale train­ing in onco-phar­ma­covig­i­lance.

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