DRUG RACEMI­SA­TION – COUN­TER­ING SE­RI­OUS­NESS OF ADRS

BioSpectrum (Asia) - - Bio Edit - Milind Kokje Chief Ed­i­tor milind.kokje@mmac­tiv.com

Med­i­cal drugs may not al­ways prove to be solution for re­cov­ery from health prob­lem(s). At times, in­stead of re­cov­ery they lead to fur­ther health prob­lems and com­pli­ca­tions in many cases. Ad­verse drug re­ac­tions (ADR) is one of the se­ri­ous is­sues in med­i­ca­tion that leaves se­ri­ous health im­pli­ca­tions, of­ten for longer pe­ri­ods, or even claims hu­man lives.

ADRs are caused by var­i­ous fac­tors like spu­ri­ous & im­pure drugs, pre­scrip­tion & con­sump­tion er­rors like wrong medicines and over­dose. But even stan­dard & good drugs pre­scribed & con­sumed with­out any er­rors can also cause ad­verse re­ac­tion.

Var­i­ous stud­ies, re­search pa­pers and ar­ti­cles have es­ti­mated the se­ri­ous­ness of ADRs. Stud­ies in UK and some other coun­tries re­ported that the preva­lence of hos­pi­tal ad­mis­sions caused by ADRs range from 2.3% to 21.2%. In Sin­ga­pore the preva­lence at ad­mis­sion in adults 12.4% and caus­ing ad­mis­sion was 8.1% ac­cord­ing to an ar­ti­cle pub­lished in Bri­tish Jour­nal of Clin­i­cal Phar­ma­col­ogy. In US there were nearly 4.6 mil­lion drug re­lated vis­its in 2009 and the cost to the so­ci­ety due to ADRs is $ 136 bil­lion per year. Ac­cord­ing to a re­search ar­ti­cle death by medicine, in US 106,000 lakh pa­tients died due to ADRs in 1997, while 2.2 mil­lion pa­tients US hos­pi­tals face ADRs.

Sig­nif­i­cantly, most of these fig­ures are re­lated to ADRs caused by good and stan­dard drugs which are pre­scribed and con­sumed with­out any er­rors. Al­though the drugs were of stan­dard qual­ity and their pre­scrip­tion and con­sump­tion was er­ror free, they still turned into harm­ful ver­sion and led to some health com­pli­ca­tion or even deaths. But Cardiff Univer­sity is now hav­ing a solution to this prob­lem.

Re­searchers at Cardiff Univer­sity, in col­lab­o­ra­tion with Liver­pool John Moores Univer­sity and As­traZeneca have de­vel­oped a new method to test the like­li­hood of a drug turn­ing into a po­ten­tially harm­ful ver­sion of it­self on en­ter­ing the body. This method as­sess the likely risk of drug un­der­go­ing racemi­sa­tion – a process in which a drug flips into a mir­ror im­age of it­self and be­comes po­ten­tially dan­ger­ous. The re­searchers sim­u­lated the chem­i­cal con­di­tions of the hu­man body and in­tro­duced a number of drugs to the sys­tem mon­i­tor­ing the rate of racemi­sa­tion of dif­fer­ent drugs. The re­searchers used these re­sults to gen­er­ate a math­e­mat­i­cal model to pre­dict rate of racemi­sa­tion and sub­se­quently how safe the drug is if ad­min­is­tered.

Risk as­sess­ment of dif­fer­ent drugs done in this way will help to man­u­fac­ture safer drugs that may not de­velop ADRs. More im­por­tantly, the early de­tec­tion of prob­lem in a drug in the drug de­vel­op­ment process will manufacturers to stop work­ing on the drugs that fail the test and in­stead fo­cus their ef­forts on other medicines that will pos­si­bly not have dan­gers of ADRs.

Al­most ev­ery drug has some type of risk as­so­ci­ated with it. If not com­pletely elim­i­nat­ing those risks, but at least to man­age and min­imise them to pro­tect the pa­tients is the most im­por­tant task of the pharma man­u­fac­turer. All the po­ten­tial risks thus man­aged and min­imised en­sure sup­ply of stan­dard and high qual­ity drugs to pa­tients.

One ob­vi­ous im­pact of the new find­ing, once it be­comes avail­able for com­mon use, will be al­most nil health prob­lems & com­pli­ca­tions caused by ADRs lead­ing to im­proved safety for pa­tients and thus re­duc­tion of fear among pa­tients about medicines and their ADRs. An­other most likely im­pact could be re­duc­tion in prices of new drugs as the new find­ing could lead to sig­nif­i­cant re­duc­tion in the fi­nan­cial risk in­volved in drug de­vel­op­ment by iden­ti­fy­ing the risky drugs early in the de­vel­op­ment process that will avoid wastage in de­vel­op­ment of the drug that would prove risky later in clin­i­cal tri­als. From both the points it may prove to be a sig­nif­i­cant find­ing in years to come.

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