End the con­fus­ing rain­bow of pills

Baltimore Sun - - COMMENTARY - By Ali Thaver Dr. Ali Thaver is an in­ter­nal medicine res­i­dent at Johns Hop­kins Bayview Med­i­cal Cen­ter; his email is athaver1@jhmi.edu.

Apa­tient of mine was re­cently hos­pi­tal­ized for high blood pres­sure af­ter miss­ing his med­i­ca­tions. I saw him in clinic a week later to dis­cuss a work­able plan. He ex­plained to me how he avoided his cur­rent “white” blood pres­sure pill and would pre­fer us­ing the “red” cir­cu­lar one in­stead. Talk­ing to him helped me re­al­ize how he as­so­ci­ated the shapes and colors of his pills with spe­cific dis­eases — and how the con­sis­tency of their ap­pear­ance was linked to his ad­her­ence.

While I love to take care of my oc­to­ge­nar­ian pa­tients, I am con­stantly wor­ried about their med­i­ca­tions and, like other physi­cians, spend a con­sid­er­able amount of time mak­ing sure my pa­tients ar­range pills in a des­ig­nated box and have an easy sched­ule to fol­low. How­ever, when pa­tients are given a generic ver­sion of the same med­i­ca­tion they’re used to tak­ing, they some­times choose to avoid it be­cause it looks un­fa­mil­iar. This un­for­tu­nately leads to hos­pi­tal ad­mis­sions, which, in ad­di­tion to in­creas­ing health care costs, sig­nif­i­cantly af­fect their qual­ity of life.

A link be­tween change in med­i­ca­tion di­men­sions and pa­tient com­pli­ance and clin­i­cal out­comes has been noted in re­la­tion to heart dis­ease and seizures. Yet it’s re­mained an is­sue be­cause of a le­gal re­stric­tion known as “trade dress.” Trade dress means that a med­i­ca­tion can­not be repli­cated in as­pects that are iden­ti­fied by con­sumers to be linked to the orig­i­nal med­i­ca­tion. There­fore a branded med­i­ca­tion and its generic ver­sion look dis­tinct by de­sign; this prin­ci­ple ex­tends to the shape, size and color of med­i­ca­tions as well, as com­pa­nies in­sist that color is a func­tional as­pect of the orig­i­nal prod­uct.

The United States Supreme Court has held that color can be pro­pri­etary if it’s as­so­ci­ated with a par­tic­u­lar brand — Vi­a­gra’s lit­tle blue pill, for ex­am­ple. But in clin­i­cal prac­tice, my pa­tients of­ten as­so­ciate the color of their med­i­ca­tions with their spe­cific dis­eases, not the med­i­ca­tion’s brand. There­fore the state­ment made by phar­ma­ceu­ti­cal com­pa­nies does not ap­pear to hold true, but the FDA hasn’t in­ter­vened, largely be­cause not enough mo­men­tum has been gen­er­ated to high­light this as a dire pa­tient safety con­cern.

Most of health care is con­sumed by pa­tients in the lat­ter end of the age spec­trum, and many of their hos­pi­tal ad­mis­sions have to do with their med­i­ca­tions — side ef­fects or non-ad­her­ence to dosage di­rec­tions. El­derly pa­tients of­ten rely on con­sis­tency and rep­e­ti­tion in their sched­ules due to mem­ory loss and de­men­tia. If the colors of med­i­ca­tions keep shift­ing con­tin­u­ously, they may not be able to keep up with th­ese changes. This leaves them at high risk to fre­quently visit clin­ics and emer­gency rooms.

A multi-pronged ap­proach will be re­quired to rem­edy the sit­u­a­tion. Be­hav­ioral change through pa­tient ed­u­ca­tion should be the first step that physi­cians take. Strength­en­ing so­cial sup­port for our pa­tients is the sec­ond step, but will vary from per­son to per­son de­pend­ing upon their avail­able net­work. The most im­por­tant step, how­ever, is lob­by­ing for a mi­nor change in the ter­mi­nol­ogy of what trade dress en­tails to al­low generic med­i­ca­tions to look like those they copy.

High­light­ing pa­tient safety is the key to cre­ate this pol­icy change. I can­not imag­ine how chal­leng­ing it must be for my pa­tient, who is suf­fer­ing from de­men­tia and heart dis­ease, to feel lost and con­fused ev­ery day in a rain­bow of pills. I worry that he may re­turn to the hos­pi­tal if he does not take the right med­i­ca­tion.

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