Database tech takes aim at the opi­oid cri­sis

Pre­scrip­tion drug mon­i­tor­ing pro­grams try to aid doc­tors, but the jury’s out on their ef­fec­tive­ness.

Health Data Management - - ACOS - By Greg Sla­bod­kin

As the health­care in­dus­try con­tin­ues to look for so­lu­tions to the opi­oid epi­demic, the tools providers are in­creas­ingly lev­er­ag­ing are state-run pre­scrip­tion drug mon­i­tor­ing pro­grams—elec­tronic data­bases meant to track con­trolled sub­stance pre­scrip­tions by flag­ging sus­pi­cious pa­tient pre­scrib­ing ac­tiv­i­ties.

The good news, ac­cord­ing to pro­po­nents, is that physi­cian use of PDMPs is dra­mat­i­cally grow­ing while doc­tors have de­creased opi­oid pre­scrib­ing na­tion­wide.

The bad news, also ac­cord­ing to sup­port­ers of the tech­nol­ogy, is that these data­bases need to be bet­ter in­te­grated into clin­i­cal work­flows and to pro­vide more com­pre­hen­sive, up-to-date data at the point of care.

The Amer­i­can Med­i­cal As­so­ci­a­tion’s Opi­oid Task Force 2018 Progress Re­port notes that the num­ber of opi­oid pre­scrip­tions de­creased by more than 55 mil­lion—a 22.2 per­cent de­crease na­tion­ally—be­tween 2013 and 2017, with a 9 per­cent de­crease—more than 19 mil­lion fewer pre­scrip­tions—be­tween 2016 and 2017. In fact, all 50 states have seen a de­crease in opi­oid pre­scrip­tions over the past five years, re­ports the AMA.

Last year, clin­i­cians across the coun­try queried PDMPs more than 300.4 mil­lion times—a 121 per­cent in­crease from 2016 and a 389 per­cent in­crease from 2014, ac­cord­ing to AMA. Fur­ther, both states with and with­out man­dates to use PDMPs saw large in­creases, re­ported the physi­cian group.

“To­day, more than 1.5 mil­lion physi­cians and other health­care pro­fes­sion­als are reg­is­tered in state-based

PDMPs—be­tween 2016 and 2017, more than 241,000 in­di­vid­u­als reg­is­tered,” ac­cord­ing to the AMA. “As PDMPs im­prove, Amer­ica’s physi­cians and health­care pro­fes­sion­als are us­ing state PDMPs more than ever.”

For its part, the Cen­ters for Medi­care and Med­ic­aid Ser­vices has been en­cour­ag­ing states to in­te­grate PDMP data into elec­tronic health record sys­tems to min­i­mize provider bur­den and im­prove in­ter­state health in­for­ma­tion ex­change.

“This in­te­gra­tion re­moves the re­quire­ment for providers to log in to a sep­a­rate sys­tem, man­age a sep­a­rate log in and dis­rupt their work­flow to query the PDMP,” wrote Tim Hill, act­ing direc­tor for the Cen­ter for Med­ic­aid and CHIP Ser­vices, in a let­ter this sum­mer to state Med­ic­aid di­rec­tors. “Sin­gle sign-on in­ter­op­er­abil­ity be­tween EHR and PDMP—such that PDMP re­sults are dis­played when the EHR in­di­cates a con­trolled sub­stance is pre­scribed—could be sup­ported, as an ex­am­ple.”

In ad­di­tion, the CMS guid­ance rec­om­mends that states con­sider in­te­grat­ing PDMPs into health in­for­ma­tion ex­changes, “where fur­ther in­te­gra­tion with phar­macy data, shared care plans, drug uti­liza­tion re­view (DUR) pro­grams, Emer­gency Med­i­cal Ser­vices (EMS) data, Med­i­ca­tion As­sisted Ther­apy (MAT) data, ad­vanced di­rec­tives and other EHR data might as­sist clin­i­cal de­ci­sion mak­ing.”

Need for alert sys­tem

How­ever, ac­cord­ing to Joel White, ex­ec­u­tive direc­tor of Health IT Now’s Opi­oid Safety Al­liance, what’s miss­ing from PDMPs is an alert sys­tem that would of­fer a much needed ca­pa­bil­ity not cur­rently pro­vided by these data­bases.

“To­day, clin­i­cians rely on PDMPs to flag fraud­u­lent opi­oid trans­ac­tions and, while these sys­tems hold great prom­ise, sig­nif­i­cant blind spots re­main,” White says. “Too of­ten, PDMPs are not up­dated in real time, do not in­clude pre­scrip­tions filled across state lines and do not in­clude fill at­tempts—leav­ing clin­i­cians with only a par­tial view of a pa­tient’s true opi­oid his­tory.”

The Opi­oid Safety Al­liance has been call­ing for a na­tion­wide Pre­scrip­tion Safety Alert Sys­tem, based on a model de­vel­oped by the Na­tional Coun­cil for Pre­scrip­tion Drug Pro­grams (NCPDP) that lever­ages ex­ist­ing ANSI-ac­cred­ited stan­dards widely adopted by the in­dus­try.

To­ward that end, bi­par­ti­san con­gres­sional leg­is­la­tion has been in­tro­duced to cre­ate a na­tion­wide Pre­scrip­tion Safety Alert Sys­tem to en­able phar­ma­cists to bet­ter pro­tect pa­tients from opi­oid overuse.

The An­a­lyz­ing and Lev­er­ag­ing Ex­ist­ing Rx Trans­ac­tions (ALERT) Act, in­tro­duced by Reps. Tom MacArthur (R-N.J.), Ann Kuster (D-N.H.) and Bar­bara Com­stock (R-Va.), would re­quire the De­part­ment of Health and Hu­man Ser­vices to work with the pri­vate sec­tor to es­tab­lish a sys­tem that an­a­lyzes the trans­ac­tion data phar­ma­cists and pay­ers—such as health in­sur­ers and Medi­care—gen­er­ate when pre­scrip­tions are filled.

“We ab­so­lutely have to get smarter about how we use tech­nol­ogy and data anal­y­sis to fight this cri­sis,” says MacArthur, who is co-chair of the Bi­par­ti­san Heroin Task Force. “By giv­ing phar­ma­cists, in­sur­ance com­pa­nies, and pro­grams like Medi­care a new tool to un­der­stand the data they al­ready have, we can help pre­vent fur­ther harm.”

Ac­cord­ing to MacArthur, the data anal­y­sis would pro­vide real-time feed­back to phar­ma­cists at the point of sale and would be in­cluded in their nor­mal work­flow.

“A phar­ma­cist will re­ceive an alert that some­one might be at risk of overuse based on their pre­scrip­tion his­tory, or might be doc­tor-shop­ping to feed their ad­dic­tion,” adds MacArthur. “In­stead of fill­ing that un­nec­es­sary pre­scrip­tion, phar­ma­cists will have an ex­tra tool to de­tect and pre­vent these dan­gers.”

The ALERT Act is en­dorsed by Health IT Now, which launched the Opi­oid Safety Al­liance in Jan­uary—along with IBM, In­ter­moun­tain Health­care, McKesson, Or­a­cle and Wal­greens—to ad­vance a health IT-cen­tric pol­icy agenda to com­bat the abuse of opi­oids.

“The Pre­scrip­tion Safety Alert Sys­tem de­lin­eated in the ALERT Act will arm clin­i­cians with the proper tools to thwart opi­oid mis­use in real-time and pre­vent un­due de­lays in ac­cess for those with a le­git­i­mate med­i­cal need,” says White, who sees the alert sys­tem as com­ple­ment­ing PDMPs by pro­vid­ing in-work­flow clin­i­cal data at the point of dis­pens­ing, us­ing al­ready ex­ist­ing trans­ac­tion in­for­ma­tion—in­clud­ing cap­tur­ing trans­ac­tions that may oc­cur across state lines and un­suc­cess­ful fill at­tempts.

“It is grat­i­fy­ing to have NCPDP’s model sup­ported by the HITN Opi­oid Safety Al­liance and Rep­re­sen­ta­tives MacArthur, Kuster and Com­stock,” says Lee Ann Stem­ber, NCPDP’s pres­i­dent and CEO. “Our mem­bers rep­re­sent­ing di­verse stake­holder per­spec­tives de­vel­oped the model to pro­vide a sus­tain­able so­lu­tion that con­forms to provider work­flows and can com­ple­ment ex­ist­ing PDMPs to pre­vent di­ver­sion, en­sure ap­pro­pri­ate ac­cess to med­i­ca­tions for pa­tients with a valid med­i­cal need, and pro­tect pa­tients.”

Ben­e­fits of PDMPs ques­tioned

How­ever, Leo Belet­sky, as­so­ciate pro­fes­sor of law and health sciences at

North­east­ern Univer­sity, is not con­vinced of the over­all ben­e­fit of PDMPs. He be­lieves that the re­cent scaleup in the num­ber, scope, fund­ing and le­gal man­dates of these state-run data­bases has led to un­in­tended harms that have not re­ceived suf­fi­cient at­ten­tion.

“By col­lect­ing in­for­ma­tion on who is pre­scrib­ing, dis­pens­ing, and re­ceiv­ing sched­uled drugs, PDMPs are in­tended to de­tect—and de­ter—prob­lem pa­tients, rogue pre­scribers, and phar­ma­cists who may be di­vert­ing po­ten­tially ad­dic­tive and oth­er­wise risky drugs,” wrote Belet­sky in the In­di­ana Health Law Re­view. “The suc­cess of PDMPs has been mea­sured pri­mar­ily by their im­pact on sup­press­ing med­i­ca­tion sup­ply with lit­tle re­gard for truly mean­ing­ful met­rics. But, when it comes to im­prov­ing pa­tient care and ad­dress­ing drug-re­lated harms, the ev­i­dence of PDMP ben­e­fit is far from clear.”

In fact, Belet­sky’s 2018 nar­ra­tive re­view of the ex­ist­ing em­pir­i­cal ev­i­dence on PDMPs in­di­cates that these pro­grams may be do­ing more harm than good. He re­viewed 34 peer-re­viewed stud­ies eval­u­at­ing PDMPs, of which only 11 (32 per­cent) con­sid­ered any over­dose out­comes. In ad­di­tion, of stud­ies as­sess­ing over­all mor­tal­ity, three found PDMP de­ploy­ment to be as­so­ci­ated with re­duced over­dose rates, four re­ported a null re­sult, and three re­ported PDMPs to be as­so­ci­ated with an in­crease in over­doses.

“These find­ings stand to chal­lenge the kind of un­bri­dled en­thu­si­asm, gen­er­ous in­vest­ment, and cava­lier pol­icy em­pha­sis that has buoyed PDMPs since the on­set of the over­dose cri­sis,” ac­cord­ing to Belet­sky. “Given ev­i­dence of mixed im­pact, the un­in­tended harms of these sys­tems war­rant ur­gent ex­am­i­na­tion. This in­cludes their po­ten­tial role in de­ter­ring proper pre­scrib­ing prac­tices; chill­ing help-seek­ing among pa­tients, es­pe­cially those made vul­ner­a­ble by a his­tory of trauma in the health­care set­tings and crim­i­nal jus­tice in­volve­ment; fur­ther fray­ing the fab­ric of provid-

“Given ev­i­dence of mixed im­pact, the un­in­tended harms of these sys­tems war­rant ur­gent ex­am­i­na­tion.”

er-pa­tient trust; and fa­cil­i­tat­ing pa­tient tran­si­tion from pre­scrip­tion to black mar­ket drug sup­plies.”

Sim­i­larly, David Fink, a doc­toral can­di­date in epi­demi­ol­ogy at Co­lum­bia Univer­sity’s Mail­man School of Pub­lic Health, has co-au­thored a sys­tem­atic re­view pub­lished this sum­mer in the An­nals of In­ter­nal Medicine, which showed that there is in­suf­fi­cient ev­i­dence to con­firm whether im­ple­ment­ing these PDMPs ac­tu­ally in­creases or de­creases over­doses.

At the same time, he con­tends that some ev­i­dence has demon­strated un­in­tended con­se­quences of im­ple­ment­ing these pro­grams. For ex­am­ple, three stud­ies showed an in­crease in heroin over­dose deaths af­ter PDMPs had been im­ple­mented.

Like­wise, a 2017 study by Univer­sity of Penn­syl­va­nia and Penn­syl­va­nia State Univer­sity re­searchers— pub­lished in the Amer­i­can Jour­nal of Man­aged Care—found that PDMPs do not drive down opi­oid over­dose death rates, but might have the un­in­tended con­se­quence of adding to them by driv­ing users to black mar­ket drugs like fen­tanyl and heroin.

“PDMPs were not as­so­ci­ated with re­duc­tions in drug over­dose mor­tal­ity rates and may be re­lated to in­creased mor­tal­ity from il­licit drugs and other, un­spec­i­fied drugs,” con­cluded the authors of the Penn-Penn State study. “More com­pre­hen­sive and pre­ven­tion-ori­ented ap­proaches may be needed to ef­fec­tively re­duce drug over­dose deaths and avoid fa­tal over­doses from other drugs used as sub­sti­tutes for pre­scrip­tion opi­oids.”

Last year, a pa­per by a Pur­due Univer­sity re­searcher dis­cov­ered that while PDMPs drove down the pre­scrip­tion rate of oxy­codone, they sig­nif­i­cantly drove up the rate of heroin use.

“It is cru­cial to de­ter­mine if these pro­grams are help­ing to re­duce opi­oid over­dose,” Fink says. “So far, the de­fin­i­tive con­clu­sion we can draw from our eval­u­a­tion is that the ev­i­dence is in­suf­fi­cient and that much more re­search is needed to iden­tify a set of ‘best prac­tices.’”

Ac­cord­ing to Fink, if pop­u­la­tion health is the fo­cus, re­searchers need to un­der­stand all ef­fects of PDMPs, in­clud­ing in­creased rates of fen­tany land heroin-re­lated over­dose. ☐

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