‘Near-misses’ list to avert drug reac­tion

India aims to pre­vent poten­tially dan­ger­ous drug reac­tions before they reach patients, mov­ing bey­ond largely ret­ro­spect­ive report­ing towards pro­act­ive drug-safety mon­it­or­ing. Under a pro­posed frame­work, health­care pro­fes­sion­als will record “near misses”—from risky com­bin­a­tions to aller­gies and dos­ing errors—so reg­u­lat­ors can identify recur­ring risks and issue safety alerts, accord­ing to two gov­ern­ment offi­cials and a doc­u­ment reviewed by Mint.
The ini­ti­at­ive, taken up by the Indian Phar­ma­co­poeia Com­mis­sion (IPC), under the health min­istry, aims to sys­tem­at­ic­ally record instances where poten­tial drug-drug inter­ac­tions and crit­ical patient aller­gies are inter­cep­ted by doc­tors, nurses, and clin­ical phar­macists before med­ic­a­tions reach people, said one of the offi­cials in the know.
“The focus is to cap­ture the inter­ven­tions made by a doc­tor before an incor­rect medi­cine or con­train­dic­ated com­bin­a­tion reaches the patient. Doc­u­ment­ing near-miss cases
will provide an action­able denom­in­ator value to cal­cu­late risk per­cent­ages, map pre­val­ent drug-drug inter­ac­tions, and issue tar­geted clin­ical alerts,” the offi­cial cited above said, request­ing anonym­ity.
Under the plan, the com­mis­sion is pre­par­ing a ‘Monthly Pre­ven­ted
Adverse Drug Reac­tions Report­ing’ form under the Phar­ma­covi­gil­ance Pro­gramme of India (PvPI) to doc­u­ment
med­ic­a­tion risks caught dur­ing hos­pital care.
Cur­rently, phar­ma­covi­gil­ance sur­veil­lance in India primar­ily cap­tures adverse drug events after a patient exper­i­ences harm or sideef­fects. Cap­tur­ing pre­ven­ted reac­tions aims to help reg­u­lat­ors identify sys­temic gaps across hos­pit­als, includ­ing lack of aware­ness.
The plan is in line with global norms. The US FDA, the European Medi­cines Agency
India aims to move bey­ond
largely ret­ro­spect­ive report­ing towards
pro­act­ive drug­safety mon­it­or­ing
and the WHO man­date vol­un­tary, non-pun­it­ive report­ing of inter­cep­ted med­ic­a­tion errors to identify pack­aging and pre­scrip­tion risks. The data is routinely ana­lyzed to update drug safety warn­ings, reform clin­ical guidelines, and redesign con­fus­ing medi­cine labels.
To imple­ment the sys­tem, the health min­istry and the phar­ma­co­poeia com­mis­sion plan to integ­rate safety report­ing tools with national digital plat­forms, includ­ing onboard­ing onto the Cent­ral Drugs Stand­ard Con­trol Organ­isa­tion’s (CDSCO) SUGAM portal.
“Hos­pit­als and med­ical col­leges in the PvPI net­work will be trained to use the stand­ard­ized report­ing format to doc­u­ment inter­cep­ted pre­scrip­tion errors and con­train­dic­a­tions,” said the second offi­cial. The gov­ern­ment will send clin­ical cir­cu­lars and alerts to hos­pit­als.
The sci­entific body of the com­mis­sion has advised a detailed eval­u­ation of the new report­ing mech­an­ism prior to its nation­wide rol­lout.
Quer­ies sent to the health min­istry remained unanswered until press time.
Source: Pressreader