Defining a Key Global Health Issue

Drug-induced Complications and Illnesses (i.e. Adverse Drug Reactions)

“Because most adverse health events are unrecognized as drug-induced, Adverse Drug Reactions are likely to be woefully under-reported or repetitious, and the extent of this medical problem is unknown.”

Adverse Drug Reactions (ADRs) are a a subset of Adverse Drug Events (ADEs), and can frequently result in hospitalizations. ADRs result from use of appropriately prescribed, and administered drugs, in contrast to ADEs which also include: improper dosing, wrong medications prescribed and/or provided, patient compliance errors. ADRs lead to unnecessary testing, additional therapies, and even surgeries, due to misdiagnosis. These events contribute to a decline in overall health of the population, often cause permanent injury, can lead to non-defensible malpractice law suits, and billions of dollars in preventable, wasteful costs to the entire healthcare ecosystem.

  • Healthcare industry faces enormous pressure & challenging goals (e.g. cost reduction, quality patient care, risk mitigation)
  • Patients take drugs from a rapidly expanding list of new and old medications or agents
  • Many new agents have far-reaching effects that are often not fully understood at the time of marketing
  • Almost every drug could lead to frank toxicity of major organ groups
  • These problems are frequently not considered or recognized in the clinical setting (cause 6.5% of hospitalizations)
  • These lead to serious (6.7%) and fatal (0.32%) injuries in hospitalized patients, of which at least 28% are preventable
  • The elderly are at higher risk; multiple drug use and associated interactions may confound or worsen drug toxicity

Office of Disease Prevention and Health Promotion (ODPHP) 2018

ADEs can happen anywhere: in hospitals, long-term care settings, and outpatient settings.

In inpatient settings, ADEs:

  • Account for an estimated 1 in 3 of all hospital adverse events
  • Affect about 2 million hospital stays each year
  • Prolong hospital stays by 1.7 to 4.6 days

Each year, ADEs in outpatient settings account for:

  • Over 3.5 million physician office visits
  • An estimated 1 million emergency department visits
  • Approximately 125,000 hospital admissions

Read More

Problem Definition – Illustrative Statistics

Summarizing the Operational Drivers and Complexity of Adverse Drug Reactions ADRs

Summary Statistics:

  • Average drug usage per a typical patient and a 65-year-old patient is ~12 and ~ 28 drugs, respectively
  • (Potential / Actual) ADRs millon times per year known and real number (much higher) since most are unrecognized
    • Yearly: Over 2 million serious inpatient ADRs reported; unknown ADRs for outpatients and ambulatory clinic patients; 350,000 ADRs for nursing home patients
  • $136 billion costs associated with ADEs; ADEs cause 1 out of 5 injuries or deaths to hospitalized patients
  • Two thirds of patient visits results in a prescription; ADEs increase exponentially with 4 or more medications
  • Number of Publicly Available Data Sources & Number of Journals Tapped Into ~ 5 and 30K, respectively
  • Number of FDA Medical Reviews and Supplements & Published Medical Literature (Articles) Searched ~ >5 million
  • Number of Safety Data Points (Tables, Statistics, Results) Analyzed ~ >10 million

Drug-Related Statistics:

  • Single or combination drug prescribed by a physician with the idea of attaining a therapeutics benefit on the patient
  • Prescription medications ~ 2,000 drugs; medical problems ~ 25,000 (based on Preferred Terms, MedDRA Coding)

Medical Problem-Related Statistics:

  • An interrelated set of patient circumstances with implications across multiple specialties, major organ systems, and services
  • Medical Problem-Related: Caring for common co-occurring conditions and complications such as illnesses, injuries, reactions, side-effects, symptoms, etc.
  • Medical Problem-Related: Categorized by Primary/Secondary Problem (PP, SP) as well as Acute/Chronic

Problem Definition – Current State of Affairs

Defining a Key Global Health Issue: The Problem with Current State of Affairs

Although adverse health states or drug events data can be found by searching the medical literature, and FDA / regulatory agencies databases,

  • such investigations are time consuming and these data sources cannot be readily navigated
  • require intricate facility or knowledge of the specific search mechanism
  • all searches provide a global list of known side effects organized by each specific drug
  • no single source of actionable drug complication information

The currently available “apps” do not fit the bill!

  • not oriented to the problems of individual patients
  • never current, do not provide enough information on drug complications, are unwieldy and inefficient
  • hardly used in a clinical setting where ease of use and a rapid response are essential

The NET-NET: Physicians and all healthcare providers are faced with a remarkable inefficiency, where large amounts of publicly available information cannot be accessed in a timely fashion by clinicians, which

  • Limits healthcare provider expansion of knowledge and understanding of iatrogenic induced health problems, and
  • Impedes the reduction of significant, yet preventable, deleterious impact upon individual patient well-being and therefore on global health