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Medication Timeline

1

1820 - 1995:

1820 - 1995

  • Served as one of the first initiatives to protect patients from hard due to inadequate preparation of medications.

  • Originally provided ‘recipes’ for how the medications should be prepared and served as one of the first standardization initiatives.

  • Recently, the organization has helped build trust in generic medications by working towards improved quality and thereby improving access for many Americans. Today, approximately 90% of prescriptions are generic, which saved an estimated $1.67 trillion in just one decade.

Reference: https://www.usp.org/200-anniversary/usp-building-trust-for-200-years

Formation of the US Pharmacopeia (USP) in 1820

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  • Provide computer-controlled storage, dispensing, and tracking of drugs and medications at the point of care.

  • According to data from 2008, more than 80% of hospitals adopted ADCs (Grissinger, 2012). The contributions of ADCs include:
  • Increase in timeliness of drug administration
  • Electronic tracking of controlled substances
  • More accurate inventory control
  • Facilitate pharmacy review of the drug before administration
  • Integration with barcode technology to track dispensing

Reference: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3462599/#:~:text=Automated%20dispensing%20cabinets%20(ADCs)%20were,care%20in%20patient%2Dcare%20units.

Automated Dispensing Cabinets (ADCs) in the 1980s

3

Betsy Lehman’s story is one of the most celebrated patient safety stories ever. Her wrongful death, involving a decimal error in chemotherapy dosing, prompted a national movement to improve patient safety and quality.

Reference: https://betsylehmancenterma.gov/about-us

Death of Betsy Lehman in 1994

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  • Convened by USP to coordinate efforts across 15 interdisciplinary organizations and agencies to actively promote the reporting, understanding, and prevention of medication errors and to focus on ways to enhance patient safety through a coordinated approach utilizing a systems-based perspective. NCC MERP ongoing work has produced:
  • Coordinated national reporting and analysis in collaboration with the Institute for Safe Medication Practices (ISMP)
  • The Taxonomy of Medication Errors, published in 1999, widely used worldwide to aid accurate reporting and analysis of medication errors, adverse drug reactions and adverse drug events.

Reference: https://www.nccmerp.org/sites/default/files/nccmerp-25-year-report.pdf

Establishment of the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) in 1995

Story of Justin Micalizzi, who died from a medication error after going into a procedure for a swollen ankle.

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  • First devised by the US Department of Veteran Affairs.
  • Contributed to a significant decrease in medication errors by facilitating the five patient rights: the correct patient, dose, drug, time, and route.
  • According to one study, implementation of barcoding technology decreased the rate of adverse drug events from .26% to .20% and decreased the rate of transcription errors from .089% to .036%. However, one study found rates of compliance with barcode administration technology to be only 55% (Othman & Darawad, 2020)

Reference: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4911988/

Barcoding in 1995

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1990s - 2000s

1990s - 2000s

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  • While initially proposed in 1972 by the Regenstrief Institute, the advent of the internet in the 1990s set the foundation for the widespread adoption of electronic medical records for data analysis, clinical communication, and performance improvement.
  • The advent of electronic medical records:
  • Removed the possibility of error due to handwriting and transcription errors
  • Reduced the possibility of medication errors via embedded drug libraries
  • Provided up to date information in one place
  • Enhanced privacy and security of healthcare data
  • Ensured documentation that could be mobilized quickly
  • However, there has been significant controversy since the advent of electronic medical records around the potential decrease in patient-provider interaction, incompleteness of fields, fragmentation of information, and gaps between professionals.

Electronic Medical Record in the 1990s

Joseph Karbelk, who died of an error due to an inappropiate chemical restraint

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  • Classified potassium chloride as a high-alert medication, along with insulin, opiates and narcotics, intravenous anticoagulants, and sodium chloride solutions about 0.9 percent.

  • Suggested to remove potassium chloride/phosphate from floor stock, to move drug preparation off units and use commercially available premixed IV solutions, and to standardize and limit the drug concentrations (Knox, Liu, & Brushwood, 2014).

  • Patients can experience severe burning, intense abdominal pain, fever, diarrhea, chills, and chest pain from potassium chloride misuse

Reference: https://pdfs.semanticscholar.org/5806/300ae14e26601f71a4ee848f8747e157acbb.pdf

The Joint Commission’s Sentinel Event Alert on Potassium Chloride in 1998

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Often credited as the first US patient safety conference, the Annenberg Conference also highlighted key pivotal patient stories, including the story of Ben Kolb (pictured), a seven year old boy who died of cardiac arrest after a medication error in the operating room (Report from the Field: National Conference on Patient Safety). Around this time, there was a shift from ‘going for the jugular’ to an attempt in understanding the human factors and gaps in reliability that lead to medical errors (How Can We Save the Next Victim?). These stories, shared at Annenberg, influential in the Institute of Medicine’s 1999 report.

Reference: https://www.law.uh.edu/healthlaw/perspectives/HealthPolicy/981113Patient.html

Annenberg Conference in 1999

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After an estimate from the Institute of Medicine that patients die every day from medical errors, the world turned to listen and ever since, hospitals and healthcare organizations have prioritized patient safety and quality improvement efforts.

Reference: https://pubmed.ncbi.nlm.nih.gov/25077248/

Institute of Medicine’s 1999 To Err is Human report

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  • Adaptation was built around security requirements, such as safeguards for automatic data backups, automatic log-offs, data encryption, access controls and audit trails.

  • Moved toward integrated and centralized systems, in which all of the patient’s data could be accessed through a single system instead of cycling through pages from disparate systems.

Electronic Health Records in the 2000s

3

2001 - 2006

2001 - 2006

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Tall Man Lettering in 2001

  • US FDA produced a list of drug names with recommended tall man lettering, considering factors such as overlapping product indications, degree of similarity between the two medications, and reports of error using the medications.

  • In a 2008 ISMP report, nearly 87% of those surveyed indicated that tall man lettering helped reduce drug selection errors and 64% indicated that this lettering actually prevented improper dispensing and administration of the wrong drug (Grissinger, 2012).

Reference: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3351881/

12

  • The Joint Commission upholds a list of look-alike sound-alike medications that hospitals can use to achieve the National Patient Safety Goals.

  • Intended to outline a list of medications that are often easily confused by patients, caregivers, and healthcare providers due to poor oral or written communication. The Joint Commission reports a 92% compliance rate with the goal that all healthcare organizations maintain their list of look-alike sound-alike drugs and yet, medication errors for this reason are still common.

NPSG for Look-Alike-Sound-Alike in 2004

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  • The Joint Commission introduced the eighth National Patient Safety Goal: “Accurately and completely reconcile medications across the continuum of care”.

  • Would involve devising a process to identify a list of medications the patient was taking, both from the organization and independent of the organization, and proper communication of this list upon transfer or discharge. See here for an outline of important steps for medication reconciliation.

Medication Reconciliation Standards in 2004

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  • President George Bush announced the initiative that all Americans would have their own electronic health record (EHR) by 2014, based on the assumption that EHR implementation would improve quality and reduce cost of care.
  • Clinicians and researchers have cited problems with the EHR such as reduced time spent with patients, distrust of data, and input errors.

Reference: https://georgewbush-whitehouse.archives.gov/infocus/technology/economic_policy200404/chap3.html

Bush’s Electronic Health Records for all Americans Initiative in 2004

Emily Jerry, who died of a sodium chloride error just before her second birthday party

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  • Found that more than 1.5 million Americans are injured every year in American hospitals, and the average hospitalized patient experiences at least one medication error each day. Estimated the cost of hospital-based medication errors to be at least $3.5 billion annually

  • Estimated that less than 20 percent of all U.S. prescriptions are transmitted electronically. Strongly recommended goals that all healthcare providers write prescriptions electronically by 2008 and use e-prescribing systems by 2010. The expert panel said all pharmacies should be able to receive prescriptions electronically by 2010 as well.

Reference: https://www.nap.edu/read/11623/chapter/1

Institute of Medicine Report on Preventing Medication Errors in 2006

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2009 - 2016

2009 - 2016

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  • Obama signed the American Recovery and Reinvestment Act, promoting the meaningful use of electronic health data through incentives. ‘Meaningful use’ was defined as the ability to capture and share data, advancement of clinical processes, and subsequent improved outcomes.

  • Allocated $19.2 billion to help hospitals and healthcare providers make the transition to implementation of electronic health records.

American Recovery and Reinvestment Act in 2009

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  • Enacted by the US Obama administration, the Affordable Care Act (ACA) expanded healthcare coverage, affordability, and accessibility and served as a step toward more universal health coverage.

  • After major implementation work in 2014, by 2016, the uninsured population had nearly halved.

  • The ACA influenced implementation of strategies to improve the safety of medication use during care transitions.

Affordable Care Act (ACA) in 2010

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  • This draft guidance evaluated the design of drug products, including nomenclature and labeling, and the associated implications for medication errors.

  • The FDA cited the 2006 Institute of Medicine report that urged for this action and the FDA noted that “it is preferable to eliminate these risk factors from the drug product design to reduce the risk of medication errors.”

“Safety Considerations for Product Design to Minimize Medication Errors” from the FDA’s Center for Drug Evaluation and Research in 2012

19

  • This medication initiative from the Canadian Patient Safety Institute in 2014 is seeking to unite all Canadian stakeholders, from government officials, to physicians, to medical educators, to members of the general public, to align their language around medication.

  • Centers on the idea of using a common toolset to prompt conversation about medication use in an organized way.

Reference: https://www.ismp-canada.org/download/HealthcareQuarterly/HQ-Vol22-SP-Watt.pdf#:~:text=CPSI%2C%20in%20partnership%20with%20ISMP%20Canada%2C%20hosted%20a,into%20the%20national%20Integrated%20Patient%20Safety%20Action%20Plan

“5 Questions to Ask About Your Medications” in 2014

Roger Jukich, who died of neglect his wishes to not have morphine administered

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  • In the 1990s, the pharmaceutical industry assured clinicians that opioids were not highly addictive and clinicians then began prescribing more freely, leading to widespread, problematic use.

  • In 2016, 42,000 deaths were the result of opioid overdoses, with 40% of those deaths involving a prescription. In November of 2016, this Surgeon General’s Report was released and curated the latest evidence-based research around the opioid crisis in America, recognizing opioid use disorder as the result of systemic gaps and social, environmental, and individual factors, highlighting the need for an equally multifaceted response.

  • Shortly after in 2017, this crisis was declared a public health emergency.

Reference: https://addiction.surgeongeneral.gov/sites/default/files/surgeon-generals-report.pdf

“Facing Addiction in America: The Surgeon General’s Report on Alcohol, Drugs, and Health” in 2016

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2017 - Present

2017 - Present

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WHO’s “Medication Without Harm” Global Patient Safety Initiative in 2017

Officially launched in 2017, the World Health Organization’s Medication Without Harm initiative seeks to minimize severe preventable harm from medication errors by 50% worldwide over the next five years and depicts four key domains in achieving this challenge: patients and the public, health care professionals, medicines and systems and practices of medication.

Reference: https://www.who.int/patientsafety/medication-safety/en/

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  • After recognizing that 1 in 10 patients is harmed while receiving hospital care annually and medication errors specifically hurt millions and cost $42 billion worldwide each year, the World Health Organization established World Patient Safety Day on September 17, 2019.

  • Each year, organizations around the world are encouraged to participate, commonly lighting up a large symbolic monument in orange, which is the color of patient safety initiatives.

Reference: https://www.ismp.org/resources/speak-medication-safety-september-17-2019-first-world-health-organization-world-patient

The World Health Organization’s First World Patient Safety Day and “SPEAK UP for Medication Safety” Initiative in 2019

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The COVID-19 pandemic brought the world to its knees, starting in late 2019 and early 2020 and continuing for years to come. Throughout multiple quarantines, relentless social distancing, extraordinarily high death rates, unprecedented hospital overload, immense burnout, and sweeping mental health issues across the general public, a vaccine could not come fast enough. Pfizer and Moderna announced their mRNA vaccines in late 2020, with many others to follow. See the PSMF’s COVID-19 Resource pages for more information about the vaccine.

Reference: https://patientsafetymovement.org/helpful-coronavirus-covid-19-resources/

Development of the COVID-19 Vaccination

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  • Nearly 7 million patients experience medication errors, contributing to the $21 billion annual impact across healthcare systems. Further, upon discharge medication reconciliation, 30% of hospitalized patients have one or more discrepancies (Silva & Krishnamurthy, 2016). Hospitals and healthcare organizations have come a long way and improved medication safety significantly. At this point, it is important to centralize these processes to fortify a person-centered culture of safety, a holistic, continuous improvement framework, and a model for sustainment in order to move forward with medication safety.

  • Medication management plans should be integrated with the patient’s individualized plan of care and should be openly discussed with the patient. The patient and loved ones are encouraged to maintain a plan of care document of their own throughout their healthcare journey. See PSMF’s Blank Plan of Care Form and Example Plan of Care Form.

Reference: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5016741/#:~:text=It%20is%20believed%20that%20preventable,discrepancy%20on%20discharge%20medication%20reconciliation.

Looking Ahead

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