A white paper on medication errors, medication pathway, causes, proposed error-free medication ecosystem leveraging HIPaR BoDK - a wholistic body of drug knowledge platform
War against Medication Errors: Creating an Error-free Medication
Eco-system
A white paper on medication errors, medication pathway, causes, proposed error-free medication ecosystem leveraging HIPaR BoDK - a wholistic body of drug knowledge platform
September 2010
Author Venkateswar Reddy Melachervu
Head of Solutions and Technology, HealthNet Global
Contributors Dr.Sanjeev Sharma, MD
Clinical Pharmacologist, Apollo Health City, Hyderabad
Venu Madhav Thirukachi Team Leader, HealthNet Global
HealthNet Global Limited Ground Floor | Life Sciences Building | Apollo Health City Campus | Jubilee Hills | Hyderabad 500033| India
Acknowledgements Some of the content on medication errors is compiled from various web resources which is used as is. The immediate response of Dr.Sanjeev Sharma on forming some form of clinical councils for my question of how do we achieve credibility and acceptability for the HIPaR BoDK content was the genesis for the clinical governance model proposed in this paper. Some of the impactful and visionary phrases used in this white paper (bold italics) are property of the author and are being copyrighted. I’d like to express my sincere thanks to Dr.Ranjith Roy Chaudhury, Governing Board Member, Medical Council of India, for his valuable inputs and support for this initiative. My sincere appreciations and thanks are due to Dr.Sanjeev Sharma for his contributions towards the sections – the current state of HIPaR, Content Sources, Global Benchmarking, Certification and reviewing and providing inputs for the rest of the sections. My sincere appreciations and thanks are due to Venu Madhav for his contributions towards the sections – Global Benchmarking, HIPaR Data Constructs. It’d be unfair on my part if I do not thank for the kind support provided by Shri Sreerama Murthy Seetepalli (father of one of my ex-colleagues Syam Sunder Seetepalli who co-ordinated this for me) who authored Visual Bhagawad Gita in guiding me to find an apt verse from one of the world’s most ancient Body of Knowledges for human beings – Shri Madhbhagawad Gita- which I read as a child without fully comprehending and appreciating the complete meaning of what I was reading which as the age passes by one feels to find more relevance and tries to find more comfort in.
War Against Medication Errors: Body of Drug Knowledge
Objectives The objectives of this white paper are:
To understand and analyze the medication errors Attempt to derive an error-free medication eco-system Arrive at quintessential role of Body of Drug Knowledge- BoDK Understand HIPaR BoDK To define and propose a model for HIPaR BoDK content update and administration that
helps tackle medication errors Clinical Governance Model for HIPaR BoDK
Prologue Everyone falls ill sometime rather the other in one’s lifetime and takes medication, if
not many times. Medication errors can occur at any point in the medication process and in any care setting. Medication errors can cause long-lasting
problems and in the most severe cases, they can result in death. The frequency of medication errors and preventable medication-related
injuries represent a very serious cause for concern. Victims of medical mistakes frequently have to endure additional
medical attention and as a result, face expensive medical bills that they are responsible for paying because of someone else's errors.
Medication Errors In the US alone, 1.5 million Americans are sickened, injured or killed each year by errors in prescribing, dispensing and taking medications of which 7,000 are deaths, annually1. On average, at least one medication error per hospital per patient occurs each day which equals 400,000 errors each year, according to IMNA2, USA. The extra medical cost of treating drug-related injuries occurring in hospitals alone, conservatively amounts to $3.5 billion annually3. As defined by a dictionary, error is an act that through ignorance, deficiency, or accident departs from or fails to achieve what should be done. Specifically, medication errors can be defined as giving the wrong medicine and/or the wrong dose at the wrong time and can be
1 Source : Medication Errors Harming Millions, The Washington Post Report, 21
st July 2006,
http://www.washingtonpost.com/wp-dyn/content/article/2006/07/20/AR2006072000754.html and Daily News Central, Health News, Medication Errors Cause 7,000 Deaths per Year, 21
st July 2006 -
http://health.dailynewscentral.com/content/view/0002352/53/ 2 Institute of Medicine of the National Academies
3 Source: Office of News and Public Information News from the National Academies, National Academy of Sciences
Medication errors injure 1.5 million people and cost billions of dollars annually: Jul 2006. http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=11623
categorized into omissions (failure to act correctly) and commissions (acted incorrectly), broadly. The practice of medicine, pharmacy and nursing in a healthcare setting is complicated and involves many steps from pen to patient. One study showed that the most common types of medication errors were a wrong dose, a wrong drug or a wrong route of administration4. Medication errors can occur at any point during the medication process—procuring the drug, prescribing, dispensing, administering and monitoring its impact—but occur mostly during prescribing and administering stages.
Medication Pathway and Points of Failures The following picture depicts various failures of medication errors at each point of what I define as Medication Pathway, comprehensively.
Figure 1: Medication Pathway and Points of Failures
5
4 Source: Phillips J, Beam S, Brinker A, Holquist C, Honig P, Lee LY,Pamer C. Retrospective analysis of mortalities
Causes Medication errors may occur more because of contributing factors such as identical doses, dosage forms or routes of administration, similar packaging or labeling, incomplete knowledge of drugs, illegible handwriting, verbal order errors and even lack of an appropriate knowledge base, performance and knowledge deficits of the drugs, non-availability of the up-to-date information of the drugs like warnings, precautions etc. It is estimated that confusion regarding drug is thought to account for 25 per cent of all medication errors. Most of these errors happen either because of improper or lack of drug information, human errors in medication pathway etc. One more research report6 shown below depicts various causes for the medication errors.
Figure 2: Most Frequently Reported Causes of Medication Errors (Percentage):
Voluntary Reporting System 2000-20047
The below visual depicts the comprehensive causes for the possible medication failures at each point of Medication Pathway.
6 Source : Data - Santell, J.P.et al. 2005. MedMarx Data Report. USP Center for the Advancement of Patient Safety.
Paradoxically, what augments the problem is the absence of a Blame-free Medication Error-Reporting Mechanism in healthcare provider setting that could keep account of errors through an internal audit process recognizing the fact that human error as an inevitable consequence and deploying systems in place to minimize consequences of medication errors. The world is yet to witness such an established mechanism for blame-free medication error reporting and management which accounts for the point of having hardly any data on medication errors in healthcare provider settings, especially for countries like India.
Prevention and Improved Patient Safety Every health care professional can recall that 9 out of 10 prescription errors are preventable. In order to ensure error-free medication procedures, hospitals adopt what is known as 5 Rights:
In spite of 5 Rights being followed diligently, it is observed that in different countries, up to 12.9% of hospitalized patients suffer at least one adverse event during their admission out of which 10.8% to 38.7% per cent were caused by medication errors9. There are two more rights that the global medical fraternity has added, of late, to this list making it 7 rights:
Right indication Right documentation
Notwithstanding, the world is yet to witness any significant improvement in prevention of medication errors. With the increased healthcare awareness, importance, growing concerns on the fatal un-desirable consequences, reducing medication errors and improving patient safety by arresting or minimizing medication errors has become one of the highest priority areas for the healthcare eco-system players – healthcare providers, pharmacists, doctors, nurses, patients etc. Enhancing patient safety by minimizing or arresting medication error requires a systems-based approach in order to control the conditions that contribute towards errors. A little more concentration, a little more discipline, little more process and systems, a little more care, a little more faith can save the entire mankind from so many injuries, permanent damages and deaths caused due to medication errors. After all, the motivation is for a better healthcare that leads to beautiful lives. Enhancing the judicious use of medications and minimizing medication errors have always been key area for the healthcare fraternity but lacked the necessary systems, platforms, ever increasing up-to-date drug knowledge of tens of thousands of generics and brands and the optimal automation and integration with Hospital Information Systems along with the requisite operational processes for seamless controls of tackling medication errors in the care settings. With the emergence and deployment of pervasive IT systems in the healthcare settings like - HIS, HMS, ePrescription - care providers have embraced the needed systems and platforms that provide a base for tackling medication errors which can be supplemented by the manual operational components enabling a seamless point and click systems that help the care givers in reducing or arresting these errors. Additionally, IT can help build and deploy seamless, blame-free medication error reporting and management systems that are equally important for this endeavor for the fact that if you cannot measure it; you cannot improve it.10
The below visual depicts and summarizes the aforementioned concepts and notions in this War Against Medication Errors11.
Figure 4: Error Free Medication Eco-system
12
However, what is critically lacking today, is a comprehensive, up-to-date drug knowledgebase that is quintessential and core of the whole solution for tackling this challenge that embodies the ever increasing and changing knowledge and characteristics of the tens of thousands drug molecules13 for it is increasingly becoming humanly impossible to remember the ever growing brands, generics and their innumerable number of characteristics that play pivotal role in this war against medication errors14 by the healthcare eco-system players. Nonetheless, reducing medication errors is not a mere onetime activity but an ongoing process of quality improvement in the care settings.
It is estimated that there are around 50,000 generic brands and 6,000 generics prevalent in India alone today. These numbers are expected to significantly go up in next 5 years as more generics get added that come out of patent regime. 14
HIPaR: Body of Drug Knowledge (BoDK) HIPaR BoDK is the Embodiment of Comprehensive Drug Knowledge from HealthNet Global offering complete drug related information such as drug - drug interactions, drug-lab modifications, and drug-food interactions, drug-disease interactions, generic search, brand search, combination drug search, alternate brands for a given brand/generic, adverse reactions, indications, contra-indications, drug dosages, route of administration, precautions and warnings, banned drugs, ATC15, retail pricing and packaging information, manufacturers details etc. HIPaR BoDK complies with international disease coding standards like ICD-10/9, HL-7, EphMRA16, WHO indications standard etc. that make it easy to integrate with other clinical/hospital management software, pharmaceutical software or any healthcare software. It can also be shared across networks in hospitals, organizations and academic institutions etc. HIPaR BoDK platform is designed keeping with the objective of helping the healthcare fraternity in creating an integrated error-free medication eco-system automating various pharmacy and pharmacological processes, 7 rights frameworks on top of a contemporary Body of Drug Knowledge.
HIPaR BoDK Salient Features Generic search, brand search, combination drug search, alternate brands for a given
brand/generic Indications, contra indications, drug-drug interactions, drug-Lab modifications, drug-
food/alcohol interactions Adverse reactions, precautions and warnings, dosages Pharmacokinetics, Anatomic Therapeutic and Chemical Classification System - ATC Mechanism of Action of the drug Manufacturer search, retail price, packaging details Information on dose form, route of administration, Strength Disease classifications, ICD-10 coding Banned drugs, bar codes, essential drug list, storage conditions etc. Therapeutic duplication and equivalent Patient counseling messages Drug content administration, period updates (role-based user management for security
and content quality) A platform approach that helps the healthcare fraternity in flexibly adapting, integrating
for achieving their objectives
HIPaR BoDK Data Constructs
15
Anatomic Therapeutic and Chemical Classification System 16
European Pharmaceutical Market Research Association
War Against Medication Errors: Body of Drug Knowledge
Evolution of HIPaR The product embodies the expertise and experience of almost 10 years of evolution of its content and application logic from the group company of Apollo Hospitals founders. The content quantity of HIPaR BoDK as of early 2010 is as below.
Parameter Quantity Brands 15000
Generics 4065
Indications 1477
Contra-indications 1229
Adverse reactions 1182
Drug-Drug 669
Dosage Information 1098
Precautions and Warnings 1312
MoA 827
Manufacturers 935
The following set of next gen capabilities are the key drivers for the evolution of HIPaR BoDK
Multi-tiered content aggregation, editing, update and administration process enabling logical separation of content activities - editing, review, approve, reject etc.
Constitution of two-tiered clinical governance board - pharmacology and clinical practice – that enables the authenticity, sanctity and control over the content quantity that impacts lives
Updating and releasing the clinical content periodically Enhancing the characteristics of drugs in the drug knowledgebase – special conditions
and dosages, drug-disease, therapeutic duplication information, drug dosages for special conditions like renal failures etc.
HIPaR Doctor
Thick client
Installs and runs on a PC
Mobile HIPaR
Mobile Phones – J2ME
Thin and thick clients
HIS Integrated HIPaR
HIS/HMS
Drug Supply Chain
ePrescription
HIPaR
Web App
Custom Built
Integration with Portals
HIPaR
SaaS API
Web Service
SOAP Support
War Against Medication Errors: Body of Drug Knowledge
Patient counseling messages - drug information to the patient in his language – is lacking
Holistic Clinical Governance One of the critical points for an acceptable and credible body of drug knowledge is a clinically governed and enterprise class content administration system. The HIPaR BoDK content administration is clinically governed as below:
Clinical governance of the HIPaR BoDK healthcare content by instituting the following councils:
Clinical Pharmacologists Council – council of prominent clinical pharmacologists drawn across Apollo group
Clinical Advisory Council – council of prominent clinical practitioners/medical services directors drawn across Apollo group
Executive Governance Council – council/board comprising of technology, clinical experts and executives that drive the direction of HIPaR BoDK
An enterprise class Next Generation Content Administration system Multiple content sources aggregation Multi-tiered Distinct roles with role-based user management Auditable and traceable content editing, update, rejection/approval and
database administration A content administration team comprising of bachelor and master pharmacists
lead by a clinical pharmacologist This section focuses on the clinical governance and the next section on the Next Generation Content Administration system. The below picture summarizes the concepts visually for the holistic clinical governance addressing the hitherto identified content sources.
War Against Medication Errors: Body of Drug Knowledge
Next Gen Content Administration System The core to the design of the Content Administration System is the fundamental concept of multi-tiered, role-based, and clinically governed Content Update Process that we’ve uniquely developed for this purpose considering the need to ensure the sanctity of the data that impacts the lives of the human beings and the focus on the India specific content. The following picture depicts the multi-tiered content update process that incorporates the Holistic Clinical Governance addressed in the previous section.
War Against Medication Errors: Body of Drug Knowledge
Figure 10: Next Generation Clinical Content Administration Platform
We at HealthNet Global have analysed, understood, recognized and built a tiered, role-based, auditable enterprise class content management system as an integral part of Next Generation HIPaR BoDK platform and have instituted content development team (pharmacists, clinical pharmacologists etc.) and experienced software development team which have developed and deployed an enterprise class Content Administration System for HIPaR BoDK where a special team of pharmacists (B.Pharms and M.Pharms) lead by a senior clinical pharmacologist are editing and updating the content aggregating the clinical content from various popular and credible sources to it one of the world’s leading BoDK for India and beyond. The BoDK Content Administrator offers drug content sources aggregation, content entry, content review, content approval, audit information, content publishing using Internet leveraging cloud technologies, role-based secured user management and database administration etc. enabling a robust anytime and anywhere secured system. Some of the screen captures of BoDK Content Administrator are shown below.
War Against Medication Errors: Body of Drug Knowledge
Content Sources The following are the content sources used hitherto for cleansing and updating the existing content:
Pharmaceutical Manufacturer Product Monographs Indian Pharmacopoeia Version 2010 Wolters Kluwer’s Drugs in Pregnancy & Lactation Version Central Drugs Standard Control Organization website
http://cdsco.nic.in/ Australian Registry of Therapeutic Goods and Medicines -
Health Canada website http://webprod.hc-sc.gc.ca/dpd-bdpp/start-debuter.do?lang=eng
New Zealand Medicines and Medical Devices Safety Authority Website http://www.medsafe.govt.nz/
US FDA website http://www.fda.gov/
Global Benchmarking We’ve benchmarked HIPaR BoDK platform clinical fields/capabilities and content with some of the national and international products used for the similar purposes and summarized below. The benchmarking focus was more on the clinical fields/capabilities as the clear data on the quantity of the content of these products is hardly available. Clearly HIPaR BoDK stands out and on top with its longer list of supported capabilities.
Certification Acceptability and credibility of the content is critical to the core of HIPaR BoDK given its impact on human lives. This typically, comes with accreditation/certification by renowned institutions and organizations globally that are independent and have acclaimed expertise in the relevant subject matter. In our research, we are yet to find such a straight body that certifies drug knowledge or drug database. We are in the process of identifying and pursuing the certification with organizations that have relevance to pharmacy and pharmacology.
Vision Transform HIPaR into next generation ubiquitous body of drug knowledge platform that plays a pivotal and core role in the prevention of medication errors, integrated medicine management throughout the medication pathway empowering healthcare fraternity with a
War Against Medication Errors: Body of Drug Knowledge
comprehensive, ever up-to-date, seamless, credible body of drug knowledge at a touch of a button that endeavors to create an error-free medication eco-system
HIPaR BoDK Applications Efficient Drug Inventory Management
Generic based Drug Inventory control using HIPaR BoDK helps achieve efficient control on stock refills.
Prescription Audit HIPaR BoDK helps the Pharmacist conduct a prescription audit providing indications for the prescribed drugs in Hospital
Drug Education for Patients HIPaR BoDK can be used as education and drug awareness by the patients
Efficient Drug Licensing HIPaR BoDK helps drug regulators to avoid Look Alike, Spell Alike and Sound Alike drugs while licensing
Drug Education for Nurses HIPaR BoDK enables nurses for educating the Patients on Drugs and monitoring Patients on drug therapy
Drug Education for Medical Students HIPaR BoDK helps students with a comprehensive drug knowledge base
Brand Equivalent HIPaR BoDK enables Pharmacist and Doctors find a Brand Equivalent of a Drug
Convenient drug identification by patients HIPaR BoDK helps patients conveniently identify a Drug for consumption based on the Color/Image?
Generic Based Prescription HIPaR BoDK enables healthcare providers especially public health care providers in implementing a generic based prescribing in place of brand based prescribing
Claims Validation HIPaR BoDK enables Insurance Providers to Validate the Insurance Claims related to Drugs - Age, Gender, and Disease
Drug Dosage adjustments for Renal Failure HIPaR BoDK enables doctors to adjust drug dosage for patients with renal failure.
Drug Dosage adjustments for Hepatic Failure HIPaR BoDK enables doctors to adjust drug dosage for patients with hepatic failure.
Contra Indications HIPaR BoDK can alert the doctors about the contraindications of the drug they are prescribing enhancing the Patient Safety
Dosage Error Prevention HIPaR BoDK enables Health Care Providers in preventing dosage errors
Prevention of Drug Errors in Pregnancy /Lactating Women
HIPaR BoDK enables Health Care Providers/Doctors in preventing Drug Errors for Pregnancy/Lactating Women
Customized Dietary Plan for Chronic Patients HIPaR BoDK enables dietitians in creating a customized dietary plan for Patients on Pharmacotherapy in case of chronic conditions
Prevention of Therapeutic Duplication HIPaR BoDK enables doctors in preventing therapeutic duplication of the drugs
Institutionalized Body of Drug Knowledge HIPaR BoDK enables health care providers in institutionalizing drug knowledge across the organization sans boundaries
Find Manufacturer of a brand HIPaR BoDK enables healthcare providers, pharmaceutical companies, regulators to find manufacturers for a given generic/brand
War Against Medication Errors: Body of Drug Knowledge
Price reference for Drug Purchases HIPaR BoDK can act as a reference tool for financial decisions by healthcare providers, pharmacies, insurance providers and patients
Drug-drug interactions
HIPaR BoDK enables doctors, pharmacists, pharmacologists for identifying drug - drug interactions and taking necessary actions for enhanced patient safety. Helps medical students, pharmacists in learning.
Drug-lab interactions HIPaR BoDK enables biochemists, micro biologists and doctors in right interpretation of lab results avoiding unnecessary or wrong treatment.
Drug-food interactions HIPaR BoDK enables dietitians and doctors plan a customized dietary for a patient for the better management of a disease avoiding treatment failure and adverse effect.
Drug-anesthesia interactions HIPaR BoDK enables anesthetists to plan anesthesia for patient on drug therapy avoiding mishaps during the anesthesia.
Drug-Alcohol interactions HIPaR BoDK enables doctors to warn the patients regarding the alcohol consumption for mishaps while patient is on drug therapy.
Precautions, warnings HIPaR BoDK enables doctors in assessing the risk benefit ratio to prescribe drugs to special category cases(Pregnancy, Lactation, Pediatric and Geriatric etc..)
Pharmacokinetics HIPaR BoDK enables researchers and medical students in analyzing and understanding Pharmacokinetic profile of drugs.
ATC information and DDD HIPaR BoDK enables researchers for doing drug utilization studies and better inventory planning control
Pharmacological category and sub-category information
HIPaR BoDK enables medical students in learning about the pharmacological classification system and helps the pharmacist in identifying therauptic substitutes.
Nursing considerations HIPaR BoDK enables Hospital nursing staff in proper reconstitution, storage, administration and monitoring the patient on drug therapy.
HIPaR Unique Article Code
HIPaR BoDK provides unique opportunity in India for regulatory agencies, Manufacturers, Insurance providers, health care providers etc. To uniquely and unambiguously address the health care item across the systems.
ICD-10 Information HIPaR BoDK provides the ICD10 Disease code information for any given disease and vice versa.
Drug Search by Disease HIPaR BoDK enables medical students and doctors in learning drug therapy for various diseases.
Drug Side Effects HIPaR BoDK enables doctors and patients in knowing and tackling the side effects while drug therapy.
OTC information of a drug HIPaR BoDK enables patients and pharmacists to identify whether a drug is OTC drug or not.
Generic Synonyms HIPaR BoDK enables doctors and pharmacists to identify the global generic synonym.
Look Alike, Sound Alike and Spell Alike Drugs Information
HIPaR BoDK enables doctors, regulators, pharmacists, nurses and patients in preventing the medical errors and enhancing patient safety.
War Against Medication Errors: Body of Drug Knowledge
Drug Packaging - bulk packaging and retail/selling packaging information
HIPaR BoDK enables pharmacy and health care providers in maintaining the better inventory management.
Integrated Pharmaco-vigilance
HIPaR BoDK Platform helps the healthcare providers and regulators in automating the process and deploying the system online for seamless easy-to-use access for pharmaco-vigilance in reporting and verifying the adverse effects along with periodic reports
Epilogue As per a latest article in a medical journal17 (2008), the medical errors kill anywhere between 48,000 – 80,000 Americans annually and the article claims majority part is due to Medication Errors. Imagine saving a fraction percentage of these lives by creating an error-free medication eco-system which can still run into saving tens of lives annually which is more than the meaning for our endeavor of War Against Medication Errors and we firmly of the view that this transformation should pick up the momentum now and should not stop at saving mere tens of lives. We humbly appeal to the healthcare fraternity through this white paper to come forward for a collaborative endeavor, join hands with us for an inclusive effort to wage and win the War Against Medication Errors18. Together, let us march forward and work towards ushering in an Error-free Medication Eco-system19 leveraging the comprehensive Body of Drug Knowledge, first in the IP care setting and then beyond IP care setting in the journey of Touching Lives.
About Author Venkateswar Reddy Melachervu Venkat is a well-rounded professional with technology expertise, business acumen and proven timely results in conceiving profitable ideas and transforming these profitable ideas into products and solutions across multiple domains leveraging cutting-edge technologies ushering positive impacts to the top lines and bottom lines – start-ups or grown-ups, locally or globally. Venkat is the member of the founding team of HealthNet Global and currently associate vice president and head of technology and solutions. In this role, he heads technology and solutions and is responsible for company’s solutions, services, technology strategy, roadmap and concept selling to - enterprises, governments, partners and investors. Venkat earned bachelor's degree in electronics and communications engineering with distinction where he was first exposed to the nature and significance of electronics,
17
Source : Clinical Review: Medication Errors in Critical Care: Critical Care 2008 18
telecommunications and information technology convergence and the power there-of, while developing hardware, software and firmware for his final year project Digital Filters Utilizing Microprocessors on Intel 8085. This work has significantly influenced his professional journey he has embarked there on. He believes in technology in isolation has no meaning neither to business nor to humans unless seen in a problem solving or value creation context, dares to dream, cares to win and works towards transforming the lives through technology. More details can be found about him on Linkedin. ------------------------------------------------ End of White Paper----------------------------------------------------
