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PART - I
Introduction
2
Introduction
Medicine heals, but this fact doesn`t hold true for every 300th
patient admitted to
hospital. Call it the law of averages or blame human error for it, but the World Health
Organization believes that one in 10 hospital admissions leads to an adverse event and
one in 300 admissions in death.
An adverse event could range from the patient having to spend an extra day in
hospital or missing a dose of medicine, said Dr Nikhil Datar, a gynaecologist and
health activist. Unintended medical errors are a big threat to patient safety.
Although there is no Indian data available on this topic, WHO lists it among the top
10 killers in the world. While a British National Health System survey in 2009
reported that 15% of its patients were misdiagnosed, an American study published in
the Journal of the American Medical Association in 2000 quantified this problem
most effectively.
It said that there are 2,000 deaths every year from unnecessary surgery; 7,000 deaths
from medication errors in hospitals; 20,000 from other errors in hospitals; 80,000
from infections in hospitals; and 106,000 deaths every year from non-error, adverse
effects of medications. In all, 225,000 deaths occur per year in the US due to
unintentional medical errors.
It is to create awareness both among doctors and patients about errors dubbed as
unintended medical errors that Datar organized a seminar to discuss patient safety at
the Indian Medical Associations office. “In the western nations, it is believed that the
incidence of unintentional medical errors is between 10% and 17% of all cases,” said
Datar.
3
The Indian government has woken up to the concept. It set up the National Initiative
on Patient Safety in the All-India Institute of Medical Sciences.
But the idea, as Dr Akhil Sangal of the Indian Confederation for Healthcare
Accreditation, points out is not to apportion blame. “When medical negligence occurs,
the first question to be asked is who is to blame. We instead have to evolve to a
system in which we ask questions about how, when and where the negligence
occurred,” said Delhi-based Dr Sangal.
Datar illustrates with an example of a 10-year-old leukemia patient in Britain who had
to be given a chemotherapy injection. “This is a published report of how due to a
series of unintended changes the boy died due to a wrong injection being given to
him,” said Datar. The boy ate food that was prohibited before the procedure; he was
hence taken hours later by a different department than the cancer doctors. “The
injections were given in a particular order but that day due to the mix-up he got the
wrong injection and died five days later.” The committee exonerated the doctor
because it found the other factors — the when, where and how — had all played a
role in the boy`s death.
“By talking about patient safety, we can reduce the overall mortality and morbidity
associated with hospitalization. Even hospitalization time and costs could come down
as a result,” said Dr Mathew Joseph who is attached to PGI Chandigarh and is
involved in a nationwide study on clinical practices. “One of our earlier studies had
shown unsafe practices associated with 70% of the injections administered in our
country,” Joseph said.
One in 10 patients is harmed while receiving hospital care.1
4
Hospital pharmacy
Hospital pharmacies can usually be found within the premises of the hospital.
Hospital pharmacies usually stock a larger range of medications, including more
specialized and investigational medications (medicines that are being studied, but
have not yet been approved), than would be feasible in the community setting.
Hospital pharmacies typically provide medications for the hospitalized patients only,
and are not retail establishments. They typically do not provide prescription service to
the public. Some hospitals do have retail pharmacies within them, which sell over-the-
counter as well as prescription medications to the public, but these are not the actual
hospital pharmacy.2
EAHP definition of hospital pharmacy3
EAHP members, meeting during its 38th
General Assembly, in June 2008
(Copenhagen, Denmark) adopted the following definition of hospital pharmacy and
hospital pharmacist: Hospital pharmacy is the health care service, which comprises
the art, practice, and profession of choosing, preparing, storing, compounding, and
dispensing medicines and medical devices, advising healthcare professionals and
patients on their safe, effective and efficient use. Hospital pharmacy is a specialised
field of pharmacy which forms an integrated part of patient health care in a health
facility.
Hospital pharmacy is the profession that strives to continuously maintain and improve
the medication management and pharmaceutical care of patients to the highest
standards in a hospital setting.
Hospital pharmacists provide services to patients and health care professionals in
hospitals.
5
The missions of the hospital pharmacist3
 To be part of the medication management in hospitals, which encompasses the
entire way in which medicines are selected, procured, delivered, prescribed,
administered and reviewed to optimise the contribution that medicines make to
producing informed and desired outcomes
 To enhance the safety and quality of all medicine related processes affecting
patients of the hospital
 To ensure the 7 “rights” are respected: right patient, right dose, right route, right
time, right drug with the right information and documentation
Hospital Formulary4
A hospital formulary is a comprehensive list of every approved drug and therapeutic
agent stocked by the pharmacy of that hospital.
A formulary includes a list of the drugs; monographs with information on each drug,
such as uses, dosages and warnings; and a general reference section with information
that might be helpful in treating patients. The purpose of the formulary is to prevent
unnecessary spending to stock medications that differ only slightly from one another.
A committee of the medical staff and pharmacists decides what drugs are included in
the formulary. This committee typically meets once monthly and is known as
Pharmaceuticals and Therapeutics Committee (PTC).
A physician can request the addition of a drug. The drug is compared with similar
agents present on the formulary in terms of effectiveness, side effects and cost.
If a necessary drug is not included on the formulary, it can be ordered from a
neighboring hospital or pharmacy.
6
PART – II
Medication Error
7
Medication Error
The National Patient Safety Agency Report 2004 (UK) and the IOM Report 2000
(USA) both highlighted that medical errors cause a large number of deaths each year.
These reports recognised that the majority of errors were not the result of reckless
behaviour on the part of health care providers, but occurred as a result of the speed
and complexity of the medication–use cycle. Medication errors are the single most
preventable cause of patient harm. Medication errors are broadly defined as any error
in the prescribing, dispensing, or administration of a drug, irrespective of whether
such errors lead to adverse consequences or not. The landmark IOM report estimated
that errors in medical management lead to between 44,000–98,000 deaths in the US
each year although these figures have been questioned. One of the difficulties in this
field is the variety of terms used in the definition and classification of medication
errors. A more recent definition of medication error as ‘A failure in the treatment
process that leads to, or has the potential to lead to, harm to the patient’ has recently
been proposed, along with a psychological approach to the classification of
medication errors according to whether they are mistakes, slips, or lapses. Medication
errors can occur at any stage of the medication use process and may or may not lead
to an ADE. Depending on the clinical setting, about one-third to one-half of ADEs are
associated with medication errors. The relationship between ADEs, potential ADEs,
and medication errors is shown in Figure 1.
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FIGURE 1 Relationship between ADEs, potential ADEs, and medication errors.
(Source: Morimoto T, Gandhi T, Seger A, Hsieh T, Bates D. Adverse drug events and
medication errors: detection and classification methods. Qual Saf Health Care 2004;
13:306–14.)
Classification of Medication Errors
The multiple steps in the medication chain, from when a drug is prescribed to when a
patient receives the drug, leads to significant scope for error. However, significant
improvements can be achieved from the prevention of medication errors, in terms of
reduced patient morbidity, length of hospital stay, and healthcare costs. A
classification system based on a psychological approach has been proposed which
allows one to identify broad categories of error, quantify them, and develop an
intervention to prevent them. This classification system divides errors into mistakes,
slips, or lapses.
Mistakes may be defined as errors in the planning of an action and may be
knowledge-based (e.g. giving a medication without having established whether the
patient is allergic to that medication) or rule-based. Rule based errors can further be
classified as either the misapplication of a good rule (e.g. injecting a medication into
9
the non-preferred site) or the application of a bad rule or the failure to apply a good
rule (e.g. using excessive doses of a drug). Slips and lapses are errors in the
performance of an action – a slip through an erroneous performance (e.g. writing the
more familiar ‘chlorpropramide’ instead of ‘chlorpromazine’) and a lapse through an
erroneous memory (giving a drug that a patient is already known to be allergic to).
Technical errors are the result of a failure of a particular skill (e.g. in the insertion of a
cannula) and are therefore a subset of slips (skill-based errors).
Medication errors may also be classified according to where they occur in the
medication use cycle, i.e. at the stage of prescribing, dispensing, or administration of a
drug.
Prescribing Errors
Prescribing errors may be defined as the incorrect drug selection for a patient. Such
errors can include the dose, quantity, indication, or prescribing of a contraindicated
drug. Lack of knowledge of the prescribed drug, its recommended dose, and of the
patient details contribute to prescribing errors. Other contributing factors include:
 Illegible handwriting.
 Inaccurate medication history taking.
 Confusion with the drug name.
 Inappropriate use of decimal points. A zero should always precede a decimal
point (e.g. 0·1). Similarly, tenfold errors in dose have occurred as a result of
the use of a trailing zero (e.g. 1·0).
 Use of abbreviations (e.g. AZT has led to confusion between zidovudine and
azathioprine).
 Use of verbal orders. In a four-week UK prospective study of 36,200
prescriptions, 1·5% were found to have a prescribing error, 25% of which
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were potentially serious. When only serious errors were examined, 58% of the
errors originated in the prescribing decision and 42% in medication order
writing.
This distribution is different from that seen in non-serious errors. Of further concern
was the fact that the majority of errors were made by relatively junior medical staff,
who are responsible for the majority of prescribing in hospitals. Medical graduates
themselves feel unprepared to prescribe shortly after graduation, emphasising the
need to ensure sufficient education in prescribing skills. Using a human error
approach, Dean et al. suggested that most mistakes were made as a result of slips in
attention, or because prescribers did not apply relevant rules. Risk factors for the
development of prescribing errors such as work environment, workload, whether
prescribing for own patient, communication within the team, physical and mental well
being, and lack of knowledge were all identified. Organisational factors such as
inadequate training, low perceived importance of prescribing, a hierarchical medical
team, and an absence of self awareness of errors also contributed to these errors. In
primary care the rate of prescribing errors has been estimated to be 11%.
Communication of prescribing information between primary and secondary care has
also been shown to be less than ideal as evidenced by a study which estimated that
50% of patients were failing to take the correct medicine one month after discharge.
Electronic prescribing may help to reduce the risk of prescribing errors resulting from
illegible handwriting, although it can in turn lead to further problems such as incorrect
drug selection. Computerised physician order entry systems eliminate the need for
transcription of orders by nursing staff and for interpretation of orders by pharmacy
staff and have been shown to have a significant effect on reducing medication errors.
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However, the effects of such systems on patient outcomes remain understudied and,
when studied, provide variable results.
Dispensing Errors
Dispensing errors occur at any stage of the dispensing process, from the receipt of the
prescription in the pharmacy to the supply of a dispensed medicine to the patient.
Dispensing errors occur at a rate of 1–24 % and include selection of the wrong
strength or product. This occurs primarily with drugs that have a similar name or
appearance. Lasix® (frusemide) and Losec® (omeprazole) are examples of
proprietary names which, when handwritten, look similar and further emphasise the
need to prescribe generically. In the US, the Food and Drug Administration has
insisted that the proprietary name of Losec® be changed as a result of a number of
fatalities associated with this confusion. Elsewhere, the name Losec® remains. Other
examples of pairs of drugs with similar names where confusion occurs include
amiloride 5 mg and amlodipine 5 mg tablets. Other potential dispensing errors include
wrong dose, wrong drug, or wrong patient and the use of computerised labelling has
led to transposition and typing errors which are among the most common causes of
dispensing error. Approaches to reducing dispensing errors include:
 Ensuring a safe dispensing procedure.
 Separating drugs with a similar name or appearance.
 Keeping interruptions in the dispensing procedure to a minimum and
maintaining the workload of the pharmacist at a safe and manageable level.
 Awareness of high risk drugs such as potassium chloride and cytotoxic agents.
 Introducing safe systematic procedures for dispensing medicines in the
pharmacy.
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Administration Errors
Administration errors occur when a discrepancy occurs between the drug received by
the patient and the drug therapy intended by the prescriber. Drug administration has
long been associated with one of the highest risk areas in nursing practice, with the
‘five rights’ (giving the right dose of the right drug to the right patient at the right time
by the right route) being the cornerstone of nursing education. Drug administration
errors largely involve errors of omission where the drug is not administered for a
variety of reasons. Other types of drug administration errors include an incorrect
administration technique and the administration of incorrect or expired preparations.
The intravenous route of administration is a particularly complex process during
which errors frequently occur and is associated with significant risk to patients as
some have died as a result of the administration of cytotoxic drugs intrathecally
instead of intravenously. The result has been that the Department of Health has made
this particular type of error one of its prime targets in increasing patient safety. A
recent study of intravenous drug administration suggested an error rate of 50% in
either the preparation of the drug or its administration. The most common type of
error identified was the deliberate violation of guidelines when injecting bolus doses
faster than the recommended time of 3–5 minutes. Causes of administration errors
included a lack of perceived risk, poor role models, and lack of available technology.
Mistakes tended to occur when drug preparation or administration involved
uncommon procedures with causes including a lack of knowledge of the preparation
or administration procedures and the complex design of equipment. In contrast a
major error rate of 0·19% in 30,000 cytotoxic preparations has been reported,
suggesting that medication error rates may be lower in situations where intravenous
drugs are administered in specialised units. Whilst this rate may be interpreted as
13
being low, if such a rate were to be extrapolated each year across a large clinical area,
the numbers of patients affected would be significant. Contributing factors to drug
administration errors include a failure to check the patient’s identity prior to
administration and the storage of similar preparations in similar areas. Environmental
factors such a noise, interruptions whilst undertaking a drug round, and poor lighting
may also contribute to these errors. The likelihood of error is also increased where
more than one tablet is required to supply the correct dose or where a calculation to
determine the correct dose is undertaken. Approaches to reduce drug administration
errors include:
 Checking the patient’s identity.
 Ensuring that dosage calculations are checked independently by another health
care professional before the drug is administered.
 Ensuring that the prescription, drug, and patient are in the same place in order
that they may be checked against one another.
 Ensuring the medication is given at the correct time.
 Minimising interruptions during drug rounds.
Incidence of Medication Errors5
Incident rates of medication errors vary widely, the reason for which can be explained
by the different study methods and definitions used. The rate of medication errors
varies between 2 and 14% of patients admitted to hospital, with 1–2% of patients in
the US being harmed as a result, and the majority are due to poor prescribing.
Medication error has been estimated to kill 7,000 patients per annum and accounts for
nearly 1 in 20 hospital admissions in the US. The incidence is likely to be similar in
the UK. Medication errors (7% of all incidents) were the second most common
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incident reported (after patient falls) in a recent National Audit Commission report on
patient safety.
Clinical pharmacists are key to ensuring the safe use of medicines and the current
system whereby wards are visited daily by clinical pharmacists places them in a good
position to recognise particular training needs that can be addressed.
Finally, an alternative approach to reducing medication errors is to target high alert
drugs and procedures. The implementation of a carefully planned series of low-cost
interventions focused on high-risk medications, driven by information derived largely
from internal event reporting, and designed to improve a hospital’s medication safety,
have been shown to significantly reduce patient harm as a result of medication errors.
Drugs which have been identified as having a high potential for error include
potassium chloride, high strength narcotics, cancer chemotherapy, heparin, insulin,
vasoactive drugs, and epidural infusions. Attempts to reduce the harm caused by
intravenous errors in the past have focused on restricting choice and removing the
nurse from the drug preparation step. Restricted supply of strong potassium chloride
to reduce medication errors has long been recommended and only stocking 1 strength
of morphine ampoule on paediatric wards has been successful in preventing errors
involving selection of the incorrect ampoule. Design issues such as ampoules that
look similar and the complex design of infusion pumps have been recognised as risk
factors for intravenous administration errors and put the onus on manufacturers to
supply products to a high safety standard. It has been suggested that the
pharmaceutical industry could apply a framework of human error theory at the
product design stage and include consultations with health care professionals who will
be using their product.
15
PART – III
Use of IT in Medication Management
16
Electronic Medical Records (EMRs)6
Major arguments in favour of EMRs state that its implementation will potentially
decrease medication adverse events, improve health and provide cost savings to
healthcare. Electronic medical records are beneficial if the information is correctly
input into the system. Patient records and history are readily accessible to clinicians
and other healthcare providers. Although cost benefits will not be evident during the
adoption period of the system, a gradual increase will be seen as time passes.
The AAOS believes that patient safety must be a top priority in healthcare. The
provision and maintenance of a safe working environment is the most cost effective
tool for achieving this standard. Some technologies may be cost prohibitive for some
hospital systems. However, cost-efficient, low technology tools are available and
should be used to ensure the safest medication practices in the absence of more
technologically advanced options.
Although CPOE, EMRs, CDSS, bar-coding, and other medical technological
advances have shown evidence of a decrease in medication errors, studies have
revealed that errors have occurred due to faulty computer interface,
miscommunication with other systems and lack of sufficient decision support. Human
errors have also played a role in errors through inexperience, inadequate knowledge,
interruptions and typing errors. Malfunctions or errors must be taken into account
when using this equipment or following procedures. There still remains the chance
that an error can occur in any situation. The medical arena will continue to advance
technologically in hopes to improve patient care and patient safety.
What is CPOE?7
CPOE is an application that enables providers to enter medical orders into a computer
system that is located within an inpatient or ambulatory setting. CPOE replaces more
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traditional methods of placing medication orders, including written (paper
prescriptions), verbal (in person or via telephone), and fax. Most CPOE systems allow
providers to electronically specify medication orders as well as laboratory, admission,
radiology, referral, and procedure orders.
On its own, CPOE has an impact on safety by ensuring that orders are legible. Yet the
value of this functionality is increased by adding clinical decision support (CDS)
systems.6-7 CDS is a technology that provides clinicians with real-time feedback
about a wide-range of diagnostic and treatment-related information as they are
entering electronic orders. By running electronic rules in the background, decision
support can check for a variety of potential errors. Examples include drug
interactions, patient allergies to prescribed medications, medication contraindications,
and renal- and weight-based dosing.
When implemented together, CPOE systems and CDS can improve medication
safety8-11 and quality of care12-15 and reduce costs of care16
. They can also improve
compliance with provider guidelines, 17-18 as well as the efficiency of hospital
workflow19-20
. Most evidence demonstrating the value of CPOE comes from research
in hospital settings. Despite its advantages, less than 5 percent of U.S. hospitals have
fully implemented CPOE.21 A survey of community hospital physicians found that,
even in hospitals that have adopted CPOE, less than half of physicians entered at least
80 percent of their orders electronically.22 The Leapfrog Group estimates that it will
take more than 20 years for CPOE to achieve “maximum penetration” within urban
hospitals.
Scope
Between 2004 and 2005, the Agency for Healthcare Research and Quality (AHRQ)
awarded over $166 million in funding for health IT. The AHRQ health IT portfolio
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consists of grants and contracts that have planned, implemented, and evaluated the
impact of various information technologies on the quality, safety, and efficiency of
health care delivery. This report focuses on a sample of ten grants from the
Transforming Healthcare Quality through Information Technology (THQIT) initiative
that supported implementation or evaluation of inpatient CPOE to improve care for
patients, increase efficiency, and contain costs. For the purposes of this report, we
have defined “inpatient CPOE” as CPOE systems that are implemented in hospital
settings and are used in the care of inpatients.
Our analysis of the grants presents a snapshot of their activities, mostly as they are
completing their implementation cycles. The scope of our analysis was limited to
challenges that grantees faced during development, implementation, or evaluation of a
health IT intervention. Evaluation of the projects’ final outcomes was not part of this
analysis in part because results were not yet uniformly available when this report was
being drafted. AHRQ encourages individual grants to disseminate final outcomes
through peer-reviewed journals, trade publications, and other dissemination vehicles.
To identify THQIT projects that were implementing CPOE interventions in hospital
settings through the THQIT mechanism, we reviewed each grant’s original
application. A convenience sample of nine urban/rural and geographically disparate
groups of projects whose leadership was available to participate was selected for
inclusion in this analysis. The National Resource Center (NRC) interviews with lead
investigators were the primary source of information for this report.
Prior to conducting semi structured interviews, we developed questions and shared
them with all of the lead investigators via email. This process enabled the NRC to
collect from investigators candid accounts of their core project design elements, key
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challenges, lessons learned, and future directions for inpatient CPOE use within their
respective hospitals. These pragmatic stories are presented below.
Interoperability
Effective CPOE implementation requires integration with existing hospital
information systems such as registration, pharmacy, laboratory, and electronic
medical record systems. All of the grantees experienced challenges in connecting
CPOE to other internal hospital systems.
One project found that, even though it had purchased its inpatient and ambulatory
CPOE systems from the same vendor, integrating the data produced by each system
was difficult. Another project reported that its vendor was unwilling to build a bridge
between the CPOE system and the hospital’s existing electronic health record (EHR)
system, which had been purchased from a different vendor. Frustrated, the project
eventually abandoned the first vendor’s system in favour of one from a vendor that
was willing to “play ball” with the hospital’s EHR system vendor.
Bar Code Medication Administration8
Bar Code Medication Administration (BCMA) is a barcode system designed to
prevent medication errors in hospitals.
It consists of a barcode reader, a portable computer with wireless connection, a
computer server, and some software. When a nurse gives medicines to a patient in a
hospital, the nurse can scan barcode on the wristband on the patient and make sure
that the patient is the right patient. The nurse can then scan the barcode on medicine
to verify if it is the right medicine at the right dose at the right time by the right route
("Five rights").
BCMA was first implemented in the Veteran Medical Center in Topeka, Kansas,
USA. It was conceived by a nurse who was inspired by a car rental service using
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barcode. From 1999 to 2001, Department of Veterans Affairs promoted the system to
161 facilities. Cummings and others recommend the BCMA system for its reduction
of errors. They suggest hospitals to consider the system first while they are waiting
for RFID. They also pointed out that adopting the system takes a careful plan and a
deep change in work patterns.
21
PART – IV
Max Healthcare Institute Limited
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Max Healthcare Limited9
Max India Limited was founded in 1988. The first Max healthcare centre was opened
as Max Medcentre in Panchsheel Park, New Delhi with OPD facilities and day care
surgeries in the year 2000.
In 2002, Max Hospital was opened in Pitampura. Dedicated to mother and child care,
Max Hospital, Noida was opened in the year 2002 with services including non-
invasive cardiology, orthopaedics, ENT, ophthalmology, nephrology etc. Max Heart
& Vascular Institute was established in 2004 with advanced cardiac life support and
air evacuation service in Saket.
Max Hospital in Patparganj was founded in the year 2005. In the same year, Max Eye
and Dental Care centre was opened at Panchsheel Park, New Delhi. Max Super
Specialty Hospital in Saket was founded in 2006 and Max Hospital, Gurgaon was
opened in 2007.
Max Hospitals
 Max Super Speciality Hospital, Saket
 Max Super Speciality Hospital (A unit of Devki Devi Foundation), Saket
 Max Super Speciality Hospital, Patparganj
 Max Hospital, Pitampura
 Max Hospital, Noida
 Max Medcentre, Panchsheel Park
 Max Hospital, Gurgaon
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 Max Super Speciality Hospital, Shalimar Bagh
 Max Super Speciality Hospital, Mohali, Punjab
 Max Super Speciality Hospital, Bhatinda, Punjab
Accreditation
 The Max Institute of Minimal Access, Metabolic & Bariatric Surgery has
accredited as a centre of Excellence for providing state-of-the-art Clinical
Services and Surgical Training Programmes for Abdominal Wall Hernia
Surgery.
 Max Super Specialty Hospital, Saket was awarded FICCI award for
Operational Excellence in Healthcare Delivery.
 FICCI awarded Max Super Specialty Hospital, Patparganj with the Healthcare
award for Operational Excellence in Environmental Conservation.
 In the inaugural edition of FICCI Healthcare Excellence Awards, Max Super
Specialty Hospital, Saket was acknowledged one of the Best Hospitals for
‘Excellence in Healthcare Delivery’.
 Max Healthcare was awarded the prestigious DL Shah National Award on
'Economics of Quality' from Quality Council of India.
 The Blood Bank at Max Healthcare was awarded the 'NABH Accreditation for
Blood Bank'.
 Max Super Specialty Hospital and Max Devki Devi Heart & Vascular Institute
at Saket, the two tertiary care hospitals of Max Healthcare, are the first two
24
hospitals of North India to have received the prestigious accreditation from
National Accreditation Board for Hospital & Healthcare Providers.
 Max Labs 24x7 at MSSH, Saket was certified by The National Accreditation
Board for Testing and Calibration Laboratories (NABL).
 Five Hospitals of Max Healthcare are ISO 9001:2000 certified. They are
located at MHVI-Saket, Max Balaji - Patparganj, Max Hospitals at Pitampura
and NOIDA and Max Med Center – Panchsheel. Max Hospital - Pitampura
has also been certified for ISO: 14001:2004.
Medication Dispensing Process in Max IP Pharmacy
1. Pharmacy receives orders in system (running on putty)
2. RPH1 keeps an eye on the system to check the non-verified orders
Order Verification
3. Once RPH1 find any non-verified order he/she starts the process of order
verification
a. Select ward (e.g. SKT-4THFLR-ONCO)
b. Select patient orders
c. Enter order type (1 for IV and 2 for UD)
d. If medicine not available “flag” it. (Depending upon the severity
telephone the Consultant) and finish the order. Otherwise move to next
step
e. System checks for possible ADRs and prompts if any
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f. Accept the order
g. Verify the dose (if system is not picking correct dose automatically,
correct it)
h. Finish the order
4. Label is generated from the printing machine containing the following
information:
a. Patient name
b. Patient SSN
c. Patient Location
d. Drug name, concentration (e.g. 40mg), type (e.g. IV, PWDR, INJ)
e. Instructions (e.g. give 40mg IV once)
f. Date and time of label generation
Drug Pulling
5. RPH2 takes the label and goes to the rack to get the required drug
6. RPH2 takes the required quantity of the drug and pastes the Bar Code on it
a. If Bar Code is not available he/she prints it from the system or asks
RPH4 (present at the system) to generate the Bar Code and tells RPH4
the drug name and batch number
b. RPH2 takes the bar code from the printer and pastes it on the drug
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NOTE: Bar Code contains the details of the drug as Name, concentration,
type (e.g. tab), expiry date, batch number and MRP.
7. RPH2 takes the Bar Coded drug to the central table, puts it in the pouch and
pastes the label on it and puts his/her signature on the label
NOTE: In case of heavy workload another RPH3 is involved. RPH3 takes the
label and speaks the name of drug to RPH2. Now RPH2 brings the Bar Code
pasted medicine to the central table where RPH3 puts it in the pouch, pastes
label on it and signs it.
8. RPH2 Repeats the process for all the labels of same patient
9. RPH2 puts all the drugs of same patient in one bag and gives it to the DEO
(Data Entry Operator) for the billing
Billing Process
10. DEO empties the bag on his/her table and starts the process of billing
a. He / She opens the patient profile in HIS
b. Scan the Bar Code on Drug
c. Enters the issued quantity
d. Repeats the process for all the drugs
e. Saves it
f. Prints the IP TAX INVOICE
11. DEO puts all the drugs back to the bag and staples the INVOICE to it
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12. DEO repeats the process for all the bags
NOTE: If the patient has been discharged the HIS shows a pop-up regarding the same
at the time of billing.
Checking of dispensed Drugs
13. All the billed bags are then moved to the Checking counter either by the DEO
or GDA.
14. At this point another RPH4 does the checking by matching the Drug, Label,
Bar Code and the INVOICE.
Delivery of the Bags
15. Floors are divided among the GDAs for the delivery of the Drugs
16. GDA separates all the bags of his/her floor from the checked bags
17. GDAs have register in which they enter the IP Issue No of the drug, floor
number and take the signature with time of either the attending nurse for the
patient or the nursing team leader.
NOTES:
1. Dispensing time for different categories of medications has been fixed as
follows:
a. STAT orders must be dispensed within 30 minutes
b. NOW orders must be dispensed within 60 minutes
c. Routine orders must be dispensed within 120 minutes
28
2. For the checking process of the dispensed drugs there are two counters; one is
for the STAT/NOW and new orders while the second counter is for the pick-
list orders.
3. In case the drug issued is not in the system (newly introduced) or a drug which
is not available in the pharmacy and pharmacy arranged it from somewhere
else all the processes related to it will be manual.
4. Clearance from pharmacy is sought before discharging the patient. To provide
clearance the DEO checks with the attending nurse for any pharmacy returns
and the manual billing if any. In case of pharmacy returns DEO deletes the
particular item from the patient profile in the HIS and then provide the
clearance.
29
PART – V
Study Design
30
Objectives of the Study
1. To identify the various types of medication errors occurring in the hospital.
2. To find the cause and streamline the medication process for the in-patient to
prevent life threatening medication errors.
3. To determine the reasons and cause for medication errors in the hospital.
4. To find out which level, these medication errors are occurring commonly.
5. To determine what are the common medication errors and how can they be
reduced or at least minimized.
6. To analyse the data and draw conclusion from the study.
7. To make recommendations on the improvement of quality service delivery for
patient satisfaction.
Research Methodology
A literature review was undertaken to find out the various medication errors occurring
all over the globe. To get familiarized with research, various aspects of Medication
errors were studied. To study the processes and policies being followed, from the
point of medication prescription to its administration, longitudinal observation of the
whole process was performed. Thereafter, secondary data was collected from Max
Healthcare Institute Limited, Saket to examine and evaluate the medication errors.
Data Source
This study is based entirely on the observation of the practices being followed and the
secondary data available. Observation included the critical analysis using time
tracking at various stages; the secondary data was collected from the records available
with Department of Medical Quality.
31
Reports of the Root Cause Analysis (RCA) done, by the Clinical Pharmacist is, also a
very important source of data for this study.
Research Design
Research technique is concerned with discovering the nature, cause of problems and
to find the opportunities to improve the existing process to further minimize the
medication errors occurring. A number of techniques have been used to study adverse
medication event – the four research methods used in the study are:
 Direct observation
 Quality Flash review (Monthly record of the Quality indicators)
 Attending rounds with the Floor Administrator to listen for clues that an error
has occurred.
 Discussions with the Pharmacists, Nurses and DEOs to find the actual cause of
the error.
32
PART – VI
Result
33
Results
During the research various aspects of the Medication management system related to
the medication error were studied and the practices used in Max Hospital had been
observed. Based on the secondary data following observations had been noticed:
In the last 3 months i.e., Nov 2011, Dec 2011 and Jan 2012 number of medication
errors found were 11, 5 and 3 respectively. Out of these errors number of dispensing
error was found as 9, 4 and 2 respectively for Nov 2011, Dec 2011 and Jan 2012.
Depending upon the above observation it can be clearly said that an average of more
than 75% errors happening in the hospital is dispensing error.
A graphical representation of both the data is given below:
0
2
4
6
8
10
12
Jan-11
Feb-11
Mar-11
Apr-11
May-11
Jun-11
Jul-11
Aug-11
Sep-11
Oct-11
Nov-11
Dec-11
Jan-12
7
2 2
1
3 3
0
4
3
8
11
5
3
Number of Medication Error
Number of
Medication
Error
34
From the RCAs (not given here due to its confidential nature) done by the Clinical
Pharmacist it is clear that in most of the cases where wrong drug has been issued is
due to the constraint of space availability. As observed during the study the returned
medicines are also kept at the place where medicines are being dispatched from.
There can be a potential risk of mixing of the drugs at this stage.
Few other important observations made are:
 As the hospital has a policy for issue of unidose only it is very likely to have
cut strips of the medicines and hence it is possible that the name and batch
number of medicine, which is being issued, has been cut. In this case the
medicine which is kept after cutting the strip will not be having this
information. If this cut strip get mixed with other look-alike medicines, it can
lead to a potential risk of dispensing error.
 Consultants use CPRS to enter the medication orders. Billing in pharmacy
uses HIS. As there is no direct linkage between the CPRS and HIS it is very
0
2
4
6
8
10
Nov, 11
Dec, 11
Jan, 12
9
4
2
DispensingErrors
Dispensing Errors by Month
35
much possible that billing of wrong medicine in a patient profile can happen
without any warning.
 Though the maximum time limit for delivery of medicines are fixed as follows
o 30 minutes for STAT orders,
o 60 minutes for NOW orders and
o 120 minutes for routine orders
There is no real time checking of the practice being followed is done
 There are coloured bags which were introduced to differentiate the
Chemotherapy, STAT/NOW and Routine drugs. These bags are not being
used as per their purpose and colour scheme is not being followed.
36
PART – VII
Discussion
37
It is evident from the results of the study that in spite of use of the modern technology
available in the Medication Management system there are some opportunities where
improvements can be made.
Pharmacy in the East block MSSH needs to be relocated at a spacious place and some
virtual partitions in the pharmacy must be created to avoid the mixing of the drugs
which are being dispensed from the returned medicines. Also when the medicines are
being returned to the pharmacy it must be ensured by the pharmacy staff that the
returned medicines have the appropriate label including the expiry date. In case the
medicine is cut from a strip and not having the details like name, batch number and
expiry date it must not be returned as it can lead to mistakes in dispensing. For
handling of this problem an appropriate policy must be formulated and implemented.
Hospital uses EMR and moving towards the aim of being a paperless hospital. There
are three major systems (software) in the hospital which work together to make the
medication management system; they are CPRS (VistA), Putty and HIS.
CPRS is used for ordering purpose and uses generic names of the drugs in case of
single salt drug and brand name if the drug is a compound. Putty is used by the
pharmacy staff and receives order from the CPRS.
HIS is used in the pharmacy for inventory management, statistics generation and
billing purpose. This system works on the brand name of the drugs as the price of a
drug is related to its brand and not the generic name.
Due to the different system of operating of the CPRS and HIS, and no communication
between these two regarding the order and issue of a drug to the patient, there is no
warning system to the DEO for issuing wrong medicine to a patient. This leaves a
38
chance of error. From the available records it can be seen that most of the errors
happening can be prevented if a warning system can be incorporated for the same.
A time tracking for the STAT medicines was performed for 3 patients (IP issue
573454, 573474, 573505) and it was found that the fixed time limit of 30 minutes was
not met in two cases. On analysis of the observation on time delay (average 20
minutes from the fixed time limit) was found due to mainly three reasons:
1. Billing of the medicines took more than the fixed time limit of 3 minutes due
to the rush at the billing counter.
2. Checking time also fixed as 3 minutes but took more than 5 minutes for same
reason as in first case.
3. GDA was not available for the delivery of the medicines as he was gone for
the delivery of other medicines.
On analysis of the observation it was found that if the DEO had the knowledge of
these medicines being STAT he/she could have given them priority on other
medicines. To reduce the delay introduction of the coloured bags was recommended.
39
Part – VIII
Recommendations
40
 A check should be put in HIS which can check the CPRS orders of the patient
before billing and if any discrepancy between CPRS and HIS exits the DEO
must be notified immediately.
 Reorder level of medicines must be discussed thoroughly and for the stock of
the medicines which are not available easily in the market reorder level should
be set carefully.
 Trainees should not be made responsible for dispensing of the medication or
the medicines issued by the trainees should pass through the mentor for
corrective checking.
 Enough space should be provided at the billing counter as not to mix the
medicines of two patients.
 Separate space should be provided for the returned medicines and medicines
being dispatched.
 If possible an alert system should be put in the CPRS for alternatives if
medicine is not available at the time, if the order is Stat/Now.
 Bags used for dispensing of the medicines are available in three colours (red,
green and yellow). It should be made a policy that Red colour bags are used
for Stat medicine, Yellow for Now and Green for the routine medicines.
41
References
1. The Times of India, 20th April 2011
2. http://en.wikipedia.org/wiki/Hospital_pharmacy
3. http://www.eahp.eu/Hospital-Pharmacy
4. http://www.ehow.com/facts_5031125_hospital-formulary.html
5. Williams, DJP, J R Coll Physicians Edinb 2007;vol 37 pp. 343-346
6. http://www.aaos.org/
7. www.ahrq.gov
8. http://en.wikipedia.org/wiki/Bar_Code_Medication_Administration#cite_note-
9. http://en.wikipedia.org/wiki/Max_Healthcare#cite_note-4

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Final dissertation

  • 2. 2 Introduction Medicine heals, but this fact doesn`t hold true for every 300th patient admitted to hospital. Call it the law of averages or blame human error for it, but the World Health Organization believes that one in 10 hospital admissions leads to an adverse event and one in 300 admissions in death. An adverse event could range from the patient having to spend an extra day in hospital or missing a dose of medicine, said Dr Nikhil Datar, a gynaecologist and health activist. Unintended medical errors are a big threat to patient safety. Although there is no Indian data available on this topic, WHO lists it among the top 10 killers in the world. While a British National Health System survey in 2009 reported that 15% of its patients were misdiagnosed, an American study published in the Journal of the American Medical Association in 2000 quantified this problem most effectively. It said that there are 2,000 deaths every year from unnecessary surgery; 7,000 deaths from medication errors in hospitals; 20,000 from other errors in hospitals; 80,000 from infections in hospitals; and 106,000 deaths every year from non-error, adverse effects of medications. In all, 225,000 deaths occur per year in the US due to unintentional medical errors. It is to create awareness both among doctors and patients about errors dubbed as unintended medical errors that Datar organized a seminar to discuss patient safety at the Indian Medical Associations office. “In the western nations, it is believed that the incidence of unintentional medical errors is between 10% and 17% of all cases,” said Datar.
  • 3. 3 The Indian government has woken up to the concept. It set up the National Initiative on Patient Safety in the All-India Institute of Medical Sciences. But the idea, as Dr Akhil Sangal of the Indian Confederation for Healthcare Accreditation, points out is not to apportion blame. “When medical negligence occurs, the first question to be asked is who is to blame. We instead have to evolve to a system in which we ask questions about how, when and where the negligence occurred,” said Delhi-based Dr Sangal. Datar illustrates with an example of a 10-year-old leukemia patient in Britain who had to be given a chemotherapy injection. “This is a published report of how due to a series of unintended changes the boy died due to a wrong injection being given to him,” said Datar. The boy ate food that was prohibited before the procedure; he was hence taken hours later by a different department than the cancer doctors. “The injections were given in a particular order but that day due to the mix-up he got the wrong injection and died five days later.” The committee exonerated the doctor because it found the other factors — the when, where and how — had all played a role in the boy`s death. “By talking about patient safety, we can reduce the overall mortality and morbidity associated with hospitalization. Even hospitalization time and costs could come down as a result,” said Dr Mathew Joseph who is attached to PGI Chandigarh and is involved in a nationwide study on clinical practices. “One of our earlier studies had shown unsafe practices associated with 70% of the injections administered in our country,” Joseph said. One in 10 patients is harmed while receiving hospital care.1
  • 4. 4 Hospital pharmacy Hospital pharmacies can usually be found within the premises of the hospital. Hospital pharmacies usually stock a larger range of medications, including more specialized and investigational medications (medicines that are being studied, but have not yet been approved), than would be feasible in the community setting. Hospital pharmacies typically provide medications for the hospitalized patients only, and are not retail establishments. They typically do not provide prescription service to the public. Some hospitals do have retail pharmacies within them, which sell over-the- counter as well as prescription medications to the public, but these are not the actual hospital pharmacy.2 EAHP definition of hospital pharmacy3 EAHP members, meeting during its 38th General Assembly, in June 2008 (Copenhagen, Denmark) adopted the following definition of hospital pharmacy and hospital pharmacist: Hospital pharmacy is the health care service, which comprises the art, practice, and profession of choosing, preparing, storing, compounding, and dispensing medicines and medical devices, advising healthcare professionals and patients on their safe, effective and efficient use. Hospital pharmacy is a specialised field of pharmacy which forms an integrated part of patient health care in a health facility. Hospital pharmacy is the profession that strives to continuously maintain and improve the medication management and pharmaceutical care of patients to the highest standards in a hospital setting. Hospital pharmacists provide services to patients and health care professionals in hospitals.
  • 5. 5 The missions of the hospital pharmacist3  To be part of the medication management in hospitals, which encompasses the entire way in which medicines are selected, procured, delivered, prescribed, administered and reviewed to optimise the contribution that medicines make to producing informed and desired outcomes  To enhance the safety and quality of all medicine related processes affecting patients of the hospital  To ensure the 7 “rights” are respected: right patient, right dose, right route, right time, right drug with the right information and documentation Hospital Formulary4 A hospital formulary is a comprehensive list of every approved drug and therapeutic agent stocked by the pharmacy of that hospital. A formulary includes a list of the drugs; monographs with information on each drug, such as uses, dosages and warnings; and a general reference section with information that might be helpful in treating patients. The purpose of the formulary is to prevent unnecessary spending to stock medications that differ only slightly from one another. A committee of the medical staff and pharmacists decides what drugs are included in the formulary. This committee typically meets once monthly and is known as Pharmaceuticals and Therapeutics Committee (PTC). A physician can request the addition of a drug. The drug is compared with similar agents present on the formulary in terms of effectiveness, side effects and cost. If a necessary drug is not included on the formulary, it can be ordered from a neighboring hospital or pharmacy.
  • 7. 7 Medication Error The National Patient Safety Agency Report 2004 (UK) and the IOM Report 2000 (USA) both highlighted that medical errors cause a large number of deaths each year. These reports recognised that the majority of errors were not the result of reckless behaviour on the part of health care providers, but occurred as a result of the speed and complexity of the medication–use cycle. Medication errors are the single most preventable cause of patient harm. Medication errors are broadly defined as any error in the prescribing, dispensing, or administration of a drug, irrespective of whether such errors lead to adverse consequences or not. The landmark IOM report estimated that errors in medical management lead to between 44,000–98,000 deaths in the US each year although these figures have been questioned. One of the difficulties in this field is the variety of terms used in the definition and classification of medication errors. A more recent definition of medication error as ‘A failure in the treatment process that leads to, or has the potential to lead to, harm to the patient’ has recently been proposed, along with a psychological approach to the classification of medication errors according to whether they are mistakes, slips, or lapses. Medication errors can occur at any stage of the medication use process and may or may not lead to an ADE. Depending on the clinical setting, about one-third to one-half of ADEs are associated with medication errors. The relationship between ADEs, potential ADEs, and medication errors is shown in Figure 1.
  • 8. 8 FIGURE 1 Relationship between ADEs, potential ADEs, and medication errors. (Source: Morimoto T, Gandhi T, Seger A, Hsieh T, Bates D. Adverse drug events and medication errors: detection and classification methods. Qual Saf Health Care 2004; 13:306–14.) Classification of Medication Errors The multiple steps in the medication chain, from when a drug is prescribed to when a patient receives the drug, leads to significant scope for error. However, significant improvements can be achieved from the prevention of medication errors, in terms of reduced patient morbidity, length of hospital stay, and healthcare costs. A classification system based on a psychological approach has been proposed which allows one to identify broad categories of error, quantify them, and develop an intervention to prevent them. This classification system divides errors into mistakes, slips, or lapses. Mistakes may be defined as errors in the planning of an action and may be knowledge-based (e.g. giving a medication without having established whether the patient is allergic to that medication) or rule-based. Rule based errors can further be classified as either the misapplication of a good rule (e.g. injecting a medication into
  • 9. 9 the non-preferred site) or the application of a bad rule or the failure to apply a good rule (e.g. using excessive doses of a drug). Slips and lapses are errors in the performance of an action – a slip through an erroneous performance (e.g. writing the more familiar ‘chlorpropramide’ instead of ‘chlorpromazine’) and a lapse through an erroneous memory (giving a drug that a patient is already known to be allergic to). Technical errors are the result of a failure of a particular skill (e.g. in the insertion of a cannula) and are therefore a subset of slips (skill-based errors). Medication errors may also be classified according to where they occur in the medication use cycle, i.e. at the stage of prescribing, dispensing, or administration of a drug. Prescribing Errors Prescribing errors may be defined as the incorrect drug selection for a patient. Such errors can include the dose, quantity, indication, or prescribing of a contraindicated drug. Lack of knowledge of the prescribed drug, its recommended dose, and of the patient details contribute to prescribing errors. Other contributing factors include:  Illegible handwriting.  Inaccurate medication history taking.  Confusion with the drug name.  Inappropriate use of decimal points. A zero should always precede a decimal point (e.g. 0·1). Similarly, tenfold errors in dose have occurred as a result of the use of a trailing zero (e.g. 1·0).  Use of abbreviations (e.g. AZT has led to confusion between zidovudine and azathioprine).  Use of verbal orders. In a four-week UK prospective study of 36,200 prescriptions, 1·5% were found to have a prescribing error, 25% of which
  • 10. 10 were potentially serious. When only serious errors were examined, 58% of the errors originated in the prescribing decision and 42% in medication order writing. This distribution is different from that seen in non-serious errors. Of further concern was the fact that the majority of errors were made by relatively junior medical staff, who are responsible for the majority of prescribing in hospitals. Medical graduates themselves feel unprepared to prescribe shortly after graduation, emphasising the need to ensure sufficient education in prescribing skills. Using a human error approach, Dean et al. suggested that most mistakes were made as a result of slips in attention, or because prescribers did not apply relevant rules. Risk factors for the development of prescribing errors such as work environment, workload, whether prescribing for own patient, communication within the team, physical and mental well being, and lack of knowledge were all identified. Organisational factors such as inadequate training, low perceived importance of prescribing, a hierarchical medical team, and an absence of self awareness of errors also contributed to these errors. In primary care the rate of prescribing errors has been estimated to be 11%. Communication of prescribing information between primary and secondary care has also been shown to be less than ideal as evidenced by a study which estimated that 50% of patients were failing to take the correct medicine one month after discharge. Electronic prescribing may help to reduce the risk of prescribing errors resulting from illegible handwriting, although it can in turn lead to further problems such as incorrect drug selection. Computerised physician order entry systems eliminate the need for transcription of orders by nursing staff and for interpretation of orders by pharmacy staff and have been shown to have a significant effect on reducing medication errors.
  • 11. 11 However, the effects of such systems on patient outcomes remain understudied and, when studied, provide variable results. Dispensing Errors Dispensing errors occur at any stage of the dispensing process, from the receipt of the prescription in the pharmacy to the supply of a dispensed medicine to the patient. Dispensing errors occur at a rate of 1–24 % and include selection of the wrong strength or product. This occurs primarily with drugs that have a similar name or appearance. Lasix® (frusemide) and Losec® (omeprazole) are examples of proprietary names which, when handwritten, look similar and further emphasise the need to prescribe generically. In the US, the Food and Drug Administration has insisted that the proprietary name of Losec® be changed as a result of a number of fatalities associated with this confusion. Elsewhere, the name Losec® remains. Other examples of pairs of drugs with similar names where confusion occurs include amiloride 5 mg and amlodipine 5 mg tablets. Other potential dispensing errors include wrong dose, wrong drug, or wrong patient and the use of computerised labelling has led to transposition and typing errors which are among the most common causes of dispensing error. Approaches to reducing dispensing errors include:  Ensuring a safe dispensing procedure.  Separating drugs with a similar name or appearance.  Keeping interruptions in the dispensing procedure to a minimum and maintaining the workload of the pharmacist at a safe and manageable level.  Awareness of high risk drugs such as potassium chloride and cytotoxic agents.  Introducing safe systematic procedures for dispensing medicines in the pharmacy.
  • 12. 12 Administration Errors Administration errors occur when a discrepancy occurs between the drug received by the patient and the drug therapy intended by the prescriber. Drug administration has long been associated with one of the highest risk areas in nursing practice, with the ‘five rights’ (giving the right dose of the right drug to the right patient at the right time by the right route) being the cornerstone of nursing education. Drug administration errors largely involve errors of omission where the drug is not administered for a variety of reasons. Other types of drug administration errors include an incorrect administration technique and the administration of incorrect or expired preparations. The intravenous route of administration is a particularly complex process during which errors frequently occur and is associated with significant risk to patients as some have died as a result of the administration of cytotoxic drugs intrathecally instead of intravenously. The result has been that the Department of Health has made this particular type of error one of its prime targets in increasing patient safety. A recent study of intravenous drug administration suggested an error rate of 50% in either the preparation of the drug or its administration. The most common type of error identified was the deliberate violation of guidelines when injecting bolus doses faster than the recommended time of 3–5 minutes. Causes of administration errors included a lack of perceived risk, poor role models, and lack of available technology. Mistakes tended to occur when drug preparation or administration involved uncommon procedures with causes including a lack of knowledge of the preparation or administration procedures and the complex design of equipment. In contrast a major error rate of 0·19% in 30,000 cytotoxic preparations has been reported, suggesting that medication error rates may be lower in situations where intravenous drugs are administered in specialised units. Whilst this rate may be interpreted as
  • 13. 13 being low, if such a rate were to be extrapolated each year across a large clinical area, the numbers of patients affected would be significant. Contributing factors to drug administration errors include a failure to check the patient’s identity prior to administration and the storage of similar preparations in similar areas. Environmental factors such a noise, interruptions whilst undertaking a drug round, and poor lighting may also contribute to these errors. The likelihood of error is also increased where more than one tablet is required to supply the correct dose or where a calculation to determine the correct dose is undertaken. Approaches to reduce drug administration errors include:  Checking the patient’s identity.  Ensuring that dosage calculations are checked independently by another health care professional before the drug is administered.  Ensuring that the prescription, drug, and patient are in the same place in order that they may be checked against one another.  Ensuring the medication is given at the correct time.  Minimising interruptions during drug rounds. Incidence of Medication Errors5 Incident rates of medication errors vary widely, the reason for which can be explained by the different study methods and definitions used. The rate of medication errors varies between 2 and 14% of patients admitted to hospital, with 1–2% of patients in the US being harmed as a result, and the majority are due to poor prescribing. Medication error has been estimated to kill 7,000 patients per annum and accounts for nearly 1 in 20 hospital admissions in the US. The incidence is likely to be similar in the UK. Medication errors (7% of all incidents) were the second most common
  • 14. 14 incident reported (after patient falls) in a recent National Audit Commission report on patient safety. Clinical pharmacists are key to ensuring the safe use of medicines and the current system whereby wards are visited daily by clinical pharmacists places them in a good position to recognise particular training needs that can be addressed. Finally, an alternative approach to reducing medication errors is to target high alert drugs and procedures. The implementation of a carefully planned series of low-cost interventions focused on high-risk medications, driven by information derived largely from internal event reporting, and designed to improve a hospital’s medication safety, have been shown to significantly reduce patient harm as a result of medication errors. Drugs which have been identified as having a high potential for error include potassium chloride, high strength narcotics, cancer chemotherapy, heparin, insulin, vasoactive drugs, and epidural infusions. Attempts to reduce the harm caused by intravenous errors in the past have focused on restricting choice and removing the nurse from the drug preparation step. Restricted supply of strong potassium chloride to reduce medication errors has long been recommended and only stocking 1 strength of morphine ampoule on paediatric wards has been successful in preventing errors involving selection of the incorrect ampoule. Design issues such as ampoules that look similar and the complex design of infusion pumps have been recognised as risk factors for intravenous administration errors and put the onus on manufacturers to supply products to a high safety standard. It has been suggested that the pharmaceutical industry could apply a framework of human error theory at the product design stage and include consultations with health care professionals who will be using their product.
  • 15. 15 PART – III Use of IT in Medication Management
  • 16. 16 Electronic Medical Records (EMRs)6 Major arguments in favour of EMRs state that its implementation will potentially decrease medication adverse events, improve health and provide cost savings to healthcare. Electronic medical records are beneficial if the information is correctly input into the system. Patient records and history are readily accessible to clinicians and other healthcare providers. Although cost benefits will not be evident during the adoption period of the system, a gradual increase will be seen as time passes. The AAOS believes that patient safety must be a top priority in healthcare. The provision and maintenance of a safe working environment is the most cost effective tool for achieving this standard. Some technologies may be cost prohibitive for some hospital systems. However, cost-efficient, low technology tools are available and should be used to ensure the safest medication practices in the absence of more technologically advanced options. Although CPOE, EMRs, CDSS, bar-coding, and other medical technological advances have shown evidence of a decrease in medication errors, studies have revealed that errors have occurred due to faulty computer interface, miscommunication with other systems and lack of sufficient decision support. Human errors have also played a role in errors through inexperience, inadequate knowledge, interruptions and typing errors. Malfunctions or errors must be taken into account when using this equipment or following procedures. There still remains the chance that an error can occur in any situation. The medical arena will continue to advance technologically in hopes to improve patient care and patient safety. What is CPOE?7 CPOE is an application that enables providers to enter medical orders into a computer system that is located within an inpatient or ambulatory setting. CPOE replaces more
  • 17. 17 traditional methods of placing medication orders, including written (paper prescriptions), verbal (in person or via telephone), and fax. Most CPOE systems allow providers to electronically specify medication orders as well as laboratory, admission, radiology, referral, and procedure orders. On its own, CPOE has an impact on safety by ensuring that orders are legible. Yet the value of this functionality is increased by adding clinical decision support (CDS) systems.6-7 CDS is a technology that provides clinicians with real-time feedback about a wide-range of diagnostic and treatment-related information as they are entering electronic orders. By running electronic rules in the background, decision support can check for a variety of potential errors. Examples include drug interactions, patient allergies to prescribed medications, medication contraindications, and renal- and weight-based dosing. When implemented together, CPOE systems and CDS can improve medication safety8-11 and quality of care12-15 and reduce costs of care16 . They can also improve compliance with provider guidelines, 17-18 as well as the efficiency of hospital workflow19-20 . Most evidence demonstrating the value of CPOE comes from research in hospital settings. Despite its advantages, less than 5 percent of U.S. hospitals have fully implemented CPOE.21 A survey of community hospital physicians found that, even in hospitals that have adopted CPOE, less than half of physicians entered at least 80 percent of their orders electronically.22 The Leapfrog Group estimates that it will take more than 20 years for CPOE to achieve “maximum penetration” within urban hospitals. Scope Between 2004 and 2005, the Agency for Healthcare Research and Quality (AHRQ) awarded over $166 million in funding for health IT. The AHRQ health IT portfolio
  • 18. 18 consists of grants and contracts that have planned, implemented, and evaluated the impact of various information technologies on the quality, safety, and efficiency of health care delivery. This report focuses on a sample of ten grants from the Transforming Healthcare Quality through Information Technology (THQIT) initiative that supported implementation or evaluation of inpatient CPOE to improve care for patients, increase efficiency, and contain costs. For the purposes of this report, we have defined “inpatient CPOE” as CPOE systems that are implemented in hospital settings and are used in the care of inpatients. Our analysis of the grants presents a snapshot of their activities, mostly as they are completing their implementation cycles. The scope of our analysis was limited to challenges that grantees faced during development, implementation, or evaluation of a health IT intervention. Evaluation of the projects’ final outcomes was not part of this analysis in part because results were not yet uniformly available when this report was being drafted. AHRQ encourages individual grants to disseminate final outcomes through peer-reviewed journals, trade publications, and other dissemination vehicles. To identify THQIT projects that were implementing CPOE interventions in hospital settings through the THQIT mechanism, we reviewed each grant’s original application. A convenience sample of nine urban/rural and geographically disparate groups of projects whose leadership was available to participate was selected for inclusion in this analysis. The National Resource Center (NRC) interviews with lead investigators were the primary source of information for this report. Prior to conducting semi structured interviews, we developed questions and shared them with all of the lead investigators via email. This process enabled the NRC to collect from investigators candid accounts of their core project design elements, key
  • 19. 19 challenges, lessons learned, and future directions for inpatient CPOE use within their respective hospitals. These pragmatic stories are presented below. Interoperability Effective CPOE implementation requires integration with existing hospital information systems such as registration, pharmacy, laboratory, and electronic medical record systems. All of the grantees experienced challenges in connecting CPOE to other internal hospital systems. One project found that, even though it had purchased its inpatient and ambulatory CPOE systems from the same vendor, integrating the data produced by each system was difficult. Another project reported that its vendor was unwilling to build a bridge between the CPOE system and the hospital’s existing electronic health record (EHR) system, which had been purchased from a different vendor. Frustrated, the project eventually abandoned the first vendor’s system in favour of one from a vendor that was willing to “play ball” with the hospital’s EHR system vendor. Bar Code Medication Administration8 Bar Code Medication Administration (BCMA) is a barcode system designed to prevent medication errors in hospitals. It consists of a barcode reader, a portable computer with wireless connection, a computer server, and some software. When a nurse gives medicines to a patient in a hospital, the nurse can scan barcode on the wristband on the patient and make sure that the patient is the right patient. The nurse can then scan the barcode on medicine to verify if it is the right medicine at the right dose at the right time by the right route ("Five rights"). BCMA was first implemented in the Veteran Medical Center in Topeka, Kansas, USA. It was conceived by a nurse who was inspired by a car rental service using
  • 20. 20 barcode. From 1999 to 2001, Department of Veterans Affairs promoted the system to 161 facilities. Cummings and others recommend the BCMA system for its reduction of errors. They suggest hospitals to consider the system first while they are waiting for RFID. They also pointed out that adopting the system takes a careful plan and a deep change in work patterns.
  • 21. 21 PART – IV Max Healthcare Institute Limited
  • 22. 22 Max Healthcare Limited9 Max India Limited was founded in 1988. The first Max healthcare centre was opened as Max Medcentre in Panchsheel Park, New Delhi with OPD facilities and day care surgeries in the year 2000. In 2002, Max Hospital was opened in Pitampura. Dedicated to mother and child care, Max Hospital, Noida was opened in the year 2002 with services including non- invasive cardiology, orthopaedics, ENT, ophthalmology, nephrology etc. Max Heart & Vascular Institute was established in 2004 with advanced cardiac life support and air evacuation service in Saket. Max Hospital in Patparganj was founded in the year 2005. In the same year, Max Eye and Dental Care centre was opened at Panchsheel Park, New Delhi. Max Super Specialty Hospital in Saket was founded in 2006 and Max Hospital, Gurgaon was opened in 2007. Max Hospitals  Max Super Speciality Hospital, Saket  Max Super Speciality Hospital (A unit of Devki Devi Foundation), Saket  Max Super Speciality Hospital, Patparganj  Max Hospital, Pitampura  Max Hospital, Noida  Max Medcentre, Panchsheel Park  Max Hospital, Gurgaon
  • 23. 23  Max Super Speciality Hospital, Shalimar Bagh  Max Super Speciality Hospital, Mohali, Punjab  Max Super Speciality Hospital, Bhatinda, Punjab Accreditation  The Max Institute of Minimal Access, Metabolic & Bariatric Surgery has accredited as a centre of Excellence for providing state-of-the-art Clinical Services and Surgical Training Programmes for Abdominal Wall Hernia Surgery.  Max Super Specialty Hospital, Saket was awarded FICCI award for Operational Excellence in Healthcare Delivery.  FICCI awarded Max Super Specialty Hospital, Patparganj with the Healthcare award for Operational Excellence in Environmental Conservation.  In the inaugural edition of FICCI Healthcare Excellence Awards, Max Super Specialty Hospital, Saket was acknowledged one of the Best Hospitals for ‘Excellence in Healthcare Delivery’.  Max Healthcare was awarded the prestigious DL Shah National Award on 'Economics of Quality' from Quality Council of India.  The Blood Bank at Max Healthcare was awarded the 'NABH Accreditation for Blood Bank'.  Max Super Specialty Hospital and Max Devki Devi Heart & Vascular Institute at Saket, the two tertiary care hospitals of Max Healthcare, are the first two
  • 24. 24 hospitals of North India to have received the prestigious accreditation from National Accreditation Board for Hospital & Healthcare Providers.  Max Labs 24x7 at MSSH, Saket was certified by The National Accreditation Board for Testing and Calibration Laboratories (NABL).  Five Hospitals of Max Healthcare are ISO 9001:2000 certified. They are located at MHVI-Saket, Max Balaji - Patparganj, Max Hospitals at Pitampura and NOIDA and Max Med Center – Panchsheel. Max Hospital - Pitampura has also been certified for ISO: 14001:2004. Medication Dispensing Process in Max IP Pharmacy 1. Pharmacy receives orders in system (running on putty) 2. RPH1 keeps an eye on the system to check the non-verified orders Order Verification 3. Once RPH1 find any non-verified order he/she starts the process of order verification a. Select ward (e.g. SKT-4THFLR-ONCO) b. Select patient orders c. Enter order type (1 for IV and 2 for UD) d. If medicine not available “flag” it. (Depending upon the severity telephone the Consultant) and finish the order. Otherwise move to next step e. System checks for possible ADRs and prompts if any
  • 25. 25 f. Accept the order g. Verify the dose (if system is not picking correct dose automatically, correct it) h. Finish the order 4. Label is generated from the printing machine containing the following information: a. Patient name b. Patient SSN c. Patient Location d. Drug name, concentration (e.g. 40mg), type (e.g. IV, PWDR, INJ) e. Instructions (e.g. give 40mg IV once) f. Date and time of label generation Drug Pulling 5. RPH2 takes the label and goes to the rack to get the required drug 6. RPH2 takes the required quantity of the drug and pastes the Bar Code on it a. If Bar Code is not available he/she prints it from the system or asks RPH4 (present at the system) to generate the Bar Code and tells RPH4 the drug name and batch number b. RPH2 takes the bar code from the printer and pastes it on the drug
  • 26. 26 NOTE: Bar Code contains the details of the drug as Name, concentration, type (e.g. tab), expiry date, batch number and MRP. 7. RPH2 takes the Bar Coded drug to the central table, puts it in the pouch and pastes the label on it and puts his/her signature on the label NOTE: In case of heavy workload another RPH3 is involved. RPH3 takes the label and speaks the name of drug to RPH2. Now RPH2 brings the Bar Code pasted medicine to the central table where RPH3 puts it in the pouch, pastes label on it and signs it. 8. RPH2 Repeats the process for all the labels of same patient 9. RPH2 puts all the drugs of same patient in one bag and gives it to the DEO (Data Entry Operator) for the billing Billing Process 10. DEO empties the bag on his/her table and starts the process of billing a. He / She opens the patient profile in HIS b. Scan the Bar Code on Drug c. Enters the issued quantity d. Repeats the process for all the drugs e. Saves it f. Prints the IP TAX INVOICE 11. DEO puts all the drugs back to the bag and staples the INVOICE to it
  • 27. 27 12. DEO repeats the process for all the bags NOTE: If the patient has been discharged the HIS shows a pop-up regarding the same at the time of billing. Checking of dispensed Drugs 13. All the billed bags are then moved to the Checking counter either by the DEO or GDA. 14. At this point another RPH4 does the checking by matching the Drug, Label, Bar Code and the INVOICE. Delivery of the Bags 15. Floors are divided among the GDAs for the delivery of the Drugs 16. GDA separates all the bags of his/her floor from the checked bags 17. GDAs have register in which they enter the IP Issue No of the drug, floor number and take the signature with time of either the attending nurse for the patient or the nursing team leader. NOTES: 1. Dispensing time for different categories of medications has been fixed as follows: a. STAT orders must be dispensed within 30 minutes b. NOW orders must be dispensed within 60 minutes c. Routine orders must be dispensed within 120 minutes
  • 28. 28 2. For the checking process of the dispensed drugs there are two counters; one is for the STAT/NOW and new orders while the second counter is for the pick- list orders. 3. In case the drug issued is not in the system (newly introduced) or a drug which is not available in the pharmacy and pharmacy arranged it from somewhere else all the processes related to it will be manual. 4. Clearance from pharmacy is sought before discharging the patient. To provide clearance the DEO checks with the attending nurse for any pharmacy returns and the manual billing if any. In case of pharmacy returns DEO deletes the particular item from the patient profile in the HIS and then provide the clearance.
  • 30. 30 Objectives of the Study 1. To identify the various types of medication errors occurring in the hospital. 2. To find the cause and streamline the medication process for the in-patient to prevent life threatening medication errors. 3. To determine the reasons and cause for medication errors in the hospital. 4. To find out which level, these medication errors are occurring commonly. 5. To determine what are the common medication errors and how can they be reduced or at least minimized. 6. To analyse the data and draw conclusion from the study. 7. To make recommendations on the improvement of quality service delivery for patient satisfaction. Research Methodology A literature review was undertaken to find out the various medication errors occurring all over the globe. To get familiarized with research, various aspects of Medication errors were studied. To study the processes and policies being followed, from the point of medication prescription to its administration, longitudinal observation of the whole process was performed. Thereafter, secondary data was collected from Max Healthcare Institute Limited, Saket to examine and evaluate the medication errors. Data Source This study is based entirely on the observation of the practices being followed and the secondary data available. Observation included the critical analysis using time tracking at various stages; the secondary data was collected from the records available with Department of Medical Quality.
  • 31. 31 Reports of the Root Cause Analysis (RCA) done, by the Clinical Pharmacist is, also a very important source of data for this study. Research Design Research technique is concerned with discovering the nature, cause of problems and to find the opportunities to improve the existing process to further minimize the medication errors occurring. A number of techniques have been used to study adverse medication event – the four research methods used in the study are:  Direct observation  Quality Flash review (Monthly record of the Quality indicators)  Attending rounds with the Floor Administrator to listen for clues that an error has occurred.  Discussions with the Pharmacists, Nurses and DEOs to find the actual cause of the error.
  • 33. 33 Results During the research various aspects of the Medication management system related to the medication error were studied and the practices used in Max Hospital had been observed. Based on the secondary data following observations had been noticed: In the last 3 months i.e., Nov 2011, Dec 2011 and Jan 2012 number of medication errors found were 11, 5 and 3 respectively. Out of these errors number of dispensing error was found as 9, 4 and 2 respectively for Nov 2011, Dec 2011 and Jan 2012. Depending upon the above observation it can be clearly said that an average of more than 75% errors happening in the hospital is dispensing error. A graphical representation of both the data is given below: 0 2 4 6 8 10 12 Jan-11 Feb-11 Mar-11 Apr-11 May-11 Jun-11 Jul-11 Aug-11 Sep-11 Oct-11 Nov-11 Dec-11 Jan-12 7 2 2 1 3 3 0 4 3 8 11 5 3 Number of Medication Error Number of Medication Error
  • 34. 34 From the RCAs (not given here due to its confidential nature) done by the Clinical Pharmacist it is clear that in most of the cases where wrong drug has been issued is due to the constraint of space availability. As observed during the study the returned medicines are also kept at the place where medicines are being dispatched from. There can be a potential risk of mixing of the drugs at this stage. Few other important observations made are:  As the hospital has a policy for issue of unidose only it is very likely to have cut strips of the medicines and hence it is possible that the name and batch number of medicine, which is being issued, has been cut. In this case the medicine which is kept after cutting the strip will not be having this information. If this cut strip get mixed with other look-alike medicines, it can lead to a potential risk of dispensing error.  Consultants use CPRS to enter the medication orders. Billing in pharmacy uses HIS. As there is no direct linkage between the CPRS and HIS it is very 0 2 4 6 8 10 Nov, 11 Dec, 11 Jan, 12 9 4 2 DispensingErrors Dispensing Errors by Month
  • 35. 35 much possible that billing of wrong medicine in a patient profile can happen without any warning.  Though the maximum time limit for delivery of medicines are fixed as follows o 30 minutes for STAT orders, o 60 minutes for NOW orders and o 120 minutes for routine orders There is no real time checking of the practice being followed is done  There are coloured bags which were introduced to differentiate the Chemotherapy, STAT/NOW and Routine drugs. These bags are not being used as per their purpose and colour scheme is not being followed.
  • 37. 37 It is evident from the results of the study that in spite of use of the modern technology available in the Medication Management system there are some opportunities where improvements can be made. Pharmacy in the East block MSSH needs to be relocated at a spacious place and some virtual partitions in the pharmacy must be created to avoid the mixing of the drugs which are being dispensed from the returned medicines. Also when the medicines are being returned to the pharmacy it must be ensured by the pharmacy staff that the returned medicines have the appropriate label including the expiry date. In case the medicine is cut from a strip and not having the details like name, batch number and expiry date it must not be returned as it can lead to mistakes in dispensing. For handling of this problem an appropriate policy must be formulated and implemented. Hospital uses EMR and moving towards the aim of being a paperless hospital. There are three major systems (software) in the hospital which work together to make the medication management system; they are CPRS (VistA), Putty and HIS. CPRS is used for ordering purpose and uses generic names of the drugs in case of single salt drug and brand name if the drug is a compound. Putty is used by the pharmacy staff and receives order from the CPRS. HIS is used in the pharmacy for inventory management, statistics generation and billing purpose. This system works on the brand name of the drugs as the price of a drug is related to its brand and not the generic name. Due to the different system of operating of the CPRS and HIS, and no communication between these two regarding the order and issue of a drug to the patient, there is no warning system to the DEO for issuing wrong medicine to a patient. This leaves a
  • 38. 38 chance of error. From the available records it can be seen that most of the errors happening can be prevented if a warning system can be incorporated for the same. A time tracking for the STAT medicines was performed for 3 patients (IP issue 573454, 573474, 573505) and it was found that the fixed time limit of 30 minutes was not met in two cases. On analysis of the observation on time delay (average 20 minutes from the fixed time limit) was found due to mainly three reasons: 1. Billing of the medicines took more than the fixed time limit of 3 minutes due to the rush at the billing counter. 2. Checking time also fixed as 3 minutes but took more than 5 minutes for same reason as in first case. 3. GDA was not available for the delivery of the medicines as he was gone for the delivery of other medicines. On analysis of the observation it was found that if the DEO had the knowledge of these medicines being STAT he/she could have given them priority on other medicines. To reduce the delay introduction of the coloured bags was recommended.
  • 40. 40  A check should be put in HIS which can check the CPRS orders of the patient before billing and if any discrepancy between CPRS and HIS exits the DEO must be notified immediately.  Reorder level of medicines must be discussed thoroughly and for the stock of the medicines which are not available easily in the market reorder level should be set carefully.  Trainees should not be made responsible for dispensing of the medication or the medicines issued by the trainees should pass through the mentor for corrective checking.  Enough space should be provided at the billing counter as not to mix the medicines of two patients.  Separate space should be provided for the returned medicines and medicines being dispatched.  If possible an alert system should be put in the CPRS for alternatives if medicine is not available at the time, if the order is Stat/Now.  Bags used for dispensing of the medicines are available in three colours (red, green and yellow). It should be made a policy that Red colour bags are used for Stat medicine, Yellow for Now and Green for the routine medicines.
  • 41. 41 References 1. The Times of India, 20th April 2011 2. http://en.wikipedia.org/wiki/Hospital_pharmacy 3. http://www.eahp.eu/Hospital-Pharmacy 4. http://www.ehow.com/facts_5031125_hospital-formulary.html 5. Williams, DJP, J R Coll Physicians Edinb 2007;vol 37 pp. 343-346 6. http://www.aaos.org/ 7. www.ahrq.gov 8. http://en.wikipedia.org/wiki/Bar_Code_Medication_Administration#cite_note- 9. http://en.wikipedia.org/wiki/Max_Healthcare#cite_note-4