Patient safety is emerging as a new healthcare discipline that
emphasizes on reporting, analysis and prevention of medical errors that
often lead to adverse healthcare events. Worldwide, the delivery of
healthcare is challenged by a wide range of safety problems. The
traditional medical oath – “First do no harm”, is not violated by any
healthcare professional intentionally, but at the same time patients are
being harmed everyday globally.

Patient safety is not and
cannot be, the responsibility of any single individual. The patient
safety system is composed of a team of individuals from different
disciplines like, physicians, nurses, pharmacists, pathological
laboratory personnel, radiology department personnel, dieticians etc. In
essence, a patient safety system is a dynamic system which requires
team work to develop and to run successfully.

Errors and adverse
events can result from a variety of issues at different levels within
healthcare—for example, at the level of government support (e.g.
funding) at the level of a healthcare facility or system (e.g. structure
or processes) or at the point of intervention between patients and
practitioners (e.g. human error). Most important of these avoidable
errors are the human errors which includes prescription errors,
laboratory tests errors, administration errors, dispensing errors, error
of patient identification and surgical errors etc.

In 2005, the
World Health Organization (WHO) launched the World Alliance for Patient
Safety and identified six action areas. One of these action areas is
the development of “Solutions for Patient Safety”. In the same year, the
Joint Commission and Joint Commission International were designated as a
WHO Collaborating Centre for Patient Safety Solutions to initiate and
coordinate the work of developing and disseminating solutions for
patient safety. The output from this component of the World Alliance is
delivered to the global healthcare community as “Patient Safety
Solutions”.

The term “Patient Safety Solution” has been defined
as, any system design or intervention that has demonstrated the ability
to prevent or mitigate patient harm stemming from the processes of
healthcare. These solutions are meant to reduce the toll of healthcare
related harm affecting millions of patients daily, worldwide. The
patient safety solutions were launched on May 2, 2007 by the World
Health Organization (WHO) at the Washington Press Club, Washington DC.

The nine major issues pointed out by the World Alliance for patient safety include the following:

Look Alike, Sound Alike (LASA) medication names
The
existence of confusing drug names is one of the most common causes of
medication errors and is of concern worldwide. With tens of thousands of
drugs currently on the market, the potential for error due to confusing
drug names is significant. This includes non-proprietary names and
proprietary (brand or trademarked) names. Many drug names look or sound
like other drug names.

Contributing to this confusion are
illegible handwriting, incomplete knowledge of drug names, newly
available products, similar packaging or labelling, similar clinical
use, similar strengths, dosage forms, frequency of administration and
the failure of manufacturers and regulatory authorities to recognize the
potential for error and to conduct rigorous risk assessments, both for
non-proprietary and brand names, prior to approving new product names.

Patient Identification
Throughout
the healthcare industry, the failure to correctly identify patients
continues to result in medication errors, transfusion errors, testing
errors, wrong person procedures and the discharge of infants to the
wrong families. The major areas where patient misidentification can
occur include drug administration, phlebotomy, blood transfusions, and
surgical interventions. The trend towards limiting working hours for
clinical team members leads to an increased number of team members
caring for each patient thereby increasing the likelihood of hand-over
and other communication problems.

Communication during patient hand – over
During
an episode of disease or period of care, a patient can potentially be
treated by a number of healthcare practitioners and specialists in
multiple settings, including primary care, specialized outpatient care,
emergency care, surgical care, intensive care and rehabilitation.
Additionally, patients will often move between areas of diagnosis,
treatment and care on a regular basis and may encounter three shifts of
staff each day—introducing a safety risk to the patient at each
interval. The hand-over (or hand-off) communication between units and
between and amongst care teams might not include all the essential
information, or information may be misunderstood. These gaps in
communication can cause serious breakdowns in the continuity of care,
inappropriate treatment, and potential harm to the patient.

Performance of correct procedure at correct body site
Wrong
site procedures—including wrong side, wrong organ, wrong site, wrong
implant and wrong person—are an infrequent, though not “rare” event as
evidenced by a steady increase in the number of reported cases.
Considered preventable occurrences, these cases are largely the result
of miscommunication and unavailable or incorrect information. Detailed
analyses of these cases indicate that a major contributing factor to
error is the lack of a standardized pre-operative process and likely a
degree of staff automaticity (checking without thinking) in the
approaches to the preoperative check routines.

Control of concentrated electrolyte solutions

All drugs, biologics, vaccines and contrast media have a defined risk
profile. Concentrated electrolyte solutions for injection are especially
dangerous. Reports of death and serious injury/ disability related to
the inappropriate administration of these drugs have been continuous and
dramatic. Most of the time it is not clinically possible to reverse the
effects of concentrated electrolytes when not administered properly
(e.g. not properly diluted, confused with another drug, etc) and hence,
patient death is usually the observed outcome. Although concentrated KCl
is the most common medication implicated in electrolyte administration
errors, potassium phosphate concentrate and hypertonic (>0.9%) saline
also have lethal consequences if improperly administered. In short,
these agents are deadly when not prepared and administered properly.

Assuring medication accuracy at transitions in care
Errors
are common as medications are procured, prescribed, dispensed,
administered and monitored but, they occur most frequently during the
prescribing and administering actions. Medication reconciliation is a
process designed to prevent medication errors at patient transition
points.

Avoiding catheter and tubing misconnections
Tubing,
catheters and syringes are a fundamental aspect of daily healthcare
provision for the delivery of medications and fluids to patients. The
design of these devices is such that it is possible to inadvertently
connect the wrong syringes and tubing and then deliver medication or
fluids through an unintended and therefore wrong route. This is due to
the multiple devices used for different routes of administration being
able to connect to each other. The best solution lies with introducing
design features that prevent misconnections and prompt the user to take
the correct action.

Single use of injection devices
One
of the biggest global concerns is the spread of the human
immunodeficiency virus (HIV), the hepatitis B virus (HBV), and the
hepatitis C virus (HCV) due to the reuse of injection devices. This
problem is worldwide, affecting developed countries as well as
developing countries and many studies have demonstrated the extent and
the severity of the problem. While there is significant variation
between countries, WHO estimates that in sub-Saharan Africa,
approximately 18% of injections are given with reused syringes or
needles that have not been sterilized. However, unsafe medical
injections are believed to occur most frequently in South Asia, the
Eastern Mediterranean, and the Western Pacific regions. Together, these
account for 88% of all injections administered with reused, unsterilized
equipment. The severe consequences of needle reuse also underscored the
need to reinforce fundamental infection control techniques among
healthcare workers. These facts emphasize the need for immediate and
decisive action to prevent the unsafe re-use of injection devices.

Improved hand hygiene to prevent HAI
It
is estimated that at any one time, more than 1.4 million people
worldwide are suffering from infections acquired in hospitals.
Healthcare-associated infections (HAI) occur worldwide and affect both
developed and developing countries. Hand hygiene is therefore a
fundamental action for ensuring patient safety which should occur in a
timely and effective manner in the process of care. However,
unacceptably low compliance with hand hygiene is universal in
healthcare. This contributes to the transmission of microbes capable of
causing avoidable HAIs.

Health is of equal importance to all the
countries. Several developed nations have their own patient safety
systems. In 1999, Institute of Medicine published a report that noted
that, in addition to causing human suffering and death, medical errors
are financially costly. With regard to direct costs, the IOM estimated
that, among the US hospital inpatients, medication errors alone cost
approximately $ two billion annually. The IOM report estimated that the
total indirect cost of medical errors that result in patient harm lies
between $17–29 billion, annually. Finally, and equally perilous in the
long run, medical errors undermine patients’ and health professionals’
confidence in the healthcare system itself.

The nine patient
safety strategies recommended by WHO are easy to be adopted in countries
which don’t have patient safety systems in place. Depending upon the
strategy in question, a set of people would need training to deliver
that outcome. All healthcare professionals, including clinicians,
pharmacists, nurses and technical staff will contribute to a safer
environment for the patient. In India, a total of 13 hospitals are
accredited by the Joint Commission International. JCI has approximately
300 standards which hospitals must meet and 1200 measurable elements.
These standards address important topics such as the qualifications of
doctors and nurses, properly assessing patients to match care to their
identified medical needs, anaesthesia procedures and safe use of
medicines. JCI demands that each prescription or order is reviewed and
evaluated for appropriateness before it reaches the patient.

The
research group at NIPER, SAS Nagar is working to generate hard data in
close collaboration with the hospitals and healthcare professionals in
the chain. Contrary to the common belief, the healthcare professionals
are very much willing to discuss the solutions offered which are based
on strong evidence. To cite one example, it was demonstrated that drug
interactions are the leading cause of medication errors. A careful
pharmacist holds the key to provide safer care to the patients.

In
view of these, it is clear that the clinical pharmacist has to play a
very important role in patient safety by identifying and intervening
with the medical care issues. In the evolving scenario in India, JCI
accredited hospitals also give opportunities for the clinical
pharmacist.

Acknowledgement: The authors wish to acknowledge the
inputs that have been drawn from various resources in preparation of
this write-up.

Pramil
Tiwari is Professor and Head, Department of Pharmacy Practice, NIPER,
S.A.S. Nagar & Sanjay is M. Pharm (Pharmacy Practice)