Safe Use of

Medications
Medication Errors,
Evaluation & Precautions For medication Error
Role of Pharmacist in controlling medication
errors
Program for safe use of drugs
Medicine safety
• Medicine safety may be defined as safe and quality
usage of medicine
• Safe use of drugs encompasses an error free
medication without occurrence of any drug
interaction, adverse drug reaction and drug toxicity.
• Unsafe medication may lead to fatality or a severe
injury or life time disability
• Unsafe medication can also increase patient
expenditure for additional treatment or a longer
institutional stay.
Cont.
• Safe use of medications (handling and administration of drugs )is the
primary responsibility of Pharmacy and therapeutic committee as an
ongoing program .
• Pharmacist has a legal and professional duty for safe drug use in an
institution
 Medication Errors
Any preventable event that may cause or lead to inappropriate
medication use or patient harm while the medication is in the
control of the health care professional, patient, or consumer
In simple word deviation of a medication dose from the
physician’s order or prescription
• In broader perspective medication error may be
administration of wrong medicine
wrong dose or wrong route or wrong patient
failure to administer prescribed medicine
Failure to administered on time or prescribed duration of
time
 Key Medication Errors
Statistics
• The US Food and Drug Administration receives over 100,000 reports of
medication errors each year.
• 41% of US citizens have claimed to be the sufferer of a medical error.
Sometimes, this was a personal encounter or from watching it happen
to someone else, like a family or friend.
• There are over 7 million American patients that have been impacted in
some way by medical errors each year.
• Every year, there are 7,000 to 9,000 Americans who die from medical
errors.
• Approximately 530,000 injury incidents occur yearly in outpatient clinics
due to medication errors.
• 10% of the patients in every hospital will be part of a medication error.
What Are The Main Causes Of
Medication Errors?

•Prescribing
•Communication
•Administration
•Ordering
•Documentation
 CASE SCENARIO:
Mrs. Ahmed a 68 years old female was admitted to the hospital for an exacerbation of her
COPD. She was prescribed several medications, including bronchodilators, corticosteroids,
and antihypertensives. During her stay, a medication error occurred, leading to significant
health complications.
• Incident Description
On the third day of her hospital stay, Mrs. Ahmed was mistakenly administered a double
dose of her corticosteroid medication due to a transcription error in her medication chart.
The nurse, unaware of the error, administered the medication according to the chart.
Factors Contributing to the Error:
Transcription Error
Lack of Double-Checking
Communication Breakdown
Categories of Medication
Errors
Medication errors is one of the common problem in Hospitals
as well as in out-patient, we can categories medication errors
as
• Omission error
• Unauthorized Drug Error
• Wrong dose Error
• Wrong route Error
• Wrong site Error
• Wrong rate Error
• Wrong dosage form Error
• Wrong time Error
• Wrong preparation of dose/Incorrect administration
techniques
 Omission Error
• Failure to administer an ordered dose
• Intake of less than prescribe dose
• Discontinuation of drug before prescribe time

Omission error may lead to sub-therapeutic level of the

prescribed drug
Error is not regarded if a patient refuse to take medication
Or dose is not administered because of any known
contraindication
Unauthorized Drug Error
• It includes, administration of drug to a wrong
patient
• Duplication of doses
• In take of unordered drug
• A dose is given outside a stated set of clinical
parameter
 Wrong dose Error
• Administration of wrong number of performed drug
units
• May be above than the ordered dose (2 tablets instead
of 1),(tea spoon instead of table spoon)
• May be below than the ordered dose
• Taking more or less no of prescribed dose in any one day
• It can lead to unpredictable plasma drug level.
• It might be sub-therapeutic or attain toxic level due to
administration of less or more doses
 Wrong route Error/wrong site Error

• Giving the drug other than the prescribed route

Administration of drug through I/M route, instead of I/V
Oral intake of capsule use for inhalers ( Rotahaler )

The drug is given at a wrong site , though via correct rout

Most common in eye and ear drops instead of right
administered to left or vise versa
 Wrong rate Error
• The administration of a drug at a rate not specified in
patient’s order
• Every drug must be administered according to Hospital
protocol or according to need of patient specially I/V
solutions
Wrong Dosage form error
• Intake of drug in a dosage form than that of the
specified Physician order
• Use of an Ophthalmic solution rather than
ointment
• Or cream rather than lotion
• Purposeful alteration (crushing of a tablet)or
substituting liquid for a tablet is not regarded as
wrong dosage form
Wrong time error
• The wrong time error is an administration of a dose of a
drug earlier or later than its schedule time
• Hospital must set a policy for maximum permissible
deviation of administration time
• In most of the institutions it is +/-1 hour
• This error also include intake of a dose prescribed as
needed, at a time other than when needed
Wrong preparation of a
dose
• An incorrect preparation of a dose not compiled with
Physician or manufacturer’s instructions
Incorrect reconstitution volume
Wrong dilution
Not shaking a suspension
Not keeping a light sensitive drug protected from light
Mixing of drug that are Physically or chemically
incompatible
 Evaluation of
Medication Errors
•Factors Contributing Error
•Corrective measures
•Safe Drug Use Program
 Factors
Contributing
Medications Errors
Here we discuss some most
common factors which contribute to
the occurrence of medication errors
• Hospital Administration related
Factors
• Personnel related Factors
• Techniques related Factors
• Facility Related Factors
 Administration
Related Factors
•Inadequate policies regarding safe
use medication
•Inadequate policies governing
reporting of incidents in
institution
•Inadequate policies concerning
performance of task for
supportive staff
 Personnel
Related Factors
•Lack of hospital Pharmacist
•Lack of administrative Nurse
•Overburdened Personnel
Techniques Related Factors

Non-professional
staff In areas of Inadequate
professional labelling of drugs
judgment
Facility Related Factor

Inadequate drug Lack of storage

stations on and equipment
patient care areas facilities
 Measures adapted to
Minimize Medication Error
Corrective measures are necessary to lowering the patient
morbidity ,to reduce patient expenditure on treatment
and to minimize the stay in hospital.
These includes :
• Administrative Related Measures
• Staff related measures
• Techniques related measures
• Facility related measures
Administration
Related Measures
• Pharmacist , Nurses , Physician and management of an
institution are responsible for safe , effective and rational use
of medication
• All healthcare members have their different roles and
responsibilities
• Administration is mainly responsible for formulating policies
regarding all hospital operation
• Institute must have adequate and clear policies as for safe drug
use.
• Policies on incident detection and subsequent reporting
system
 Cont.

• All policies contributes to enhance patient care standards

• Policy requires reporting of any happening not consistent with routine hospital
operations or routine patient care leading to a real accident or a situation which might
result in an accident
• Policies for duties of pharmacy supporting staff (pharmacy technician) i-e tasks that
they can perform independently
tasks that can perform under pharmacist supervision
tasks strictly prohibited
Once policy prepared should be recorded in the form of job descriptions
Personnel related measures

• Large no. of hospitals particularly medium and small size private hospitals
have not deployed Pharmacist in Pharmacy
• Similarly, a lot of public sector institute working without pharmacist
• Some institute have pharmacist without their actual job description
• Subsequent no. of Pharmacist must be present in every institution according
to the size (no. of beds) of institution
Cont.

• Supporting staff for Pharmacy Department to assist Pharmacist i-e Pharmacy

Assistant (Technician) Porters.
• Lack of administering nurse and over-burdened personnel are the other
reason for medication error.
• Sufficient no of Nurses in each ward in every shift must be deployed.
• Supporting staff in all hospital wards like Aid Nurse or Porters , according to
requirement of ward.
 Techniques
Related
Measures
Proper Labelling :
Mainly two purpose of labelling , to
identify the contents and to bear
certain information considered
necessary.
Through using color coding system
label can be served as additional
safety factor.
Color coding system use to
discriminate various material and
route of administrations.
 Cont…..
• Under color coding system on white background
the label with red indicates poisons, blue
indicate non poison medicine for oral use , green
stands for topical products , black for nasal
preparations and purple for ophthalmic
products.
• The containers dispensed to nursing station must
properly labeled.
• Format and type of label varies in according to
individual Pharmacist preferences or policies.
Cont.

Avoid using of supporting personnel in professional judgment tasks:

• Taking telephone order of new prescription or prescription refills
• Weighing or measuring ingredients for compounding prescription
• Mixing of already measured ingredient
• Compounding of prescriptions
• Provision of information on use and precaution to patient and professional
personnel
 Facilities Related
Measures
• Proper space required for storage of
medicines
• Proper shelving for medicines and
surgical items
• In large hospital satellite pharmacies
for different areas
• Biological grade Refrigerators to
maintain cold chain
• Proper room temperature in
according to pharmacy requirement
 Program for safe use of drug
Rectification of the problem underlying medication errors can
be achieved by implementation of safe use of medication
program in hospital.

The major segment of this program are:

1. Medication error reporting system
2. Detection of adverse drug reaction
3. Drug utilization review
4. Drug interaction surveillance
5. Drug product defect reporting system
6. Therapeutic drug Monitoring
7. Patient care audit
8. Good pharmaceutical practice guidelines
 • An error detection system must be
established to minimize errors in
medication . This system facilitate reporting
of medication error of clinical significance
• On receipt of the reports, reason of
reporting error is established, and error are
classified as non-significant, minor ,
significant and critical,
• Incase of clinically significant error , proper
action is taken to minimize the recurrence
Medication of the medication error in future.
Error Detection
and Reporting
 A typical medication error reporting form contain
a. Patient Identification
b. Name of the drug
c. Strength and the route of administration
d. Time and date of the error
e. Name and title of person who made error
f. Category of error
g. Name of doctor or nursing supervisor to whom
incident was reported
Content of a h. Brief description of treatment given by a Doctor
as a result of the error
medication i. Nursing supervisor statement about the
error reporting measures taken by nursing department
to prevent such error in future
form
 WHO Definition;
Any undesirable effect of a drug beyond its
anticipated therapeutic effects occurring during
clinical use.
Basically, an adverse drug reaction is any response to
a drug which is noxious unintended, and which
occurs at doses level(normal dose) used for
prophylaxis , diagnosis or therapy .
Adverse drug reaction may include such events as
toxicity caused by overdose(therapeutic , accidental
and homicidal), hypersensitivity , allergy or injury
from any medication error .
Monitoring of
Adverse drug
reaction
 • Therapeutic use of drugs involve
unavoidable risks of developing ADR
in some patient
• An ADR may cost heavily to a patient
for treatment and in severe cases
may lead to patient fatality
Cont. • An effective monitoring program for
ADR can reduce treatment
expenditure minimize patient
morbidity and help over all patient
care
 • In an institute , Pharmacy and therapeutic
committee assumes responsibility of ADR
monitoring and to formulate prevention system
Role of • Under ADR reporting program , Pharmacy and
therapeutic committee advise following
Pharmacy and 1. Medical staff is to report an ADR to chairman
therapeutic P & T committee
2. In some institute Nurses are also involved in
committee reporting ADR
in ADR 3. A Pharmacist can effectively be involved in
reporting of a potential ADR . In some institution
monitoring allowance has been given to patient for reporting
a reaction on standard form
 Cont.
• Based on reports from all Hospital healthcare
members , a data bank occurrence can be formulated
which is helpful for
a. Study(research)
b. To implement an effective prevention program
Pharmacy and Therapeutic Committee support post
marketing surveillance carried out collaboratively by
hospital Pharmacy and Pharmaceutical industry
 • It as an authorized , structured on going
system for improving quality of drug use
within Hospital
• Pharmacy and medical staff both are
involved
Drug Utilization • DUR program requires development of an
evaluation process for prescribing ,
Report dispensing , administering and ingesting
of prescription drugs
• DUR leads to corrective measures that
helps identifying problems in drug use ,
reduces adverse reaction , optimize drug
therapy and minimizes drug-related
expenditure
 Cont.
• Pharmacist always have recognize their responsibility
to check safety of the dosage regimen for each
medication dispensed.
• DUR is accomplished by taking patient history , patient
medical profile laboratory test profile .
• A clinical Pharmacist takes medication histories of
every patient admitted to hospital or seen in
ambulatory care section
• Medication history is taken by personal interview or via
computerized questionnaire designed for purpose
 • In addition to personal information and
general diagnosis , medication profile
contain following information

• Medication History i-e Prescription ,

OTC drugs and home remedies
Cont. • Chronic Disease status
• History of drug allergies ,idiosyncrasies
, and adverse reaction
• Laboratory test performed
• Idiosyncrasy towards food product
 Advantage of Patient
Medication Profile in DUR
Patient medication profile developed by Pharmacist, it helps in
the;
a. Improvement in drug prescription practices (safe & rational
use)
b. Detection and prevention of potential drug interaction
c. Detection and prevention of adverse drug reaction
d. Detection and prevention of I/V drug incompatibilities
e. Detection of drug induced laboratories test abnormalities
f. Detection of possible drug induced diseases
g. Prevention and detection of potential drug toxicities
 Cont.
• Manual compilation of drug utilization it is very difficult , it
can be simplified by automated system .
• A computer- based system provide for the entry of
information into the computer through keyboard or
scanning device.
• Under this system prescription of a new drug or any
modification in therapy is entered into computer
• Other information such as Patient Name , age , sex , ethnic
background , diagnosis , drug product , manufacturer ,
therapeutic class , dosage form strength , route of
administration ,direction for use , amount dispensed , days
of therapy , effectiveness , adverse reaction , toxicity ,
reason for termination , prescriber information
 Cont.

• This data can be incorporated with

retrospective , prospective review for
continuing surveillance of drug utilization
• A drug utilization review committee of
Hospital does this review
• Hospital Pharmacist must be its member
• Other members From medical sides Such
As Physician and Nurses
Responsibilities of Pharmacist in
Drug Utilization Review
committee
• Preparation of drug use criteria and standards in liaison
with medical staff
• Obtaining quantitative data on drug use
• Reviewing medication orders against the drug use
criteria and standards
• Participating in follow up activities of review program i-e
educational programs directed to prescriber
• Development or recommendation of formulary
• Changing drug control procedures(in response to result
of review process)
 Drug interaction surveillance
• Drug interaction surveillance is a program for a method to
check on effect of one drug action by concomitant
administration of other drug or laboratory test agent
• Drug-Drug interaction are not classified as adverse drug
reactions ,an interaction may either increase the toxicity or
reduce the therapeutic efficacy of drug , safe drug use in
hospital requires drug interaction monitoring.
• Now software are available for ready evaluation of
interacting drug in prescription , computer aided
dispensing (CAD) can very effectively be used for purpose
of safe drug administration without occurrence of an
interaction
Drug product defect reporting
program
• Highest quality of medicines and surgical items should be
dispensed and supplied from pharmacy
• Some time an error or accident happens with a finished
product during distribution where it does not confirm its
specifications.
• A defect in drug may be any thing which, in a professional
opinion , is considered to be defective or undesirably
associated with the product
• Any of the defects may lead to an impaired therapeutic
efficacy of product and effect adversely the health of
patient
 cont.

• The Pharmacy committee set down a system for drug

defect reporting program. In this system Physicians ,
Nurses or Hospital Pharmacists report any defect in a
drug observed during its distribution,
• This includes
▪ Inadequate Packaging
▪ Confused or inadequate labelling
▪ Deteriorated,contaminated or defective dosage form
▪ Change color or taste
▪ Inaccurate fill or count of a drug product
 Cont.
• These product defect report are judged for
non-significance , minor , major event and for the
corrective action required
• Reports can be shared with manufacturer or distributor or
drug regulatory authority for information and
improvement
• Pharmacists play important role in detection and
reporting of product defects through participation in
defect reporting program
• Information gathered through this program help to
Hospital , manufacturer and drug authority in maintaining
quality standard of drug.
Therapeutic Drug Monitoring

• Therapeutic drug monitoring is a routine estimation of

plasma concentration of drug , the therapeutic or toxic
effect has a direct correlation with its concentration in
blood .
• Drug assay technology has made it possible to measure
the plasma concentration of most of the drugs used in
clinical practice.
• A clinical Pharmacist having comprehensive training in
clinical Pharmacy should ideally supervise Therapeutic
Drug Monitoring
Cont.

• TDM program provides clinician with valuable

information towards maximum maximizing safety and
efficacy of drug therapy.
• Patients with impaired renal , hepatic function and
congestive heart Failure get benefited from therapeutic
drug Monitoring program
• All these patient required dose adjustment based on the
measured level of respective drug
 Cont.

TDM program may be useful :

• Confirmation of adequate dosing
• Identification of non-compliance
• When patient response poorly to therapy
• When possible, drug interaction is suspected
 Guidelines indicates for
Therapeutic Drug Monitoring
• A narrow therapeutic index
• Non- linear pharmacokinetics
• Large inter-individual Pharmacokinetic variability
• Major side effects related to plasma concentration
 Commonly Monitored drug
under TDM program
• Anticonvulsant
Carbamazepine , Phenobarbital , Phenytoin , Valproic
acid, primidone
• Antibiotics
Amikacin , chloramphenicol , tobramycin , Vancomycin
• Cardiovascular Agents
Digoxin , Lidocaine , Procainamide , Quinidine
• Other drugs
Cyclosporine , Lithium , salicylic acid Theophyline
Occasionally Monitored Drugs

• Anticonvulsant : Clonazepam , Mephenytoin

• Antidepressants : Amitriptaline , Fluoxetine ,
Imipramine , Maprotiline , doxepin
• Cardiovascular Agents : Amiodarone , Encainide ,
Flecainide , propranolol , verapamil
• Other drugs : Acetaminophen , Ethanol , Fluphenazine
, Methotrexate
 Cont.

• The routine monitoring of plasma drug concentration is

of proven clinical value of only few drugs
• After the drug analysis , a meaningful data
interpretation with the clinical context is necessary
• A full appreciation of Pharmacokinetics is necessary to
allow such interpretation and for drawing of conclusion
 Patient care audits
• Patient care audits are needed for safe drug
administration
• Audit means a comparison of actual practice
with the practice to judge
• Patient care audits uses the measurable
process and out come criteria applied for large
no of patient records to evaluate quality
• A good and effective therapy coupled with
good clinical care can reduce the patient length
of institutional stay.
• Poor therapy leads to complications and
thereby , increase the patient hospital stay
 Component of
Patient Care Audit
The patient care audits includes;
1. Choice of therapeutic agent
2. Choice of dosage
3. Choice of route of administration
4. Drug allergy and Pharmacogenetics
5. Effect of therapy upon utilization of
hospital facilities
6. Follow up medication
 Good Pharmaceutical
Practice
• Increased no. of both inpatient and out
patients being treated , the multiplicity of
drugs and increase no. of prescribed drug
per patient , have led to greater chances of
medication errors.
• To improve care of and safeguard
hospitalized patient , following guidelines of
good pharmaceutical practice are necessary
Labeling
• Medication container for general use
a. Prescription labels and pharmacy stock labels should be used only
by hospital Pharmacy
b. Label should bear the name , address and telephone no. of Hospital
c. A label should not be superimposed on another label
d. One order or prescription should be filled and labeled at a time
e. The label should be firmly affixed to container
f. Metric system is to be used on all label
 g. The following labels and caution statements
that should appear where indicated
1- Poison
2-Not to be taken internally
Cont. 3-Shake well before use
4-For external use only
5-Storage instruction
warnings e.g Not for injection, do not use
after ,not to be swallowed
 h. Name of therapeutically active ingredients
should be indicated in compound mixtures
i. Drug which needs dilution or reconstitution
should carry direction
j. Whenever possible dilution should be done in
Cont. pharmacy
k. For perishable drugs such as antibiotics and
biological, should clearly indicate the expiration
date on label
 • In addition to the guidelines that mentioned
under general labeling
the Inpatient prescription label should bear
following information
Labeling and a . Patient Full Name and Medical Record
dispensing In number
Patient b . Proprietary / Non proprietary name of the
drug actually dispensed
prescription c . Strength
d . Date of Issue
e . Name and Signature of dispensing
Pharmacist
 • Patient full name
• MR no or any identification no.
• Name of prescribing physician
Labeling and • Specific direction for use
dispensing • Name or initial of Pharmacist
out patient • Date of issue
prescriptions
Reference:
Safe use of Medications, Page no. 607
William E.Hassan , Hospital Pharmacy ,