2. 2
TABLE OF CONTENT
1. Introduction................................................................ (4)
a. Scope of the Manual........................................ (4)
b. Purpose of the Manual...................................... (4)
c. Objectives of the Manual................................. (4)
2. Standard Operating Procedures …………………… (5)
3. Clinical pharmacy Services....................................... (6-14)
a. Pharmaceutical Care…………………………. (7-9)
b. Clinical Audit of Medical Record………………(10)
c. Medication Error……………………………... (11)
d. Adverse Drug Reaction (ADR)/ Adverse Drug Event (ADE)….. (12)
e. Drug Interaction……………………………… (13)
f. Patient Counseling…………………………… (14)
4. Drug Information and Educational Services……….. (15-17)
5. Policy Development………………………………… (18-31)
a. High Risk Medication………………………… (19-20)
b. Look Alike and Sound Alike Drug (LASA)…. (21-22)
c. Expiry Drug Policy……………………………(23-25)
d. Medication Error Policy……………………….(26-28)
e. Policy on ADR………………………………....(29-31)
6. Formulation of Lists………………………………... (32-57)
a. High Risk Medication……………………….... (33-34)
b. Look Alike and Sound Alike Drug (LASA)….. (35-39)
c. Drug- Food Interaction……………………….. (40-42)
3. 3
d. Expiry Date for Open Medication List……….. (43)
e. Fall Risk Drug List…………………………… (44-47)
f. Fridge list for Drugs and Vaccine…………….. (48-55)
g. Error Prone Abbreviation List…………………. (56-57)
ABBREVIATION:
PTC- Pharmacy & Therapeutic Committee
MPAR- Medication Prescription & Administration Record
MAR- Medication Administration Record
DOS- Doctor’s Order Sheet
NCCMERP- National Coordinating Council for Medication Error Reporting and Prevention
DTP- Drug Therapy Problems
SOP- Standard Operating Procedure
FIP- International Pharmaceutical Federation
ISMP- Institute for Safe Medication Practice
PvPI – Pharmacovigilance
CME- Continuous Medical Education
CNE- Continuous Nursing Education
NABH- National Accreditation Board for Healthcare
4. 4
INTRODUCTION
The American College of Clinical Pharmacy defines clinical pharmacy as a health science discipline in which
pharmacists provide patient care that optimizes medication therapy and promotes health, wellness, and care.
The practice of clinical pharmacy embraces the philosophy of pharmaceutical care.
The International Pharmaceutical Federation (FIP) defines pharmaceutical care as the responsible provision
of pharmacotherapy for the purpose of achieving definite outcomes that improve or maintain a patient’s quality
of life. Clinical pharmacy blends a caring orientation with specialized therapeutic knowledge, experience, and
judgment for the purpose of ensuring optimal patient outcomes.
This standard operating procedures (SOP) manual has been developed to standardize and formalize the
provision of clinical pharmacy services in the hospital. SOPs on how to provide clinical pharmacy services
for inpatients, and to document and report the services provided are addressed in this manual. The terms
clinical pharmacy services and pharmaceutical care are used interchangeably in this manual.
SCOPE OF MANUAL
To describe the specific steps pharmacists providing clinical pharmacy services to inpatients in this hospital
should follow. It contains SOPs for the provision of clinical pharmacy services at the inpatient level, with the
necessary documentation and reporting systems.
PURPOSE OF THE MANUAL
This manual describes specific procedures in pharmaceutical care practice. It should be used as a hands-on
reference for pharmacists providing clinical pharmacy services, thereby helping to standardize the practice in
this hospital, with the ultimate goal of optimizing patient care. The manual may also be used as a reference
for health system managers, policymakers and health care providers.
OBJECTIVES OF THE MANUAL
General Objective
The general objective of the clinical pharmacy SOPs is to standardize the provision of clinical pharmacy
services, thereby optimizing patient outcomes by ensuring the rational use of medicines.
Specific Objectives
Ensure that standardized clinical pharmacy services are provided in entire hospital
Clarify roles and responsibilities of pharmacists providing pharmaceutical care.
Provide a description of how to perform clinical pharmacy activities.
Serve as a source of guidance for new employees.
Improve the standards for clinical pharmacy services on a continual basis.
Provide evidence of commitment to improvements in the quality of patient care.
DEPARTMENT OF PHARMACY PRACTICE MANUAL
CLINICAL PHARMACY SERVICES
5. 5
STANDARD OPERATING PROCEDURE
This SOP cover the procedures to be followed when providing clinical pharmacy services to inpatients. They
include: assessment; development and implementation of a pharmaceutical care plan; follow up, monitoring
and evaluation; discharge planning and counseling; multidisciplinary team activities; and pharmacy-led care
planning sessions.
The pharmacist providing clinical pharmacy services for inpatients should start providing the services as soon
as the patient is admitted so that he/she can support the prescriber in the selection of medicines for individual
patients.
Fig. 1: Clinical Pharmacist’s Work Flow Chart
Review
Medical
Records of
In-patients
Plan
Standard
Drug
Therapy
Assess
if given
therapy is
compliant
with the
standard
Discuss &
Implement
modification
in therapy if
required
Follow
up:
Monitor/
Evaluate,
Counsel
Patient
Centered
Care
COLLABORATE
7. 7
1. PHARMACEUTICAL CARE
1.1 DEFINITION
Authorized, structured, ongoing review of practitioner prescribing, pharmacist dispensing and patient use of
medications.
1.2 SCOPE
Drug related problems are an undeniable fact in hospitals which involves providing medical care to patients
with complicated conditions and regimen.
1.3 PURPOSE
To ensure drugs are used appropriately, safely, and effectively to:
– Improve patient care
– Lower the overall cost of care
– Foster more efficient use of health care resources
1.4 PROCESS
The delivery of effective pharmaceutical care to patients requires pharmacists to practice in a way that uses
their time effectively and reflects their responsibility and accountability. The systematic approach to the
delivery of pharmaceutical care involves the following four steps, as depicted in figure 1.
Step 1: Assess the patient’s drug therapy needs and identify actual/potential drug therapy problems
(DTP)
Step 2: Develop a care plan to resolve and/or prevent the DTPs
Step 3: Implement the care plan
Step 4: Follow Up and Evaluate
Step 1: Assess the patient’s drug therapy needs and identify actual / potential drug therapy problems
Table 1. Categories and Common Causes of Drug Therapy Problems (DTP)
ASSESSMENT DRUG THERAPY
PROBLEM
CAUSES
Irrational therapy
No valid indication for the medicine at the time
Drug duplication when single drug therapy is
effective
Choosing Pharmacological over effective Non-
Pharmacological approach
When root cause is not resolved (drug abuse/ alcohol
use/smoking/diet)
THERAPEUTIC
INDICATION
8. 8
Needs additional drug
therapy
A existing medical condition that requires the
initiation of new drug therapy
Preventive therapy is needed to reduce the risk of
developing a new condition
A medical condition requires combination therapy to
achieve synergism or additive effects
Ineffective drug
Drug is not the first line agent or choice of therapy
Medication is not effective for the condition as per
evidence
The condition is refractory to the medication being
used
Inappropriate dosage form
Sub-therapeutic
dosing
The dose is too low to give the desired outcome
The dosage interval is too infrequent
The duration of therapy is too short
A drug interaction reduces the amount of active drug
available
Adverse drug reaction
Drug causes an undesirable reaction that is not dose-
related
A safer alternative is needed because of patient risk
factors
A drug interaction causes an undesirable reaction
The regimen was administered or changed too
rapidly
Product causes an allergic reaction
Drug is contraindicated because of patient risk
factors
Supra-therapeutic
Dosing
The dose is too high for the patient
The dosing frequency is too short
The duration of therapy is too long
A drug interaction causes a toxic reaction to the
patient
Dose administered too rapidly
Noncompliance
Patient fails to understand the drug related
instructions
Patient prefers not to take the medication
Patient forgets to take the medication
The medication is too expensive
Patient unable to swallow or self-administer the
medication properly
The medication is not available to the patient
EFFECTIVENESS
SAFETY
COMPLIANCE/
ADHERENCE
9. 9
Step 2: Develop a care plan to resolve and/or prevent drug therapy problems
Prioritize Drug Therapy Problems
Identify Desired Therapeutic Goal and Proposed Intervention
Develop a Monitoring Strategy
Document the Care Plan
Step 3: Implement the Care Plan
The pharmaceutical care plan is implemented with the agreement of the patient and within the context of the
overall care of the patient, in cooperation with other members of the health care team.
Step 4: Follow-up and Evaluate
Elicit and document clinical evidences of patient’s actual outcomes, including
effect of treatment
evidence of ADE
Assess the patient for any new DTP
Evaluate effectiveness and safety of pharmacotherapy
Determine patient compliance
Schedule a follow up evaluation and provide continuous care
Compare to goal of therapy
10. 10
2. CLINICAL AUDIT OF MEDICAL RECORDS
2.1 DEFINITION
Clinical audit is a quality improvement process that seeks to improve patient care and outcomes through
systematic review of care against explicit criteria and the implementation of change.
2.2 SCOPE
To maintain a good clinical practice some kind of systematic review of their daily work, recording and
assessing the accuracy of documentation involved in patient care is necessary.
2.3 PURPOSE
Potential benefits of prescription audit:
1. Identify and promote good practice
2. Improve professional practice and quality standards
3. Supports learning and development of staff and organizations
4. Identify and eliminate poor or deficient practice
5. Identify and eliminate waste
6. Promote working with multidisciplinary teams
7. Allocate resources (financial, human) to provide better patient care
8. Develop opportunities to present findings with relevant faculty and facilitate shared learning.
2.4 PROCESS
Randomly select patient
Medical Records
Review (DOS), (MAR)
and transfer criteria
Check all parameters of
DOS, MAR, Transfer
Sheet audit as per the
check list
Negative marking for
error prone abbr.,
Incomplete Rx,
Improper Doc
Analyze retrieved data
Present the findings
with CAPA in PTC
meeting
11. 11
3. ASSESSMENT OF MEDICATION ERROR
3.1 DEFINITION
According to the National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP),
medication errors can be defined as ‘any preventable event that may cause or lead to inappropriate use or
patient harm while the medication is in the control of the health care professional, patient or consumers’.
Medication errors are mishaps that occur during prescribing, transcribing, dispensing, administering,
adherence, or monitoring a drug.
Examples of medication errors include misreading or miswriting a prescription. Medication errors that are
stopped before harm can occur are sometimes called “near misses” or “close calls” or more formally, a
potential adverse drug event. Not all prescribing errors lead to adverse outcomes. Some do not cause harm, while
others are caught before harm can occur (“near-misses”)
3.2 SCOPE
All medication errors involving any medicine used both in In-patient and Out-patient sector should be
assessed.
3.3 PURPOSE
The primary objective of medication error reporting is to obtain information on the occurrence of medication
errors, maintain a database of medication errors, analyze reports, propose remedial actions and monitor the
situations in an effort to minimize the reoccurrence of such errors and, ultimately, to improve patient safety.
3.4 PROCESS (To be corrected and documented immediately on identification)
Reported To and
Documented By
Clinical Pharmacists
Error Identification and
Discussion by
Clinical
Pharmacists/Pharmacists/
Nurses/Doctors
Root Cause Analysis
& CAPA
Clinical Pharmacists
Presented in
PTC and other
Departmental meet
12. 12
4. ADVERSE DRUG REACTION (ADR)/ ADVERSE DRUG EVENT (ADE)/ SIDE EFFECT vs
ALLERGY
4.1 DEFINITIONS
ADR: Any noxious, unintended, undesirable, or unexpected response to a drug that occurs at doses used in
humans for prophylaxis, diagnosis, therapy of disease, or for modification of psychological function.
ADE: “An injury resulting from the use of a drug. Under this definition, the term ADE includes
Harm caused by the drug (Adverse drug reactions and overdoses) and
Harm from the use of the drug (including dose reductions / discontinuations of drug
therapy).”
Adverse Drug Events may results from medication errors but most do not.
Allergy vs Side Effect:
An allergy is an adverse drug reaction mediated by an immune response (e.g., rash, hives).
A side effect is an expected and known effect of a drug that is not the intended therapeutic outcome.
The term “side effect” tends to normalize the concept of injury from drugs.
4.2 SCOPE
There is the potential for an adverse effect to occur with the use of any medicine or vaccine - whether it is
supplied:
On prescription
Over-the-counter
As a complementary medicine.
4.3 PURPOSE
When a medicine or vaccine is first registered and made available in India, information about its safety and
efficacy is usually available only from clinical trials. Post-market monitoring of the safety of medicines and
vaccines contributes to a better understanding of their possible adverse effects when they are used outside
the controlled conditions of clinical trials. The obtained details can be forwarded to PvPI for further
monitoring and developing drug safety protocols. It also serves as a way to create awareness and prevent
further occurrence of the same ADR for patients via providing ADR Alert Card.
4.4 PROCESS (To be documented within 30 minutes of occurrence)
ADR Identification and
Discussion by
Clinical
Pharmacists/Pharmacists/
Nurses/Doctors
Reported To and
Documented By
Clinical Pharmacists
Root Cause Analysis
& CAPA
Clinical Pharmacists
Finding forwarded to
Pharmacy
Pharmacovigilance
Department
Presented and
Discussed In
PTC meeting
13. 13
5. DRUG INTERACTION
5.1 DEFINITION
A drug interaction can be defined as an interaction between a drug and another substance that prevents the
drug from performing as expected. This definition applies to interactions of drugs with other drugs (drug-
drug interactions), as well as drugs with food (drug-food interactions) and other substances.
5.2 SCOPE
Whenever two or more drugs are being taken, there is a chance that there will be an interaction among the
drugs. Since poly-pharmacy and complicated drug regimens are a common in hospital, occurrence of drug
interactions are inevitable.
5.3 PURPOSE
The interaction may increase or decrease the effectiveness of the drugs or the side effects of the drugs. Drug
interactions contribute to increase in cost of healthcare because additional expense may be required to treat
the problems caused by changes in effectiveness or side effects. Interactions also can lead to psychological
suffering that can be avoided.
5.4 PROCESS (to be documented and informed immediately)
DI Identification by
Clinical Pharmacists
Reported and
Documented By
Clinical Pharmacists
Management
suggested to:
Doctor verbally/ written
form- providing info on DI
(Severity, PK/PD profile
and Management/
alternative)
Required measures
implemented by:
Doctor (alter/continue the
therapy with caution)
Presented and
Discussed In
PTC meeting
14. 14
6. PATIENT COUNSELING
6.2 DEFINITION
It’s a process of providing medication information orally or in written form to the patients or their
representatives on directions of use, advice on side effects, precautions, storage, diet and life style
modifications
6.3 SCOPE
Without a discussion with the care providers, the patient leaves the hospital with nothing more than the
directions on the label and the medication leaf let that may or may not make it into the patient's prescription
bag. Time constraints of the physician and the nursing staff plays as a barrier in counseling. Thus patient ends
up having no knowledge on importance of the drug regimen and seriousness of the medical condition resulting
in poor medication adherence and drug abuse.
6.4 PURPOSE
To promote adherence to medications and avoid treatment failure and future hospital admissions
Helps patients cope with their disease and any medication side effects that might occur
Important to avoid potential drug interactions with OTC, herbal, and prescription medications
6.5 PROCESS
Gather knowledge about the patient and treatment details from patient’s case notes
Prepare the session based on mental and physical state of the patient.
Self-introduction
Confirm Patient identity
Collect background information
Characteristics of disease
About the Medications
Lifestyle modifications
Ask questions to assess
Check the patients’ understanding
Feed-back questions: Do u know…/Can u tell…
Summarize the main points
About satisfaction & queries
Visit your doctor regularly and ensure good health
Plan follow up
Wish you speedy recovery, Contact us: place/time/phone no
STEP 1: Prepare for the session
STEP 2: Opening of session
STEP 3: Counseling point’s
information
STEP 4: End of session
16. 16
1. DRUG INFORMATION SERVICES
1.1 DEFINITION:
Knowledge of facts through; reading, study, or practical experience on chemical substance that is used in
Diagnosis
Prevention
Treatment of a disease
It covers all types of information including; objective and subjective information as well as information
gathered by scientific observation or practical experience.
1.2 SCOPE:
Promote evidence based practice.
Meet the patient’s needs while providing pharmaceutical care.
Improve the patient adherence.
Enhance the image of the career by gaining self-confidence
1.3 PURPOSE:
Drug information aims to provide clear, concise, unbiased and accurate drug related information in
response to patient oriented drug problems that are received from health care professionals in a variety of
settings.
These activities are undertaken by clinical pharmacists in providing information to optimize drug use.
Scientific literature Review:
1.4 PROCESS:
Step 1: Secure Demographics of the requestor
Step 2: Obtain Background Information
Step 3: Determine and categorize the actual Question.
Step 4: Develop the Search Strategy and Conduct the Research (Tertiary, Secondary and Primary)
A tertiary source to familiarize yourself with the topic.
Secondary to identify appropriate primary literature.
Carefully evaluated primary literature
Tertiary-
Textbooks
Secondary- Bibliography,
Reviews, Abstracting and
Indexing services
Primary- Patents, Conference paper
(abstract), Case reports, Journal Articles,
Thesis
COMMUNICATION SKILL
17. 17
Step 5: Perform Evaluation, Analysis and Synthesis
Introduction to clinical studies
Introduction to critical appraisal of clinical study
Evaluation of websites that provide health information.
Step 6: Formulate and Provide a Response
Present the competing viewpoints or considerations.
State the assessment of the literature or information reviewed and emphasize the superior viewpoint.
Compactly refute the major strengths and present weaknesses of the inferior viewpoint.
Defend the major weaknesses and promote the strengths of the superior viewpoint.
Restate the final assessment in support of the superior viewpoint.
2. EDUCATION AND TRAINING
1.1 DEFINTION:
Continuing professional development (CPD) or continuing professional education (CPE) is the
means by which people maintain their knowledge and skills related to their professional lives.
1.2
o Educating health care professionals on safe and effective medication-use policies and processes,
including development of resources to communicate this information.
o Leading or participating in continuing education services for health care professionals. (CME, CNE)
o Pre-cepting and educating pharmacy students and residents.
o Participating in quality improvement research projects and drug cost analyses.
19. 19
DEFINITION: High-alert medications are drugs that bear a heightened risk of causing significant patient
harm when they are used in error.
SCOPE: This policy applies to Hospital and its Medical Staff.
PURPOSE: The purposes of this policy are to increase patient safety by avoiding preventable injuries
associated with high alert medications and to provide standardized drug safety policies for “high alert”
medications as identified by National Accreditation Board For Hospitals & Healthcare Providers (NABH).
Clinical staff must be aware of medicines on this list and of the need to take extra care in their safe storage,
handling, prescription and administration with reference to local protocols. Work practices related to high
risk medicines should be periodically reviewed.
PROCEDURE FOR STORAGE
In Pharmacy
Display the list of High Risk Medicines available in stock.
All drugs in stock should be stored in labelled containers (BRAND names only), arranged in
alphabetic order under manufacturer specified period and storage condition.
High alert medicines should be differentiated from general medicines by the use of RED color
coded labels.
The following class of High risk medicines need to separately stored:
o Controlled Drugs
- Schedule II drugs (Narcotics) should be kept under lock and key.
- Schedule III & IV Controlled drugs should be kept unlocked.
o Concentrate Electrolytes
All LA & SA drugs should be labelled with RED color stickers in addition to LA & SA stickers.
Monthly auditing on the purchase, sale and available stock on High Alert and Controlled drugs
should be performed and checklist to be maintained.
In Patient Care Area
Display the list of High Risk Medicines available in stock.
All drugs in stock should be stored in labelled containers (BRAND names only), under manufacturer
specified period and storage condition.
High alert medicines should be differentiated from general medicines by the use of RED color coded
labels.
As per the list, stickers should be placed for all the categories namely:
Emergency Life Saving Drugs
Crash Cart Drugs
Unit Stock medication
All Schedule II drugs (Narcotics) should be kept under lock and key in a cupboard.
All LA & SA drugs should be labelled with RED color stickers in addition to LA & SA stickers.
HIGH RISK MEDICATION POLICY
20. 20
PROCEDURE FOR PRESCRIPTION
Write legible, clear prescription in Capital letters.
Prescription should clearly specify name of medication, dosage form dose and complete direction for
use.
No oral orders should be entertained, except in emergency condition followed by documentation
within 24 hours.
PROCEDURE FOR OBTAINIG DRUG BY NURSES
Ordering, receiving, checking, recording and storing stock.
Recording the amount issued to medical staff.
Monthly auditing of drug stock by senior nurse & ANS should be performed and checklist to be
maintained.
Return near expiry medicines back to pharmacy.
Replace the ward stock as per usage.
PROCEDURE FOR DISPENSING
All drugs should be dispensed only by pharmacist.
All personal should read the “HIGH ALERT MEDICATION “labels carefully before storing, to
ensure medications are kept at the correct place.
Prior to dispensing, prescription should be read carefully to confirm the name of the drug, in case of
confusion clarify with chief pharmacist.
Double checked before dispensing.
Pharmacists should compulsorily sign on the bill copy after dispensing High Alert Controlled
Drugs
PROCEDURE FOR ADMINISTRATION
Follow 8 Rights of medication administration.
Loaded syringes should be labelled with all the necessary details like drug name, dose etc.
The entire process should be Independently Double Checked by two nurses.
The double check is documented with the sign of both nurses on the MPAR/MAR in red ink.
NOTE 1: Follow appropriate disposal policies
NOTE 2: The High Risk drug list needs to be reviewed and updated periodically at least once
REFERENCE: NABH 4th Edition
RESPONSIBILITY OF RENEWAL: Clinical Pharmacist
COLLABORATED DISCUSSION WITH: PTC members.
21. 21
DEFINITION: Medications that are visually similar in physical appearance or packaging and names of
medications that have spelling Similarities and/or similar phonetics.
SCOPE: Healthcare organisations need to institute risk management strategies to minimise adverse events
with LA and SA medications and enhance patient safety.
PURPOSE: As more medicines and new brands are being marketed in addition to the thousands already
available, many of these medication names may look or sound alike. Confusing medication names and similar
product packaging may lead to potentially harmful medication errors. The increasing potential for LA and SA
medication errors was also increases Sentinel Event Alert.
With this policy, it is hoped that errors relating to LA and SA medications can be minimised, if not eliminated,
through identification and implementation of safety precautions.
6.6 PROCESS
1. Procurement
Minimize the availability of multiple medicines strengths.
Whenever possible, avoid purchase of medicines with similar packaging and appearance.
As new products or packages are introduced, compare them with existing packaging.
2. Labelling and Storage
Use Tall Man lettering to emphasise differences in medications with sound-alike names
(metFORMIN and metoPROLOL, DOPamine and DOBUTamine.)
Use additional warning labels for Look-Alike (Stickers) and Sound-Alike (Stickers) drug
All LA & SA drugs are High Risk Drug as per NABH 4th Edition hence labelling along with High
Risk Drug sticker is a must.
As per the list stickers should be placed for all the categories namely:
Emergency Life Saving Drugs
Crash Cart Drugs
Unit Stock medication
For sound-alike medications where TALL MAN letter are not applicable, brand or trademarked names
may be added.
Avoid storing LA and SA drug of different strengths of the same drug side by side.
Store LA and SA medications separately from their LA and SA pair.
Used vials should be adequately labelled mentioning the opening date and expiry date.
Every drug should be stored only as per the manufacturer specified period and storage conditions.
Monthly auditing of drug stock by senior nurse.
Near expiry medicines should be replaced with new stock.
3. Prescribing
Write legible, clear prescription in Capital letters.
Prescription should clearly specify name of medication, dosage form dose and complete direction for
use.
No oral orders should be entertained, except in emergency condition followed by documentation
within 24 hours
POLICY ON LOOK ALIKE & SOUND ALIKE DRUGS
22. 22
4. Dispensing/Supply
Identify medicines based on its name and strength and not by its appearance or location.
Check the appropriateness of dose for the medicines dispensed.
READ medication labels carefully at all dispensing stages and perform triangle check.
Double checking should be conducted during the dispensing and supply process.
Highlight changes in medication appearances to patients upon dispensing.
5. Administration
READ mediactions labels carefully and perform the triangle check.
Do not rely on visual recogniton or loaction.
Make read back clarification of verbal order
6. Monitoring
The LA and SA list needs to be reviewed and updated periodically at least once a year.
REFERENCE: NABH 4th Edition
RESPONSIBILITY OF RENEWAL: Clinical Pharmacist
COLLABORATED DISCUSSION WITH: PTC members.
Prescription/ Drug
Order Form
Nurse confirms Drug
label
Pharmacist confirms
Dispensed
Medicine
23. 23
3.1 DEFINITION
The expiry date is the point in time when a pharmaceutical product is no longer within an acceptable condition
to be considered effective. The medication reaches the end of its ‘shelf life’.
3.2 SCOPE
This policy applies to all in and out patient care areas which stores drug and medical products.
3.3 PURPOSE
The shelf life of products is determined by either the breakdown of the active drug or by risk of contamination.
Certain external factors can affect expiry – contact with water, temperature, air and light. Not all drugs
deteriorate at the same rate.
Effects of using expired stock
The active drug could become chemically unstable
The effectiveness of the drug may change
The break down products of the drug may be toxic and harmful to the patient
Increased risk of contamination
KEY POINTS FOR BASIC STORAGE GUIDELINES
Keep all medication in the original container.
Keep medicines in their original outer packaging, to protect from sunlight.
All medicines should be stored in a cool (below 25C) dry place unless refrigeration is required
(between 2C and 8C).
The expiry date of products can change once opened.
Record the opening date and the calculated expiry on the medicine package/label.
Be vigilant with product expiry dates.
Store as recommended by the manufacturer.
Use disposable gloves per patient when applying creams or ointments
Medication should be user specific and ‘sharing’ of medicines including creams and ointments is
prohibited.
3.4 PROCEDURE
1. Ordering medication
Order as per the requirement in order to avoid medication wastage.
A nominated staff nurse should be responsible for ordering medication.
2. Receiving medication from pharmacy
Check if there are any specific expiry date instructions on labels.
Check the medication is still within its expiry date.
The expiry date on the product must be visible and clear. Products that do not have visible expiry
date must not be stocked and used.
3. Storing medication
POLICY ON EXPIRY DATE OF MEDICINES IN PATIENT CARE AREA
24. 24
Note and act on any specific storage instruction e.g. store in the fridge.
Rotate stock so the earliest expiry is at the front and therefore going to be used first i.e. ‘first expiry,
first out method’.
Check expiry dates of medication stock monthly & document in the register – Near expiry dates of
total number of drugs.
Medication is to remain in the container in which it was received – batches must not be mixed.
4. Administering medication
Check expiry date before each administration.
Record the date opened and the calculated expiry on the medicine package/label where appropriate.
Highlight any short expiry as a reminder to all staff.
Any product whose appearance suggests it may be unfit for use should be discarded – irrespective of
expiry date. If there is any doubt contact the hospital pharmacist for advice.
5. Replacement / disposal from wards
If 6 MONTHS
Shelf life period
NEAR EXPIRY DRUGS
o Collect,
o Label clearly as near expiry items and
o keep in a separate place
If ≤ 6 MONTHS
Shelf life period
Return to the Pharmacy
ONLY
3 months prior to manufacturer’s expiry
date.
Return to the Pharmacy
ONLY
1 month prior to manufacturer’s expiry
date.
25. 25
6. Replacement / disposal from pharmacy
The above mentioned shelf lives are to be followed unless otherwise specified by the manufacturer.
Write the DATES (opening & expiry) and patient MR NUMBER when opened.
ALL UNOPENED MEDICINES can be stored until MANUFACTURER’S EXPIRY DATE.
RESPONSIBILITY OF RENEWAL: Clinical Pharmacist
COLLABORATED DISCUSSION WITH: PTC members.
Near expiry/expired drugs received from
wards.
INTERNAL AUDITOR will perform –
o Physically Check (compare returned
medicines with drug expiry book)
o System Check:
Quantity
Batch no.
Expiry Date
Equal amount of same drug
from recent stock will be send
to ward along with drug
expiry book.
NEAR EXPIRY EXPIRED
Returned to supplier for
reimbursement
Goes to expired drug
disposal bin
Disposed as per biomedical
waste management policy
Deducted from accounts
department
26. 26
INTRODUCTION
1. DEFINITION:
According to the National Coordinating Council for Medication Error Reporting and Prevention
(NCCMERP), medication errors can be defined as ‘any preventable event that may cause or lead to
inappropriate use or patient harm while the medication is in the control of the health care professional,
patient or consumers’. Medication errors are mishaps that occur during prescribing, transcribing,
dispensing, administering, adherence, or monitoring a drug.
2. POLICY:
A. Medications shall be properly prescribed, dispensed, and administered in accordance with
Hospital policies and procedures showing compliance with patient “Rights” (Right patient, Right
medication, Right dose, Right route, Right time and frequency, Right indication, Right
Documentation, Right monitoring, Right response).
B. All errors or unanticipated events associated with the medication system or a step in the
medication process shall be reported using the medication error reporting form whether or not the
error reached the patient.
C. Clinical Pharmacist must be notified as soon as medication error occurs; notification needs to be
documented for the same.
D. Education for the same to be provided by the Clinical Pharmacist for the respective staff
members involved in error as a corrective action.
E. Root Cause Analysis done based on the case by the Clinical pharmacist needs to be discussed in
various meetings (PTC).
3. SCOPE:
3.1 This policy applies to all healthcare staff involved in any medication processes including
Medical staff
Nursing staff
Pharmacy associated staff
Allied Health Care Professionals
Pre-registration Healthcare Professional Students (e.g. Medical, Nursing or Allied Health Care
Professionals)
3.2 All staff involved in the prescribing, dispensing and administration of medicines must be able to
demonstrate understanding and compliance with relevant professional guidance, policies and
procedures.
4 PURPOSE:
To define the procedure for reporting medication errors to ensure accurate and appropriate
use of medications.
MEDICATION ERROR POLICY
27. 27
To identify medication errors and provide information for review to allow follow up and
implementation of change to prevent future medication errors.
5 PROCEDURE:
A. NOTIFICATION
Medication error reported to Clinical Pharmacist’s by Doctor/ Nurse/ Pharmacist using report
form
B. DOCUMENTATION
On receiving the notification Clinical Pharmacist will conduct the Root Cause Analysis
including assessment of error severity using NCCMERP Index followed by Corrective
actions taken and preventive actions implemented if any.
C. DISCUSSION AND PRESENTATION
All the medication errors are to be presented graphically to highlight different observations
such as
Overall medication error
Medication Error as per number of files audited
Types of medication error
Error severity as per NCCMERP Index
Different professionals involved in medication error
Different areas involved in medication error
Graphical analysis constitute for 3 months data so as to correlate the improvement or
deficiencies if any.
Both detailed discussion on RCA and graphical analysis related to medication error shall be
conducted in monthly held PTC meet.
6 REFERENCE: NCCMERP
7 RESPONSIBILITY OF RENEWAL: Clinical Pharmacist
8 COLLABORATED DISCUSSION WITH: PTC members.
28. 28
MEDICATION ERROR REPORTING PROCESS
NOTE:
Above MER flow chart is applicable for both voluntary reporting and identification during active file
audit.
Reported To and Documented
By
Clinical Pharmacists
Root Cause Analysis & CAPA
Clinical Pharmacists
Presented and Discussed In
Departmental Meetings (Nurses)
PTC meeting
CAPA finalized and
implemented by:
Clinical Pharmacist’s, PTC
members Departmental HODs
Error Identification and Discussion by
Nurses PharmacistDoctors
Clinical pharmacistNursing Superintendent
/ Nursing Manager
NOTIFIED TO
29. 29
INTRODUCTION
1. DEFINITION:
ADR: Any noxious, unintended, undesirable, or unexpected response to a drug that occurs at doses used
in humans for prophylaxis, diagnosis, therapy of disease, or for modification of psychological function.
2. POLICY:
A. Any patient who is admitted with ADR or is a known case of ADR or have developed an ADR while
in care of our hospital setting shall be notified to Clinical Pharmacist.
B. The time frame for notification is within half an hour of occurrence of the reaction for In-patient
while immediate reporting in case of admission with ADR.
C. Education (patient/ care giver) and Documentation to be conducted by Clinical Pharmacist.
D. Each ADR case shall be discussed in various meetings (PTC) by the Clinical Pharmacist.
3. SCOPE:
3.1 This policy applies to all healthcare staff involved in any medication processes including
Medical staff
Nursing staff
Pharmacy staff
3.2 All staff involved in the prescribing, dispensing and administration of medicines must be able to
demonstrate understanding and compliance with relevant professional guidance, policies and
procedures.
4 PURPOSE:
To define the procedure for reporting Adverse Drug Reaction for all healthcare members to
ensure accurate and appropriate use of medications.
To educate the patient or care giver by providing an ADR card in order to prevent future
occurrence of any such events.
5 PROCEDURE:
A. NOTIFICATION
An ADR can be reported by Doctor/ Nurse/ Pharmacist using ADR reporting form to Clinical
Pharmacist’s
An ADR form raised should be filled by the Nurse, Hospital Pharmacist and countered signed
by the responsible consultant.
POLICY ON ADVERSE DRUG REACTION
30. 30
B. DOCUMENTATION AND PATIENT EDUCATION
On receiving the notification (via call) Clinical Pharmacist will conduct the assessment of
patient’s medical record and document the following findings:
Patient’s Demographic
Type of ADR
Suspected drug
Date &Time of occurrence
Route of administration
Antidote used
Replacement Drug
After all the information is gathered and thorough confirmation is done the patient or care
giver is educated well in comprehensible manner along with an ADR card.
ADR card serves as an alert card so patient could use it in future at any other healthcare
center
Suspected Drug is entered on patients file in Red Ink by Nurse or Clinical Pharmacist.
ADR form is then forwarded to pharmacy dept. to fill up the related area.
In the end ADR form is reviewed and counter signed by PTC chairperson.
C. DISCUSSION AND PRESENTATION
Graphical analysis 3 months data on ADR is presented highlighting
Percentage of ADR observed over 3 month period
ADR with admission
Both detailed discussion and graphical analysis related to ADR shall be conducted in monthly
held PTC meet.
6 REFERENCE: NONE
7 RESPONSIBILITY OF RENEWAL: Clinical Pharmacist
8 COLLABORATED DISCUSSION WITH: Pharmacovigilance dept. & DTC members.
31. 31
ADR REPORTING PROCESS
ADR Identification and
Discussion by
Clinical
Pharmacists/Pharmacists/
Nurses/Doctors
Reported To and Documented
By
Clinical Pharmacists
Root Cause Analysis & CAPA
Clinical Pharmacists
Finding forwarded to
Pharmacy-(HOD/ Senior
Pharmacist),
Pharmacovigilance Department
Presented and Discussed In
PTC &
Departmental meet
40. 40
LIST OF COMMON DRUG-FOOD INTERACTION
CLASS DRUG FOOD DRUG-FOOD INTERACTION
ANTICOAGULANT WARFARIN High-protein diet (meat, egg, milk,
liver, curd all nuts and soyabean)
Raise serum albumin levels,
decrease in international
normalized ratio (INR)
Vegetables containing vitamin k
(Vegetable oils – canola, soybean
and olive oil), asparagus, broccoli,
brussel sprouts, cabbage, Broccli
lettuce, parsley, peas)
Interferes with the effectiveness
and safety of warfarin therapy.
Charbroiled Decrease warfarin activity
Cooked onions, Raw-garlic, ginger
mango grape fruit juice (> 700ml)
Increase warfarin activity
Cranberry juice Elevated INR without bleeding in
elderly patient
Leafy green vegetables (spinach) Thromboembolic complications
may develop
MONOAMNINE
OXIDASES
ISOCARBOXAZID
PHENELZINE
TRANYLCYPROMINE
NARDIL
PARNATE
Tyramine-containing food (beer,
wine, bean curd, aged cheeses,
smoked/ fermented/ pickled fish,
liver, aged meats (sausage,
pepperoni, salami); yeast, dairy
products close to expiration date
and some processed meats)
Over ripped and dried fruits, soya
sauce.
Alcoholic beverages
Hypertensive crisis
Ginseng Cause headaches, trouble
sleeping, nervousness and
hyperactivity
CARDIOVASCULAR
DRUGS
PROPRANOLOL Rich protein food Serum level may be increased
CELIPROLOL,
ALDACTONE,
HYDRODIURIL
Orange juice
K+ rich food
The intestinal absorption is
inhibited, reduces the effect of
antihypertensive drug
Increase in serum K+ levels
ACEIs (RAMIPRIL) Empty stomach Absorption is increased
CCB (AMLODIPINE),
CARVEDILOL,
CYCLOSPORIN,
Grape fruit juice Increases the bioavailability
41. 41
LOVASTATIN,
ATORVASTATIN,
AMIODARONE,
DIGOXIN Licorice Risk of digoxin toxicity
ANTIBIOTICS LEVOFLOXACIN
CIPROFLOXACIN
TETRACYCLINE
MINOCYCLINE
DOXYCYCLINE
With milk products [Take 1
hour before or 2 hours after
calcium, magnesium, and iron
supplements or milk and dairy
products]
Calcium in the milk products
complex with some antibiotics
and prevent their absorption.
Reduced bioavailability
METRONIDAZOLE Do not drink alcohol during, and
72 hours after, therapy
Combination can cause flushing,
headache, nausea, vomiting,
sweating, and rapid heart rate
ANALGESIC ACETAMINOPHEN Pectin, Alcohol (3 drinks per day) Increase risk of liver damage
Delays its absorption and onset
NSAIDS ASPIRIN
IBUPROFEN
NAPROXEN
KETOPROFEN
Alcohol Can increase risk of liver damage
or stomach bleeding
Beverages (Coca-Cola) The c max and auc0-alpha significantly
increased
Ginseng Enhance the bleeding risk
BRONCHODILATOR THEOPHYLINE High-fat meal and grape fruit juice Increase bioavailability
Caffeine Increases the risk of drug toxicity
PPI &
ANTIHISTAMINES
ESOMEPRAZOLE High-fat meal- Cheese, Fatty Fish,
Nuts, Coconuts and Coconut Oil
etc.
Bioavailability was reduced
CIMETIDINE,
RUPATADINE
With food(any type) Increase bioavailability
ANTI- TB DRUGS ISONIAZIDE Plants medicinal herbsoleanolic
acid, alcohol
Exerts synergistic effect
Increase risk of liver side effect
ANTI-DIABETIC DRUG GLIMEPIRIDE With breakfast Absolute bioavailability
ACARBOSE At start of each meal Maximum effectiveness
IMMUNO-
SUPPRESSANT
MERCAPTOPURINE Cow's milk Reduce bioavailability
ANTICANCER DRUG TAMOXIFEN Sesame seeds Negatively interferes with drug
action
THYROID HORMONE LEVOTHYROXINE Grapefruit juice, Cabbage family
(RAW) and alcohol
Delay the absorption
42. 42
ANTIBIOTIC CYCLOSERINE High fat meals Decrease the serum
concentration
IMMUNO-
SUPPRESSANT
CYCLOSPORINE Grapefruit juice Higher level of the drug causing
side effect.
ANTI-ANXIETY BUSPIRONE
ANTI-MALARIA QUININE
ANTI-EPILEPTIC CARBAMAZEPINE
INSOMNIA DRUG TRIAZOLAM
SEDATIVE-
HYPNOTICS
ZOLPIDEM Chocolate Decreasing the drug effect
Additive effect of taking two food combination
Vitamin C and iron: Drinking a glass of citrus juice at the same time that you take an iron supplement is
beneficial because the vitamin C in the citrus juice increases the absorption of iron. Do not take iron with
with cereals, nuts, seeds, rice, beans, dietary fiber, tea, coffee, dairy products, or eggs. Take calcium, zinc, or
copper supplements separately.
Lithium (Lithobid, Eskalith)—Take with food. Maintain adequate fluid intake. Limit caffeine intake.
Consistency of sodium (salt) intake is the key to stable lithium levels.
LIST OF FOOD RICH IN:
NUTRIENTS &
MINERALS
RELATED FOODS
SODIUM Processed and cured meats (cold cuts, hot dogs, deli meats), canned vegetables, soups and
meats, frozen dinners, olives, pickles, meat tenderizers, prepared sauces, MSG, cheese,
tomato juice
POTASSIUM Most fruits and vegetables (potatoes, yams, tomatoes, winter squash, avocado, dried fruit,
oranges, bananas, melons)
PHOSPHORUS Meat, fast food, cheese, milk/ Products, seeds, nuts, canned fish (TUNA), soft drinks.
VITAMIN C Oranges, strawberries, grapefruit, red peppers, tomatoes, raw cabbage
FOLIC ACID Dark green leafy vegetables, oranges, legumes, asparagus, broccoli, liver, whole grain
cereals, nuts, corn
TYRAMINE Soy Sauce, sauerkraut, chocolate, coffee, raisins, cheese, bananas
CALCIUM Milk, cheese, tofu
IODINE Cheese, Cow milk, Eggs, Frozen Yogurt, Ice Cream, Iodine-containing multivitamins, Iodized
table salt, Saltwater fish, Seaweed (including kelp, dulce, nori) Shellfish, Soy milk, Soy sauce
and Yogurt.
IRON Red meat, Pork, Poultry, Seafood, Beans, Dark green leafy vegetables, such as spinach, Dried
fruit, such as raisins and apricots, Iron-fortified cereals, breads and pastas, Peas.
HIGH-PROTEIN DIET Meat, Egg, Milk, Liver, Peanut Butter, Almonds, Spinach, Broccoli.
URIC ACID Organ meats, Meats, Anchovies, sardines, herring, mackerel, and scallops, Gravy, Beer.
43. 43
EXPIRY DATE OF OPEN MEDICINE CONTAINERS IN PATIENT AREAS
PREPARATIONS DETAIL EXPIRY DATE
TABLETS & CAPSULES In blister strips –where expiry
date is in intact
Manufacturer’s expiry date
NICORANDIL TABLET Any unused tablets held for 30
days after opening the blister
strip should be discarded
ORAL LIQUIDS Bulk bottles not requiring
reconstitution in original
manufacturer’s packaging
or amber bottles
6 months from date of opening
Bulk bottles requiring
reconstitution
As per manufacturer’s
recommendations for expiry date
INJECTABLES Ampoules Discard remainder immediately
after use
Single dose vials (preservative
free)
Discard remainder immediately
after use
Multiple dose vials (with
preservative)
30 days after opening with
proper storage conditions
INSULINS 28 days after opening with
proper storage conditions
TOPICALS
Creams, ointments, lotions,
pastes
Open top 1 months after opening with
proper storage conditions
Tubes/
pump dispenser
3 months after opening with
proper storage conditions
OPHTHALMICS Drops and ointments with
preservative
30 days after opening with
proper storage conditions
Drops and ointments without
preservative
Discard remainder immediately
after use
EAR DROPS Follow guidance in PIL
NOSE DROPS/SPRAY Follow guidance in PIL
INHALERS Inhaled medical devices as Turbo
halers, MDI, Evohalers
As per manufacturer’s
recommendations for expiry date
SALBUTAMOL (NEBULIZATION
SOLUTION)
In Bottle 30 days after opening with
proper storage conditions
In Sterinebs Use once only
NITROGLYCERIN/ GLYCERYL
TRINITRATE
Sublingual tablets 8 weeks after opening with
proper storage conditions
Sublingual spray 2 years after opening with proper
storage conditions
44. 44
LIST OF DRUGS ASSOCIATED WITH INCREASED RISK OF FALL IN
ELDERLY PATIENT’S
Sl.
No DRUG CLASS GENERIC NAME RISK FACTOR
ANTIPSYCHOTIC- AFFECTING THE CNS & CVS
1.
TYPICAL
ANTIPSYCHOTICS
CHLORPROMAZINE
HALOPERIDOL
TRIFLUOPERAZIN
All have some alpha receptor blocking
activity and can cause orthostatic
hypotension.
Sedation, slow reflexes, loss of balance.2.
ATYPICAL
ANTIPSYCHOTICS
ARIPIPRAZOLE
CLOZAPINE
OLANZAPINE
QUETIAPINE
RISPERIDONE
ANTIDEPRESSANT- AFFECTING THE CNS & CVS
1.
SSRIs
(SELECTIVE SEROTONIN
REUPTAKE INHIBITORS)
ESCITALOPRAM
FLUVOXAMINE
PAROXETINE
SERTRALINE
Cause falls as much as other
antidepressants in population studies
2. SNRIs
(SEROTONIN
NONEPINEPHRINE
REUPTAKE INHIBITORS)
VENLAFAXINE
DULOXETINE
DESVENLAFAXINE
Commonly cause Orthostatic
hypotension
(through noradrenaline re-uptake
blockade)
3.
TCA
(TRICYCLIC
ANTIDEPRESSANT)
AMITRIPTYLINE
DOXEPIN
CLOMIPRAMINE
IMIPRAMINE
NORTRIPTYLINE
All have some alpha blocking activity and
can cause orthostatic hypotension.
All are antihistamines and cause drowsiness,
impaired balance and slow reaction times.
Double the rate of falling
4.
MAOIs
(MONOAMINE
OXIDASE INHIBITORS)
RASAGILINE
All (except MOCLOBEMIDE) cause severe
Orthostatic Hypotension
SEDATIVE/ HYPNOTICS- AFFECTING THE CNS
1.
BENZODIAZEPINES
(Long Acting)
CHLORDIAZEPOXIDE
CLONAZEPAM
DIAZEPAM
Drowsiness, slow reactions, impaired
balance.
Caution in patients who have been taking
them long term
2.
BENZODIAZEPINES
(Intermediate Acting)
ALPRAZOLAM
ESTAZOLAM
LORAZEPAM
OXAZEPAM
3.
BENZODIAZEPINES
(Short Acting)
MIDAZOLAM
RED: High Risk of FALL, alone/combination
GREEN: Moderate Risk of FALL, mostly in combination
45. 45
4. NON-
BENZODIAZEPINES
HYPNOTIC
ZOPICLONE
ZOLPIDEM
OPIOID ANALGESICS- AFFECTING THE CNS
1.
OPIOID
FENTANYL
MORPHINE
TRAMADOL
PENTAZOCINE
Sedate, slow reactions, impair balance,
cause delirium
SKELETAL MUSCLE RELAXANT- AFFECTING THE CNS
1. ANTI-SPASTIC/
MUSCLE RELAXANT
BACLOFEN Sedative. Reduced muscle tone
ANTICONVULSANT- AFFECTING THE CNS
1.
ANTIEPILEPTIC PHENYTOIN
[Phenytoin may cause permanent cerebellar
damage and unsteadiness in long term use
at therapeutic dose]
Excess blood levels cause unsteadiness
and ataxia
2.
ANTIEPILEPTIC
CARBAMAZEPINE
PHENOBARBITONE
Sedation, slow reactions. Excess blood levels
cause unsteadiness and ataxia.
3.
ANTIEPILEPTIC
SODIUM VALPROATE
GABAPENTIN
Some data on falls association
4.
ANTIEPILEPTIC
LEVETIRACETAM
PREGABALIN
TOPIRAMATE
Use with caution- insufficient data on fall
ANTI PARKINSON’S DRUG- AFFECTING THE CNS
1.
DOPAMINE
PRECURSOR
LEVODOPA
Sedative, Drowsiness and Orthostatic
Hypotension
2. PERPHERAL
DECARBOXYLASE
INHIBITOR
CARBIDOPA
3.
DOPAMINE AGONIST
PRAMIPEXOLE
BROMOCRIPTINE
4.
MAOI B
(MONOAMINE
OXIDASE INHIBITORS)
SELEGILINE
5. DOPAMINE
FACILITATOR
AMANTADINE
ANTIHISTAMINE- AFFECTING THE CNS
1.
ANTIHISTAMINICS
DIPHENHYDRAMINE
(BENADRYL)
HYDROXYZINE
PROCHLORPERAZINE
PROMETHAZINE
CHLORPHENAMINE
TRIMEPRAZINE
CINNARAZINE
BETAHISTINE
Sedation
46. 46
ANTICHOLINERGICS ACTING ON THE BLADDER
1.
ANTICHOLINERGICS OXYBUTININ
TOLTERODINE
SOLIFENACIN
No data, but have a known CNS effects
ANTIHYPERTENSIVE- AFFECTING CVS
1. ALPHA
RECEPTOR
BLOCKERS
HYDRALAZINE
PRAZOSIN
Used for hypertension or for prostatism in
men. They commonly cause severe
Orthostatic hypotension. Stopping them
may precipitate urinary retention in men
2.
ANTIANGINAL
ISOSORBIDE
DINITRATE/MONONITRATE
NITROGLYCERIN
A common cause of syncope due to sudden
BP drop
3. CENTRALLY
ACTING ALPHA 2
RECEPTOR
AGONISTS
CLONIDINE
MOXONIDINE
May cause severe orthostatic hypotension.
Sedation
4.
ACEIs
(ANGIOTENSIN
CONVERTING
ENZYME
INHIBITORS)
LISINOPRIL
RAMIPRIL
ENALAPRIL
PERINDOPRIL
These drugs rely almost entirely on the
kidney for their elimination and can
accumulate in dehydration or renal failure
5. THIAZIDE
DIURETICS
CHLORTHALIDONE
METOLAZONE
Cause orthostatic hypotension, weakness
due to low potassium. Hyponatraemia
6. LOOP DIURETICS FUROSEMIDE
Dehydration causes hypotension. Low
potassium and sodium
7. ARBs
(ANGIOTENSIN
RECEPTOR
BLOCKERS)
LOSARTAN
VALSARTAN
OLMESARTAN
TELMESARTAN
May cause less Orthostatic Hypotension
then ACEIs.
8. BETA BLOCKERS ATENOLOL
BISOPROLOL
CARVEDILOL
LABETALOL
METOPROLOL
PROPRANOLOL
TIMOLOL
Can cause bradycardia, Orthostatic
Hypotension
9.
CCBs
(CALCIUM
CHANNEL
BLOCKERS)
AMLODIPINE
NIFEDIPINE
DILTIAZEM
VERAPAMIL
May cause hypotension
ANTIARRHYTHMIC- AFFECTING CVS
1. DIGITALIS DIGOXIN
May cause bradycardia and other
arrhythmias.
2. CLASS 1A SODIUM
CHANNEL
BLOCKER
DISOPYRAMIDE
47. 47
Many factors are associated with falls in the elderly, including frailty, disease, vision, polypharmacy,
and certain medications. Above list should be used to assess your patient to prevent any incidence
related to Drug Induced Fall.
REFERENCES:
1. Woolcott JC, Richardson KJ, Wiens MO. Meta-analysis of the impact of 9 medication classes on falls in
elderly persons. Arch Intern Med. 2010 Mar 8;170(5):477
2. de Jong MR, Van der Elst M, Hartholt KA. Drug-related falls in older patients: implicated drugs,
consequences, and possible prevention strategies. Ther Adv Drug Saf. 2013 Aug;4(4):147-54.
3. Darowski A, Chambers SCF and Chambers DJ. Antidepressants and falls. Drugs and Aging 2009 26 (5)
381-394
4. Darowski A and Whiting R. Cardiovascular drugs and falls. Reviews in Clinical Gerontology 2011, 21
(2), 170-179
5. WEBSITE: www.drugguide.com
48. 48
LIST OF DRUGS WITH TEMPERATURE GUIDE
DRUG NAME
BEFORE DILUTION AFTER DILUTION
BRAND NAME GENERIC NAME
Note: REF = Refrigerate (2 – 8 C). Do not freeze
RT = Room temperature (less than 25C)
ANTI-NEOPLASTIC AGENTS
INJ. ADRIM (solution)
DOXORUBICINE
2 - 8° C
-
ADRIAMYCIN 10 & 50
MG INJ
-
INJ. BLEOCIP BLEOMYCIN RT - 24 hours
INJ. CYTOCRISTEN VINCRISTINE -
CYTOBLASTIN INJ
VINBLASTINE
-
INJ.
FARMORUBICIN
EPIRUBICIN RT - 24 hours
CHEMODAC 20, 80 &
120 MG INJ
DOCETAXEL
2 - 8° C -
DOCAX 20, 80 & 120
MG INJ
DOCETAXEL
2 - 8° C -
DOCETAX 20, 80 &
120 MG INJ
DOCETAXEL
RT -
DABAZ 200 & 500 MG
INJ
DACARBAZINE
2 - 8° C -
DACAREX 200 & 500
MG INJ
DACARBAZINE
2 - 8° C -
GENEXOL PM INJ PACLITAXEL RT -
HOLOXAN 1 & 2 GM
INJ
IFOSFAMIDE
2 - 8° C 2 - 8° C
ANTIDOTE & IMMUNOGLOBULINS
ANTI SNAKE VENOM INJ RT -
RHOCLONE 300MCG
INJ
ANTI-RH D
IMMUNOGLOBULIN
2-8 °C
-
ANTIBIOTICS/ ANTIFUNGAL
INJ. AMFOCARE
AMPHOTERICIN B
(ANTI- FUNGAL)
2 - 8° C
The concentrate
REF - 1 week
Intravenous infusion
solution
Use promptly after
preparation
INJ. DALCINEX CLINDAMYCIN 2 - 8° C RT - 24 hours
TEGLIN INJ
TIGECYCLINE
RT -
TEVRAN INJ
TIGEBEX INJ
49. 49
TOBAMIST
RESPULES
TOBRAMYCIN 2-8 °C
-
OTHER DRUGS
LOFH 5,000 IU
HEPARIN RT RT
LOFH 25,000 IU
TROYHEP 25,000 IU
TROYHEP 5,000 IU
INJ. ALPOSTIN ALPROSTADIL
2 - 8° C
RT - 24 hours
INJ. CARBOPROST 250MG -
TERLISTAT 1MG INJ TERLIPRESSIN -
THINWES INJ
-
INJ. CPRESSIN
VASOPRESSIN -
INJ. CPRESSIN P
INJ. CRESP DARBEPOETIN ALFA -
INJ. EPOTRUST ERYTHROPOIETIN -
CUDO FORTE CAPS -
INJ. MIRCERA EPOETIN ALFA -
INJ. NEORECORMON EPOETIN BETA -
DILZEM INJ DILTIAZEM
REF / RT - 24 hours in
glass or PVC bags
REGEN- D OINT
RECOMBINANT HUMAN
EPIDERMAL GROWTH
FACTOR
-
EUGRAF 60 GEL -
INJ. FERTIGYN HCG -
INJ. FOSPHEN FOSPHENYTOIN -
INJ. HAMOSTAT EPSILON AMINOCAPROIC
ACID
-
INJ. LEUCOVERIN CALCIUM FOLINATE
REF - 24 hours
LOPEZ INJ LORAZEPAM -
ROCURONIUM INJ ROCURONIUM BROMIDE
-
INJ. NEOCURON PANCURONIUM
REF / RT - 48 hours in
glass or plastic containers
INJ. GRAFEEL
FILGRASTIM
RT - 24 hours
Inj. NEUPOGEN
300MU -
LUPIFIL 300 MCG PFS
INJ
-
50. 50
INJ. NEUKINE -
INJ. NEOSURF
PHOSPHOLIPIDS
At -10C – shelf life – 36
months
At 2 - 8°C – shelf life – 10
months
-
SURVANTA 4 ML INJ Unopened: 2-8° C
Before administration: To
be warmed
Allow to stand at
room temperature for
20 min
Hold in hand for 8
min
Tab. NIKORAN (5 & 10
MG)
NICORANDIL
Do not store above 25°C.
Store in the original package
in order to protect from
moisture.
-
NIKORAN IV 2-8 °C -
Tab. NIKORAN OD
10MG
2-8 °C -
NIMODIP INFUSION NIMODIPINE 2-8 °C -
INJ. OCTREOTIDE 50
& 100 MCG
OCTREOTIDE 2-8 °C -
ACTON
PROLANGATUM INJ
CORTICOTROPHIN 2-8 °C -
OSTOSPRAY
CALCITONIN
UNOPENED: 2-8°C
OPENED: 20-25°C (Upright
position)
-
UNICALCIN-50 & 100
I.U INJ
Parenteral: 2-8°C.
Nasal: 2-8°C. -
STPASE INJ 1500000 U STREPTOKINASE Unopened vials: 2-8 °C Reconstituted solution if
stored: 2-8 °C.
U-FRAG 5000 IU & 5 K
INJ
UROKINASE 2-8 °C
-
INJ. ARTACIL ATRACURIUM
2 - 8° C
[Note: If removed from REF
to RT (25°C) –stable for 14
days even if re-refrigerated]
REF or at RT - 24 hours
BIONASE 10 L INJ ASPARAGINASE 2-8°C Reconstituted solution at
2-8°C
Discard after eight hours,
or sooner if it becomes
cloudy.
FOROCART 0.5 MG
RESPULES
FORMOTEROL
FUMARATE,
BUDESONIDE
Store in the protective foil
pouch: 2°C to 8°C. Do not
Opened foil pouch
containing the Respules:
RT up to 4 weeks.
51. 51
freeze.
VSL CAPS PROBIOTIC DIETARY
SUPPLEMENT
2-8 °C
-
SUCOL INJ SUCCINYLCHOLINE
CHLORIDE
Unopened: 2- 8°C
Multi-dose vials: RT
SIMENDA
12.5MG/5ML
LEVOSIMENDAN Stored at 2 -8°C
The colour of the
concentrate may turn orange
during storage, but NO loss
of potency until reached
expiry date
-
SIPHENE 50MG TAB CLOMIPHENE RT
-
PROTA INJ PROTAMINE SULFATE RT
-
CERVIPRIME GEL DINOPROSTONE
Cervical gel: 2-8°C.
Vaginal supp: freezer below
-20°C.
Vaginal insert: freezer
between -20°C & -10°C
-
INSULIN PREPARATION
BRAND NAMES GENERIC NAME
Not In-Use (Un-Opened) to
be refrigerated (2-8°C)
[DO NOT FREEZE]
In- Use (Opened) kept
at RT
[PROTECT FROM
HEAT & LIGHT]
ACTRAPID
CARTRIDGES &
NOVOLET
Insulin Regular 2-8°C RT
BASALOG REFILL Insulin Glargine 2-8°C RT
HUMALOG MIX 75/25
& 50/50
Insulin Lispro Protamine
Suspension + Insulin Lispro
Injection, (rDNA)
2-8°C RT
HUMAN ACTRAPID
40 IU INJ
Insulin Regular 2-8°C RT
HUMAN
INSULATARD 40 I.U.
INJ
Insulin Isophane (NPH) 2-8°C RT
HUMAN MIXTARD
40,50 & 100 IU INJ
Insulin Isophane (NPH) 2-8°C RT
HUMINSULIN 30/70
{CARTDG }100 IU
Regular Human Insulin 30 %,
NPH Human Insulin 70 %
2-8°C RT
HUMINSULIN 30/70,
N & R 10ML INJ
Regular Human Insulin 30 %,
NPH Human Insulin 70 %
2-8°C RT
52. 52
INSUGEN 30/70,
INSUGEN N/R 40 IU
INJ
Regular Human Insulin 30 %,
NPH Human Insulin 70 %
2-8°C RT
INSUGEN 30/70
REFILL
Biphasic Isophane Insulin 2-8°C RT
INSUMAN COMB-
25MG CARTRID 3ML
Insulin Aspart 2-8°C RT
INSUMAN RAPID
100IU CARTRID 3ML
Insulin Regular 2-8°C RT
LANTUS SOLOSTAR
PEN
Insulin Glargine 2-8°C RT
LUPISULIN M 30 & R
CATRIDGE
Insulin Regular 2-8°C RT
LUPISULIN M30 40 IU
30/70 INJ
Regular Human Insulin 30 %,
NPH Human Insulin 70 %
2-8°C RT
MIXTARD 30
FLEXIPEN & PENFIL
Insulin Regular + Insulin
Isophane
2-8°C RT
NOVOMIX 30
FLEXPEN & PENFIL
Insulin Aspart / Protamine-
Crystallised Insulin Aspart
(30/70)
2-8°C 4 weeks: RT
NOVOMIX 50
FLEXPEN
Insulin Aspart / Protamine-
Crystallised Insulin Aspart
(50/50)
2-8°C
NOVORAPID
FLEXPEN 100U/ML
3ML
Insulin Aspart 2-8°C
TRESIBA FLEX
TOUCH PEN
Insulin Degludec 2-8°C 8 weeks: RT
VICTOZA PEN Liraglutide 2-8°C 1 month: RT
WOSULIN 30/70 100IU
CARTRIGES
30% Regular Insulin Human
(Neutral) And 70% Isophane
Insulin
2-8°C Vials: 6 weeks at RT
Cartridge: 4 weeks at RTWOSULIN 30/70, N &
R 40 IU INJ
2-8°C
WOSULIN-N 40 IU INJ Insulin Isophane (NPH) 2-8°C
WOSULIN-R 40 IU INJ Regular insulin 2-8°C
ALL INSULIN
PREPARATIONS
READ LABEL INFO 2-8°C RT
ALL VIALS/ PEN CARTRIDGES TO BE PROTECTED FROM LIGHT AND EXCESSIVE HEAT
Note:
For Penfill: Keep the cartridge in the outer carton in order to protect it from light.
For FlexPen: Keep the cap on FlexPen in order to protect it from light
53. 53
COMMON TERMS
The following terms relate to temperature and medical supplies. It is important to follow the manufacturer’s
recommended storage conditions for all products.
Store at 2°-8°C (36°-46°F):
Some products are very heat sensitive but must NOT BE FROZEN.
To be kept in the first and second shelf of the refrigerator (never the freezer).
Keep all products in the centre away from chiller area
This temperature is appropriate for storing vaccines for a short period of time.
Do NOT store any drug under this temp range in door or bucket/bin
Keep cool: Store between 8°-15°C (45°-59°F).
Store at room temperature (RT)
Store at 15°-25°C (59°-77°F).
To be kept in the 3rd
shelf / bucket / door of the refrigerator
All CRITICAL CARE AREAS should keep the “RT specified drugs” outside the refrigerator as
surrounding temperature is maintained below 25°C
Store at ambient temperature:
Store at the surrounding temperature.
storage in a dry, clean, well-ventilated area at room temperatures between 15° to 25°C (59°-77°F) or up to
30°C, depending on climatic conditions.
3rd shelf/ BUCKET/ DOOR
RT (ROOM TEMPERATURE)
<25°C
1st
& 2nd
shelf
Refrigerator temperature
REF (2-8°C)
NO STORAGE
AREA- DOOR
for REF
DRUG (2-8°C)
Since Fridge
door may
have temp.
Fluctuation
PICTOGRAPHIC REPRESNTATION FOR STORAGE
1
2
3
NO STORAGE AREA:
BUCKET/ BIN for REF
DRUGS (2-8°C)
BIN
DOOR
54. 54
LIST OF VACCINES WITH STORAGE TEMPERATURE GUIDE
Sl
No.
GENERIC NAMES BRAND NAMES TEMPERATURE SCALE
1 BCG [BACILLUS CALMETTE-GUÉRIN]
(for TUBERCULOSIS)
ONCO BCG INJ UNOPENED: 2-8°C
RECONSTITUTED: Kept in Ice bath
during immunization session and
discarded at end of session
2 BIVALENT POLIOMYELITIS VACCINE
type 1 & 3, LIVE (ORAL)
BIVALENT ORAL POLIO
VACCINE
To be kept deep frozen at (-20°C) at
central and at provincial store levels
whenever possible.
Multi-vial to be stored at: 2 - 8°C for
up to 4 weeks/ 1 month
3 INACTIVATED POLIOMYELITIS
VACCINE (TRIVALENT)
POLPROTEC VACCINE PFS
0.5mL
2-8°C
4 DTP
(Diphtheria, Tetanus, Pertussis)
vaccine
TRIPLE ANTIGEN
VACCINE
2-8°C
5 DTP-HIB
[Diphtheria, Tetanus, Pertussis &
Haemophilus Type B Conjugate
Vaccine]
QUADRIVAX 2-8°C
6 DTP- IVP-HIB [Diphtheria, Tetanus,
Pertussis Poliomyelitis & Haemophilus
Influenza Type b]
PENTAXIM VACCINE 2-8°C
7 DTP-HB-HIB (Diphtheria, Tetanus,
Pertussis , Hepatitis B, Haemophilus
influenza type B) PENTAVALENT
VACCINE
PENTAVAC VACCINE 2-8°C
EASY 5
8 HB VACCINE
HEPATITIS B (RECOMBINANT)
REVAC-B 1 ML VACCINE 2-8°C
9 HIB
Haemophilus Type b Conjugate
Vaccine
HIB PRO
10 HBIG VACCINE
HUMAN HEPATITIS B IMMUNOGLOBULIN
PLASMAHEP INJ 2-8°C
INJ. EL-HEP
11 HEPATITIS A VACCINE BIOVAC-A VACCINE 2-8°C
HAVRIX
12 MMR VACCINE
(MEASLES, MUMPS & RUBELLA)
PRIORIX VACCINE
(MMR)- 1 DOSE
2-8°C
TRESIVAC 0.5ML 2-8°C
13 MEASLES VACCINE M-VAC
14 MENINGOCOCCAL POLYSACCHARIDE
VACCINE
QUADRI MENINGO
VACCINE
2-8°C
15 PNEUMOCOCCAL VACCINE
POLYVALENT
PNEUMO - 23 VACCINE 2-8°C
55. 55
16 PNEUMOCOCCAL 13-VALENT
CONJUGATE VACCINE [Diphtheria
CRM197 Protein
PREVNAR VACCINE 2-8°C
17
RABIES VACCINE
BERIRAB INJ 2-8°C
ROTARIX VACCINE 2-8°C
RABIS ANTI SERUM 2-8°C
RABIPUR INJ
(INACTIVATED RABIES
VIRUS)
2-8°C
18 ROTAVIRUS VACCINE ROTATEQ VACCINE 2-8°C
19 TYPHOID VACCINE TCV PFS INJ (Typhoid
Conjugate Vaccines)
2-8°C
TYPBAR INJ 2-8°C
20 TETANUS TOXOID VACCINE TETANUS TOXOID INJ 0.5 2-8°C
21 TETANUS IMMUNOGLOBULIN TETGLOB 250 & 500 MG
INJ
2-8°C
22 VARICELLA VACCINE
(CHICKEN POX)
VARILRIX INJ 2-8°C
BIOVAC-V VACCINE 2-8 °C
SPECIAL INSTRUCTION:
All the diluents should be stored at room temperature (<25°C)
The Joint Commission has clarified that vaccines are an exception
to its usual “28-day rule” for use of medications in MULTIDOSE VIALS.
Providers are directed to follow guidance from CDC and vaccine
manufacturers.
Rotate Stock so that the shortest dated material is used first.
If vaccine has reached expiry date, immediately remove them
from the unit so that they are not accidentally administered.
56. 56
ISMP’s List of Error-Prone Abbreviations, Symbols, and Dose Designations
ABBREVIATIONS INTENDED MEANING MISINTERPRETATION CORRECTION
μg Microgram mg mcg
AD, AS, AU Right ear, left ear, each ear OD, OS, OU (right eye, left eye, each eye)
Right ear, left ear or each
ear
OD, OS, OU Right eye, left eye, each eye AD, AS, AU (right ear, left ear, each ear)
Right eye, left eye, or
each eye
BT Bedtime BID (twice daily) Bedtime
cc Cubic centimeters u (units) mL
D/C Discharge or discontinue
D/C (intended to mean discharge)
misinterpreted as “discontinued” when
followed by a list of discharge medications
or vice versa
Discharge and
Discontinue
IJ Injection IV or Intrajugular Injection
IN Intranasal IM or IV Intranasal or NAS
HS
hs
Half-strength
At bedtime, hours of sleep
Bedtime
Half-strength
Half-strength
Bedtime
IU International unit IV (intravenous) or 10 (ten) Units
o.d. or OD Once daily right eye (OD-oculus dexter) Daily
Per os By mouth, orally left eye (OS-oculus sinister) PO, by mouth, or orally
q.d. or QD Every day q.i.d Daily
qhs Nightly at bedtime qhr (every hour) Nightly
qn Nightly or at bedtime qh (every hour) Nightly or at bedtime
q.o.d. or QOD Every other day
Mistaken as “q.d.” (daily) or “q.i.d. (four
times daily) if the “o” is poorly written
Use “every other day”
q1d Daily q.i.d. (four times daily) Daily
q6PM, etc Every evening at 6 PM” Mistaken as every 6 hours
Daily at 6 PM or 6 PM
daily
SC, SQ, sub q Subcutaneous
SC: SL (sublingual);
SQ: 5 every
Q in “sub q”: every (heparin sub q 2
hours before surgery misunderstood
as every 2 hours before surgery
Subcut or
subcutaneously
ss
Sliding scale (insulin) or ½
(apothecary)
55
Spell out “sliding scale;”
use “one-half” or “½”
SSRI
SSI
Sliding scale regular insulin
Sliding scale insulin
Selective-serotonin reuptake inhibitor
Strong Solution of Iodine (Lugol's)
Spell out “sliding scale
(insulin)”
i/d One daily tid 1 daily
TIW or tiw 3 times a week 3 times a day or twice in a week 3 times weekly
U or u Unit
Number 0 or 4, (4U/4u - “40” or “44”);
cc (4u seen as 4cc)
Unit
UD As directed (“ut dictum”) Unit dose As directed
DOSE
DESIGNATIONS
INTENDED MEANING MISINTERPRETATION CORRECTION
Trailing zero after
decimal point (1.0
mg)
1 mg 10 mg Do not use trailing zeros
“Naked” decimal
point (.5 mg)
0.5 mg 5 mg
Use zero before a
decimal point
Abbreviations such
as mg. or mL. with a
period following
Mg
mL
Unnecessary. Could be mistaken as the
no.1 if written poorly
Use mg, mL, etc
57. 57
Drug name and
dose run together
(Inderal40 mg)
Inderal 40 mg Inderal 140 mg Place adequate space
between the drug name,
dose, and unit of
measure
Numerical dose and
unit of measure run
together (10mg)
10 mg
100 mL
“m” mistaken as a zero or two zeros
Large doses
without properly
placed commas
(100000 units;
1000000 units)
100,000 units
1,000,000 units
10,000 or 1,000,000;
100,000
Use commas for dosing
units at or above 1,000
DRUG NAME
ABBREVIATIONS
INTENDED MEANING MISINTERPRETATION CORRECTION
APAP Acetaminophen Not recognized as acetaminophen
Use complete drug name
ARA A Vidarabine Mistaken as cytarabine (ARA C)
AZT Zidovudine (Retrovir) Mistaken as azathioprine or aztreonam
HCl
Hydrochloric acid or
hydrochloride
Potassium chloride
(The “H” is misinterpreted as “K”)
HCT Hydrocortisone Hydrochlorothiazide
HCTZ Hydrochlorothiazide Hydrocortisone
MgSO4 Magnesium sulfate Morphine sulfate
MS, MSO4 Morphine sulfate Magnesium sulfate
MTX Methotrexate Mitoxantrone
PCA Procainamide Patient controlled analgesia
PTU Propylthiouracil Mercaptopurine
T3 Tylenol with codeine No. 3 Liothyronine
TAC Triamcinolone Tetracaine, Adrenalin, cocaine
TNK TNKase TPA
TPA or tPA
Tissue plasminogen activator,
Activase (alteplase)
TNKase (tenecteplase), or less often as
another tissue plasminogen activator,
Retavase (retaplase)
ZnSO4 Zinc sulfate Morphine sulfate
STEMMED DRUG
NAMES
INTENDED MEANING MISINTERPRETATION CORRECTION
“Nitro” drip Nitroglycerin infusion Sodium nitroprusside infusion Use complete drug name
SYMBOLS
INTENDED
MEANING MISINTERPRETATION CORRECTION
x3d For three days 3 doses For three days
> and < More than and less than Mistaken as opposite of intended More than or less than
/ (slash mark)
Separates two doses or
indicates “per”
Number 1 Per
@ At 2 At
& And 2 And
+ Plus or and 4 And
° Hour Zero (e.g., q2° seen as q 20) hr, h, or hour