PRACTICE REPORT

A Report on

STANDRAD
OPERATING
PROCEDURE

Submitted To:
Bhavdiya institute of pharmaceutical
Sciences and Research
Ayodhya (UP)

Under the supervision of

Miss. Jyoti Vaish
Assistant Professer

Affilliated to

DR. A.P.J Abdul Kalam Technical University, Lucknow (U.P.)

Submitted By
Seema sinha
Roll No. 2008510500078
B.Pharma 4th year (7th Semester)
2023-2024
 CONTENT
S. No. Topics Page Number

1 Abbreviations

2 Introduction

3 Overall pharmacy services and usage of medication in the health facility

4 Procedure for indenting of drugs from warehouse

5 Procedure for local purchase of drugs .

6 Procedure for receiving of drugs.

7 Procedure for storage of drugs

Procedure for maintenance of temperature of pharmaceutical
8
refrigerator/ deep freezer/ ice-lined refrigerator
9
 Introduction
Provision of quality health care to the people is a commitment of Government of
NCT of Delhi. Availability of quality medicines and their rational use is important
for this to be achieved. Ensuring that essential medicines are available for the
patients at all times and they are rationally used requires an awareness of the
multiple steps involved in the “Medicine cycle”, if the aim of ensuring that the
right medicines is available for the right patient at all times has to be fulfilled.
These steps include :-

1) Selection of a list of medicines which are essential to meet the health care requirements
of the people . This is dependent on the morbidity and mortality pattern of that region.
The word essential has been defined by the World Health Organization as

“Essential medicines are those medicines that meet the priority health care needs of
majority of the population. They are selected with due regard to public health relevance,
evidence on efficacy and safety and comparative cost effectiveness. Essential medicines
are intended to be available at all times in adequate amounts, in the appropriate dosage
forms, with assured quality and adequate information, and at aprice the individual and
community can afford”

2) Assessment of the quantity of medicines that are required within the health facility.
Accurate quantification is important to ensure that there are no shortages in availability
of essential medicines for the patients.

3) Procurement of these medicines by the health facility. The process would be from the
Central Procurement Agency of the Government(CPA) of the Delhi or the Delhi Health
Corporation Ltd (DHCL) that has been made. In case medicines are not available in the
CPA / DHCL these would have to be made available by the hospital for the patients by
either borrowing from other hospitals or procuring locally.

4) Storage- The medicines obtained by the hospital must be stored in conditions to ensure
that the quality of the medicine does not deteriorate. The storage must be as specifiedby
the manufacturer.
5) Distribution-The medicines would have to be distributed to the different areas of use
within the hospital- Main Drug store- Outpatient Pharmacy, Hospital Emergency,
Inpatient departments. At each place, conditions for storage must be as specified in the
manufacturers brochure.

6) Prescribing of medicines must be based on principles of rational prescribing

7) Administration of medicines must follow safe medication practices

8) Dispensing of medicines must follow good dispensing practices.

8) Disposal of medicines found unfit for use must be in accordance with the existing rules
for bio- waste management

9) Well Informed Patients: Patients must be informed about proper use of medicines
prescribed to them.

10) Monitoring of the Medicine Cycle within the health facility ie from the procurement to
use.

11) Education of health care providers, including doctors, nurses and pharmacists on a
continuous basis

12) Correction/ Modification/ Changes in the processes at any step based upon
problems encountered

A thorough review of all these steps is required on a regular basis to ensure

that quality medicines are available for the patients at all times and they are
rationally used.

Such an elaborate process requires that there be Standard Operating

Procedures ( SOPs) for each step under defined conditions. They are
necessary to ensure the proper conduct of processes, in continuity, to achieve
quality performance. These mustbe available at all times in the locations
where they are required.

These standard operating procedures have been made for management of

medicines availability, distribution , storage and rational use within hospitals
under Government of NCT of Delhi. They have been made keeping in mind
the practices that are already in existence within the hospitals. It has been
the endeavor of the Committee to make
the SOPs simple and easy to use. Experience of people involved in
actually managing different aspects of medicine cycle has been used for
making these SOPs. The Order of the SOPs is as they would be required
in the different aspects of the Medicine procurement and use cycle
within a hospital- Selecting medicines, quantification, procurement,
storage, distribution, prescribing, dispensing, administration,
monitoring, quality checksIn all this the role of the Hospital Drugs and
Therapeutics Committee (DTC) will be paramount. It will play a key
role in improving the use of medicines in the health facilities( hospitals).
It is important that all hospitals establish DTCs as a first step to
improving quality of management of drug use.The first section deals
with general aspects required in a health facility to ensure that essential
medicines can be made available.In the SOPs that follow the word
“drug” has been used for medicines, as that is the word used in the
Drugs and Cosmetics Act 1940. Although for therapeutics it is
preferable to use the word “medicine”.For procurement of drugs CPA
has been used interchangeably with District Drug Warehouses, as that is
the way the Government proposes to distribute the medicines to the
health facilities in the future.Some SOPs have been adapted from those
of the National Accreditation Board for Hospitals and Health Care
ProvidersThese SOPs have been made as a preliminary guide for basic
processes involved in the medicine procurement-use cycle. Once these
are established and put in place, more SOPs to further strengthen the
medicine (drug) cycle in the health facilities will be formulated.
Definition
“Drug” includes

(i) All medicines for internal or external use of human beings or animals and all substances
intended to be used for or in the diagnosis, treatment, mitigation or prevention of any
disease or disorder in human beings or animals, including preparations applied on human
body for the purpose of repelling insects like mosquitoes;

(ii) Such substances (other than food) intended to affect the structure or any function of the
human body or intended to be used for the destruction of [vermin] or insects which cause
disease in human beings or animals, as may be specified from time totime by the
Central Government by notification in the Official Gazette;

(iii) All substances intended for use as components of a drug including empty gelatin
capsules; and

(iv) Such devices intended for internal or external use in the diagnosis, treatment, mitigation
or prevention of disease or disorder in human beings or animals, as may be specified from
time to time by the Central Government by notification in the Official Gazette, after
consultation with the Board

Drugs & Cosmetics Act, 1940

 Department: PHARMACY SO 1
P
Division: Store, Sub Store, IPD, OPD Implementation Date:
Review Date:
Prepared by:
Approved By:

Overall pharmacy services and usage of drugs in the

health facility
1.1 Purpose

To provide guide lines for the organization of pharmacy services,

management,procurement of drugs and their usage.

1.2 Scope
All activities and areas in a health facility (Hospital) concerned with
procurement, storage, use and disposal of drugs.

1.3 Responsibility
• Head of the Institute
• DTC
• Departmental Heads
• Purchase Officer
• Officer in-charge MDS
• Pharmacist in-charge MDS
• Officer in-charge OPD Pharmacy
• Pharmacist in-charge OPD Pharmacy
• Nursing Sister in-charges of Department sub-stores.

1.4 Procedure
1.4.1 The overall management of pharmacy services in the hospital will be a
coordinated activity involving the DTC, Purchase officer, Officer in-charge MDS,
all Heads of departments, Pharmacist in-charge MDS and Pharmacy, Nursing
Sister in-charge's of different wards and sub stores. They will all work under the
guidance of the Head of the Institute.
1.4.2 The Pharmacy shall comply with the following laws and regulations: Drugs
and Cosmetics Act; Narcotics and Psychotropic Substances Act; Drugs and
Magic Remedies Act.

1.4.3 The principles enunciated in the Drug Policy of Government of NCT of Delhi, 1994 (or
any revision) shall be followed in the health facility

1.4.4 Only drugs as included in the Essential Drugs(medicines) List of Government of NCT
of Delhi will be procured and used. In addition the health facility may specify other drugs
which they specifically require for the patients. This will be decided by the DTC and
justification forthe same will have to be given. Inclusion of drugs must based on their efficacy,
safety, suitability and cost.

1.4.5 Every hospital shall have a DTC which shall annually review the appropriateness of the
health facility drug list to meet the needs of the health facility. The DTC will form the core
group for coordinating all activities related to rational use of medicines in the health facility.

1.4.6 Scientific and rational principles will be followed for selecting the list of essential
medicines for the health facility, estimating quantities of medicines required, storage,
dispensing, prescribing, administering and use of medicines.

1.4.7 Documentation of all aspects related to the drug management cycle must be in place there
and the records must be maintained preferably electronically. These must be audited regularly
by Officers appointed by the Head of the Institute.

1.4.8 There should be a Hospital Information Management System(HIMS) for maintaining

drug accounts, efficient procurement, distribution within the health facility and prescription
details.

1.4.9 The health facility must specify the budget for drugs under a separate head ,”Budget for
Drugs”. The budget spent on drugs must never be clubbed together with other hospital
consumables.

1.4.10 A system for providing updated information in relation to drugs, to the doctors, nurses,
pharmacists, should be readily available within the health facility. Electronically available, peer
reviewed sources of drug information can be used for the same.
1.4.11 The policies and processes of the health facility as regards the drug supply and their use
cycle must be informed to all the health care providers within the health facility

1.4 12 A system for continuous monitoring of the drugs supply use cycle in the health facility
must be established. The DTC must coordinate the monitoring within the health facility.
Regular review, with an analysis of the strengths and weaknesses of the drug supply use cycle
in the health facility must be done and corrective action should be taken for further
improvement from time to time.

1.4.13 Standard Operating Procedures as specified for procurement, storage, distribution,

dispensing, prescribing, administering, disposal of drugs must be strictly followed.

1.4.14 All processes must be followed, to ensure that patients receive appropriate drugs for
their medical illness and do not suffer any harm.

1.5 Records
All records pertaining to activities related to drug supply use cycle as written in
the specific SOP ( SOP 2-18) must be maintained.

1.6 Process Efficiency Criteria

There should be no shortages of quality, essential drugs in the health facility for
the patients.These must be stored and rationally used causing no harm to the
patients.

1.7 Activity
All activities as related to drug supply use cycle as given in the specific SOP ( SOP 2-
18)
 Department: PHARMACY SO 2
P
Division: Store, Sub Store, IPD, OPD Implementation Date:
Review Date:
Prepared by:
Approved By:

Procedure for indenting of drugs from warehouse

2.1 Purpose

To establish procedures for indenting of drugs and items from DDW/ CPA for the
hospital.

2.2 Scope
All activities related to determining the nature and quantity of drugs required by
the hospitalfor indoor, outdoor and emergency patients and ensuring their
availability at all times.

2.3 Responsibility
• Officer in- charge MDS
• Pharmacist in- charge MDS
• Ware house in- charge
• Officer in- charge CPA
• Pharmacist in-charge CPA

2.4 Procedure
2.4.1 The list of drugs to be indented must be in accordance with the EDL prepared by the
Hospital DTC.

2.4.2 Officer In-charge MDS will determine the total quantity of the drugs required on an
annual basis using the past consumption pattern, morbidity data & hospital requirements. A
buffer stock of drugs for 90 days must be maintained by the hospital.

2.4.3 The total indent of drugs shall be approved by the Head of the Institute and foorwarded
to the DDW . The indent will be sent to the DDW preferably electronically usingGovernment
approved software.
2.4.4 The indent should be sent quarterly i.e. four times a year to the DDW except in rare
emergencies.

2.4.5 The DDW** will deliver the drugs to the hospital. It will be the responsibility of the DDW
In-charge to ensure timely delivery of indented drugs to the MDS of the health facility.

2.4.6 These indented drugs will be received by the Pharmacist In-charge of the MDS of the
hospital and counter checked by the Officer in-charge of the MDS of the hospital. A record of the
same must be maintained preferably by Electronic means.

2.4.7 The Warehouse will only send those drugs to the health facility which have been declared
“as of standard quality.”

** Delivery of drugs by the DDW to the health facility is being proposed, hence the
same has been incorporated.

2.5 Records
• List of essential drugs prepared by the DTC of the hospital.
• Total quantity of drugs estimated by the Officer In-charge of the MDS, based on
consumption pattern, morbidity data and hospital demand, sent to the warehouse.
• The individual Indent vouchers sent to the warehouse.

2.6 Process Efficiency Criteria

• Timely indenting of drugs from warehouse
• Availability of all essential drugs in the hospital at all times.

2.7 Activities
• Review of timing of indents sent to the warehouse by Head of the Institute and Officer
In-charge MDS.
• Review of availability of drugs in the hospital, by the DTC at quarterly intervals.
*******
 Department: PHARMACY SO 3
P
Division: Store, Sub Store, IPD, OPD Implementation Date:
Review Date:
Prepared by:
Approved By:

Procedure for local purchase of drugs

3.1 Purpose

To ensure availability of essential drugs in the hospital that were not obtained
through regular indenting from the DDW and to meet special requirements,
medical emergency situations and exigencies of the hospital.

3.2 Scope
Emergency and Indoor Patients. It should preferably not be used for OPD patients.

3.3 Responsibility
• Hospital DTC
• Officer in-charge of the MDS
• Pharmacist in-charge MDS
• Purchase Officer

3.4 Procedure
3.4.1 The demand for the drugs will be sent by the Officer in-charge of the MDS to the
Purchase Officer.

3.4.2 In case of Emergency, the demand will be sent by the User Department through Officer
in-charge MDS to the Purchase Department.

3.4.3 The Officer in-charge of the MDS will forward the demand to Purchase officer after
verifying the non availability of the drugs with reasons and justification.

3.4.4 The purchase officer of the hospital will arrange the drugs through
 • Local purchase
• Any other valid rate contract of Delhi Government hospital.
• Under General Financial Rules 145 & 146.

3.4.5 The Purchase Officer will take the approval from the Head of the Institute for procurementof
drugs .

3.4.6 The drugs will be received and recorded by the MDS and issued to concerned user
department.

3.4.7 For purchase of drugs made at odd hours, the concerned department will bring to the notice
of person authorized by the Head of Institute for such purposes who will make the drugs available
from authorized local chemist.

3.4.8 A detailed analysis and review of drugs procured through local purchase throughout the year
must be made by the Hospital DTC, in consultation with the Officer in charge of the MDS. Reasons
for local purchase must be analyzed and ways to decrease the same for future must belooked for.

3.5 Records
• Stock register of MDS
• Stock Register of User Department
• Local purchase records by the Purchase Department.
• Indent vouchers sent to Purchase departmen

3.6 Process Efficiency Criteria

• Decrease in the number of drugs procured through local purchase.
• Minimum time required to obtain drugs through local purchase.

3.7 Activities
• Review of timing of indents sent to the warehouse by Officer in-charge MDS

Page 19
• Review of availability of drugs in the health facility by the DTC bi-annually.
• Review of the hospital EDL
• Review of the drug quantification process of the hospital

******
*
 Department: PHARMACY SO 4
P
Division: Store, Sub Store, IPD, OPD Implementation Date:
Review Date:
Prepared by:
Approved By:

Procedure for receiving of drugs

4.1 Purpose

To ensure that the drugs are received by the hospital as per indent in appropriate
specifications and quantity.

4.2 Scope
All activities concerned with ensuring proper receiving of drugs indented by the
healthfacility.

4.3 Responsibility
• Officer in-charge MDS
• Pharmacist in-charge MDS

4.4 Procedure
4.4.1 All the drugs received in MDS of the health facility must be verified by the Officer in-
charge MDS and Pharmacist in-charge MDS as per indent. The drugs must be checked for their

• Physical appearance

• Quantity

• Number,

• Expiry date

• “Hospital Supply NOT for sale” Logo.

Page 21
Page 21
The same should be recorded in the Stock register.

4.4.2 At the time of receiving of drugs, if the drugs do not appear in appropriate physical
conditions then the drugs should not be accepted. These should be sent back to
warehouse / Supplier. The same may be informed to Purchase Officer and the Head of
the Institute.

4.5 Records
• Stock register of MDS

4.6 Process Efficiency Criteria

• Receiving of appropriate drugs in appropriate quantity & quality at all times.

4.7 Activities
• Random checking of the drug entries in the stock register and verifying with the indent
vouchers /Challan/Invoice.
 Department: PHARMACY SO 5
P
Division: Store, Sub Store, IPD, OPD Implementation Date:
Review Date:
Prepared by:
Approved By:

Procedure for Storage of Drugs

5.1 Purpose

To provide guidelines for proper activities relating to storage of drugs.

5.2 Scope
• MDS, Sub Stores of respective Departments.
• Pharmacy (OPD).

5.3 Responsibility
• Officer in-charge of MDS.
• Pharmacist in-charge of MDS.
• Pharmacist's in-charge/Nursing Sister In-Charge of various department sub stores.

5.4 Procedure
5.4.1 All the drugs are to be stored as per the instructions mentioned on the label by the
manufacturer . These should address issues pertaining to temperature ( refrigeration), light,
ventilation, preventing entry of pests/ rodents and vermin's) at all location of storage such as
stores and pharmacy

5.4.2 Drugs shall be stored in a clean, well lit and ventilated environment.

5.4.3 There should be no direct sunlight in the area where the drugs are stored

5.4.4 The storage areas should be free of vermin and pests.

5.4.5 Consistently monitor the temperature of the different areas within the storeroom. Keep
thermometers in various places for monitoring.
5.4.6 Do not keep boxes on the floor directly. Keep on pallets with air space in between
5.4.7 The storage of drugs should be done preferably in alphabetical order of their generic
names in all the areas.

5.4.8 Refrigerator used for storage of drugs should have a continuous temperature
recording device like data logger and same should be documented. Refrigerator temperature
shall be recorded ideally three times a day in the stores and in the pharmacy
and the same shall be verified and counter signed by the in-charge staff.

5.4.9 Drugs should be stored in a manner to avoid pilferage and theft by installing CCTV at
strategic locations.

5.4.10 All look alike, sound alike drugs should be stored separately in all the areas.

5.4.11 Inventory practices (like first in and first out (FIFO, ABC, VED) shall be followed
whileissuing inventory.

5.4.12 Records of the drugs in all storage areas should be maintained preferably in electronic
mode.

5.5 Process Efficiency Criteria

a) All the drugs are to be stored as per manufacturer’s instructions on the label.

5.6 Process Activity

b) Audits and physical verification at regular intervals of all the storage areas by a
committee constituted by Head of the Institution.

References
c) Drugs and Cosmetics Act,1940
d) Drugs and Cosmetics Rules, 1945.
e) Delhi Narcotic Drug Rules, 1985
f) Pharmacy Act, 1948
g) NABH: Pre Accreditation Entry Level Standards For Hospitals, April 2014
h) World Health Organization: Guidelines for storage of essential medicines and other
health commodities, 2003.
Definitions

a) Protect from moisture: Store the product in a space with no more than 60% relative
humidity.

b) Store frozen: Store products at -20 degree C ( 4 degree F)

c) Store at 2-8 degrees C ( 36- 46 degree F) : These are usually kept in the first and second
part compartment of the refrigerator ( never the freezer)

d) Cool Place: Store between 10 degree C and 25 degree C

e) Cold Place: Store at a temperature not exceeding 8 degree C

f) Store at ambient temperature: Store at the surrounding temperature. This term is not
widely used due to significant variation in ambient temperatures. It means “room
temperature” or normal storage conditions, which means storage in a dry, clean, well
ventilated area at room temperatures between 15 to 25 degree C or up to 30 degree C,
depending on climatic conditions.

g) Whenever storage condition is not specified store at room temperature.

 Department: PHARMACY SO 6
P
Division: Store, Sub Store, IPD, OPD Implementation Date:
Review Date:
Prepared by:
Approved By:

Procedure for maintenance of temperature of

pharmaceutical refrigerators/ deep freezer/ ice-lined
refrigerator
6.1 Purpose

To ensure that drugs are stored at appropriate temperature in the hospital.

6.2 Scope
All activities related to storage of drugs at appropriate temperature required in
pharmaceutical refrigerator/deep freezer/ ice-lined refrigerator.

6.3 Responsibility
• Pharmacist in- charge of MDS
• Pharmacist in- charge of pharmacy(OPD)
• Nursing Sister in charge of IPD sub-stores & OPD sub-stores

6.4 Procedure
6.4.1 The temperature of all electrical cold chain equipment (pharmaceutical refrigerator / deep
freezer, ice-lined refrigerator) should be recorded at least thrice daily i.e. opening, closing time
of drug store and once midway.

6.4.2 Pharmacist in-charge of MDS , Sister in-charge of sub-stores of various

departments of the hospital will sign the record and the same should be randomly checkedby
Officer in-charge.
6.4.3 Continuous power supply must be ensured for maintenance of the temperature by
suitable electricity backup.
6.4.4 In case of non-maintenance of temperature, the pharmacist or nursing sister in-charge should
immediately intimate the same to concerned Officer in-charge of the department. They will also
inform immediately to Institution Repair Maintenance Department, Electrical Department,
Supplier of the equipment in case of equipment being in the warranty period or with Annual
maintainer contract .

6.4.5 The drugs stored in the non-functioning refrigerator must be shifted to alternative
pharmaceutical refrigerators.

6.4.6 In case drugs have been stored at sub-optimal temperature for an inappropriate time this
information must be brought to the notice of Officer in-charge of MDS & concerned unit in-
charge. Such drugs must be returned back to MDS for disposable.

6.4.7 Proper records of drugs which have not been stored at the temperature required for the
duration specified by the manufacturer, must be maintained.

6.4.8 Placing of refrigerators

Place refrigerators and freezers with space between and about an arm's length away
from the wall. This will increase air circulation. Ideally rooms with multiple
refrigerators and or freezers should have air conditioning. If it is not possible to have
air conditioning , install fans around theequipment to increase airflow. Ideally, larger
facilities should have a cold room rather than numerous refrigerators.

6.5 Records
• Temperature log book.
• Temperature charts.
• Record of drugs that could not be used due to inadequate temperature maintenance ofthe
refrigerators
6.6 Process Efficiency Criteria
• Maintenance of appropriate temperature in the refrigerator at all times.
• Minimal wastage of drugs due to improper storage of drugs .

6.7 Activity
• Review of temperature maintenance process and records of the refrigerators at regularintervals.
• Review of records of drugs that may have been disposed off due to improper storage.