Standard Operation Procedure (SOPs )for Clinical Pharmacy

(Dispensing,Store/Stock Management of medicine and Cold chain

Management .
Contents
1. Duties/Responsibilities for concerned person
2. Dispensing
I. Scope

II. Objectives

III. Responsibilities

IV. Definitions

V. Principle

VI. Pre-request

VII. Procedures

2. Store/ Stock Management of Medicine.

3. Management of Controlled Medicine
4. Cold Chain Management
1. Duties/Responsibilities for concerned person

Pre-Departure
The concerned person from pharmacy will be responsible as follows:

A. Before attending the site

1. The good/ medicines must be identified as per the standard list enclosed in guide line.
2. Pack the items/goods as per the standard list in designated boxes/bags/carriers after
proper segregation and labeled well.Controlled drugs to be kept under lock and key
3. Special care to be given to perishable items and controlled items as per the required
norms.
4. Clearance from the customs, regulatory bodies from the host country as well as Bhutan
must be sought as per the requirements, specially the controlled drugs with proper
documentation.
5. Overall, stocks ledgers/challans must be maintained for record.

B. After Arrival at Site.

1. All Pharmacy goods to be stored at the designated area(Store)
2. Verify all the goods with proper documentation
3. Arrange the medicines at the dispensing counter with proper documentation and proper
storage condition. (alphabetical or therapeutic group)
4. Controlled medicines to be kept under lock and key with strict supervision and
documentation.
2. Dispensing
1. Scope
This Sop covers all the steps involved in dispensing starting with receipt of prescription
till handing over of medicines.
2. Objective
To provide standard procedures for dispensing of medicine. It will cover all aspects of
dispensing, starting with receipt if prescriptions till medicine are dispensed.

3. Responsibilities
Pharmacist /Pharmacy Technician should familiarize and comply with this SOP.

4. Definitions
4.1. Dispensing: It refers to the process of preparing and giving medicine to a named
person on the based on prescription. It involves the correct interpretation of the
wishes of the prescriber and the accurate preparation and labeling of medicine for
use by the patient.
4.2. Pharmaceutical care issue: Problems in the pharmacotherapy of individual patient
that actually or potentially interfere with desire health outcomes.
4.3. Professional check: A clinical assessment of prescription undertaken, by a
pharmacy professional, to determine the suitability of medicine, the
appropriateness on the quality and its dose frequency for patient.
4.4. Contraindication: A specific situation in which a medicine should not be used
because it may be harmful ton person.
5. Principel
Promote safe and effective use of medicines through Good Dispensing Practice

6. Pre-Request
6.1 Suitable dispensing premises

6.2 Staff-2. One each in dispensing and store

6.3 Working tables with drawer and chairs

6.4 Medicine trolley

6.5 Plastic Dispensing envelopes

 6.6 Counter scissors

6.7 Powder free gloves

6.8 Plastic Medicine containers with cover

6.9 Isopropyl alcohol

6.10 Register

7. Procedures
7.1 Received the Prescription from patient

7.2 Verify the prescription

7.3 Record patient details

7.4 Label and pack the prescribed medicine

7.5 Dispense medicines with proper Counseling/Advise if necessary

1. Store/ Stock Management of Medicine.

1. Scope
This SOP applies to all activates related to stock management of medicines

2. Objective
To provide standard procedures for stock management of medicines

3. Responsibilities
Pharmacist /Pharmacy Technician should be familiarize and comply with this SOP

4. Definitions
4.1 Stock Control: It is the process of checking the quantity of each item in the inventory
at any given time and keeping track of it.
4.2 FEFO: It is an acronym which stands for “First Expiry, First out”. This means the
product with the deadline for next intake will be the first to be serve or remove

5. Principle
 Ensuring uninterrupted supplies od medical good through the practice of Good Store
Management

6. Pre- request
6.1 Suitable Medicine store with adequate space with Fan if it is in hot place

6.2 Field Medical boxes for store

6.3 Cupboard with locking system

6.4 Stock Ledger /Register

7. Procedure
7.1 Indenting: Indent the medicines as per consumption pattern and physical balance
7.2 Receiving: Upon the receipt, verify each medicines with Name, Quantity, Expiry
date, For any damages , Arrange and Update the stock ledger.
7.3 Issuing: Issue medicines as per the requirement in different units
7.4 Stock control: Monitor Stock on daily basis for the following
 Physical balance of each medicines
 For any damages /Expiry
 If each items are arrange appropriately
 Update all units and prescribers on stock status.

3. Management of Controlled Medicines

1. OBJECTIVE

This Standard Operating Procedure describes procedures for management and dispensing of
Schedule C medicines (controlled medicines).

2. SCOPE
This SOP applies to all the procedures involved in the management and dispensing of the
controlled medicines.
3. RESPONSIBILITY BEMT professional designated for the purpose for the management
of controlled medicines.

4.DEFINITIONS

4.1.Controlled medicines: Category of medicines which are controlled under the Narcotics
Drugs and Psychotropic Substance and Substance Abuse Act of Bhutan, 2015 and the Medicines
Act of the Kingdom of Bhutan, 2012.

 Schedule C1: Refers to controlled drugs which belongs to narcotics

 Schedule C2: Refers to controlled drugs belonging to category of psychotropic substances

5. Principle

Ensuring responsible use of controlled medicines, in keeping with legislative

requirement, through effective stock control and documentation

7. Pre-request
Cabinet with lock and key
Forms
Stock ledger/Register

7. PROCEDURE

7.1 Issuing to Unit

 Fill all the required details of the standard form with quantity of medicines
 Sign the form with name and handover the medicines to the designated staff.
 Record in the stock ledger

7.2. Dispensing to out patient

  Verify the following in the prescription:
 Date:
 Registration number and patient details:
 If the prescription is valid and from an authentic prescriber:
 If the prescription contains sign and seal of the prescriber; and
 Therapeutic relevance and dosing appropriateness.
 Pack and label accordingly.
 Dispense with appropriate counselling.
 Record:
 Patient name/Registration No./Bed No.;
 Age and Gender;
 Quantity of each medicine to be dispensed;
 Prescribed by;
 Dispensed by; and Balance quantity

Annexure I: Controlled Medicine Form

(Record keeping in wards /Units)

Controlled Medicine Form, Name of the medicine, Strength and dosage form

Section: _______________________________ Balance: ______________________

In-charge’s Name: ___________________ Quantity requested: _____

Quantity issued: ________
Total quantity: ________

Ordered by Name &

Bed Dose &
Date Time Patient Name Reg. No. & BHMC Signature of Balance Signature
No. Frequency
No. dispenser

                   
                   

                   

                   

                   

                   

                   

                   

                   

                   

                   

Received by: Issued by:

In-Charge: ______________________ Pharmacist/Technician: ________________

Date: _____________ Date: _____________

Annexure 2: Record keeping in OPD

Sl Time Name of Age /Gender Category of Dosage Qty Balance Initial of

No patient prescriber . dispenser
1
2
3
4
5
6
2. Cold Chain Management

1. Scope
This SOP to the storage of medicine which required cold conditions.

2. Objectives
This SOP describe pricedures for handling and storing medicine requireing cold
storage condition

3. Responsibility
Designated staff should familiarize and comply with nSOP

4. Defenition : Cold chain :It is a system of storing and transporting vaccine ast
recommended temperatures form the point of manufacturing to the pointn of us.

5. Principle
Ensuring potency of the medicine requiring cold storage in maintained throughout
their shelf life.

6. Pre request
6.1 Cold chain boxes with bag
6.2 Thermometer
6.3 Tempertature monotoring chart
7. Procedure
 Monitoring records must be record twice daily, preferably at the same time
each day using standard temprteure chart.
 Should chang the ice pack every 12 hourly.
 The temperature should be maintain between 2-8 degree centigrade
Guideline for Reporting Adverse Drug reaction

Definition

 ADRs have been classified as type A or type B.

Type A reactions are predictable from the known pharmacology of a drug and are associated
with high morbidity and low mortality.

Type B reactions are idiosyncratic, bizarre or novel responses that cannot be predicted from the
known pharmacology of a drug and are associated with low morbidity and high mortality.

Not all ADRs fit into type A and type B categories; therefore, additional categories have been
developed. These include type C (continuing), type D (delayed use), and type E (end of use)
reactions.

Point of contact : Incase of an event of adverse drug reaction the point of contact shall be
Pharmcay technician, The respective unit shall file up the adverse drug event and it will be
compiled by the Pharmacy technician. BEMT will use the standared suspected adverse drug
reaction form which is being used in the hospital to document.

BEMT might not come across The adverse drug reaction due to taking medication orally because
it is a type one fixed medical team but most probable and likely adverse drug reaction that
BEMT might come across is while using injectables.

SUSPECTED ADVERSE DRUG REACTION (ADR) REPORTING

CONFIDENTIAL

If you are suspicious that an adverse reaction may be related to a drug or a combination of drugs,
PLEASE COMPLETE THIS FORM and send it to the nearest Pharmacovigilance Centre / Drug
Regulatory Authority.
 A. PATIENT INFORMATION***

1. Patient Details* Patient name or Initials:

_____________________________________________ Age/Sex:____________

Weight (if known): ________________________________________ Ward/Dept/Unit:

_____________________

2. Relevant Tests/Laboratory Data(If any):

3. Other Relevant Information (including Pre-existing medical conditions viz. allergies,

pregnancy, alcohol use, renal dysfunction, diabetes etc.):

B. SUSPECTED DRUG (S) *

Drug name Prescribed Manufactured Batch no /Exp Rout Dose/strength Date Date stopped
for/indication by date e started

C. SUSPECTED DRUG REACTION(S)* 1. PLEASE DESCRIBE THE REACTION & ANY

TREATMENT GIVEN /ACTION TAKEN
DATE REACTION STARTED: _______

DATE REACTION STOPPED: _______

OUTCOME: (TICK ALL THAT IS APPROPRIATE)

RECOVERED RECOVERING CONTINUING

OTHERS (SPECIFY)___________________

2. DO YOU CONSIDER THE REACTION TO BE SERIOUS? YES NO IF YES, PLEASE

INDICATE WHY THE REACTION IS CONSIDERED TO BE SERIOUS (TICK ALL THAT
IS APPROPRIATE)

i. PATIENT DIED DUE TO REACTION ii. PROLONGED HOSPITALIZATION

iii. LIFE THREATENING

iv. SIGNIFICANT DISABILITY v. MEDICALLY SIGNIFICANT (including

congenital anomaly), GIVE DETAILS:
D. OTHER MEDICATIONS (INCLUDING SELF‐MEDICATION, (HERBAL AND
TRADITIONAL MEDICINES) DID THE PATIENT TAKE ANY OTHER MEDICINES
PRIOR TO THIS REACTION? YES NO

Drug Name( Both generic and Dosage Route Date started Date stopped
Brand)

E. REPORTER DETAILS * **

NAME: ___________________________________________

DESIGNATION: ______________________________________

ADDRESS:
_____________________________________________________________________________

CONTACT NO._________________________ DATE: ______________________________

SIGNATURE: _____________________________________

A. Patient Information

1. Patient Details

 Patient name or initials: A reporter should mention the name of the patient or initials of a
patient. For e.g.: xxxxx.
 Age at time of event or date of birth: A reporter must report either the date of birth or age
of the patient at the time the event or reaction occurred.
 Sex: A reporter must mention the gender of the patient.
 Weight: If known, the weight of the patient should be in kilograms (Kg).

2. Relevant tests/ laboratory data:

  A reporter must mention any laboratory data (if available).

3. Other relevant history:

 A reporter must mention any relevant history pertaining to the patient including pre-
existing medical conditions (e.g. allergies, pregnancy, alcohol use, hepatic/renal
dysfunction).

B. SUSPECTED DRUG(S)

 It maybe one drug or more than one drug.

 The details of suspected medication(s) such as the drug name (brand or generic name),
manufacturer, batch no/lot no, expiry date, dose used, route used, dates of therapy started
and stopped, and indication of use must be provided by the reporter.

C. SUSPECTED ADVERSE DRUG REACTION

1. Describe reaction and any treatment given:

 A reporter must briefly describe the event in terms of nature, localization etc. For
eg;patient developed rash over upper and lower limbs following Ranitidine injection.
 The reporter must also indicate if any treatment is given against the Suspected Adverse
Drug Reaction.
 Date of reaction started: A reporter must report the date on which the reaction was first
occurred.
 Date of reaction stopped: If the reaction recovered, the date on which the reaction
recovered should be reported.
 Outcomes: The reporter must tick the outcome of the event as:

Recovered– if the patient has recovered from the event

Recovering– if the patient is recovering from the existing adverse event
Continuing– if the patient is continuing to have the symptoms of the adverse event which
occurred
2. Seriousness of the reaction:

 If any event is serious in nature, a reporter must select the appropriate reason for
seriousness.

Death– if the patient died due to the adverse event

Hospitalization/prolonged– if the adverse event led to hospitalization or increased the hospital
stay of the patient
Life-threatening– if patient was at substantial risk of dying because of the adverse event
Significant Disability– if the adverse event resulted in a substantial disruption of a person’s
ability to conduct normal life functions
Congenital anomaly– if exposure of drug prior to conception or during pregnancy may have
resulted in an adverse outcome in the child.
Other Medically Significant-when the event does not fit the other outcomes, but the event may
put the patient at risk and may require medical or surgical intervention to prevent one of the
other outcomes.

D. OTHER MEDICATIONS:

 A reporter should include all the details of concomitant drugs including self-medication,
OTC medication, herbal remedies with therapy dates (start and stop date.)

E. REPORTER

 Name and Professional address: A reporter must mention his/her name and professional
address on the form. The identity of the reporter will be maintained confidential if
necessary.
 Date of report: Mention the date on which he/she reported the adverse event.

NOTE: For quality reporting, all the above mentioned fields are essential. In case of incomplete
information, the reporter must take care that at least mandatory fields are present. Following are
the mandatory fields for a valid case report and it is marked with asterisk on the form:
Patient information: initials, age at onset of reaction, gender.
Suspected adverse reaction: A reaction term(s), date of onset of reaction
Suspected medication: Drug(s) name, dose, and date of therapy started, indication of use,
seriousness, and outcome.
Reporter: Name and address, date of report
REQUIREMENTS

1. )

After the mission is complete, pharmaceutical wastes may be segregated as per the nature of the
drugs and disposed as per the standard waste disposal norms.

Pack the balance goods (if any) and return back.