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Purpose Mom

The document outlines the policies and procedures for pharmacy services at a hospital. It details the purpose of maintaining adequate stock of medicines according to categories, legal compliance, guidelines for the pharmacy therapeutics committee, acquisition, storage and dispensing of medicines, and obtaining medications not listed in the formulary.

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0% found this document useful (0 votes)
81 views19 pages

Purpose Mom

The document outlines the policies and procedures for pharmacy services at a hospital. It details the purpose of maintaining adequate stock of medicines according to categories, legal compliance, guidelines for the pharmacy therapeutics committee, acquisition, storage and dispensing of medicines, and obtaining medications not listed in the formulary.

Uploaded by

yourfamilydoctor
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Purpose: To provide 24X7 pharmacy services, according to the needs of the patients.

Hospital’s pharmacy store has adequate stock of all medicines as listed in hospital’s formulary.
Medicines are classified in to Vital, Essential and Desirable category and it is ensured that stock
out situations is not reached for vital and essential medicines.
Storage:
Storage is done as per manufacturer’s recommendation and as per document ‘storage of
medicines’ (SGHS/MOM/005).
Dispensing of Medicine:
This is done as per document ‘dispensing of medicines’ (SGHS/MOM/011). Caution is taken to
prevent dispensing error.
Legal Compliance:
The pharmacy adheres to rules and regulations laid down by the various government Acts
governing its function and notifications issued from time to time by the office of the Drugs Controller,
Government of Punjab.
1. The Drugs & Cosmetics Act 1940 and the rules 1945
2. The Narcotics & Psychotropic Substances Act and rules1985
3. The Pharmacy Act 1948
4. Food and Drugs Act
5. Drugs and Magical Remedies Act
Personnel working in the pharmacy are well versed with the requirements of these acts and are
followed.
Pharmacotherapeutic Committee / Formulary Committee:
The Pharmacotherapeutic committee is multidisciplinary, having members from all clinical
departments, administration, pharmacy, nursing and Quality. It oversees the implementation of safe,
effective, efficient pharmacy services and safe medication usage. It also issues additional protocols
for safe medicine procurement, selection of new salts, their usage, prescription, dispensing,
administration, monitoring and use of medications, medication errors, ADRs etc. and effective
pharmacy services, as documented in the hospital Pharmacy Manual (Medication Management
Manual). The Pharmacotherapeutic committee meets once in every three months to review the
proper functioning of pharmacy services.
Guidelines
1. The Pharmacotherapeutic committee, operations mainly include:

a. To monitor literature review


b. To review the best practices information on medication management.
c. To use the up to date information to update medication management processes.
d. Selection of medications for the hospital Formulary.
e. Rational use of medicines
f. Medication errors
g. Medication management, especially high-risk medications.
h. ADR
i. Patient safety issues.
j. Drug recalls are informed 24X7.

This information is used to update medication management processes in the hospital.


2. Activities include but are not limited to; comprehensive medication review and drug utilization
reviews.

3. The PTC, promotes, safe medication practices as well as development, implementation and
evaluation of these practices.
4. The pharmacists participate in the review of medication related incidents like Adverse Drug
Reaction (ADR), medication error and provide recommendations to prevent recurrence.
5. Pharmacy staff in the Pharmacy manages drug distribution system by performing,
supervising or reviewing the functions of selection, distribution and storage of drugs to
ensure safety, accuracy and quality of supplied products.
6. Pharmacy personnel establish a positive working relationship with health care providers in
order to meet the objective of positive health care outcomes.
7. Pharmacy maintains all documentation including statutory requirements and licenses
required for running an In-house Pharmacy and also ensures renewal of Licenses before the
tenure is over.
8. Pharmacists contribute in the quality improvement and patient safety program in the hospital.
9. Any change in the in the day to day working of the department is informed to the concerned
staff department and other related departments, by the in charge. Communication can be
verbal, written by email etc. it is documented. at the earliest.
10. Hospital pharmacy services are available 24X7.
Purpose: To prepare a list of medications, appropriate to the use in our hospital.
This formulary is prepared with the intention to achieve optimal patient care and safety through
rational drug therapy. This covers all the medicines required for treatment and rehabilitation of sick
patient.
1. The Hospital Formulary exists with a list of drugs of all prescribed categories, which are
required in the hospital. The formulary has been developed by Pharmaco Therapeutic
Committee.

2. The formulary is available at all patient care areas. This is referred whenever required for
prescription of a medicines. The clinicians of the hospital adhere to the hospital formulary.

3. The formulary is updated once in a year to incorporate newer drugs and to remove obsolete
drugs. Brand name and generic name are standardized for special categories of drugs (e.g.
antibiotics, anticancer drugs etc.). Pharmacy store management and cost to patient are kept
into consideration while incorporating drugs or modifying the formulary.

4. The clinicians adhere to the hospital pharmacy, the adherence to the formulary is monitored.

5. The “HOSPITAL FORMULARY” includes the details of drugs like Formulation, drug content,
generic name, brand name & strength etc. and is available to the clinicians.

6. Specific criteria as enlisted below is referred to, for addition of new drugs
a) Clinical need,
b) Therapeutic efficacy and safety,
c) Advantage over similar items on the current formulary,
d) Anticipated frequency of use, or
e) Cost/benefit of adding the item.

7. The medicines listed in the formulary are acquired from vendors as per document
‘Acquisition of medicines’. For medicines not listed in formulary, if required, are obtained as
per document ‘obtaining medications not listed in formulary’.
Purpose: To have an efficient method of acquisition of medicines.
Medicines are purchased from the identified vendors of the hospital. The procedure documented
below is followed for acquiring medicines from the vendors. Purchase and pharmacy store work in
coordination to determine the appropriateness of purchase of medicines. Following aspects are
taken care of while acquiring medicines:
1. Vendors whose quality of service is ranked better in evaluation are given preference for
purchasing.
2. Re-order level for all medicines is followed for determining the time of acquiring medicines.
3. The purchase order quantity, as far as possible, conforms to the economic order quantity.
4. Proper record keeping is maintained (such as copy of purchase order, receipt of goods,
GRN etc.)
Procedure:
S.
Procedural steps Responsibility
No.
1. Method of Tendering: Before issuing any purchase order, stock is Pharmacist and
verified as per reorder level & if required a note is made for pharmacist attendant
purchase.
2. The prepared PO is intimated to supplier through telephonic call. Pharmacist
3. Pharmacy supply is received by pharmacist & makes their inward Pharmacist
as per the protocol & then inward is accepted by pharmacy.

4. Method of transportation of medicines is verified as per the norms.


5. When the material is received it is checked according to the bill Pharmacist and
quantity, expiry, batch no and after that pharmacy updates their pharmacist attendant
stocks.
6. During checking the order received, errors are found in quantity Pharmacist
received from the supplier, then the supplier is informed and the
inward is cancelled in pharmacy.

Purpose: To timely procure medications not listed in the formulary.

Hospital formulary is comprehensive enough to incorporate all the medicines required in the
hospital. These medicines are stored in pharmacy store and appropriate inventory control measures
are used to avoid situation of stock out.
However, in case a drug, which is not listed in formulary or not available in pharmacy, is acquired by
given process.
Responsibility
Store pharmacist
Procedure
1. The Unit Nurse/Nurse in charges attending the patient sends the print of medicine(s) to the
Pharmacy.
2. If the medicine mentioned in prescription is unavailable in the Pharmacy, the Store
Pharmacist informs the same to the consultant/ MO in wards.
3. The consultant/ M.O, first asks the Consultant for an alternative brand available in
Pharmacy.
4. If the Consultant agrees, the prescription of alternative brand is re-sent to Pharmacy and
necessary changes are made in Treatment Sheet etc.
5. If the Consultant emphasizes on giving only a specific brand, then the Store Pharmacist
contacts the Supplier to purchase it.
6. If the purchase and supply to Hospital is a time taking process, then the specific brand is
purchased from outside Pharmacy and the medicines purchased are added into patient’s
folio.
7. Medicines purchased through this method are checked for clear label with mention of name,
dose and expiry dates.
8. The occurrence of such instances wherein medicines had to be purchased from outside
source is recorded.
9. Medicines for which availability is on the higher side are included in the formulary after
approval from Pharmacy & Therapeutics Committee.

Purpose: To safely store medications as per recommendations of the manufacturers.


Proper storage of medicines for their optimal use:
a) Storage of medication- Care is taken to store medicines in a store where temperature is
regulated lighting/Ventilation/humidity conditions are proper for the work. Room temperature/
Refrigerator temperature is checked in each shift and a record is kept for the same. Care is
taken to prevent entry of pests/Rodents and vermin's.

b) Medicines are stored in safe, secure and clean environment. Proper temperature conditions
are maintained to store the medicines as per manufacturer's guidelines or as per good
storage practices. Care is taken to prevent theft of medicines.

c) Sound inventory control practices are followed throughout the hospital.

d) Physician samples are kept with them and are given to patients at their discretion. These
samples are checked for their expiry as per expiry policy of the hospital. These samples are
not for sale.

e) A list of LASA drugs is prepared. Different concentrations of same medicines are stored
safely, as far apart as possible. These safe practices are followed in pharmacy as well as all
clinical areas.

f) A method of storing drugs by generic name is followed to identify and store Sound-like and
look-like medicines.

g) High risk medicines are stored in a clinical area according to the requirement of that
particular area such as in emergency department, critical care departments, pediatric wards,
NICU, wards, OT etc. Narcotic drugs are used according to the Narcotic Drugs Policy.
h) High risk medications, LASA drugs and different concentrations of the same medications are
stored separately to prevent wrong medication.

i) A crash cart checklist is used to store the medicines in standardized manner. No other drugs
are stored with emergency medications in this cart. List of drugs is uniform across the
hospital. Contents of the crash cart are checked on monthly basis.

j) Adequate quantity of emergency medicines is stocked, at all times.no other medicine is


stored with the emergency drugs.

k) Emergency medications are updated in timely manner when required. These are replenished
timely for ready availability at all time.

l) Regular audit of stocks is done to check for any loss / theft in the Pharmacy. Audit is done
for high cost / Medium Cost / Low cost inventory on regular, defined intervals.
Purpose: To prevent adverse events from high risk medicines.

High-risk medications include low therapeutic window, controlled substances, psychotherapeutic


medications, LASA and concentrated electrolytes etc., that bear a heightened risk of causing
significant patient harm when they are used in error. Although mistakes may or may not be more
common with these drugs, the consequences of an error with these medications are clearly more
devastating to patients.
1. The hospital has defined a list of High risk medication, taking into consideration statutory
requirements e.g. NDPS Act. (The list is given below). Pharmacotherapeutic committee
revises list of High risk medicines from time to time as decided by the committee.
2. These are made available only on provision of written prescription/order of a qualified doctor
3. The drug, dose, route, time and frequency of administration is double checked before
administering the drugs
4. These drugs are administered only by qualified nurse / doctor. Self-medication is not allowed
for these drugs.
5. These drugs are always kept safely and separate from other medicines
6. Patient is monitored, after administration of these medicines, for any signs of adverse
reaction.

If any adverse reaction is noted the administration of these drugs is discontinued and concerned
doctor is informed immediately. The sample of the drug administered is preserved for analysis. The
event is reported as per ‘unwanted event reporting policy’ and managed as per management of
adverse drug reaction.

Following is the list of high risk medicines. High risk medicines are well defined by the following
mnemonic: A PINCH. certain antibiotics, Potassium, insulin, narcotic and psychotropic substances,
chemotherapeutic agents and heparin and all other blood thinners.

Narcotics

Sr. No. Generic name Brand Name


1. Fentanyl citrate Fentanyl citrate injection 2 ml
2. Morphine sulphate Morphine 15 mg inj.

IV Sedation

Sr. No. Generic name Brand name


1. Propofol Propofol Lipuro 1% 20 ml, Troypofol

2. Thiopentone Thiosol 1g inj., Thiosol 500 mg inj.

MUSCLE RELAXANT

Electrolytes

Sr. No. Generic name Brand name


1. Potassium chloride Potassium chloride inj.
Inotropics

Sr. No. Generic name Brand name


1. Dopamine Dopacef 200 mg inj, Dopa plus

2. Dobutamine Dobier inj.

3. Adrenaline Vasocon inj.

4. Nor-adrenaline Adrenor inj., Norad, Noradria

5. Digoxin Lanoxin 0.25 tab, Dixin inj.

Vasodilators

Sr. No. Generic name Brand name


1. Glyceryltrinitrate Nitroderm TTS 5 patch, Nitrocontin 2.6 mg tab,

Nitrocontin 6.4 mg tab


2. Sodium nitroprusside Pruside inj.

Insulin

Anti arrhythmic

Sr. No. Generic name Brand name


1. AmiodaroneHCl Cordarone X 200 mg tab,Cordarone inj.

PsychotropicDrugs

Sr. No. Generic Name Brand Name


1. Lorazepam Ativan 1 mg tab ,Ativan 2 mg tab, Lopez 2
mg /ml inj.
2. Nitrazepam Nitravet 5 mg tab

3. Clonazepam Clonotril 0.25 mg tab, Clonotril 0.5 mg tab,


Zapiz 0.25 mg tab

4. Diazepam Calmpose inj,Valium 2 mg tab, Valium 5 mg


tab
5. Pentazocine Fortwin
6. Phenobarbitone Fenobarb 200 mg inj., Gardenal 30 mg tab,
Gardenal 60 mg tab
7. Chlordiazepoxide Librium 10 mg tab
8. Chlordiazepoxide+Clidinum Librax tab
bromide
9. Chlordiapzepoxide+Amitryp Libotryp
tylline
10. Alprazolam Alprax 0.25 mg tab,Alprax 0.5 mg tab,
Trika 0.25 mg tab,Trika 0.5 mg tab
11. Zolpiderm Nitrest 5 mg tab,Nitrest 10 mg tab,
Zolfresh 5 mg tab,Zolfresh 10 mg tab
12. Clobazam Frisium 5 mg tab,Frisium 10 mg tab,
Cloba 5 mg tab

Sound alike medications (some e.g.)

Sr. No. Medicine name Medicine name


1. Losar Tozaar
2. Vizylac Bifilac
3 Alphadol Alphadol C
4 Rizact Tazact
5. Prilox Lox
6. Hemsyl Hemsi
7. Lanoxin Zanocin
8. Asacol Mesacol
9. Lornit Monit
10. Anovate Tenovate
11. Norcuron Neocuron
12. Gabapin Gabantin
13. Zienam Cilanem
14. Zosta Zostum
15. Althrocin Eltroxin
16. Cetzine Phexin
17. Cilamin Cilanem
18. Finast Finast T

Look alike medications (some e.g.)


Sr. No. Medicine Name Medicine name
1. Domstal tab Alprax 0.25 tab
2. Udiliv 300 tab Unicontin 600 tab
3. Zyloric tab Buscopan tab
4. Strocit tab Panlipase
5. Vertin 8 tab Vertin 16 tab
6. Lasix tab Avil tab
7. Karvol Plus cap Evion 400 cap
8. Hetrezan tab Pacitane tab
9. Trental 400 tab Hifenac P tab
10. Diapride 1 tab Dilzem 30 tab
11. Amlovas 10 tab Amlovas 5 tab
12. Tramazac cap Butaproxyvon cap
13. Sparacid syrup Mucolite syrup
14. Reflin 0.5 inj Reflin 1g inj.
15. Aminosterile Hepa 500 ml Aminoven 500 ml
16. Heparen 5000 inj Heparen 25000 inj.

Purpose: To ensure availability of emergency medications, at all times.

Emergency medicines, (as per the list and quantities mentioned at the end of this document) are
kept in all patient areas and are used at the time of medical emergencies. These medicines are
stored in Wards, (sub stores and crash carts), trolley (in OTs, ICUs and Radiology) and are checked
regularly for ensuring the availability of right medicines.
It is ensured by department / unit in charge that all emergency medicines with quantities as
specified in the list is available round the clock in all patient areas. Physical verification of crash cart
materials is done once monthly and a record of check will be maintained in register.
The list of emergency medicines is displayed on crash cart. The crash cart is kept under breakable
seal. These medicines are used only during emergency situations. Whenever used, these
medicines are replenished by sending requisition to pharmacy store within half an hour of use of
these medicines. Look alike and sound alike medicines are stored separately in the pharmacy as
well as patient care areas.

Pharmacy store shall stock sufficient amount of emergency medicines. The stock quantity and re-
order level is determined by using past 3 months’ data of their usage.
Procedure
S. No. Procedural steps Responsibility
1. Use emergency medicines in crash cart only in Staff nurse / Medical office
emergency situations
2. Follow code blue procedure in case of anticipated Ward staff
cardiac arrest situation in a patient
3. Emergency medicines used during emergency situation Nursing staff
or during cardiac arrest are replenished immediately
4. Fill up the standard crash cart list form indicating the Nursing staff
quantity of medicines used and replenishment required.
This shall be done after every event of emergency in
which crash cart materials were used
5. Send the form to central store for getting the Nursing staff
replenishment required. This is done within 1 hour of use
of emergency medicines
6. Central store shall send the requested replenishment of Pharmacist
emergency medicines as soon as possible
7. Nursing staff to receive the emergency drugs and Nursing staff
replenish the same in crash cart.
1. Based on the usage of emergency medicines in the Pharmacist
hospital central store is to keep sufficient stock and
buffer stock of all emergency medicines.

List and quantities of emergency medicines to be maintained in all patient areas


Emergency
S.No. Quantity
medicines
1. Inj. Atropine 30
2. Inj. Adrenaline 30
3. Inj. Sodabicarb 30
4. Inj. Dopamine 2
5. Inj. Dobucin 2
6. Inj. Xylocard 1
7. Inj. Effcorlin 5
8. Inj. Deriphyllin 5
9. Inj. Cordarone 10
10. Inj. Isoprenaline 4
11. Inj. Noradrenaline 4
12. Norcuron (Powd.) 2
13. Inj. Atracurium 2
14. Inj. Lasix 10
15. Inj. Propofol 1
16. Inj. Sucol 1
17. Thiopentone Na 2
18. Inj. KCl 5
19. Inj. Calcium gluconate 5
20. Inj. Protamin 2
21. Inj. Metoprolol 5
22. Inj. Aminophyllin 2
23. Inj. Midazolam 2
24. Inj. Dytor 5
25. Inj. Adenocor 4
26. Inj. Vasopressin 2

Purpose: To ensure medication are prescribed safely and rationally.


a) Policies and procedures for prescription of medication are documented. Medicines are
prescribed only by the authorized persons in the hospital.

b) Practices/guidelines for rational prescription of medications are followed. For prescription


writing good clinical practices/guidelines are followed. Medicines prescribed are appropriate
to the clinical needs of a patient.

c) Minimum requirements of a prescription are determined. The prescription contains the


following:
 Name of the patient
 Unique hospital number
 Name of the drug (generic composition is mandatory except in combinations of
vitamins and minerals), dose, route and frequency of the administration
 Name and signature of prescribing doctor
 Registration number of all doctors is printed on the OPD/IPD slip of the prescribing
doctor.

d) Known drug allergies are ascertained before prescribing the medicines. A column of known
drug allergy is incorporated in OPD cards, IPD treatment charts and initial nursing
assessment. It is filled regularly for its application.

e) Only qualified doctors (Minimum MBBS) are allowed to write medication orders.

f) The prescribing doctors are vigilant about drug interactions, food-drug interactions,
therapeutic duplication, dose adjustment etc.

g) Medication orders are recorded on a uniform location in a case sheet. Use of abbreviation is
avoided and only expectable abbreviations are used.

h) Medication orders are clear, preferably in capital letters, legible and dated/timed/signed by
the prescribing Physician.

i) Medication orders contain the name of medicine (generic composition is mandatory except
in combinations of vitamins and minerals), route of administration and time/frequency of
administration.

j) Verbal medication orders are taken only in cases of emergency after routine working hours
when treating physician is unable to reach hospital. All verbal orders are confirmed by way of
"Read back".

k) A list of high- risk medication is defined and available at all points of use.

l) Regular monthly prescription audits are done to check for safe and rational prescription.

m) Prescribed medicines are checked for accuracy at transition points such as at the time of
admission, transfer of the patient from one ward to another or at the time of discharge. Past
clinical treatment history is taken and recorded, at the time of admission, for reconciliation
with the current medical treatment.

n) Corrective and preventive actions are taken on analysis where appropriate.

Purpose: To ensure that verbal communication of prescription or medication orders are effectively
followed and documented.
Verbal orders for medication are limited to urgent situations where immediate written communication
is not possible. and in no case it substitutes written medication order. Only primary consultant of the
patient can give verbal orders and only medical officer / senior staff nurse can receive the verbal
orders. Verbal orders are not given for high risk medicines. (Ref. list of medicines, which can be
prescribed verbally).
Documentation: All verbal orders are read back for confirmation, documented by person receiving
orders in patient’s progress sheet and properly endorsed with date, time, name and signature of
the person making entry. The name of the doctor who has given the verbal order is also
documented. These documented orders are cross checked as soon as possible (within 24 hours) by
the consultant who has given the verbal orders. The cross check is endorsed by sign, name, date
and time of the consultant.
Procedure:
Sr. Procedural steps Responsibility
No.
7. The Resident doctor/staff nurse takes the verbal order from the Resident
patient’s consultant if situation warrants the need of a verbal order. doctor/staff nurse
8. The Resident doctor/staff nurse repeats the verbal order to confirm Resident
the patient’s name, medication, strength, route of administration, and doctor/staff nurse
dosing, with the consultant.
9. The verbal orders are documented in the treatment sheet Resident
immediately with the time and date of the call to the consultant. doctor/staff nurse
Along with the name, signatures, date, and time of person receiving
the verbal orders.
10. Thereafter follow the medication dispensing procedural steps Staff nurse
11. The consultant who has given verbal orders, cross-checks the orders Consultant /
and signs, the documentation, on his next visit, to the area( within Resident doctor
24hrs.),

Approved list of verbal order medicines, that can be prescribed verbally is described in Verbal/
Telephonic Orders policy, Policy No. SGHS/ Policy / 047, same is communicated to the Treating
Physicians, Doctors and Nurses.
Purpose: To write all medication orders in a uniform location, to minimize medication error.
a) The Hospital management has authorized, only the duly qualified doctors-MBBS and above.
All the medication orders are documented by the authorized doctors only. Even when
transcribing from an OP card to IP record, the medication orders are written by an authorized
doctor. All the medication orders are authorized by date, time and signatures of the treating
doctor.
b) The normal practice is to write medicines in IP record, on a uniform location (on the right
side of the progress sheet, (in the column of Medication orders). If anyone, has by mistake
put the orders on any other location, they are transcribed to the desired location by the MO
on duty. Only the medicines prescribed in these columns are administered to the patients.
The consultants are advised to write directly on the Medication administration record sheet
of the patient. All the features of a good prescription are followed while writing a prescription.
In case of modification of an existing order for a particular drug, a fresh order is written for
that drug. A strike-through or overwriting the previous order is not acceptable.
c) All medication orders are written in capital letters. Abbreviations used are according to the
hospital’s approved list of abbreviations. all medication orders are authenticated by the
name, signature of the prescriber, with date and time of prescription.
d) Medication orders contain the name of the medicine, route of administration, strength to be
administered and frequency/ time of administration. In case of combination drugs, strength of
all the individual drugs is written separately.
e) Regular prescription audits are done for both OP / IP cases. Deficiencies are conveyed to
the concerned.

Purpose: To ensure safe and accurate dispensing of medicines.


Medication dispensing is done with care to prevent any medication error.
Following is checked before dispensing of medication. These checks are done at central store level
and at sub store level.
1. Generic name/ composition of the medicine
2. Dose of prescribed medicine
3. Expiry date
4. Particulate matter in liquid dosage forms and parenteral drugs
5. Labels (if reconstituted drugs)

Labeling is done for every prepared / reconstituted medication, which includes name, strength and
frequency of administration of drug, expiry date. Even in the wards all prepared doses are similarly
labelled.

Procedure:
S. No. Procedural steps Responsibility

1. Consultant writes the prescription on the treatment sheet Consultant


for all IPD patients
2. Sister in charge then make the prescription in duplicate Staff nurse
and keep the copy in patient file and hand over the
original copy to patient attendant / ward boy.
3. According to the prescription pharmacist dispenses the Pharmacist / pharmacy
medicines. attendant under pharmacist
supervision.
4. Pharmacist enters the medicines dispensed and takes a Pharmacist
printout of the bill.
5. Once the medicines are issued, pharmacist cross checks Pharmacist.
the medicines against prescription thoroughly.
6. Then pharmacist packs the medicines and ward boy / Ward boy / Attendant
attendant deliver the medicines to the respective floor.
7. On the floor, all the medicines are cross checked by Staff Nurse
sister in front of the ward boy / patient attendant.
8. When ward boy brings the medicine, prescription copy Staff nurse
along with the bill is attached in the patient file.
9. In case of cash payment in the pharmacy the patient’s Patient attendant
attendants, keeps the bill with them.
10. If there is any problem with the medicines such as Staff nurse
quantity or dosage, staff nurse immediately informs the
pharmacy.
11. Pharmacist rectifies prescription error immediately. Pharmacist

12. If any new drug is required and is not found in the Pharmacist / Resident
pharmacy, the pharmacy tries to find the drug in nearby doctor
stores or hospitals and also medical helpline, and
pharmacist / resident also calls consultant to
confirm/change the drug in case if specific drug is not
available easily.
13. When the new drug is available, pharmacist intimates the Pharmacist
respective department to collect the medicines.
14. Near expiry medications are handled effectively and are Pharmacist/ Pharmacy in-
withdrawn three months before the expiry date, to ensure charge/ Nursing staff
its non-availability. In case of non- availability of fresh
stock, expiry date is high-lighted to prevent its in-verdant
use.
15. High-risk medications are given only after written orders Pharmacist / Resident
and same are double checked by the staff before doctor
dispensing.
16. The medications, are acceptable with original bill, batch Pharmacist/ Pharmacy in-
number, date of expiry/ manufacturing and no visible charge
damage. Temperature sensitive medications are not
acceptable.

Purpose: To remove undesirable medications, from circulation.


Medicine is recalled to pharmacy central store from the sub-store, wards, and other patient care
areas in case of following:
1. On intimation from regulatory authorities about stopping the use of a particular drug.
2. On intimation from supplier about the inaptness, in particular drug supplied to the hospital.
3. In case physical incompatibility is noted or reported to pharmacy store (for e.g. visible
contamination in IV fluid) of particular batch.
4. On decision of Pharmaco-therapeutic committee about inaptness of a particular drug.
5. Near expiry medicines – 3 months prior to expiry date except
1. in case of medicine with 1year expiry such as Atropine / Adrenaline (in such cases it is 1
month prior)
2. When not available for any reason, in such cases these medicines will be prominently
marked as near expiry and will be used till the expiry date.
The recall of medicine is done as per below mentioned procedure and reason for recall is recorded
in pharmacy store.
Procedure:
S.No. Procedural steps Responsibility
12. Reconfirm the entire details of drug being recalled in case of Pharmacist/ Pharmacy
notification via phone call and immediately reduce it to in-charge
written recall.
13. Batch number of the medicine to be recalled is determined Pharmacist/ Pharmacy
and used to identify the medications to be recalled. in-charge
14. Check the entire pharmacy stock as well as the pharmacy Pharmacist/pharmacy
storeroom stock for drug being recalled. attendant under
pharmacist supervision
15. Quarantine the recall drug stock removed from the Pharmacist/pharmacy
pharmacy and the store stock attendant under
pharmacist supervision
16. Place the recall drug stock in a designated location away Pharmacist/ pharmacy
from the dispensing area attendant under
pharmacist supervision

17. Send the recalled item back to the wholesaler or the Pharmacist/ Pharmacy
manufacturer directly in-charge

18. Date vise entry in system for recall drug notifications and Pharmacist/ Pharmacy
date of physical removal of drug being recall from the in-charge
inventory, for future reference
19. All recalls are discussed in the Multi-disciplinary Pharmacotherapeutic
Pharmacotherapeutic committee of the hospital. If the committee
adverse event is reportable, it is inform to the
Pharmacovigilance center at PGI.

Appropriate labeling is done wherever medicines are stored. All medicines prepared for dispensing
and kept for future use are properly labeled with name of the patient, drug name, strength,
frequency of administration with date & time of preparation.
It is ensured that high-risk medicines are dispensed/ administrated only after written orders are
received. The staff dispensing these medications verifies them from the prescription before
dispensing.

Purpose: To ensure safe dispensing and documentation of medication administered.


1. Medications are administered by Doctor/qualified Staff nurse only. Self-administration of
medicines is not encouraged in the hospital.
2. All medicine requirements of inpatients are fulfilled through hospital pharmacy store. Outside
medication if required is purchased by the patient / relatives under the advice of the
concerned physician.
3. Prepared medications are labeled prior to preparation of second drug. The label includes
patient identification detail, drug name, dose, and frequency of administration with date and
time.
4. Following parameters are verified before administration of drugs by the person administering
the drug:
a. Patient is identified by the 2 Identifiers-Name of the patient & UHID/ IPD No.
b. Written medication order (For verbal order refer the document ‘verbal orders for
medications)
c. High risk medication orders are verified by at least two staff (Nurse-Nurse, Nurse-
Doctor) independently and documented. The nurses are empowered to highlight
prescription errors noted while verifying the orders.
d. General appearance (physical incompatibility) of the medicine for administration (for
e.g. melting, clumping etc.)
e. Dosage and strength of medication
f. Route of administration
g. Time of administration
5. Every care is taken to prevent catheter and tubing misconnection during administration of
medication. All the lines are carefully kept separate from each other. Staff administering
medications, trace all lines from their origin to the connection port to verify attachments,
before making any connections or reconnections, or administering medications, solutions or
other products. Different lines are labelled to ensure compliance. Intravenous (IV) extensions
tubes are not used for epidurals, irrigations, drains, and central lines or to extend enteric
feeding tubes.
6. The documentation of medication administration is done by the person administering the
drugs in Medication Administration record sheet. All fields of medication administration sheet
are appropriately filled with name/signatures ID number of the person administering
medication.
7. The verification of administration of high risk medications is done by two staff (nurse-nurse
or nurse-doctor) independently and documented. For administration of high risk medications,
follow the documented ‘list of high risk medication’.
8. Any patient who is taking medicine for his/her chronic condition like Hypo/hyperthyroidism,
hypertension, diabetes etc. is permitted to continue with their previous medication. Their
doses are confirmed, noted and they are reminded to take these medicines at appropriate
time.
9. All medicines brought from outside are checked for their name, strength, expiry date before
dispensing.

Purpose: To prevent medication errors, adverse drug events and to observe the effectiveness of
the medication administered.
Safe dispensing of medicines to all the patients visiting the Hospital.
Only authorized personnel are permitted to administer medications from containers that are clearly
marked with the name of the drug, concentration, dose, route and expiration date. Outdated drugs
must not be given. Patients may not take their own medications unless ordered by a physician and
per policy.
Any patient requiring IV drug therapy which necessitates continuous cardiac and/or hemodynamic
monitoring will be monitored.
Nurses who have demonstrated competency in this area may only administer IV push
chemotherapy agents.
Medication Routes:
1. Nurses may administer medications via the following routes:
Oral/enteral/Parenteral (IV, IM, SC)/Sublingual /Inhalation/Dermato-mucosal /Intradermal.
2. Nurses may not administer medications via the following routes:
Intra-cardiac / Intra-articular

For inpatients, the correct patient identifiers are the patient’s name and UHID/ IPD No. Patient
identification is checked just prior to medication administration.
Appropriate physiological parameters are measured prior to administration of medications.
Administering nurse remains with patient when administering oral medications.
Immediately upon administration of medication, the actual admission time of the medication is
appropriately documented.
If medication cannot be administered due to a change in patient status or the patient refuses the
medication, the unopened/unused medication is to be returned to the appropriate medication drawer
and same is documented in patient record.
The High risk medications orders are to be checked prior to administration, by two nurses, or a
nurse and a physician and record for the same is maintained in the patient's records

Monitoring of patient after medication administration

All patients are observed and monitored after medication. This is done to ensure safe and effective
medication. Patients are monitored for any complication arising out of the administration of
medicine. A medication error is any preventable event that may cause or lead to inappropriate
medication use or harm to a patient (USFDA). Examples include, but are not limited to - Errors in
the prescribing, transcribing, dispensing, administering, and monitoring of medications. Wrong drug,
wrong strength, or wrong dose errors; Wrong patient errors; Wrong route of administration errors;
and Calculation or preparation errors.
Any adverse reaction to the transfusion of blood or blood components shall be considered as
transfusion reaction. It may range from an allergic reaction to a life threatening complication like
TRALI and Graft Versus Host Reaction The complications, following medication administration arte
divided into three categories as:
i. Any medication error.
ii. Near miss event
iii. Adverse drug event.
The events are reported according to the hospital policy on Incident reporting in the Incident
reporting form. These events are reported in the specified time frame as mentioned in incident
reporting policy.
The reported events are analysed for RCA of every event, by the Multidisciplinary Patient Safety
Committee. An appropriate CAPA is taken to prevent recurrence of similar incidents.
Purpose: To reduce the chances of occurrence of adverse drug events and to have a fool proof
system for management of patients with adverse drug event.
Adverse drug events are reported through incident form, available in every Department.
Near miss, medication error and adverse drug reactions are defined and posters for the same are
displayed in every department.
Responsibility:
Primary consultant, Departmental heads, Medical Officers / Resident Doctors, Staff nurses and
Pharmacotherapeutics / Formulary Committee.
1. Always suspect an ADR in the patient feels unwell after taking any medication.
2. The first step in the management is to withhold or withdraw the suspected drug.
3. Further treatment is decided on an individual basis.
4. Always tell the patient of a suspected ADR so that they are able to take precautions in the
future.
5. Consider whether the ADR warrants reporting to the medicine supplier/ fit to report as ADR
Following measures are undertaken to identify, manage and reduce the adverse drug events.
Monitoring of Patients on Medication
After administration of the medicine, patient is monitored for any symptoms and signs for allergy,
breathing difficulty, giddiness, light headedness, drowsiness, sinking sensation, nausea, vomiting,
Diarrhea, shivering, cold sweats, hot flushes, any other abnormal feeling. Temperature, pulse, B.P.
and the abnormal symptoms are recorded and concerned doctor is informed in case any symptoms
suggest occurrence of adverse drug reaction.
Categorization of ADR
Any adverse drug reaction can be considered in following categories and their management can be
done accordingly.
Type of Category Features
reaction
A: dose related Augmented Related to pharmacology (toxic effect or side effect--for
example, digoxin toxicity)
B: non-dose Bizarre Unrelated to pharmacology (idiosyncratic for example,
related malignant hyperthermia, or immunological--for example,
penicillin rash)
C: dose and Continuous Related to cumulative drug use--for or chronic example, NSAID
time related or chronic induced renal failure
D: delayed Delayed Apparent only some-time after use of drug, for example,
effect thalidomide in first trimester and phocomelia(limb defects)
E: Withdrawal End of use Related to discontinuation that is too abrupt--for example,
addisonian crisis after steroid withdrawal

Assessing Likelihood That an ADR Has Occurred

An ADR is considered in any patient taking prescribed or over the counter medications. One of the
first issues to consider is if the time scale of onset of the adverse reaction fits with the timing of
dosage or peak plasma concentration. A similar relation may be seen between withdrawal of the
drug and abatement of symptoms. In the case of drug allergic reaction, there is often (though not
always) a history of previous exposure to the drug. Finally, there is also the option of reintroducing
the suspected drug. This may be of long term benefit to the individual, especially for those in whom
alternative pharmacological options are limited. This is not undertaken without careful consideration
and observation.

Management of a Suspected ADR

For Type-A Reactions, the management is simply reduction in the dose or withdrawal of the
medication altogether. By contrast type E reactions require reintroduction of the drug and more
gradual withdrawal. By the time a type C or D reaction occurs, it may be irreversible or at best only
partially reversible on drug withdrawal.

Type-B reactions are both uncommon, unpredictable, and have high morbidity and mortality. The
first step is always the immediate withdrawal of the drug. If the reaction is mild, no further
intervention may be necessary. Urticarial rashes, and to a lesser extent non-urticarial rashes, may
be treated with antihistamines such as chlorpheniramine and an adrenocortical steroid. In more
severe cases, these drugs may be given intravenously or intramuscularly. If angioedema develops
with threatened laryngeal oedema, consideration should be given to adrenaline (see below).

Anaphylaxis is a medical emergency. Senior’s help should be summoned, including an anesthetist.


The patient is positioned flat, with feet raised and airway secured. Oxygen should be administered.
0.5-1.0mg of adrenaline should be given intramuscularly as first line treatment (equivalent to 0.5-
1.0ml of 1:1000 adrenalines). This is repeated every ten minutes according to cardiovascular
parameters and clinical improvement. Chlorpheniramine (10-20mg) should also be administered by
slow intravenous injection, and hydrocortisone (100-300mg), though the onset of action of the latter
may not be for several hours. Further deterioration may necessitate intravenous fluids, nebulized
inhalers, and intubation or tracheostomy.

Other ADRs may involve any body system and manifest in several different ways. The correct
management of these patients should be considered on an individual basis. Often this is delayed by
failure to consider an ADR as the underlying cause of a patient's deterioration.

Reporting of ADR
Adverse drug events are reported immediately to the residents by the nurses. Patient is also
informed of the ADR. In case adverse event is not controlled within 10 to 15 minutes, consultants
are informed by the residents for further management.
Adverse drug reaction forms are completed within 24 hours. A copy of adverse drug reaction
form is also to be kept in patient’s file. All ADRs will be reported through the
pharmacovigilance app by the chief pharmacist.
Compiling and Analysis of Adverse Drug Events
Adverse drug events due to IV infusions of fluids, blood and blood components are recorded with
details of the batch No., expiry date, manufacturing date of I/V fluids, IV sets, blood, blood
transfusion sets. The infusions are discontinued immediately, bottle and I/V transfusion set are
sealed and sent to the laboratory for cultures and incompatibility if any. After getting the report from
the lab / blood bank, the event is analyzed, the pharmacy is instructed to stop issuing the concerned
lot with same batch no. and distributor / manufacturer is intimated. Corrective and preventive
actions are taken on the basis of analysis of data. Pharmacotherapeutics / Formulary Committee
analyze ADR and take necessary preventive actions for reducing the risk of ADRs.
Purpose: To make safe use of narcotic drugs and psychotropic substances, chemotherapeutic
agents and radioactive agents according to the prescribed guidelines.
a) Narcotic drugs and psychotropic substances, chemotherapeutic agents and radioactive
agents are used safely, according to the regulatory guidelines These drugs are prescribed
by the authorized/ appropriately qualified, physicians only. The hospital has a license for all
these drugs/ substances.

b) The Narcotic drugs are stored in secured manner under double lock and key (Narcotic drugs
are stored in double lock and key). Keys are kept with authorized persons only. One key is
kept with the ward in charges and second key is kept with shift in charge / senior staff nurse.
Chemotherapeutic agents are accessible only to the authorized personnel only.
Radioactive substances are stored according to the guidelines prescribed by AERB.

c) Chemotherapy and Radioactive agents are prepared properly, safely at a dedicated


chemotherapeutic preparation area and administered, by qualified personnel.

d) These drugs are disposed according to existing statutory requirements (including Narcotic
Drugs and Psychotropic Substances Act, AERB rules and Biomedical Waste Management
Rules and the manufacturers recommendation (where applicable).

e) A proper record is kept for their receipt, use, administration and disposal of these drugs. All
inventories are signed by the authorized person and clinician, using them.

f) These drugs are used, only on the prescription of an authorized clinician.

Purpose: To ensure safe procurement and usage of implantable prosthesis and medical devices.

1. Selection of implantable prosthesis is based on scientific criteria and internationally recognized


approvals. Criteria for selection will include:

a) Technology, safety, effectiveness and clinical uses of devices.


b) Medical professional's opinion.
c) The regulatory status of the device, both nationally and internationally.
d) Medical literature review
e) Economic Issues

2. Implantable prosthesis and medical devices are stored as per manufacturer’s guidelines and is
used in every department as per requirement.

3. The implants are pre-approved by the Clinical Head.

4. Patient and his/her family are informed about the use of implantable prosthesis and medical
devices. They are also informed about precautions/ restrictions to be observed during this
period.

5. After use the batch and serial number of the implantable prosthesis are recorded in the patient’s
medical record and the master logbook.

6. In case of a recall notice, the recall procedure is followed.


Purpose: To ensure safe acquisition, storage and availability of medical supplies and consumables.
Safe acquisition, storage and use of medical supplies and consumables is done according to the
Hospital Pharmacy Manual.
1. Medical supplies & consumables are procured after approved from the top management. Items
are procured only from the approved vendors.
2. Medical supplies and consumables are used in a safe manner so as to maintain its sterility &
integrity.
3. Medical supplies and consumables are stored in a clean, safe and secure environment and in
accordance with manufacturer’s recommendations.
4. Sound inventory control practices are followed for the storage of medical supplies and
consumables.
5. The condition of the medical supplies and consumable are checked before dispensing from the
store and is verified by the staff before dispensing to the patients.

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