Drug standard & lageslation By Saeed anwar

1. Drugs standards and legislation
Dr Saeed Anwar
Lecturer Pharmacology
Swat College of Nursing Swat

2. Drug Regulation And Legislation
Manufacturing, regulation, dispensing and
administration of medications are all covered by laws
in every Country.

3. Internationally………..
1. 1st Law to regulate drugs passed in 1906, Stated
that drugs should be free of “adulterants”
2. Food, Drug and Cosmetic Act, passed in 1938:
All drugs must be tested for safety and must be
OK by FDA for marketing
3. Kefauver-Harris Amendments to the Food, Drug
and Cosmetic Act Passed in 1962 after
thalidomide (sedative) cause birth defects in
Europe in pregnant women (>10,000 infants born
with Phocomelia [absence of arms and legs)

4. In Pakistan
1. Poisonous act 1919
2. Dangerous act 1930
4. Pharmacy act 1967
5. Drug act 1976
6. NWFP Drug sale rules 1982
7. KPK Amended Drug sale Rules 2017

5. Dangerous Drug Act – 1930
It is an act that governs the procurement and use
of some drugs especially the narcotics e.g.
morphine, pethedine, cocaine etc. These drugs are
prescription only drugs hence cannot be bought or
administered without prescription.
Dangerous drugs are always kept under lock and
key in the Dangerous Drug Cupboard under the
care of trusted senior nurses
Pharmacy act 1967
An act to establish Pharmacy Councils to regulate the practice
of Pharmacy

6. Drug Act, 1976
Regulates the pharmaceutical industry (import of
raw material, export of medicines, sale,
manufacturing and registration of drugs).
Appointment of drug inspectors
Ensures availability of safe, effective and quality
products at reasonable price in Pakistan.
Central Licensing and Registration Board
provides system of licensing and registration of
medicines, inspections of pharmacy and
laboratories by inspection officers.

7. NWFP Drug sale rules 1982
Sale and purchase of drug in KPK
Amended DSR 2017
Amended after35 years under sec 44 of drug act 1976
by KP govt, unfortunately zero implementation yet
Sale and purchase of drug

8. Resources to collect and
utilize drug information

9. 1. Preclinical testing (In Animals)
2. Clinical testing (in Humans)
3. Post marketing studies

10. Scientific Researchers to discover/synthesize new
drug or improve existing drug
1. Pre clinical studies
Animal models
First of all they studied in animal models,
different animals like pigeon, mice rat etc. used
2. Clinical studies
Clinical trials on humans, kidneys and liver
are two most important organs,
It contain phase 1, phase 2 & phase 3.

11. 1. Phase I trials,
The researchers test a new drug or treatment in a small group of people
(20-100) for the first time to evaluate its safety, determine a safe
dosage range, and identify side effects.
2. Phase II trials
The study drug or treatment is given to a larger group of people (100-
300) to see if it is effective and to further evaluate its safety.
3. Phase III trials
The study drug or treatment is given to large groups of people (1,000-
3,000) to confirm its effectiveness, monitor side effects, compare it to
commonly used treatments, and collect information that will allow the
drug or treatment to be used safely.
3. Post marketing studies
Additional information including the drug's risks, benefits, and optimal
use added after come into market.

12. Medication Order
 Standing order
 P.R.N order
 STAT order
 ASAP order
standanding order: (regular) medication order for patients to receive medication at
scheduled intervals (e.G., 1 tablet every 8 hours)
Prn order (pro re nata) an order for medication to be administered only on an as
needed basis (e.G., 1 tablet every 4 to 6 hours as needed for pain).
Stat order
 An order for medication to be administered immediately
 Should be administered within 5 minutes or less of receiving the written order
ASAP order
 Not as urgent as STAT
 As soon as possible
 Should be avaliable for administration to the patient with 30 minutes of the
written order

13. Purpose of medication
Drugs can be administered for the purposes
1. Diagnostic purpose:
To identify any Disease.
Some drugs used to help diagnose certain
medical problems. These agents are used in
the diagnosis of….
 Blood vessel diseases of the heart:
Diatrizoates, Iopamidol, Metrizamide
 Brain diseases and tumors: Diatrizoates,
Ioversol, Ioxaglate, Metrizamide
 Urinary tract problems & Breast lesions:
Diatrizoates, Iohexol, Iopamidol,
Iothalamate, Ioversol
2. Prophylaxis:
To prevent the occurrence of
disease.
 Heparin to prevent thrombosis
 Antibiotics to prevent infection
 Vaccination
3. Therapeutic purpose :
To cure the disease.
Therapeutics is treatment and care
of a patient for the purpose of both
preventing and combating disease
or alleviating pain or injury.

14. Drug supply system
It is One of the basic services provided by hospital
pharmacy department is drug distribution.

15. Drug distribution is one of the basic service provided by the
hospital pharmacy
In patient service
Out patient
service
Drug distribution
In patient
service
Drug distribution

16. Out-patient department (O.P.D)
Out patient refers to patients not occupying beds in a
hospital, clinics, health centers
The patients with minor and common illness go to
O.P.D for consultation to the physician

17. In – patient services
The drug distribution to the inpatient department can be carried out
from the outpatient dispensing area.
The staff involved in dispensing the drugs for outpatient can dispense
drugs for inpatients too.
If the work load seems to be heavy then additional personnel can be
employed.

18. Three systems for inpatient drug distribution
1. Individual prescription order system
2. Complete floor stock system
3. Unit dose dispensing method

19. INDIVIDUAL PRESCRIPTION ORDER SYSTEM
This system is mainly used in small or private
hospitals because of its economic consideration and
reduced manpower requirements

20. COMPLETE FLOOR STOCK SYSTEM
Under this system then using station carries both
charge and non charge patient medication.
According to this condition the nurses store the drug
and administer them to the patient according to the
physician’sorder.
Only the commonly used drugs are taken in this system.

21. Drugs on the nursing station are known as Floor Stock Drugs
FLOOR STOCK DRUGS
CHARGE FLOOR
STOCK DRUGS
NON-CHARGE
FLOOR STOCK
DRUGS

22. Dispensing Of Charge Floor
Stock Drugs
These are drugs for which patient
is charged for every single dose
administered to him
Selection of these drugs is made by
P&TC
 Charge floor stock drugs are
stored at various nursing stations
An envelope is used to dispense
such drugs
Dispensing Of Non-charge Floor
Stock Drugs
These are medicaments placed at
the nursing station for the use of
all patients on the floor
Drug basket method

23. UNIT DOSE DISPENSING
Unit Dose System was first used in hospitals in 1960’s. Which was Used to decrease
medication administration errors by nursing staff, and reduce medication waste.
Those medications which are ordered, packaged,
handled, administered and charged in multiples of
single dose units containing a predetermined amount
of drugs or supply sufficient for one regular dose
application or use.”
e.g: 1 tablet or 1 capsule.

24. Advantage of unit dose system
 All doses of medication required at the nursing
station are prepared by the pharmacy thus
allowing the nurse more time for direct patient
care.
 Elimination excessive duplication of orders and
paper work at the nursing station and pharmacy
 Eliminates credits.
 Conserves space in nursing units by
eliminating bulky floor stock
 Eliminates drug waste.
 Medications Ready for Administration.
 Patient Safety.

25. LABELLING
Labeling ultimately reflects the pharmacy
department. The pattern of labeling is as follows:
Name
Dosage form
Strength
Batch number
Expiry date
Special direction if required.

26. DISPENSING OF CONTROLLED DRUGS
A separate register is maintained for controlled drugs.
Various steps involved are as follows
Medical superintend is overall responsible for handling of
controlled drugs, chief pharmacist procures, stores and
responsible for proper dispensing of drugs within the
hospital.
Required information
Full name of the patient
Address
Date
Name and strength of drugs
Quantity of drug
Signature of the prescriber
Dose and route of administration.

27. All medicines must be stored in a cool dry place
(usually in cabinets, medicine carts or fridges)

28. Learn to prepare drug cards
Drug card is the most up-to-date nursing
information guide , including descriptions,
uses, mechanism, pharmacokinetics,
side/adverse effects, contraindications/
precautions, interactions, dosing, and
nursing management priorities.

29. Drug
card
Medication
Classification

30. Generic Name: Paracetamol
Trade Name: Panadol, Tylenol
Classification: Non-narcotic Analgesic, Antipyretic
Action/Effects:
Antipyretic Activity, Analgesic Activity
Inhibition of central peripheral
prostaglandin synthesis
Indication: Fever, Pain
Contraindication: Hypersensitivity
Side Effects: Nausea, Possible Sleepiness
Adult Dose: 325-1000mg p.o. or Rectal (every 4
hours)
Pediatric Dose: 15mg/kg p.o. or Rectal (caution on max
dose)(Liquid Form)
Max: 4gms per day
Cautions: Extreme caution must be used when
considering the use on a suspected liver
dysfunction.
Acetaminophen

31. Generic Name:Aspirin
Trade Name: Disprin, Aspirin
Classification: Anti-platelet,
Antipyretic
Action/Effects: Decreases platelet
aggregation, prolongs
clotting time.
Antipyretic Activity
Indication: Pain killer, MI,
Coronary Artery
Disease, Pericarditis
Contraindication:
Side effects:
Aspirin

32. References:
1. Pharmacology for Nurses Tara V. Shanbhag, Smita Shenoy and Veena Nayak (2nd edition) 2016.
2. Goodman & Gilman’s the Pharmacological Basis of therapeutic 12th Edition 2011. Mc Graw-Hill, Medical publishing
division.
3. Oldham, F. K.; Kelsey, F. E.; Geiling, E. M. K. Essentials of Pharmacology; Lippincott: Philadelphia, 1955.
4. Byrant, B., Knights, K., Salerno, E. 2007, 2nd Ed., Pharmacology for Professionals, Australia : Mosby.
5. Dr. Ramesh K. Goyal, Dr. R. K. Parikh, Dr. Mayur M. Patel – AText book of Hospital Pharmacy, Pg.no: 101 – 103
6. Goyal RK, Parikh RK, Patel MM. A Text book of Hospital Pharmacy.13th edition. Ahmedabad: BS Shah Prakashan;
2015. 101-123.
7. Nand P , Khar RK. A Textbook of Hospital and Clinical Pharmacy. Delhi: Birla publishers; 2009. 53-70.
8. Pubmed and google scholor etc