Pharmacy law and Ethics

1. B. Pharm. (Honors) Part-IV
Course: 408/Unit - 1
Full marks: 100
Subject:
Clinical Pharmacy and Pharmacy Law & Ethics

2. Introduction
 The emergence of clinical pharmacy as branch has opened a new
and challenging avenue for the Pharmacists.
 Pharmacy contribution in recent years has increased considerable
beyond drug manufacture and distribution in developed and
developing countries.
 The reliance on the clinical pharmacy services has been largely
because of an explosive increase in the availability of a large
number of drugs and the excessive load on the physicians.
 The physicians has now to depend upon the pharmacist for
imparting drug related information to the patient especially in
hospitals settings.

3. Definitions
 Clinical Pharmacy is that branch of Pharmacy which is
concerned with various aspects of patient care and deals not
only with dispensing of drugs but also on advising the patient on
the safe and rational use of drugs.
 Clinical Pharmacy involves the participation of clinical
pharmacists in drug therapy decisions in patient care areas.
 The clinical pharmacists serves as a source of information on
drugs and dosage forms to the members of the physicians,
nursing staffs and other health care professionals.

4. Clinic & Pharmacists
Clinic:
 A clinic is an establishment or area of a hospital where ambulatory
patients are admitted for special study and treatment by a group of
physicians, practicing together and where patients are not confined to a
hospital.
 The clinic is used to indicate the out-patient diagnostic facilities
operated by a hospital or other agencies for the care of patient.
Clinical pharmacist?
 It is the person (clinical pharmacist) who can play a vital role in
assisting physicians to prescribe drug- who can help and noticed that
the right drug is given to the right patient at the right time in the right
amount with due consideration of cost and informed the patient what
amount (dose), how (route), when (frequency or before/after meal) of
drugs to be taken and the side effects of drug.

5. Pharmacy Practice in Bangladesh
 As a profession it was recognized in Bangladesh after the
promulgation of Bangladesh Pharmacy Ordinance-1976. Although, the
pharmacy education started its journey by the hand of the Department
of Pharmacy, Dhaka University in 1964.
 Still now almost twelve government universities and twenty three
private universities offer Bachelor of Pharmacy (Honours) degree.
Among these universities only 4-5 universities offers five year
Bachelor of Pharmacy (Honors) professional degree but other
remaining universities offers four year bachelor degree.
 Major work field for pharmacist in hospital as hospital pharmacist, in
clinic as clinical pharmacist and community pharmacist in a specific
community. Industrial pharmacy practices are only a work field for
pharmacist.

6. Contd.
 In Bangladesh perspective for a new pharmacy graduate, industrial pharmacy
practices are major option to build up his career, as a result proper health
services are not maintained and job crisis for a graduated pharmacist day by
day increases.
 In real conditions of Bangladesh pharmacy practice areas for graduate
pharmacist is limited in industry i.e., industrial pharmacy practices or in the
marketing sections.
 A few numbers of pharmacists are involved in administrative positions. In the
area of industry or marketing sections graduate pharmacists involved in
production, research & development, quality control, quality assurance and
product marketing, etc.
 But graduate from other disciplines like biochemistry, microbiology,
biotechnology, chemistry can also work in these sections.
 The educational system of pharmacy is one of the major reasons for bounded
pharmacy practices because the courses included in bachelor degree
principally emphasize on industrial practices.

7. Present Status of Clinical Pharmacy in
Bangladesh
 In the recent year, Hospital and Community Pharmacy Practice has
become an important part in the health care system worldwide. In
Bangladesh, this system is still in the primary stage.
 The fields of pharmacy practices like hospital pharmacy, clinical
pharmacy or community pharmacy not well established in
Bangladesh.
 Some private hospitals like Apollo hospital, Square hospital,
United hospital etc. are established only in one sector i.e., hospital
pharmacy department where graduate pharmacist worked in 24
hours successfully and it was proved that their quality of treatment
and services to the patient is quite appreciable.

8. Contd.
 But we do not see the regulatory authority of Bangladesh to take any step to
establish hospital pharmacy, clinical pharmacy or community pharmacy
practice services in hospital and clinic for the graduate pharmacist.
 In these areas of hospital some B-grade (diploma) or in community C-grade
pharmacist are working having 2 years of diploma or 2-3 months foundation
courses.
 A hopeful statistics is that, in 2006 the number of hospitals in Bangladesh is
more 1683 (678 govt. hospitals and 1005, non-govt.). In that case if we
consider a simple statistics, that if in every hospital 10 gradate pharmacists
are involved (as in Apollo hospital it is 24) in patient care system then the
required number of pharmacists will be 16830.
 So, it is the time for the pharmacist, health professional, entrepreneurs and
government to come forward to establish standard Hospital and Community
Pharmacy setting throughout the country.

9. Status of Clinical Pharmacy In Bangladesh
Hospital pharmacy in Bangladesh has not made success beyond
purchase, storage, dispensing and distribution of drugs. Several
challenges in the current pharmacy education in Bangladesh have
been identified.
The major constraints are as follows:
 Global pharmacy education has dramatically shifted away from its
original product-oriented focus toward a patient-oriented clinical
curriculum. However, there is no initiative from govt. to establish
Pharm.D. curriculum in BD.
 There is no emphasis in undergraduate course towards the application
of pharmaceutical knowledge in patient care, only ~5% of the total
course credits are allocated toward clinical pharmacy.
 Clinically, oriented pharmacy practitioners are not involved in in
undergraduate course. This deficiency does not motivate pharmacy
students towards making career in this field.

10. Contd.
 Pharmacy graduates do not get any training in clinical pharmacy in
hospitals so they remain isolated from patient care.
 Moreover, as of now, there are no patient care roles of B.Pharm.
graduates in clinical or community practice settings in the country.
 There is lack of multi-disciplinary approach to drug therapy in BD.
Medical professionals other than pharmacy are more involved in
drug therapy.
 The pharmacists contribution for patient care has been limited
because of socioeconomic condition of the patient.
 Career opportunities in clinical pharmacy in BD are not good
enough comparatively to other pharmacy job for pharmacy
graduates.

11. Goals of Clinical Pharmacy
The goal of clinical pharmacy activities is to promote the
correct and appropriate use of medicinal products and
devices. These activities aim at;
(1) Maximizing the clinical effect of medicines, such as,
using the most effective treatment for each type of patient.
(2) Maximizing the risk of treatment-induced adverse
events, such as, monitoring the therapy course and
patients compliance with therapy.
(3) Minimizing the expenditures for pharmacological
treatments born by the government and by the patients,
such as, trying to provide the best treatment alternative
for the greatest number of patients.

12. Functions of Clinical Pharmacy
 Preparation of patient medication history chart:
Patient prescription and non-prescription drugs, allergic
disorder and adverse drug reactions including patient
compliance are recorded in the medication history chart. It
helps the physicians in making decision on current
treatment in the patient best interest.
 Monitoring patient's response to the current medication is
done in order to maximize benefits and to either medication
problems arising or to help their early recognition and
correction if any arisen.
 It involves in increasing the knowledge about the disease
and their drug therapy. He can guide the patient for proper
use of drugs therapy and possible drug interactions. He can
also advise on drug compliance.

13. Contd.
 Participate in drug emergencies.
 It also provides provisions of consultation in various areas
like total parenteral nutrition. intravenous therapy, clinical
pharmacokinetics, selection of drug therapy and
determination of therapeutic end point.
 Management of chronic disease.
 Clinical pharmacists participate in clinical drug
investigation along with other medical staff member.
 Clinical pharmacists is involved in drug administration and
drug distribution in the patient care areas.

14. Contd.
 Clinical pharmacists is involved in the education of
medical, pharmacy and nursing personnel in the patient
care areas.
 Clinical pharmacists is involved in the detection and
reporting of adverse drug reaction and drug
interactions.
 Clinical pharmacists is involved in conduction of drug use
reviews and participation in patient care audits.
 Clinical pharmacists has the responsibility to communicate
the development made in drug delivery system and
clinical pharmacy services.

15. Self-medication
 It means the medication process or treatment of a disease which is not
prescribed by the physician is self-medication. Here, the prescription is
made by the patient or the drugs that are used for the treatment are chosen
by the patient. When a physician suffers from a disease the prescription
order written by the physician himself is also self-medication.
Benefits of self-medication
 Quick medication
 To relief from mental anxiety or physical discomfort (pain/fever)
 To experience benefits of medication (sleeping pill)
 Economic that is one can avoid physician visiting charge

16. Limitations of self-medication
 In case of self-medication proper diagnosis of
disease is not possible and
 So, proper treatment is not always done.
 In disease state a patient cannot understand
himself and mentally confused, nervous and
depressed
 Leading to the wrong diagnosis and wrong
prescriptions which may endanger patient life.
 Most importantly a patient is not a specialized
person and lack of knowledge.
 So, one should not have self-medication.

17. Dangers of self-medication
1. Complications of the treatment:
Normally, it takes 2 to 3 days to get sign of
relieving a particular disease. In case of self-
medication the patient wants prompt relief and for
this purpose he/she takes more drugs than
normally required. This increases the no. drugs
intake and ultimately creates complications.
2. Suicidal tendency:
Many people have attempted suicide by self-
medication. Over-enthusiastic medication without
medical advice can endanger patient life eg.
sedatives or hypnotics.

18. Contd.
3. Drug resistance:
In case of self-medication, antibiotics are used either
overdoses or insufficient doses and the treatment
course is not completed. So, this misuse of antibiotics
leads to a generation of resistant organisms which
may infect others in the population and infections are
very difficult to treat.
4. Habituation and drug dependence:
By self-medication, the patient gets overdoses of
sleeping or tranquilizing pills and thus drug habit is
formed to them. This leads to drug dependence-
addiction, and it is a nuisance to the family and to the
society.

19. Contd.
5. Poisoning, toxicity or adverse drug reactions:
If a potent drug is taken accidentally or overdose of
drug is taken then drug poisoning or toxicity occurs.
Again, if the drugs taken are contraindicated or not
suitable for the patient then drug adverse effects
develop. Examples-
(a) If aspirin is taken in overdoses for a long time, it
may cause gastric ulceration with severe bleeding –
causes drowsiness or coma, and it produces
respiratory alkalosis, metabolic acidosis- fatal effect.
(b) Penicillin may cause drug fever, rash, even
anaphylactic shock (hypotension, bronchospasm).

20. Contd.
6. Drug induced disease:
Self-medication produces drug induced disease from a
disease. Example- Streptozotocin is an anticancer drug
(pancreas) produces diabetes as a result of excessive
destruction of beta-cells.
7. Drug-drug interactions:
In self-medication drug-drug interaction is ignored which
may leads to toxic effects or no effects of drug.
8. Dose & dosage regimen:
Self-medication- dose, dosage regimen etc. is not exactly
maintained. So, one will not get the desired effect of
medication.

21. Prescription
Prescription is an authorized order for medication issued by a
physician. Includes- medication, dose, dosage form, interval, drug-
food interaction etc.
 Single drug prescription
A single drug is prescribed for the treatment of specific diseases. It
requires the skillness of the physician to find out the primary cause
of a specific disease. This primary cause is responsible for
secondary trouble.
 In iron deficiency anemia, the primary cause of disease is the
deficiency of iron which is associated- loss of appetite, body weight
loss, generalized weakness and growth retardation.
 The secondary troubles are the characteristics symptoms of the
primary disease. In such case disease, a single drug- iron
preparation is prescribed.

22. Requirement for single drug
therapy
 Single drug therapy requires the skillness of the physician to
find out the particular cause of the disease. The physician
should have vast knowledge about pharmacology, physiology,
toxicology and pathology.
Advantages of single drug therapy
 Economy
 No drug-drug interaction
 Very less adverse effects
 No confusion in taking drug since only one drug is
prescribed.

23. Drug Abuse and Drug Dependence
Every society has a history of use of drugs that affect mood, thought and feeling and
behavior. Even drugs used for therapeutic purposes have opportunity of causing
dependence.
Drug Abuse:
 Drug abuse refers to the inappropriate, excessive and persistent use of a drug for non-
therapeutic purposes. It means the use of a CNS active drug usually by self-medication
of the drugs in a manner that deviates from the acceptable medical and social use in a
given society.
 The term conveys social disapproval of the manner and purpose of drug use.
The purpose of drug abuse includes-
 To relive anxiety, tension, depression, for recreation.
 Drug abuse is a dangerous thing in that sequentially it can leads to drug dependence.
 Firstly, a person simply takes a drug
 It produces drug habituation
 Then, it results in drug addiction
 Lastly, drug dependence.

24. Class of Commonly Abused Drugs:
1. Opioids (morphine, heroine, codeine, pathidine)
2. CNS depressants (ethanol, benzodiazepines)
3. Psychostimulants (caffeine, nicotine, amphetamines,
cocaine)
4. Cannabinoids (Gaza, Marijuana)
5. Phenothiazine
Drug Misuse:
Drug misuse means taking a drug other than CNS
active drug for a wrong indication, in a wrong dosage,
for a duration other than the medical prescribed.

25. Tolerance Vs Cross-tolerance:
 Tolerance:
It is form of drug resistance induced by exposure of
the individual to the drug in question. If a drug is
taken repeatedly, it is likely to become progressively
less effective so that the dose has to be increased to
get the same original effect.
 Cross-tolerance:
The tolerance that develops to some drugs also causes
tolerance of drugs of the same pharmacological class.
This is the phenomenon cross tolerance.

26. Drug Habituation:
It is a condition resulting from the repeated consumption of a
certain drug.
It is characterized by-
 Less intensive involvement with the drug
 Withdrawal syndrome is mild (discomfort)
 Psychological dependence on the effect of drug (no physical
dependence).
Example- consumption of tobacco, tea, coffee and social drink
etc.
 Addiction & habituation imply different degrees of
psychological dependence.

27. Drug Addiction:
It is a state of chronic intoxication produced by the repeated
consumption of drug.
Its characteristics –
 An over powering desire or need (compulsive) to continue the
drug and to obtain by any means
 Procuring the drug and using it takes precedence over other
activities
 A tendency to increase the dose
 A psychic (sleep/euphoria) and physical dependence
(neuroadaptation) on the effect of drug.
 Withdrawal syndrome
Examples- Amphetamines, cocaine, cannabis, LSD (lysergic
acid diethylamide) etc.

28. Drug Dependence
 Drugs are capable of altering mood and feelings
are liable to repetitive use to derive euphoria,
withdrawal from reality, social adjustment etc.
It results from the interaction between drug and
person due to repeated, periodic or continuous
administration of the drug.
 Example- morphine, heroine, pathedine,
cocaine, codeine and alcohol.

29. 1. Psychological dependence:
It is a condition in which a drug produces optimal
state of well being and a psychic drive that require
continuous administration of the drug to produce
pleasure or to avoid discomfort.
Characteristics includes-
 Liking for the drug effects (psychic effect of drug)
 To avoid discomfort of drug
 May progress to compulsive (periodic/continuous) use
of drugs
 Tolerance may or may not develop
 Withdrawal symptoms characterized by psychic
disturbances like headache, restlessness, emotional
upset and convulsion.

30. 2. Physical dependence:
It is a physiological state produced by repeated administration
of a drug which requires the persistent presence of the drug to
maintain physiological equilibrium.
Characteristics includes-
 Discontinuation of the drug results in a characteristics
withdrawal syndrome which is manifested by physical
disturbances.
 Physical dependence cannot occur without tolerance.
 It is an altered or adaptive physiological state of body
(neuroadaptation- adapt nervous system to function normally
in the presence of the drug).
 Examples- Opioids, barbiturates, other depressants like
alcohol, benzodiazepines.
Stimulants like amphetamine, cocaine produces little or no
physical dependence.

31. General treatment of Drug Dependence
Drug dependence once developed, difficult to treat. A full co-
operation is necessary from the individual.
The principles of treatment are-
1. Gradual or sudden withdrawal of the drug. Abrupt withdrawal is
possible without any harm for the drugs not producing physical
dependence.
2. Specific substitution therapy is based on the advantage of
development of cross tolerance. Drugs which produce cross
tolerance and less severe side effects may be given eg. methadone
replaces morphine.
3. Psychotherapy and occupational therapy.
4. Specific drug therapy for example in case of alcohol poisoning a
drug antabuse (propietery: disulfirum) is used. Alcohol is
metabolized to acid and then to aldehyde. The end product aldehyde
is responsible for the severe condition. Antabuse helps in treatment
of alcohol by blocking the metabolism of alcohol to aldehyde.
5. Correction of nutritional deficiencies.
6. Community treatment and rehabilation.

32. DIAGNOSIS
 Diagnosis
The process for the determination/identification of disease
state from which a patient is suffering.
 Diagnostic tests / Clinical methods / Clinical laboratory
tests:
The techniques applied for the determination of diseases are
called diagnostic tests. Tests are primarily an aid to diagnosis
and aid in determining extent of disease.
The art of diagnosis depends on the skill full combination of
two sets of facts-
 Information procured from the patient at bedside (clinical
problem presented by the patient)
 Other obtained indirectly through the diagnostic tests-
chemical or microscopic study of blood, excretions, secretions
and tissues important in determining the clinical problem
presented by the patient).

33.  Wrong diagnosis
1. A proper diagnosis (correct prescription) depends on-
2. The correct history of the patient
3. Education of the patient
4. Correct diagnostic tests
5. Correct interpretation of the test results (Intelligence of the
physician).
 Causes of wrong diagnosis
1. Illiteracy or ignorance of the patient
2. Incorrect history of patient
3. Incorrect diagnostic test
4. Lack of intelligence of physicians
5. Wrong interpretation of diagnostic test results or history by
the physician.

34. Effects of wrong diagnosis
A wrong diagnosis may be made due to any one of the above
points and leads to-
 If diagnosis is wrong, a wrong prescription is written by a
physician.
 Due to a wrong prescription, a wrong treatment is provided to
a patient
 Due to wrong treatment the patient will not be cured and
suffer from diseases for long time.
 Ultimately, aggravation of disease condition.
 Simply, psychological upset of patient, disturbance to the
family member, loss of money and sparing of time.
 Further, wrong treatment may causes adverse effects which
may produce further complications, gives rises to another
diseases and even death.

35. Routine Tests for Diagnosis
 The serum, urine and body fluids of patients are routinely analyzed; however, the
economic cost of obtaining these data must be balanced by benefits to patient
outcomes.
 Generally, laboratory tests only should be ordered if the results of the test will affect
decisions on the therapeutic management of the patient.
 Clinical laboratories may analyze sample specimens by different laboratory
methods; therefore, each laboratory has its own sets of normal values (which may
differ from one procedure to another).
A list of routine laboratory procedures includes the following-
A. Hematology
 Erythrocyte Sedimentation Rate (ESR, “Sedimentation Rate”)
 Hematocrit (HCT, PCV, “crit”)
 Hemoglobin (Hb)
 White Blood Count (WBC)
 Differential (Differential Count)
 Serologic Test for Syphilis (STS)
B. Urinalysis
 Specific Gravity (Sp. Gr.)
 pH
 Protein
 Glucose
 Examine Urinary Sediment
C. Feces
 Occult Blood

36. Laboratory Errors
The possibility of laboratory errors must always be considered when
laboratory results do not correlate with the clinical expectations.
Common sources of laboratory error are as follows-
 Spoiled specimen: Improper handling, improper preservation, or undue
delay in analyzing the specimen may invalidate test results. For
example, if a blood sample is allowed to hemolyze, a spurious
hyperkalemia may noted because potassium concentrations are higher
within erythrocytes than in plasma.
 Specimen taken at wrong time: The concentrations of substances in
biological fluids can be influenced by time of day and relationships to
meal as well as other factors. Thus specimen obtained at improper times
can mislead the results.
 Incomplete specimen: Studies requiring 24-hours collections (urine) can
be a source of error because of the difficulty inherent in the collection of
all sample specimens.

37.  Faulty reagent: Reagents which are improperly
prepared or those have deteriorated (more common
with infrequent tests) may produce faulty results.
 Technical errors: Technicians may make an error
in reading an instrument or making a calculation.
Patient names and sample might be interchanged or
results can be transcribed incorrectly.
 Diagnostic and therapeutic procedures: Some
diagnostic and therapeutic procedures can alter
laboratory test results. For example- digital
examination of the prostate can increase the serum
concentration of acid phosphatase and
electrocardioversion can increase the serum
concentration of creatine kinase (CK).

38.  Diet: Certain foods contain substances which can
appear in biological fluids and interfere with various
laboratory tests.
 Medication: Drugs can alter laboratory results by-
(a) Interfering with the testing procedure. For example
ascorbic acid can cause false negative results when
urine glucose is tested by the glucose-oxidase method.
(b) Altering laboratory values by virtue of their
pharmacological or toxicological properties. For
example thiazide diuretics can increase uric acid
serum concentration by inhibiting the tubular
secretion of urate.

39. Why should the clinical pharmacist be
concerned with clinical laboratory tests?
1. The major reason is to facilitate communication
in the clinical environment
2. Conversation with physicians, reading patients
chart and reading medical literature all require
knowledge of laboratory tests.
3. Laboratory studies are also important in
determining doses of anticoagulants, anti-
neoplastics and doses of drugs to be used in a
patient with renal disease.
4. Study of adverse drug reactions and drug effects
on laboratory results requires a working
knowledge of clinical laboratory testing.