Drugs used in special populations | Geriatric | Pediatric patients | Pregnant women

Prof. Shaikh Abusufiyan
Assistant Professor,
AIKTC-School of Pharmacy,
New Panvel-410206
Part-01: Drugs Used In
Special Population
Pharma Learning Forever

At the end of this e-learning session you are able to…
A. Why there is increase in incidences of ADR
and DI in elderly patients?
B. Discuss Pharmacokinetic and
pharmacodynamic changes in elderly patients.
Copyright @shaikhabusufiyan2021

l Special Population:
- Geriatrics
- Paediatrics
- Pregnancy

l ADR and DI become more common with
increasing age
l Prevalence:
- 11.8 % of patients aged 41-50
experience ADR
- It increase to 25 % in patient over
80 years of age.
GERIATRICS (Elderly)

Why In Geriatrics (Elderly) patients there
are increase in incidences of DI and ADR?
q Elderly patients needs more no of drugs at a time
- Drug elimination become less efficient
Lead to drug accumulation
- Haemostatic mechanism
Less compensation for ADR such as postural hypotension

Continue…
q CNS become more sensitive to the action of
sedatives and hypnotics
- Change in immune response
More liable to allergic reactions
- Impaired cognition
Inadvertent overdose

l 2 types of changes may occur in
elderly patients:
- PHARMACOKINETIC
- PHARMACODYNAMICS

PHARMACOKINETIC CHANGES:
q ABSORBPTION
l Carbohydrates, iron, calcium & thiamine -->
Reduced
l Lipid soluble drugs --> Not impaired by the
age
- Intestinal blood flow --> reduced by up to 50 %
Reduced absorption

Distribution:
- Loss of lean body mass with ageing:
l Increase ratio of fat to muscle and fat to body water
Enlarges the volume of distribution of fat soluble drugs ex.
Diazepam and Lidocain
l Distribution of polar drug is reduced ex. Digoxin

Distribution:
- Change in plasma proteins:
l Fall in albumin
l Rise in gamma-globulin

Q&A
Q.1 Why there is increase in incidences of ADR and DI in
elderly patients?
Q.2 What happens to absorption of Carbohydrates, iron,
calcium & thiamine in case of elderly patients?
Q.3 What happens to distribution of fat soluble drugs in case
of elderly patients?

l Hepatic Metabolism:
- Decrease in the hepatic clearance of some drugs
l Reduced metabolism of drugs ex. Benzodiazepines
Slow accumulation
Adverse effect (Onset from days or weeks after
initiating therapy)

l Renal Excretion:
- Decline renal function
- GFR < 50 ml/ min
- Require dose adjustment
- Ex. of drugs that require dose adjustment
in elderly:
l Aminoglycoside
l Atenolol
l Diazepam
l Digoxin
l NSAIDs
l Oral Hypoglycaemic agent
l Warfarin Copyright @shaikhabusufiyan2021

PHARMACODYNAMIC CHANGES
l Increases sensitivity to CNS
- Ex. Benzodiazepine given to elderly at hypnotic dose
can produces long day time confusion even after single
doses
l Increase incidence of postural hypotension (Ex.
Phenothiazine, diuretics)

PHARMACODYNAMIC CHANGES
l Reduced clotting factor synthesis
- reduced the dose of warfarin
l Increase toxicity to NSAIDs
l Increase incidence to allergic reactions to drugs

COMPLIANCE IN ELDERLY
l Incomplete compliance
- Due to failure of memory
- Not understand how to take drug
l Previously prescribe drugs stored in cupboard -->
may take from time to time
l Solution:
- Drug regimen should be as simple as possible
- Improved method of packaging

PRACTICAL ASPECT OF PRESCRIBING FOR THE ELDERLY
l Take a full drug history including:
- ADR
- Use of OTC
l Know the pharmacological action of drug
employed
l Use:
- lowest effective dose
- Fewest possible no. of drugs
l Consider:
- Potential for drug interaction
- Co-morbidity on drug response
TKUC Copyright @shaikhabusufiyan2021

l It is imp to pay attention on formulation of the drug to
be used
- Many old people tolerate elixirs and liq medicines
better than Tab and Cap
l Supervision of drug admin is necessary
l Container should have clear labelling and easy to open
- Child proof container are often also grand parent
proof!!

Case history
l A previously mentally alert and well oriented 90 year old women became acutely
confused 2 nights after hospital admission for bronchial asthma which on the
basis of peak flow had responded well to inhaled salbutamol and oral
prednisolone.
l Her other medication was cimetidine (for dyspepsia)
l Digoxin (for an isolated episode of atrial fibrillation two years earlier)
l And Nitrazepam (for night sedation).
Q. Which drugs may be related to the acute confusion.

Reference:
• James M Ritter, Lionel D Lewis, Timothy GK
Mant and Albert Ferro. Clinical Pharmacology
and Therapeutics, 5th edition. Companion Web.
Pg. No:56-61.

Q&A
Quiz-Attendance/Feedback:
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New Panvel-410206
Part-02: Drugs Used In Special
Population- Pediatric Patient

A. Explain challenges in giving medicines to
paediatric patients?
B. Discuss Pharmacokinetic and pharmacodynamic
changes in paediatric patients.

Challenges of paediatrics Medications
l Children cannot be considered as miniature adult
l because:
- difference in Body constitutions (ADME)
- difference in Sensitivity to ADR

Continue…
l Informed consent is problematic
& Commercial interest is limited
Clinical trial in children have
lagged behind those in adult.

l 2 types of differences are seen in paediatric patients:
- PHARMACOKINETIC
- PHARMACODYNAMICS

Pharmacokinetics
l Absorption:
- GI absorption – Slower
- IM - Faster
l Solution:
- To ensure adequate blood concentration
reach systemic circulation
use IV preparations.

l Skin: is thin
Percutaneous absorption
causes systemic toxicity Ex. Topical
corticosteroids

l Oral liquid preparation are commonly used
Less accurate dosing

Q&A
Q.1 What are the challenges in giving medicines to
paediatric patients?
Q.2 Which rout of drug administration helps to ensure
adequate plasma concentration in pediatric patients?
Q.3 What happens to percutaneous absorption of drugs
in pediatric patients?

l Distribution:
- Body fat content --> is relatively low in
children
- Water content is greater
Lower volume of distribution for fat soluble
drugs (Ex. Diazepam)

l Distribution:
- Plasma protein albumin Reduced in neonates
Risk of kernicterus caused by displacement of
bilirubin by sulphonamide
- BBB --> more permeable
Increase risk of CNS adverse effect.

l Metabolism
- At birth --> Hepatic enzyme system
Relatively immature (Particularly in infant)
Chloramphenicol causes --> Gary baby
syndrome in neonates

l Metabolism
- After 1st four weeks
Mature rapidly
Because the ratio of wt. of liver to body wt. is
up to 50 % higher than in adult
Phenobarbitone metabolism is faster

l Excretion:
- All renal mechanisms (Filtration,
secretion and reabsorption) reduced in
neonates
Renal excretion is relatively reduced in
infant

PHARMACODYNAMICS
l Documented evidences of differences in receptor
sensitivity in children --> lacking
l Unusual effects Effect such as:
- Hyperkinesia (with phenobarbitone)
- Sedation of hyperactive children (with
amphetamine)
Unexplained

PHARMACODYNAMICS
l Augmented response --> to warfarin
l Cyclosporine added in vitro to
cultured monocytes
Greater effects in cells isolated from
infants

Reference:
• James M Ritter, Lionel D Lewis, Timothy GK
Mant and Albert Ferro. Clinical Pharmacology
and Therapeutics, 5th edition. Companion Web.
Pg. No:62-66.

Q&A
https://forms.gle/N7BEgeQVGT4rcaAQ7

New Panvel-410206
Population- Pediatric Patient

A. Explain about breast feeding and effect of
drug on paediatric patients?
B. Discuss practical aspects in prescribing drugs
to pediatric patients.

BREAST FEEDING
l If drug enter the milk in
pharmacological qty
Breast feeding lead to toxicity in
the infant

BREAST FEEDING
q The milk concentration of drugs (ex.
Iodide) may exceed the maternal plasma
conc.
but total dose delivered to the baby is
usually very small.
Hypersensitivity reactions even occur at
very low doses.

q Virtually all drugs that reach the
maternal systemic circulation will enter
breast milk
Especially lipid soluble unionized low mol
wt. drugs

q Continue….
- Milk is weakly acidic --> drugs which are weak
bases
Concentrated in breast milk by trapping
charged form of drug
Breast feeding should be cease during
treatment – if there is no safer alternative.

Drugs avoided during breast feeding:
- Amiodarone, Aspirin
- Benzodiazepine
- Chloramphenicol, ciprofloxacin, cyclosporine
- Cocaine
- Combine oral contraceptives
- Cytotoxic
- Ergotamine etc

l Infant should be monitored if following drugs are
prescribed to the mother:
- Beta adreno-receptor antagonist
Rare but causes significant bradycardia to infant
- Carbimazole:
Should be prescribed at lowest dose --> to reduced the
risk of hypo-thyroidism in the neonate/ Infant

l Continue…
- Corticosteroids
At high dose can affect the infant adrenal function
- Lithium
Causes Intoxication to suckling infant
- Aspirin
There is theoretical risk of rey syndrome

l Bromocriptine and large doses of diuretics
Suppresses lactation
l Metronidazole
Give unpleasant taste to milk

Q&A
Q.1 Which type of drugs consumed by mother may
enter breast milk?
Q.2 What can be done to overcome toxicity
related to maternal administration of Carbimazole
to neonates.
Q.3 Which drugs should be avoided during breast
feeding?

PRACTICAL ASPECT Of PRESCRIBING
COMPLIANCE AND ROUTE OF ADMINISTRATION
l For accurate dosage sick neonates require IV drug administration.
l Difficulty in swallowing
Liq. preparations with pleasant and sweat taste.
l However, chronic use of sucrose
lead to tooth cavities and gingivitis.

PRACTICAL ASPECT IN PRESCRIBING
Continue….
l Dyes and colouring agent – induces hypersensitivity
l Pressurize aerosol (Ex. Salbutamol inhaler)
Only practicable in the children over the age of 10 years.

Topical application:
- Nebulizer --> enhance local therapeutic effect and reduce
systemic toxicity.
- Inflamed or broken skin or in infant --> (causes systemic
absorption of drug ex. Steroids, neomycin)
l IM:
- Should be used when absolutely necessary

Continue….
l IV:
- Less painful
- But skill is required to cannulate infant veins
- Children find IV infusion --> uncomfortable and restrictive

l Rectal administration:
- Convenient alternative
- can be used when child is vomiting
- ex. Rectal Metronidazole --> to treat anaerobic infection
l Rectal diazepam for the treatment of --> status epilepticus can
also be administered by parents.

l Proper communication must be required with
child parents:
- This should include information such as:
l How to administer the drug?
l Why it is being prescribed?
l How long treatment should continue?
l Whether any ADR are likely?

ADVERSE EFFECT RELATED TO PADIATRIC PATIENT
l Chronic corticosteroids
- Inhibit growth
l Aspirin
- Avoided in children under 16 years --> Due to association of rye's syndrome
l Tetracycline
- Deposited in growing bone & teeth, causes staining and occasionally dental
hypoplasia.
- Contraindicated

l Fluoroquinolone
- Damage growing cartilage
l Metoclopramide
- Produces dystonias
l Valproate
- Hepatotoxicity

l Case history:
- A two year old epileptic child has been fitting for at least 15 minutes.
- The casualty officer is enable to cannulate a vein to administer IV diazepam.
- The more experience medical staff are dealing with emergencies else where in
the hospital.
Question:
- Name a drugs and their route of administration with which the casualty officer
may terminate the convulsion.

Q&A
https://forms.gle/duGH1mrnejRQFdUSA

CASE HISTORY
l A 14 year old boy with a history of exercise-induced asthma,
for which he uses salbutamol is seen by his GP because of
malaise and nocturnal cough.
l On examination he has mild fever (38 o C), bilateral swollen
cervical lymph nodes and bilateral wheeze. Ampicillin is
prescribed for a respiratory tract infection.
l The next day boy develops a widespread maculopopular rash.
l Question:
- What is the cause of rash

New Panvel-410206
Population- Pregnant Women

A. Explain why use of drugs in pregnant
women is complicated?
B. Discuss harmful effect of drug in
pregnant women and four stages of
pregnancy.

DRUGS IN PREGNANCY
l Use of drug in PREGNANT WOMEN is
complicated by:
- Potential for harmful effects on the
growing foetus
- Altered maternal physiology
- Difficulty of research in the field

HARMFUL EFFECTS ON THE FETUS
l Since there is limited experience on
usage of drugs on pregnant women
All the drug should be assumed as
potentially harmful

HARMFUL EFFECTS ON THE FETUS
l Social drugs (Alcohol and Cigarette smoking)
Definitely damaging and their use should be discourage

l Most drugs with mol wt of less than 1000 can crosses
the placenta
By passive diffusion
- Rate of diffusion is depend on the:
l Conc of free drug
l Unionized form of drug
l Lipid solubility

l Placental function is also modified by change in
blood flow:
- Drug which reduces placental blood flow :–
l Reduces birth Wt
l Ex. Treatment of mother with Atenolol

l BBB --> not developed until second half of the pregnancy:
Susceptibility of CNS is more
l There are multiple placental enzymes
contribute to drug metabolism

Q&A
Q.1 why use of drugs in pregnant women is
complicated?
Q.2 Which drugs can cross placenta (In
term of drugs attributes)?
Q.3 What is effect of atenolol on placental
blood flow?

l Effect of drug on 4 stages of pregnancy:
- Fertilization
- Organogenesis/ Embryonic stage
- Fetogenic
- Delivery

1. Fertilization:
- Animal studies: (Evidences)
- Fetus before 17 days of gestation causes
abortion
- If pregnancy continues the fetus is
unharmed

2. Organogenesis/ Embryogenesis
- Fetus is differentiated to form major organs.
- Teratogen causes abnormalities in development of embryo.
Ex. Thalidomide --> Phocomelia.
- Special precaution is needed --> b/w 4th and 7th week of pregnancy.
- Ex. of teratogenic drugs
l Thalidomide, Cytotoxic agent, alcohol, warfarin, lithium etc

3. Fetogenesis
- Fetus undergo further development and maturation
- Drug produces significant Adverse effect on fetal growth and development:
Eg. ACE Inhibitors and angiotensin receptors antagonist
Fetal and neonatal renal dysfunction

3. Fetogenesis
l Tetracycline
Inhibit growth of fetal bones and stain teeth
l Warfarin
Fetal intracerebral bleeding
l Aminoglycoside
Fetal VIIIth Nerve damage

4. Delivery:
- Drug given late in pregnancy or during delivery
l Pethidine- analgesic
Fetal apnoea (Reversed by Naloxone)

l Warfarin
Haemostasis defect and fetal cerebral haemorrhage
during delivery
l Anaesthetic agents given during caesarean
Depress neurological, respiratory and muscular
function

Reference:
• James M Ritter, Lionel D Lewis, Timothy GK Mant and Albert
Ferro. Clinical Pharmacology and Therapeutics, 5th edition.
Companion Web. Pg. No:45-51.

Q&A
https://forms.gle/46qehXRD1yp2mQhU7

New Panvel-410206
Population- Pregnant Women

A. Explain pharmacokinetic changes in
pregnant women?
B. Discuss practical aspects of prescribing
drugs in pregnant women and
classification of teratogenic drugs.

PHARMACOKINETIC CHANGES IN PREGNANCY
l Absorption:
- Increase vomiting
Make oral drug administration impracticable
- Decrease gastric emptying
- Decrease small intestinal motility

l Distribution:
- Blood volume --> increased by one third
- Increase in body water -->
- Due to large extracellular volume and change in uterus and
breast.
- Oedema --> add up to 8 L to the volume of extracellular water
- Plasma protein – Concentration fall

l Metabolism:
Increased due to enzyme induction
• Increase rate of elimination of drugs ex.
Theophylline

l Renal Excretion:
renal plasma flow is almost double
Increase renal excretion
- Ex. Digoxin, lithium, ampicillin etc

Practical Aspect of Prescribing/ Dispensing the medicines In Pregnancy
l Prescribing in pregnancy is balance
b/w:
- risk of ADE on the fetus
- and the risk of leaving maternal
disease untreated.

Continue….
l The effect on human fetus
not possible to predict from animal
experiment.
l Untreated maternal disease causes
morbidity or mortality to mother or fetus.

Continue…
l Minimize prescribing
l Use
- Tried and tested drug
- Smallest possible effective dose
l Remember that
- Fetus is most sensitive in the first trimester

Continue…
l Consider
- Pregnancy in all women of childbearing potential
l Seek guidance:
- From British national formulary
- Drug information service
- National Teratology Information Services etc.

Continue…
l Discuss --> potential risk of taking or
withholding therapy
l Warn the patient about the risk of:
- Smoking, alcohol
- OTC drugs
- Drug Abuse

Q&A
Q.1 How pregnancy affect absorption of
drugs?
Q.2 What are different parameters which
leads to change in drug distribution in
pregnant women?
Q.3 Give few practical aspects of
prescribing drugs to pregnant women?

RECOGNITION OF TERATOGENIC DRUGS
l There are two principal problems --> in
deciding the teratogenicity of drug:
1. Many drugs produce birth defect when
given to pregnant animals.
It doesn't mean that they are teratogenic
in human at therapeutic doses.

RECOGNITION OF TERATOGENIC DRUGS
2. Some time effect on the fetus
may take several years to become clinically manifest.
Ex. Diethyl-stilbesterol used in late 1940 to prevent miscarriage and preterm birth
1971, an association was reported b/w adenocarcinoma of the vagina in girl in their
late teen whose mothers had been given diethyl-stilbesterol during the pregnancy.

• The FDA has categorized these drugs by using an
A, B, C, D, X system of classification:
Category A:
• Studies failed to demonstrate a risk to the fetus in
the first trimester.
• No evidence of risk in late trimesters.
• Drugs in this class are considered as safe to use in
pregnant women's.
• Ex. vitamins and levothyroxine.
A, B, C, D, X system of classification of teratogenic drugs

Category B:
• Animal studies showed no fetal risk and also there are no controlled studies in
pregnant women
• or animal studies showed a risk to the fetus but it was not confirmed in
controlled studies in pregnant women in the first trimester and also there is no
evidence of a risk in late trimesters of pregnancy.
• Drugs in this class are considered as safe to use in pregnant women's.
• Ex. Acetaminophen and amoxicillin.

Category C:
• Animals Studies revealed adverse effects on the
fetus
• but there are no controlled studies in women, or
studies in women are not available.
• Drugs from this class can be given to pregnant
women --> if the benefit to the mother outweighs
the risk to the fetus.
• Ex. Diltiazem and spironolactone.

Category D:
• Evidence of human fetal risk are available --> but also the
benefits to the mothers can be acceptable despite the risk
to the fetus.
• Drugs in this class may be used in pregnancy --> if the
benefits to the mother outweigh the risk to the fetus
• Can be used in a serious disease where other safer
alternative drugs are not efficacious.
• Ex. Phenytoin and valproic acid.

Category X:
• Animals or humans studies have demonstrated
teratogenic effects.
• The risk to the fetus clearly outweighs any benefit
to the mother.
• Drugs in this class are contraindicated in pregnant
women.
• Ex. Thalidomide and warfarin.
Copyright@shaikhabusufiyan2021

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