This ppt is about pharmacology

1. SIDE EFFECTS OF DRUGS
Prepared by:Zhanabatyr Gulnur

2. • On average, adverse reactions occur in 10-20% of hospitalized
patients, in developing countries this figure is 30-40%. Patients
admitted to hospitals due to adverse adverse reactions account
for 2.5-28% of the total number of hospitalized patients. In the
USA alone, from 3.5 to 8.8 million patients are hospitalized
annually due to the development of adverse reactions, and about
200 thousand people die annually from complications associated
with the use of drugs. The economic costs associated with drug
complications in the United States are $76.6 billion per year.

3. • Over the past 40 years, more than 130 medicines (drugs) have
been withdrawn from the pharmaceutical market for reasons
related to insufficient safety. A third of these seizures
occurred within 2 years and half within 5 years of drug
registration. Despite the global implementation of safety
pharmacology (PS) surveillance systems, adverse reactions
(AEs) still remain one of the significant causes of death
worldwide. In 1994, NDP caused more than 100 thousand
deaths in the United States, becoming the fourth leading
cause of death.

4. Drug side effect/side effect
• any unintended effect of a drug that goes beyond the
calculated therapeutic effect due to its
pharmacological properties and is observed when the
drug is used in recommended doses.

5. Adverse reaction
• any unintended and harmful reaction to the human
body that occurs when the drug is used in normal
doses for the purpose of prevention, treatment and
diagnosis

6. Side effects
• any medically untoward events that occur during
treatment with the drug, but which Not necessarily
have a causal relationship with this treatment. It is
possible that adverse manifestations coincide in time
with taking the drug.

7. Classification of adverse
reactionsmedicinalfunds(Patterson R.et al, 1986)
Predictable Unpredictable
• Pharmacological
• toxic
• Interaction of the drug
with other drugs
• The nature of the disease
* immune
* idiosyncrasy
* genetic disorders

8. serious frivolous Expected unexpected
- pose a threat to life
- lead to death
- lead to losswork-
capabilities,
- need to be extended
or durationhospital-
lysis,
- give rise to
tumors,
- cause congenital
anomalies,
- may be a consequence
overdose,
-may be the result of abuse
and addiction formation,
- cause significant harm or
damage due to these
conditions.
- Determined like any of
adverse reactions that are
not
meets the criteria for
"serious side
reactions."
- reaction,sve-
deniaabout nature
and gravitykoto-
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brochureis-
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e
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- reaction, information
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which lackVbrochure
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tionsfor the drug.

9. The criteria for establishing a reliable causal
relationship are:
• a clinical case (including changes in laboratory tests) that
arose in a reliable temporal relationship with the
prescription of the drug and which cannot be explained by
concomitant diseases or the action of other drugs and
chemicals;
• the presence of a clinically significant response to the
cancellation and resumption of the event when trying to
prescribe the drug again;
• the case must be determined pharmacologically or
phenomenologically.

10. A causal relationship is not subject to assessment and
classification if the following criteria are present:
• an adverse reaction report cannot be assessed due to
insufficient information or inconsistent data; cannot
be completed or verified;
• the case of an adverse effect may be due to the
already known pharmacological or allergic effect of
one of the suspected drugs or chemical compounds.

11. Waysdetermining the relationship of an adverse event with the
use of drugs:
• Comparethe frequency of the event in persons who do not take
and take drugs;
• Assess the body's response to the cancellation and re-appointment
of this drug. If the adverse event disappeared after withdrawal and
reappeared after the re-appointment of the drug, most likely it is
an adverse drug reaction.

12. Risk/benefit ratio
• The risk is determined by the frequency of
occurrence of adverse drug reactions inherent in
this drug, and their severity. The more severe the
ADR, the lower the frequency of its occurrence,
which can be considered acceptable. The risk is
weighed against the benefit of the drug, which in turn
is evaluated based on the effectiveness of the
treatment and the severity of the disease.

13. ADR risk classification:
• Negligible means less than 1 in 1 million.
• "minimal" - the risk is from 1 in 1 million to 1 in 100
thousand.
• "very low" - from 1 in 100 thousand to 1 in 10 thousand.
• "low" - from 1 in 10 thousand to 1 in 1 thousand.
• "moderate" - from 1 per 1 thousand to 1 per 100 people
• "high" - more than 1 per 100 people

14. Classification of adverse reactions (WHO
Expert Committee)
• TypeA - dose dependent
• Type B - dose-independent
• Type C - effects with long-term use (withdrawal syndrome)
• Type D - delayed effects

15. Type A Adverse Reactions (Dose
Dependent)
Near80% of all ADRs are type A and relate to the most commonly
prescribed drugs.
Forthey are characterized by:
• pharmacological action of the drug;
• dose dependence;
• predictability;
• quite frequent development;
• identification of most of the CPD before widespread use in practice;
• relatively low mortality during their development.

16. • An example would be:cardiotoxicactiondigoxin,
thyrotoxicamiodarone, nephrotoxic -furosemide; NSAID-
induced lesions of the gastrointestinal tract; hypotension
and orthostatic reactions to a series
ofantihypertensivefunds, etc.
• Physician's actions: reduce the dose or discontinue the drug
and evaluate the effect of concomitant therapy.

17. Adversetype B adverse reactions (dose-independent):
Immunologicalreactions,pseudo-allergyAndidiosyncrasy
• Notdose dependent;
• unpredictable;
• rarely occur;
• often detected at the stage of widespread use;
• usually serious;
• relatively high mortality during their development.

18. Adversetype C adverse reactions (with long-term use)
• Developmenttolerance (addiction)
• withdrawal syndrome
• Dependence mental and physical, abstinence syndrome

19. Adversetype D adverse reactions (delayed reactions):
• infrequentlymet;
• usuallydose-dependent;
• usually occur some time after the start of the drug.

20. Examples:
• carcinogenicity;
• violation of reproductive function;
• teratogenicity;
• birth pathology/birth defect that developed after the
patient stopped taking the study drug before
pregnancy, or if the study drug was taken during
pregnancy.

21. Polypharmacy

22. Pregnancy
(safety categoriesFDA)
• A- drugs that have been taken by a large number of pregnant women and women of childbearing age
without any evidence of their effect on the incidence of congenital anomalies or damaging effects on
the fetus;
• B - drugs that were taken by a limited number of pregnant women and women of childbearing age
without any evidence of their effect on the frequency of congenital anomalies or damaging effects on
the fetus. At the same time, in animal studies, there was no increase in the frequency of fetal damage,
or such results were obtained, but there was no proven connection between the results obtained and
the use of the drug;
• C - medicines that have shown in animal studiesteratogenicorembryotoxicaction. There are suspicions
that they can cause reversible damaging effects on the fetus or newborn, due to pharmacological
properties, but not causing the development of congenital anomalies. There are no controlled studies
in humans;
• D - drugs that cause or are suspected of causing congenital anomalies or irreversible damage to the
fetus. The risk to the fetus should be weighed against the potential benefit of the medicinal product;
• X - drugs with a high risk of congenital anomalies or permanent damage to the fetus, because there is
evidence of theirteratogenicorembryotoxicactions in both animals and humans. Should not be used
during pregnancy.

23. NSAIDs
• Acetylsalicylic acid is recognized as dangerous for
children in the treatment of influenza, acute
respiratory viral infections and chicken pox, since it
causes Reye's syndrome, the mortality rate in which is
more than 30% (in children under 5 years old - at least
50%). The elimination of aspirin use in children in the
United States led to the almost complete
disappearance of Reye's syndrome: in 1980, 555 cases
were reported, in 1987-1997. - 36 cases per year, in
1994-1997. - 2 cases per year

24. Nimesulide
• Someyearsback tosome CIS countries registered as an
antipyreticnimesulide(a drug from the group of non-steroidal anti-
inflammatory drugs in children's form - for use in "fever of various
origins" without age restrictions. This drug is indicated for rheumatic
diseases, ithepatotoxic(increasetransaminasesin 0.5% of patients),
therefore, children are not allowed for use in almost any of the countries
outside the CIS. Toxic hepatitis in children, including with a fatal
outcome in the treatment of this agent, is not uncommon, so
registrationnimesulidein child form should be considered a gross error.

25. Paracetamol
• According to official data, the use of paracetamol is the
most common cause of liver damage in the United States.
Every year, 56,000 people come to the doctors with this
diagnosis, on average 458 cases end in death. The
poisoning was not prevented even by a long-term
educational campaign conducted by the authorities.
Americans drink paracetamol more often than other
painkillers, as they believe that it does less harm to the
digestive system.

26. Ibuprofen
• However, paracetamol remains the safest antipyretic
drug. Ibuprofen is recommended by many pediatric
societies as a second-line antipyretic for use in cases
of pain.