Revision For Forensic Examination
Revision For Forensic Examination
Revision For Forensic Examination
1 what is the condition for the registration of the drug med devices or herbal drugs as stipulated
in the TFDA act
The availability of the drug in the interest of the public
Safety and efficacy and of acceptable quality
Drugs for human in relation to the effect on human health
For animals in relation to its effect on animal health, consumers of animal products the
environment and users.
For medical devices its safety and efficacy
The premises and the manufacturing should meet the current GMP requirements as stated in
the act.
2.What are the three omissions that can lead to the registered person to be removed from the
register.
Who no longer complies with the requirements and conditions to be registered as a pharmacist
Who fails to pay the annual fees or
Who is deceased
3. What are the two principles that should be applied for a pharmacist for the stock rotation?
FEFO first expiring first out
It is common knowledge that issuing out drugs with the shortest remaining shelf life is the best way to
reduce waste and increase profitability in pharmaceutical products management in all pharmaceutical.
FIFO first in first out
Control inventory level.
For fast moving items.
To minimize price fluctuation.
Contra indication; is a condition or factor that serves as a reason to withhold a certain medical
treatment.
Some contraindications are absolute, meaning that there are no reasonable circumstances for
undertaking a course of action. For example, children and teenagers with viral infections should not be
given aspirin because of the risk of Reye's syndrome, and a person with an anaphylactic food or
medication allergy should never eat the food or medication to which they are allergic.
Side effects; Side effect is an effect that is secondary to the one intended.
Side effect may also refer to
Therapeutic effect, an unintended but desirable consequence of medical treatment
Adverse effect, an unintended and undesirable consequence of medical treatment
An adverse drug reaction (abbreviated ADR) is an expression that describes harm associated with the
use of given medications at a normal dosage during normal use. ADRs may occur following a single
dose or prolonged (cumulative) administration of a drug or result from the combination of two or more
drugs. The meaning of this expression differs from the meaning of "side effect", as this last expression
might also imply that the effects can be beneficial.
An adverse drug event (ADE) refers to any injury caused by the drug (at normal dosage and/or due to
overdose) and any harm associated with the use of drug (e.g. discontinuation of drug therapy). ADRs
are a special type of ADEs
5.Comment on the following cases.
a) You are asked by a nurse to inform her staff about the recommendation for the drug therapy
on HIV PEP for low risk and high risk.
In most cases for the PEP therapy it should include a double therapy for a low risk and triple therapy for
a high risk.
The ARV regimen according to level of risk.
6. a) briefly discuss the title pharmaceutical assistant, pharmaceutical technician and pharmacist
under section 19 of pharmacy act 2002.
Pharmaceutical assistant means a person enlisted under section 28 of this act
Pharmaceutical technician means a person enrolled under section 24 of this act.
Pharmacist means a person registered under section 16 of this act
b) What is the:
Certificate of enlisting is a certificate issued to the pharmaceutical assistant under section 29
of this Act.
Certificate of Registration is a certificate issued to the pharmacist under section n 16 of this
Act
Certificate of Enrollment is a certificate issued to the pharmaceutical technician under section
25 of this Act
7. section 3 of the pharmacy act of 2011, states that there is hereby establish a Council to be
known as the pharmacy council which shall be a sole authority for Registering, Enrolling and
listing all the pharmacists, pharmaceutical technicians and pharmaceutical assistants
respectively.
a) With reference to the above quoted section answer the following questions
i. Describe the composition the pharmacy council
8 what information or documents are required by the pharmacy council when the person applies
to be registered enrolled or enlisted as a full pharmacist, pharmaceutical technician, and
pharmaceutical assistant in Tanzania?
13.With reference to the Tanzania Food, Drug and Cosmetics Act of 2003.
a) What are the conditions for a body of corporate to become authorized seller of drugs and
poisons?
Anybody of corporate carrying out the business involving the sell of drugs shall be an
authorized seller of drugs within the meaning of this Act if:
i.With regard to the keeping , selling, dispensing and compounding the business is under the management of
a superintendent who;
(一) Is a pharmacist
(二) Has signed and sent to the director general a statement in writing on behalf of the body of corporate
stating his name and specifying whether or not he is a member of the body of corporate and
(三) Is not at the same time acting at the similar capacity for any other body.
In each set of premises for the sell of drugs the business is carried out either under the personal
supervision of the superintendent or subject to his direction under the personal control of
another pharmacist.
ii.The name and the certificate of registration of the superintendant or of another pharmacist having control
of the business are conspicuously exhibited in the premises.
b) Give a short explanation on the procedures followed when one wants to destroy the expired
drugs in Tanzania?
a) Request on writings to the general director of TFDA by using the application form (annex II)
available at the TFDA head offices, TFDA zonal offices, regional and district medical officers offices and
TFDA web sites
b) A request is shall be a companied with a list of products to be disposed and should state clearly the
trade name, the generic name, strength where applicable, dosage form, pack size , quantity,
manufacturer, batch number and market value of the product.
c) Once the request has been received by TFDA the authority shall acknowledge and inform the
applicant through a letter to contact the directorate of medicine and cosmetics to arrange or TFDA
zonal offices for the verification of the product, in case the is not TFDA zonal offices the applicant
shall be informed to contact the regional or district medical officers offices for the same issue.
d) The TFDA H Q or TFDA zonal offices or regional or district medical officers offices shall send
inspectors to the premises to verify and authenticate the information submitted.
14. you are a drug inspector, visiting a certain pharmacy in town. The premises deal with the
compounding and dispensing of medicines. On fascia of the pharmacy there is an advertisement
that reads
Best quality medicament
Most qualified professional advice
All drugs are available including antibiotics, injections and capsules for human and veterinary
use
Affordable prices
What does the law say about this discuss?
A person shall not advertise and promote any medicine, medical devices or herbal medicine in a
manner that is false misleading, deceptive or that is likely to create incorrect impression its values,
safety, quantity composition or efficacy as the case may be.
A person shall advertise or sale by retail any medicine or medical devices or herbal medicine in
connection in any offer or bonus or discount.
A person shall not carry out any promotion to the any medical devices or herbal medicine in
relation to pharmacy practices without any written approval of the council.
15. (a) compare the effectiveness between amoxicillin and ampicillin.
Amoxicillin and ampicillin similar except Amoxicillin has an OH group on the benzene ring
Amoxicillin is better oral absorption than ampicillin
Amoxicillin less cause diarrhea due to its better oral absorption
Amoxicillin is less interfered with food
Amoxicillin has smaller rate super infections occurance
Amoxicillin is less effective against shigella and H.Influenza
Amoxicillin and ampicillin antimicrobial effectiveness is enhanced when formulated with clavulanic
acid and salbactam respectively.
b) the label on the bottle of dry powder mix for reconstitution states that when 128ml of water are
added, 150ml of an oral suspension, containing 250mg of amoxicillin in each of 5ml each. How
many mls of water should be added to the dry powder mix if the strength of 150mg of amoxicillin
per 5ml is desired?
Soln:
128ml + 150mls= 278ml
250mg = 5ml
Xmg= 278ml
=13900mg
150mg=5ml
13900mg=xml
=463.33ml
463.3ml-150ml = 313.3ml
16. Define the following terms
a) Spirits
Is an alcoholic or hydroalcoholic soln of volatile substance with alcohol content ranging from 62-85%
b) Plasters
Is a small dressing used for injuries not serious enough to require a full-size bandage. "Bandage" is
the common American English term, while "plaster" is the term in British English usage.
The adhesive bandage protects the cut, e.g. from friction, bacteria, damage, or dirt. Thus, the healing
process of the body is less disturbed. Sometimes they have antiseptic properties. An additional function
is to hold the two cut ends of the skin together to make the healing process faster
c) Aerosol
Tiny solid particles or liquid suspended in a gas, used in a can or bottle that contains a liquid under
high pressure
The word aerosol derives from the fact that matter "floating" in air is a suspension (a mixture in which
solid or liquid or combined solid–liquid particles are suspended in a fluid).
d) Tinctures
Is an alcoholic extract or solution of a non-volatile substance e.g. of iodine. To qualify as a tincture,
the alcoholic extract is to have an ethanol percentage of at least 40-60% (sometimes a 90% pure
[
liquid is even achieved).
e) Emulsion
f) Shelf life is the length of time that foods, beverages, pharmaceutical drugs, chemicals, and many
other perishable items are given before they are considered unsuitable for sale, use, or
consumption. In some regions, a best before, use by or freshness date is required on packaged
perishable foods。
Shelf life is the recommendation of time that products can be stored, during which the defined quality of
a specified proportion of the goods remains acceptable under expected (or specified) conditions of
distribution, storage and display
]
g) Immune reconstitution inflammatory syndrome (also known as "Immune recovery syndrome" )
is a condition seen in some cases of AIDS or immunosuppression, in which the immune system
begins to recover, but then responds to a previously acquired opportunistic infection with an
overwhelming inflammatory response that paradoxically makes the symptoms of infection
worse
h) Generic name, drug:
A term referring to the chemical makeup of a drug rather than to the advertised
brand name under which the drug is sold.
A term referring to any drug marketed under its chemical name without
advertising.
i) prescription, extemporaneous,
(Magisterial prescription) a prescription for a nonofficial drug.
2. A prescription that directs the pharmacist to compound the specified medication, as
contrasted with a prescription that specifies medication available in precompounded
form.
j) Polypharmacy is the use of multiple medications by a patient, especially when too many
forms of medication are used by a patient, when more drugs are prescribed than is
clinically warranted, or even when all prescribed medications are clinically indicated but
there are too many pills to take (pill burden). Furthermore, a portion of the treatments may
not be evidence-based. The most common results of polypharmacy are increased adverse
drug reactions, drug-drug interactions and higher costs. Polypharmacy is most common in
the elderly but is also widespread in the general population.
Polypharmacy is most common in people with multiple medical conditions. Combination
therapy is the use of multiple drugs specifically to treat a single medical condition;
monotherapy is the use of a single drug.
7. The pharmacy council may upon recommendation by pharmacy committee grant a temporary
registration to an applicant if he satisfy some conditions. Please mention them.
is to work in Tanzania in the capacity which he is applying for the express purpose of
carrying out specific assignment for research or teaching.
harmacist and he is eligible
for registration as a pharmacist under section 15 of the this Act
be registered pharmacist.
18. Briefly explain the factors which guide the ARV initiation.
• For adults and adolescents, initiation of therapy is dependent on clinical staging and CD4
count.
Tanzania’s national guidelines endorse the WHO recommendations for initiating HAART:
– WHO stage IV disease irrespective of CD4 count.
– WHO Stage III disease with CD4 count <350/mm3
– WHO Stages I-II disease with CD4 count <200/mm
For infants aged 1.5 yrs and above
Stage III and IV irrespective of the CD4 count
Stage I and II with CD4 count less than 15 %
Starting HAART is rarely an emergency MERGENCY
However, treatment of opportunistic infections may be an emergency
19.
a) Discuss the difference between the clinical trial certificate and an ethical clearance
certificate
A clinical certificate is certificate offered to an individual or group of individuals authorised by the
authority to carry out a clinical trial after certifying the necessary conditions before starting a clinical
trial.
An ethical clearance certificate is issued by any approved institution for medical research and
any relevant information as provided under the guidelines for the registration of a drug for the
clinical trial
b) A researcher has been authorised to carry out a clinical trial on a certain drug what are the
condition that should be fulfilled before carrying out a clinical trial?
Inform all person taking part in the trial or person whose animals’ will take in the trial about
一、 The aims and objectives of the clinical trial and way it will be conducted and
二、 The possible risks discomforts and other adverse effects that may result may there from
Ensure in such conditions as may be prescribed from time to time by the authority and
animals or persons taking part in the clinical trial against any injury or risk of that may be
sustained during the trial.
20. Define IPT (intermittent preventive treatment), aim, gestational time of administration
and alternative drug for IPT.
IPT the administration of drug therapy at full therapeutic doses at predetermined intervals
during pregnancy even if an individual has no signs of malaria.
Aim
It should not be considered for chemoprophylaxis; the aim is to prevent the worst effect of
malaria infection in pregnancy rather than to cure the potential illness
Gestation time of administration:
Between 20-24 weeks for the first dose and between the 28-32 weeks for the second dose
The alternative drug
Sp (sulfadoxine pyrimethamine) remain the only drug of choice though not regarded first drug of
choice for malarial treatment since it is known to be safe in pregnancy
21. Explain the management and treatment of severe malaria
Severe malaria is a medical emergency, commonly presented with anemia and cerebral
symptoms of malaria.
At home At dispensary At Health centre At Hospital level
General Pre referral General
management management management
Carry out early
diag nos is
Control fever Carry out early including blood Carry out early
with ant diagnosis testing of diagnosis including
Administration
pyretic and including blood malaria w hich blood testing of
of intra muscular
fanning testing of malaria should not malaria which should
quinine
which should not delay treatment not delay treatment
delay treatment Provide
intravenous Provide intravenous
quinine quinine
Where meningitis
Provide pre- and septicemia Treatment of
referral are suspected hypoglycemia a
Administration
treatment with antibiotics e.g. major problem to
of oral ALU
intra muscular chloramphenicol children and General management
quinine should be pregnant women health care and
administered nursing
Correction of
Continue Immediate
hypoglycemia Immediate Treatment of
feeding and referral with a
using oral sugar referral with a complications
fluid intake referral
water referral eg.blood transfusion
summary to
summary to the Treatment of
the nearest
Control fever nearest hospital hypoglycemia a
Immediate health care
with ant pyretic when clinical major problem to
referral to the where the
and fanning need dictates children and
nearest facilities for the
e.g. blood pregnant women
health care management of
Control transfusion or
facility severe malaria
convulsion with intensive care Lab investigation on
are available
diazepam other complications
At dispensary, health care centre and hospital levels the following assessments and
resuscitation should be performed.
Maintain airway open
Pull the patient at semi prone position
Ensure proper breathing
Measure PR and BP
Blood glucose estimation
Hb estimation
Blood slide for MPS
26. The council for the purpose of pharmacy practice shall prescribe (section 38)
The scope of practice of a
registered, enrolled, or enlisted under this act be deemed to act pertaining to the pharmacy
profession and conditions under which services must be provided
The services to be provided in
various pharmacies and the conditions under which the services shall be provided
Rules relating to:
Codes of conduct of pharmacist,
pharmaceutical technician and pharmaceutical assistants
Good pharmacy practice
The services under which the
pharmacist may levy fees
The titles or trading names
under which a pharmacy may be conducted
Matters relating to investigation
and inspection of pharmacy practice and the conduct of the business of a pharmacist.
27. What are the types of permits issued by the council shall consist of ;( section 37)
Retail
Distribution
Institutional
Any other business the council;
may deem fit for the purpose of this act.
28. You are a pharmacist in a community pharmacy.
a) How many books of records
you will need?
3
b) Give the details of each book?
Prescription book (retail pharmacy only)
Poison book (whole sale and retail)
Dangerous drugs book (whole sale and retail)
29. What are the procedures of dispensing controlled drugs such as morphine and pethidine?
a) qprescription is signed by a
licensed medical practitioner/veterinary surgeon
And then check on the following’
a) Has to be well dated
b) Should have patient name,
age, sex and address
c) Name, quantity, strength and
dosage form of the drug
d) Date of dispensing
e) It shall bear the official seal of
the institution from which it is prescribed
f) Should contain only one drug
only the controlled drug only
g) The signature of the
prescriber
h) The prescription containing
the controlled drug shall not be dispensed on the 21 days lapse from the date it was issued
i) The person dispensing the
prescription has taken reasonably sufficient steps to satisfy himself that it is a genuine
prescription.
j) The dispenser has to be
familiar with the signature of the prescriber
k) The drug shall not be supplied
for more than once one the same prescription provided that if the prescription so direct, the
drug can be supplied for more than once but not more than three times at interval specified
on the prescription
l) The person dispensing shall
mark there on the date on which it is dispensed and shall keep it in the premises where it is
dispensed so that it shall be available for inspection
m) Every person who supply the
narcotics shall enter into a special register drug purchasing or received or supplied on the
same day following the transaction
n) He shall cancel or alter any
entry. Any mistake shall be corrected at the marginal note or foot note giving correct
particular and date
30. what are the side effects of asprin
drowsiness; or
Headache.
rd
31. Explain the aims of the First international Narcotic Control of January 23 1972
32.Why many anti biotic cause diarrhea
Normal floras in the colon are interfered making room for the growth of dangerous
bacteria
Depletion of vitamin B complex causing the morphological deformation
33. What is the composition of the ministerial board?
Permanent secretary who is the chairman
Not more than 12 members appointed by the minister
The DG who is the secretary to the board bamc 27267