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FORENSIC EXAM REVIEW REVISIONS:
4
th
SEPTEMBER 2013
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
o Drugs for human in relation to the effect on human health
o For animals in relation to its effect on animal health, consumers of
animal products the environment and users.
o 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.
z Who no longer complies with the requirements and conditions to be
registered as a pharmacist
z Who fails to pay the annual fees or
z Who is deceased
3. What are the two principles that should be applied for a
pharmacist for the stock rotation?
1. FEFO first expiring first out
2
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.
2. FIFO first in first out
• Control inventory level.
• For fast moving items.
• To minimize price fluctuation.
4. What do u understand by the following words in a package insert?
Indication; is a valid reason to use a certain test, medication, procedure,
or surgery
Indications for medications are strictly regulated by the Food and Drug
Administration (FDA), which includes them in the package insert under
the phrase "Indications and Usage". Most countries and jurisdictions have
a licensing body whose duty is to determine whether to approve a drug
for a specific indication, based on the relative safety of the drug and its
efficacy for the particular usage being investigated e.g.TFDA in Tanzania
Contra indication; is a condition or factor that serves as a reason to
withhold a certain medical treatment.
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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
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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.
Risk
category
ARV regimen Drug regimen
Low risk
Dual
therapy
ZDV+3TC (COMBIVIR) or TDF+FTC (TRUVADA)
High risk
Triple
therapy
ZDV+ 3TC + EFV or ZDV+ 3TC + Lopinavir/(r)
b) A terminal ill patient is prescribed morphine for pain management :
• Given as a palliative care to relieve the pain for the terminal ill patient
• It helps the family members and other care takers on the management of
the patient
• It gives a social, psychological and physical relief to the patient to ensure
the quality of life to the patient though at terminal stage of illness.
• The patient should be give morphine at a dosage of 5- 10ml for every 4
hrs orally.
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• The patient may encounter shortness in breath, vomiting, constipation;
therefore morphine at these conditions should be dispensed concomitantly
with laxatives and antiemetic.
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 20 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 of
pharmacists, pharmaceutical technicians and pharmaceutical
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assistants respectively.
a) With reference to the above quoted section answer the following
questions
i.Describe the composition the pharmacy council
ii.What are the committees of the pharmacy council?
The pharmacy committee
There shall be a committee to be known as the pharmacy committee
whose function shall be to prescribe and evaluate the qualification for
the enlisting, ``enrollment and registration and evaluation application
for premise registration under this act and making recommendations to
the councils.
The pharmacy committee shall consist of the chairman to be appointed
from amongst the members of the council and for other four members
to be appointed by the council
The disciplinary committee
There shall be a committee to be known as the disciplinary committee
whose function shall be to conduct preliminary investigation into any
case where it has alleged that a registered, enrolled or enlisted person has
misbehaved to his capacity as a pharmacist, pharmaceutical technician or
pharmaceutical assistant or should be for any reason be a subject for a
proceeding before the council.
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The disciplinary committee shall consist of the chairman to be
appointed from amongst the members of the council and for other
four members to be appointed by the council
Other committees
iii.List down at least five functions of the councils
• Enlisting, registering and enrolling the PA,PST and PT
• Enquire any issue arising from the community regarding pharmacy
profession for interest of the public.
• Upholds and safe guard the acceptable pharmaceutical conduct in the
public and private systems.
• Prescribe the scope of practice of the persons registered, enrolled and
enlisted under this act.
iv.Mention the tenure of the office for the council members
• A member shall unless his appointment is terminated by the minister or
he ceases in any other way to be a member, hold office for a period of
three years and shall be eligible for reappointment
• Members appointed by the virtues of their offices shall cease to be
members upon ceasing to hold the office entitling to the appointment to
the council.
• Member of the council shall cease to be a member if
z The minister in the public interest terminates his membership after giving
a written notice to the member to show why his membership should be
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terminated.
z Ceases to hold the position entitled his appointments
z He fails without good cause to attend three consecutive meetings of the
council.
z He is convicted of a criminal offence and sentenced to save jail for a term
of beyond six months.
z He becomes mentally ill.
z He is disqualified to practice under this act.
z deceased
v.Describe the quorum of the council
The quorum at any meeting of the council shall be half of the members
b) Basing on its function differentiate between the pharmacy council
and the TFDA.
TFDA PHARMACY COUNCIL
Is a National regulatory Authority
registering products (i.e. drugs,
herbal drugs, medical devices,
poisons, foods and cosmetics) used
in provision of medical and health
care services.
Is a sole National professional body
registering, enrolling and enlisting
of the pharmaceutical personnel’s.
Keeps and maintains the registers Keeps and maintains the registers
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for:
All products registered (drugs,
herbal drugs, medical devices,
poisons, foods and cosmetics)
under TFDC Act 2003.
Whole salers, distributors
purporting for exports and
importers products licenses,
certificates and permits.
Holder of ethical clearance
certificates granted permits for
conducting clinical trials.
for:
Registered pharmacists
Enrolled pharmaceutical
Technicians.
And list for enlisted
pharmaceutical assistants.
Ensure that clinical trials are
performed under the prescribed
standards in this act
To prescribe the scope of practice
of the registered, enlisted and
enrolled pharmaceutical personnel’s
under this act.
Appoint inspectors and order
inspection of premises
Regulate standards and practices of
pharmacy profession.
Ensures unbiased information about
products regulated under this act.
Advice the minister on matters
relating to the pharmacy profession.
Be responsible for its human
resource development and
Determine fees payable under this
act.
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managements.
Foster cooperation with other
bodies
Ensure proper collection of fees
payable under this act.
Registration of products Pay any member, staff, committee
or any person entrusted by any task
under this act such allowances as
may determined.
Promote rational use of drugs,
medical devices and herbal drugs.
Promote rational use of drugs.
Attend to and where possible and
takes the legal actions on
complaints made by the consumers,
manufacturers of the products
regulated under this Act.
Enquire into any queries related to
pharmacy practice raised by the
public.
Approve and register products
regulated under the TFDC Act
2003, to be manufactured within or
imported into and intended to be
used in the united Republic of
Tanz ania .
Ensures that the pharmaceutical
education is provided up to the
prescribed standards.
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Establish and maintain the Tanzania
national formulary and
pharmacopoeia
Regulate all matters relating to
quality and safety of foods, drugs,
herbal drugs, medical devices,
poisons and cosmetics.
Examine, grant, issue, suspend,
cancel and revoke certificates and
licenses for permits and products
issued under the Act.
Ensure that evidence existing and
new ADRs and information about
pharmacovigillance of products
monitored globally are analyzed
and acted upon.
Promote interest in the
advancement of the pharmacy
profession.
Regulate activities of the
pharmacists, pharm tech and pharm
assistants.
Uphold and safe guard the
acceptable standards of the
pharmaceutical profession to the
private and public sectors.
Collaborate with TCU and NACTE
to evaluate the academic and
practical qualifications for
pharmacists, pharm tech and pharm
assistant for the purpose of
registering, enrolling and enlisting.
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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?
Pharmacist Pharmaceutical
technitician
Pharmaceutical
assistant
Fill and submit form
PCF 1 to the registrar
as set out in the first
schedule to these
regulations.
Fill and submit form
PCF 3 to the registrar
as set out in the first
schedule to these
regulations.
Fill and submit form
PCF 5 to the registrar
as set out in the first
schedule to these
regulations.
A certified copy of his
pharmaceutical degree
or qualification
equivalent to a degree
offered in Tanzania.
A certified copy of his
pharmaceutical
diploma or certificate
as the case may be
A certified copy of his
pharmaceutical
certificate.
A full transcript of the
academic record
certified by the head of
institution or the
academic body where
A full transcript of the
academic record
certified by the head of
institution or the
academic body where
A full transcript of the
academic record
certified by the head of
institution or the
academic body where
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he graduated as a
pharmacist。
he graduated as a
pharmaceutical
technician
he graduated as a
pharmaceutical
assistant
A letter of completion
of internship from a
supervisor of in case of
those sponsored by the
ministry of health a
letter from the chief
pharmacist thereby
that he has completed
internship.
Certificate of good
standing from
apprenticeship
supervisor
Certificate of good
standing from
apprenticeship
supervisor
Two recent passport
size photographs
endorsed at the back
by a public notary as
true likeness of the
applicant
Two recent passport
size photographs
endorsed at the back
by a public notary as
true likeness of the
applicant
Two recent passport
size photographs
endorsed at the back
by a public notary as
true likeness of the
applicant
A letter of passing the
forensic examination
A copy of current cv A copy of current cv
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9. What does the abbreviation ALU stand for?
ALU-Artemether Lumefantrine
How would u advice an adult patient on how the ALU dose?
Dosage:
Day 1
st
day 2
nd
day 3
rd
day
Dose 1
st
2
nd
3
rd
4
th
5
th
6
th
Hours 0 8 24 36 48 60
Tabs 4 4 4 4 4 4
Effect of food and interactions
Food enhances the absorption of both artemether and lumefantrine，
patients are advised to take medication with fat food, this is because
lumefantrine is well absorbed with fat food.
Artemether has a potential to prolong the QT interval, so combinations
with other drugs having that property can cause irregular heartbeat,
potentially leading to lethal ventricular fibrillation.
The combination with halofantrine, another antimalarial drug, can
cause a life-threatening QT prolongation.
Drugs and other substances influencing the activity of the liver enzyme
CYP3A4, including, can either increase or lower blood levels of
artemether/lumefantrine, grapefruit juice depending on the sort of
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substance. This can either lead to more severe side effects or to
reduced efficiency.
10. Why are code of ethics and professional conduct important for
pharmaceutical Personnel’s?
• Express broad ideas of pharmaceutical practices.
• It spells out what values are required at particular circumstances.
• Set standards of professional conduct of all pharmaceutical personnel’s.
• Form a base of complains for misconduct.
• Put emphasis on the societal duty of the pharmaceutical personnel as
stipulated in the oath of the pharmaceutical personnel “Concern for
Human Welfare’’ and “Relief of human sufferings’’.
11. a). What do you understand by the term rational use
of medicine
This is the term expresses the medicine has been dispensed to the right
patients, at right dose/ regimen, right time and route of administration at
low treatment cost/ economic treatment cost and as well with right
documentations.
Rational use of medicine leads to patient appropriate medication for
their clinical needs in a dose that does meet their own individual needs
for an adequate period of time at lower cost for them and their
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community.
a) List down types of irrational use of medicine
Prescribing
The factors that cause irrational use of medications are:
• Prescriber; Failure to initiate the right diagnoses due to lack of skills and
drug information.
• Patient: Failure to express correctly to medical practitioners to what is
suffering from.
• Dispensing; Failure to read and interpret correctly the prescription
regarding to prescribed medications, which leads to wrong counting or
filling of the prescribed medicines, or a patient not able to provide basic
information regarding to the use of the dispensed medicines and
precautions to be observed in the storage of the medicines at home during
treatments.
Under prescribing: It occurs when the indicated medications are no t
prescribed due to lack of prescriber important skills and information or
the patient didn’t provide all information to the prescriber during history
taking, which may lead to the dosage prescribed not enough for
treatments.
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Over prescription: Occurs if a drug prescribed is not needed or dose is
too large or administration time length is too long. Also over prescribing
may occur if done empirically without requesting labs results to be sure
of the patient diagnosis in order to prescribe the indicated medicines.
Incorrect prescribing: Occurs when a drug is given for an incorrect
diagnosis, wrong drug selection for the diagnosed indication. Also it may
occur if the prescriber lacks important drug information and skills to
handle the case, from diagnosis up to prescribing.
The use of too many medicines per patient (polypharmacy):
Is a situation where a patient is prescribed with multiple medications
which are not coordinated in the management or treatment of the patient
clinical indications. Also polypharmacy occurs if the patient is prescribed
medications from different prescribers visited for seeking treatments, as
the result patient became dispensed with multiple medicines for the
clinical condition to be treated.
Inappropriate use of antibiotics: Always occurs if medicines are used
without establishment of right diagnoses and patient indication as the
result the patient take not indicated antibiotic medications in a wrong
regimen not sufficient for treatments, or sometimes taking antibiotics for
non-bacterial infections also inappropriate use of antibiotics.
Over-use of injections: It occurs when injectables are used in the
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treatment while an alternative for oral formulations would be more
appropriate to manage the patient clinical conditions.
Inappropriate self-medication: Often occurs if medications are taken
for wrong indication, e.g. antibiotics taken for flue indications or other
unindicated clinical conditions. Also the use of prescription-only
medicines without diagnosis establishment from a licensed medical
practitioner is a major cause of inappropriate self-medication.
Dispensing: It occurs when the dispenser do:
• Incorrect interpretation of the prescription.
• Incorrect counting, weighing, volume filling, apparatus calibration and
compounding.
• Inadequate labeling.
• Don’t adhere to dispensing protocols (Good Dispensing Techniques) and
professional ethics which leads to patient not following to directions
given by the dispenser due to lost hope of being cured from the
medications given.
b) What is the role of the pharmacist promotion rational use of
medicine?
• Proper cancelling when dispensing medications to the patient and advice
on storage conditions, drug interaction, side effects of the drug and any
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other important information on the safety use of medication.
• Tidiness: Ensure sanitary procedures laid down in the dispensing outlet
and compounding area.
• Communication skills: Ensure good communication with patients,
doctors, nurses and other hospital staffs or facility staffs, and clear any
doubt between prescriber and dispenser when arise to the patient
prescribed regimen.
• Promotion and provision of general drug information education to the
public on proper of medicines.
12. The proliferation of the counterfeit drugs in Tanzania is
increasing at an alarming rate, as the result to cause a great impact
on public healthcare.
a) What do you understand by counterfeit in relation to medicinal
products?
A counterfeit drug or a counterfeit medicine is a medication which is
produced and sold with the intent to deceptively represent its origin or
effectiveness to that already present superior drug in the market.
Counterfeit medicines are drug copy imitated from the patented and
registered medicine manufactured from the originator drug manufacturing
company.
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A counterfeit drug may be one which does not contain active
ingredients, contains an insufficient quantity of active ingredients, or
contains entirely incorrect active ingredients (which may or may not
be harmful), and which is typically sold with inaccurate, incorrect, or
fake packaging.
Fake medicines and generic drugs which are deliberately mislabeled in
order to deceive consumers are therefore counterfeited.
b). List down three characteristics that could help to
recognize the counterfeit medicine in your practice.
• Packaging: The container and packaging of the drug will show
difference in dimensions appearance to that of the original drug container.
• Font colour: The colour of text and font can be different to that of the
original drug labeling.
• Label appearance: It will also show differences to that of the original
drug label due to differ in label length and width dimensions and water
mark sign imbedded from the original label.
c). What do you think are the best measures to be taken to
combat this alarming situation in the country?
• Raising Awareness: Government typically view and thus manage the
counterfeit drug issue as a public health and criminal enforcement
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challenge, yet indisputable and growing links between this industry and
organized crime and terrorist organizations indicate that the national
security community must play a larger role in preventing counterfeit
drugs. Government must encourage a more widespread recognition of the
multidimensional nature of this growing threat and institute appropriate
collaborative mechanisms. Legitimate private industry must also
recognize their role in prevention and work more transparently with the
government.
• Mandate action by the national security community: The growth of
trafficking networks around the globe has helped bring about a
convergence of threats: counterfeit pharmaceuticals, narcotics, human
trafficking, dual-use nuclear black markets, small arms and conflict
resources including diamonds and timber. Together, these challenges
have become so widespread that they threaten to overwhelm the
capabilities of even well-intentioned government to mitigate their
destructive effects. The national security community must be given an
explicit mandate to address these challenges in order to ensure the
adequate and coordinated resources necessary to ameliorate the threat. In
short, like the prevention of drug and human trafficking, counterfeit
pharmaceuticals must become a mandate of government security
apparatuses.
• Enhanced security over international purchasing and distribution: At
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present, the lion’s share of concern over the counterfeit pharmaceutical
threat remains the developing world. As a large percentage of
pharmaceutical products are distributed by international relief agencies
and through government assistance programs, it is incumbent upon these
actors to ensure that the products they are distributing are safe. At times,
these agencies’ pursuit of low-cost drugs has led them to deal with
unapproved suppliers. This irresponsible practice should stop as it
provides a direct conduit for organized crime and terrorist organizations
to capitalize upon well-meaning development assistance for nefarious
purposes.
• Development of a transparent and verifiable chain of custody from
point of production to point of sale: Efforts to establish a so-called “e-
pedigree” system to track and trace pharmaceuticals have lagged because
of the costly and complex infrastructure necessary to institute such a
system, lack of agreed-upon industry standards, and questions regarding
patient privacy raised by some civil liberties organizations pressure
should be brought to bear by the national security community to ensure
that the public and private sectors collaborate in the design and
implementation of a nationwide drug serialization system with a track-
and-trace capacity. Governments should work collaboratively with
industry to identify common e-pedigree standards and, where necessary,
incent compliance with those criteria.
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• Legal gap analysis: the government should be encouraged to ensure that
they have relevant, up-to-date laws, as well as rigorous penalties
consistent with the trafficking in illicit narcotics to ensure that traffickers
can be prosecuted and/or sufficiently deterred.
• Enhanced early “authentication” procedures: Governments should be
more proactive in exercising early validation of manufactured products
circulating in the market obtained from reputable registered potential
suppliers.
• Identification Manufacturing sites: Through scheduled visit and
inspection and formal registration/validation of all importers both from a
public health perspective, as well as from a national security standpoint.
This should include not only more rigorous enforcement of importers and
at national borders, but also with domestic manufacturers whose
standards and custody practices may not be consistent with either public
health standards or national security interests.
• Enhanced enforcement: Although public health agencies—even in the
developed world—recognize the challenges presented by counterfeits,
their ability to enforce compliance with existing laws is ineffectual due to
limited resources. Recognizing that the challenges these products pose are
not only a threat to public health but also a direct threat to international
security, additional resources should be directed toward enforcement
agencies at all levels, in all countries, to inhibit the growth of this
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scurrilous industry.
• Quality insurance systems.
• Regular inspection.
• Post marketing inspection.
• Control of import and export on free trade zones.
• Cooperation with other bodies.
• Education on counterfeit identification.
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;
• Is a pharmacist.
• 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,
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• 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 in writings to the TFDA general director by using the
application form (Refer to annex II) available at the TFDA head offices,
TFDA zonal offices, regional and district medical officer’s offices and
TFDA web sites.
b) A request 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
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directorate of medicine and cosmetics or TFDA zonal offices to
arrange a day for the unfit product verification process, in case there is
no TFDA zonal offices the applicant shall be informed to contact the
regional or district medical officer’s offices for the same issue.
d) The TFDA HQ or TFDA zonal offices or regional or district medical
officer’s 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 regarding to its values, safety,
quantity composition or efficacy as the case may be.
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• A person shall not advertise or sale by retail any medicine or medical
devices or herbal medicine in connection with 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 are similar in chemical structure except
Amoxicillin has an OH group on the benzene ring.
• Amoxicillin have better oral absorption than ampicillin.
• Amoxicillin cause fewer diarrheas due to its better oral absorption.
• Amoxicillin is less interfered with food.
• Amoxicillin has smaller super infections occurrences than ampicillin.
• Amoxicillin is less effective against shigella and Hemophilus influenza.
• Amoxicillin antimicrobial effectiveness is enhanced when formulated
with Clavulanic acid, and while ampicilline is formulated with
Salbactam.
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
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150mg of amoxicillin per 5ml is desired?
Soln:
• Let; C
1
=250mg/5ml and V
1
=150ml
and C
2
=150mg/5ml and V
2
=? (To be determined).
By using the relation C
1
V
1
=C
2
V
2
Then on making V
2
the subject;
V
2
=C
1
V
1
/C
2
• On substituting the data; V
2
=[(250mg/5ml)X150ml]/(150mg/5ml)
=250ml.
The 250ml is the volume of suspension resulted after reconstitution of
powder.
• On taking the proportions of water and final suspension volume formed,
the unknown volume can be found.
128ml/150ml = X/250ml
Then X = (128ml X 250ml)/150ml
=213.33ml
ANSWER: 213.33ml of water will be added in a dry powder mix for
reconstitution to give 250ml suspension of concentration 150mg/5ml.
16. Define the following terms
a) Spirits:
Is an alcoholic or hydroalcoholic soln of volatile substance with alcohol
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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 cane 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
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achieved).
e) Emulsion:
A dosage form consisting of two phase systems comprised of two
immiscible liquids, one of which is dispersed as droplets within the other
liquid in a continuous phase.
Emulsion can be oil in water (O/W) means oil is dispersed phase and
water is the continuous phase or water in oil (W/O) which means water is
dispersed phase and oil is the continuous phase.
f) Shelf life:
• Is the length of time assigned to foods, beverages, pharmaceutical
drugs, chemicals, and many other perishable items to be used 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 also 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.
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g) Immune reconstitution inflammatory syndrome:
It also known as "Immune recovery syndrome" It is a condition seen in
some cases of AIDS patients co-orinfected with tuberculosis or having
strong immunosuppression, when the patient treated with ant
tuberculosis and antiretrovirals in which when the immune system begins
to recover, but the patient condition responds to a previously acquired
opportunistic infection with an overwhelming inflammatory response
that paradoxically makes the symptoms of infection worse.
h) Generic name, drug:
• The chemical name of a 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,
1. (Magisterial prescription) is a prescription for a non-official 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.
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3. Extemporaneous prescription is also a fresh prepared medicine upon the
request prescription written by registered prescriber, to be taken by the
patient at once or in continuation whose shelf life (expire date) is fourteen
days effectively from the date of preparation.
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 be taken (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.
• He is not a resident of TANZANIA.
• He is intends to work in Tanzania in the capacity which he is applying for
33
the express purpose of carrying out specific assignment for research or
teaching.
• He is or immediately before entering in Tanzania was acting as a
pharmacist and he is eligible for registration as a pharmacist under
section 15 of the Pharmacy Act 2011.
• His professional and personal conducts render him fit to be registered
pharmacist.
18. Briefly explain the factors which guide the ARV initiation.
• For adults and adolescents, initiation of therapy is dependent on
WHO 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. However, treatment of
opportunistic infections may be an emergency.
19. a). Discuss the difference between the clinical trial
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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 certificate issued by any approved
institution for medical research and bearing relevant information for
conducting the clinical trial 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.
• The aims and objectives of the clinical trial and the way it will be
conducted.
• The possible risks or discomforts and other adverse effects that may
result 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
35
of administration and alternative drug for IPT.
• IPT is 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.
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21. Explain the management and treatment of severe malaria.
Severe malaria is an emergency medical emergency, commonly
presented with anemia and cerebral symptoms of malaria.
At home At dispensary At Health centre At Hospital level
Control fever
with ant pyretic
and fanning
General
management
Pre referral
management
General
management
Carry out early
diagnosis including
blood testing of
malaria which
should not delay
treatment
Administration of
intra muscular
quinine
Carry out early
diagnosis including
blood testing of
malaria which
should not delay
treatment
Carry out early
diagnosis including
blood testing of
malaria which should
not delay treatment
Provide intravenous
quinine
Provide intravenous
quinine
Administration of
oral ALU
Provide pre-referral
treatment with intra
muscular quinine
Where meningitis
and septicemia are
suspected
antibiotics e.g.
chloramphenicol
should be
administered
Treatment of
hypoglycemia a
major problem to
children and
pregnant women General manage ment
health care and nursing
Continue feeding
and fluid intake
Immediate referral
with a referral
summary to the
nearest health care
where the facilities
for the management
of severe malaria
are available
Correction of
hypoglycemia
using oral sugar
water
Immediate referral
with a referral
summary to the
nearest hospital
when clinical need
dictates e.g. blood
transfusion or
intensive care
Treatmen t of
complications eg.blood
transfusion
Immediate
referral to the
nearest health
care facility
Control fever with
ant pyretic and
fanning
Treatmen t of
hypoglycemia a major
problem to children
and pregnant women
Control convulsion
with diazepam
Lab investigation on
other complications
At dispensary, health care centre and hospital levels the following
assessments and resuscitation should be performed.
• Maintain airway open
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• Pull the patient at semi prone position
• Ensure proper breathing
• Measure PR and BP
• Blood glucose estimation
• Hb estimation
• Blood slide for MPS
21. Explain the treatment of uncomplicated malaria in pregnant
women.
Malaria is a common infection among pregnant women especially the
primigravidae.
Uncomplicated malaria management.
• During the history taking and physical examination it important to elicit
signs and symptoms of severe malaria.
• Whenever malaria is suspected laboratory investigation should be
performed if possible, if laboratory facilities are not available treatment
should be started basing on the clinical presentation.
• If the laboratory results shows a negative results should not rule out
malaria.
• Quinine is safe during pregnancy in all gestational ages.
• It is the drug of choice during the first trimester for the uncomplicated
malaria treatment, during the second and third semesters ALU should be
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used.
• Under therapeutically dosage quinine does not induce labor.
• ALU is not recommended for the treatment of malaria in pregnancy
during the first trimester of pregnancy.
22. What are the powers of the council?
• Appoint any officer or inspector to perform any duty or act on behalf
of the council as the council may determine.
• Prescribe and determine the powers and the duties of the officers and
inspector appointed to pursue the above role.
• Remove any name from the register, roll or list su bject to such
conditions as the council may impose.
• Consider any matter affecting the pharmacy profession and take such
action in connection there with as the council as may consider necessary.
• Delegate any of its power to any officer, inspector or organization.
23. What do you understand about the secretariat of the council?
• From section 13 of the Pharmacy Act 2003, it is stated “there shall be the
secretariat of the council which shall consist of The Registrar, Deputy
Registrar and such oth er officers or staffs as the council may
determine’’
• The officers or the staffs of the council shall be the government
employees.
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• The officer of the council shall be paid allowances or remuneration as the
council may determine subject as the minister may approve.
24. Who is the registrar and what are his responsibilities?
• From section 12 of the Pharmacy Act 2003 “the minister shall appoint a
registered senior pharmacist in the public services to be the registrar for
the council.
• Shall be secretary of the council.
• Subject to this act he shall be responsible for the management and
administration of the affairs of the council.
• There shall the deputy registrar appointed by the minister who shall
assist the registrar on the day to day of activities and such other
activities as the council may determine.
25. What are the types of the registration and their conditions?
Permanent registration Temporary registration Provisional registration
Given to a pharmacist Given Foreigners Given Intern pharmacist
Holder of a
pharmaceutical degree or
any other relevant
qualification being
equivalent to a
pharmaceutical degree.
Intends to be employed
in Tanzania for express
purposes
Holder of a pharmaceutical
degree or any other relevant
qualification being
equivalent to a
pharmaceutical degree.
A letter of passing forensic
pharmacy examination
Practicing as a
pharmacist before
entering in Tanzania and
is eligible for
registration.
Dully completed application
form
A full academic transcript
certified by the head of an
institution or an academic
Professional and general
conduct and professional
conduct render him fit
A full academic transcript
certified by the head of an
institution or an academic
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body where he graduated
as a pharmacist
for registration. body where he graduated as
a pharmacist
Three passport size photos
endorsed at the back by a
public notary as a true
likeness of an applicant
Three passport size photos
endorsed at the back by a
public notary as a true
likeness of an applicant
A cv A cv
A letter of completion of
internship from the
supervisor or from the
chief pharmacist.
Completed filled and
signed contract as approved
by the council for taking of
internship
Additional requirements
or documents as the
council may determine.
Evidence of approve by the
council of where the
internship shall taken.
A fully filled PCF 1 Evidence of approval by the
council of the pharmacy or
provider where the
internship shall be
undertaken.
A subscribed fee A subscribed fee A subscribed fee
26. The council for the purpose of pharmacy practice shall prescribe
(section 38)
1. 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.
2. The services to be provided in various pharmacies and the conditions
under which the services shall be provided
3. Rules relating to:
Codes of conduct of pharmacist, pharmaceutical technician and
pharmaceutical assistants
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4.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. How
many books of records you will need? Give the details of
each book?
The retail pharmacy superintendent shall cause records in each particulars
of the pharmacy documentation and record books:
-Ledger book or an appropriate inventory control system.
-Sales book it also referred to Prescription book (in Pharmacy Act
2011, used in retail pharmacy only) or poison book (in Poison Act
1978, used in retail pharmacy only).
-Inspection reports file complaints handling book
42
-Expired drugs register.
-Controlled drugs register (Pharmacy Act 2011) or Dangerous
drugs book (poison Act 1978) either of the books are used in
whole sale and retail pharmacy).
In addition to the above, a retail pharmacy shall maintain a dispensing
book for enabling traceability of any drug dispensed.
The whole sale pharmacy shall in addition maintain the following
records:
-Final invoices with corresponding certificates of importation.
-Recall book.
-Copies of delivery notes.
29. What are the procedures of dispensing controlled drugs such as
morphine and pethidine?
1.Check whether the prescription is signed by a licensed medical
practitioner/veterinary surgeon. And also, then check following on the
prescription:
-Dated, have patient name, age, sex and address.
-Have drug name, quantity, strength and dosage form of the drug.
-Date of dispensing.
-It should bear the official seal of the institution from which it has
43
been prescribed.
-Should contain only one drug only the controlled drug only
-The signature of the prescriber.
2.The prescription containing the controlled drug shall not be dispensed
on the 21 days lapse from the date it was issued.
3.The person dispensing the prescription has taken reasonably sufficient
steps to satisfy himself that it is a genuine prescription.
4.The dispenser has to be familiar with the signature of the prescriber
5.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
6.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
7.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.
8.He shall cancel or alter any entry. Any mistake shall be corrected at the
marginal note or foot note giving correct particular and date.
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30. What are the side effects of aspirin.
• Lack, bloody, or tarry stools;
• Coughing up blood or vomit that looks like coffee grounds;
• Severe nausea, vomiting, or stomach pain;
• Fever lasting longer than 3 days;
• Swelling, or pain lasting longer than 10 days; or
• Hearing problems, ringing in your ears.
Less serious side effects may include:
• upset stomach, heartburn;
• drowsiness; or
• Headache.
31. Explain the aims of the Narcotic & Psychotropic convention of
January 23
rd
1972
The convention enlisted the psychotropic substances which were not
included in the previous International conventions which were highly
abused in the society which would lead to deterioration of social health
and welfare.
32．Why many antibiotic may cause diarrhea
Normal floras in the colon are interfered making room for the growth of
dangerous bacteria. Furthermore depletion of vitamin B complex causing
45
the morphological deformation.
33. What is the composition of the inter-ministerial commission?
The inter-ministerial commission is composed of the followings:
-The Prime Minister who will be the Chairman of the commission.
-The Ant-drug commissioner, appointed by the United Republic of
Tanzania, will be the secretary of the commission.
-The minister for Legal affairs.
-The minister for Home affairs.
-The Minister for Health & Social Welfare.
-The Minister for Community development.
-The Minister for Foreign affairs.
-The Minister for Finance.
-The Minister for Youth developments.
-The Minister of state (Office of the Chief Minister Zanzibar).
-The Minister for Tourism (Zanzibar).
-The Minister of State and Planning (Zanzibar).
-And other members active in the drug abuse control.
-In additional: Other Ministers may be called upon to serve on the
commission in accordance with the items on the agenda.
The commission may also invite any other person to attend, if it is
deemed necessary to invite
such person.
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34. Define the following terms:
a) Superintendent, b) Business, c) Pharmacy, d) Retail Pharmacy, e)
Controlled drugs, f) Drug, Medicine or Pharmaceutical products.
a). Superintendent: Means is any person who is a manager and controls
the business of a pharmacist.
b). Business: Means is a professional practice and any other activities
carried on by the person or persons in relation to products regulated
under TFDC Act 2003.
c). Pharmacy: Means registered pharmacy department in a hospital,
clinic or health centre or community pharmacy.
d). Retail Pharmacy: Means a business which consists of or includes
the retail sale of drugs products but does not include professional
practice carried by medical practitioner, dentist or veterinary surgeon.
e). Controlled drugs: Means any narcotic drug, psychotropic substance
or precursor chemicals as provided under section 77 of the TFDC Act
2003.
f). Drug, medicine or pharmaceutical product: Means any substance or
mixture of substances manufactured, sold or presented for use in:
i). The diagnosis, treatments, mitigation or prevention of diseases
disorder, abnormal physical or mental state, or the symptoms
thereof, in man or animal or,
ii). Restoring, correcting or beneficial modifications of organic or
47
mental functions in man or animal or
iii). Disinfection in premises in which drugs are manufactured,
prepared or kept in hospitals equipment and farm houses.
iv). Article intended for use as a component of any article
specified in clause (a), (b), or (c) but does not include medical
devices or their components, parts of accessories.
Prepared& compiled By Samson Jeremiah
Intern pharmacist 2012/2013
MHN
