The document discusses guidelines for the proper disposal of pharmaceutical waste in Tanzania as outlined by the Tanzania Food and Drug Authority (TFDA). It begins with definitions of key terms related to pharmaceutical waste and healthcare systems. It then describes the structure of Tanzania's national health system and introduces the TFDA guidelines for improper disposal. The guidelines stipulate that pharmaceutical waste must be disposed of safely and legally to avoid environmental contamination and diversion for resale. The document outlines procedures for pharmaceutical waste disposal according to the TFDA guidelines.

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2. 1. Definitions of terminologies used
2. Structure of national health and pharmaceutical in
Tanzania
3. Intro to TFDA Guidelines of improper disposal
4. Procedures for disposal according to TFDA Guidelines
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3. • A drug, medicine or pharmaceutical product means any substance
or mixture of substances manufactured, sold or presented for use
in the diagnosis, treatment, or prevention of a disease, disorder,
abnormal physical or mental state, or the symptoms thereof , in
man or animal.
• Unwanted pharmaceuticals/Pharmaceutical waste: For the purpose
of this study, unwanted pharmaceuticals (Pharmaceutical waste)
included all expired, unusable, damaged, improperly handled cold
chain (e.g. vaccines), improperly sealed and wrongly labeled
medicines.
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4. • Healthcare Waste (HCW) (including unwanted pharmaceuticals) is
defined as all the waste hazardous or not, generated by health
institutions during medical activities, clinical trials, research,
preventive, curative and/or diagnostic.
• Medical Waste: any waste generated in the diagnosis, treatment,
or immunization of human beings or animals, related to research,
production or testing of biologicals from all types of healthcare
institutions, including hospitals, clinics, dental or veterinary and
medical laboratories.
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5. • Improper Disposal: Usually means disposing medicines in the
garbage, indiscriminate throwaway to unauthorized
dumpsites in neighbourhoods or even flushing
pharmaceuticals down the toilet, whereby they enter the
sewage stream.
• Medicines Disposal: This entails the procedures by which
unwanted medicines are safely handled, professionally and
terminally discarded as per relevant national laws and
regulatory frameworks
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6. • Healthcare Waste Management (HCWM): Entail all activities
that lead to proper and safe disposal of waste produced from
health facilities.
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7. • The healthcare system in Tanzania has two major
components; the public and the private sector.
• The public share is 56%; the private share is 44%.
• The system works at four levels; the community, the ward
where there is a dispensary and a health centre at the division
level.
• As one moves further there is the district and regional
hospitals at district and regional levels respectively whereas
at the zonal and national levels, are the consultant/ referral
hospitals
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8. Tanzania Food and Medicines Authority (TFDA) Guidelines for Safe Disposal
of Pharmaceuticals stipulates that improper disposal of unwanted medicines
is hazardous as it can lead to contamination of water supplies or local sources
used by nearby communities or wildlife. Unwanted medicines may come into
the hands of scavengers and children if a landfill is insecure. Pilfering from a
stockpile of waste medicines or during sorting may result in unwanted
medicines being diverted to the market for resale and misuse.
Defective medicines disposal practices carry a public health risk. The main
health risks stated in these guidelines (i.e. WHO, 1999 & TFDA, 2009) include;
a) Contamination of drinking water.
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9. b) Non-biodegradable antibiotics,
antineoplastic(Inhibiting or preventing the growth or development of maligna
nt cells) and disinfectants may kill bacteria necessary for the treatment of
sewage.
c) Burning medicines at low temperatures or in open containers results in
release of toxic pollutants into the air which should ideally be avoided.
d) Inefficient and insecure unwanted medicines handling and sorting may
allow medicines to be diverted for resale to the general public.
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11. • In the following slides we will learn how to dispose waste legally in
Tanzania and TFDA (Tanzanian food and drug authority) is authority
which handles disposal of waste.
• The guidelines is divided into four sections which
a. define unfit medicines and cosmetics products
b. guidance on handling of unfit medicines and cosmetic products at
a facility,
c. procedure for application for disposal of unfit medicines and
cosmetic products and the actual destruction exercise. The last
d. part contains formats of application form, verification form,
disposal methods, disposal form and disposal certificate.
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12. • Medicines and Cosmetic products shall be considered as unfit
when they are: -
a. expired
b. improperly sealed
c. damaged, unexpired and improperly stored
d. improperly labeled
e. faulty, inadequate and contaminated
f. prohibited
g. unauthorized
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13. In order to manage properly unwanted medicines at a facility level, the
following requirements must be adhered to;
a) Maintain a register book for unwanted medicines
b) Keeping them into different categories by dosage (e.g. Solids, semi-solids,
powders and liquids)
c) Keeping separately medicines which fall under controlled medicines,
Antineoplastic
(Inhibiting or preventing the growth or development of malignant cells),
antibiotics and any other hazardous medicines.
d) Keeping in containers according to their dosage forms to facilitate
verification exercise, sorting and selection of disposal method.
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14. e) Demarcating an area for keeping containers of unwanted medicines which
shall be conspicuously labelled with words “Unwanted medicines– Not for
Sale” or “Dawa hizi hazifai kwa matumizi – zisiuzwe” in red ink.
f) Maintaining safe custody of unwanted pharmaceutical products in
registered premises until they are disposed off to avoid theft.
g) Application for disposal of unwanted medicines from Government
institutions shall be accompanied by an approval from Accountant General
declaring that the products have been written off and that are subject to
disposal as required by law under Section 256 of the Public Finance
Regulations, 2004
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16. Any person who intends to dispose of unwanted medicines shall adhere To
the following procedures:
a) Request in writing to the Director General of TFDA by using application
form which is available at TFDA headquarter offices, TFDA zone offices,
Regional and District Medical officer’s offices and TFDA website:
http://www.tfda.or.tz/.
b) And that the request shall be accompanied with a list of products to be
disposed of and should state clearly trade name, generic name and strength
(where applicable), dosage form, pack size, quantity, manufacturer, batch
number and market value of product.
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17. c) Finally TFDA-HQ or TFDA zone office/Regional/District
Medical officer’s offices shall send inspectors to the premises
to verify and authenticate the information submitted.
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19. • During verification exercise, the drug inspector shall
supervise sorting exercise of unfit medicines and
cosmetics products before determination of disposal
method.
• Some of the examples of category of products and their
recommended disposal methods are highlighted on the
table below:
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20. S/N CATEGORY DISPOSAL METHODS
1. Solids, semi-solids and powders Landfill, incineration and
waste immobilization
2. Liquids Sewer, high temperature
incineration and treated
waste
3. Antineoplastic(Inhibiting or preventing the gr
owth or development of malignant cells)
Treated waste and
landfill, high temperature
incineration and return to
manufacturer
4. Controlled drugs Treated waste and
landfill, high temperature
incineration
5. Aerosols and inhalers Landfilling without waste
incertization
6. Disinfectants Sewers or fast flowing
watercourse
7. PVC plastics, glass (ampoules, bottles and
vials)
Landfilling and recycling
8. Paper, cardboard Recycle, burn or landfill
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21. • Sorting should be done in an open or in a well ventilated area/building
as close as possible to the stock pile in an orderly manner.
• After verification exercise is completed, a verification form shall be
filled and signed by both parties.
• Verification process shall involve the following stages:
a. Identification of the product.
b. Separate medicines which fall under controlled drugs, antineoplastic
(Inhibiting or preventing the growth or development of malignant cells),a
ntibiotics and any other hazardous medicinal or cosmetic products
c. Sort according to Destruction Method(explained later).
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22. • Staff involved in sorting exercise shall be provided with protective
gears such as gloves, boots, overalls and dust masks and shall be
briefed on the sorting exercise, health and safety risks associated
with handling the materials.
• Sorted medicines and cosmetics shall be carefully packed into steel
drums or cardboard boxes or jute bags and information to be
indicated outside the container shall include; dosage form(s) and
proposed mode of destruction. The materials should be kept in a
dry secure and preferably separate room to avoid being confused
with in–date medicines cosmetics until disposal is carried out.
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23. • After verification the applicant shall be informed by either
TFDA-HQ or TFDA zone office, Regional or District Authorities
through a letter on the proposed mode of destruction and
shall be directed to arrange with the respective local
authority e.g. Municipal/ District Medical Officer/Pharmacist
to determine disposal site, cost and date of destruction.
• The cost of destruction shall be born by the owner of the
product as stated under Section 99 of Tanzania Food, Drugs
and Cosmetics Act of 2003.
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24. • Procedures of destruction :
• A Drug Inspector, Health Officer, Environmental Officer and
Policeman shall supervise the transport of consignment from the
owner’s premises to the disposal site for destruction exercise.
• The destruction exercise shall be supervised by Health Officer,
Environmental Officer, Policeman and Drug Inspector.
• Unfit medicines and cosmetic products shall be transported in a
closed motor vehicle to avoid theft.
• Supervisors shall wear protective gears such as overalls, gloves,
masks, caps and boots during the exercise
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25. • Upon completion of the exercise, a Drug Disposal Form shall be
duly filled in and signed by the supervisors and owner/owner’s
representative.
• Drug Disposal Form shall be sent to TFDA headquarter offices.
• Once TFDA has received the form, a certificate of destruction of
unfit medicines and cosmetic products shall be prepared and sent
to the consignee.
• Particular care shall be taken while handling anti cancer drugs,
narcotic drugs and penicillin to avoid associated hazards.
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26. 1. Landfill
 This is a disposal method, which involves placing unfit medicines
and cosmetic products directly into a land disposal site without
prior treatment.
 The method is used in disposing off solid waste.
 Small quantities of unfit medicines and cosmetic products produced
on a daily basis may be land filled provided that they are dispersed
in large quantities of general waste.
 Cytotoxic, narcotic drugs and cosmetic products containing heavy
metals such as mercury should not be land filled, even in small
quantities.
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27. 2.Sewer
This is a method used whereby waste medicines and cosmetic
products in liquid form e.g. syrups, lotions and intravenous fluids
are diluted with water and flushed into a proper functioning
sewerage system/sewers in small quantities over a period of
time without causing serious public health or environmental
effect. Fast flowing watercourses may likewise be used to flush
small quantities of well-diluted liquid medicines/cosmetics or
antiseptics.
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28. 3. Medium temperature incineration
• This method involves the use of medium temperature incinerators. Unwanted
solid pharmaceuticals may be destructed by using a two-chamber incinerator
that operates at the minimum temperature of 8500C, with a combustion
retention time of at least two seconds in the second chamber.
• It is recommended that prior to destruction; pharmaceutical waste should be
diluted with large quantities of municipal waste (approximately 1:1000).
• Medium temperature furnaces may be used in absence of medium
temperature incinerators. This type of incinerator is not suitable for
incineration of halogenated compounds, as they need a more high
temperature incinerator.
• The method is applicable to solids, semi-solids, powders and controlled drugs
of that nature.
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29. 4. High temperature incineration
• This involves the use high temperature incinerator, which operates at
a temperature well in excess of 8500C. Our country does not possess
such expensive and sophisticated incinerators so the uses of industrial
plant such as cement kilns serve the purpose. Cement kilns can reach
temperatures of 14500C – 20000C that is suitable for total destruction
of organic waste component. These have long combustion retention
times and disperse exhaust gases via tall chimneys, often to high
altitudes thus reducing the risk ofenvironmental effect.It may be
necessary prior to incineration to remove packaging materials to avoid
clogging and blockage of incinerator or kiln.
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30. 5. Burning in open containers
• Paper and cardboard packaging materials, if they are not to
be recycled, may be burnt. Polyvinyl Chloride (PVC) plastic
however must not be burnt. Unfit medicines and cosmetics
should not be destroyed by burning at low temperatures in
open containers, as toxic pollutants may be released into the
air. It is strongly recommended that only very small quantities
of unfit medicines and cosmetics be disposed of in this way.
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31. 6. Return to donor or manufacturer
• Wherever practical the possibility of returning unfit medicines
and cosmetic products for safe disposal by the manufacturer
should be explored; particularly medicines and cosmetics
which present problems, such as antineoplastic and heavy
metals. For unwanted, unrequested donations, especially that
arrive with past or unreasonably expiry dates, it may be
possible to return them to the donor for disposal.
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