NTA Level 4 • Semester 2 • PST04208

Sorting and Verification of Unfit Medicines and Cosmetic Products

Law and Ethics in Pharmacy Practice • Source Session/Topic 11

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Sorting and Verification Exercise of Unfit Medicines and Cosmetic Products

Students Learning Tasks

By the end of this session students are expected to be able to:

Define the term sorting of unfit medicines and cosmetic products

Describe the sorting categories with their recommended disposal methods

Describe sorting process of unfit medicines and cosmetic products

Describe verification exercise of unfit medicines and cosmetic products

Describe the Model of the Verification form(Annex III)

Definition of the Term Sorting of Unfit Medicines and Cosmetic Products

Sorting of unfit medicines and cosmetic products

Sorting of medicines and cosmetic products means to separate the medicines and cosmetic products into separate categories for which different disposal methods are required.

The separation should be made into those that can be safely used and returned to the pharmaceutical supply system and those that require disposal by different methods. For example, controlled drugs (e.g. narcotics), antineoplastic drugs and antibiotics all require special methods of disposal. Substantial investment in human resources may be required for identifying and separating those products.

Sorting Categories and their Recommended Disposal Methods

Sorting categories and their recommended methods

Some of the examples of category of products and their recommended disposal methods are highlighted on the table below:

S/N

Verification process shall involve the following stages:

Identification of the product.

Separate medicines which fall under controlled drugs, antineoplastics, antibiotics and any other hazardous medicinal or cosmetic products.

Sort according to Destruction Method (Annex IV).

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 borne by the owner of the product as stipulated under Section 99 of Tanzania Food, Drugs and Cosmetics Act of 2003.

Description of Model of Verification Form

Annex III

Model of Verification Form

Form No……………

TANZANIA FOOD AND DRUGS AUTHORITY

P.O. BOX 77150, DAR ES SALAAM

Email: info@tfda.or.tz

Telephone: 255 22 2450512, 2450751

Direct Line: 255 22 2450979

Fax No: 255 22 2450793

Name of applicant…………………………………………………………………………..

of (postal address)… … … … … … … …… … … … … … undertaking the business

of(specify)……………………………………………………………………………………….

Location of Business…………………………………………………………………………….

Weight (in Kg)……………………………………………………………………………………….

Value (in Tshs)……………………………………………………………………………………..

Does the actual product(s) tally with the list of product(s) submitted to TFDA?

YES/NO

Other observation (s)………………………………………………………………………………

…………………………………………………………………………………………………………..

Suggested mode of destruction…………………………………………………………………

…………………………………………………………………………………………………………..

Name of Applicant……………………………………………………..Signature………….

Date of verification……………………………….

1. Name of Drug Inspector…………………………………………Signature……………..

2. Name of Drug Inspector…………………………………………Signature………………

Handout 13.1: Sorting Categories and their Recommended Methods of disposal

Sorting categories:

The objective of sorting is to separate the medicines and cosmetic products into categories that require different disposal methods.

The appropriate safe disposal method recommended will depend principally on the pharmaceutical dosage form of the drugs. Segregated temporary storage areas or receptacles must be provided for each sorted category.

Practical advice on sorting

Sorting involves an initial overall evaluation of the stockpile and subsequent division of pharmaceuticals into those suitable for use and those to be discarded. For those to be discarded a decision is made on the best method of disposal. To be efficient items should only be handled once. Pharmaceuticals suitable for use should remain in their packaging. The pharmaceuticals to be discarded should, when necessary, be separated from their packaging as late in the process as possible.

The sorting process includes:

identifying each item;

making a decision on whether it is usable;

if usable, leaving packaging intact;

if not usable, making a judgement on the optimal method of disposal and sorting accordingly;

leaving packages and boxes intact until reaching their location, prior to definitive disposal or

Transport to an institution for use.

Optimum conditions for sorting

Sorting should be done in the open or in a well ventilated and, if necessary, heated covered structure designated by the local authority. Sorting should be done as close as possible to the stockpile in an orderly way, with all sorted material clearly labeled and separated at all times.

Staff supplied with protective equipment (gloves, boots, overalls, dust masks, etc.), should work under the direct supervision of a pharmacist, and should receive training on the sorting criteria, and health and safety risks associated with handling the materials.

Once sorted, the pharmaceuticals should be carefully packed into steel drums or into containers such as sturdy cardboard boxes, with the contents clearly indicated on the outside of the containers. The materials should be kept in a dry secure and preferably separate room to avoid being confused with in-date pharmaceuticals, until disposal is carried out.

Sorting categories

The top priority of the sorting process is to separate out the pharmaceuticals that are categorized as controlled substances (e.g. narcotics), antineoplastic (cytotoxic-anti-cancer) drugs and any other hazardous non-pharmaceutical products that may have been mixed among the pharmaceuticals. These must all be stored in separate, secure designated areas prior to their separate, safe disposal.

The remaining unwanted pharmaceuticals must be further sorted into different categories by dosage form, (capsules, powders, solutions, suppositories, syrups, tablets).

The following sorting categories and subcategories are suggested.

Expired or unwanted pharmaceuticals

Pharmaceuticals that should never be used and should always be considered as unfit products are: all expired pharmaceuticals; all unsealed syrups or eye drops (expired or unexpired); all cold chain damaged unexpired pharmaceuticals that should have been stored in a cold chain but were not (for example: insulin, polypeptide hormones, gamma globulins and vaccines); all bulk or loose tablets and capsules. If unexpired these should only be used when the container is still sealed, properly labelled or still within the original unbroken blister packs; all unsealed tubes of creams, ointments, etc. (expired or unexpired).

Sorted by active ingredient (special disposal needed):

controlled substances; e.g. narcotics, psychotropic substances;

anti-infective drugs;

antineoplastics;

cytotoxic-anti-cancer drugs, toxic drugs;

Antiseptics and disinfectants.

The last three groups require special consideration.

Sorted by dosage form (all other pharmaceuticals):

solids, semi-solids and powders

tablets, capsules, granules, powders for injection, mixtures, creams, lotions, gels, suppositories, etc.;

liquids

solutions, suspensions, syrups, ampoules;

aerosol canisters

including propellant-driven sprays and inhalers.

Disposal Methods

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.

Three types of landfill methods are recognized as outlined below:

Landfill for untreated unfit medicines and cosmetic products. The method is applicable to small quantities of unfit medicine and cosmetic products. It involves placing untreated waste medicine and cosmetic into an uncontrolled, non-engineered open dump. The unfit medicine and cosmetic products should be covered immediately with large quantities of other type of waste or soil/sand to prevent scavenging by unscrupulous people. Discarding of untreated unfit medicine and cosmetics into such a site is not recommended except as a last resort. They should preferably be discharged after immobilization by encapsulation or inertization. It should be noted that discarding in open uncontrolled dump with insufficient isolation from the aquifer or other watercourses can lead to pollution, with the risk of drinking water contamination in the worst cases. The disposal exercise should be done amid tight security by Police and be supervised by technical personnel. This method is applicable to solids, semi-solids, powders, medicines, waste dosage forms and cosmetics.

Engineered landfill: Such landfill has some features to protect from loss of chemicals into the aquifer. Direct deposit of medicines and cosmetics is second best to discharging immobilized unfit medicines and cosmetic products into such a landfill.

Highly engineered sanitary landfill: Properly constructed and operated landfill sites offer relative safe disposal route for unfit medicines and cosmetic products. An appropriate landfill consists of an evacuated pit isolated from watercourses and which is above water table. Once unfit medicine and cosmetic products are thrown into the pit, they are compacted and covered with soil to maintain sanitary environment. The term ‘safe sanitary landfill’ means a site that is adequately situated, constructed and managed. Limited quantities of untreated medicines and cosmetics waste in form of solids, semi-solids and powders are disposed of by this method.

Landfill for treated unfit medicines and cosmetics (medicines and cosmetics waste immobilization).Immobilization of unfit medicine and cosmetics can be done in the following ways:

Encapsulation:

In this process waste medicines and cosmetics are immobilized in a solid block within a plastic or steel drum. The drum should be cleaned before using them and they should not have contained explosive or hazardous materials previously.

The exercise starts by filling the drum to 75% of their capacity with solid and semi-solid waste medicines and cosmetics. The remaining space is filled by pouring in a medium such as cement or cement-lime mixture, plastic foam or bituminous sand. For ease and speed of filling, the drum lids should be cut open and bent back.

Once the drums are filled to 75% capacity, the mixture of lime, cement and water in the proportions 15:15: 5 (by weight) is added and drum filled to capacity.

Steel drum lids should then be bent back and sealed by seam or spot welding.

The sealed drum lids should be placed at the base of a landfill site and covered with fresh municipal solid waste.

The method is applicable to solids waste, semi-solids, powders, and liquids.

Inertization

The method involves removing the packaging materials (inner and outer container). The unfit medicines and cosmetics are then ground and a mix of water, cement and lime added to form a homogenous paste. The paste is then transported in liquid state by concrete mixer truck to a landfill site and decanted into a normal municipal waste. The paste then sets as a solid mass dispersed within the municipal solid waste.

The main tools required for the operation are a grinder or road roller to crush the medicines/cosmetics, concrete mixer, cement, lime and water.

Medicines or cosmetics waste, lime, cement and water are mixed in the following ratios by weight 65%, 15%, 15% and 5% respectively. Water can be added more than the required amount when need arises to have satisfactory liquid consistency.

The method is applicable to solids, semi-solids, powders, antineoplastics controlled drugs of that nature and cosmetics containing heavy metals (e.g. mercury).

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.

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.

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 of environmental effect.

It may be necessary prior to incineration to remove packaging materials to avoid clogging and blockage of incinerator or kiln.

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.

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 antineoplastics 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 donors for disposal.

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