Uganda - Apply for Certificate of Expired Medical Disposal

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Procedure

Undoubtedly many of the pharmaceuticals save lives and alleviate suffering, but absolute pharmaceutical items if not well managed may cause problems to the public.

1. A certificate of expired medical disposal can be obtained from National Drug Authority for both Government owned and public not for profit health facilities in Uganda.
   • It is naturally expected that about 5% of pharmaceuticals in the distribution chain is bound to end up as obsolete or expired.
2. Fill up the appropriate application form as described by the National drug Authority in collaborative partnership with National Medical Stores (NMS), Joint Medical Stores (JMS) and Ministry of Health (MoH).
   • At least the applicant must be a licensed practitioner, nurse, pharmacist or other person authorized by the National Drug Authority.
   • National Drug Authority utilize the existing NMS mechanisms for collection of the obsolete items from the various Public, and Private Not for Profit (PNFP) health facilities across the country and have them incinerated.
   • Conduct an inventory of all expired medicine to be disposed off/destroyed and record the information on the application form. Register to track all expired or spoiled medicines and supplies from a health facility.Please note the following specific information/instructions should be captured.
   • Indicate the Name of the Health facility.
   • Indicate the Strength and Dosage Form of the expired medicine (e.g., 0.5 mg, tablet, capsule, liquid, and patch).
   • Indicate the Quantity or Liquid Amount.If the expired medicine is a liquid, enter the total liquid amount (e.g., 2 ml).
   • Indicate the Reason for Disposal/Destruction (e.g. undesired, discontinued, expired).
   • Indicate the Source of expired medicine (e.g., pharmacy name).
   • Health facilities/programs must include the Lot number associated with the Expire medicine or substance. Do not include patient names!
3. Inform the district authorities or Joint Medical Stores(JMS) about the expired items, especially when they come for a supervisory visit.
4. The district authorities will arrange to collect the expired item; fill out and sign a requisition and issue voucher (keep a copy for the facility).
5. At the end of a reporting period (quarterly),calculate the total value of expired stock that has expired and include this in the facility’s regular reports to the district Authorities.
6. At the District Health office they shall make an expired stock register similar to that at the health facility, but including an extra column to write the facility from which it was received.
7. The district health officer shall Record all expired stock in the register.
8. At the end of each month, HDO shall calculate the total value of expired stock for the whole district.
9. The HDO shall Arrange to hold a Board of Survey once a year in accordance with regulations for disposal of public assets.
   • The board of survey will prepare a report in triplicate.
10. The Board survey shall inform the National Drug Authority if expired stock is to be destroyed locally within the district. NDA is mandated to advise on the suitability of the destruction and supervise the process.
11. If advised otherwise the Ministry of Health will periodically collect expired medicines for safe disposal or destruction using National Medical Stores vehicles or other transporters.
12. The original inventory form of expired medicine will be returned to you when you submit the inventory form and expired medicine to the NMS trucks during the routine schedule when delivering pharmaceuticals.
    • The Obsolete Pharmaceuticals in Public Health facilities - from Health Centre II up to Regional Referral Hospitals (RRH) - and Private Not for Profit facilities (PNFPs) will be collected on return trips by NMS trucks during the routine scheduled deliveries for the viable medicines to these health facilities.
13. Submit your application form, if the request is approved, you may proceed as proposed. If the request is partially approved or denied, you will be provided with instructions on how to proceed.
14. After all the documents have been submitted, the approval form shall be signed by the District Health officer and Certificate of Medical disposal is issued by National drug Authority.

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Required Documents

1. The Name of the Health facility.
2. Strength and Dosage Form of the expired medicine
3. Total Quantity or Liquid Amount expired.
4. Reason for Disposal/Destruction the Medicine
5. The Source of expired medicine.
6. The Lot number associated with the Expire medicine or substance.
7. Document on pharmaceutical management system.
8. Document on generated Pharmaceutical waste.
9. List of expired or unused tablets.
10. The proposed method of disposal/destruction.
11. Product Destruction Form
12. Copy of permit and receipt (One copy)
13. Dossier formatted according to National drug Authority's requirements (one copy).
14. Copy of Current Certificate of Registration Retention.
15. The documents in respect of inspection - R4.
16. Comprehensive Certificate of analysis.
17. Certificate of pharmaceutical products.
18. Chemical and pharmaceutical documentation

Office Locations & Contacts

The Pharmaceutical Society of Uganda - Head Office,
Pharmacy House,
Plot 1847
Kyambogo Banda
P.O.Box 3774
Kampala Uganda
Tel: +256 414 348 796 / +256 392174280
Email: [email protected]
Email: Link

National Drug Authority - Head Office,
Plot 19 Lumumba Avenue (opposite TWED plaza)
Kampala, Uganda
P. O Box 23096,
Kampala, Uganda
Tel: +256 [0]417 788 100
Directorate of Product Safety : +256 [0]417 788 124
Directorate of Inspectorate Services : +256 [0]417 788 129
Email : [email protected]
Website :Link

Eligibility

Registered hospitals, district or regional pharmacist or organizations with pharmaceutical programmes and other public medical facilities with a valid certificate of registration and wants to dispose off /destroyed unwanted pharmaceuticals or expired drugs.

Fees

Free of Charge.

Validity

Validity: 1 Year

Documents to Use

Please attach documents that can be used by people. e.g. links

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

Maximum Processing Time: 21 Days.

Related Videos

Videos explaining the procedure or to fill the applications. 
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites. 	
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver, 
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

• Disposal/destruction must be in accordance with applicable health laws.
• The Application must include the names of two individuals who will conduct the disposal/destruction.
• Destruction of controlled substances must render them unrecoverable and beyond reclamation.
• Expired medicines may no longer be effective and may be dangerous
• Damaged or expired stock should be placed in a designated salvage area
• A written record of all stock consigned to this area should be maintained.
• Expired or damaged stock must be destroyed in accordance with local regulations

Required Information

The key information required is as follows

1. Application form for Disposal of Pharmaceutical waste.
2. Written application stating name of medical facility and name (and brand, if applicable) of product to be destroyed.
3. Completed National Drug Authority application form.
4. Certificate of Incorporation with the Corporate Affairs Commission, if a company
5. Certificate of Pharmaceutical Products (COPP) duly issued and authenticated
6. Premises Registration License from the Council of pharmaceutical society of Uganda.

Need for the Document

• To reduce Expired pharmaceuticals since they a growing concern in the country and can also result into a risk to national security. unsafe disposal of these unwanted or expired drugs often creates a major problem.

Information which might help

1. Currently, the estimated quantities of expired medicines all over the country are believed to be about 1,200 to 1,500 tons.
2. Smaller quantities of pharmaceutical waste may accumulate in the absence of emergency situations, due to inadequacies in stock management and distribution, and to lack of a routine system of disposal
3. Donated pharmaceuticals with a long shelf-life may be mismanaged, particularly in the confusion during and after armed conflict or a natural disaster. Staff and storage space may be lacking and the pharmaceutical management system in disarray. Such problems also occur when drug donations form part of development assistance.
4. Pharmaceutical waste is generated both by households and health care organisations. All unused or expired drugs, or drugs whose use is prohibited by an authority, the manufacturer, marketing authorisation holder, or registration holder are considered to be pharmaceutical waste.
5. Pharmaceuticals may arrive past or near their expiry date, may be inappropriate for the needs, be unrecognizable because they are labelled in a foreign language or may have been sent in unwanted quantities.
6. Pharmaceutical waste is always hazardous waste that can cause particular danger or harm to human health or the environment, and it must be properly disposed off. Check the contents of your medicine cabinet and dispose of pharmaceutical waste as instructed.

Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

• External Link 1
• External Link 2
• External Link 3

Others

Checking the medicine cabinet and disposing of pharmaceutical waste.

• Go through the contents of your medicine cabinet regularly and remove any expired or unused drugs.
• Tear off the instruction labels from prescription medicines to maintain your privacy.
• Remove expired or unused tablets and capsules from the carton, and place the blister, bottle or individual tablets or capsules in a transparent plastic bag and take them to a pharmacy.
• Fold used transdermal patches in half with the sticky sides together and place them in the protective pouch if you still have it.
• Return liquid medicines, creams and aerosols to a pharmacy in their original packaging. Make sure the liquid medicines do not leak.
• Keep iodine-containing drugs and mercury thermometers separated from other pharmaceutical waste when delivering them to a pharmacy.
• Return cytotoxic drugs (preparations used for treating cancer and preparations containing e.g. methotrexate) in their original package in a separate plastic bag.
• Return syringes and needles separated from pharmaceutical waste; package them in a non-puncturable plastic bottle or glass jar.
• Never put pharmaceutical waste in a mixed waste container, since that might allow children to reach it.
• Do not flush pharmaceutical waste down the drain, because if the pharmaceutical substances end up in the environment, they can affect the microbes or flora and fauna of the soil and water.
• Always return pharmaceutical waste to a pharmacy or a municipal disposal point, from where it will be delivered to a hazardous waste plant. The above instructions also apply when you return pharmaceutical waste to a municipal disposal point. Households can return pharmaceutical waste to a pharmacy free-of-charge.