Expiry Drugs Removal and Handling and Disposal.

Compiled by Alok  Bains

Expired medicines are not suitable for consumption. Their disposal should be safe and in an environmentally friendly manner. Their disposal is regulated by the government regulations at the central level, state level and local levels. In India, following regulatory authorities regulate the removal, handling and disposal of expired medicines.

1. State Drug Control Department regulates it as per provisions mentioned in the Drug and Cosmetic Act and Rules. It states Drugs shall not be stocked or sold after the expiry date mentioned on the label of drugs. These drugs can be stocked if proper steps have been taken to withdraw these drugs by the manufacturers for their proper disposal. But it shall be stored separately from the trade stock. Expired drugs shall be kept in a package/cartoon with prominent words “Not of sale” on the package/cartoon.

2. Hazardous and Other Waste (Management & Transboundary) Rules 2016 framed by Central Pollution Control Board. Schedule I of this rule put the Production/formulation of drugs/pharmaceutical and health care product with expiry dates under the list of hazardous processes generating hazardous waste. It regulates the removal, handling and disposal of these products by its own regulations. This rule states that bio-medical wastes covered under the Bio-Medical Wastes (Management and Handling) Rules, 1998 are not covered under this Act;

3. Biomedical Waste Management Rules 2016 Notification of Government of India, Ministry of Environment, Forest and Climate Change. It states hazardous chemicals covered under the Manufacture, Storage and Import of Hazardous Chemicals Rules, 1989 are not covered under this Act.

   This act has divided biomedical waste into different categories through colour coding. It puts Discarded or Expired Medicine like antibiotics, cytotoxic drugs and includes all items contaminated with cytotoxic drugs along with glass or plastic ampoules, vials etc under yellow categories.

4. World Health Organization and US FDA also suggest methods for removal, handling and disposal of expired medicines. They suggest the following for removal handling and disposal of expired drugs: Return to the manufacturer, landfill, immobilization by encapsulation, immobilization by inertization, sewer disposal, burning in open, medium-temperature incineration, Novel high-temperature incineration and chemical decomposition depending upon the type of the medicines.

Below is the summary to be opted by the pharmacy for the safe disposal of medicines by protecting human health and without violating government regulations.

Medicines are not suitable for the landfill, or to be poured down into the sink, or flushed down into the toilet. High-temperature incineration is the best method to dispose of unused expired medicines.

Biomedical Waste Management Rules 2016 Notification of the Government of India clearly states to use incineration method to dispose of expired drugs like antibiotics, cytotoxic drugs including all items contaminated with cytotoxic drugs along with glass or plastic ampoules, vials at a temperature of more than 1200 degrees C.

Following steps shall be followed to remove, handle and dispose of expired drugs.

1. Identification: Pharmacists shall be responsible to trace expired drugs and maintain their records with the following information:

   • Name of the drug (Generic/Brand),

   • Dosage form,

   • Strength,

   • Batch number,

   • Expiry date,

   • Total quantity,

   • Name of the department from received and

   • Name of the manufacturer.

2. Segregation: Expired drugs are segregated as per their disposal methods.

3. Storage: Segregated expired drugs are stored in a leak-proof, puncture-resistant appropriate container labelled as “expired drug” preferably in a separate room earmarked for this purpose or in a separate cupboard with a board “Expired drugs not for use”. The room or cupboard shall be under the supervision of the pharmacist in charge.

4. Information: The pharmacist shall send a list of expired drugs to the manufacturer, or distributor or hospital biomedical waste in charge for their safe transportation and disposal.

5. Transportation: Expired drugs shall be transported through authorized transporters following the rules of the state pollution control board and central pollution control board. All expired drugs shall be transported in a leak-proof, puncture-resistant appropriate container labelled as “expired drug” and properly sealed as per rules of biomedical waste management rules.

6. Disposal: Competent authority shall dispose of the expired medicines by any one of the following methods depending upon the type of medicines.

   • Landfill: It is the oldest and most widely practised method. Expired drugs are directly placed into land disposal sites without prior treatment. This method is not in use.

   • Waste immobilization: Encapsulation: Fill expired drugs into plastic or steel drum to occupy 75% of drum space. Place a mixture of lime, cement and water in a ratio of 15:15:5 to fill the full capacity of the drum. Seal it by welding. Place it at the base of the landfill and cover it with municipal solid waste. Encapsulation of antineoplastic agents is done by incineration in the double chamber at a temperature not less than 1200 degrees C. The secondary chamber ensures complete incarnation without the release of degraded components in the atmosphere.

   • Waste immobilization : Inertization: Inertization is the removal of drugs from their packaging materials, their grounding and mixing with the water, cement and lime to form a homogeneous paste. Transport them to landfill areas and disperse them with municipal solid waste. The ratio of the expired drug: lime: cement: water is 65: 15:15:5.

   • Sewer: Liquid expired medicines like syrup, IV fluids, etc are diluted and flushed into sewers in small quantities by using the fast flow of water current.

   • Burning in open containers: Burning medicines in open containers at low temperature develops toxic materials in the air.

   • Medium temperature incarnation: In emergency conditions, expired drugs are burnt at a temperature not less than 850 degrees C in a two-chamber incinerator. Pharmaceutical waste should be diluted with large amounts of municipal waste (1:1000)

   • Novel high-temperature incineration: Furnaces such as coal-fired thermal power or foundries work at 850 degrees C. During this burning furnace cement material temperature increases up to 1450 degrees C while combustion gas temperature up to 2000 degrees C. At this temperature, all organic chemicals decompose perfectly. Halogenated compounds, X-ray contrast media, povidone-iodine, etc are disposed of by this technique.

   • Chemical decomposition: This method is used in the absence of an incinerator. It is a tedious and time-consuming method. and require chemical expertise. It is not suitable for large quantity medicines such as 50 kg or more. Even small quantity needs to be treated repeatedly.

     Compiled by Alok Bains