ES3-1 A pharmacist shall accept and dispose of unwanted drugs presented to him for disposal from a private household, a children’s home or a residential care home where the AT in whose area the pharmacy is located has in place suitable arrangements for the collection and disposal of medicines from pharmacies. ToS - 14(1)

Does the pharmacy have a Standard Operating Procedure (SOP) which covers the receipt, storage, handling (including segregating hazardous waste and incompatible products if appropriate), record keeping and disposal of unwanted drugs, including the denaturing of controlled drugs, which is signed by all relevant staff to say they have read it, understand it, and will follow it?

Note, a SOP is not required for this service, but a written SOP would assist you in meeting your obligations to operate the service safely for staff, and to protect the environment. Don’t forget, the legislation dealing with waste medicines in complex. Guidance has been issued by the Department of Health⁷. The pharmacy should have alternative arrangements in place for disposal of items that fall outside the requirements of this particular term of service.

Please download Numark’s Disposal of Waste Medicines SOP and Disposal of Unwanted CDs SOP for details on handling returned drugs. Ensure that you have denaturing kits available in your pharmacies.

Disposal of Unwanted Medicines SOP

Disposal of Unwanted Controlled Drugs

Controlled Drug Denaturing Kits

ES3-2 Store the drugs in containers provided by the AT, or by a waste disposal contractor retained by the AT, for the purpose of storing drugs of that description. ToS - 14(3)(b)

Does the pharmacy have a suitable bin or bins (where segregation is required) for unwanted medicines, which is/are stored safely?

During the monitoring visit, the AT may ask to see the storage⁸. Don’t forget, medicines held in the pharmacy for NHS dispensing purposes can be disposed of in the same bins, but they must be properly described as originating in the pharmacy on the waste disposal consignment or transfer notes. Disposal of sharps is not an essential service, so the AT does not need to provide collection arrangements for sharps – however, the AT does not expect you to accept sharps unless arrangements have been made. Please discuss sharps with the AT.

ES3-3 Comply with any other statutory requirements in respect of storing or the disposal of drugs of that description. ToS - 14(3)(c)

Do you meet other relevant regulations?

New regulations on waste exemptions were introduced on 6 April 2010. Some forms of waste storage no longer require registration with the Environment Agency (EA) and this includes ‘temporary storage at a collection point’⁹. Pharmacies should check to see if they meet the requirements of the ‘temporary storage at a collection point’ exemption. The exemption from the need to register does not affect the requirement to notify the Environment Agency that the pharmacy is a producer of hazardous waste, if the pharmacy produces more than 500kg of hazardous waste per year. Most pharmacies will produce much less than 500kg of hazardous waste, and if so, no notification is required, but if this threshold is likely to be exceeded notification is required.

Pharmacy contractors will need to register with the environment agency for T28 exemption to destroy controlled drugs

Waste Exemption

ES3-4

Do you retain in the pharmacy the consignment notes/waste transfer notes for at least three years?

During the monitoring visit, the AT may ask to see the consignment notes/waste transfer notes.

Please download Numark’s Disposal of waste medicines SOP and Disposal of unwanted controlled drugs SOP for details on handling returned drugs. Ensure that you have denaturing kits available in your pharmacies.

Disposal of Unwanted Medicines SOP

Disposal of Unwanted Controlled Drugs

Controlled Drug Denaturing Kits

ES3-5

Do you store returned medicines securely (ie so that all reasonable precautions are taken to ensure that the waste cannot escape from the waste container and members of the public are unable to gain access to the waste)?

ES3-6

How frequently are unwanted medicines collected?

The exemptions from 6 April 2010 apply to the ‘temporary’ storage of waste. The Environment Agency suggests generally that waste should not be stored for longer than three months.

ES3-7

Is the frequency of collection about right/too frequent/not frequent enough?

This information is helpful to the AT so that they can arrange collection at appropriate times so that you do not accumulate excessive amounts of waste.

ES3-8 Ensure all staff are aware of the risks associated with the handling of waste drugs and the correct procedures to be used to minimise those risks. ToS - 15(a)

Have members of staff been trained, in order to protect themselves and others from harm, and to protect the environment?

During monitoring visits the AT may ask appropriate members of staff questions to assess their understanding of the requirements.

ES3-9 Ensure that the pharmacist and any staff, have readily available and close to any place where waste drugs are stored appropriate protective equipment, including gloves, overalls and materials to deal with spillages. ToS - 15(b)

Do you have protective equipment, including gloves, overalls and materials to deal with spills?

The AT may ask to see this protective equipment during our monitoring visit.

Most spills in pharmacy tend to be small amounts of medicine. Numark advised members to have adequate cleaning and protective material to hand. Extra precautions must be taken if members are dealing with hazardous chemicals, There is a specific Numark SOP on liquid and bodily fluids spills.

Liquid and Bodily Fluids Spillage SOP

ES3-10

Do you have a controlled drug denaturing kit available?

The use of a CD denaturing kit is not mandatory, but is recommended. If you do not use a CD denaturing kit, then the AT may ask you, during the monitoring visit, to describe how you denature controlled drugs in a way that protects staff and the environment.

Members can order the CD denaturing kit via the e-shop on NumarkNet. A complete range of SOP for CD handling is available on the SOP download section.

Downloads

Controlled Drug Denaturing Kits