The relevant legislation pertinent to medicine waste disposal is the Waste Framework Directive (WFD) (2006/12/EC). To help explain the Directive, there is a Department of Health guidance booklet entitled Environment and Sustainability Health Technical Memorandum 07-01: Safe management of healthcare waste.

More specific to the veterinary sector are the British Veterinary Association (BVA) Waste Guidelines 2008.

Veterinary surgeons are advised to start with the veterinary guidelines. If these, or the other sources of information mentioned above do not answer any queries the practice may have regarding medicine waste disposal, advice from the BVA or waste contractor should be sought.

Whole pharmaceuticals
These are made up of the following:

• Returned stock
• Out-of-date stock
• Damaged stock.

Returned stock: Client returns of unused medicines: whilst there is no legal duty to accept dispensed medicines back into the practice, there is often pressure from the client to do so. Veterinary surgeons may wish to take into consideration the practice’s standard operating procedure (SOP) for advising clients on medicine returns. It is not permissible to reuse returned medicines and there is a cost involved in their disposal. Disposal legislation is far more onerous for the veterinary practice than it is for domestic disposal. The decision to accept returned medicines will vary on an individual basis and should include consideration of refunds, social responsibility for taking the medicine out of circulation, and the practice relationship with the client. The only consistency is the inability to reuse the medicine once it is returned to the practice.

Out-of-date stock: Out-of-date medicines should always be disposed of due to the inherent danger of using out-of-date stock. This category includes all injectable medicines, 28 days after the broaching of a multidose vial.

Damaged stock: Damaged stock includes any in-transit damages or spillages and breakages. For spilled drugs, the medicine should be contained with the practice ‘spill kit’ (sand, sawdust or cat litter), swept into a container, and the content and amount estimated and recorded. The container can then be disposed of into the pharmaceutical waste bin.

Disposal
The medicines should be collected into a leak-proof storage container. It is important to ensure that solid and liquid medicines are kept separate. There have been several recorded incidences of fires started by chemical reactions within pharmaceutical waste bins. Tablets should be kept within blister packs or the original packaging. If these are not available, tablets of the same medicine should be collected into tablet envelopes or tablet pots before disposal.

The contents of the bin must be recorded and the record made available to the disposal contractor. It is good practice to create a client file on the practice management system, be that computerized or manual, for this purpose. The date, type and amount of medicine can then be recorded. Computerized practices will then automatically ‘de-stock’. A printout or photocopy of the record is then the basis of the contents list of the pharmaceutical waste bin, along with a list of any medicines returned by clients. This information is an important component of the audit.

Controlled Drugs: Controlled Drugs require additional recording and action before disposal. All Schedule 2 medicines must be effectively denatured before disposal. This applies to out-of-date whole medicines; it is not necessary to apply denaturing to residual amounts left in used vials, syringes or needles. It is permitted to open packaging and de-blister to aid denaturing. Denaturing kits are available from veterinary wholesalers. When denaturing Schedule 2 medicines, a witness must be present and sign that the procedure has been carried out. The record of disposal should be entered into the Controlled Drugs Register so that purchase, use and disposal appear in one single record. An authorized witness list is regulated by the Royal Pharmaceutical Society of Great Britain. However, for small volumes it is acceptable for a veterinary colleague to sign the witness section.

Once mixed with the denaturing agent, the waste can be deposited into the standard pharmaceutical waste bin. It needs to be recorded on the pharmaceutical waste bin list as a denatured Controlled Drug. Schedule 3, 4 and 5 Controlled Drugs are not subject to such rigour, but they still need to be denatured prior to disposal. This does not need external witnessing by an authorized person, but it is best practice to record the event witnessed by two members of the practice staff.

Cytotoxic and cytostatic drugs: This is a special category of medicines that has been introduced under the Disposal of Healthcare Waste Regulations. These medicines are deemed to be Hazardous Waste and will carry variable hazard codes. They all fall under the generic European Waste Catalogue (EWC) coding system of 18 02 07. This means that they must be segregated from all other pharmaceuticals and be disposed of by specialist contractors. The items for disposal include unused medicine, residue in used vials, contaminated syringes, needles, cannulae and contaminated protective clothing. It is important that the medicines are defined by their particular hazardous properties, which may include the following:

• H6 Toxic teratogenic
• H7 Carcinogenic
• H9 Infectious
• H10 Toxic for reproduction
• H11 Mutagenic.

The following classes of medicines should be included in this classification:

• Cancer chemotherapeutics: including vincristine, pharmarubicin, methotrexate and all similar classes of tumour toxic medicines
• Antiviral medicines: including aciclovir (Zovirax) ophthalmic ointment
• Ciclosporin medicines in any form
• Certain hormonal preparations: including prostaglandins and androgens
• (e.g. Tardak, Alizin and Mesalin).

These wastes must be segregated into purple flagged containers (i.e. the separate sharps bin should have a purple top, the separate pharmaceutical waste bin should have a purple lid or label and the yellow waste bag should be purple labelled). In addition, the EWC code and the H codes must be clearly visible. The waste needs to be consigned to a specialist contractor and a fee is payable to the Environment Agency on disposal. Such waste items should not be moved between branch surgeries, unless specific dispensation is allowed (for example, there may be a local agreement with the Environmental Agency). Carriage of cytotoxic and cytostatic waste in unlicensed vehicles is illegal.

In practical terms, it is unlikely that the volume of this type of waste will be high. It is probably sufficient for the practice to have one cytotoxic sharps bin that is used for all such needles, syringes and used vials. Out-of-date cytotoxic drugs can also be added, provided they are listed and mixing precautions are observed. Where other contaminated items are produced, e.g. giving sets, canullae, gloves, etc., these too can be disposed of via the cytotoxic sharps bin. For practices producing large volumes of such waste, e.g. oncological specialists, larger volume sharps bins could be considered. If large volumes of soft, cytotoxic contaminated waste is produced, these can be disposed via a yellow and purple striped bag.

Residue pharmaceuticals
Used vials of injectable medicines
This type of waste includes all empty multidose bottles, vaccine vials and contaminated tablet pots. These are best collected into a pharmaceutical waste bin separate from whole medicines. A detailed list is not required as these are classified as non-hazardous waste. If Hazardous Waste (e.g. cytotoxic drugs) are added, the whole bin has to be classified as Hazardous Waste and subject to rigorous (and expensive) disposal. Some contractors are now happy for residue and whole pharmaceuticals to be placed in the same bin. It is still important to ensure that details of the whole pharmaceuticals are recorded, and again hazardous and non-hazardous waste must be segregated. Items allowed in these bins include:

• Vaccines bottles
• Empty injection bottles
• Syringes.

It should be ensured that all syringes placed in the bin have been fully discharged of content. Snap-top vials should not be placed in these bins, unless they conform to the British Standard for ‘sharps’. Snap-top glass should be placed in the sharps bin.

Needles
There is some controversy surrounding the disposal of ‘sharps’. The Environment Agency have insisted that all ‘sharps’ are de facto Hazardous Waste. The BVA guidelines state this clearly. It is also Environmental Agency advice that the needle is not removed from the syringe body after use and the whole lot is disposed of as ‘sharps’. If this advice is followed, there is no need to segregate cytotoxic drugs, but the correct H codes must be applied to the bin. Larger sharps containers are available. Disposal of ‘sharps’ and syringes together will prove expensive because charges are usually calculated by volume.

Provided the practice has carried out training and a risk assessment, the separation of needle and syringe after use can be considered. The syringe can be segregated into the empty vials pharmaceutical waste bin. The needle needs to be disposed of into the proprietary sharps container. These must comply with British Standard 7320:1990. If cytotoxic/cytostatic contaminated needles are segregated, the needle can be deemed non-hazardous.

To dispose of ‘sharps’ as non-hazardous:

1. Ensure the waste contractor has facilities to transport and dispose of non-hazardous ‘sharps’. The NHS has made the decision to classify all ‘sharps’ as hazardous to avoid the segregation requirements.
2. Prepare a proper risk assessment for separating ‘sharps’ from syringes.
3. Make sure staff are properly trained.
4. Place hypodermic syringe needles in a British Standard sharps bin. The non-hazardous white-topped bin is now not available due to low demand. A yellow-topped bin is acceptable, but ensure that the hazardous transportation label (diamond symbol with a ‘6’ code with in it) has been blanked out.
5. Apply the EWC code 18 02 01 to denote the waste as ‘sharps’.
6. Ensure that there is no addition of needles contaminated with cytotoxic/cytostatic medicines.
7. Ensure that there is no contamination with H9 waste (infectious; see Hazardous Waste guidelines).

Practices are advised to make sure that their waste contractor is licensed for disposal of this type of waste.

Post script
The new waste regulations have made some traditional definitions obsolete. Waste from the practice should now be referred to as healthcare waste. Use of the words ‘clinical waste’ should be avoided as this now carries a legal definition and refers specifically to Hazardous Waste. Traditionally, pharmaceutical disposal was covered by the DOOP Regulations and such waste was called DOOP waste. It is more accurate now to refer to the waste as pharmaceutical waste as a category of healthcare waste. DOOP bins are now pharmaceutical waste bins.

Variations in legislation for Scotland
These regulations are specific to England and Wales. By and large the above information is relevant to Scotland. The key difference is the substitution of the word ‘special’ for ‘hazardous’, i.e. Scottish Special Waste is equivalent to English Hazardous Waste.

Where Scottish waste contractors are giving different advice, it is advised to seek a further opinion from the Scottish Environment Protection Agency (SEPA).