Controlled drugs

The new waste regulations (Hazardous Waste Regulations, 2005) 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 Disposal Of Old Pharmaceuticals (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.

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’ thus Scottish Special Waste is equivalent to English Hazardous Waste.

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 (ACE inhibitors, some antibiotics, anabolic steroids, NSAIDs)

H7 Carcinogenic 

H9 Infectious 

H10 Toxic for reproduction 

H11 Mutagenic.

The following classes of medicines should be included in this classification – the list of drugs contains some that overlap the above categories:

Cancer chemotherapeutics: including vincristine, pharmarubicin, methotrexate and all similar classes of tumour toxic medicines (Figure 1) Antiviral medicines: including aciclovir (Zovirax) ophthalmic ointment

Figure 1: Vincristine is an example of a cancer chemotherapeutic that should be kept refrigerated during storage

Cylosporin medicines in any form (Figure 2)

Figure 2: Cylosporin is classified in the grouping of cytotoxic and cytostatic pharmaceuticals

Certain hormonal preparations: including prostaglandins and androgens, such as Tardak, Alizin and Mesalin. (Figure 3)

Figure 3: Examples of hormonal preparations

These wastes must be segregated into purple, flagged containers (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 by marking on the containers. 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 in the purchase and disposal records and noted in the risk assessments carried out by the practice; and that mixing precautions are observed.

Where other contaminated items are produced – giving sets, cannulae, gloves, for example – these too can be disposed of via the cytotoxic sharps bin. For practices such as oncological specialists, producing large volumes of such waste, a bigger sharps bin could be considered.

If large volumes of soft, cytotoxic contaminated waste are produced, these can be disposed of via a yellow and purple striped bag.

Residue pharmaceuticals and used vials

This type of waste includes all empty multi-dose 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 for instance, cytotoxic drugs) are added, the whole bin has to be classified as Hazardous Waste and subject to rigorous (and expensive) disposal. Items allowed in these bins include vaccines bottles, empty injection bottles and 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.

Destruction of Controlled Drugs

Controlled Drugs awaiting destruction should be stored separately from current stock but within the Controlled Drugs cabinet. If a client returns a Controlled Drug that the practice has dispensed, it should not be entered into the Controlled Drugs Register.

A separate book should be kept to record the return and destruction of these products. Although this is not a legal requirement, it is strongly recommended as there is a requirement to have in place a SOP detailing how medicines returned from clients should be handled.

Destruction of out-of-date Controlled Drugs must be witnessed by someone authorised by the Home Office, such as a local police officer. An entry must be made in the Controlled Drugs Register detailing the items destroyed and the running total updated. This entry must be signed by the authorised witness.

Method of Controlled Drug Destruction

Wear gloves

Use a denaturing kit where possible (Figure 4)

Figure 4: Example of a denaturing kit

Crush solid dosage forms in a mortar and pestle and add to the denaturing kit Pour in liquids

Add parenteral preparations, open ampoules and empty into denaturing kit, and remove medicines from vials Fold any transdermal patches in on themselves

Fill denaturing kit with water and store in the Controlled Drugs cupboard for 24 hours until denaturing is complete Incinerate with other pharmaceutical waste.

Medicine waste disposal

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 these veterinary guidelines.

Whole pharmaceuticals

These are made up of returned stock, out- of-date stock and damaged stock.

Returned stock

With respect to 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 re-use 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 attitude of the client.

The only consistency is the inability to re-use the medicine once it is returned tothepractice.

Out-of-date stock

Out-of-date medicines should always be disposed of owing to the inherent danger of using such time compromised stock. This category includes all injectable medicines, 28 days after the broaching of a multi-dose vial or bottle.

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 via the pharmaceutical waste bin.

Disposal and audit

The medicines should be collected into a leak-proof storage container. It is important to ensure that solid and liquid medicines are kept separate.

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 dispaaal.

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 computerised or manual – for this purpose. The date, type and amount of medicine can then be recorded. Computerised practices will then automatically ‘de-stock’; and a print-out or photocopy of the record can form 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 any pharmacy audit, during which premises will be inspected to ensure that:

Schedule 2 Controlled Drugs are kept in a secure lockable and immoveable container, which can only be opened by a veterinary surgeon or a person authorised by them a Register is kept of the receipt, use and supply of specified categories of Controlled Drugs. This Register may be computerised, but if so, the system must be secure an informal Register of ketamine use is kept. Again, this can be computerised, if secure.

Author

Amanda Rock bvsc mrcvs pgce

Amanda graduated from Liverpool University in 1998 and has since worked as a veterinary surgeon in Cornwall, first in mixed practice and later in critical care and emergency work. She enjoys writing for the veterinary press and has contributed to several nursing textbooks.

Nicola Ackerman

BSc(Hons) RVN CertSAN MBVNA

Nicola works as the senior medical nurse at The Veterinary Hospital in Plymouth. Nicola graduated from Hartpury College with an honours degree in Equine Science, and subsequently qualified as a veterinary nurse. Nicola is past officer of the BVNA, but now is the vice-chair of The Pet Obesity Taskforce, and sits on the VMD's appraisal panel for suspected human adverse reactions.

Veterinary Nursing Journal • VOL 25 • No7 • July 2010 •