A standard operating procedure (SOP) is a written document describing routine procedures carried out in veterinary practice. They should be:
- Provided for all staff members
- Regularly reviewed
- Designed according to practice policy.
Use of SOPs may be taken, along with relevant training and continuing professional development (CPD), as sufficient evidence that staff are regarded as ‘competent’ under the requirements of the Veterinary Medicines Regulations (VMR).
Benefits of implementing SOPs include:
- Assures of the quality of the service
- Ensures the achievement of good practice
- Enables veterinary surgeons to delegate and so free time up for other duties
- Avoids confusion over who does what
- Provides advice and guidance to locums and part-time staff
- Provides a useful tool for training new staff members
- Contributes to the audit process
- Provides financial benefits
- Most importantly, SOPs protect staff and clients.
How to write a standard operating procedure:
1. Decide the purpose, e.g. how to receive a drug from a wholesaler.
2. Decide on the author. This should be someone who performs the task regularly.
3. Draft the content. Various styles can be used such as bullet points, flow charts or detailed information. There should be logical steps that are easy to read and understand.
4. Consult others. Ideally, input from someone new to the task should be sought to ensure the information is clear and detailed enough, and someone who knows the task well in case anything has been missed.
5. Once the final draft is complete, the SOP should be put into circulation. It may be useful to ask staff to sign to say that they have read and understood the document.
6. SOPs should be reviewed regularly.
Some examples of SOPs are shown below. These examples are illustrative and should be adapted according to practice policy.
Waste medicines returned by clients
1. Greet the client and ask if there are any ‘sharps’ (i.e. hypodermic needles or syringes) or Controlled Drugs in the returned waste. Carefully accept the returned waste from the client, holding the bag by the handles (if it has any) to avoid potential needle stick injuries.
2. Remove any Schedule 2 and 3 Controlled Drugs from the returned waste immediately and store in the Controlled Drugs cupboard, clearly separated from other stock until they are denatured.
3. Place the remaining waste in a designated area for sorting at a suitable time. The designated area must be chosen to prevent contamination or mixing with dispensary stock (e.g. stock room bench).
4. Put on protective clothing before handling.
5. Tip out the contents of the bag into a returns tray in the waste designated area – this avoids contact with cytotoxic/cytostatic substances or ‘sharps’.
6. Labels with patient details must be removed from containers and disposed of as confidential waste. Remove blister strips from the outer carton. To comply with waste regulations, do not remove medication from blisters or decant from containers (except Controlled Drugs).
7. Store the waste in a secure location and then wash your hands. Do not store waste in excess of 5 m3 or for longer than 6 months.
8. After waste collection, file the collection dockets issued by the waste contractor and retain for 5 years.
9. A summary consignment note listing all the collections made in the past 3 months will be sent to the practice by the contractor. This should be filed and retained for 5 years and may be audited by the Environment Agency (Scottish Environment Protection Agency (SEPA) and Animal Health in Scotland) at any time or at the annual notification of waste collection.
Using ampoules
1. Injectable drugs should be treated as intended for single-use only, unless the label specifically indicates that they are authorized and intended for use on more than one occasion. When a dose is decided upon, choose the closest volume ampoule for dispensing.
2. Draw up the correct volume and empty the remainder of the ampoule into a ‘sharps’ bin. If it is a Controlled Drug, this must be witnessed.
3. Place the empty ampoule in the ‘sharps’ bin.
4. If the medicine is a Schedule 2 Controlled Drug, a record must be made in the Controlled Drugs Register. Note the amount used and the amount discarded, for example if 0.5 ml was used from a 1 ml ampoule, the register should read ‘0.5 ml given and 0.5 ml wasted.’
5. Label the sharps bin as ‘mixed pharmaceutical waste and sharps – for incineration’ when it is sent for destruction.
Date-checking the dispensary
1. Develop practice-specific date-checking matrices.
2. Take care to include all dispensary stock on the matrices, e.g. fridge, liquids, Controlled Drugs and injectables. Ideally distribute the workload evenly by dividing the dispensary into equal parts on the matrix and planning throughout the month.
3. Date-check all dispensary stock every 3 months, following the date-checking matrices. Ideally, each area should be date-checked regularly by the same team member.
4. As each area is date-checked, move the stock with the shortest expiry date to the front and the stock with the longest expiry date to the back of the shelf. Identify stock with <4 months shelf-life and record short-dated items in a book used for this purpose. Highlight short-dated stock with short-dated stickers.
5. Remove stock within 1 month of the expiry date. Place this stock in a location, differentiated from normal stock, clearly marked ‘out-of-date’ stock, whilst the rest of the date-checking is completed.
6. Record quantities and values of out-of-date medicines for accounts purposes and the annual audit, and dispose of this stock appropriately in a yellow pharmaceutical waste bin.
7. Record completion of date-checking of each area on the matrices by initialling and writing the date of completion in the relevant box. Every 4 weeks, check the short-dated stock book and remove any stock that is within 1 month of its expiry date.
8. Retain matrices for 6 months. The matrices must be available for inspection by authorized persons.
Receiving a Schedule 2 or 3 Controlled Drug
1. Check that any packages received are intact and not damaged. If the stock received is damaged or incorrect, notify the supplier immediately.
2. Immediately open the package(s) containing the Controlled Drug(s) and check the stock received against the invoice and delivery note or the request made to another pharmacy. Check the product name, strength, dosage form, pack size, expiry date and that the manufacturer’s tamper-evident seal is intact.
3. If the medicine received is a Schedule 2 Controlled Drug, record the amount received in the relevant section of the Controlled Drugs Register. Make a manual count of the stock received and any stock already held to ensure that the resulting balance is correct. If there is any discrepancy, notify the person in charge. If the Controlled Drug is damaged or irretrievable, a veterinary surgeon should make a footnote to indicate this and ask a second person to sign the record to confirm that the stock was received in this condition.
4. Store all Schedule 2 and 3 Controlled Drugs requiring safe custody in the Controlled Drugs cupboard. Damaged stock should be stored in the Controlled Drugs cupboard, in a sealed bag, clearly marked as ‘Damaged Stock’.
5. When any damaged/incorrect stock is returned to the supplier, ensure records of the return are made in the Controlled Drugs Register.
6. It is good practice to keep invoices for all Controlled Drugs for 5 years.
Placing an order with a wholesaler
The stock order should be placed by a competent member of staff with the authorization of the veterinary surgeon.
Disposing of out-of-date Controlled Drugs
1. Identify any Schedule 2 and 3 Controlled Drugs that have been returned by a client or that are obsolete, expired or unwanted.
2. Record the details of any Schedule 2 Controlled Drugs returned by the client in the client returns register. This information should include: the date of return of the Controlled Drugs; name, quantity, strength and form of the Controlled Drugs; the role of the person who returned the Controlled Drugs (if known); name and signature of the person in the practice who received the Controlled Drugs; and owner’s name and address and animal name (if known). This is a legal requirement.
3. If it is not possible to denature them immediately, store the Controlled Drugs in a sealed bag, clearly marked as ‘Patient Returns – Not for Use’ or ‘Out-of-Date Stock – Not For Use’ and lock the bag in the Controlled Drugs cupboard.
4. Make sure that an authorized person is present to witness the destruction of the Controlled Drugs (this can be the veterinary surgeon for patient returns. For stock Controlled Drugs, the witness must be either a member of the Animal Medicines Inspectorate, an inspector of the RCVS Practice Standards Scheme, a veterinary surgeon who is independent of the practice, or a police officer (such as a Controlled Drugs Liaison Officer – a list can be found at www.vmd.gov.uk/VetSQP/pcdl_officers.pdf).
5. Put on gloves, apron and goggles if required.
6. Denature the Controlled Drugs by crushing in a tablet crusher or mortal and pestle.
7. Place the denatured Controlled Drugs in to the Controlled Drugs denaturing kit or waste container.
8. Update the records with details of any client-returned Schedule 2 Controlled Drugs that have been destroyed: the name, position and signature of the person who destroyed the drugs and the witness, and the date of destruction, should be added to the record. The information recorded should include: the drug name, form and strength; quantity being destroyed; date of destruction; signature of the authorized person and the signature of the witness.
9. Record the destruction of any stock Schedule 2 Controlled Drugs (i.e. non-client returns) in the relevant section of the Controlled Drugs Register. All stock of the Schedule 2 Controlled Drug in question must be counted manually to ensure that the amount of stock held corresponds to the balance in the stock record.
10. Store the waste in a secure location and then wash your hands. Do not store waste in quantities in excess of 5 m3 or for longer than 6 months.
11. After waste collection, file the collection dockets issued by the waste contractor and retain for 5 years. A summary consignment note listing all the collections made in the past 3 months will be sent to the practice. This should be filed and retained for 5 years and may be audited by the Environment Agency (SEPA and Animal Health in Scotland) at any time or at the annual notification of waste collection.
Hazardous Waste spillages
All members of staff should be aware of where the spillage clean up kit is stored.
Handling medicines
Members of staff must:
- Treat all medicinal products as potentially harmful; direct contact with and inhaling dust or vapours should be avoided
- Be aware of the hazards associated with the medicines to be handled and the safety measures required to minimize any risks to health; staff must know the results of the Control of Substances Hazardous to Health (COSHH) and risk assessments
- Wear disposable gloves when handling any open or loose products
- Use additional protective clothing and equipment as and when specified in the practice rules, other SOPs or medicine safety data
- Be familiar with the type, position and operation of safety equipment (e.g. fire extinguishers, spillage kits, eye wash and first aid kits)
- Deal with any accidental spillage of medicines immediately and refer to the medicine safety datasheets or seek advice from the health and safety officer
- Inform a senior member of staff in the event of any accident
- Inform the health and safety officer if they are or expect to become pregnant, or if they suffer from asthma or any known allergy or any condition that they consider may put them at increased risk
- Inform the health and safety officer if they experience any adverse effects thought to be caused or made worse by the handling of/and exposure to veterinary medicine products (VMPs)
- Wash their hands after handling medicines, even if disposable gloves have been worn.
Members of staff must not:
- Eat, drink or smoke in the medicines handling or storage areas
- Take medicines from the storage area for their own use or make such medicines available to other persons
- Handle any medicine unless they are familiar with the relevant safety data and know the hazards, safety precautions and spillage procedures, and the first aid requirements if exposed
- Handle any medicine if they know or think that to do so will put them at risk
- Handle either cytotoxic medicines or Controlled Drugs unless as a veterinary surgeon or pharmacist, or on the instructions of a veterinary surgeon or pharmacist.