PHARM11.2016 Prepare extemporaneous medicines

Overview

This standard covers your role in preparing and making extemporaneous medicines for individual use. This involves accurately calculating the quantities of the ingredients needed, making, packing and labelling the product correctly taking account of relevant legal requirements. Your practice will be consistent with your occupational role and carried out under the regulatory, professional and ethical frameworks established in the context of current legislation. You will need to take a reflective approach to your work. You will work at all times within Standard Operating Procedures that relate to the way in which a pharmacy service is provided in your place of work. A caring and compassionate approach should be adopted in line with current healthcare guidance. Users of this standard will need to ensure that practice reflects up to date information and policies. Version No 2

Knowledge and Understanding

You will need to know and understand:

1. the Standard Operating Procedures and the importance of adhering to them at all times
2. the importance of working within the limits of your competence and authority, when to seek agreement or permission from others and when to refer on to an appropriate person
3. current health and safety legislation and how it applies to the working environment
4. legal, organisational and policy requirements relevant to your role, the role of others in your organisation and the activities being carried out
5. the relevant national and local guidelines, policies and procedures that are available and how and when they should be accessed
6. the importance of adhering to information governance policies and maintaining confidentiality when sharing information about individuals with others
7. the duty to report any acts or omissions that could be detrimental to individuals, yourself, colleagues or your employer
8. current ethical and legal requirements that govern the preparation of extemporaneous medicines
9. the principles of good manufacturing practice, including pharmaceutical quality systems and your role within that
10. chemical and physical properties of ingredients relevant to formulation and compounding
11. factors which cause deterioration of stock including:
1. environmental conditions
2. storage conditions
3. microbial contamination
12. sources of contamination and appropriate methods of prevention
13. the importance of maintaining a clean working environment
14. how to clean the preparation area and equipment, before and after use
15. the importance of personal hygiene and correct use of personal protective clothing
16. the importance of selecting the correct equipment for use
17. the importance of correctly using and maintaining equipment
18. the properties of different types of container and when to use each type
19. the safe handling and storage of hazardous material and procedures to minimise risk
20. the principles of formulae calculations, weights and measures and the importance of carrying out in process checks
21. labelling requirements and conventions
22. guidelines for the safe disposal of waste materials
23. when and why patient medication records are used
24. how to report, record and take action in response to potential and actual errors using the appropriate documentation
25. the causes and consequences of near misses and errors
26. local and/or national error reporting procedures and communication channels
27. the importance of recording, storing and retrieving information in accordance with organisational procedures

Performance Criteria

You must be able to do the following:

1. work within the relevant Standard Operating Procedures including the relevant health and safety procedures and within your own limits of competence
2. check the prescription / order to confirm it indicates clearly the product required
3. select the correct formula in respect of the prescription / order
4. confirm the preparation area and equipment are clean and ready for use
5. select and use the correct equipment for the process and the product
6. confirm that the correct documentation, raw materials, equipment and consumables are available and ready for use, before you start the preparation
7. confirm that the ingredients you select match the formula and are fit for purpose
8. take the appropriate action where there are inconsistencies, near misses or errors with the medicine or product
9. act within the limits of your authority and refer any problems to an appropriate person
10. accurately calculate and measure the ingredients to meet the formula requirements
11. ensure checks are carried out by an appropriate person on calculations and measurements
12. prepare the product according to the correct formula using the correct equipment and the correct process
13. pack and label the product correctly
14. ensure the relevant checks have been completed by the appropriate person and forward for the final accuracy check
15. clean and decontaminate all work areas using the appropriate method and equipment and remove all waste
16. complete all relevant documentation and store appropriately in accordance with legal and organisational requirements

Additional Information

This National Occupational Standard was developed by Skills for Health. This standard links with the following dimension within the NHS Knowledge and Skills Framework (October 2004): Dimension: HWB10 Products to meet health and wellbeing needs