When operating a pharmacy, the General Pharmaceutical Council (GPhC) will come and inspect you against the pharmacy standards, do you know what evidence you will need to present to demonstrate how your pharmacy adheres to the standards?
This blog is the first in a 5-part blog series which will look at each principle in turn.
An outline of the standards for each principle is available on the GPhC website. All words in Italics have been taken directly from the document hyperlinked. https://www.pharmacyregulation.org/sites/default/files/document/standards_for_registered_pharmacies_june_2018_0.pdf
This blog will focus on the standards associated with Principle one: The governance arrangements safeguard the health, safety and wellbeing of patient and the public.
The overarching purpose of this principle is to ensure that the pharmacy has arrangements in place to ensure all team members operating within the pharmacy have clearly defined roles and responsibilities. Furthermore, the management should be ensuring that the risks associated with operating a pharmacy and any additional services provided and fully assessed, controlled and managed. Finally, the management should be reviewing and evaluating their service to ensure that all team members are continuously learning from errors and an ethos of continuous improvement is established and maintained.
How do you as pharmacy, evidence this in an inspection?
There are eight standards associated with the governance principle. In this blog we will take each in turn providing examples of evidence you could present to address the standard.
Standard one: The risks associated with providing pharmacy services are identified and managed.
A detailed risk register or series of risk assessments which addresses the core business functions and any additional services provided on the premises is crucial in demonstrating that management has identified the risks associated. In conjunction with a plan of controlling the identified risks and a method of detecting new risks as they arise.
The assessment should:
- Identify the risk,
- Outline root causes,
- Indicate the potential harm,
- Risk rating,
- Outline controls implemented,
- Residual risk rating once controls are in place,
- Is the residual risk acceptable.
There are several methods for risk rating recording:
- High medium low
- Red amber green
- Number system
When assessing a risk ensure you evaluate the severity of the risk should it occur against the likelihood of the risk occurring taking into consideration how easy is it to detect the risk from occurring. the higher the severity and likelihood the more significant the risk especially when the risk is hard to detect prior to occurrence.
When assessing a business ensure continuity plans are agreed in advance to maintain the provision of your service. This will also allow you as a pharmacy owner to have processes in place for your team members to follow in the event of an incident such as flood, power cut, sickness etc.
Ideally, when you controlling the risk identified you need to reduce the likelihood of occurrence, increase the detection rate, where possible your detection methods should indicate a potential problem prior to occurrence and reduce the severity of the risk where possible. Bear in mind that sometimes the severity will not be reduced. Consideration should be given to the records which will need to be maintained to provide evidence of controlling a risk. For example: for an online prescribing service having a method to record all consultation notes and prescribing decisions will increase patient safety and decrease the risk of prescribing errors as they can be recalled for secondary review in the event of a complaint.
A proactive approach to risk should be implemented across the pharmacy. Examples of this include but not limited to:
- Assessing a prescriber’s credentials prior to use
- Eligibility questionnaires for online prescribing
- Temperature monitoring set to alarm prior to breach of temperature
- Maintaining records of temperature for future recall
- Maintaining records of reviewing recall alerts to evidence that they have been actioned appropriately
- Maintaining records of destruction to evidence destroying expired stock
- Conducting documented walk throughs of the pharmacy to highlight any concerns
- Checks on the qualifications of locum pharmacists
- Consent records when operating at a distance such as a distance selling model or online prescribing service
Communication is key here to ensure all team members actively participate in controlling risks present in your pharmacy. Team members should be aware of any implemented control methods and should be actively completing tasks that are deemed detection methods to preventing risk from occurring. Furthermore, communicating errors or abnormalities that team members detect can reduce the severity of an incident as remedial actions can be taken more quickly when reported or when a trend is identified.
Reviewing risk documentation is fundamental especially when a service changes or when implementing a new service as different risks can be present. By maintaining a regular reviewing process your risk register or assessments remain up to date and current to the risks present.
Once your risk documentation is in place you should ensure you have Standard Operating Procedures for the services you intend to provide which actively reflect your control measures documented. Word of warning, should you choose to utilise a third party template Standard Operating Procedure set ensure they have been reviewed and amended to match what you actually do. Furthermore, where you offer additional services outside the normal templates ensure that all services are covered in the Standard Operating Procedures. For example: if you intend to provide a influenza vaccination service ensure you have a Standard Operating Procedure that details the processes for carrying out a vaccination.
Standard two: the safety and quality of pharmacy services are reviewed and monitored.
Implementing a process for recording near misses, errors, incidents and complaints with a process of establishing root cause and a process of regular review to identify trends provides a crucial review of the pharmacy services provision. Management will need to ensure they are actioning any remedial actions and communicating the findings, actions and key learnings back to the team, so they are able to understand the importance of their actions and learn to prevent further occurrence.
An extension of identifying and recording deviation is utilising a prescheduled auditing process which carries out a critical evaluation of the service you are auditing. Looking for areas of non-compliance to the principles or standard operating procedures, as well as identifying improvement areas to increase the safety and quality of the services you provide. Once the audit is complete any non-conformance or improvements identified should be documented and remedial actions established and implemented. This should then be communicated to the team, so they all understand the importance of the non-conformances identified and the reasoning behind implementing the remedial actions.
Furthermore, a regular documented review of the Standard Operating Procedures identifying any amendments or missing processes should be conducted ensuring key personnel are part of the reviewing team. This should ensure that the services provided are all conducted in the same manner following the same process which is up to date.
Regular documented meetings held with the team are also a good way to illustrate ongoing monitoring and compliance. Not only does it provide a platform for staff to raise their concerns, but it allows management to relay any key learnings identified from errors or near misses. These meetings can also provide a platform to discuss incidents, Standard Operating Procedure changes, training opportunities, remedial actions implemented and risk assessment review findings etc.
Additional reviews should be carried out when the following occurs:
- Identification of a fundamental breakdown through the regular audit process
- Regulatory change which affects the service you provide
- A significant change in your provision such as increased volume or change in services provided
- A breach in data security
- Change to your premises, equipment, facilities or technology
- An incident, concern or negative feedback
- Near misses or error recording indicates a trend in non-compliance
Where the pharmacy owner is an active member of the day-to-day team it may be prudent to utilise a third-party specialist to conduct an external review to prevent complacency.
Standard three: Pharmacy services are provided by staff with clearly defined roles and clear lines of accountability.
Team members should have documented job descriptions which outline their roles within the pharmacy and their role in providing the pharmacy services provision. Furthermore, the roles should be outlined within the Standard Operating Procedures providing a clear line of accountability as well as documenting any responsibilities to a specific process. This should include what actions team members are allowed to complete when the responsible pharmacist is not present.
Team members are traditionally questioned to confirm their understanding and confirming that they have signed that they have read and understood/been trained on the Standard Operating Procedures. Therefore, when you are assessing compliance to this standard a review of training records would be crucial.
When utilising template Standard Operating Procedures ensure you know what is contained within them. There is no point having a training matrix indicating the roles within the pharmacy and the Standard Operating Procedures they are expected to have been trained in if you do not then follow what is documented. This is a clear indication that the Standard Operating Procedures are not being used correctly and your team members are not following them.
Further consideration is required if you are operating from more than one location, carrying out deliveries or utilising third parties to ensure the roles and responsibilities are clearly defined with accountability channels especially if the direct line manager is situated elsewhere. If utilising a third party ensure measures are in place for assessing that party prior to use and ongoing monitoring of their capabilities and works carried out.
Standard four: feedback and concerns about the pharmacy services and staff can be raised by individuals and organisations, and these are taken into account and action taken where appropriate.
The pharmacy must ensure they have a process in place for recording feedback, incidents and concerns raised. The process must include documenting what happened, investigating to identify the root cause and implementing control measures to prevent future occurrence. Where a patient wants to remain informed this must also be captured including a copy of what has been said or provided both verbally and in writing.
Where the incident relates directly to product quality or an adverse reaction, the pharmacy has a duty to report this to the MHRA and therefore must ensure there is a process to facilitate this and ensure it is documented correctly.
As discussed in standard two, implementing a regular meeting process to provide a platform to raise internal concerns as well as discuss external feedback and concerns. Furthermore, it will allow for management to discuss incidents, relay key learnings and implemented control measures to the team. Meetings will also allow for team members to ask questions or raise additional measures they believe are necessary to continue to carry out their roles effectively and ensure they fully understand the reasons behind implementation of new measures and the importance of their actions.
Standard five: appropriate indemnity or insurance arrangements are in place for the pharmacy services provided.
This standard is self-explanatory. As a pharmacy owner you need to ensure that the pharmacy has the correct indemnity insurance in place for all activities carried out. Therefore, if you provide additional services such as online prescribing or travel vaccination service then you will need to ensure that the insurance protects you against all services not just the traditional dispensing.
Standard six: all necessary records for the safe provision of pharmacy services are kept and maintained.
There are specific records which the legislation outlines must be maintained at the pharmacy:
- Responsible Person Register (including displaying their credentials within the pharmacy)
- Temperature records for your cold chain medicines
- Best practice to maintain temperature records for your ambient medicines too
- Emergency supply records
- Dispensing private prescription records
- Controlled drug register including orders, requisitions, returns and destruction
- Patient Medical Records (PMR)
- Unlicensed Medicines register
- Advanced and enhanced services records
- Records as recommended by your Standard Operating Procedures such as near miss register, risk assessments etc
Remember if it is not documented it didn’t happen!
Standard seven: information is managed to protect the privacy, dignity and confidentiality of patients and the public who receive pharmacy services.
The pharmacy has a duty to ensure that people’s confidential information is kept secure. Firstly, consider the placement of your dispensing area, does the area ensure that the screens and prescriptions are not overlooked by patients? You need to ensure that whilst team members are operating in the pharmacy confidential information is not inadvertently on display.
Furthermore, you should ensure that your computers and software containing confidential information is password protected. NHS card usage should be restricted to individual personnel and should not be shared.
The consultation room and any further treatment rooms should allow for private conversations which can not be overheard. Moreover, the rooms should not display other people’s information, if utilised for storage of dispensed prescriptions they should be held within a locked cabinet.
Confidential information waste should be held separately and disposed of securely to ensure data integrity is not breached.
Standard eight: children and vulnerable adults are safeguarded.
To meet this standard ensure that you have evidence of at least level two safeguarding training for key personnel. It is also recommended that you have a safeguarding procedure in place and the contact details for your local safeguarding agencies are readily available in the event they should be required. Furthermore, ensure as part of your procedure there is a process documented that outlines what information should be recorded and how it should be documented in the event a situation or concern arises. This should be communicated to all team members so they are fully aware of their roles and responsibilities. Finally, where additional services are provided the safeguarding measures need to be reflective of the service provided. A couple of scenarios representing this:
- A child attending the pharmacy for travel vaccinations as they are travelling to the parent’s home country. Has the practitioner considered Female Genital Mutilation (FGM) as grounds for travel? For traditional pharmacies this would not necessarily be a safeguarding risk to consider. However, if providing a travel service then it would become a factor that a practitioner would need to consider.
- Offering medicines at a distance as an online prescribing service. A 16 year old tries to purchase erectile disfunction medication. How do you prevent a child from purchasing medicines? Are you safeguarding that child by verifying identification? If relying solely on credit card information how do you know that it isn’t a child using an adult’s card? Moreover, what measures do you have in place to ensure the person requires the treatment?
The safeguard measures you put in place should be based upon the risks that your services present and you should ensure you are controlling them to make sure you do not inadvertently create a safeguarding problem putting a vulnerable person or child in danger as they are utilising your service deceitfully. Does your pharmacy require help to maintain compliance to principle one? Contact us to today for a no obligation quote to carry out a benchmark audit of your services.
