How to set up an online pharmacy? – Online Prescribing

How long does it take to start a distance selling pharmacy?

Mike Bereza — Wed, 10 Aug 2022 00:59:55 +0000

The quickest it can be done is around 3 months. However, this fully depends on the bottlenecks of the process.

The first thing that needs to be decided is whether you want to operate an NHS pharmacy or a Private Pharmacy. If you choose to do both this could take more time. The simplest form of a pharmacy in the UK is a Private Pharmacy however, this is limited in that it cannot receive or dispense NHS commissioned prescriptions. A private pharmacy can only receive private prescriptions from doctors working within the private sector.

The quickest way to start a pharmacy in the UK

Apply to the UK pharmacy regulator (the GPhC) via this link.
In order to be accepted the application must include the details of a selected director representative and a superintendent pharmacist. If you need to find the latter please contact us.
Within the application there are specific questions which need to be answered concerning the clinical governance of the business, questions to expect include: whether you will be selling P medicines, whether you will be preparing unlicensed medicines or whether you will be prescribing online via the pharmacy website.
Once these questions are sufficiently answered, the application is sent off to the GPhC to make a determination, this is the main bottleneck of this process and often takes 2-4 weeks to reply.
A typical initial response from the GPhC often includes a request for Pharmacy Standard Operating Procedures (SOPs) for instance for Pharmacy Cyber Security or an online prescribing risk matrix.
Once these have been submitted, the GPhC will schedule an inspection which may be physical or online.
Once the inspection has successfully been passed a Pharmacy Notice of Entry is granted (see below) which highlights the fact that “Under the Pharmacy Order 2010 your pharmacy’s entry in the register is valid for one calendar year from the date of entry“.

Pharmacy Notice of Entry

How to set up a distance selling pharmacy in the UK.

Mike Bereza — Mon, 13 Jul 2020 05:45:26 +0000

5 Steps to owning your own pharmacy.

In the UK, a business which can dispense Prescription Only Medicines (POMs) against a prescription is termed a ‘Pharmacy‘ and must be registered with the General Pharmaceutical Council (GPhC), the UK pharmacy regulator. “Pharmacy” is considered a protected title by the UK government, meaning using the title in regards to a business without registration can result in prosecution by the GPhC for “risk to public safety“. It is often prohibitively expensive to purchase an existing pharmacy as prices can range between £50,000 and £1,000,000+, entrepreneurs often find it easier to start one from scratch with the guidance of experienced veterans in the industry. This article has been created for business people looking to start an online pharmacy and acquire the ability to dispense POMs against a legal prescription.

How to set up an online pharmacy?

On average (we have dealt with over 1,000 applications), it takes 3 months to start an online pharmacy. The most important thing to understand is that there are two kinds of pharmacies in the UK, one which has been awarded a contract to serve the NHS and one which has not. Put simply:

An NHS-contracted pharmacy must abide by stipulations of both the Regulator, the GPhC (via the 5 principles) and the NHS via the Community Pharmacy Contractual Framework. Whereas a private online pharmacy, only needs to meet the requirements of the GPhC.

The next stage after deciding whether to pursue an NHS or Private Pharmacy is that you will then need to choose whether you want to have a presence on the high street or not. The following decision matrix can help you make this decision:

NHS contracted pharmacy – this is the most common type of pharmacy you find in the UK. and includes the common high street pharmacies such as Boots, Llyods or Well. These pharmacies are contracted by the NHS to enable the UK public to hand the pharmacist a standard green FP10 prescription which was obtained from their NHS GP and receive the dispensed medicine at the standard NHS prescription charge which currently is £9.15.
Private Pharmacy – are less common in the UK as the majority of healthcare provision is by an NHS-commissioned GP and Pharmacist. However, in recent years due to the lack of funding of the NHS, there has been an increase in the number of private prescribers and private pharmacies offering services to patients who are willing to pay for more convenient medicine.
Easiest route – is to follow the right-hand path of the image to the left. i.e. dispense only private prescriptions via a distance-selling pharmacy.

Stage 1: Create or use an existing Companies House registered entity.

You do not need to be a pharmacist to start an online pharmacy (termed Distance Selling Pharmacy by the GPhC) in the UK. The essentials of the GPhC application process entail that you simply require to be a director of a Limited company / NHS trust / sole trader / partnership and be associated with a pharmacist who will represent your business as a “Superintendent“. By far the easiest mechanism to achieve this is to register a new limited company and contract the use of a remote Superintendent. A Superintendent is a special class of pharmacist who has at least 3 years of pharmacy experience and is not a superintendent of any other organisation.

Stage 2: Find a suitable location.

Once the fundamentals of the Companies House entity have been established, the next stage is finding a suitable location, this can be broken down into four distinct stages:

A great way to get a head start would be to open a pharmacy within a GPs centre, i.e. make a jeweller next to a gold mine, however, this has been explicitly excluded by GPhC stipulation. The site should not be next door or in the vicinity of any other Primary Care setting (GP Surgery, another pharmacy).

Stage 3: Making the GPhC application.

If you are making an application for an NHS Distance Selling Pharmacy this is initially done on a local level, you will need to find what local health authority your pharmacy will be under by consulting a list of local Clinical Commissioning Groups (CCG). Once you know which CCG you will be applying to you will need to contact NHS England to get their contact details via their website.

If you intend to register a private distance-selling pharmacy, you can bypass this first step and make an application directly to the GPhC using this form. Filling out this application form is simple up until section 5 where you have to give examples of how you intend to meet the GPhC’s five principles, we have created an automatic distance-selling pharmacy compliance tool you can use to check these points. Applicants often get stuck when they are asked for the following:

Feedback and your complaints systems – the GPhC require all pharmacies to have a system in place which allows patients using the service to complain about the service.
Standard Operating Procedures – this is usually required by the GPhC for submission ensuring that the pharmacy has sufficient clinical safeguards to ensure the safe dispensing of medicines.
Online prescribing – this is a relatively new development in online pharmacy service provision. Because pharmacies in the UK are CQC-exempt, they may employ prescribers to prescribe medicines online. However, specific clinical governance requirements first must be met. These must include systems to ensure the safe management of:
- Antimicrobial or antibiotic medicines
- Medicines that are liable to abuse, overuse or misuse
- Medicines that need to be monitored or managed

Stage 4: Making the MHRA Application

Due to Brexit in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has temporarily decided to not make this step mandatory, you can read their full release here. We have included some information about what the requirements were previous to 2021 as it is likely that they will be reinstated at some point in a different form. Pre-2021 a new DSP would have had to pay the MHRA ≈£200 to ask them permission to use your GPhC license to offer medicines online. Once the application was complete the MHRA would have given the online pharmacy an additional logo with a hyperlink to their verified online pharmacy register.

Optional Stage 5: NHS Contract Application

Before a registered pharmacy can dispense prescriptions issued under the National Health Service, it must be included in the pharmaceutical list relating to a Health and Wellbeing Board Area, maintained by NHS England (administered by the local team). Applications to join this list can be submitted to NHS England via their Primary Care Support England (PSCE) website.

Within the NHS Distance Selling Application, you will be required to submit the following details:

Opening hours – you will need to specify within what hours the service will be provided.
What Advanced & Enhanced Services you will offer – will you offer smoking cessation? Needle exchange?
Health and Wellbeing Board needs assessment – is there a need in the area?
Pharmacist Declarations – you will need a pharmacist on board.

Online Pharmacy Issues

Once you have set up correctly and are up and running there are a few other attributes to your business you should consider. One is how does an online pharmacy check a patient’s identity will you do this in-house or use a third party, another is how to mitigate the medico-legal risks of online prescribing. For further information, we have made a list of the most common online pharmacy issues.

Conclusion

Overall, each application to the GPhC costs ≈£750. We provide a wide range of consultancy services to help you get online prescribing and dispensing to Best Practice in no time, get in contact with one of our consultants today.

GPhC Inspection Open Data Analysis

Mike Bereza — Sun, 10 Nov 2019 17:28:43 +0000

The GPhC is now following suit with the CQC and openly publishing inspection data on https://inspections.pharmacyregulation.org/.

It makes for a fascinating read why certain pharmacies do not meet the standards required by the regulator. As there is a lot of data (see below) we have amalgamated the “Standards Not Met” section of the reports. Standards Not Met are those pharmacies which have been found at fault and have been requested to submit a plan to remedy the lack in standards.

In order, the categories which were found to be lacking the most by the GPhC inspectorate:

Governance (42.3%)
Premises suitability (13.9)
Staff and Training (16.6%)
Service Quality (25.7%)
Health and Safety (3.9%)

We have analysed the wording in all published reports from the GPhC and compiled the following word cloud.

Below are the current anonymised Standards Not Met listed on the GPhC website.

1.6

The pharmacy doesn’t keep all the records it needs to by law.

All relevant team members to be retrained on the CD SOPs and also the requirements for CD register entries. Including a re-evaluation of team members competence.

All relevant team members to be retrained on the company “Specials” process and the recording requirements Team to bring the private prescription register up to date and then maintain as per company policy. Training to be provided on NUMSAS and the requirements of records to be made to all appropriate team members. Further training to be provided on the requirements for entries being made in the private prescription book, to include Private prescriptions, Emergency supplies and NUMSAS.

1.5

The pharmacy does not have appropriate indemnity insurance in place.

Currently in discussion with insurance companies to determine best option to obtain appropriate indemnity insurance cover for the pharmacy.

1.7	The pharmacy does not always protect people’s personal information properly. This could result in this information being disclosed.	We have had staff meetings about confidentiality. About going over the sops and protecting patients personal information. we have also made sure that there is a shredder on premises so that all identifiable information can be removed accordingly. Confidential waste and disposal has been highlighted and managed.
2.2	A team member is doing tasks that they are not trained in or qualified for.	The team member has been assigned new duties within the shopfloor and has read the sops and signed them accordingly.
4.3	The pharmacy does not always keep prescription only medication securely.	We have removed all patient returns and any medicines that are not secure. We have moved them into our rooms

1.1	The pharmacy does not identify and manage its risks, such as organisation, storage conditions and management of medicines, appropriately. It cannot show that its written procedures are reviewed regularly. Or that team members are familiar with them.	Have bought and starting to implement new set of standard operating procedures which all the relevant staff will need to read and sign. Health & Safety Folder bought which includes risk assessment – which will now be completed on a monthly basis. Floors and areas are to be kept clean and clutter free from now.
1.2	The pharmacy cannot show how it records and learns from dispensing mistakes.	Created Near miss logs and near miss summary forms which are to be stored in Current Operations Folder – To be regularly reviewed to minimise errors and learn from mistakes. Staff involved and others to be notified of near miss and errors and sign document to show confirmation and actions implemented, for example amitriptyline different strengths but same packaging have been separated with a divider.
1.3	Some members of the team are not clear about what they can or can’t do in the absence of the responsible pharmacist.	Responsible pharmacist SOP has been shown to all and list of dos and don’ts have been printed and left near the tills as a reminder.
1.7	The pharmacy doesn’t always manage or dispose of people’s private information properly.	A shredding time has been made available twice during the day. Allocated baskets labelled confidential waste are to be kept out of patient view and shredded in the afternoon and at close of business.
2.1	The pharmacy does not have enough staff for its services.	We have decided to place an advert in the window to see if we can recruit – if we do not have any luck we will have to place adverts online.
2.2	Some team members haven’t done the right training for the tasks they do. Such as selling pharmacy only medicines.	Appraisals will begin as have invested in a HR support folder and from there will identify individual staff needs and place them on appropriate courses. All staff on the counter and selling medicines will be signed up to the appropriate course – contacted YJ at Avicenna
3.1	The pharmacy is disorganised and cluttered. And this could increase risks to people’s safety.	Re-organisation of dispensary and work flow has been looked at and new motto of clean and clutter free to help minimise risks.
4.2	The pharmacy doesn’t always provide its services safely. It doesn’t always label multi-compartment compliance aids when they are assembled. Or store them appropriately. It doesn’t always provide the extra information people taking higher-risk medicines need to take them safely.	Risk assessment to be completed taken from Health and safety folder. Re-educated all staff of labelling multi-compartment compliance aids and the safe storage of compliance aids to minimise mixing and risk to the patient. Staff aware that extra information needs to be provided to those people taking higher risk medicines even if they are on them regularly.
4.3	The pharmacy doesn’t always store medicines securely or appropriately. And it doesn’t remove date-expired medicines promptly. It doesn’t always record the fridge temperatures regularly. This makes it harder to show that the medicines inside are still safe for people to use.	New forms have now been created and to be used stored in Current Operations and then historically in another new folder termed Clinical Governance. Shelves are being cleaned and re-organised. I have ordered stickers from NPA e.g. Fridge and CD. New date checking forms have also been created and implementation begun.

4.2

The pharmacy does not fully manage the risks associated with the multi-compartment compliance aid services.

Prescriptions will be ordered one week before compliance aids are due to be collected. To help aid this process, we will implement a notification grid for all multi-compartment compliance aid patients indicating collection dates and next due dates.
Information leaflets will be provided for all medicines dispensed in compliance aids at each point of dispensing. Pharmacy labels on compliance aids will include advisory warnings and free type labels will be avoided. A drop sheet for each compliance aid patient will be created. This will include information regarding medicines that are kept inside and outside the tray. The dosing frequency of each medicine will be noted. The drop sheet will be kept up to date and adjusted based on communication from prescribers. Dose changes and drugs added or stopped will be recorded on this drop sheet with a date indicating when this change occurred. This change will be initialled by the member of staff making note of the change.Medicines that are used in the preparation of the compliance aid will be stored appropriately. If pressed out of blister, tablets and capsules that are not being used immediately will be kept in bottles with CRC lids or caps with name of medicine, batch number and expiry date clearly marked on the bottle

3.2

The confidentiality of people who receive pharmacy services is not fully maintained.

The pharmacy as a whole will be cleaned, dusted and tidied up.
A curtain is being fitted to close off the assembled prescription area from any patient walking past to go into the consultation area.

5.2

The pharmacy’s monitor used for the stop smoking service isn’t checked (calibrated) regularly as required.

The pharmacy has contacted the local CCG and arranged to pick up a new device which will no longer need calibrating. This was done on Monday 8 July 2019. Since the inspection, the service has been suspended and will recommence for clients once the correct equipment is in place.

2.2

Some members of the pharmacy team carry out tasks they aren’t appropriately trained to do.

The counter assistant will be enrolled upon an accredited training programme relevant to their role within the pharmacy.

3.3	The premises are not maintained to an appropriate level of hygiene for some of the services provided.	The pharmacists have agreed with the management to produce a cleaning rota and have delegated named staff and provided allocated time to clean the premise specifically the floor, workspace, shelves and equipment.
4.3	The pharmacy does not always keep prescription only medication securely. And the temperature probe for the fridge is not working.	Medicines will be stored securely and in accordance with the relevant legislation. Fridge Thermometer: The thermometer has been repaired as the battery became loose and now it has been secured and is working correctly.

1.7	The pharmacy doesn’t protect people’s personal information properly, which could mean that unauthorised people could access it.	A new shredder is to be purchased as well as a re-education to staff on how to dispose of confidential information. A key for the consultation room is to be located. Staff to read confidentiality procedures again. Any dispensed bags of medicines to be securely packed away.
2.2	Team members have not all completed or been registered on the required accredited training courses. This could mean that they do not have the knowledge and skills they need to undertake their tasks safely.	To enrol staff on accredited training course. Staff on existing training courses encouraged to complete courses in good time.

1.7	The pharmacy team need to ensure that dispensed prescriptions are stored such that people’s information cannot be viewed by other members of the public. The team also needs to ensure that they do not reveal the identity of one person’s medication to another.	The management team have reiterated the importance of confidentiality to all members of the wider team. We have discrete notices, reminding all staff to uphold the highest standards when discussing treatments and medications with patients. All new members of the team are specifically trained on handling confidential information, respecting individual’s privacy, and methods by which to avoid divulging sensitive information over the counter when holding discussions with customers.
5.3	Facilities and equipment should be used in a way that will keep people’s prescriptions out of view from other members of the public.	All prescriptions are stored in a discrete location away from the direct sight of the public. The pharmacy is also installing a screen to create a barrier, in order to eliminate the chance of inadvertently exposing confidential information.

2.2

Not all team members have the appropriate qualifications for the tasks that they carry out.

• Will adhere to the education and training requirements for pharmacy support staff document published in June 2019.• All staff members “will need to be able to understand how their role contributes to person centred care, collaborate effectively with patients, members of the wider pharmacy/healthcare team, and the public, and carry out their role in a way that maintains trust in pharmacy services”.• “all support staff should have skills appropriate for the activities they perform and the setting in which they work.”

Support staff will be enrolled onto a training course as soon as practical and within three months of commencing their role. We will continue to provide internal as well as external training (we can send you the certificates of our current full-time staff). We are also looking to appoint another member of staff to cover at least the afternoon shift after our part-time counter assistant leaves at 2pm as the pharmacy is getting busier. They will receive the necessary training.

3.3	The premises are not maintained to an appropriate level of hygiene for some of the services provided.	Cleaning rota set up
4.3	The pharmacy does not always secure its medicines in line with legislation.	Patient returns segregated. Stock handling SOP reviewed. CD stock control and record-keeping SOP reviewed.
4.2	The pharmacy does not fully manage the risks associated with dispensing and with the multi-compartment compliance aid services.	Risk assessment and multi-compartment compliance aid to be handed out with a description of the medicine.
4.4	There is no procedure in place to deal with concerns raised when medicines or medical devices are not fit for purpose.	Recording of drug recalls and evidence of action taken.

1.6	The pharmacy is not maintaining all of its records in accordance with the law. This includes the RP record and records for private prescriptions. Staff have not kept appropriate records of Controlled Drugs brought back by the public for disposal. At the point of inspection, the team was unable to provide records for unlicensed medicines or all of the private prescriptions dispensed in the pharmacy	• Inform and remind all pharmacists that the RP record is a legal document and therefore all entries should be made in chronological order and unaltered, they must not be cancelled, obliterated or altered. Corrections made must be made by dated marginal notes and amendments should be initialled and dated with the pharmacists GPhC number. • Pharmacists will be informed that CDs returned by patients should be entered in the register for patient returned CDs at the point of arrival and not made at the point of destruction. • A Folder has been made for the invoices/ certificates for unlicensed medicines and which must be kept for 5 years. • All private prescriptions are to be filed in chronological order, and all entries are to be made upon receipt.
1.7	The pharmacy is not routinely safeguarding people’s confidential information and there is no evidence that governance arrangements are in place for this. There is confidential information left in an unlocked consultation room, the team does not remove confidential information before placing medicines requiring disposal within waste bins, there are no specific documented details to support the management of confidential information, staff have not signed confidentiality agreements and this includes people working at the pharmacy who are not employed by them, the pharmacy does not inform people about how their private information is maintained, staff are not trained on recent developments in the law and people’s sensitive information can be seen from the way signatures are obtained during the delivery service	• All pharmacy staff have been informed of the importance of patient confidentiality and have signed confidentiality agreements. • All staff will undergo the necessary safeguarding training with CPPE • Inform all the staff understand the importance of safeguarding confidential information, and ensure that the private consultation room must be locked if there if confidential information left in there • All confidential labels must be removed from patient returns prior to being placed in medicine return disposal bins • pharmacy privacy policy notice is to be displayed • change the method of the delivery log as suggested by the inspector, make a numbered list of the patients names and addresses for the delivery driver, and on the reverse, where there is no sensitive information, the patient signs alongside their corresponding number once they have receive their medication.
1.2	There is not enough assurance that the pharmacy has a robust process in place to manage and learn from dispensing incidents. Staff are not routinely recording near misses, their dispensing incidents are not recorded in a way where details can be easily retrieved, full details are not documented and there is limited evidence of remedial activity or learning occurring in response	• Ensure all staff members are aware of the location of the near miss/incident log, and instructions on how to make an entry. • Highlight to all staff on the importance of recording near misses and incidents. • Discuss incidence with all members of staff involved, undertaking a root-cause analysis. As well as to establish methods on how to overcome the error and stop it being repeated
1.1	The pharmacy is not identifying and managing several risks associated with its services as failed under the relevant principles. The pharmacy’s standard operating procedures (SOPs) do not reflect current practice and staff are not working in line with these. There is no evidence that the team has read the SOPs. Staff are not trained to safeguard vulnerable people and they are posting medicines through people’s doors without making relevant safety checks	• Ensure that all members of staff have read all relevant SOPs, which have been signed and dated as evidence • Amend SOPs to reflect current practice e.g. prescriptions are filed in retrieval system not attached to dispensed medicines awaiting collection. • Ensure all members of staff have undertaken training in safeguarding with certificates for proof of assessment • Oral Consent to be obtained from patients for posting medication and are to be assessed individually for appropriateness i.e. children or pets at home
1.3	Pharmacy services are not provided by staff with clearly defined roles and clear lines of accountability. There is evidence of errors but there are no audit trails in place to identify who was involved, the roles and responsibilities of staff are not clearly documented, the pharmacy’s SOPs do not make it clear where responsibility lies for different pharmacy activities. The pharmacy is not routinely maintaining audit trails so that it can always identify who was responsible for any professional activities	• Ensure all staff members are aware of their roles and responsibilities. • Create a document that clearly outlines each staff members roles and duties, which is signed and dated once read by the staff. • Ensure all pharmacy dispensary staff are signing off medicines when being dispensed and checked, to ensure an audit trail can be established in case an error arises and therefore to identify who was involved. • Ensure SOPS clearly explain and highlight the roles and responsibilities of each staff member.
1.4	There are limited systems in place to deal with complaints or feedback. The pharmacy does not provide people with information about how they can complain and there is no documented complaints procedure in place	• Display a complaints poster in the pharmacy instructing patients on what to do if they are unhappy with the staff or services provided in the pharmacy. • Provide patients with pharmacy leaflets, with information of the complaint’s procedure. • Ensure all members of staff have read and signed the complaints procedure.
2.1	The pharmacy does not have enough staff to safely and effectively provide pharmacy services	• the owner is aware of the situation and has put out advertisements to recruit more members of qualified staff; qualified MCA and pharmacy technician. • The owner/ manager has set his hours to 9am-7pm Monday to Friday • The pharmacy has recruited part time pharmacy student(s) working 2 days a week
2.2	There is not enough assurance that staff have the appropriate qualifications for their role(s) or are enrolled onto accredited training in line with the GPhC’s requirements. This includes the relative of the owner who is not employed by the pharmacy but sometimes works for them and sells medicines	• provide certificates and evidence of all staff qualifications as well as the courses they have been enrolled into
3.1	Pharmacy services are not provided from an environment that is appropriate for the provision of healthcare services. Most of the pharmacy is extremely cluttered, this includes the consultation room, there are several unnecessary items present in the back area, dispensed medicines stored here in plastic bags are not sealed appropriately to prevent contamination from spiders and staff are not ensuring that the fire exit is kept clear at all times in line with Health and Safety legislation	• ensure the pharmacy environment is always clean, organise and not cluttered. • Hiring a cleaner • Clearing the back storage area to ensure that the fire exit is kept clear.
4.3	There is insufficient assurance that stock is stored and managed appropriately. The pharmacy stores some of its medicines in a disorganised way, there are mixed batches, loose blisters, access to some medicines that need to be kept more secure, evidence that patient returned medicines are stored close to dispensary stock, there are no means available to store patient returned hazardous and cytotoxic medicines appropriately and verifiable processes to routinely identify as well as remove date-expired medicines are lacking	• Ensure no mixed batches are kept, and no loose blisters. • Patient returned medicines must be stored away from dispensary stock. • Call medical waste company and ask them to provide the pharmacy with hazardous and cytotoxic waste bins. • Put up a list of hazardous and cytotoxic medicines that must be disposed of in the special bins. • Put a chart in place to ensure stock dates are checked routinely.
4.2	Pharmacy services are not managed or delivered safely and effectively. The team is not using dispensing audit trails, prescriptions are not used during the dispensing process or when dispensed medicines are handed-out, staff are routinely claiming payment for medicines before they have been collected by people, owing slips are not routinely used, compliance aids are sometimes left unsealed overnight, descriptions of medicines and Patient Information Leaflets are not routinely provided when people are supplied with these, and people prescribed higher-risk medicines are not routinely identified, counselled or relevant checks made	• Ensure prescriptions are used throughout the dispensing process i.e. print the eps token and use it to pick stock and for final check and when handing out. • Ensure prescriptions are only claimed once medicines have been collected by the patient. • Inform all dispensary staff that Owing slips must always be used when issuing part supplies. • Inform all staff to make sure all stock is available prior to starting a dossette box to ensure compliance aid and is not left unsealed. In addition, descriptions of medications are to be written and PILS are to be provided and supplied with every dossette box supplied. • Identify patients prescribed with higher risk medicine and provide them help and advice

2.2

The pharmacy does not always ensure that team members are registered on the required accredited training courses in a timely manner.

All staff have been enrolled on accredited courses with the NPA

2.2

Team members do not always start the required accredited training course in a timely manner. This could increase the risk that they do not have the skills and knowledge they need to provide the services safely.

All team members in future will be enrolled on the appropriate training or induction course as soon as they start employment or move to a different job role.

1.7

The pharmacy doesn’t secure people’s personal information properly. This increases the risk that it can be accessed by unauthorised people.

Locks have been fitted to both doors, consultation room and where prescriptions are kept. The keys are kept in the dispensary.

1.2

The pharmacy does not record incidents and errors which can help them to identify areas of improvement and learning.

1. The Near Misses logs have been located and shared with the Inspector.
2. Separate the logs into a new separate file and keep in a prominent location.
3. Brief all the concerned staff about the new folder and its location.
4. Ask all concerned Staff to endeavour to record ‘Near Misses’ promptly and keep paperwork in File.

1.3	The responsible pharmacist is not always present as required by law meaning staff members will be working unsupervised.	Inconsistencies in the recording of in and out by the responsible pharmacist makes it look like he is not always present at the pharmacy during opening hours. The responsible pharmacist will ensure to correctly log in the times that he is on and off site on a daily basis.
2.1	A dispenser working in the pharmacy is not suitably qualified or on an approved training programme.	Register the dispenser on NPA approved course

3.1	There are dirty and untidy areas of the pharmacy that are detrimental to the safe provision of services. There are significant health and safety risks presented by the locked and obstructed fire exit, the lighting arrangements for the toilet and tripping hazards.	The Pharmacy has been intensively cleaned and all surfaces have been wiped and cobwebs cleared. The Fire exit has been cleared from all obstruction and will be unlocked when the store is open. I have arranged for a builder to start works on the 15th of June 2019. It is anticipated for this to be completed in 4 working days time.
3.3	There is inadequate hygiene and infection control for the safe provision of services as a result of the lack of hot water on the premises.	The hot water tap issue will be replaced and a new immersion heater will be installed to provide hot water.

2.2	Not all team members have the appropriate qualifications or training for the tasks that they carry out.	Member of staff that was highlighted as not undergoing training has been signed up to the Dispensing Assistants course provided by the NPA
4.3	The pharmacy does not always keep its medicines securely and in accordance with legislation. And cannot show that it always stores medicines which require refrigeration appropriately.	Responsible Pharmacist and the whole dispensing team have been retrained on the safe storage of medicines in accordance with legislation. They have also re-read the SOPs;3. SOP for ordering and Storage of Schedules 2 and 3 Controlled Drugs4. SOP for Running Balances6. SOP for carrying out stock checks of Schedule 2 Controlled Drugs8. SOP for disposing of stock of Schedules 2,3 and 4 Part 1 Controlled Drugs and have signed in confirmation of compliance. Responsible Pharmacist has additionally gone through all Controlled Drug Registers and has included in the running balance any expired Controlled Drugs in line with Britannia Pharmacy SOPWe have additionally purchased two extra-large medicine grade LEC fridges to store medication as per guidelines. Please refer to the delivery address at the bottom left of the invoice. All staff have been retrained on refrigeration requirements in line with Britannia Pharmacy SOP number 29, SOP for Fridge Maintenance and Monitoring. This specifically includes what to do when the temperature falls outside acceptable ranges. All staff have signed the SOP in confirmation of its compliance

3.1

The pharmacy was dated in appearance, had rotten woodwork around the doorframe and a trip hazard in the dispensary due to cracked flooring.

The floor in the dispensary to be repaired with a cover plate where it is cracked. The entrance doors which are badly worn will be replaced and the timber threshold strip will be replaced in aluminium as part of this work.

3.4

People accessing the toilet to the rear of the dispensary can see other people’s private information. This includes people using some of the pharmacy’s services and non-pharmacy staff.

The two nail technicians have been told to use the upstairs bathroom and not access back room toilet. Patients participating in the Chlamydia screening programme will also use upstairs toilet. Note has been put on door entering back area to confirm these steps.

1.2	Near misses are not routinely recorded or reviewed.	A new Near Miss recording and reviewing system to be implemented. Pre-Registration Pharmacist to keep own record of near misses. Superintendent Pharmacist to follow up once implemented
1.1	Standard operating procedures have not been reviewed recently or signed by the current members of staff.	Standard Operating Procedures to be reviewed, updated as necessary and signed by the current members of staff.

4.3

The pharmacy doesn’t record the medicines fridge temperatures regularly.

The inspection was on 2nd May. Since 3rd May the pharmacy has been keeping a daily log of fridge temperatures. This is recorded every morning using our “Daily Fridge Temperature Check” sheet.

1.2	The pharmacy does not record all incidents in the pharmacy.	Most incidents were recorded on book – we are now actively recording all incidents on our PMR system which allows us to write more details on WHY the incident occurred.
4.3	The pharmacy does not store all schedule 2 and 3 medicines in accordance with the requirements of the Safe Custody Regulations.	CDs to be destroyed and this will ensure no CDs are kept outside the cupboard.

1.7	The pharmacy cannot show that the way it stores or disposes of confidential waste is effective or legal.	All confidential waste bins marked clearly All confidential waste is shredded and waste disposed of as per SOP standard
1.1	There were no up-to-date written procedures in place for staff to access to see how they should perform day-to-day tasks.	Up-to date SOP’S to be provided for staff to access at all times and staff to follow procedures in day to day procedures in pharmacy (staff training being provided so all staff have understanding to perform in their various roles using SOP ) OTC medication training: Monthly up to date training provided for staff to cover OTC updatesAppropriate procedures are reviewed ie retrain staff on near miss errors recording and action plans to follow-up on weekly basis to correct near miss and errors proceduresControl drug keys handling i.e held in safe with sign out and sign in procedures by Responsible Pharmacist followed appropriately Customer survey for 2019 is republished and report to be displayed for public access Consultation rooms are kept at required standards for patient use onlyRobot training is in progress to up date staff on date checks (with documentation) and full utilisation of robot for dispensing purposes
4.3	The pharmacy doesn’t store all its medicines safely or in keeping with legislation. The pharmacy cannot demonstrate that medicines which require cold storage are stored correctly.	All procedures for safe keeping of medicines are reviewed for compliance with current standards and staff validated on procedures outlined in SOPDispensing/assembly areas are marked clearly and items are arranged in designated areas accordingly to avoid errors Area in dispensary allocated for assembling of multi-compartment trays Retrain staff and validate procedures for dispensing multi-compartment trays such as individual master dispensing sheets for dispensers to follow for assembling of traysAll prescriptions are accuracy checked before dispensing of trays and patient prescriptions put together with the assembled trays while awaiting collection. Full utilisation is made of PMR for clinical checks/documentation of INR, METHOTREXATE, LITHIUM Use of warning stickers/cards used where appropriate on medication bags and shelvesPharmacy has regular subscription for MHRA ALERT NOTIFICATION and compliance to action is taken for alerts as appropriate

4.3

The pharmacy does not monitor or record the maximum and minimum temperatures of the fridge used for the storage of temperature sensitive medicines. The pharmacy stores some stock medicines in bottles without the appropriate labelling.

The team have downloaded and SOP for fridge monitoring from the NPA website. Stock in bottles without complete labels has all been destroyed.

2.2

Some members of the pharmacy team carry out tasks they aren’t appropriately trained to do.

Enrol the staff members who works on the counter on the NPA Medicines Counter Assistant Course.

1.1	The pharmacy team has not identified the risks to patient safety, including having untrained staff dispensing, working with old SOPs and having medicines on the shelves without appropriate labelling.	Ongoing and new Staff training to commence with NPA dispenser training course. Current, updated and signed SOPs are used at the pharmacy. Medicines on the shelves have been checked and all appropriately labelled with name, batch numbers, expiring dates and brands name where available.
1.2	The pharmacy team does not regularly record and review near misses and SOPs have not been reviewed in the last 2 years.	Near misses are recorded on our PMR computer, with root cause analysis carried out in a review meeting, necessary actions taken (shelf separation of Tegretol tablets from the Retard formulations, Demarcation of different strengths of Atenolol tablets with Alfacalcidol Caps etc) and documented in the computer. Dates of review meetings and discussions to be on a regular basis and be logged henceforth. Our current and ongoing SOPs was review in November 2018 by Superintendent and signed by all staff. The NPA SOPs in the pharmacy is for our guide and information only and therefore do not need to be signed off by either the Superintendent or the team
1.3	The staff do not have clear job descriptions or lines of accountability.	Dispensary and Counter staff have clear job descriptions, lines and consequences of accountability and aware of their responsibilities. These have been further established.
1.6	Patient returned controlled drug records are not accurate or kept up to date.	Patient returned controlled drug register have been regularly accurate and kept up to date, and the last entry update within 24hrs allowed by law
1.7	Confidential patient information is not kept secure or protected.	Patient confidential will henceforth be shredded by a shredder and by hand and kept secured in a separated waste container.
2.2	Staff are not trained to requirements set out by the GPhC.	Ongoing and new Staff training to commence with NPA dispenser training course, in addition to our inhouse on the job training. Staff are regularly asserted in their in house on the job training needs and competence.

1.7	The pharmacy does not store all its prescriptions on the premises. And it cannot show that these are kept securely.	All prescriptions are now stored on the premises after the inspection.
3.1	The pharmacy is not maintained to a level of hygiene appropriate to the pharmacy services provided. Parts of the pharmacy are dirty or cluttered.	All parts of the pharmacy dispensary that were dirty have been cleaned. Spots clustered with prescriptions have been cleared and this will be on going.
4.3	The pharmacy does not manage its medicines appropriately to ensure that these are safe to use.	• Started keeping prescriptions with dispensed medication in drawers or shelves. • Keeping medicine in appropriately labelled containers. • Highlighting dispensed prescriptions for scheduled 3 and 4 control medications in drawers or shelves to avoid risk of dispensing medication when script has expired. • Patient information and warning cards has been given with each supply of valproate dispensed since the inspection date. • All medications are now kept in their original packs • A new thermometer has been installed to monitor fridge temperature • The fridge has been defrosted to remove build up of ice on the back wall of the fridge. • Part dispensed prescriptions that have owings will be kept in a pile until all medication is collected • Backing sheets will be attached to multi-compartment compliance aids before collection. • Signatures will be obtained in order to prove medication has been safely delivered. • Will promptly action email for drug alerts and recalls.
4.2	The pharmacy does not always ensure that medicines are supplied in accordance with a legally valid prescription.	Private prescriptions from out of area (especially) and all prescriptions, following my inspection, are well checked to confirm authenticity and that they are legally valid and written on the right form for control drugs.

1.1	The pharmacy doesn’t have the written procedures in place it needs to by law.	The current standard operating procedures (SOPs) will be made available to the pharmacy team. The company’s SOPs will be reviewed and updated. And they will be made available to the pharmacy team on the company’s intranet in the next seven working days. The pharmacy manager will print a copy for the pharmacy team to read and sign.
1.7	The pharmacy team doesn’t always keep people’s information safe.	A digital door lock is to be installed on the door to the consultation room and the pharmacy team reminded of the company’s obligations to keep people’s information safe.Staff will be reminded to close the patient medication record (PMR) software in the consultation room when not in use to protect people’s information.
2.1	The pharmacy doesn’t have enough staff. And its team members struggle to cope with the workload and the tasks they’re expected to do.	The normal complement of staff would be at least one more person to assist at the counter. An advert has been placed online and in the pharmacy. Interviews are currently been carried out and at least one additional member of staff will be employed imminently.In the interim there will be extra staff support to cover lunch breaks and prescription runs.Only the delivery driver will go to the surgery to save time to the pharmacy staffAs part of our internal risk analysis that was prompted by the inspection report we have implemented a staff buddying-up system between the pharmacy and a nearby branch which is about two miles away to share staff if any problems arise.
3.1	The pharmacy is poorly maintained, doesn’t present a professional appearance and is unsuitable for some of the services it provides.	The directors of the company agree to the extent of the cosmetic improvements needed at the pharmacy. The kitchenette, which is currently used to prepare liquid medicines, will be cleaned immediately. Updated plans for the refurbishment of the internal area of the pharmacy will be drawn up and these will be amended to allow for extra dispensing space. The company will seek to commission the internal works, including fixing the cause of the damp, replacing or deep cleaning the pharmacy’s flooring, fixing the kitchenette’s light and running hot water. The pharmacy’s entrance will be levelled with the outside pavement to help people with reduced mobility enter it. And a doorbell will be installed to aid people who might struggle to open the door.
5.3	The pharmacy doesn’t always use its equipment to make sure people’s private information is protected.	A digital door lock is to be installed on the door to the consultation room and the pharmacy team reminded of the company’s obligations to keep people’s information safe. Staff will be reminded to close the PMR software in the consultation room when not in use to protect people’s information.

1.7	The pharmacy does not always manage confidential information properly or securely dispose of confidential waste. This could result in people’s personal information being disclosed.	All confidential information and by product waste will be safely disposed daily in the shredder so there will be minimum risk that information can be disclosed . All data will be kept in the dispensary safe haven place until it is disposed of.
1.6	The pharmacy does not keep all its records fully in line with legal requirements.	Members of the pharmacy team will ensure that all records are updated at the latest at the end of the day if they cannot do so during busy dispensing times.
4.3	The pharmacy does not always keep prescription only medication securely. And it does not store medicines which require refrigeration appropriately.	The team will ensure that all SOPs procedures are followed to keep medicines securely and at safe temperature

4.3

A small amount of stock is not properly labelled or packaged. This means that staff may not be able to identify it when it has reached its expiry date or has been recalled.

Briefing for colleagues that split packs should not be mixed. Blisters from split pack to remain in the original box.

3.1

Damaged flooring in the shop area and dispensary is a significant tripping hazard to team members and people who use the pharmacy.

Affected flooring will be fixed or replaced

1.6

The pharmacy doesn’t keep all the records it needs to by law.

All relevant team members to be retrained on the CD SOPs and also the requirements for CD register entries. Including a re-evaluation of team members competence.

All relevant team members to be retrained on the company “Specials” process and the recording requirements Team to bring the private prescription register up to date and then maintain as per company policy. Training to be provided on NUMSAS and the requirements of records to be made to all appropriate team members Further training to be provided on the requirements for entries being made in the private prescription book, to include Private prescriptions, Emergency supplies and NUMSAS.