Part 2: Relating to the PGD packages and training
1.Definitions
1) The term ‘Accredited Pharmacist’ is a qualified pharmacist registered with the GPhC or PSNI AND certified to provide PGD Services following successful completion of all relevant training and assessment.
2) The term ‘Registered Pharmacy technician’, is a level 3 accredited pharmacy technician, who is registered with the GPhC.
3) The term ‘Authorised Users’ are Accredited Pharmacists enrolled onto the PGD Service(s) and authorised by name by the PGD provider to provide the PGD Service(s).
4) The term ‘Business Day’ is any day that is not a Saturday, Sunday or public holiday anywhere in the United Kingdom.
5) Force Majeure means any acts, events, omissions or accidents beyond our reasonable control, including, without limitation, strikes, lock‐outs or other industrial disputes (whether involving the workforce of our PGDs and/or training providers or any other party), failure of a utility service or transport or telecommunications network, act of God, war, riot, civil commotion, malicious damage, compliance with any law or governmental order, rule, regulation or direction, accident, breakdown of plant or machinery, fire, flood, storm or default of service providers or sub‐contractors.
6) The term ‘ General Pharmaceutical Council’ (GPhC) is the regulatory body for pharmacists in England, Scotland and Wales.
7) ‘Late arrival’ means arriving at the practical vaccination training session later than the start time / after the session has started. Please note: the timetable has been planned to ensure everyone gets ample opportunity to practice techniques under the close supervision of our trainers. Therefore, anyone arriving more than 15 minutes late will not be able to join the session.
8) Medicines and Healthcare products Regulatory Authority (MHRA) is the regulatory body for all human medicines, devices and healthcare products in the UK.
9) Patient Group Direction (PGD) is a written protocol used by Accredited Pharmacists ONLY as Authorised Users to supply/administer prescription‐only medicines (POMs) to patients who meet the inclusion criteria for each medicine. Registered Pharmacy Technicians must not use PGDs to administer or supply POMS, under any circumstance. If you are a registered pharmacy technician, you may disregard any references to PGD terms and conditions, from this point forward in this document.
10) PGD Provider means the Independent Medical Agency (IMA) supplying the PGDs for the PGDPro.com PGD Services.
11) PGD Service(s) includes the PGDs and associated training available from PGDPro.com which enables Authorised Users to offer a range of POMs to patients under PGDs.
12) Pharmaceutical Society of Northern Ireland (PSNI) is the regulatory body for pharmacists in Northern Ireland.
13)The term ‘Training Provider’ is the company providing relevant training on behalf of PGDPro.com to pharmacists to enable pharmacists to administer/supply relevant vaccines/medications under PGDs to patients.
14) PGD Service/Package options (‘service’) – available to accredited pharmacists only:
- Flu Pack
- Travel Pack
- Oral PGDs – available single or bundle
- Vaccination PGDs – available single or bundle
Full descriptions of the above options are available on the PGDPro.com website at: www.PGDPro.com
2. General conditions
1) These Terms and Conditions are applied on behalf of the Training Provider (Charles Bloe Training Ltd) and the PGD Provider (Medical Prescription Services Ltd) and are applicable to all Authorised Users of the PGD Services AND their superintendent pharmacists/pharmacy owners; all parties must agree to adhere to these Terms and Conditions.
2) It is a condition precedent of these Terms and Conditions that:
- All legislation covering supply / administration of medication/vaccines under PGDs must be adhered to in all circumstances; AND
- All Authorised Users must have signed hardcopies of the relevant PGD(s), plus accompanying relevant paperwork and references as referred to in the PGDs, available for ready reference during each and every patient consultation when providing PGD Services, whether providing PGD Services on the registered pharmacy premises or off‐site; AND
- The Authorised Users meet their personal and professional responsibilities, in all cases, to ensure that they are trained, confident and competent to offer the PGD Services to patient; AND
- Adequate professional liability insurance is in place.
Failure to adhere to these requirements will invalidate supply/administration of medication/vaccines under the PGDPro.com PGD Services.
3) Medicines included in the PGD Services can only be supplied or administered from GPhC/PSNI registered community pharmacy premises (except PGDs for vaccines where authorisation exists to administer them off-site premises; you are expected to ensure that any off‐site premises meets the criteria for providing PGD Services as described in the PGD content and follow GPhC and PSNI professional standards). Refer to Appendix 2 for compliance information for ‘off site’ use of vaccination PGDs.
4) Only Authorised Users may offer PGD Services and operate the PGDs; support staff or unauthorised users are not permitted to do so.
5) An Authorised User, upon signing the PGD declaration, takes full responsibility for making appropriate supply/administration of the medication/vaccines under the relevant PGD(s).
6) Authorised Users must use only the PGDs supplied under the PGDPro.com PGD Services to assess patients and supply/administer medication/vaccines in conjunction with any associated consent/risk assessment forms.
7 &a) Patient consultations should be conducted face-to-face in the pharmacy between the patient and authorised user before supply or administration of a medication or vaccine. In exceptional circumstances where this is not possible (for example, due to social distancing measures during the COVID 19 pandemic) patient consultations via an appropriate digitally secure medium (for example via video conferencing or telephone consultation, in conjunction with using the online electronic PGD portal (ePGD), are permitted. Where a video or telephone consultation is required, the pharmacist is expected to adhere to the guidance issued by the GPhC./PSNI. Additionally, the pharmacy is required to have appropriate arrangements in place to ensure digital security and maintain patient confidentiality. These measures must be able to authenticate patient identity. This may be evidenced by ensuring that the pharmacy’s IT systems meet the requirements of the Data Security and Protection (IG) Toolkit (or equivalent), for example, and the GDPR requirements are met.
Supply / administration of medicines.
Self-administered medicines supplied under oral PGDs.
- Following a patient consultation face-to-face, the medication must be supplied from the registered pharmacy premises.
- Following an ePGD application, which may be supported by a video or telephone consultation, the patient (or their verified representative) should attend the pharmacy to collect the medication.
- If the patient (or verified representative) are not able to attend the pharmacy and it is not possible to speak with the patient directly (i.e. where it concerns a young child or when an adult lacks the capacity) then an assessment should include a discussion with a parent/guardian/carer where appropriate.
- Following an ePGD consultation, supported by video or telephone consultation, if the patient (or their verified representative) cannot attend the pharmacy to collect the medication, the pharmacist should first consider a delivery using the pharmacy’s own delivery service if the address is within a reasonable distance. Alternatively, for non-local supplies, a professional decision must be made about the suitability of posting the medication. This includes assessing the proximity of the patient to the pharmacy and whether they can access a private PGD service more local to them rather than posting the medication.
- If it is decided to post the medication, the posted package must be via special recorded delivery signed for delivery and only posted to patients in the UK.
Medicines to be administered parenterally.
- Patients must attend the pharmacy in person for all parenterally administered medication. The suitability of operating PGDs during the COVID 19 pandemic should be risk assessed and actions taken that minimise patient contact and maximise patient and staff safety.
- A risk assessment must be conducted before providing private PGD services.
7b) Distance Selling pharmacies.
An Authorised User may only offer PGD Service(s) via a Distance Selling Pharmacy if it is clearly stated on the PGD that the service is suitable and authorised to be offered via a Distance Selling Pharmacy.
Pharmacy owners / superintendent pharmacists should consider all legal requirements before deciding whether any parts of their pharmacy service can be provided safely and effectively at a distance (including on the internet), rather than in the traditional face-to-face way. Guidance from the GPhC and PSNI is available to aid this process.
The pharmacy owner /superintendent pharmacist is responsible for making sure this guidance is followed. Everyone in the pharmacy team, including managers with delegated responsibility and the responsible pharmacist, should understand the guidance and be aware of their responsibilities to follow it. If the registered pharmacy is owned by a ‘body corporate’ (for example a company or an NHS organisation) you should make sure the superintendent pharmacist understands it should be followed.
The GPhC guidance must be read alongside the standards for registered pharmacies, which pharmacy owners must meet, and the Inspection decision making framework. The standards for registered pharmacies are about creating and maintaining the right environment, both organisational and physical, for the safe and effective practice of pharmacy.
The PSNI guidance must be read alongside the standards for registered pharmacies, which registered owners must meet and comply with any legislative updates. The standards for registered pharmacies are about creating and maintaining the right environment, both organisational and physical, for the safe and effective practice of pharmacy.
Under EU and UK legislation, a Distance Selling Pharmacy relates to a person selling, supplying or offering to sell or supply a medicine over the internet at a distance to the public via the internet, in accordance with the Electronic Commerce (EC Directive) Regulations 2002.
To harmonise a common approach across all countries in the EEA and to encourage the use of legitimate sources of sales of medicines online, the European Commission has introduced a registration scheme for online retail sellers of human medicines through the Falsified Medicines Directive 2011/62/EU and has adopted a new EU Common Logo through the Implementing Regulation EU/699/2014. The aim of this registration scheme and the use of the EU Common Logo are to help members of the public identify which websites can legally retail medicines. Every pharmacy (including traditional “bricks and mortar” pharmacies with an online presence) authorised by the Medicines and Healthcare Products Regulatory Agency (MHRA) to sell human medicines online in the UK must display the EU common logo on every page of their website offering to sell human medicines. You also must be registered with and be on MHRA’s list of UK registered online sellers available here. Patients will be able to verify your entry on MHRA’s register of authorised online sellers of medicines as the EU common logo will contain a hyperlink to the seller’s entry on the register. The EU Common Logo shall be clearly displayed on websites offering medicinal products for sale online to the public.
The UK’s registration scheme for the online retail selling of a medicine is set out in regulations 256A to 256N of the Human Medicines Regulations 2012.
MHRA is the UK competent authority for human medicine and is responsible for managing the UK list of online retailers that sell a medicine to the public that have to display the EU Common Logo on the website pages where they offer their medicine. In order to register with MHRA a person must make a valid application to MHRA via the PCL portal Applications can take up to 90 days to process. Full details of the MHRA guidance can be found here
In circumstances where a medication is marketed to be supplied by a Distance Selling Pharmacy, the consultation process must only be undertaken using the ePGD online assessment and consent form. Any subsequent supply of a medication may be posted to the patient’s verified address. All parts of this process, including the packing and labelling of the parcel, must be conducted by the authorised pharmacist. The authorised pharmacist must ensure that there are governance and operating procedures for such practice in place at all times.
All instances of vaccine supply and administration require the patient to be present in the pharmacy or at an approved premise where the authorised pharmacist may administer the vaccine.
8) All medication/vaccines supplied/administered must be labelled and/or recorded in accordance with the PGD instructions and The Human Medicines Regulations 2012.
9) Authorised Users must not use the PGD for their patients if they feel that by doing so, they would be working outside their area of competence.
10) Authorised Users subscribed to the PGD Services are only authorised to use the PGD for the 12‐month period of subscription to the PGD Services. The PGD Provider’s authorisation is then deemed to have expired and any use of the PGDs outside of the period of subscription will be in breach of the PGDPro.com’s PGD Services Terms and Conditions and will constitute an illegal act.
11) Each PGD will state an expiry date after which they are not valid.
12) All Authorised Users must be fully compliant with Information Governance and digital security requirements.
13a) Login details for the MPS’ Medescribe (where applicable) /Charles Bloe Training PGD Services’ e-learning portal must not be shared with any unauthorised users or persons outside the GPhC/PSNI registered pharmacy premises listed on the registration form.
13b) You must ensure that all personal and sensitive information is protected, in accordance to the Data Protection Act 2018 (DPA) and best practice data protection practices and procedures are strictly followed, and personal and sensitive information is not accessible to any other person. You must supervise every consultation, ensuring that both you and your patient have successfully logged off all Medescribe portals at the end of each consultation.
14) Individual pharmacists (managers/employees/relief pharmacists/locum pharmacists) can register to use the PGD Services only with permission from the superintendent pharmacist/pharmacy owner.
15) Superintendent pharmacists/pharmacy owners are responsible for ensuring that:
- All the requirements under these Terms and Conditions are adhered to.
- They have proper oversight of the use of PGD Services within their organisation; relevant standard operating procedures (SOPs) must be in place and being implemented.
- Face to face PGD consultations with the patient (or their representative) must take place in an approved GPhC or PSNI consultation room or approved premises that meets the requirements of the service. Non face-to-face consultations via an appropriate digitally secure medium (for example via video conferencing or telephone consultation, in conjunction with using the online electronic PGD portal (ePGD) are permitted, however, the requirements of point 7 of the General Conditions must be met.
- Authorised Users use PGDs in accordance with the PGD criteria only and do not work outside of these parameters.
- They inform PGDPro.com immediately via email (pgd@PGDPro.com) if:
- Authorised Users need to be added or removed from the PGD Services OR
- If any Authorised User(s) is/are removed/suspended from the GPhC/PSNI register.
16) PGDPro.com reserves the right to add, remove or suspend any or all parts of the PGD Services and/or PGD(s) offered within PGD Services, at any time without prior notice.
17) PGDPro.com reserves the right to change these Terms and Conditions at any time, without prior notice.
18) Appendix 1 summarises the Patient Group Direction (PGD) and electronic Patient Group Direction (ePGD) options for authorised pharmacists.
3. Online training accounts
- Registered users must immediately inform us if there is any reason to believe that a user ID or password has or is likely to become known to someone not authorised to use it or is being or is likely to be used in an unauthorised way.
- Registered users are responsible for the security and proper use of all user IDs and passwords used in connection with our websites and must take all necessary steps to ensure that they are kept confidential, secure, used properly and not disclosed to unauthorised people.
- You must not use your account or user ID for or in connection with the impersonation of any person.
- Registered users must not change or attempt to change a user ID. In the case where a user has forgotten or lost a password or user ID they must contact us and satisfy such security checks as we may operate.
- We reserve the right to suspend user ID and password access to the website if at any time we consider that there is or is likely to be a breach of security.
- We reserve the right (at our sole discretion) to require registered users to change any or all of the passwords used by you in connection with the website.
- Registered users must immediately inform us of any changes to the information supplied when registering – where this facility is provided, this can be achieved by updating your profile appropriately via online forms.
4. Training and authorisation
This section is currently only applicable to Accredited Pharmacists.
1) All participating pharmacists must fully read and understand the online training modules on the relevant medical conditions, undertake and successfully pass the online assessments, and upon renewal, to ensure their knowledge is current.
2) Accredited Pharmacists must sign the relevant PGD document(s) to declare confirmation that they have read and understood the content of the PGD(s) and received the appropriate training to implement them effectively; they agree to work within the parameters of the PGD.
3) The PGD authorisation process must be completed once training and assessment has been undertaken before the PGD is valid for use.
4) AccreditedPharmacists need to be familiar with any PGD updates; Authorised Users will be notified via email of changes and must ensure they are working with the most up‐to‐date version of the PGD(s).
5) Annual online training is required for each of the PGD services.
6) Complete practical (face-to-face) vaccination training, which includes Basic Life Support and Anaphylaxis training, is a mandatory requirement triennially (at least every three years).
This permits accredited pharmacists to administer injectable medicines (i.e. influenza vaccines). If accredited pharmacists are unsure of their own professional capabilities or if they wish to provide more complex vaccination services such as travel vaccines, Medical Prescription Services (the private PGD provider) recommends that accredited pharmacists undertake complete practical training more frequently. Competence to provide vaccination services must be self-assessed annually by every practitioner to ensure practical skills and patient safety is maintained to appropriate professional standards.
A vaccination competency self-assessment must be completed for all accredited pharmacists intending to vaccinate to ensure that individuals are trained, confident and competent to offer vaccination PGD services. The competency self-assessment form provides details to enable each individual to assess their own competency to provide safe vaccination services and identify any training requirements.
Any training requirements identified can be met by completing either online training or self-directed learning. All new vaccinators must attend complete training and supervised administration of vaccination procedures before they are permitted to vaccinate unsupervised.
Any pharmacists who consider themselves as ‘inexperienced’ (i.e. have not administered a vaccine for 18 months, as of 1st September 2022) should consider complete training, but as a minimum must complete ‘renew’ training.
7) If more than twelve months have passed since completing the complete practical (face-to-face) training, you should complete a self-assessment form (provided with every vaccine PGD) to determine whether you remain both competent and confident to deliver vaccination services. This requirement is irrespective of the number of vaccines that you administered in the previous 12 months.
8) It remains the personal and professional responsibility of the Authorised User, in all cases, to ensure that they are trained, confident and competent to offer the PGD Services to patients, including administration of vaccines, treatment of anaphylaxis and resuscitation techniques where appropriate; the pharmacist must decide for themselves whether they should undergo the complete vaccination training or the online ‘renew’ in view of this.
5. Registration, fees and subscription period
5.1. Paying online
How to book / pay for your purchase:
- Please book online using our secure booking system to pay using credit/debit card.
- Fee is exclusive of VAT. VAT @ 20% will be added at checkout. Includes tuition, course materials, access to PGDs and a certificate of completion.
- We do not accept provisional bookings.
- All fees charged include 13 months subscription to use the chosen PGD(s) plus attendance at one complete practical vaccination training session (if applicable), plus any associated online learning/training plus assessment; fees are charged per pharmacist.
- Your registration and attendance details will be held securely for 3 years.
- Replacement training certificates for training previously undertaken from CB Training are available at the following link: https://www.cb-training.com/product/certificate/
Please note: We advise you not to book any travel or accommodation in advance. Charles Bloe Training Ltd do not accept any liability for travel and accommodation costs booked in advance.
5.2 Locum Pharmacists signing up in their own right
1) The subscription is attributed to the locum
2) The locum can operate PGDPro.com’s PGD Services at any GPhC/PSNI registered premises, including pharmacy premises belonging to large pharmacy chains (multiples); the premises does not need to be already registered with PGDPro.com to provide PGDPro.com PGD services.
3) It will be down to the pharmacy owner / superintendent pharmacist in question to decide whether they will allow an ‘outside’ PGD to be used in their premises.
4) If the pharmacy owner / superintendent pharmacist allows the locum to use PGDPro.com PGD Services within their premises, the PGD Provider will require a letter of authorisation from the pharmacy owner / superintendent pharmacist of the pharmacy to give permission regarding this.
5) All terms and conditions for the PGD Services must be adhered to (i.e. record keeping, keeping a signed copy of the PGD at every premises).
6) The locum must inform MPS where they will be operating the PGDPro.com PGD Services before they provide any services to patients under the PGDPro.com PGD Services.
5.3 Locum Pharmacists whose subscription to use the PGDPro.com PGD Services has been paid by the pharmacy owner
1) The subscription is attributed to the pharmacy
2) PGDPro.com’s PGD Services must be operated only within the registered premises of the pharmacy.
3) All terms and conditions for the PGD Services must be adhered to.
5.4 All
1) For those subscribing to the Flu Pack, the 12-month period of subscription to use the Flu pack PGDs will run from 1st September in the year it was purchased until the end of March the following year.
2) For those subscribing to any vaccination services and/or the Travel Pack with complete practical vaccination training, the 12‐month period of subscription to use the PGDs will commence from the day after attending the practical vaccination session. It is expected that you will attend practical vaccination training session held on a date closest to the payment invoice date, at a venue, suitable for you to travel to.
3) For those subscribing to any vaccination service and/or the Travel Pack with online ‘renew’ vaccination training only, the 12‐month period of subscription to use the PGDs will commence one month from the invoice due date.
4) For Oral PGD single or Oral PGD bundle, the 12‐month period of subscription to use the PGD(s) will commence one month from the invoice due date.
5) In all cases, use of PGD(s) is not permitted unless ALL relevant training – complete practical vaccination training (if applicable) and/or online learning/online vaccination training plus assessment has been successfully completed.
6) Meningitis ACWY PGD, Meningitis B and Pneumonia Pneumococcal (PPV) are included as part of the Travel PGD Pack. They are also available separately as single Vaccination PGDs if you are not subscribing to the travel pack at the same time. No discount will be given nor any refund issued if, having already paid the fees for these vaccinations as single PGDs, you subsequently subscribe to the travel pack. Under these circumstances, you will still be charged the full fees for the travel pack.
7) Malaria prophylaxis is covered under both the travel pack and the oral bundle of PGDs. A discount has already been built into the fees charged when subscribing together to the travel pack and the oral bundle at the same time. However, if you subscribe to the travel pack and the oral bundle at different times, you will be charged the full fees due for each as individual subscriptions; no discount and/or refund will be made under these circumstances.
8) Subscribing to more than one PGD option(s) at different times will be charged at the full cost of the individual option(s) chosen which may be higher than if you had subscribed to multiple options at the same time.
9) Registering additional pharmacist(s) or replacing pharmacist(s) will require the full payment for the additional pharmacist(s) and each will need to undergo the registration and training process required to offer the PGD Services.
10) PGD Services fees must be paid as due to use the PGD Services for each Authorised User offering the service within each pharmacy.
11) Renewal fees are due every 12 months.
12) Upon renewal, the same process of training and PGD authorisation must be undertaken before proceeding with the PGD Services service.
13) The price charged by the pharmacy for providing PGD Services to patients is a matter for each pharmacy/organisation to decide and is not the responsibility of PGDPro.com.
14) Annual subscription costs for the PGD Services are subject to review and may change without prior notice.
15) No refunds will be issued if the subscription has been paid but the PGD Services are not used.
6. Refund policy
- PGDPro.com offers a 14 day cooling off period during which a full refund will be given.
After 14 days we will not offer any refunds, however we may accept named replacements.
- Please email info@PGDPro.com for further details / questions.
- If you would like to change your booking to another date / location please contact us as soon as possible and we will try to accommodate your request. However, we cannot guarantee an offer of a place on another day / location.
Please note: We advise you not to book any travel or accommodation in advance. PGDPro.com / CBT nor MPS do not accept any liability for travel and accommodation costs booked in advance.
7. Distance contracts: cancellations and refunds
- This Section (Part 2: 7) applies if and only if you offer to contract with us, or contract with us, as a consumer – that is, as an individual acting wholly or mainly outside your trade, business, craft or profession.
- You may withdraw an offer to enter into a contract with us through our website, or cancel a contract entered into with us through our website, at any time within the period (subject to Section 7.3):
(a) Beginning upon the submission of your offer; and
(b) Ending at the end of 14 days after the day on which the contract is entered into,
You do not have to give any reason for your withdrawal or cancellation.
- You agree that we may begin the provision of services before the expiry of the period referred to in 7.2, and you acknowledge that, if we do begin the provision of services before the end of that period, then:
(a) If the services are fully performed, you will lose the right to cancel referred to in Section 7.2;
(b) If the services are partially performed at the time of cancellation, you must pay to us an amount proportional to the services supplied or we may deduct such amount from any refund due to you in accordance with this Section 7.
- In order to withdraw an offer to contract or cancel a contract on the basis described in this Section 7, you must inform us of your decision to withdraw or cancel (as the case may be). You may inform us by means of any clear statement setting out the decision. In the case of cancellation, you may inform us using the cancellation form that we will make available to you. To meet the cancellation deadline, it is sufficient for you to send your communication concerning the exercise of the right to cancel before the cancellation period has expired.
- If you withdraw an offer to contract, or cancel a contract, on the basis described in this Section 7, you will receive a full refund of any amount you paid to us in respect of the offer or contract, except as specified in this Section 7.
- We will refund money using the same method used to make the payment, unless you have expressly agreed otherwise. In any case, you will not incur any fees as a result of the refund.
- We will process the refund due to you as a result of a cancellation on the basis described in this Section 7 without undue delay and, in any case, within the period of 14 days after the day on which we are informed of the cancellation.
8. Intellectual Property (IP) rights
1) All IP rights for all PGDs, consent/risk assessment forms and flu manual supplied under the PGD Services belong to the PGD Provider; no changes and/or amendments are permitted to be made to any content therein.
2) Any changes and/or amendments made to any content will invalidate the PGDs and associated materials.
3) All IP rights for all the training materials supplied under the PGD Services belong to the Training Provider (Charles Bloe Training Ltd); no changes and/or amendments are permitted to be made to any content therein.
4) All IP rights for any promotional and marketing materials, as well as any other PGDPro.com resources/materials belong to PGDPro.com; no changes and/or amendments are permitted to be made to the content therein unless specifically permitted to do so for the purpose of personalising the marketing material where relevant and indicated as such.
5) Any attempt to copy, duplicate, modify, create derivative works from or distribute all or any portion of the PGD Services will constitute an illegal act.
9. Termination
1) Charles Bloe Training Ltd and MPS reserves the right to terminate the PGD Services at any time.
2) Termination of the PGD Services for whatever reason shall not lead to return of fees paid.
3) PGDPro.com shall be entitled to terminate the PGD Services with immediate effect if, in its reasonable opinion, the conduct of the Authorised User/superintendent pharmacist/pharmacy owner is considered by PGDPro.com to be prejudicial to the goodwill, reputation, standing of PGDPro.com.
