Guidance For Registered Pharmacies Providing Pharmacy .
Guidance forregistered pharmaciesproviding pharmacyservices at a distance,including on theinternetApril 2019
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ContentsAbout this guidance . 4Introduction . 7Guidance for registered pharmacies providing pharmacy services at a distance,including on the internet . 8Principle 1 .8Principle 2 . 12Principle 3 . 13Principle 4 . 15Principle 5 . 20Other useful sources of information . 21
April 2019About thisguidanceThe General PharmaceuticalCouncil (GPhC) is theregulator for pharmacists,pharmacy technicians andregistered pharmacies inEngland, Scotland andWales. As part of our role,we set the standards thatpharmacy professionalshave to meet throughouttheir careers.This guidance explains whatpharmacy owners should considerbefore deciding whether any parts oftheir pharmacy service can beprovided safely and effectively at adistance (including on the internet),rather than in the traditional face-toface way.As the pharmacy owner, you are responsible formaking sure this guidance is followed. Everyonein the pharmacy team, including managers withdelegated responsibility and the responsiblepharmacist, should understand the guidanceand be aware of their responsibilities to followit. If the registered pharmacy is owned by a‘body corporate’ (for example a company or anNHS organisation) you should make sure thesuperintendent pharmacist understands itshould be followed.You should read this guidance alongside thestandards for registered pharmacies, whichpharmacy owners must meet, and ourInspection decision making framework. Thestandards for registered pharmacies are aboutcreating and maintaining the right environment,both organisational and physical, for the safeand effective practice of pharmacy.Our standards for pharmacy professionalsdescribe how safe and effective care is delivered4Guidance for registered pharmacies providing pharmacy services at a distance,including on the internet
through ‘person-centred’ professionalism.Therefore, you must be familiar with thosestandards, and also the guidance we havepublished on our website to help pharmacyprofessionals apply our standards and meettheir professional obligations.Pharmacy owners must also make sure theykeep to all the laws that apply to pharmacies.This includes the law on supplying andadvertising medicines, new consumerinformation for online sales, and dataprotection.Following this guidance is an important part ofmaking sure you meet our standards forregistered pharmacies. These are groupedunder five principles, which we refer tothroughout this guidance. We therefore expectthis guidance to be followed.Not following this guidance, or not taking theappropriate steps to achieve a desired outcomeunder our standards, could mean that you failto meet one or more of the standards forregistered pharmacies. This could result in ourtaking enforcement action.In this document, when we use the term ‘staff’this includes: employees (registrants and non-registrants) agency and contract workers, andIn this document, the term ‘you’ means thepharmacy owner.In some limited circumstances (for examplefollowing death or bankruptcy), a representativemay take the role of the pharmacy owner. Inthese cases, the representative will beresponsible for making sure these standardsare met.Examples of the pharmacy services covered bythis guidance include:1.a pharmacy service where prescriptionsare not handed in by people usingpharmacy services but are collected bypharmacy staff, or received by post orelectronically2.a delivery service from the registeredpharmacy to people in their own home, acare home or a nursing home3.a collection and delivery service4.a ‘click and collect’ service5.a mail-order service from a registeredpharmacy6.an internet pharmacy service, includingone linked to an online prescribing service,whether or not the prescribing service isowned and operated by you or by a thirdparty business any third party who helps the pharmacy7. a ‘hub and spoke’ pharmacy service –provide any part of the pharmacy service,where medicines are prepared,and deals on behalf of the pharmacy ownerassembled, dispensed and labelled forwith people who use pharmacy servicesGuidance for registered pharmacies providing pharmacy services at a distance,including on the internet5
April 2019individuals against prescriptions at acentral ‘hub’ registered pharmacyTypes of pharmacy servicesCollection and deliveryA collection and delivery service is defined inRegulation 248 of the Human MedicinesRegulations 2012.Click and collectThis usually refers to the service where acustomer can buy or order goods from astore's website and collect them from a localbranch.Hub and spokeThe dispensed medicines are supplied bythe ‘hub’ to ‘spokes’ or delivered direct topatients in their homes or to care homes.The ‘spokes’ may be other registeredpharmacies; or non-registered premises,where patients drop off their prescriptionsand from where they collect their dispensedmedicines.6Guidance for registered pharmacies providing pharmacy services at a distance,including on the internet
IntroductionBecause of changes in society and advances intechnology, different ways of providingpharmacy services are becoming morecommon. Pharmacy services will continue toadapt and change, bringing opportunities todeliver pharmacy and other healthcare servicesin new ways. We support and encourageresponsible innovation as long as people usingthese services receive safe, effective andperson-centred care.But providing pharmacy services at a distance,especially online, carries particular risks whichneed to be managed. We want this guidance tosupport appropriate provision of medicines,medical devices and pharmaceutical care, whichkeeps to the law and meets our standards.The same laws apply whether you providepharmacy services in a traditional face-to-faceway, at a distance, or on the internet. Forexample: if you offer a delivery service, thehandover to the delivery agent of a pharmacy(P) or prescription-only (POM) medicine musttake place at a registered pharmacy under thesupervision of a pharmacist.If you sell or supply medicines to people inother countries you must keep to any other1laws that apply. Countries have differentrestrictions and some do not allow the onlinesupply of medicines at all. It is yourresponsibility to make sure the medicine yousupply has the marketing authorisation neededfor it in the country of destination1.If you sell or supply medicines for animal use,the parts of the law that apply – and theexemptions that allow this – are coveredelsewhere2. The Veterinary MedicinesDirectorate (VMD) licenses and approvesanimal medicines and issues guidance onsupplying medicines for animals. The VMD alsooperates a voluntary accredited internetretailer scheme (AIRS) for online retailers ofveterinary medicinal products. The aim of thescheme is to provide assurance to the publicthat they are buying veterinary medicinalproducts from a reputable UK-based retailer.The NHS Regulations in England3 include anumber of specific situations that allowdistance-selling pharmacies to open andoperate. In Scotland4 and Wales5 the regulationsare not the same. However, they do not preventpharmacies that are already open fromproviding pharmacy services at a distance or onthe internet.4Regulation 28 of the Human MedicinesThe National Health Service (Pharmaceutical(Amendment) Regulations 2013Services) (Scotland) Regulations 200925Veterinary Medicines Regulations 2013The NHS (Wales) Act 20063The National Health Service (Pharmaceuticaland Local Pharmaceutical Services) Regulations2013Guidance for registered pharmacies providing pharmacy services at a distance,7including on the internet
April 2019Guidance for registered pharmaciesproviding pharmacy services at adistance, including on the internetThe standards for registeredpharmacies are grouped under fiveprinciples, and this guidance is setout under each of the five principles.Principle 1: The governancearrangements safeguard thehealth, safety and wellbeing ofpatients and the public.You should review your risk assessmentregularly and whenever circumstances change –for example, when you make significantbusiness or operational changes (also seesection 1.2).To meet the standards under Principle 1 weexpect you as the pharmacy owner to makesure:1.you gather evidence about the risks foreach individual service, medicine andmedical device that you provide at adistance, including on the internet, beforeyou start providing the service2.your risk assessment includes considering:1.1 Risk assessmentThe provision of pharmacy services at adistance, particularly online, carries particularrisks by its nature.A risk assessment will help you identify andmanage risks. It is a careful and thorough lookat what in your work could cause harm topeople who use pharmacy services, and whatyou need to do to keep the risk as low asreasonably practicable.Risk assessments may apply across wholeorganisations but still need to take into accountthe circumstances of each individual pharmacy.This includes the staff working in it; the activitiesof third parties, agents or contractors; and eachindividual part of the pharmacy service youintend to provide. It should cover the wholeservice.8 the risks you have identified and howthese will be managed how staff tell people about thepharmacy services they will receive,and how they get their consent how staff communicate betweendifferent locations how medicines are supplied, includingcounselling and delivery (see section4) your business’s capacity to provide theproposed servicesGuidance for registered pharmacies providing pharmacy services at a distance,including on the internet
business continuity plans, includingfor your website, data security, andequipmentWorking with prescribers who are notappropriately registered with the relevantUK professional regulator, and withprescribing services not based in the UK,could create significant extra risks forpatients and the public. If your servicelawfully involves working with prescribersor prescribing services operating outsidethe UK, you should make sure that: what records you will keep, dependingon the nature of the pharmacyservices you provide the behaviour of people usingpharmacy services or of staff different technologies operatingtogether, and you successfully manage the extrarisks that this may create changes in the number or scale ofservices you have sufficient indemnityinsurance in place to cover:3. your staff know the outcome of any riskassessment and contribute to itappropriately your service that uses prescribersor prescribing services basedoutside the UK, and4. any risk register you keep is kept up todate, and any actions you have taken arerecorded pharmacy staff supplyingmedicines against prescriptionsissued by these prescribers orprescribing services5. if parts of your pharmacy service are theresponsibility of several differentpharmacies and staff – or theresponsibility of a third party, agent orcontractor – you have considered how thesystems you use to provide yourpharmacy service work together. Thisincludes IT systems for exchanginginformation between different locations.You should also consider how you monitorthe accuracy of these systems andmanage any potential failures6. We expect you to make sure you do notwork with online providers who are tryingto circumvent the regulatory oversight putin place within the UK to ensure patientsafety throughout the healthcare system. the prescriber is registered in theirhome country where the prescriptionis issued and can lawfully issueprescriptions online to people in theUK the prescriber is working withinnational prescribing guidelines for theUK7. We expect you to make sure that anycross-border arrangements in your servicedesign are lawful under UK law.1.2 Regular auditThe safety and quality of pharmacy servicesmust be reviewed and monitored. You shouldcarry out a regular audit, at an interval that youGuidance for registered pharmacies providing pharmacy services at a distance,including on the internet9
April 2019can show to be appropriate for your pharmacyservices. The audit should be part of theevidence which gives assurance to people whouse your pharmacy that it continues to providesafe pharmacy services. Regular audits may becorporate wide, but still need to be relevant tothe circumstances of each individual pharmacy. any information about your pharmacyservices on your website how you keep to your informationsecurity policy, to the Payment CardIndustry Data Security Standard (PCI DSS)and to data protection law feedback from people who usepharmacy servicesIf you identify any issues, you should take actionto put them right. This may lead to you carryingout a ‘reactive’ review. You should record thisreactive review and say clearly when a new riskassessment needs to be carried out.To meet the standards under Principle 1 weexpect you as the pharmacy owner to makesure:1.your regular audit includes: staffing levels, the training and skillswithin the team, and any additionaltraining needed so that all staff have theappropriate skills and competence forthe tasks they carry out suitability of communication methodswith people using pharmacy services,and between staff and other healthcareproviders, including between hubs andspokes and with collection and deliverypoints systems and processes for receivingprescriptions, including the electronicprescription service (EPS) records of decisions to make or refuse asale systems and processes for securedelivery to people receiving care10 concerns or complaints received activities of third parties, agents orcontractors2.you show how your staff are involved in theaudit3.a reactive review is carried out when any ofthe following happens: you identify any issues during yourregular audit there is a change in the law affecting anypart of your pharmacy service there is a significant change in any partof the pharmacy service you provide,such as an increase in the number ofpeople you provide services to; or anincrease in the range of services youintend to provide; or a change in a thirdparty, agent or contractor you use there is a data security breach there is a change in the technology youuse concerns or negative feedback arereceived from people who use pharmacyservices a review of near misses and error logsidentifies a concern about an activityGuidance for registered pharmacies providing pharmacy services at a distance,including on the internet
4.your information security practices areaudited by independent experts,depending on the type of service youprovide1.3 Accountability – staffWhen parts of a pharmacy service take place atdifferent locations (such as in a ‘hub and spoke’or ‘click and collect’ service) you must be clearabout which pharmacist is accountable andresponsible for each part of the service, andwhich pharmacy technician and other staff areinvolved.When medicines are not given to the person ortheir representative in the registered pharmacy,but are delivered by a member of staff or anagent to the person’s home or workplace, theremay be more risk of medicines being lost ordelivered to the wrong person. You must makesure there are clear lines of accountability andresponsibility in these circumstances.If you contract out any part of your pharmacyservice to a third party you are still responsiblefor providing it safely and effectively. Youshould carry out ‘due diligence’ in selecting anycontractors.1.4 Record keepingYou must keep and maintain the necessaryrecords depending on the nature of thepharmacy services you provide. This includesmaintaining a daily log of the responsiblepharmacist.When a person has direct face-to-face contactwith pharmacy staff in a pharmacy, no recordsof the sale of P medicines are usually made. Andwhen a product is unsafe or unsuitable, and nosupply is made, staff tell the person but norecords are usually kept.When there is no face-to-face contact, youshould consider what information you and yourstaff record and keep to show that thepharmacy service you provide is safe. Therecords you keep are important evidence forthe judgements you and your staff make. Theycan also be a powerful tool for serviceimprovement and quality management.Although medicines law says how long youshould keep certain records, you should keepother records for as long as you consider, andcan show, to be appropriate.To meet the standards under Principle 1 weexpect you as the pharmacy owner to makesure:1.your records include: details of the staff who are accountableand responsible for providing each partof your pharmacy service the information and advice on usingmedicines safely that you give peoplewho use pharmacy services the key points on which you made thedecision to sell or not to sell a particularmedicine consent to use a particular deliverymethod, and the date of dispatch of themedicine information on complaints or concernsfrom people who use pharmacyservices and what you have done todeal with these IT records (see section 5)Guidance for registered pharmacies providing pharmacy services at a distance,including on the internet11
April 2019Principle 2: Staff are empoweredand competent to safeguard thehealth, safety and wellbeing ofpatients and the public.2.1 Trained and competent staffThe staff you employ, and the people you workwith, are key to the safe and effective practice ofpharmacy. communication skills to support staff inmanaging effective non-face-to-facecommunications with pharmacy usersand prescribers (for more informationon communications training, please seethe ‘Other useful sources ofinformation’ at the end of thisdocument) using specialised equipment and newtechnologyYou are responsible for creating a culture ofperson-centred professionalism within yourpharmacy. Incentives or targets must notcompromise the health, safety and wellbeing ofpatients and the public, or the professionaljudgement of staff. Staff should be empoweredto use their professional judgement so that theycan act in the best interests of the personreceiving your services.You must make sure that all staff are properlytrained and competent to provide medicinesand other professional pharmacy servicessafely. The GPhC has produced guidance toensure a safe and effective team. Theguidance explains what you should do to makesure you are meeting the standards underPrinciple 2 of the standards for registeredpharmacies.To meet the standards under Principle 2 weexpect you as the pharmacy owner to makesure:1.you provide, where appropriate extratraining in the following areas: information security management –how data is protected; and cybersecurity12Guidance for registered pharmacies providing pharmacy services at a distance,including on the internet
Principle 3: The environment andcondition of the premises fromwhich pharmacy services areprovided, and any associatedpremises, safeguard the health,safety and wellbeing of patientsand the public.3.1 Your premisesYou must make sure your pharmacy and thepremises you use for any part of your pharmacyservices meet the standards for registeredpharmacies.Your registered pharmacy must be fit forpurpose to reflect the scale of the work you do.If you automate certain activities, there must beenough space to use automated dispensingsystems safely. You must have suitable areas inyour registered pharmacy to send medicines topeople safely.3.2 Your websiteIf you sell and supply P medicines on theinternet, you must make sure that these aredisplayed for sale only on a website that isassociated with a registered pharmacy. Thiscould be under a service-level agreement orsome other arrangement. The public may beable to access the site directly or through athird-party site.Your website should be secure, and followinformation security management guidelinesand the law on data protection. This isparticularly important when you ask peopleusing pharmacy services for personal details.You should make sure that your website hassecure facilities for collecting, using and storingpharmacy users’ details and a secure link forprocessing card payments, for example, asecure link that meets the Payment CardIndustry Data Security Standard (PCI DSS). Formore information on the use and storage ofdata, see the ICO website.To meet the standards under Principle 3, asthe pharmacy owner:1. We expect you to make sure your website isclear, accurate and updated regularly. Itshould not be misleading in any way. Yoursite may include information aboutmedicines, health advice and links to otherinformation sources such as relevanthealthcare services and other regulators.However, your site should be clear and notmislead pharmacy service users about theidentity or location of the pharmaciesinvolved in providing your pharmacyservices. This includes the identity andlocation of any online prescribing service.2. We expect you to make sure that anybusiness that is either hosted on yourwebsite, or reached by an external link, islegitimate. This includes any onlineprescribing service. Businesses you link tomust be registered with the appropriateregulator such as the Care QualityCommission (CQC), HealthcareImprovement Scotland (HIS) or the HealthInspectorate Wales (HIW) and meet therelevant national regulatory standards andrequirements.3. We expect you to be able to show how youare assured that all prescribers, whethermedical or non-medical, follow the relevantGuidance for registered pharmacies providing pharmacy services at a distance,including on the internet13
April 2019remote consultation, assessment andprescribing guidance. (for more informationon prescribing, please see the ‘Other usefulsources of information’ at the end of thisdocument)4. Under the good practice guidance,prescribers must prescribe drugs only whenthey: have adequate knowledge of theperson’s health, and are satisfied that the drugs serve theperson’s need5. We expect you to make sure that yourwebsite and the websites of companies youwork with are arranged so that a personcannot choose a POM and its quantitybefore there has been an appropriateconsultation with a prescriber. It should bemade clear that the decisions abouttreatment are for both the prescriber andthe person to jointly consider during theconsultation. However, the final decisionwill always be the prescriber’s.6. We expect you to make sure your websiteprominently displays: the pharmacy’s GPhC registrationnumber your name as the owner of theregistered pharmacy the name of the superintendentpharmacist, if there is one the name and physical address of theregistered pharmacy or pharmaciesthat supply the medicines14 the email address and phone number ofthe pharmacy details of the registered pharmacy wheremedicines are prepared, assembled,dispensed and labelled for individualpatients against prescriptions (if any ofthese happen at a pharmacy differentfrom that supplying the medicines) information about how to check theregistration status of the pharmacy – andthe superintendent pharmacist, if thereis one details of how users of pharmacyservices can give feedback and raiseconcernsIf the person is prescribed medicinesfollowing an online consultation, yourwebsite should also prominently display: the name of the prescriber and theaddress of the prescribing service the prescriber’s registration number andthe country they are registered in whether the prescriber is a doctor or anon-medical independent prescriber –for example a pharmacist, nurse orphysiotherapist information about how to check theregistration status of the prescriber7. We expect you to make sure you considerthe design and layout of your website andmake sure that it works effectively andlooks professional.Guidance for registered pharmacies providing pharmacy services at a distance,including on the internet
The Distance Selling Logo and GPhCinternet logoIn July 2015, the MHRA launched thecompulsory EU common logo, now known asthe ‘Distance Selling Logo’. If you intend tosell or supply any General Sales List (GSL),POM or P medicines on the internet youmust apply to the MHRA for this logo anddisplay it on every page of your website. Youwill need to meet all the conditions set out inthe law before the MHRA will register you intheir list of UK-registered online retail sellersand give you the Distance Selling Logo fordisplay. (The Distance Selling Logo must alsobe displayed on the websites of nonpharmacy retailers of GSL medicines.)You may also apply to use the voluntaryGPhC internet logo on your website. Thelogo links directly to the GPhC register entryfor your pharmacy. You can have thevoluntary GPhC internet logo only once youhave applied for, and been given, the MHRADistance Selling Logo. The GPhC internet logocan be displayed only on your own website.You must not allow it to be used by a thirdparty, prescribing or other website.Principle 4: The way in whichpharmacy services, including themanagement of medicines andmedical devices, are deliveredsafeguards the health, safety andwellbeing of patients and thepublic.4.1 Transparency and choicePeople receiving care have the right to makedecisions about their care and medicines, andthe services they want to receive. This includesbeing able to choose where they want theirmedicines supplied from. Pharmacyprofessionals must give the person receivingcare the information they need so they canmake an informed decision about theirmedicines and the pharmacy services they use.Your pharmacy service may be associated with amedical or non-medical prescribing service. Theprescribing service may be: one where you order and collectprescriptions from the doctor’s surgery onbehalf of people, or one where you receive prescriptions by postor electronically, or an online service that people can access onyour pharmacy website or by a link fromyour pharmacy websiteDistanceSelling LogoVoluntary GPhCinternet logoIf parts of your pharmacy services are providedat different locations you should explain clearlyto people who use pharmacy services whereeach part of the service is based. You shouldavoid any information that could mislead theGuidance for registered pharmacies providing pharmacy services at a distance,including on the internet15
April 2019user of the pharmacy service about the identityor location of the pharmacy or of any onlineprescribing service.In all cases, you and your staff must make surepeople receiving care explicitly consent to anypharmacy service you provide using theseprescribing services as set out in the ICO’sguidance on consent. This includes serviceslawfully provided by a prescriber not regulatedby a UK health professional regulator.To meet the standards under Principle 4 weexpect you as the pharmacy owner to makesure:1.you provide transparency to the peopleusing your pharmacy services, so thatthey: know who the responsible pharmacistis when their medicines or medicaldevices are supplied have enough information about theservice to make an informed decision,and can raise concerns about the qualityof the service, if they need to2.3.you provide information about theindemnity and regulatory arrangementsfor those prescribers who are not based inthe UK, especially if they are not regulatedby a UK health professional regulator4.2 Managing medicines safelySelling and supplying medicines at a distance,including on the internet, brings different risksto those of a ‘traditional’ pharmacy service. Youshould include these in your initial riskassessment (see section 1.1).To meet the standards under Principle 4 weexpect you as the pharmacy owner to makesure:1.you show the steps you have taken tominimise the risks you identify. Thisshould include how you: decide which medicines areappropriate for supplying at adistance, including on the internet make sure your pharmacy staff can: check that the person receivingpharmacy services is who theyclaim to be, by carrying out anappropriate identity check (forexample by keeping to theIdentity Verification andAuthentication Standard forDigital Health and CareServices, which provides aconsistent approach to identitychecking across online digitalhealth and care services) get all the information they needfrom people receiving pharmacyyou are able to show that yourarrangements with medical or nonmedical prescribers are transparent, anddo not: cause confl
the parts of the law that apply – and the exemptions that allow this – are covered elsewhere 2. The Veterinary Medicines Directorate (VMD) licenses and approves animal medicines and issues guidance on supplying medicines for animals. The VMD also operates a voluntary accredite
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includes 65,000 pharmacies representing most major retail pharmacy chains. For OptumRx pharmacies in Washington state, consult the list below. For information about pharmacies outside the state, please contact Customer Service at 1-888-901-4636
e_2_.pdf. Standards for registered pharmacies 6 Reised une 2018 Standards for registered . to exercise their professional judgement in the interests of patients and the public 2.4 There is a culture of openness, honesty and learning
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