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Saaliha - Pharmacy Law and Ethics > Pharmacy Services at a distance > Flashcards

Pharmacy Services at a distance Flashcards

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1
Q

Different ways to provide a pharmacy service

A
  • Traditional
  • Distance selling
  • Internet

Same laws apply

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2
Q

What is a ‘traditional’ pharmacy service?

A

All parts of the service are provided at the same registered pharmacy

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3
Q

Examples of when traditional activities are carried out at diff registered pharmacies or places

A
  • Rx not handed in by pt, but collected by pharmacy staff or received by post or electronically
  • Delivery service from registered pharmacy to patients homes/care/nursing homes
  • Collection and delivery service
  • Click and collect service
  • Mail order service from registered pharmacy
  • Internet pharmacy service including ones linked to online prescribing service
  • Hub and spoke pharmacy service

DONT NEED TO MEMORISE THESE, JUST BE AWARE FOR DIFFERENCES

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4
Q

Problems with accessing POM illegally from internet without prescription

A
  • may not be prescribed by HCP
  • may be no checks and controls on quality or effectiveness of meds
  • may be no legal recourse in the event of a problem
  • introduces a culture of self diagnosis and self treatment
  • supply of certain meds not regulated
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5
Q

Falsified Medicines Directive

A
  • brought in to address the issues of falsified medicines directives in med supply chain across Europe
  • All packs of prescription med placed on market in Europe has to bear two safety features: a unique identifier (IU) in the form of a 2D data matrix barcode and an anti-tamper device (ATD)
  • FMD applied to POMs for human use, NHS and private supplies
  • FMD does not apply to OTCs, medical devices, specials and vet meds
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6
Q

Scanning authentication process in Falsified medicine directive

A
  • manufactures will upload unique identifier on European med verification system, act as a hub linking national systems together
  • data can then be accessed via a national data base and enable verification and authentication of packs by pharmacy teams
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7
Q

Pharmacist Requirements in FMD

A

Verify authentication: check anti tamper device is intact, scanning IU on barcode on pack to receive a status message confirms authenticity, inactive means cannot be supplied

  • decommission the UI- changing status from a active to inactive dispensed fore very pack before supplied
  • hospitals and dispensing doctors will be exempt from these requirements and wholesalers will have to carry out these steps for them
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8
Q

Opening an Internet Pharmacy

A
  • dont need to notify NHS agency to justify opening an internet pharmacy
  • need to identify suitable premises
  • if you want to dispense NHS prescriptions you need to be included in the local pharmaceutical list
  • need to apply for NHS dispensing contract
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9
Q

NHS dispensing contract application

A

need to put in an application that pharmacy premises secure the uninterrupted provision of essential services during open hours of premises to persons anywhere in England who requested them
~£750 to submit application
-once application is approved, have 6 months to open, need to be approved by GPhC

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10
Q

What are essential services?

A

dispensing med, dispensing appliances, repeat dispensing, clinical governance, sign posting, disposal of unwanted meds

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11
Q

Key points of internet pharmacy

A
  • must be no face to face contact between patients and pharmacy staff for delivery of essential services
  • prescriptions are not handed in by patients but are collected, received by post or electronically
  • patients are allowed to access pharmacy but only for non-essential services like MURs, NMS
  • must be willing to supply medication against a prescription to anyone in England (however, if anyone arrives to the pharmacy with a prescription they must be turned away
  • cant charge for delivery of prescriptions
  • pharmacy needs RP in charge of pharmacy who needs to be present during sale and supply of P meds and POMS; preparation, assembly labelling,
  • if there is a delivery service, handover to delivery person of a P or POM needs to take place in the registers pharmacy under RP supervision
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12
Q

Pros of Internet pharmacy

A

For Pharmacists: Offers pharmacists an opportunity to own their own pharmacy without having to buy and existing business
-offers chance for pharmacies to be built in a real where community pharmacies are not traditionally located

For patients: ease, convenience, increased choice, anonymity, general chaperons costs

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13
Q

Cons of Internet Pharmacy

A

For Pharmacists:

  • lack of patient contact
  • making the case to use you rather than walk into local pharmacy

For patients:

  • Confusion over which are legal websites
  • difference in appearance of package and in drug names -fakes, counterfeits
  • can obtain meds without clinical checks
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14
Q

Risk assessment of internet pharmacies for GPhC

A
  • identify and manage risks
  • should cover the whole pharmacy process including staff working
  • how staff tell patients and the public about the pharmacy services, and how they get their consent
  • how staff communicate between locations
  • med supply including counselling and delivery
  • business capacity to provide proposed services
  • record keeping
  • if there is online prescribing service
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15
Q

Internet pharmacies and prescribing services

A

some internet pharmacies can work alongside prescribing services; this includes a private online prescribing service based in GB or one located abroad w a prescriber who is not registered with GMC

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16
Q

If working with a prescriber outside UK, should make sure that

A
  • they manage the extra risks that this might create
  • they have sufficient indemnity insurance in place
  • prescriber is registered in home country and can lawfully issue prescriptions online to people in UK
  • prescriber is working with national guidelines of UK
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17
Q

Regular Audit

A
  • should be part of the evidence which gives assurance that shows your pharmacy continues to provide safe pharmacy services
  • concerns staffing levels and training within the team
  • suitability of communication with patients and between other staff members
  • systems and processes for receiving scripts
  • record keeping
  • systems and process for secure delivering to patients
18
Q

take a reactive review if regular audit identifies a problem of when any of the following happens

A
  • change in law affecting any part of pharmacy service
  • significant changes in any of the pharmacy service you provide
  • data security breach
19
Q

Accountability-staff

A
  • need to understand who is accountable for what service and who is involved in processes
  • this is included when things go wrong or if third party is involved
20
Q

Record Keeping

A
  • when there is no face to face, staff must record what goes wrong to prove that service provided is safe
  • Standard legal records, but also consider the following:
  • decisions to make or refuse sale
  • any info about pharmacy services on website
  • data protection law
  • feedback from people who use service
  • concerns or complaints received
  • activities of third parties, agents
21
Q

Trained and competent staff

A
  • Need to ensure staff are empowered and competent to safeguard the health, safety and well-being of patients and public
  • Consider extra training in the following areas:
  • information security management (patient data protection/cyber security)
  • communication skills for non face to face consultations with patients and prescribers
  • use specialised equipment and new technology
  • document and keep evidence of training that has been done
22
Q

Premises

A
  • must meet the standards for registered pharmacy as set out by GPHC
  • must be fit for the purpose to reflect scale of work done e.g. have enough space to automate activities like dispensing, have a consultation room for non-essential services, preparing and sending meds

- must be fit for purpose to reflect scale of work being done

23
Q

Website

A
  • if you sell P med on internet, make sure only displayed on website associated with registered pharmacy
  • design and layout of website should look professional
  • website must be secure and follow laws on data protection
  • all info must be clear, accurate and updated regularly, and it must no be misleading in any way
  • make sure that any business that is either hosted on your website, or reached by an external link, is legitimate
  • show how you are assured that all prescribers follow relevant remote consultation, assessment and prescribing guidance
  • make sure that your website and websites your associated with are arranged so the patient cannot choose POM and quantity before having a consultation with prescriber to ensure appropriateness
24
Q

Website must clearly display

A
  • GPhC pharmacy registration number
  • name and owner of pharmacy
  • name and address of registered pharmacy that supplied med
  • where applicable, name of SIP
  • details of registered pharmacy were meds are prepared, assembled, dispensed and labelled (if different to where supply is made)
  • info about how to check registration status of pharmacist and SIP if there is one
  • email address and phone number of pharmacy
  • details on how patients can give feedback and raise concerns
25
Q

if person is prescribed meds following an online consultation, your website should prominently display

A
  • name of prescriber and address of prescribing service
  • prescribers reg number and country their registered in
  • whether prescriber is doc or non medical independent prescriber, and their role
  • info on how to check registration of prescriber
26
Q

Website Logo - “Distance Selling Logo” from MHRA and GPHC logo

A
  • needs to be registered with MHRA and be on MHRA list of uk register online retail sellers
  • must display compulsory distance selling logo on every page of website offering meds
  • when the logo is clicked on, it will divert to a page showing a list of all approved UK-registerd online retail sellers on MHRA website
  • GPhC logo voluntary, put on front page of websites, has “registered pharmacy” and reg no, when clicked on will show proof of GPHC registration
27
Q

Transparency and patient choice

A
  • patients must be free to access pharmaceutical services wherever they wish , and have enough info to make informed decisions about their meds and the pharmacy services they use
  • must not get into agreement with prescriber that would limit patients choice
  • patients must be able to identify which pharmacy they are involved with and be satisfied they have consented to this
  • explicit consent for prescribing service that is associated with internet pharmacy
28
Q

Managing Meds Safely

A
  • think of what meds are safe for supplying at distance
  • make sure that person who is receiving pharmacy services is who they claim to be, carrying out appropriate identity check
  • ensure advice is available for all meds
  • provide counselling on safe and effective use
  • awareness of abuse potential - requests for large quantities, tracing sales through record keeping
  • ensure patients can ask questions and they know who to ask questions
  • be able to sign post elsewhere for face to face interactions if believed to be better
  • prescribers must be aware that some meds are not suitable to supply online unless safeguards have been placed to make sure its clinically appropriate
29
Q

Examples of meds not appropriate to prescribe for independent pharmacy

A
  • ABx
  • meds liable to abuse (opiates, sedatives, laxitivites)
  • meds require ongoing management and monitoring (insulin, warfarin, lithium, epilepsy)
  • non surgical cosmetic products (botox)
30
Q

Supplying meds safely

A
  • need to make sure meds are supplied to correct person when they need them
  • think of delivery method
  • make sure delivery method safe guards patient confidentiality, safe and appropriate condition delivered
  • need to assess suitability of packing
  • obtain consent to provide delivery service
  • check laws of import or export if patient is outside of UK
31
Q

Info for pharmacy users

A
  • pharmacists should contact patients on med correct use as there is no face to face
  • ensure generic health advice is up to standard and up to date
  • info of meds includes contraindications and side effects etc
  • product recommendations are given in respect to individual patients
  • signposting
32
Q

Specialist equipment and facilities

A

eg. automated dispensing systems, labelling equipment
- high specification, accuracy and security
- calibrated, maintained and serviced regularly
- latest security specifications

33
Q

Regulation of Internet Pharmacy by MHRA

A

MHRA enforcement team

  • monitors internet sites
  • focus on advertising and supply of POMS
  • will remove site and prosecute those responsible
  • work with police, ISPs, DoH, GPHC to ensure sale and supply of meds is legit
34
Q

Export of Meds

A

Pharmacist may supply POM wholesale dealing or with prescription

  • if prescription doc must be UK or EEA/Swiss but drug must have uk MA
  • can export to hospital, clinics, pharmacies, wholesale business
  • before exporting need to check with the embassy of country whether import certificate is needed, and with MHRA for any export certificate requirements. Should check whether any packing or labelling requirements are necessary for postage and custom purposes
  • Records need to be kept of every wholesale transaction for 2 years - good practice to record in POM register, legal if private Rx
  • Wholesale export of CDs needs a Home Office license
35
Q

Records for Export of MEd

A

Must be kept of every whole sale transaction for two years, good practice to put in POM register

36
Q

Export on prescription

A

individuals may need to apply for person licences in certain circumstances, but not if carrying less than 3 months supply of CD.

37
Q

Drug Donations to developing countries only satisfactory if

A
  • medicines donated are considered wholesale transactions
  • no obsolete drugs
  • only drugs estimated to have shelf life of 1 year after arrival in country
  • no patient returns
  • consider alternatives:
  • In acute phase of emergency, standardised health kids of meds recommended for donation
  • Donation of cash more useful than drugs after acute phase
  • Inter Care: medical aid for Africa
38
Q

What is a traditional pharmacy service

A

Where all parts of service are provided at the same registered pharmacy

39
Q

Examples of advanced and enhances services

A

CPCS, flu vax, pharmacy contraception service, hypertension case-finding service, NMS, smoking cessation

40
Q

Requirements if online prescribing service

A
  • qualifications of professionals involved
  • online consult process is of the same clinical standard as f2f
  • making it clear from the start that supply of the product, whether POM, P or GSL, is depending on clinical reviewing suitability as part of consultation
  • ensuring POMs cannot be prescribed without thorough consultation an disport from appropriate clinician
  • any algorithms used in clinical decision making process are registered with MHRA and meet NHS Digital Standard
  • algorithms need to be centres on medical condition, not product

Saaliha - Pharmacy Law and Ethics (32 decks)

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