Internet Pharmacy Flashcards
How does principle 3 of the pharmacy standards relate to internet pharmacies?
Principle 3: The environment and condition of the premises from which pharmacy services are provided, must safeguard the health, safety and wellbeing of patients and the public
1 - website should be clear, accurate and updated regularly. it should not be misleading
2 - any business hosted on the website, or reached by an external link, must be legitimate
3 - assurance is needed that all prescribers (medical or non-medical) follow the relevant consultation, assessment and prescribing guidance
4 - prescribers must only prescribe drugs in their competence and for the benefit of the patient
5 - the website should be arranged so POMs can only be given after an appropriate consultation with a prescriber, and the prescriber has the final say
6 - the website should prominently display:
= GPhC registration number, name of the owner, email and phone number
How does principle 4 of the pharmacy standards relate to internet pharmacies?
Principle 4: The way in which pharmacy services, including the management of medicines and medical devices, are delivered safeguards the health, safety and wellbeing of patients and the public
1 - transparency and choice
= explicit consent must be given for prescribing services
2 - managing medicines safely
= decide which medicines are safe to be sold at a distance, make sure the pharmacy staff can check the patients are who they say they are, make sure patients know who they can contact for help
What products cannot be sold by internet pharmacies unless safeguards are in place? What is required if they are supplied?
antimicrobials – due to antimicrobial resistance
medicines liable to abuse, overuse or misuse, or risk of addiction
- e.g. opiates, sedatives, laxatives, pregabalin, gabapentin
medicines that require ongoing monitoring or management
- e.g. narrow therapeutic index
non-surgical cosmetic medicinal products
- e.g. botox
If any of these are supplied full patient information is needed, including GP details and their consent to contact the GP about the prescription
What is an internet pharmacy?
a registered pharmacy which offers to sell or supply medicines (or other pharmaceutical products) and/or provides other professional services over the internet, or makes arrangements for the supply of such products or provision of such services over the internet
sale of GSL, P medicines and POMs
What are the issues with internet pharmacies?
may not be prescribed by a healthcare professional
may be no checks and controls on quality and effectiveness of medicines supplies (fake or counterfeit)
may be no legal recourse in the event of a problem (not effective or causes harm) especially if supplier is outside of the UK
introduces a culture of self-diagnosis and self-treatment
What must the pharmacy website display?
name of the owner of the business
address of the pharmacy at which the business is conducted
where applicable, the name of the superintendent pharmacist
information about how to confirm the registration status of the pharmacy and pharmacist
how to make a complaint about the on-line service
What can be included in the pharmacy website as good practice?
use of the GPhC Pharmacy logo
- can click on the logo – connect to GPhC and verify registration details of both the pharmacy and pharmacist(s) behind the website
front page of participating websites
issued with a html code for the logo
premises registration number is at the bottom and unique to each pharmacy
How does the MHRA regulate internet pharmacies?
MHRA enforcement team will:
- monitor internet sites
- focus on advertising and supply of POMs in UK
- will remove site and prosecute those responsible
- work with police, ISP’s, DoH and GPhC
How must patient choice be protected?
patients must be free to access pharmaceutical services wherever they wish
- patient or carer can request the prescriber to send the prescription to a particular pharmacy (should record that the request came from the patient)
How must the supply of medicines to patients be made?
patients are entitled to expect the same quality of pharmaceutical care whether they are face-to-face or online with the pharmacist
must:
- ensure advice/counselling is available for all medicines for their safe and effective use
- inform patients of the identity of the pharmacist assuming professional responsibility for their supply
How should overseas prescriptions be made?
prior to overseas supplying:
- must have legally valid prescription
- must consider any licensing differences or legal class changes
= inform patient - must give appropriate information and advice
- must meet any legal requirements for exporting medicines
- must ensure safe, secure delivery
- must ensure any professional indemnity insurance arrangements adequately cover the supply of medicines and provision of pharmaceutical advice to overseas patients
How should records be kept? What is required?
sufficient records should be kept to guard against misuse or abuse of medicines
must have a clear audit trail from initial request to supply, dispatch and delivery
requirements:
- customer identity, medicines requested and supplied, information upon which decisions to supply were made, on-line consultations, identity of pharmacist who has assumed professional responsibility for supply of a medicine
Where can internet pharmacies export medicines to?
can export to hospitals, clinics, pharmacies, wholesale businesses
can export overseas if the prescribers are registered in the UK or EEA and the medicines have a UK MA
Before exporting need to check with
- the embassy of the recipient country whether an import certificate is needed
- the MHRA for any export certificate requirements
How long should records be kept for the export of medicines?
must be kept of every wholesale transaction for 2 years
it is good practice to make an appropriate entry in the prescription record book
Which medicines can be exported?
may export a POM by wholesale dealing or via a prescription
may export CDs but would need a Home Office license
- Sch 2 = need an entry in CD register
- Sch 3 and 4 Part 1
- Sch 4 Part II = no license needed if exporting the drug in the form of a medicinal product and is for self-administration
individuals may need to apply for personal licenses in certain circumstances, but not if carrying less than 3 months supply of CD