• Pharmacy Regulation
• Current Issues
• Opening Hours
• Disability Discrimination Act (DDA) 1995 / Equality Act 2010
• Fitness to Practise
• Control of Entry
• Responsible Pharmacist
• Rural Issues

• Sign up for
  email list
• Feedback to PSNC
• RSS Feeds
• Services
  database
• LPC and Regional
  Websites
• LPC members only

Internet Pharmacy FAQ's

Any person considering establishing an internet pharmacy service, as part of their existing contract, or under the exemption from control of entry must ensure that their systems comply fully with all the requirements.

The following Q & A paper has been prepared by staff at the Pharmaceutical Services Negotiating Committee, to provide advice to Local Pharmaceutical Committees and pharmacy contractors on the legislation and guidelines relating to mail order and internet pharmacy. In doing so, we are seeking to answer the many questions that have been asked of PSNC. The guidance combines legislative provisions, the professions' Code of Ethics, advice issued by the Royal Pharmaceutical Society and information provided by the NHS Counter Fraud and Security Management Service. We wish to thank both the RPSGB and the CFSMS for their assistance.

If you have any questions that are not answered within this paper, or if you require further assistance, please contact Steve Lutener

Registering an Internet Pharmacy

Is it possible to register a virtual pharmacy?
Part IV of the Medicines Act 1968 sets out requirements for registration of a pharmacy, and s74 defines a pharmacy as ‘premises for the time being entered in the register required to be kept under section 75 of this Act'. The guidance notes on the completion of the application form for registration under s75, issued by the Royal Pharmaceutical Society of Great Britain, requires the address of the premises, including the street and postcode to be stated. It follows that a pharmacy must be a building rather than a ‘virtual' site. Advice on registration of pharmacy premises can be obtained from the Royal Pharmaceutical Society's registration section.

Do I need to register as an internet pharmacy in order to conduct business over the internet?

Any person who wishes to sell or supply medicines other than general sales list medicines, must register as a pharmacy with the General Pharmaceutical Council. The GPhC register is available by clicking here. 

The GPhC is also able to supply an Internet Pharmacy logo to authenticate on-line pharmacies and details are available on the GPhC website.

To provide NHS services, a pharmacy must be included on a PCT pharmaceutical list (there are different arrangements for pharmacies wanting to provide services under a Local Pharmaceutical Services contract – see LPS section on Funding and Drug Tariff section of the website).

The following links on our website provide links to the Regulations (The National Health Service (Pharmaceutical Services) Regulations 2005 No. 641) http://www.psnc.org.uk/pages/pharmacy_regulation.html and The Control of Entry provisions under which new pharmacy premises may open http://www.psnc.org.uk/pages/control_of_entry.html The document entitled ‘DH guidance to PCTs on Control of Entry’ available for download on this page contains further information on the internet pharmacy (referred to as Distance Selling Premises in the Regulations) exemption to the Control of Entry test.

An existing ‘bricks and mortar’ pharmacy that is included on a PCT’s pharmaceutical list does not need to apply additionally for the ‘distance selling’ exemption in order to provide pharmaceutical services from its existing pharmacy via the Internet. The exemption is only necessary for those people who want to open a new pharmacy which is not already on the pharmaceutical list and which cannot satisfy the ‘necessary or expedient’ test. So, an existing pharmacy can provide goods and services via the Internet (so long as the pharmacy complies with the Medicines Act and NHS terms of service) from its existing bricks and mortar pharmacy.

There have been cases where existing pharmacy owners have applied for distance selling premises on the same site as a traditional bricks and mortar pharmacy. This may be due to a misunderstanding about what is required or it may be to set up to separate businesses on the same site. However, because the NHS pays establishment payments for each pharmacy, the regulations have been amended to ensure that only one pharmacy can be included on the pharmaceutical list on any one premises unless the PCT is satisfied that these are separate businesses is conducted by different persons.

Registration of Pharmacy Premises

I have a registered pharmacy, can I now dispense all prescriptions?
All pharmacies can dispense prescriptions issued privately. But, the National Health Service will fund the dispensing of NHS prescriptions only if those pharmacy premises are included in a pharmaceutical list maintained by a Primary Care Trust (see Regulation 4 of the National Health Service (Pharmaceutical Services) Regulations 2005).


I am not included in a Pharmaceutical List. Can I dispense an NHS prescription privately?
The NHS prescription form is the property of the NHS and should not be used for other purposes. In addition, for those patients from whom a prescription charge is due, the NHS would lose that part of its income, if the prescription is dispensed privately. The NHS has taken action, unsuccessfully, in the past, but could take action again, in the future.

Electronic Prescriptions & Prescription Messages 

Can NHS prescriptions now be sent electronically to internet pharmacies?
No, The POM Order was changed to allow prescriptions to be signed electronically using Advanced Electronic Signatures. This was done via the Medicines for Human Use (Prescribing) Order 2005 (SI 2005/765).

The change came into force on the 7th April 2005 and means that "a prescription, other than one given by a veterinary surgeon or veterinary practitioner, or for a controlled drug specified in Schedule 1, 2 or 3 of the Misuse of Drugs Regulations, does not have to be signed and written in ink if it is created in electronic form and signed with an advanced electronic signature and transferred to the person by whom it is dispensed as an electronic communication."

The legislation applies to both NHS and Private Prescriptions. Prescribers are free to continue to issue paper prescriptions.

However, Statutory Instrument 2005 No 893, NHS (Primary Medical Services) (Miscellaneous Amendments) Regulations 2005 which came into force on the 14th April 2005 amended the NHS (General Medical Service Contracts) Regulations 2004 to state that:

"39A. - (1) A prescriber may only order drugs, medicines or appliances by means of an electronic prescription if -

(a) the contractor holds a contract with a Primary Care Trust which is specified in directions issued by the Secretary of State under section 17 of the Act as being a Primary Care Trust which can authorise its contractors to use the ETP service[16];

(b) the patient to whom the prescription relates has -

(i) nominated one or more dispensers in his NHS Care Record,

(ii) confirmed that he intends to use that dispenser (or one of them) for the purposes of obtaining the drugs, medicines or appliances ordered on the electronic prescription in question, and

(iii) consents to the use of an electronic prescription on the particular occasion; and

(c) the prescription is not -

(i) for a controlled drug within the meaning of the Misuse of Drugs Act 1971[17], other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001[18],

(ii) for supply by instalments under paragraph 39(4), or

(iii) a bulk prescription issued for a school or institution under paragraph 44."

This means that General Medical Services contractors will only be able to send (legal) prescriptions electronically if they have been authorised by their Primary Care Trust. Primary Care Trusts can only authorise their GMS contractors if they are specified in Directions issued by the Secretary of State. No such Directions have yet been issued.

If the prescriber prints off an NHS prescription which he signs but also sends a message electronically with information on the content of the NHS prescription, can I dispense against the electronic message?
No, as until the Secretary of State issues directions to allow prescribers to create legal electronic NHS prescriptions, electronic messages being sent can not be considered a valid NHS prescription, and therefore there is no authority to supply a POM on its receipt. A pharmacist should supply only against the hard copy prescription produced and signed by the prescriber.


Does the hard copy need to be in my possession before I supply the POM?
As the Act requires the supply to be in accordance with the prescription, it would be usual to have possession of the prescription before supply.

However, if the pharmacist is sure that the prescription has been printed and signed and contains all the necessary information to be valid, he can supply it without it actually being in his possession (unless the prescription orders a controlled drug in which case he must have possession). There are considerable dangers in dispensing before the prescription is in the possession of the pharmacist. These include:

• All prescriptions against which a POM is supplied must be preserved by the pharmacy for two years from the date of supply. There is an exemption for NHS prescriptions, but the pharmacist is required to submit prescriptions to the pricing division not later than the fifth day of the month following that in which the supply was made
  
• If a prescription is not retained (or in the case of an NHS prescription sent to the pricing division), then the pharmacist would be unable to show that his supplies of POMs were in accordance with valid prescriptions. Prosecution and / or disciplinary action could result
  
• If the prescription is handed to the patient by the prescriber, and this is taken to another pharmacy, the patient may obtain duplicate supplies.
  
• If the prescription is amended by the prescriber between being generated and received at the pharmacy, and the pharmacist has already supplied the POM, then the supply would not be in accordance with the prescription

• If the prescription has not actually been printed off and signed at the time at which the supply is made, there is no valid prescription, and a criminal offence is committed, even if the prescription is produced and signed later. The exception, for emergency supplies, requires the prescriber to request the pharmacist to dispense and by reason of some emergency he is unable to furnish a prescription immediately, a record has to be made in the prescription register, an undertaking has to be given by the prescriber to furnish the prescription within 72 hours, and the pharmacist must make an annotation in the prescription register of the date the prescription is received. Therefore, it is highly unlikely that this could work in relation to remote pharmacies because there has to be some reason why the patient must be treated so urgently that an emergency exists - with remote pharmacies, the time taken to deliver the dispensed medicines would suggest that there was no such pressing emergency).
  
• If the pharmacy does not receive the prescription, then the pharmacist who dispensed the prescription only medicine could be prosecuted or referred for disciplinary action by the RPSGB. There have been Statutory Committee cases for example in which telephoned requests for items to be dispensed have not resulted in the production to the pharmacy of a valid prescription.
  

I have heard that some pharmacies have set up a practice of dispensing against a fax and the RPSGB accepts this. What difference does a fax make?
The RPSGB is aware of two basic schemes involving dispensing against a fax. The first involves a scheme where the prescriber routinely sends a fax to the pharmacy, so that it can be dispensed, and hands the original to the patient for transmission to the pharmacy (or agrees to post in a day or so). The second involves arrangements, mainly between a contract and non-contract pharmacy, where the non-contract pharmacy sends the fax to the contract pharmacy for dispensing, prior to returning the dispensed item to the non-contract pharmacy for supply to the patient.

In the latter case, the system is closed and secure. The pharmacist receiving the fax can be confident that the medicine will not be handed to a patient in the absence of a prescription, and that the prescription will not be altered before dispensing. In the former case, certain safeguards can be built in to try to prevent the potential problems.

The benefit of a fax, is that the pharmacist can see the prescription, and the signature, and therefore most importantly of all, know that the prescription has been printed and signed, and that the prescription is in existence, but the potential for forgeries or for the prescription to be taken or sent to another pharmacy still exist.

Collecting the Exemption Information

If the prescription comes later in the post can we sign on behalf of the patient, if we are told the exemption status by the patient?
This issue is governed by the "Law of Agency" This states that a representative, in this case the pharmacy acts as if they are an extension of the patient. Consequently any liabilities incurred by acting as an "agent" are in fact liabilities of the patient. All liabilities for penalties will always be that of the patient.

The reason for this is that the patient is the original source of information which is provided to the pharmacy and the ultimate beneficiary of a free prescription. Therefore, if the information is incorrect the patient will be liable, not the pharmacy.

In order to act as agent for the patient, the pharmacist would need to be sure that the patient understands that he had asked him to sign as his agent, to create the agency relationship.

The Counter Fraud and Security Management Service advice is that generally, pharmacists should not sign as the patient's representative as they are financially involved in the transaction.

As part of the exemption checking procedures, before signing an exemption declaration on behalf of the patient, the pharmacist would be responsible for establishing that the patient is exempt from prescription charges. This would necessarily involve seeing the original proof of exemption (as the pharmacist would be acting improperly in signing both as agent, and annotating the prescription with proof of exemption not seen.

Unfortunately, PSNC has been informed of cases where pharmacists or their staff have erroneously signed prescriptions on behalf of patients, where the patient was not present in the pharmacy at the time of dispensing, and the patients have received letters from the Counter Fraud Service seeking repayment where the patient was not entitled to exemption from charges. The signing of the exemption claim is therefore not recommended, unless the pharmacist or his staff see the proof of entitlement to exemption.


Is it acceptable for pharmacists to sign on behalf of the patient if they believe them to be exempt, without checking proof of entitlement on each occasion?
As part of the Point of Dispensing checking pharmacies have a duty to take the proper responsibility for checking a patient's exemption status on the first occasion, including whether the pharmacy has seen evidence of age or it is printed on the prescription form, or the pharmacy has seen the original certificates and noted the details on the patients' record.

The patient then instructs their representative i.e. the pharmacy to bill them through their debit/credit cards for other purchases. Although the representative will sign the back of the prescription stating that the patient is exempt the patient is liable if their exemptions change in any form.

On receipt of an original copy of the exemption certificate, the pharmacy should make a note of the expiry date on their records, which will enable them to identify when a patient's exemption certificate is due to expire. Should they choose to do so, they will be able to identify when a certificate is nearing expiry and contact the patient concerned and ask for a copy of the new valid certificate, limiting the possibility for incorrect claims.

A possible exception to a patient's liability may be in the case of a pharmacy "assuming" a patient's exemption without asking the patient or fraudulently claiming an exemption when they have already been paid. Where there is a suspicion that either of these has occurred the information should be reported to the Pharmaceutical Fraud Team. As the investigation of this may come down to deciding between the patient and the pharmacist as to who is telling the truth, the pharmacist is putting themselves at risk (Obviously, if the patient can produce a valid receipt, this will prove double claiming). It is worth repeating the point above that generally, pharmacists are advised not to sign as the patient's representative as they are financially involved in the transaction.

The pharmacist would have a responsibility to check the proof of exemption and maintain an accurate record. If the pharmacist is negligent in maintaining the record or in signing the exemption on behalf of the patient, then he could be liable if a false exemption claim is made.


Is it appropriate to seek to impose a duty on the patient to notify the pharmacy, and if a change to exemption status does occur, would the failure to notify the pharmacy of that fact, render the person completing the original declaration liable to any sort of action?
Under the Law of Agency as described above, if the pharmacy completes the original declaration (i.e. that on the prescription) on behalf of the patient, the patient is always liable.

Furthermore, the onus is always on the patient to claim help with health costs correctly. They are ultimately responsible for the accuracy of the declaration. Therefore, if a patient fails to notify the pharmacy about a change in exemption status, they will be liable, and if the patient is subsequently found to have wrongly claimed help from the NHS with the cost of their prescriptions they, and not the pharmacy, will face a Penalty Charge and in some cases prosecution.
However, when forming the agency relationship, the pharmacist must take care to ensure that the patient understands that he must inform the pharmacist of changes, and that if he did not, then a false claim made on his behalf would render the patient liable for prosecution. It would be eminently sensible to double check, on each occasion when a request for the service is made by the patient, whether the patient's exemption status has changed.


Is it acceptable to verify entitlement against a photocopy version?
With relation to the use of a photocopy as exemption evidence: It would appear that there is no official guidance on what is acceptable identification, but best practice dictates that the pharmacy should have seen evidence of age (or it is printed on the prescription form) and in the case of certificates, the pharmacy should have seen the original and noted the details on the patients record.

The only information given seems to be in relation to the type of evidence that a patient uses. It also specifies that the proof should be valid on the day that the prescription is claimed and this may pose some problems for a mail order or internet pharmacy.
From a Counter Fraud and Security Management Service perspective, there exists the potential for photocopies to be fraudulently used on a large scale and they would advise that in all cases pharmacies ask to see the original form of evidence.

Data Protection

Does the Data Protection Act 1998 have an impact on mail order or internet pharmacies?
The Information Commissioner maintains, under the Data Protection Act 1998, a public register of data controllers. A pharmacy that intends to process personal data must notify the Information Commissioner. Any individual can check whether a particular pharmacy owner is on the register - penalties for non compliance with the Act are severe.

There are eight principles under the Data Protection Act 1998 to make sure that information is handled properly. They say that data must be:

• fairly and lawfully processed
• processed for limited purposes
• adequate, relevant and not excessive
• accurate
• not kept for longer than is necessary
• processed in line with the patient's rights
• not transferred to countries without adequate protection.

The impact of the legislation is therefore considerable. Pharmacy owners will need to ensure that they have notified the Information Commissioner about the uses to which data will be put, ensure that there are adequate safeguards for access to the data (for example passwords to allow appropriate staff access to patient data), secure storage of backups, policies and practices to make sure data is up to date, deleted when it is no longer necessary to hold it, and all data processed in accordance with patient's rights. Further guidance can be obtained from the Information Commissioner.

It is essential that information is disclosed only to those who have a legitimate interest in the information, so pharmacists must ensure that security systems are stringently applied. Passwords must not be shared; they must be regularly changed and must be sufficiently robust to counter attempts to gain unauthorised access to the system. Information which is accessed either from the national spine or the pharmacist's local system must be protected from any misuse or unauthorised disclosure, otherwise there is a real danger that pharmacy will be removed from the list of those entitled to access the NHS Care Records.

Marketing

Can I market the service I provide, to patients, using email?
The Privacy and Electronic Communications (EC Directive) Regulations 2003 cover unsolicited direct marketing by electronic mail (and also telephone and fax). There are two new rules, the first is that the sender must not conceal his identity (which would be unlikely in the case of a pharmacy seeking to promote its services) and must provide a valid address for opt-out requests. The second rule is that unsolicited messages cannot be sent unless the sender has the recipient's prior consent. This strict ‘opt-in' rule is relaxed if the recipient's email address was collected in the course of negotiations for a sale, the sender only sends promotional messages relating to their similar products and services, and when the address was collected, the recipient was given the opportunity to opt out (free of charge) which they did not take. The opportunity to opt out must be given with every subsequent message.

Privacy and Electronic Communications (EC Directive) Regulations 2003

In addition, the Royal Pharmaceutical Society of Great Britain includes in the Service Specifications annexed to the Code of Ethics, a prohibition of publicity by use of un-solicited emails.


Can I write to individuals to inform them of my services?
Yes. A direct marketing letter is not covered by the above directive.


Can I obtain mailing lists from prescribers to target particular localities?
A mailing list can be obtained from any legitimate source. But, the person collating the mailing list must be registered under the Data Protection Act 1998, the use to which the data is being put (i.e. sale of mailing lists) must be identified, and the patient must have given consent to the disclosure. If a list of patients was provided to a pharmacy by a prescriber, it is highly likely that the prescriber will have contravened the Data Protection Act principles. In such a case, a patient should write to the ‘data controller' at the prescriber's premises and if no reply is received or the reply is not satisfactory, a complaint could be made by the patient to the Information Commissioner.

Direction of Prescriptions

Can I ask the prescriber to issue prescriptions and send them to me?
Yes, at the request of the patient or their carer. The Royal Pharmaceutical Society of Great Britain's Service Specification 6, contained within the Code of Ethics and Standards sets out the professional requirements for handling repeat medication services.

Service Specification 6, (PDF File) 

The importance of the audit trail and especially the record of the request coming from the patient or their carer cannot be over-emphasised. There have, unfortunately, been cases of pharmacists who have requested prescriptions without the authority or knowledge of the patient. In those cases where this has been with fraudulent intent, criminal prosecutions have sometimes followed, and in some cases where the request was simply down to poor procedures, disciplinary action through the Statutory Committee has followed.


Can the prescriber recommend to the patient or decide without the consent of the patient, to which pharmacy prescriptions can be sent?
The Government has expressed commitment to promoting choice. In the Proposals to reform and modernise the NHS (Pharmaceutical Services) Regulations 1992, published 29 Aug 2003 it stated that the Government considers it may be beneficial to have a series of measures which aim to achieve a more even balance, helping promote competition and choice for patients in choosing their pharmacy.

Section 28F of the National Health Service Act 1977 sets out the framework for regulations that confer on a person a right to choose the medical practitioner from whom he is to receive medical services, subject to various criteria (such as list size, consent of the practitioner etc). The Act does not make any point on choice of pharmacy.

It is likely that any attempt by a prescriber to direct prescriptions to a particular pharmacy, particularly against the patient's will, would be seen as undermining choice.

As with many general rules, there are exceptions. Some treatments are very specialised, for example Total Parenteral Nutrition or Continuous Ambulatory Peritoneal Dialysis, where the storage or transport requirements mean that only a small number of pharmacies wish to offer the services. In those cases, the prescriber may continue, with the patient's consent, to direct prescriptions to a pharmacy that was contracted by the hospital, when the supply was initiated.

In out of hours situations, a prescriber may recommend a pharmacy or pharmacies that he knows are open out of hours, to minimise delays in commencement of treatment, and in the palliative care setting, prescribers may direct patients or their carers to a list of pharmacies that are part of a palliative care program, at which the necessary range of medicines are always held in stock.

It is anticipated that in Release 2 of the Electronic Prescription Service, patients will have the option of nominating a pharmacy to receive their prescriptions electronically. Patients will be able to change their nomination settings at any pharmacy and at any GP Surgery. In time, it is expected that patients will also be able to log their nomination preference online via HealthSpace.

On the 14th April 2005, the National Health Service (Primary Medical Services) (Miscellaneous Amendments) Regulations 2005 came into force which stipulate that when operating the electronic prescription service, a prescriber must not seek to persuade a patient to nominate a pharmacy recommended by the prescriber. If asked to recommend a pharmacy, the prescriber is to provide a list of pharmacies that operate ETP, as provided by the Primary Care Trust.

PSNC is in ongoing discussions with the Department of Health on this issue. Consideration is being given to electronic systems to support PCTs in monitoring for abuse as well as the action that would be taken if the procedures have not been followed.

Other

Are there any other requirements I should comply with?
The Pharmaceutical Services Negotiating Committee web site has details of the new pharmacy contract, as and when they become available. There is an extensive description of the IT issues for community pharmacy

New Pharmacy Contract

IT Issues for Community Pharmacy

Related Guidance

The Royal Pharmaceutical Society of Great Britain has issued a number of Fact Sheets, dealing with Home Delivery (Number 7), and Confidentiality and Data Protection (Number 12). These can be downloaded from the RPSGB web site. Medicines, Ethics and Practice, a Guide for Pharmacists, 30th Edition, and published July 2006 is also a source information on the Code of Ethics and Service Specifications.

Home Delivery (PDF File) 

Confidentiality and Data Protection (PDF File) 

RPSGB Guidance on Internet Pharmacy Services  (PDF File)