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Regulation

Do you know... about the risks involved with internet pharmacies? New regulation seeks to control them

Do you know...

...about the risks involved with internet pharmacies? New regulation seeks to control them

Q: How are you able to buy prescription medicines online, and how safe are drugs bought online from internet pharmacies?

A: Today, everybody is aware that prescription drugs can be bought over the internet from a variety of sources.

There must be very few people in parts of Europe with regular access to email who have not received spam messages offering them Viagra or maybe other lifestyle drugs, such as Propecia.

While the vast majority of people will not pay any attention to these advertisements and will immediately delete the emails, there are some people who may be tempted to check what sort of offers are available. They may click through to a website that dispenses a variety of prescription-only drugs, yet often without requiring a prescription for supply.

These websites are a source of several concerns for pharmaceutical companies, and for many reasons.

Online menace
First, there is the obvious safety problem. Whilst many pharmaceuticals available online have proven safety records, prescription drugs tend to be available on a prescription-only basis due to the fact that their administration requires monitoring by a healthcare professional.

All kinds of prescription-only medicines, such as antidepressants, pain killers and anti-epilepsy drugs can be purchased online without a prescription and, crucially, without the monitoring of a healthcare professional.

In 2003, the press carried reports about a 24 year old musician called Liam Brackell who was purchasing products from these online pharmacies. He was ordering opiates and anti-depressants online (according to UK newspaper the Observer, receiving 300 antidepressant tablets in the post every day at his home in London), and became dangerously addicted to them, eventually throwing himself in front of a train.

Even in less severe cases, it is always possible that patients, having taken the wrong dosage or having ignored the prescribing information, could suffer severe side effects, including death.

Secondly, some internet pharmacies are prone to making inflated claims about the efficacy of the products for sale, promoting them in such a way that is inconsistent with national Codes of Practice for the pharmaceutical industry.

Reputation damage
While it may be obvious to seasoned observers of the pharmaceutical industry that claims made on these websites are not made by the manufacturers of the products, to a member of the general public who is interested in making a purchase these claims appear to have come directly from the manufacturer.

As a result, when the product does not have the effect that the website boasted, the manufacturer's good name is sullied.

A third problem for pharmaceutical firms is that there is no control over the products supplied by these internet pharmacies. As a result, there is no guarantee that the `patient' is receiving genuine products, or that they are even getting the product they ordered.

It is a well known practice of less scrupulous online pharmacies to replace branded, patented products with copied, or generic, versions which may not have been approved for sale in the country/market in which the patient resides. This is frustrating for pharmaceutical companies as frequently these generic products are supplied in countries where the patent protection for the original product has not yet expired.

What causes even more concern, however, is that sometimes the product supplied is counterfeit (ie, packaged to look like the product from the proper manufacturer but actually manufactured by a third party) and these products may contain the wrong active ingredient, or no active ingredient at all.

In the worst cases, these counterfeit products can be taken by patients for whom they are contra-indicated, resulting in severe side effects.

Q: What standard of service can you expect?

In the US, in the first six months of 2004, researchers working on a government project ordered drugs from 90 internet pharmacies by posing as patients.

According to the BBC, one out of every two internet pharmacies supplied the medicines without asking to see a prescription, and most of the drugs received were unapproved for use in the US; probably mostly being unapproved generic versions.

The research revealed that at least four of the pharmacies had sent counterfeit versions of brand name drugs, and six of the pharmacies took the patients' money, but sent nothing at all. While this would appear to paint quite a negative picture, there are, in England at least, new regulations that legalise and regulate internet pharmacies for the first time.

It is hoped that such regulations will enable customers to make an informed choice between what are legitimate and illegitimate pharmacies, and so hopefully avoid many of the potential dangers.

Earlier this year, the UK government introduced the National Health Service (Pharmaceutical Services) Regulations 2005 which revamped the system for authorizing pharmacies that supply NHS services.

Under this regulation, Primary Care Trusts receive applications from parties that want to provide pharmaceutical services from a premises in the Primary Care Trust's area.

The list of people that can provide these services is known as the Pharmaceutical List. For a normal `bricks-and-mortar' pharmacy, there is a set of criteria that it must meet before it will be included on the Pharmaceutical List - this is known as the control of entry test, or the necessary or desirable test.

However, under the regulations, pharmacy businesses that are wholly mail order and internet-based (so called distance selling pharmacy services) are exempted from these criteria. This is because the criteria involve an examination of the local market, and mail order and internet pharmacies may face difficulty in proving a need for such services by reference to the immediate vicinity in which they propose to locate.

Q: How will e-pharmacies continue to operate?

The UK's Department of Health has issued guidance for Primary Care Trusts regarding the control of entry test.

Factors that are usually taken into account under this test include whether any of the services proposed are already provided within the neighbourhood, whether there are any local pharma services provided under a pilot scheme which are the same as any in the application, and whether the recipients of pharmaceutical services already have a reasonable choice regarding the services or the range of persons already on the Pharmaceutical List.

Representations received from those invited to give views are also taken into account.

Remote services
As mentioned above, internet and postal pharmacies are exempted from the test, but there are still key points that such pharmacies must satisfy.

For example, the guidance for the Primary Care Trusts states that an internet-based pharmacy should operate like any other mail order company, and as such should receive and fulfil orders for medicines remotely for a patient or customer, rather than face to face as in a traditional pharmacy.

Also, any applications to a Primary Care Trust will be refused if the premises to which the application relates are on the same site as a provider of personal medical services with a patient list. This is to avoid circumstances arising where patients might inadvertently present prescriptions for dispensing if such facilities are available nearby.

As with any pharmacy, a UK internet pharmacy will need to be registered with the Royal Pharmaceutical Society of Great Britain (RPSGB), whose Code of Ethics and Standards sets out rules regarding remote delivery and online pharmacy services.

The delivery rules provide that, unless alternative arrangements have been made, medicines must only be handed over to the patient or their carer, and after the delivery person has confirmed with the patient or carer that the name and address of the patient is correct.

Also, wherever possible, a signature should be obtained so that there is a record of safe delivery of the medicines.

Patient protection
In relation to online pharmacy services, the RPSGB Code provides that in addition to complying with all other professional requirements relating to the sale or supply of medicines, online pharmacists must also ensure that the confidentiality and integrity of all patients' information is protected. This is usually done by the use of electronic encryption for the orders and receipts.

In cases where medicines classified as pharmacy medicines are requested, pharmacists must ensure that sufficient information is available to enable a professional assessment of the request and must also take the opportunity to provide appropriate counselling and advice. Where a request for a medicine (or the symptoms described) indicate that the patient's interest would be better served by a face to face consultation, the pharmacist must advise the patient so.

In summary, the new regulations that permit internet pharmacies to provide pharmaceutical services to NHS patients are likely to be of great assistance as, particularly in conjunction with the e-transmissions of prescriptions and new rules relating to repeat notes, patients will be able to receive prescription drugs through the post without having to visit their doctor or go out to a pharmacy.

For many people with long-term illnesses, this is a great improvement on the old system. However, while those pharmacies that are covered by the new regulations, and also generally any pharmacies that are covered by the RPSGB Code, will be providing genuine products to patients with prescriptions - whose usage of the products will be monitored - there still exist many unscrupulous internet-based pharmacies across the European region that will continue to operate for the foreseeable future.

These pharmacies will continue to target patients who want lifestyle drugs, in particular who may be embarrassed to ask for a prescription, and as such will be able to continue to cause problems.

Q: What other risks are patients vulnerable to?

A further problem with these unregulated online pharmacies is that with the growth of the internet, and all the medical information websites that can be found there, many people now attempt self-diagnosis.

This can often result in people purchasing medicines without a prescription because they feel that they need the drugs, when in truth they may not be required at all.

The issues have now been around for several years, and whilst the regulation of NHS internet pharmacies is to be welcomed, further measures need to be taken to address the problems caused by illegitimate online pharmacies trading throughout the European region.

The Authors
Nicola Dagg is a partner and Paul Brown is an associate solicitor in Lovells' international life sciences practice (www.lovells.com)

2nd September 2008

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