Clicking for pills

Abstract

With more and more people buying prescription only drugs over the internet, how can doctors help to protect their patients from the risks of internet pharmacy? Graham Easton investigates

There's something shady about buying medicines over the internet—pushy emails offering budget Viagra and a bigger penis, or hairless men doing faceless deals for baldness drugs. If you're after cut price, stigmatised, or unauthorised medicines, cyberspace is the place. And just like a drug deal in a dark alley, it's a risky business. Who are you dealing with? Exactly what are you buying? If anything goes wrong, have you got a leg to stand on? But such easy access also has obvious benefits, which is why more and more people are willing to take the risk and internet pharmacy is growing fast. So what should doctors know about this new online market, and how can we protect our patients from the possible pitfalls?

The first point to make is that not all internet pharmacy sites are dodgy. Legitimate online pharmacies are regulated in the same way as high street pharmacies—pharmacists and pharmacy premises in Great Britain have to be registered with the Royal Pharmaceutical Society—and they can offer easy (often cheaper) access to safe medicines from the privacy of your home. It's really no different to doing your supermarket shop over the internet. Most offer just a dispensing service, and you still need a doctor's prescription for prescription-only medicines. This sort of online dispensing is bound to blossom as electronic prescribing becomes the norm. Some sites also offer a prescribing service, where private online doctors prescribe and dispense medicines after some sort of virtual consultation or questionnaire.

Risky sites

The trouble is that there are plenty of other sites that aren't playing by the rules. According to Lynsey Balmer, head of professional ethics at the Royal Pharmaceutical Society of Great Britain, “There are a number of illegal operators which are being run by people who don't have any health expertise or qualifications and are selling medicines—usually prescription-only medicines—directly to the public. Many of these sites tend to be based abroad so they actually fall outside UK jurisdiction.” That leaves the UK Medicines and Healthcare Products Regulatory Agency effectively impotent, although it says it does continually monitor the net for illegal sites and has prosecuted several sites based in the UK. It refers overseas sites to the appropriate regulatory agency in that country.¹

The agency's main worries are that patients who go internet shopping for prescription-only medicines are exposing themselves to three main risks: the drugs may not have been prescribed by a healthcare professional, they may not have been checked for quality or effectiveness, and the patient may have no legal recourse if a problem arises.¹ The US Food and Drug Administration has similar concerns and estimates that there are at least 400 websites that both dispense and offer a prescribing service, half located outside the US.² Some estimates suggest that the number of websites selling prescription drugs may now be closer to 1000. The FDA doesn't have accurate figures on adverse events from internet medicines, but its postmarketing surveillance data indicate that the sale of unapproved drugs and the illegal sale of approved drugs over the internet pose a serious public health risk. The FDA website talks of a man who came to grief through using sildenafil (Viagra) bought from a website without an examination by a healthcare professional. Unfortunately, he had a family history of heart disease and died after taking the drug.²

Even I, a cyber dunce, managed to find all sorts of prescription-only medicines for sale in just 10 minutes of Googling. I could buy myself some sildenafil (discretely packaged) without prescription by filling out a basic health questionnaire. The slimming pill sibutramine was no problem either—a longer questionnaire this time. And it was shockingly easy to find the hypnotic zopiclone for sale without any sort of questionnaire at all. All the sites I visited had extensive disclaimers, generally advised people to get advice from their doctor, and provided some information on the drugs in question. But I have no idea where the medicines would have come from or what they would have contained had I ordered them.

The World Health Organization is particularly concerned about fake or substandard drugs available over the net.³ The US based Center for Medicine in the Public Interest predicts that counterfeit drug sales will reach $75bn (£38bn; €57bn) globally in 2010, an increase of more than 90% from 2005. WHO says that internet based sales are a major source of counterfeit medicines in industrialised countries and to some extent in poorer countries. Medicines bought over the internet from sites that don't give their physical address are counterfeit in more than half of cases. In February 2006, all 193 member states of WHO signed up to a global partnership to fight fake drugs, the International Medicinal Products Anti-Counterfeiting Taskforce (IMPACT). As well as tightening up on regulation, enforcement, and legal systems, it will be launching initiatives to make internet users aware of the risks they run when buying medicines from unknown sources.³

Doctors' role

So how can doctors help to protect their patients from the shadier sides of internet pharmacy? What for instance, should doctors do if they discover that a patient is taking prescription medicines bought over the internet? Doctors are not responsible for drugs they have not prescribed themselves, but Nicholas Norwell, medicolegal adviser for the Medical Defence Union says we should be very clear about explaining the risks. “The MDU's advice is to talk to the patient about the risks of obtaining drugs through the internet. Doctors should act in the patient's best interests by investigating whether the drugs the patient has obtained are contraindicated with their existing medication or medical condition. In some cases, it may be appropriate to tell a patient to stop taking drugs sourced from the internet. Doctors should make a note in the clinical record of the fact that the patient is obtaining drugs over the internet and for how long, as well as any discussion with the patient and any action taken.”

One online pharmacy I visited suggested that some doctors are now starting to advise patients to get prescription-only drugs over the internet because it may be cheaper. The MDU's advice is that this is not acceptable: “If doctors feel that there is a clinical need for a particular medication, then they should prescribe it in the normal way.”

And what about the issue of online prescribing—is it really OK for doctors to prescribe medicines on the strength of a questionnaire alone? Dr Norwell says that doctors should abide by the General Medical Council's latest guidance, Good Practice in Prescribing Medicines. ⁴ Paragraph 5b is particularly pertinent: “Be in possession of, or take, an adequate history from the patient, including: any previous adverse reactions to medicines; current medical conditions; and concurrent or recent use of medicines, including non-prescription medicines.” According to the American Medical Association though, a healthcare professional who offers a prescription for a patient the practitioner has never seen before and based solely on an online questionnaire, generally has not met the appropriate medical standard of care.²

One of the big difficulties for patients is deciding which sites are legitimate. Lynsey Balmer explained how the Royal Pharmaceutical Society of Great Britain is doing its bit to make the distinction clearer. “We are piloting a logo which will be displayed on internet sites which are operated by registered pharmacies. The purpose of the logo is to help patients more readily identify the bona fide pharmacy sites from some of the illegal sites. By clicking on the logo, patients would be directed to the society's online register so that they would be able to confirm the registration status of the pharmacy and the pharmacist.” There are similar schemes in the US, Canada, and New Zealand, and if the UK pilot is successful the society is looking to roll out the logo widely to all registered pharmacies during 2007.

In the meantime, doctors could tell patients about the society's code of ethics on the information that registered online pharmacies should provide.⁵ The code requires that pharmacy websites display the name of the owner of the business, the address of the pharmacy at which the business is conducted, the name of the superintendent pharmacist where applicable, and details of how to confirm the registration status of the pharmacy and pharmacist.

These days we do our Christmas shopping and choose cars, houses, and even spouses on the web. We can't hide from internet pharmacy—nor should we try. But while the regulators and enforcers try to keep pace with the rapid growth, doctors need to be aware of the risks and be ready to protect our patients from them.

What to advise patients

• Never buy prescription-only medicines from sites that don't require a prescription from a doctor or suitably qualified health professional

• Beware of pharmacies that don't give a physical address

• Avoid websites that advertise miracle cures

• Make sure that the pharmacist and pharmacy are properly licensed

• Talk with your doctor before starting a new medicine for the first time