Approval of a 3D-printed drug opens up a new world of customised medication, but also the possibility of counterfeit drugs, mislabelling and a regulatory vacuum

The prospect of tailor-made drugs that are customised to your individual needs has moved a step closer with the recent announcement of the first 3D-printed (3DP) drug to gain approval from the US food and drug administration (FDA).

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A visit to the pharmacy may soon involve being questioned on your weight, or having your percentage of body fat measured so that the medication can be printed to match your size. Young children, often resistant to taking medication, may be able to choose the colour, shape and design of a tablet that could be designed to dissolve easily. Imagine antibiotics that look like Peppa Pig or superhero characters.

But as access to the technology expands, what are the potential downsides? Will 3DP be safe? Could it lead to a proliferation of illegal drugs and how will regulation adapt?

Personalised medicine

The vision behind 3DP is that medication will be customised to individuals in ways that make it safer and more effective. The size, dose, appearance and rate of delivery of a drug can be designed to suit an individual. FDA approved Spritam, for example, uses 3DP technology to create a more porous pill that is easier to swallow.

“Now that this approval has gone through, more drugs are likely to come to market,” says Dr Stephen Hilton, of University College London (UCL) School of Pharmacy. The chances are that high street pharmacists will be able to tailor and print out customised drugs within the next decade.

The possibilities seem endless. For example, some patients have to have their stomach removed as part of their treatment for stomach cancer. Drugs could be designed to be absorbed from the intestine rather than from the stomach for these individuals. The opportunities to fit the drug to the patient will increase as individuals get their own gene profile.

Obese patients could swallow components that assemble in the stomach to create a structure that takes up a lot of room as an alternative to a gastric band. Another idea could link the release of a drug that kills cancer cells with blood levels of a tumour marker. As the cancer grows, blood levels of the tumour marker rise and this would trigger release of the drug into the cancer.

Lee Cronin, professor of chemistry at Glasgow University, says that current technology allows ready-made drugs to be adapted and produced by 3DP. “Like taking a solid bar of chocolate and adding air bubbles to make an Aero,” he says. The 3DP acts as a proxy robot, mixing individual constituents like an automated cocktail maker, he explains.

But the real challenge is to digitise the chemistry so you have a blueprint for molecules and can build drugs from scratch. The blueprint could be encrypted to ensure that drugs are only produced according to a validated blueprint and, the hope is, counterfeit drugs would become a thing of the past.



In a TED talk, Cronin explained how it could be done. “It requires software, it requires hardware and it requires chemical inks. And so the really cool bit is the idea that we want to have a universal set of inks that we put out with the printer and you download the blueprint, the organic chemistry for that molecule, and you make it in the device. And so you can make your molecule in the printer using this software.”

If Cronin’s vision becomes a reality, the blueprints could be downloaded for a small fee. The drugs themselves could be manufactured in local pharmacies, which are likely to see their role change radically over the next five years.

Instead of storing packets of tablets, pharmacists will have reels of filaments of the base product (our prescribed drug) and will customise the dose and shape of tablet to our individual needs. There would be an onus on the pharmacists to check the customised pills, just as they do now, says Hilton.

Pharmaceutical companies should not lose out substantially as pharmacists will still have to buy the base products and sell only patented formulations of drugs. But Cronin predicts that if 3DP takes off as predicted, they will have to undergo “an unprecedented period of innovation” to adapt to the new challenges.

The implications

As with any new technology, it can be a race against time to anticipate and manage the downsides.

Critics, such as the journalist Mike Power, have raised concerns about the potential for blueprints to be mislabelled, filed under the wrong description or to have a higher strength than advertised.

According to Hilton, any mistakes are likely to be due to human error (such as putting the wrong spool of base material into the printer) but the final product will have to pass a validation check – which compares the chemical formulation of the tablet to a standard – as they do now. There’s a 4-5% failure rate in standard manufacturing, says Hilton and he thinks this is unlikely to change when 3DP technology is used.

There is also concern about blueprint hacking. For his part, Cronin accepts that encrypted codes can be hacked but says that the 3DP will have an inbuilt validation system to allow drugs to be checked against known standards.

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And for those who envisage crowds of partygoers waiting for sheets of ecstasy to come off the printer, this may not be routed in reality. The scope for manufacturing illegal drugs already exists and using a 3DP to customise drugs won’t help the illegal drug trade.



One major issue is how to regulate this brave new world. David Hodgson, partner in Deloitte’s healthcare and life sciences team, says that the new technology poses many questions that have yet to be resolved: “The current global, regional and local regulatory environment is incapable of accommodating the ambiguity of a 3D printing process. The question is are we regulating the printer as a medical device, the ingredients, or the person or organisation doing the printing as the manufacturer and distributor?” In other words, where will the liability lie when a drug causes an adverse reaction?

The global nature of the technology also poses problems, according to Hodgson. How would drug companies ensure that the right packaging and user instructions were accessible? And is printing of a drug in a country where it is not approved by the regulators acceptable?

The complexity of these challenges means “it may take time to embrace 3D printing as a technology,” Hodgson predicts.

The future

3DP technology is already up and running in many areas. It allows orthopaedic surgeons to print artificial bone, using scans to mould surgical materials into exactly the required size and shaped piece to replace damaged or missing bone. They’ve created skull implants for people with head trauma and titanium heels to replace a bone eroded by cancer.



But these customised surgical implants and grafts, like the new drug Spritam, are fairly crude adaptations of existing materials. The really exciting innovation is yet to come: the ability to create bespoke materials. Let’s hope regulation can keep up.