In 3D-printing, pharmacists have a tool that if understood and used appropriately, can elevate their ability to perform research and provide service levels not even previously envisaged.
i2P often claims that “it lives in the future to reflect a pathway back to its present readers”.
Believe me, this claim refers to the topics contained within this article, and are in a sense, the “dynamite” that will make or break the entire pharmaceutical industry.
So this is a reference article and the future referred to is well within a time-span of five years.
Although commercial 3D-printing models suitable for drug printing are not openly available as yet, they are beginning to make an appearance in various university science faculties in the UK, US and recently, through Monash University in Australia.
3D printers have both the potential to disrupt drug manufacturing and distribution, including the small scale individual manufacturing that is central to the business of compounding pharmacies.
However, as the concept takes hold there is a high potential for 3D printing to be able to bypass pharmacies completely, particularly for those patients being treated for chronic illness within their own homes (and that may be the majority over the next 30 years).
This objective has already been stated by one of the original inventors, Professor Lee Cronin of Glasgow University.
As a means of keeping costs down it is attractive for any individual to move into their own individual drug production system giving control to that individual.
It would be a bit like the dream that every householder has through control of solar energy, to replace the unpopular high-priced utilities that we all have to deal with.
Hand-in-hand with 3D-drug printing is the need to independently verify the final drug product to ensure that what is presented is a true product that has not been distorted in some way through a bug in the software written to control the process of its manufacture.
Fortunately that solution is already available in the form of a near-infrared spectral analysis camera that has the ability to photograph a tablet from any source (including those from major manufacturers) and produce an electronic “footprint”.
That footprint has then to be compared with a footprint library prepared from an independent source for verification.
So, this single tool has the capacity to eliminate drug products that are counterfeit, or not true to label, whether manufactured by the 3D process or any standard process.
In amongst all that disruptive technology lies a wealth of opportunity for pharmacists and pharmacies to move in behind, and I can see clinical pharmacists writing programs to “print” drugs and drug combinations in a way that increases compliance levels of patients and more conveniently packed (tablet combinations may reduce reliance on Webster-Pack presentations, again reducing cost, but disrupting dose administration aid systems and packaging services).
Another very important consideration contained in these disruptive influences is the need to protect intellectual property from competitor “pirates”.
Lessons have been already learned in the area of online music, where piracy began in 1990 with offenders being still frustratingly pursued, because the theft is hard to prove.
The peer-to-peer (P2P) file-sharing service allowed Internet users to download songs and albums free of charge, upsetting the industry’s traditional business model.
The casual theft of companies’ intellectual property (IP) became so widespread that the Recording Industry Association of America reported the legitimate sales of music fell by half, from US$14 billion in 1999 to $7 billion in 2014.
Today, 3D printing may pose a similar risk, but on an even wider scale. The novel technology employs computer-assisted design (CAD) to enable users to build a physical item, typically out of plastic or metal or other materials formed up into “filaments” for use in the actual printer.
Printing is performed by the printer reducing filament to a mobile “ink” (usually through a heat process) and printing successive layers of material, until the structure is formed.
Users can churn out an astonishing array of complex items, from medical equipment to weapons, and the innovative potential is vast.
Some researchers are even looking at using 3D-printing to reproduce human organs.
Both P2P downloading and 3D-printing revolve around computer files packed with intellectual property — performing artists’ copyrighted songs, in the former, or CAD files that contain industrial blueprints or drug software, in the latter.
These files are shared and posted all over the Internet.
And just as with music, 3D-printing is hard to track because it can occur in the privacy of someone’s home or office; requires little manufacturing equipment or investment beyond the device itself; and features a robust, supportive online community that generally doesn’t view the activity in immoral terms.
Of course pharmacy will not have to argue too strongly with government to restrict the drug printing process to a pharmacist or other responsible business.
The last thing we need is a new outbreak of something like “ice” to be able to be freely made at pharmacy grade quality.
So there is a need to start thinking about how this technology can be absorbed into the structure of pharmacy – from the political level to the final product manufactured and distributed.
And in the pharmaceutical industry it could represent a legal battleground unless appropriate regulations and laws can be introduced well in advance of large-scale use.
The nearest analogy is the music industry, the levels of “pirating” that occur in that industry and the perceptions of the end-users of a product.
There are a number of lessons from the music industry that could be adapted for use in pharmacy, as follows:
“Consumer expectations are relatively dynamic.”
In just a few years, file sharing, portable listening devices, and high-quality headphones fundamentally altered how consumers bought and consumed music.
Already, developers of 3D-drug printing are looking at an end-user patient model.
How disruptive will that be for pharmacies?
But that’s the good news for companies worried about 3D-printing, because the technology is still in the embryonic stage, and firms (manufacturer, wholesaler and community pharmacy) have time to manage consumer expectations and ensure they don’t box themselves in with defensive anti-piracy type strategies.
Note that this technology has the potential to be disruptive at multi-levels of the supply chain, and for government regulation.
Illegal manufacture can occur in breaching patents as well as illicit street drugs.
Pharmacists can steal each other’s intellectual property depending on who, and how, access to these assets is enabled.
After all, the success of P2P file sharing underscores how willing consumers are to purchase illegal items if they are cheaper and comparable to the real thing.
Many of the music industry’s attempts to fight technology with technology (through digital rights management, for example) were viewed as backward steps by consumers, whereas Napster’s appeal lay in its interoperability: It fit in perfectly in the era of expanding hard drives, MP3s, and iPods.
Companies must ensure they retain the flexibility to compete with emerging technologies, because consumer expectations are continually in flux.
“Legal recourse can be like using a sledgehammer to crack a nut.”
The music industry fought back against piracy largely through legal channels.
But in the court of public opinion, many record companies and prominent bands lost big.
In particular, Metallica’s lawsuit against Napster in 2000 resulted in a backlash from fans and undercut the rock band’s long-standing iconoclastic image.
Given the expensive, lengthy, and unpredictable nature of legal action, IP owners should think carefully before going this route — and if they do, they must try to make their case plainly and sympathetically in the media (and mainstream media will need to lift its own professional standards if it is to be effective for pharmacy).
Pharmacy’s detractors, particularly in recent times, mount media campaigns to influence public opinion against the solidarity of pharmacy infrastructure.
But what if that infrastructure is diminished or undermined in a major capacity?
What if it disappears completely?
3D-printing is not going to go away – it will simply become an enormous industry that will take on a life of its own.
Imagine if this technology develops outside of pharmacy control?
It will not only sow the seeds of pharmacy destruction, but will create an illegal drug traffic unlike anything we currently know – from drug counterfeiting to uncontrolled narcotic production never before experienced.
So, all the petty boundaries around real-time monitoring of all drugs that currently exist, will be seen in hindsight to have been not enough, nor introduced soon enough.
Arguments around location rules and pharmacy ownership begin to assume different proportions when viewed against the disruptive potential of 3D-printing.
“You can’t put a genie back in its bottle.”
Record companies tried several different tacks to limit the spread of piracy.
They asked Internet service providers to target illegal users and released distorted songs on P2P networks.
In 2009, the industry finally succeeded in getting some countries to block the prominent P2P website the Pirate Bay.
But in reality, proxy sites still give users access to the site’s downloadable torrents.
Responses can involve multiple tactics, including legal action or competing, but the IP owner must recognize that technology and the advances it brings cannot be subdued.
Instead, companies should willingly embrace the new paradigm.
Apple’s iTunes program, for example, was a hit with music lovers even in the age of piracy because it provided a highly functional, legal alternative to comparatively unreliable, unauthorised platforms.
And here is the lesson for the pharmaceutical industry – Apple has maintained integrity, market leadership, price and reliability against the odds.
Pharmacy leaders need to be mounting this debate with government and industry with urgent haste – because this technology is already available and proven.
“Antipiracy strategy is a cat-and-mouse game.”
During the protracted struggle between pirates and music companies, both sides won some and lost some.
The most high-profile setback for the industry was probably Sony’s attempt to retroactively add copy protection to recordings, rendering copied files unplayable in a computer drive.
Not only did people quickly circumvent the new security — using the decidedly low-tech means of a marker or a piece of tape to cover up the security code — but the technology also caused glitches and crashes for many legitimate users.
DVDs, however, were security-encrypted from their inception, and couldn’t be burned as easily as CDs.
Similarly, there’s still time to standardize the copyright protections surrounding the 3D-printing process and at least make pirating more technically complex if not outright impossible.
But don’t expect the battle to be won overnight.
While this battle will affect mainly patented drugs at the “big end of town”, protections will be needed at all levels for a range of yet to be determined intellectual assets for IP safeguards.
Part of the reason for the music industry’s muddled response to piracy was the lack of cooperation between the major players, which tried to come up with their own disparate solutions to the growing threat rather than developing a coordinated plan of defense.
But research has shown that networking enables IP owners to stabilize and strengthen their copyright protections by collaborating with other firms, lobbying government agencies, and launching educational or media campaigns about the value of maintaining their products’ integrity.
As iTunes shows, consumers don’t necessarily prefer disjointed black-market offerings; they will flock to legal outlets if the price and quality are right (Chemist Warehouse?).
Essentially, companies should try to control the narrative in the still-nascent era of 3D-printing.
Pharmacy leadership organisations already work as an effective network and they should all embrace some aspect of 3D-printing covering education in their use, and a code of conduct component embracing their ethical use, as it affects their members.
The technology isn’t going away, but it’s not so well established that consumers’ expectations have been set in stone.
Rather than stifling or ignoring 3D-printing, firms should develop reasoned responses to consumers so that legal, habitual relationships can be formed before pirate services proliferate.
Again, we will see a shift towards consumer power.
Consumers sense when an industry, or an industry making a product, is doing so unfairly,in a biased manner, or too costly.
3D-printing empowers an intelligent individual with leadership qualities to lead consumers out of a “hole”.
Many unethical practices that have been uncovered at the “big end of town” fit that description, so unless these practices disappear by design, they will be made to disappear in practice.
Meanwhile, pharmacy cannot and should not ignore the opportunities that will open up with the development and understanding of 3D-printing.
Don’t squander the opportunity.