As advances in 3-dimensional (3-D) printing bring fabrication to users’ fingertips, researchers from the University of Illinois at Chicago suggest that the technology could be part of pharmacy’s future.
Research by Iulia Ursan, PharmD, Ligia Chiu, PharmD, and Andrea Pierce, PharmD—published in the March/April 2013 edition of Journal of the American Pharmacists Association—surveys existing studies on 3-D printing for pharmaceutical manufacturing. The research, conducted during the authors’ time at the University of Illinois College of Pharmacy, suggests several potential benefits for patients, although the authors acknowledge the importance of regulatory requirements in integrating the technology into pharmacy practice.
Q: What piqued your interest in 3-D drug printing and why?
Iulia Ursan: Since the process was first described in the 1990s, 3-D printing has been used in many fields, such as architecture, medicine, the food industry, and even pharmaceutical manufacturing. As 3-D printers are becoming more widely available, we wanted to perform a comprehensive literature review of the use of this technology in the area of pharmaceutical manufacturing. We were interested in the limitations of the 3-D printing process and the potential of these technologies in pharmacy practice.
Q: How do you see this changing pharmacy practice?
Andrea Pierce: We see the 3-D printer as a valuable tool to create individualized medications, tailored to specific patients, and changing the way they take their medications. There is a growing trend toward personalized medicine, and we feel the 3-D printer may be the next step in that process. If common medications for chronic diseases were available in the 3-D printer, a customized “polypill” could be created that could potentially contain all the medications a patient needs in 1 pill. Think of how much easier it would be for a patient to take 1 pill daily instead of 15, of how much this could improve adherence.
Q: What about the literature review surprised you, if anything?
Ligia Chiu: It was surprising to see there was, in fact, research being done on 3-D drug printing. Since the concept seemed just a theory in our minds, we were all pleasantly surprised at just how in depth and how many areas of research existed on this topic. Another remarkable point to make about the literature review is how much 3-D printing is being used in the medicine realm, however relatively lacking in the pharmaceutical environment.
Q: What would you say is the most important conclusion from your research?
Iulia Ursan: 3-D printing technologies may transform pharmacy practice by allowing medications to be truly individualized and tailored specifically to each patient, although technical and regulatory hurdles remain. Further study and use of 3-D printing technology may offer an important benefit to patients who need medications that have narrow therapeutic indices or a higher predilection to be influenced by genetic polymorphisms.
Q: How do you see common therapies being further tailored to patients through 3-D printing?
Andrea Pierce: Pharmacists could use patients’ characteristics (eg, age, race, elimination, metabolism) and pharmacogenetic profile to predict a specific medication dose. The medication then could be dispensed by an automated system that incorporates 3DP technology. The dose then could be adjusted by changing printer parameters based on the patient’s clinical response. Vital to this process would be a collaborative relationship with the patient’s prescriber.
Narrow therapeutic index medications or those highly influenced by genetic polymorphism may be ideal for utilization with this technology, for example warfarin and phenytoin. Additionally, as mentioned in question in 2, this technology has the potential to print multiple medications onto 1 pill. Instead of getting prescriptions for 12 medications, a patient would just have 1 that contained all 12.
Q: Given the recent press regarding compounding, what is your opinion on integrating 3-D printing into that environment? What potential challenges could it face, and are these unique to that environment?
Iulia Ursan: Meeting the regulatory requirements of the US Food and Drug Administration could be a hurdle to be cleared before large-scale use of 3-D printed products could be realized. We are talking about an immensely complex regulation process. Different manufacturing regulations and state board requirements could impose obstacles to the adoption of the drug printers in practice. An imperative difference must be established to distinguish drug printers as manufacturing or compounding technologies.
However, the advantage of this technology compared with current compounding as we know it is the software behind it. The blueprint applications give us access to a tightly controlled process. This software would be tested or validated in the lab before being put on the market. We can also link the ink production to the software and encrypt them. Therefore, any attempt to open the printer and adulterate the ink will not work.
Q: What sorts of training requirements could you see put into place, should 3-D printing become a service for pharmacy's future?
Andrea Pierce: In the setting of a community pharmacy, a pharmacist and possibly a technician from each site utilizing the printer would need to be trained in its operation and basic trouble-shooting. This training could be through online modules or in-person continuing education classes, which must be completed prior to use of the 3-D printer (similar to training required to operate an automated dispensing machine or TPN compounder). Its basic operation would be straightforward, with much of the operational work conducted using a computer program. For maintenance or more complicated problems, the printer’s manufacturer would have trained service technicians available to make repairs and fix problems.
Q: Do you have a hypothesis as to the time period for seeing 3-D drug printing in pharmacy practice?
Ligia Chiu: 3-D printing will much sooner be found in drug manufacturing companies than everyday pharmacy practice such as community or hospital, which makes sense since it is more of an innovative manufacturing device. Timeline for use within a manufacturing setting will probably be within a decade. Timeline for use in another pharmacy practice site will be at least 2 to 3 decades away.
Q: What factors of the study influenced your conclusion that 3-D drug printing in the pharmacy is “worth” the time and funding needed to bring it to pharmacy practice?
Ligia Chiu: As alluded to earlier, this technology has become more advanced in medicine, and its benefits are apparent. Why should pharmacy be behind in this? If anything, we should be at the forefront! Our vision is personalized medication that is tailored to the specific needs of the patient. Increasing compliance, decreasing pill burden, and inherently increasing efficacy of medications is the goal of every single generation of pharmacists that enter the realm of pharmacy. It is our belief that we fall short on this NOT because medications out there are not good, but because patients do not see results and give up trying to take these medications. We may not be able to change patients’ perspectives, and medications are life changing, therefore we do not want to change them. However, we can change the way these medications are formulated based on the needs and wants of patients.