Personalized Medicine Brings Pharmacy Science Back to the Future

Ruth E. Nemire, PharmD, EdD

Michael De Giglio, RPh

Personalized medicine, an emerging priority of health care reform, will bring consumers back to the future—back to the days when apothecaries mixed a precise therapeutic compound to help treat whatever ailed an individual patient.

With the advent of mass production pharmaceuticals and the spread of retail pharmacies in the mid-to-late 20th century, the science of compounding—creating effective mixtures of medications customized to the specific needs of a consumer—was relegated to the fringes of medicine.

But what’s old is new again. Today, we are armed with advanced genetic research and a wealth of patient health information, and the success of personalized medicine will depend to a large extent on our ability to train the next generation of pharmacists to deliver individualized care that not only treats, but also prevents, illness.

Millions of individuals in the United States who need medication at a strength that is not on the market or need a drug that is commercially unavailable rely on pharmaceutical compounds mixed by highly specialized compounding pharmacists. For a broad swath of patients, including the very young, the very old, allergy sufferers, children with autism, cancer survivors, people with HIV and AIDS, and even pet owners, only customized compounds can deliver the best health outcomes.

Instead of routinely filling a one-size-fits-all prescription in which only the strength of the medication varies, the pharmacist of the near future will need to work closely with physicians and private sector researchers to develop specialized patient-specific compounds of varying strengths and combinations.

At the same time, scientific researchers and compounding pharmacists will also need to work together to develop more accessible drug delivery methods.

Any parent who has struggled to give medication to a young child and any pet owner who has wrestled to get their sick cat or dog to swallow a pill knows just how badly new drug delivery applications are needed. To help patients get the individualized dosages they need, more drugs and drug compounds will have to be delivered through melt-in-your-mouth strips, lollipops, gummy candies, nasal sprays, creams, and skin patches.

But the number of pharmacists qualified for the modern demands of compounding is limited, creating a potential challenge as our society pursues a treatment methodology designed to more effectively prevent and better treat a broad spectrum of illness on a one-to-one basis.

This challenge is why our two institutions recently entered into a partnership to help train the next generation of pharmacists in personalized medicine and to pursue joint research and development that will improve patient access to vital, customized compounds and applications.

Many physicians have a good idea of what pharmaceutical compound and delivery method might work best for an individual patient’s needs but find it very difficult to work with global pharmaceutical companies to engineer solutions. Collaboration between smaller compounding providers and academic institutions with pharmacy science expertise can advance small to medium projects that address this challenge.

We believe that close-knit, scientific collaborations like ours will yield unique advances that may not be on the research-and-development radar screen of large biotechnology, bioengineering, and pharmaceutical companies.

Pharmacy practice has evolved, and pharmacists have taken their rightful place on the patient care team. Increasingly, they will need to understand who the patient is, their family history, their genetic blueprint, their behaviors, and their environment. They will also need the education and expertise to create compounds specially formulated for each individual.

Ironically, we find ourselves replicating the approach of apothecaries that first surfaced during the Middle Ages. In fact, compounding was common practice at neighborhood drug stores until mass production techniques changed the nature of pharmaceuticals about a half century ago.

There is absolutely no doubt that large-scale, uniform drug production has improved the health of our society in compassionate and miraculous ways, and will continue to do so into the future. But research shows that a one-size-fits-all approach also has had drawbacks for developing and dispensing drugs that are effective, stable, and accessible for the millions of patients who cannot get the personalized therapies they need from commercially available drugs. Moreover, as drug shortages continue, compounding pharmacists can fill a critical gap, replicating drugs that are commercially produced but unavailable. In the case of some oncology drugs, this can mean the difference between life and death.

We are confident that, with the right focus, education, and teamwork, the pharmacist of the future will join physicians as collaborative primary care providers, improving medication safety, treating and preventing illnesses more effectively, and reducing health care costs.

Ruth E. Nemire, PharmD, EdD, is founding dean of the Fairleigh Dickinson Medco School of Pharmacy in Madison, NJ. Michael De Giglio, RPh, is chief executive officer of Prescription Dynamics, a compound pharmaceutical provider in Montvale, NJ.