Pharmacy: A Report from the 22nd Century

Pharmacy: A Report from the 22nd Century

APhA2001 2001 Remington Lecture Pharmacy: A Report from the 22nd Century With a clear, strong vision for the future, pharmacy can preserve and enhan...

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APhA2001

2001 Remington Lecture

Pharmacy: A Report from the 22nd Century With a clear, strong vision for the future, pharmacy can preserve and enhance its role in the service of humanity. Jerome A. Halperin

Delivered by Jerome A. Halperin, recipient of the Remington Honor Medal, at the APhA2001 Annual Meeting & Exposition, March 18.

Good evening. I am Jerry Halperin, C3. C3 is my designation as a third-generation clone. I was created in the late 21st century, and I am a pharmacist practicing in the year 2101. I was invited this evening by the Jerry Halperin you know to report to you on the status of pharmacy in the 22nd century. His paper, which was provided to you, is his view of what would be necessary for pharmacy's success in the 22nd century. I am here to tell you how it came out. First, I should tell you a little about myself. I said I am a thirdgeneration clone. You may like to know how that came about. To celebrate the second millennium and APhA' s Sesquicentennial, APhA Executive V.P. John Gans inaugurated the Remington Medalist DNA Bank to preserve genetic material from all living Remington medalists. He believed this would be a valuable contribution to pharmacy's posterity and a good revenue source for APhA. All the living medalists agreed to deposit DNA samples, and efforts were made to collect samples from deceased medalists to complete the collection. The project was so successful that an editorial in Pharmacy Today was headlined: "Genes Get Good Gelt. Gans Goes Gonzo."

Jerry Halperin-100 Years Later As the fIrst medalist of the 21st century, Jerry Halperin was given the honor of being the fIrst contributor to the DNA bank. Although human cloning did not become legal in the United States until 2035, APhA obtained special permission to create his fIrst clone, Cl, to begin the program in 2005. Barbara Halperin was offered the opportunity to gestate her husband's fIrst clone. She declined. I believe her words recorded on the occasion were, "Thank you, but I've been carrying him for over 40 years already." A surrogate mother was recruited-a Playmate of February .. .! forget the year.

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My father, C2, was cloned in the mid-21st century. By that time, transgenic technology had progressed to using other species for human gestation. His "mother" was an orangutan. Family members noted that familial resemblance was unmistakable. By the time I came along, technology had progressed to ectogenesis, a technology of gestational pods, each essentially an artifIcial uterus to gestate a clone or an in vitro fertilized egg. In 2101, reproduction is considerably different from how it was 100 years ago. The dominant mode is procreation without pregnancy. Prospective parents now have choices. They can choose cloning. They can order an in vitro fertilized embryo with specifIc genetic qualities, such as enhanced intellectual or physical capacities or appearance. Or, as a surprising number of couples do, they can choose the 21st century method of reproduction, which is still highly prized for its physiologic and recreational benefIts. Human cloning and genetic predetermination are not without controversies even in 210l. They continue to pose significant challenges to our moral, social, and legal values. Civilization may value the contributions of another da Vinci, Shakespeare, Mozart, or Marie Curie, but it would feel quite different about another Stalin, Hitler, or Pol Pot.

About the Remington Honor Medal The Remington Honor Medal, which is the pharmacy profession's most prestigious award, was established in 1918 to recognize distinguished service on behalf of American pharmacy during the preceding years, culminating in the past year, or during a long period of outstanding activity or fruitful achievement. It was created by the then APhA New York Chapter in honor of Joseph P. Remington (1847-1918), eminent community pharmacist, manufacturer, and educator.

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Perhap we have been lucky. We were concerned that parents would opt for athletic prowe or phy ical attractiveness, but parents who have elected genetic predetermination for their children have tended toward more ocially valuable qualities, including intellectual hone ty, compa sion, and emotional intelligence. There are twice a many of u living in the United States in 2101 as there are of you in 2001: 571 million compared with 281.4 million. We are a more diverse society, too. The 2100 census revealed that the black, American Indian, Aleut and Eskimo, Asian and Pacific Islander, and Hispanic populations all increased in proportion to the white population. We are living longer, too. Life spans for males increased from 74.1 years in 2000 to 88.0 years in 2100. Female life spans increased from 79.7 years to 92.3 years over the same period.

Coming Soon to a Civilization Near You The dominant medical technology in 2101 is nanotechnology, the science of machines with self-replicating, reversible, variable speed motors a trillionth of the size found in children's toys. We use therapeutic regenerators to heal wounds and burned skin. Most surgery has been replaced by noninvasive procedures employing nanotech assemblers and dissemblers to effect manufacture or repair at the cellular level. These nanotech devices are more accurate than their human counterparts for surgical procedures. They are also faster, less traumatic, and less expensive than surgical procedures. They have reduced hospital stays or, in many instances, eliminated them altogether. Nanotech robots ("nanobots") are in common use to prevent and repair problems before they become serious enough to be diagnosed, and they serve as sophisticated drug delivery systems. Ultrasensitive nanotech sensors routinely read chemical base sequences of the DNA of individual molecules. It is interesting to note that the plans to build these devices and their modes of locomotion and action were fIrst described in a textbook published in 2000. The "one size fIts all" approach to 21st century medicines has been replaced entirely by a "one size fIts one (or few)" concept. Our medicines are based upon genomic concepts for individual patients and their personal genotypes. They have highly predictable and controlled onsets and durations of action. Most are entirely free of side effects, helped, in part, by the presence of full genetic profiles on each person to predict the probability of side effects or the use of routine skin testing of individual patients to identify single nucleotide polymorphisms (SNPs). Most dosage forms are transdermal and have nanotech carriers. The Food and Drug Administration approved the fust nanotech "drug" in 2033. Vaccines were retired in the 2040s, when the diseases that required them were eradicated through genetic procedures that prevent the disease from developing or being transmitted. Implanted microcapsules with nanomechanical valves detect proteins from cancer cells and release just the right amount of

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anticancer drug at the exact location and time; this contributed to that disease being defeated in the 2050s. AIDS was conquered in about 2020, but before successful countermeasures appeared, the disease claimed tens of millions of lives in Africa alone. Inborn errors of metabolism, autoimmune diseases, deafness, and other diseases and disabilities have been virtually eliminated. For the most part, disease and congenital conditions are prevented, cured, or compensated for before conception or prevented or repaired in utero or in the early months of life. Modem health technologies are genomic, robotic, or implanted. For example, about 60 years ago, we developed an artifIcial eye and an occipital lobe implant to correct blindness. We are virtually a diseasefree society, but, when genetic mutations in humans or other species evolve new diseases, we have the technology to eliminate them or, at least, curb potentially fatal conditions. Consumers benefited from these changes, too. We no longer have problems of access to and payment for health care services. In this age of ultima't ely personal medicine, consumers have access to information and services that are readily available, high quality, and free. Pharmacy services now include routine visits by holographic pharmacists. The visits are available through home holographic imagers, which replaced television in the last century. These may be programmed by a pharmacist or physician or upon demand of a patient or consumer to occur at specific times or whenever necessary to monitor symptoms and progress or to provide information. The results of these sessions are immediately transmitted to the patient's comprehensive medical record to alert the health care team of changes required in the medication regimen or to schedule follow-up visits. We have fully exploited the genomes of humans, food-producing animals, and plants. Using this knowledge, we have maximized food production, bred healthier cattle, swine, poultry, and other food species, and created transgenic factories for medicines. By the middle of the 21 st century, we found that it is more efficient and considerably less costly to grow protein (animal and vegetable) in cell culture. Cell culture techniques are now so ophisticated that you can't distinguish cell culture meat, fish, or bean from the real thing. Through this technology, we have virtually aboli hed famine around the world and have ended forever concerns of animal diseases like the bovine spongiform encephalopathies transmitted to humans that plagued Europe 100 years ago. The health professions went through considerable soul-searching and transition throughout the last century. They had grown closer through shared knowledge and use of expert systems used in practice. By the end of the second quarter of the 21st century, the combination of virtual reality and artifIcial intelligence technologies completely revolutionized education and teaching, and they made it possible to balance the curricula scientifIcally, clinically, and culturally. Together, they eliminated the need for memorization, which had been necessary for professionals to master their disciplines.

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During this transition, shared knowledge bases combined with shared training and interdependence in professional practice resulted in the individual professions treading on each other's turf. Each profession had a difficult time demonstrating its unique contributions to health care. For many years, efforts were made to combine the three professions or evolve new ones, but each profession steadfastly held on. Medicine, pharmacy, and nursing managed to retain their individual identities, but none is exactly as it was a century ago. By 2065, English and Mandarin were the only languages in general use in science, commerce, and diplomacy. These two languages, coupled with the use of the global "UniNet" by more than 80% of people around the world, greatly facilitated global education and communication among health professionals and between professionals and consumers, leading to better health services and improved health.

Pharmacy Meets Its Future Good planning and concerted action throughout the 21 st century enabled pharmacy to recognize that the profession was capable of much more than dispensing medicines and counseling patients. Counseling was only the first step along pharmacy's path to greater cognitive contributions to health, but in 2001, even this

flfst step was not being taken with assurance. Indeed, some pharmacists still questioned whether it was even the right step. Pharmacists knew that they could do more. They determined that in addition to formulating and deli vering new drugs, they could also provide healing interactions, care, and reassurance. While this expanded pharmacy's role was not greeted by medicine and nursing with enthusiasm, pharmacy persevered and eventually gained acceptance for its broader role. Pharmacy continued to search for its defining, unique contribution to health care. In the 20th century, clinical pharmacy was thought to be that difference. It wasn't. In that same era, the concept of pharmaceutical care emerged. It had the potential to become that difference, and pharmacists liked the way it sounded. But, it still took three generations of pharmacists before they felt comfortable with the concept in a way that made each practitioner feel that he or she was a part of it. The 21st century's attempt to define pharmacy's unique contribution was the pharmacist-scientist who used genomic technologies to create the unique drugs and dosage forms for individual patients. Like nuclear pharmacy before it, this too became a niche practice, albeit an important one. But it was neither unique to pharmacists nor broad enough for all to fit under its umbrella.

Jerome A. Halperin The distinguished career of Jerome A. Halperin has embraced many facets of pharmacy. Perhaps the capstone of his career was his tenure at the helm of the U.S. Pharmacopeia (USP), where he instituted fundamental changes throughout the organization, increased USP's international reach, and positioned it as the most respected pharmacopeia in the world. He also maintained and expanded relationships among the various scientific and health professions during times of change. After beginning his career in hospital pharmacy within the Indian Health Service and the Public Health Service (PHS) Division of Hospitals, Halperin held positions of leadership in the U.S. Food and Drug Administration (FDA), the radiological and environmental health programs of the PHS, and the state health departments of California and Kansas. During his term with the FDA Bureau of Drugs, he was directly involved in international harmonization of regulatory and compendial standards for pharmaceuticals. Halperin retired from PHS in 1983 and joined the aTC Division of CiliA-Geigy, where he was responsible for product development, clinical evaluation, regulatory affairs, and quality assurance. Halperin was the third pharmacist to reach the PHS rank of Rear Admiral and, for a time, he was the highest ranking career pharmacy officer in the FDA. In 1984, he organized and chaired the flfst Conference on Pharmacy in the 21st Century. Recently, he became president and chief executive officer of the Food and Drug Law Institute in Washington, D.C. Halperin has been awarded four honorary doctorates and was elected to the Noble College of Chemists and Pharmacists of Rome for his leadership in pharmacopeial harmonization. He is an honorary member of the Rho Chi Society and was named the 1998 PPSI Distinguished Person of the Year. He received a Resolution of Recognition from the APhA Board of Trustees in 1983 upon his retirement from federal service. He is the 2001 Remington Honor Medalist and the recipient of the 2001 Distinguished Career Award from the Drug Information Association. He is a fellow of the APhA, the AmeriHalperin can Association for the Advancement of Science, the American Association of Pharmaceutical Scientists, and the American Public Health Association. He received his bachelor of science in pharmacy from Rutgers University, New Brunswick, N.J., a master of public health from Johns Hopkins University, Baltimore, Md., and a master of science in management as a Sloan Fellow at the Massachusetts Institute of Technology, Cambridge.

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Nanotechnology opened new opportunities for pharmacists to marry technology with genomic technologies to create drugs and dosage deli very mechanisms for the Age of Nanomedicine. Coupled with the expanded concept of pharmaceutical care, nanotechnology served as the uniting force with which pharmacists used their scientific, clinical, and cognitive skills to serve individual patients and their unique needs. Twenty-first century pharmacy recognized that its challenge for success in the 22nd century was to determine its most valuable contribution to human health and to bring that contribution into reality. That realization of the need to find its unique contribution awakened the profession. Pharmacists recognized that they Jerome A. Halperin (first row, center), winner of the Remington Honor Medal, must make their contribution not just to with past medalists. one patient at a time, but also to humanity as a whole, in part, through the concept of contribution without compensation. Opportunity for humanitarian nized that only those people living in enlightened societies, service became easier throughout the 21 st century as the work employing their economic and social capacities to provide a readecreased. Our workweek averages about 22 hours. Workweeks sonable standard of living, had a chance for long, healthy, producin your time averaged about 37.5 hours. We have more opportu- tive lives. People less fortunate remain doomed to lives that are brutish, vulgar, and short. nity for humanitarian pursuits. The U.S. Healthy People 2010 Objectives process established two overarching health goals for the United States in the first A Guiding Vision for Pharmacy To prepare for the challenges of the 22nd century, 21st century decade of the 21 st century: longer years of life and elimination of health disparities. The U.S. policy paralleled the World Health pharmacists addressed the need for pharmacy to have a clear, Organization' s Health for All vision, which called for greater strong vision of its future. They understood that pharmacy ' s health equity, reflecting humanity'S evolving perceptions of vision is its statement of aspiration, and failure of the profession human rights. to aspire is to expire. American pharmacists joined in addressing these overarching The prophet Isaiah said, "Without vision the people will pergoals. They addressed questions about needless drug-related mor- ish." His words apply as well to a profession. But, merely having tality and morbidity by joining the global dialogue to examine a vision is not enough. Pharmacy's vision requires continual tunlegislative and regulatory requirements for placing and maintain- ing to assure that it stays focused on its polar star, so' the profesing drugs on the market. Pharmacists advocated adequate testing, sion knows where it is heading and why. especially for the potential for serious or fatal adverse consePharmacy needed a vision of that strength to address its contriquences. They sought better defined and more objective methods butions to humanity and to invest each pharmacist with the underof determining appropriate benefit/risk ratios for drugs. They standing and satisfaction that he or she is contributing to creating demanded mandatory protective mechanisms, including the skin structures and behaviors that will endure and serve humanity tests for SNPs to identify those persons who may be at risk of well. Pharmacy succeeded in creating a vision of such power and, serious adverse reactions and must avoid the use of particular in doing so, preserved and insured its future and its role in the serdrugs. vice of humanity. Closer to home, pharmacists scrutinized their own practices Your generations accomplished this feat in a creative way. and established procedures and safeguards to make them as free Your leaders throughout the 21st century committed to and led a from medication errors as possible. Virtual reality, artificial intel- series of decennial (every ten years) conferences, which were ligence, and new technologies virtually eliminated pharmacist- held at the midpoints of the decades from 2005 through 2095. Those conferences committed to rolling 25-year horizons with the caused medication errors. More broadly, pharmacists joined with other health profession- ultimate goal of creating the unique contributions that defmed its als to guarantee equity in the delivery of health care. They recog- service and sustained the profession.

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The decennial conferences established audacious, unreasonable goals for the 22nd century in these areas: • Phannacy's unique contributions to humanity; • Content of pharmacy's knowledge base; • Commitment to adapting and employing new technologies in education, teaching, practice, and research; • Pharmacy's contributions to ensuring optimum health outcomes; • Safety, equity, and cost-effectiveness in the provision of pharmacy services; and • Continual stretching of the profession's horizon to assure that it continues to aspire. The French statesman, Clemenceau, once said, "Generals cannot be trusted with anything, not even war." There were some who believed that the sentiment might also have applied to pharmacists' ability to envision their preferred future and to establish and achieve the goals necessary to attain it. They were wrong! Pharmacists in the 21 st century probably believed that they could have planned their future alone, but they were wise enough to know that they should not. Phannacists, instead, convened the decennial conferences; they did not dominate them. Wisely, they included social scientists, ethicists, futurists, economists, legislators, biomedical scientists, and other health professionals, including representatives of some ideologies that were considered com-

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plementary or alternative in the 21st century, but which are mainstream today. Your leaders had a global view. They recognized that planning for phannacy's future in the United States was important, but insufficient. Pharmacy is a global profession, and its service to humanity knows no borders. American phannacists proselytized their colleagues around the world to join the efforts. They enlisted the World Health Organization, the International Federation of Pharmacy, and other international and national organizations to join them. Their efforts resulted in other countries beginning their own national planning efforts and joining the global effort. These efforts led to a parallel system of international conferences held at the end of each decade to create a global vision and plan. These efforts, too, met with success, and pharmacy was united and strong as the 22nd century dawned. Your efforts throughout the 21 st century extended pharmacy's horizons and energized the profession so that it entered the 22nd century better organized, surer of its place in the global health system, and confident of its contributions to humanity. In these past few minutes, I have tried to describe pharmacy and its place in health care at the beginning of the 22nd century. If you like what you heard and want it to become reality, make it so. You have the knowledge. You have the capacities. You need only the will.

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