Biotechnology: An Opportunity for Pharmacists Pharmacists must prepare themselves to deliver biotechnology drug products or other health care specialties may assume responsibility for these products. by Dorothy A. Wade and Richard A. Levy

y the year 2000 biotechnology will have a significant influence on the practice of pharmacy. Biotechnology will generate potent new medications-requiring custom dosing for individual patients-while the advent of peptides and other new classes of fragile drug molecules will require the use of, and patient familiarity with, sophisticated drug delivery systems. These pivotal developments may catapult the pharmacy profession into new roles and may provide many opportunities for pharmacists to enhance the professional dimension of their practice-but only if they are prepared. "Biotechnology is an area that many pharmacists have ignored, but they ign~re it at their peril," warns Marilyn Speedie, PhD, professor and chairman of the Biomedicinal Chemistry Department at the University of Maryland School of Pharmacy. Are pharmacists-particu-

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larly community pharmacists-willing to accept and address the need to expand their knowledge and skills to meet the challenges and responsibilities of biotechnology products? Exactly what does the pharmacist need to know and how will the pharmacist use this knowledge? We attempt to provide some answers to these questions.

The Biotechnology Revolution Biotechnology is based on developments in intracellular chemistry, molecular biology, recombinant DNA technology, genetics, and immunopharmacology.l Experts predict that advances in medical technology in the next decade are likely to make today's technology seem primitive, and will radically alter the health care field. A wide variety of unique therapeutic agents will be developed by pharmaceutical companies to treat many different diseases. The first of these novel pharmaceuticals will be proteins. Eventually , an increasing number will be small molecules, discovered through biotechnology-based methods that determine how proteins work. 1 More important, advances in molecular biology will help professionals tmderstand ftmdamental disease processes and mechanisms-including the underlying causes of cancer, cardiovascular disease, neurological diseases, immtmological diseases, and even aging. This, in turn, will enable not only the diagnosis and treatment, but also prevention, of disease. 1

Development of Medicines A variety of biotechnology-based pharmaceuticals are already commercially available, including human insulin, human growth hormone, the interferons, erythropoietin, and several colony-stimulating factors. Worldwide sales for therapeutic products introduced by the biotechnology industry approached $2 billion in 1990 and could top $2.5 billion in 1991.2

The number of biotechnology medicines in development has increased more than 60% over the past four years, according to the latest Pharmaceutical Manufacturers Association survey. There are now 132 biotechnology-derived agents in clinical trials or at the Food and Drug Administration for fmal approval, compared with 81 in 1988. 3 Biotechnology medicines currently in clinical trials target chronic conditions of the elderly and many of the leading causes of death among persons over age 65 (Table 1). 4 Future discoveries in neurobiology may have major implications for Alzheimer'S disease, and research exploring the immune system could alter arthritis and other autoimmune disease treatments. 2 Biotechnology has clearly established itself as a mainstay in pharmaceutical research and development, and new products will enter the market at an increasingly escalated pace during the next decade. 2 AMERICAN PHARMACY

Avoiding Missed Opportunities Pharmacists must not assume that they will automatically be given the responsibility for dispensing the new biotechnology products. 5 Many of these products are actually human proteins manufactured by recombinant DNA or monoclonal antibody technology, and may not be considered "dnlgs" in the traditional sense. 6 Other health care specialties do and will increasingly compete with pharmacy, seeking to assume responsibility for the dispensing and clinical use of these products. For example, pharmacy failed to assume responsibility for radioactive pharmaceutical products that are used to diagnose and treat disease. Although an entire specialty of pharmacy practice developed as a result of this technology, at many, if not most hospitals, radiopharmaceuticals are managed by nonpharmacists. 7 The same is tnle for patient-controlled analgesia; pharmacy departments that did not prepare for and assume responsibility for this technology lost control to anesthesia departnlents in many hospitals. The potential to miss opportunities continually faces community pharmacists. For example, with the increased use of parenteral products in non-hospitalized patients, community pharmacies that are not ready to enter this market are losing business to home care companies and alternative health care sites such as dialysis centers. Community pharmacists who want to get into distribution of biotechnology products must establish value-added components to their services or forge new and unique relationships with specialty clinics, where many of the biotechnology drugs are likely to be used. Although there are few biotechnology-based products for chronic conditions currently available in community pharmacies-with the exception of the diagnostic tests, insulin, and some vaccines-dnlgs initially used exclusively in hospitals as well as newly developed agents will work their way into the community in the near future. TIus is especially tnle for products that are used to treat chronic conditions-such as arthritis, heart disease, emphysema, Alzheimer'S disease, and

Table 1

Leading Causes of Death Among the Elderly Heart disease* Cerebrovascular disease* Obstructive lung disease* Pneumonia/influenza Lung cancer* Colorectal cancer*

*" Conditions for which significant products are under development within the biotechnology industry. Source: Reference 4.

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AIDS-because it will not be feasible to hospitalize patients with chronic diseases for long-term therapy. The University of Maryland's Speedie notes that if the dosage form used for these medications is not a "tablet or capsule," the widespread use of these products in ambulatory patients will be limited by drug delivery and distribution. "Pharmaceutical companies must be able to rely on pharmacy to handle these medications as they become available to treat chronic diseases," Speedie says. "If pharmacy cannot deal with the technology, distribution will be limited and the role of the pharmacist will be diminished."

Fiscal Concerns The significant expenses associated with the development and manufacture .of biotechnology agents add to their cost, and pharmacists need to adequately prepare to manage their use. The fmancial impact of biotech products so far has been felt most acutely in hospitals; some of these dnlgs cost thousands of dollars per dose. 8 Calvin Knowlton, president of Amhurst Pharmacy and associate professor at the Philadelphia College of Pharmacy and Science, says the only impact that biotechnology drugs have had in his pharmacy has been on the budget. When new biotechnology-derived insulins became available , it made no difference to pharmacists how they were produced, but the high cost did have an impact. Because of the expense associated with many of these products, pharmacists must develop cooperative relationships with wholesalers and manufacturers to establish just-intime inventory systems that ensure timely product availability while minimizing inventory costs. Although biotechnology products may represent a major component of the increase in pharmaceutical costs in the foreseeable future , they have the potential to decrease overall health care costs by shortening hospitalizations, restoring or increasing productivity, and improving the length and quality of life.1

Pharmaceutical Care in a Biotechnology Age With the evolution of new functions and responsibilities within pharmacy practice, the scope of contemporary pharmacy practice has expanded beyond the dispensing process (Table 2) to include the provision of pharmaceutical care 9 (see box). The ability of pharmacists to provide pharmaceutical care to patients using biotechnology products will depend primarily on their knowledge of the new biotechnology agents and their willingness to assume greater responsibilities, especially in communications with other health professionals and patients. 10

Pharmaceutical care Pharmaceutical care is the responsible provision of drug therapy with the goal of achieving definite outcomes toward improving a patient's quality of life. These drug therapy outcomes are (1) curing a disease; (2) eliminating or reducing symptoms; (3) arresting or slowing a disease process; (4) preventing a disease; and (5) achieving desired alterations in physiological processes, all with minimum risk to patients. 9

What Pharmacists Need to Know According to Speedie, pharmacists probably do not need to have an in-depth knowledge of how biotechnology drugs are manufactured. "It is not the production phase that is most critical from the pharmacist's standpoint. However, in order to understand the use, side effects, toxicity, stability, and delivery of biotechnology dnlg products, pharmacists should develop a basic knowledge of protein chemistry, especially as it relates to stability and stnlcture, as well as immlmology." The reason pharmacists must have an understanding of immunology, Speedie explains, is because a major area of biotechnology dnlg development is drugs that act on the immune system (e.g. , colony stimulating factors, interleukins, and interferons). "Because the immune system has not often been targeted by more traditional agents," Speedie notes, "pharmacists generally do not have the knowledge base Table 2

Scope of Contemporary Pharmacist's Activities • Participating in the process of drug therapy decisions • Se lecting the drug product dosage form • Determining the dose and dosage schedule • Selecti n g the drug product source of supply • Preparing the drug product for patient use • Prov iding the drug product to the patient • Prov id ing drug information to the patient • Monitoring the patient to maximize compliance with therapy instructions • Monitoring the patient to detect adverse drug reactions and drug interactions • Monitoring the patient to enhance the probability that therapy proceeds with established therapeutic objectives Source: Reference 9.

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upon which to evaluate information about the actions of the new agents." "Pharmacists must be able to evaluate the literature in order to stay current on specific areas of practice, and it is no different for biotechnology," Speedie adds. "If pharmacists wait until the technology is more readily available for the ambulatory patient, it will be too late. Side effects must be known, and allergies may take on a more important aspect when administering proteins. Pharmacists must know about proper storage, stability, and routes of administration if they are going to advise on the proper use of these products. " Additionally, as new agents are introduced that may offer incremental advantages over existing biotechnology products, pharmacists must be able to advise other health care professionals and patients on product differences. "Pharmacists will need to understand the basic differences and similarities between biotechnology dnlgs of the same class to make the appropriate choice of a drug for a specific condition," says Thomas Foster, PhannD, professor of pharmacy at the Center of Pharmaceutical Science and Technology at the University of Kentucky in Lexington. Knowlton adds, "Pharmacists need a baseline understanding of biotechnology to evaluate if a product is the right dnlg at the right cost for a particular patient, and if there are any reasonable alternatives." Pharmacists must also develop an understanding of quality of life and patient outcome principles as they relate to the use of biotechnology medicines. Speedie suggests that pharmacists can assess their basic knowledge of biotechnology by reading the information that has been published in the pharmacy and medical literature; if the pharmacist understands the terminology and can make comparisons of the structure, actions, and differences among products, then the basic knowledge level is probably sufficient. If not, pharmacists must lmdertake the edl:lcation and learning necessary to gain the knowledge required to properly manage the use of biotechnology products.

Drug Information and Education The increasing availability of biotechnology dnlg products will enhance the position of the knowledgeable pharmacist as an educator and drug information resource. At least initially, most physicians will know little about the properties, new dosage forms and delivery systems, indications, approved uses, and cost-effectiveness of these agents. Pharmacists will be expected to answer questions on indications and dosages for specific patient populations, such as pediatrics, geriatrics, and patients with altered organ function; the stability of new products; and their compatibility with other drugs. 6 The need to communicate with and effectively counsel and monitor patients will grow in importance as therapies become more complex, potent, expensive, and open to misuse. Therapeutic failures or drug misadventures due to poor AMERICANPHARMACY

Getting Ready for Biotech Drug Delivery Drug delivery for biotechnology medicines in the future may require that pharmacists be competent to: • Administer dnlgs through novel drug delivery systems and monitor their therapeutic efficacy, including the influence of disease state, patient age, and gender on the performance of dnlg delivery systems. • Identify appropriate vehicles for delivery. • Compolmd sterile and other individualized dosage forms and doses of unstable drugs. • COlmsel patients on the correct use of highly sop histicated and costly drugs. Source: Reference 11.

compliance are always costly; however, the additional expense associated with the cost of many biotechnology medicines make compliance even nlore important. Patients will find the pharmacist to be an absolutely essential resource for providing advice on the correct and safe use of these highly sophisticated and potent drugs. In addition to new dnlg products, new biotechnologyderived diagnostic products on the horizon will allow patients to monitor therapeutic blood levels, much the way blood glucose can be monitored today. As the trend to selfcare expands, pharmacists have a key role to play in dispensing these diagnostic kits and in educating patients to use the kits correctly and to interpret the results. 1

Drug Delivery and Compounding Biotechnology medicines will require sophisticated delivery systems to transport the dnlg to the site of action in the body. Innovative delivery systems may limit toxicity of these potent dnlgs and free patients from remembering to take medications at specific times. 11 There is a particular need for systems that will deliver proteins, peptides, and other large, high molecular weight products of biotechnology, as well as drugs with very short half lives that require unique delivery systems. Although many of the currently marketed biotechnology products and those in development must be administered parenterally, novel drug delivery systems will allow large proteins to be administered without injection. 6 Many of the novel drugs reSUlting from biotechnology research will require pharmacists to revisit their historic and traditional roles of compounding and drug delivery, according to Foster. Product preparation may be different because of the protein nature of many of the dnlgs. Compounding will also be a prerequisite to dispensing to reduce waste in delivering these very expensive products. Pharmacists will be preparing drugs in new and specialSeptember 1992/720 Vol. NS32, No.9

ized delivery fonns, such as liposomes, microspheres, transdennal and implantable systems, polymers, and other exotic dnlg delivery systems. "Phannacists, in part, must embrace a leadership role for dnlg delivery systems-taking the product, determining the appropriate vehicle for delivery, and then making it," says Foster. "In the long tenn, biotechnology's impact on phannacy will require pharmacists to extemporaneously prepare biologics and their appropriate dnlg delivery systems. "

Meeting the Challenge The ability of the profession to meet these new challenges will require fashioning a phannacy curriculum that prepares students as well as practicing phannacists. "The schools and colleges of phannacy are actively pursuing strategies to ensure that pharmacy graduates are wellequipped to meet the demands of contemporary phannacy practice, including those presented by biotechnology," says Carl Trinca, PhD, executive director of the American Association of Colleges of Phannacy. "As .a result of advances in the understanding and application of phannaceutical biotechnology, phannacy schools are adapting their curricula to ensure phannacy graduates are prepared to provide phannaceutical care, regardless of their practice site or the source of the phannaceuticals used." The colleges of phannacy are also cognizant of their role in ensuring the continued competency after graduation. "Pharmaceutical education-in partnership with the profession-is committed to providing stnlctured postgraduate education and training," says Trinca. "This will enable practitioners to maintain their competence and acquire new competencies, which include the knowledge and skills necessary to manage biotechnology products. " Phannacists must actively seek out appropriate continuing education opportunities concerning biotechnology, which will stimulate the educational efforts of the colleges of pharmacy, professional phannacy associations, and the biotechnology phannaceutical industry. Phannacists must also develop working relationships with the originators of new therapeutic agents and delivery systems. Participation with innovators in developing and testing new technologies will help pharmacists establish a strong position in the deployment of these innovations to patients. In introducing new technologies , originators will select providers who will best ensure the proper use of the product. There is also a role for phannacists in developing these new treatment modalities, either by working for the companies or in the contract testing of the products. The pharmaceutical industry must also collaborate with phannacy in educating and training practitioners. By creating a demand for continuing education opportunities, phannacy will demonstrate its interest in remaining actively involved in the use and distribution of biotechnology products. Vol. NS32, No.9 September 1992/ 721

Opportunity for Empovverment The emergence of biotechnology-based pharmaceuticals will spawn an array of new health professionals and a realignment of the responsibilities of existing providers. Traditional roles are changing and current lines of distinction among physicians, nurses, physician assistants, pharmacists, and other health professionals are now blurring as these providers acquire new skills. There will be much competition for new roles and phannacy will have to engage in a vigorous effort to assure involvement. The phannacy profession is confronted with the opportunity to empower its practitioners in response to biotechnology initiatives. But to do so, pharmacists must establish collaborative programs with academia, professional associations, and the phannaceutical industry. To avoid a missed opportunity, community pharmacists must marshall their resources, establish their roles, expand their services, and enhance phannaceutical care in the age of biotechnology. Dorothy A. Wade is vice preSident, professional relations, National Pharmaceutical Council, Reston, Va .. RichardA. Levy, PhD, is vice preSident, scientific affairs, National Pharmaceutical Council. The authors wish to acknowledge the assistance ofJanice L. Feinberg in the preparation of this manuscript.

References 1. Montague M. The impact of biotechnology on the practice of pharmacy in the year 2000. Am J Pharm Educ. 1989;53:21S-6S. 2. Miller L. Momentum builds in biotechnology. Biotechnology Medicines in Development. Washington, DC: Pharmaceutical Manufacturers Association,1991:13. 3. Mossinghoff GJ. 132 biotechnology medicines in testing represent a 63% increase over 4 years. Biotechnology Medicines in Development. Washington, DC: Pharmaceutical Manufacturers Association, 1991:1. 4. American Medical Association. Biotechnologies targeting the diseases of the aged. Report of the Council on Scientific Affairs. Chicago, IL: American Medical Association, 1991. 5. Hepler CD. Unresolved issues in the future of pharmacy. Am J Hosp Pharm.1988;115:1071-81. 6. Stewart CF, Fleming RA. Biotechnology products: new opportunities and responsibilities for the pharmacist. Am J Hosp Pharm. 1989; 46(SuppI2):S4-8. 7. Anderson RW. Opportunities in high technology. Am J Hosp Pharm. 1986;43:903. Editorial. 8. Chi J. Going for broke: how the 1992 game is shaping up. Hosp Pharm Rept. 1991;Dec:1,11. 9. Anonymous. JCPP provisional draft mission statement for pharmacy practice. Am Pharm. 1991;NS31(10):28. 10. Colaizzi JL. Biotechnology: a new horizon for pharmacy. US Pharm. 1989;14(2): 105-6. 11. Robinson DH, Mauger JW. Drug delivery systems. Am J Hosp Pharm. 1991;48(SuppI1):S14-23.

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Biotechnology: an opportunity for pharmacists.

Biotechnology: An Opportunity for Pharmacists Pharmacists must prepare themselves to deliver biotechnology drug products or other health care specialt...
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