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Pharmacists in the Health Care System

Wayne K. Anderson, B.S. in Pharmacy, M.S., Ph.D.
Dean, University at Buffalo School of Pharmacy and Pharmaceutical Sciences

Drug therapy represents a major component of modern medicine — cures for fatal diseases, treatment of acute conditions and management of chronic conditions have made it possible for people to live longer, more productive lives. More than 13,000 prescript ion drugs are available in the United States and, particularly with the newer more potent drugs that have highly specific cellular "targets" the management of drug therapy is one of the most important challenges in health care management.

The management of drug therapy is one of the most important challenges in health care management.

The effectiveness of the drug therapy must be monitored on a continuing basis and potential adverse effects must be recognized. Some drugs function well in isolation but present difficulties when taken with a second drug, and these drug interactions can result in serious adverse effects. This is a large and growing problem, particularly in the elderly population of patients with chronic diseases. In 1995, according to US Bureau of the Census data, 13.3% of the New York State population was over the age of 65 (compared to 12.8% nationally). New York's Medicare population in 1995 was 2.69 million (14.8% of the total NY population compared to 14.3% nationally) according to HCFA data, and this sector of the population is increasing rapidly. It is estimated t hat the current age 65+ population consumes 35% of health care services.

A study of 1992 data showed that the "indirect" costs exceeded the direct costs for prescription medication! The drug related problems included an untreated condition for which a drug was indicated, an improper drug selection for a condition, sub-therapeutic doses, failure to receive the drug, overdose, adverse drug reaction, drug interactions and drug use with no indications.¹ The "indirect costs" include the costs associated with additional prescriptions, unnecessary emergency room visits, unnecessary visits to the physician's office, unnecessary hospital admissions, unnecessary long-term care admissions, and deaths.

The cost associated with the management of preventable prescription-drug associated problems is more than the actual cost of the medication.

The "indirect" cost estimates do not include the economic impact of lost productivity (which some have estimated to be equal to the direct costs of the medication).

Total pharmaceutical sales in the US was $77.14 billion in 1995 [total health care costs in the US were over $1 trillion in 1995, 15% of the GDP compared to 6% in 1965 (US Department of Commerce data)]. Retail prescription sales were $63.8 billion (2.1 billion prescriptions: 1.2 billion new and 0.9 billion refills). This corresponds to approximately $5.92 billion in total pharmaceutical sales in New York; in 1995, according to IMS Market View data, retail prescription drug sales totaled $4.9 billion in New York (142.3 million prescriptions, or 7.9 prescriptions per New York State resident). The Medicaid share of the 1995 retail prescription sales was 18.4%, or $0.9 billion, for the 3,035,000 Medicaid recipients [(16.7% of the total New York population) according to federal Health Care Financing Administration (HCFA) data].

The 1995 data for New York ($5.92 billion "direct cost" of total pharmaceutical sales and with a $0.9 billion component consisting of Medicaid retail prescription drug sales) provide the basis for estimation of the additional "indirect" costs (1.3 times the "direct costs", excluding lost productivity) to the New York medical system.

Preventable prescription-drug associated problems added $7.7 billion to the cost of health care in New York in 1995 (with the Medicaid "share" at $1.17 billion).

The potential savings with drug therapy management are very significant and go well beyond the so-called "indirect costs" linked to preventable prescription-drug associated problems. Pharmacists Care ("cognitive services") has been shown to have a considerable impact on patient outcomes with marked reductions in the overall cost of medical care. The underlying philosophy of Pharmacists Care is that pharmacists are responsible (accountable) for pharmacotherapy outcomes of patients under their care.²

"Pharmaceutical Care", as defined by the American Pharmaceutical Association, "is patient-centered, outcomes oriented pharmacy practice that requires the pharmacist to work in concert with the patient and the patient's other healthcare providers to promote health, to prevent disease, and to assess, monitor, initiate and modify medication to assure that drug therapy regimens (diagnostic or therapeutic) are safe and effective. The goal of Pharmaceutical Care is to optimize the patient's health-related quality of life, and achieve positive outcomes, with realistic economic expenditures".

The "indirect" cost assessment does not include assessment of noncompliance costs which have been estimated to add about 30% to the estimated "indirect" costs. The "costs" of noncompliance, according to a 1995 estimate³, include 125,000 deaths, 20 million workdays ($1.5 billion), 10% of all hospital admissions (25% among the elderly), and 23% of nursing home admissions:

The cost of noncompliance with drug therapy in New York State4 in 1995 was 8,600 deaths per year 1.4 million lost work-days corresponding to $100 million in income 10% of all hospital admissions (25% among the elderly) 23% of nursing home admissions.

An analysisof 1995 and 1996 pharmaceutical sales by class of trade (Appendix 1) shows 18.9% of the total in hospitals for 1996, down 1.5% from 1995 (and down 4.7% from the 23.6% share in 1990).⁵ Total retail prescription sales accounted for 66.04% of the total, up 0.31% from 1995. These data reveal the shift toward ambulatory care and emphasize the need for drug therapy management (Pharmacist's Care) in ambulatory settings. The significance of effective drug therapy management assumes even greater consequence as concerns for cost-efficiency continue to move more patient care from inpatient to outpatient settings (ambulatory care) and as patients leave "same-day" surgical centers with written prescription. Effective drug therapy management is also more critical as a wider range of health care providers have prescriptive authority.

The Pharmacist's Role in the Health Care Delivery System

The changing health care environment in the United States is creating a tremendous impact on the health care system and the "customer". The changes in pharmacy are no less profound than the changes in the overall system, and the role of the pharmacist as a "druggist" — a drug dispenser — is changing. The pharmacist has an expanding role as a drug therapy manager in a disease state management team and as a drug therapy consultant on the team.

Pharmacists must still maintain (manage) a reliable drug distribution system following ethical and legal practices, but new paradigms for dispensing involve greater automation (robotics) and more extensive use of technical personnel. In that regard, the pharmacist is responsible for:

• the evaluation of drug orders and prescriptions for accuracy and safety (including the selection and use of computer systems developed to check for potential drug interactions);
• the storage, preparation, dispensing (including unit dose systems) and compounding of medicines (including IV admixtures, chemotherapy and parenteral nutrition preparations);
• recommending the use of non-prescription over-the-counter (OTC) medication (according to Datamonitor USA, the OTC market was $46 billion in 1995; furthermore, many potent prescription drugs have made the so-called "R_X to OTC" transition and more than 600 OTC products contain ingredients that were marketed by prescription 20 years ago or less).
• the supervision of technical personnel involved in the storage, preparation, dispensing and compounding of medicines;
• the use of information technology in the maintenance of records and in medical information;
• communication
1. with patients to provide counseling and,
2. with other health professionals regarding pharmacotherapy;
• pharmacy management.

The responsibilities given above are a limited set, largely associated with the drug distribution role of the pharmacist. However, the pharmacist, as a drug therapy manager, has a much broader range of responsibilities in the role of a Pharmaceutical Care provider.

The profession is moving to a doctor of pharmacy (Pharm.D.) which, like medicine and dental medicine, is a four year professional doctorate program (following completion of the required college prerequisites). Post-Pharm.D. residencies in specialized are as of training (e.g., geriatrics, pediatrics, infectious diseases, ambulatory care, pharmacoepidemiology, etc.) are used to extend the professional expertise of the Pharm.D. The Pharm.D. has been an optional program for advanced training in most pharmacy schools for many years, however, Pharm.D. degree programs have replaced the existing B.S. in Pharmacy programs in most pharmacy schools and the transition to the all-Pharm.D. should be complete by the year 2000. Existing pharmacists with a B.S. have or will be given the option (by most pharmacy schools) to earn the advanced degree; alternatively the pharmacist can enroll in comprehensive disease management certificate programs to gain the necessary expertise.

Pharmaceutical Care in Disease Management

The process of disease management⁶ involves: (1) the identification of the medically at risk patient; (2) systematic management of the patient to improve care and promote wellness in an information-intensive process, and; (3) outcomes evaluation. In the patient centered program, costs are usually reduced, the quality of care is increased and patient satisfaction is increased. In the process the focus moves from episodic care to disease management to wellness management to disease prevention. The key is continuity, continuity of care with the opportunity for intervention by any member of the "management team" at any stage. The pharmacist is a key member of this "management team".

The first step in a disease management program involves case selection — a process that involves risk assessment. This process draws from patient population database systems which track diseases in relation to the overall health status and age of the patient, the patient's living conditions and other related factors. The case typically will be selected (recommended) by a case manager for a managed care organization or by a physician, however other members of the team can intervene and suggest a case for more intensive management.

The next step involves the development of clinical pathways and disease management interventions. The various interventions and pathways are developed on the basis of clinical research literature and the "best" clinical practice; these treatment protocol libraries and guidelines (so-called population-based data) are based on integrated health information computer databases but are tailored to suit the individual patient. The pathways also establish outcome goals and articulate the responsibilities of team members. The pharmacist, as a disease manager, is a member of the disease management team consisting of physicians, non-physician providers and other allied health professionals. The pharmacist participates in the drug use decision making process and in some instances is responsible for the selection of the appropriate medication(s), dosage form(s), dose(s) and dose schedule(s). The pharmacist has access, and the expertise to use drug information from a variety of sources including the primary literature. The pharmacist will interpret biostatistical and clinical information in the literature and assess experimental protocols in order to evaluate published conclusions which are often conflicting.

Pharmaceutical Care in an Ambulatory Environment.

The pharmacist, as a drug therapy manager in the disease management team, provides more intensive patient care for patients identified as "at risk" by the disease management team. The "value" of pharmaceutical care (cost savings and improved health care) is being recognized by third party payers. However, greater recognition of this type of care must be made before pharmaceutical care is realized as a norm for "at risk" patients. Reimbursement for this care is independent of the payment for the actual medication and the "routine" counseling services provided with each prescription.

A disease management strategy must match the structure, skills, and culture of each organization in the health care system. Success will never be achieved without this alignment. Structure should support the strategy; skills will enable successful implementation of the strategy; and a receptive culture will encourage the systems approach disease management needs to emerge and thrive in a practical reality.7

Key elements of Pharmaceutical Care in an ambulatory setting involve a number of different skills.

• Patients will be given an initial counseling session to develop a complete and timely patient history [family history, health status, medical and medication history (prescription and OTC medication), diet and physical activity status, history of current condition, etc.]. The patient (or, if not possible, the principal caregiver) will fill out a questionnaire and will be interviewed. The pharmacist must use well developed interview skills to identify problems. The pharmacist must be able to capture, organize and interpret new information, develop comprehensive patient-specific records and exchange this confidential information with other members of the patient's health "team". The pharmacist's records must be part of the "team's" record to ensure continuity of care. A critical component in this phase is the availability of, and access to clinical databases in an integrated, patient-based, computerized health system information network. The pharmacist must use skills in medical informatics and in the evaluation of diagnostic information (laboratory test and medical imaging data). The pharmacist must be skilled in the use of clinical practice guidelines and protocols.

Core Competencies for the Pharmacist

1. THERAPEUTICS - comprehensive education in the biomedical and pharmaceutical sciences to permit management of drug therapy and specific disease states; use clinical practice guidelines and protocols
2. PHYSICAL ASSESSMENT - skills in physical assessment to monitor the outcome of pharmacotherapy
3. COMMUNICATION - interview skills to identify problems, communication skills to educate patients and other health care providers; skills in the usage of devices and test kits to instruct patients on their operation
4. BIOSTATISTICS AND EPIDEMIOLOGY - interpretation of biostatistical and clinical information in the literature and assessment of experimental protocols in order to evaluate published conclusions (which are often conflicting); analysis of population-based data on drug distribution, drug use and outcomes
5. MEDICAL INFORMATICS - use skills in medical informatics and in the evaluation of basic diagnostic information; assess laboratory data and recommend laboratory tests required to monitor therapeutic outcomes

• The process of patient education will also begin during this initial session. The patient will learn about the disease, the medication, the nature of the treatment plan, expected outcomes and how they will be monitored, the importance of compliance with the treatment as well as other responsibilities of the patient, possible side effects of the pharmacotherapy and potential drug interactions (including over-the-counter drugs). The information must be given at a level the patient can understand. Written educational materials as well as computer based education programs will be presented. The pharmacist has a strong set of skills in the biomedical and pharmaceutical sciences in the context of drug therapeutics and specific disease states (See Appendix 2 for a partial statement of ACPE Accreditation Standards).

• The education process includes instruction and training in the use of medical devices [e.g., peak flow measurement devices, metered-dose inhaler (MDI), dry-powder inhaler (DPI), insulin syringes, insulin pumps, etc.] and/or clinical test kits. An importan t feature of the patient education process is the emphasis on a set of plans for self management (acute and chronic management). These plans must be based on the patient history and clinical assessment. For example, inhalation medication of patients with asthma could involve any one of several drug delivery devices and the pharmacist must determine whether the patient can use a MDI, DPI or nebulizer (with or without an air compressor); the pharmacist must also determine whether the patient requires a breath-actuated device (Autohaler¨) or a holding chamber-type valve spacer (InspireEase¨ or Aerochamber¨). The pharmacist has skills in the use of devices and test kits and can instruct patients on their use and misuse (limitations). Information on nutrition, and life style and environmental conditions that could exacerbate the disease will also be provided. The pharmacist must use expert communication skills.

• The pharmacist may make a follow up telephone call 24-48 hour after dispensing the drug to an "at risk" patient (surveillance). The pharmacists may also use telephone or mailed reminders to ensure timely refills. The pharmacist must also interview the patient at the time of refills to determine what has taken place during this period, including the results of patient self-monitoring, and document the results. The pharmacist must establish a caring, ethical professional relationship with the patient.

• The pharmacist will develop a follow-up plan and will monitor drug-induced therapeutic effects (e.g., blood pressure, cholesterol levels, blood glucose levels, airway function, etc.), monitor the patient for potential adverse effects of the drug (assess laboratory data and recommend required laboratory tests to monitor therapeutic outcomes), monitor the patient for potential disease complications [e.g. ophthalmic screening and foot examinations for progression of long-term complications in patients with d iabetes (retinopathy and peripheral vascular disease)] and document the results. The pharmacist must use skills in physical assessment. In New York, this will require legislative changes in the pharmacy scope of practice laws to allow pharmacists to carry out assessments.

• The pharmacist will also have limited authority to initiate prescriptions, modify therapy and authorize continuation of therapy as a member of a disease management team. The pharmacist must have a strong professional relationship with other members of the integrated "team". This will also require legislative changes in pharmacy scope of practice laws in New York to give pharmacists limited prescriptive authority.

Pharmaceutical care in an ambulatory environment will take place in a private setting, in a suite designed for that purpose. The practice opportunities may, for example, be in or near the pharmacy, in an ambulatory care center away from the pharmacy, or in a physicians group. Home visits are appropriate in some cases for pharmacists involved with home care agencies.

The continuing process in disease management involves the measurement of outcomes which include clinical, patient compliance, patient satisfaction and financial measures. The outcomes are measured in relation to "performance indicators" derived from stat istical evaluations of large patient populations. Desired outcomes are generally plotted at the onset of treatment by the disease management team. The pharmacist will determine therapeutic outcomes, monitor patient compliance and track patient education.

• "Short term" clinical outcomes are measured by the immediate effects of the treatment following specific protocols (e.g., cholesterol levels, glucose levels, blood pressure, etc.); evaluation of these results could lead to recommendations for changes in t he medication, the dose, dosage form, or dosage frequency. Outcomes are also measured by the continuing process of patient interviews. All of these data will be managed in an database that can be analyzed, with appropriate quality controls, and used to generate reports for the patient and for other members of the health care team.

• "Long term" clinical outcomes assess mortality, morbidity and complications.

• Patient compliance assessments may require intervention to improve compliance and the intervention may involve a change to "unit-of-use" packaging⁸, a change in medication or a simplification of the regimen, or it could involve more patient education; the intervention could also involve more supervision by a care giver or specialty services that assist patients in drug compliance. Behavioral outcomes go beyond compliance and include the patient's role in self-management of a healthy life style.

The pharmacist will be involved with some measurements of patient satisfaction, but satisfaction, financial and health care system assessments must be a health care system-wide program (i.e. patient focused rather than an isolated encounter focus).

• Patient satisfaction measures — quality outcomes — include health-related quality of life, changes in life style restrictions, productivity (work), and satisfaction with care (provider performance).

• Financial outcomes (cost) using pharmacoeconomics must consider the cost of the integrated care system (visits to physician's office , emergency room visits, hospitalization, laboratory tests, imaging, medication, etc.) and not just the cost of one component. Analysis of economic outcomes must also include worker productivity (lost work days).

• System outcome measurements include evaluations of the care structure and process, communication and information systems, "team" recruitment and retention, and profitability.

System-wide assessments also must include population-based outcomes. These outcomes are given in terms of the percentage of patients in any particular risk group that achieve certain outcome goals.

There are a variety of conditions that can be accommodated in the disease management process (weight loss and smoking cessation programs are also amenable to pharmaceutical care). The selection of particular states for management will be based on the impact of the disease (human, monetary and scope), the availability of effective interventions, and the value of the program in terms of human and economic considerations. Examples of management programs include:

1. infectious diseases
2. respiratory diseases (e.g., asthma)
3. endocrine/metabolic disorders (e.g., diabetes)
4. gastrointestinal disorders
5. cardiovascular disease (e.g., essential hypertension, dyslipidemia)
6. anticoagulant therapy
7. pain management
8. women's health (e.g., hormone replacement)
9. orthopedic disorders (e.g., osteoporosis, osteoarthritis, lower back disorders)
10. psychiatric disorders (e.g., depression)

It is important to reemphasize that all patients will receive "basic" Pharmaceutical Care and some patients — those patients who are most "at risk" — will be managed intensively.

Pharmaceutical Care in an Institutional (Inpatient) Environment. Pharmaceutical care, as a component of disease state management, occurs as part of inpatient care in hospitals, hospices and long-term care facilities. The details of the care differ in each setting, however in every case the pharmacist serves as the drug therapy manager in the health care team. Efficiency in the delivery of care is also an important consideration. The pharmacist, in a mid-level practitioner position, focuses on pharmacotherapy as an area of expertise.

Hospital (or Health Systems) Pharmacy. Adverse drug effects (ADEs) have a significant effect on the length of hospital stays and patient mortality. The rate of ADEs in short-term hospitalized patients has been estimated to be approximately 6.5%, and of that number, approximately one-half are potentially preventable.⁹ Several recent studies have estimated, for the nearly 32 million annual hospital visits nationally, that the total hospital costs of all ADEs occurring during hospitalization (not the costs associated with admissions related ADEs) was $2 to $4 billion.^{10, 11} The hospital costs of preventable ADEs was estimated at $1 to $2 billion! These costs do not include malpractice costs¹² or the very substantial costs associated with injuries to the pat ient (outpatient treatment, disability, etc.). In one three-year study of 91,574 patients in a single hospital, ADEs were associated with a 2-fold increased risk of death.¹³

Integration of pharmacists on medical teams and patient care units provides an effective method of promoting appropriate medication use.

An analysis of factors leading to ADEs in a hospital pointed to a number of sources.¹⁴ Prescribing errors (e.g., drug choices, doses, dose frequencie, route of administration, dosage form, drug interactions, contraindications) by physicians and nurses was the major factor (35%) associated with of preventable ADEs. Some of these ADEs can be prevented by computer-based processes and by improving the system used to order medications. Another import ant factor leading to ADEs was the availability of patient information (e.g., patient's condition, laboratory tests, current medication and recent doses) and the study concluded that "pharmacists sometimes lacked information about clinical characteristics of patients and results of laboratory tests that would have enabled them to intercept an improper order." The hospitals which participated in the ADE analysis implemented a number of changes as a result of the study, "among the most interesting is an enhancement of the role of the pharmacist by increasing his or her participation on the unit as a member of the patient care team, including participation in physicians' rounds." A related study also concluded that "integration of pharmacists on medical teams and patient care units provides an effective method of promoting appropriate medication use."¹⁵

The hospital (or health systems) pharmacist provides medication distribution services and a range of acute care clinical services including:

• participation in the disease management team as the drug therapy manager. In most instances the pharmacist will have advanced specialized training (post-graduate residencies and fellowships) in areas such as pediatrics, geriatrics, infectious diseases, immunology, etc.
• monitoring for contraindications, adverse drug reaction, drug interactions, drug allergies, drug-food interactions and for drug interference with laboratory tests. Medications are administered to hospitalized patients about 10.3 million times a day (3.75 billion per year). There is a significant potential for errors in prescribing, dispensing, administration and monitoring of drug therapy; one estimate has an error rate of 12% in a typical hospital many of which could have produced serious consequences without pharmacist intervention.¹⁶
• evaluation of creatinine clearance calculations and monitoring drug profiles of patients with elevated serum creatinine;
• antimicrobial therapy optimization in association with culture and sensitivity information. Cost savings are seen in two major ways:
1. expensive, ineffective drugs are not used, and
2. hospital stays are shortened;
• pharmacokinetic dosing consultations for antibiotics (e.g., aminoglycosides and vancomycin), digoxin, phenytoin, theophylline and other drugs (when appropriate). The pharmacist's particular knowledge of pharmacokinetics and pharmacodynamics (the rate and extent of drug absorption, distribution, metabolism and elimination) is needed to evaluate the patient's often unique response to specific drugs;
• clinical pharmacist/physician rounds;
• skilled nursing facility consultant;
• drug information and medication inservices to other health professionals. The pharmacist must communicate new information concerning drug therapy to other members of the health team.
• coordination and evaluation of new drug clinical research studies (phase I, II, and III drug trials) as well as post-marketing surveillance studies (phase IV);
• the conduct and documentation of pharmacoepidemiology, pharmacoeconomic and drug outcome studies;
• participation in continuous quality improvement (CQI) process teams, in the Pharmacy and Therapeutics (P&T) Committee, and in other committees;
• drug formulary development and management.

The consultant pharmacist serves many of the same clinical services as described for the hospital (or health systems) pharmacist except that it is carried out in a long term care facility (nursing home, skilled nursing facility, etc.) environment. The complexity of Pharmacists Care in this chronic care setting involves the analysis of multidrug therapies, frequently in patients with multiple disease states. The absorption, metabolism and elimination of drugs is often altered in these patients. The consul tant pharmacist may also be involved in hospice care.¹⁷ The goal in palliative care is to make the patient comfortable with an emphasis on quality of life. Pain management is a major function.

The consultant pharmacist also provides home care services and is involved in many of the same functions described as ambulatory care. Pharmaceutical Care in home care has been shown to decrease the requirement for nursing home care. The consultant pharmacist, as a member of the health care team, is involved in the development of a clinical pathway (disease management program) with intervention guidelines and with a program for patient (family) education. The consultant pharmacist is involved in the measurement and evaluation of outcomes data.

Conclusions.

The pharmacist plays an integral role in the health care team as a pharmacotherapy expert. The pharmacist is responsible for the accurate and efficient distribution of medications. The pharmacist is also responsible for the pharmacotherapy outcome of the patient.

References and Footnotes.¹⁸

¹ Johnson, J. A.; J. L. Bootman, J. L. "Drug-Related Morbidity and Mortality. A Cost-of-Illness Model." Archives of Internal Medicine, Volume 155, October 9, 1995, pp 1949-1956;

² Brushwood, D.B.; Hepler, C. D. "Redefining Pharmacist Professional Responsibility", in Pharmaceutical Care; Knowlton, C. H.; Penna, R. P., editors; Chapman and Hall, New York, p. 195, 1996.

"Responsibility is sometimes confused with authority, although the ideas are quite different. Responsibility is defined as and ability to answer for one's conduct and obligations, and as being morally trustworthy within a specific office, duty, or trust."

³ Fincham, C.; Hunter, J. NARD Journal April, 1996; 29-32. "Documenting the worth of pharmacist care."

⁴ Estimates for New York are based on national statistics and the 6.9% distribution of the national population in New York State.

⁵ IMS Class-of-Trade Analysis 1996.

⁶ Todd, W. E.; Nash, D., Editors, Disease Management, a Systems Approach to Patient Outcomes, American Hospital Publishing Inc., Chicago, 1997. (Foreword by Bill Frist, MD, U.S. Senator from Tennessee).

⁷ Eichert, J. H.; H. Wong, H.; Smith, D. R., in Disease Management, a Systems Approach to Patient Outcomes, W. E. Todd and D. Nash, Editors, American Hospital Publishing Inc., Chicago, 1997, pp 28-29.

⁸ Data for Medicaid, Medicare and federal employee groups show that a combination of mailed refill reminders and unit-of-use packaging resulted in a $67.67 saving per patient (considering pharmacy, physician, laboratory, and hospital costs): Barr, C. E.; Bouwman, D. L.; Lobeck, F., in Disease Management, a Systems Approach to Patient Outcomes, W. E. Todd and D. Nash, Editors, American Hospital Publishing Inc., Chicago, 1997, p 141.

If, for sake of example, one disease state is considered — diabetes. An estimated 564,000 New York residents have diagnosed diabetes [3.1% of the population (an estimated additional 538,000 are undiagnosed)]. Furthermore, if only one treatment is considered — oral agents — and, according to national statistics, 49% (276,360) take oral hypoglycemic agents, then a savings of $18.7 million ($67.67 x 276,360) could be realized by using mailed refill reminders and unit-of-use packaging for all of these patients. The $18.7 million savings is for a single drug class in one disease. Much larger savings could be realized in this one disease with this single drug class if the group of noncompliant patients were identified and only these patient were placed in such a program.

⁹ Bates, D. W.;; Cullen, D. J.; Laird, N.; Peterson, L. A.; Small, S. D.; Servi, D.; Laffel, G.; Sweitzer, B. J.; Shea, B. F.; Hallisey, B. F.; Vliet, M. V.; Nemeskal, R.; Leape, L. L. JAMA, Volume 274 (No. 1), 29-34, 1995. "Incidence of Adverse Drug Events and Potential Adverse Drug Events."

¹⁰ Classen, D. C.; Pestonik, S. L.; Evans, R. S.; Lloyd, J. F.; Burke, J. P. JAMA, Volume 277 (No. 4), 301-307, 1997. "Adverse Drug Events in Hospitalized Patients: Excess Length of Stay, Extra Costs, and Attributable Mortality".

¹¹ Bates, D. W.; Spell, N.; Cullen, D. J.; Burdick, E.; Laird, N.; Petersen, L. A.; Small, S. D.; Sweitzer, B. J.; Leape, L. L. JAMA, Volume 277 (No. 4), 307-311, 1997. "The Costs of Adverse Drug Events in Hospitalized Patients".

¹² Drug injuries are a common reason for malpractice claims and, in a study of closed claims, was found to account "for the highest total expenditure of any type of procedure-related injury" (see Bates et al. JAMA. 1997; 277:307-311).

¹³ Classen, D. C.; Pestotnik, S. L.; Evans, R. S.; Lloyd, J. F.; Burke, J. P. JAMA, Volume 277 (No. 4), 301-307, 1997. "Adverse Drug Events in Hospitalized Patients: Excess Length of Stay, Extra Costs, and Attributable Mortality".

¹⁴ Leape, L. L.; Bates, D. W.; Cullen, D. J.; Cooper, J.; Demonaco, H. J.; Gallivan, T.; Hallisey, R.; Ives, J.; Laird, N.; Laffel, G.; Nemeskal, R.; Petersen, L. A.; Porter, K.; Servi, D.; Shea, B. F.; Small, S. D.; Sweitzer, B. J.; Thompson, T.; Vliet, M. V. JAMA, Volume 274 (No. 1), 35-43, 1995. "System Analysis of Adverse Drug Events".

¹⁵ Lesar, T. S.; Briceland, L.; Stein, D. S. JAMA, Volume 277 (No. 4), 312-317, 1997. "Factors Relating to Errors in Medication Prescribing".

¹⁶ Todd, M. W. in, APhA Guide to Drug Treatment Protocols: A Resource for Creating & Using Disease-Specific Pathways; "Improving the medication Use Process: Advances in Evaluating the Medication Use Process;" P. G. Manolakis, Editor, American Pharmaceutical Association, 1996.

¹⁷ Riley, K. Y. The Consultant Pharmacist, Vol. 11, No. 12, Dec. 1996, pp 1313-1315. "The role of the consultant pharmacist in hospice care."

¹⁸

APPENDIX 1.

Class of Trade	% of Total Pharmaceutical Sales		% Growth in Dollar Sales
	1995	1996
RETAIL
Independent Pharmacy	17.9%	16.5%	7.1%
Chain Pharmacy	25.6%	26.2%	13.7%
Foodstore with Pharmacy	7.2%	7.0%	15.1%
Mass Merchandiser with Pharmacy	7.5%	7.5%	13.1%
Mail Order Pharmacy	7.8%	8.9%	29%
Retail Total (written Rxs)	$51.59 billion	$59.85 billion	13.8%
NON-RETAIL
Hospital	20.4%	18.9%	5.6%
Clinic	5.3%	5.7%	18.6%
Healthcare Plans	2.2%	2.2%	16.2%
Nursing Home	3.8%	3.9%	18.9%
Miscellaneous	2.3%	3.2%	38.6%
Non-Retail Total (Doctor Orders)	$26.9 billion	$30.78 billion	12.3%
Total Sales	$78.49 billion	$90.63 billion	13.3%

APPENDIX 2.

The American Council on Pharmaceutical Education (ACPE): "The Proposed Revision of Accreditation Standards and Guidelines for the Professional Program in Pharmacy Leading to the Doctor of Pharmacy Degree, January 15, 1996".

STANDARDS FOR CURRICULUM

Standard No. 8.

The Curriculum in Pharmacy The College or School of Pharmacy should offer an organized program of study intended to prepare its graduates to become generalist practitioners of pharmacy. Knowledge, skills, attitudes, and values should be achieved that are necessary to the provision of pharmaceutical care in any pharmacy practice. The goals and objectives of the pharmacy curriculum should embrace the scope of contemporary practice responsibilities as well as emerging roles that ensure the rational use of drugs in the individualized c are of patients. The need for life-long learning should be reflected as an integral theme of the curriculum.

Standard No. 9.

Curricular Organization and Length The curriculum should provide sufficient content for the achievement of professional competencies necessary to the general practice of pharmacy and to satisfy educational requirements for licensure as a pharmacist, and should meet the requirements of the institution for the doctor of pharmacy degree. The College or School of Pharmacy's organized plan of study should focus upon the content, sequence, process, and outcomes of the curriculum. The curriculum in pharmacy requires a minimum of four academic years or the equivalent in order to ensure competency in all of the fundamentals necessary to become a generalist practitioner.

Standard No. 10.

Professional Competencies Key professional competencies that should be achieved through the College or School of Pharmacy's organized plan of study are an ability to: (a) evaluate drug orders or prescriptions, accurately and safely compound drugs in appropriate dosage forms, and package and dispense dosage forms; (b) manage systems for storage, preparation, and dispensing of medicines, and supervise technical personnel who may be involved in such processes; (c) manage and administer a pharmacy and pharmacy practice; (d) apply comp uter skills and technological advancements to practice; (e) communicate with health care professionals and patients regarding rational drug therapy, wellness, and health promotion; (f) design, implement, monitor, evaluate, and modify or recommend modifications in drug therapy to insure effective, safe, and economical patient care; (g) identify, assess, and solve problems, and provide a clinical judgment as to the continuing effectiveness of individualized therapeutic plans and intended therapeutic outcomes; (h) evaluate patients and order medications in accordance with established standards of practice; (i) monitor and counsel patients regarding the purposes and uses of their medications and related therapy; (j) understand relevant non-drug therapies; (k) recommend, counsel, and monitor patient use of nonprescription drugs; (l) retrieve, evaluate, and manage professional information and literature; (m) use clinical data to optimize therapeutic drug regimens; (n) collaborate with other health professionals; and (o) evaluate and document interventions and pharmaceutical care outcomes. The College or School should encourage self-assessment of personal and professional development, and should set forth its outcome expectations for student performance in all of the professional competencies.

Standard No. 11.

Curricular Content The curriculum should provide the student with a basic core of knowledge, skills, and attitudes, which in composite, relates to the expectations for the stated set of professional competencies necessary to become a generalist practitioner, who renders pha rmaceutical care. The curriculum should provide opportunity for selection by students of courses and practice experiences in keeping with particular interests and goals. The various components of the curriculum should be in phase with one another and a balance consistent with the College or School of Pharmacy's mission should exist among the following five areas of the core curriculum: biomedical sciences, including content in anatomy, physiology, pathophysiology, microbiology, immunology, biochemistry, molecular biology, and biostatistics; pharmaceutical sciences, including content in medicinal chemistry, pharmacognosy, pharmacology, toxicology, and pharmaceutics which encompasses physical/chemical principles of dosage forms and drug delivery systems, biopharmaceutics, and pharmacokinetics; behavioral, social, and administrative pharmacy sciences, including content in health care economics, pharmacoeconomics, practice management, computer applications, communications applicable to pharmacy, the history of pharmacy, ethical foundations to practice, and social and behavioral applications and laws pertaining to practice; pharmacy practice, including content in prescription processing, drug distribution and drug administration, epidemiology, pediatrics, geriatrics, gerontology, nutrition, health promotion and disease prevention, physical assessment, emergency first-care, clinical laboratory medicine, clinical pharmacokinetics, patient evaluation and ordering medications, pharmacotherapeutics, disease-state management, outcomes documentation, self care/non-prescription drugs, and drug information and literature evaluation; and pharmacy practice experience, acquired throughout the curriculum as a continuum, progressing through introductory practice experiences and advanced practice experiences in a variety of practice settings.

Guideline 11.1

New and innovative technologies, including biotechnologies and informatics, applicable to the provision of pharmaceutical care should be appropriately integrated and applied throughout the five areas of the core curriculum.

Guideline 11.2

The biomedical sciences should provide the basis for understanding and treating humans in health and disease. Instruction provided in these areas by other academic units of the University should be developed in accord with the goals and objectives for the curriculum in pharmacy. The biomedical and pharmaceutical sciences should be of such depth, scope, timeliness, quality, sequence, and emphasis to provide the foundation for and support the intellectual and clinical objectives of the profes sional program in pharmacy. Appropriate liaison mechanisms should be established to insure effective instructional delivery and to assure satisfaction of biomedical science objectives for the professional program in pharmacy.

Guideline 11.3

The behavioral, social, and administrative pharmacy sciences area should provide the basis for understanding and influencing human behavior in health and disease, the management process in pharmacy, and pharmacy and health care systems. The behavioral, social, and administrative pharmacy sciences area should attend to the knowledge, skills, and abilities necessary to the efficient and effective management of patient-centered practice, including administrative and management matters related to drugs and supplies, as well as administrative and management activities related to personnel and finances. Moreover, the behavioral, social, and administrative pharmacy sciences area should contribute to the development and implementation of care plans and to the management of the patient's drug therapies.

Guideline 11.4

The pharmacy practice experience should be of adequate intensity, breadth, and duration so as to achieve the professional competencies as demonstrated by assessment of expected outcomes. This curricular area should include introductory pharmacy practice experiences throughout the didactic component of the curriculum followed by sustained advanced pharmacy practice experiences. Ordinarily, the duration of the pharmacy practice experience should be the equivalent of one academic year.

Guideline 11.5

Introductory practice experiences should be offered in various practice settings during the early sequencing of the curriculum for purposes of providing transitional experiential activities and active learning. Such practice experience should be organized as a curricular progression so as to support growth in the student's capabilities to render pharmaceutical care. The scope and breadth of the introductory experiences should include the initial development of practice skills, and should be consistent with these stated purposes; the introductory experiences may be designed in conjunction with didactic courses or as a discrete experiential offering.

Guideline 11.6

Advanced practice experiences should provide active participation and in-depth experiences to acquire practice skills and judgment and to develop, in a graded fashion, the level of confidence and responsibility needed for independent practice. Toward this end, a spectrum of practice experiences should be deployed, wherein the biomedical sciences; pharmaceutical sciences; behavioral, social, and administrative pharmacy sciences; and pharmacy practice are integrated, professional knowledge and skills are applied, and professional attitudes, ethics, and behaviors are developed so as to enable students to provide pharmaceutical care. Students should render pharmaceutical care under the close supervision of pharmacist role models. Advanced practice experiences should enhance communication skills with patients and other professionals, including the ability to work and communicate effectively with diverse colleagues and patients. The advanced practice experiences should also provide experience in prescription processing, drug distribution systems, documentation of services, the taking of drug histories, participating in drug therapy decisions, monitoring, educating and counseling patients, solving problems, and systematically evaluating drug use. Advanced practice experiences should include application of clinical pharmacokinetic principles in the development and management of dosing and should incorporate knowledge and skills in the searching, analysis, and interpretation of drug information.

Guideline 11.7

The organization of advanced practice experiences should provide a balanced series of core and selective experiences that cumulatively provide advanced experiences of adequate intensity, breadth, and duration to enable achievement of the professional competencies. Generally, the core and selective practice experiences should be full-time and provide continuity of care, with pharmacy faculty supervision and monitoring. Core practice experiences should develop pharmaceutical care capabilities in institutional environments and ambulatory care settings, especially community pharmacies. Selective practice experiences should complement the core practice experiences and provide adequate and innovative opportunities for students to mature professionally in accord with their individualized interests. The series of core and selective practice experiences should be philosophically and educationally coordinated to achieve, in composite, the experiential whole of the advanced practice experiences.

Guideline 11.8

The advanced practice experiences should be provided in both ambulatory and hospital/institutional settings and should include acute, chronic, and preventive care among patients of all ages. The core practice experiences should provide substantial experience in a community pharmacy and an institutional pharmacy, as well as substantial practice experience with general medicine acute care patients. Most of the advanced practice experiences should involve direct patient care. However, some of the advanced practice experiences may involve indirect patient care or may occur in non patient care areas, such as research, management, and marketing. Innovative experiences, including those in managed care, should be available.