Showing papers in "Journal of the American Pharmaceutical Association in 2001"

Drug-related morbidity and mortality: updating the cost-of-illness model

Abstract: Objective: To update the 1995 estimate .of $76.6 billion for the annual cost of drug-related morbidity and mortality resulting from drug-related problems (DRPs) in the ambulatory setting in the United States to reflect current treatment patterns and costs. Design: For this study, we employed the decision-analytic model developed by Johnson and Bootman. We used the model's original design and probability data, but used updated cost estimates derived from the current medical and pharmaceutical literature. Sensitivity analyses were performed on cost data and on probability estimates. Setting: Ambulatory care environment in the United States in the year 2000. Patients and Other Participants: A hypothetical cohort of ambulatory patients. Main Outcome Measures: Average cost of health care resources needed to manage DRPs. Results: As estimated using the decision-tree model, the mean cost for a treatment failure was $977. For a new medical problem, the mean cost was $1,105, and the cost of a combined treatment failure and resulting new medical problem was $1,488. Overall, the cost of drug-related morbidity and mortality exceeded $177.4 billion in 2000. Hospital admissions accounted for nearly 70% ($121.5 billion) of total costs, followed by long-term-care admissions, which accounted for 18% ($32.8 billion). Conclusion: Since 1995, the costs associated with DRPs have more than doubled. Given the economic and medical burdens associated with DRPs, strategies for preventing drug-related morbidity and mortality are urgently needed.

Performance of Community Pharmacy Drug Interaction Software

Abstract: Objective To evaluate the performance of computerized drug-drug interaction (DDI) software in identifying clinically important drug-drug interactions. Design One-time performance test of computer systems using a standard set of prescriptions. Setting Community pharmacies or central corporate locations with pharmacy terminals identical to those used in actual pharmacies. Participants Chain and health maintenance organization (HMO) pharmacies with seven or more practice sites in Washington State. A total of nine different DDI software programs were installed in 516 community pharmacies represented by these chains and HMOs. Main Outcome Measures Sensitivity, specificity, and positive and negative predictive values of software in detecting 16 well-established DDls contained within six fictitious patient profiles. Results The software systems failed to detect clinically relevant DDls one-third of the time. Sensitivity of the software programs ranged from 0.44 to 0.88, with 1.00 being perfect; specificity ranged from 0.71 to 1.00; positive predictive value ranged from 0.67 to 1.00; and negative predictive value ranged from 0.69 to 0.90. For software packages that were installed at different locations, between-installation differences were observed. Conclusion The performance of most DDI-detecting software programs tested in this study was suboptimal. Improvement is needed to advance their contribution to detection of DDls.

Research: Improving Drug Therapy for Patients with Asthma-Part 1: Patient Outcomes

Abstract: Objective To evaluate the effects of a therapeutic outcomes monitoring (TOM) program on selected process and outcome measures. Design Prospective, controlled, multicenter study. Setting Community pharmacies throughout Denmark (16 intervention, 15 control). Patients Five hundred patients with asthma aged 16 to 60 years and treated in primary care. Intervention TOM is a community-based program for pharmaceutical care. Using a structured, seven-step, cyclical outcome improvement process, TOM pharmacists identify and resolve (or refer) problems with drug therapy that, if not addressed, might result in therapeutic failure or adverse effects. Equal emphasis is placed on the patient's perspective (e.g., coping, control, and empowerment) and the professional's perspective (e.g., adherence, patient knowledge, and therapeutic problems). TOM requires cooperation among pharmacists, patients, and physicians. Main Outcome Measures Asthma symptom status, days of sickness, health-related and asthma-specific quality of life, use of health care services and resources, and satisfaction with health care and pharmacy. Intermediate Outcome and Process Measures Peak expiratory flow rate (PEFR), knowledge of asthma and asthma medications, inhalation errors, and drug therapy problems in the TOM group. Results The mean individual differences for TOM and control patients were tested. Beneficial effects were found for the following outcome measures: asthma symptom status, days of sickness, and health-related and asthma-related quality of life. Satisfaction with health care and pharmacy varied throughout the course of the project, with no significant difference between groups at the final evaluation. Although not statistically significant, differences in use of services were considered to be clinically significant and encouraging. Beneficial effects were found for knowledge of asthma and medications, inhalation errors, drug use and drug therapy problems. No significant differences were found for PEFR. Conclusion The project demonstrated that therapeutic outcomes monitoring by community pharmacists is an effective strategy for improving the quality of drug therapy for asthma patients in primary health care.

Pharmaceutical Care Research and Education Project: Patient Outcomes

Abstract: Objective To compare patients' adherence to therapy, expectations, satisfaction with pharmacy services, and health-related quality of life (HRQOL) after the provision of pharmaceutical care with those of patients who received traditional pharmacy care. Design Randomized controlled cluster design. Setting Sixteen community pharmacies in Alberta, Canada. Patients and Other Participants Ambulatory elderly (≥ 65 years of age) patients covered under Alberta Health & Wellness's senior drug benefit plan and who were concurrently using three or more medications according to pharmacy profiles. Intervention Pharmacies were randomly assigned to either treatment (intervention) or control (traditional pharmacy care) groups. Patients at treatment pharmacies were recruited into the study, and pharmacists provided comprehensive pharmaceutical care services. Pharmacists at control pharmacies continued to provide traditional pharmacy care. Main Outcome Measures Study participants' opinions, adherence to therapy, and scores on the Medical Outcomes Study 36-ltem Short Form Health Survey (SF-36). Results Compared with those of patients receiving traditional care, treatment patients' expectations that their pharmacist would perform activities congruent with pharmaceutical care changed over the study period. Treatment patients' satisfaction with the constructs "trust," "evaluation and goal setting," and "communicates with doctor" were also positively affected. HRQOL and patient adherence were not significantly affected by pharmaceutical care interventions. Conclusion Successful implementation of a pharmaceutical care practice model has the potential to increase patients' satisfaction with their pharmacists' activities and may increase patients' expectations that pharmacists will work on their behalf to assist them with their health care needs. If pharmaceutical care affects patients' HRQOL, instruments more specific than the SF-36 may be needed to detect the differences.

Effects of Estrogen on Cognition, Mood, and Degenerative Brain Diseases

Abstract: Objective To review research findings on the effects of estrogen on cognition, mood, memory, and degenerative brain disease in women. Data Sources English-language journal articles published primarily since 1995, retrieved from a MEDLINE search and from bibliographies of selected reviews. Study Selection Investigational studies, clinical trials, and review articles examining the effects of estrogen on the central nervous system. Data Synthesis Although scientific study of the brain is in its infancy, numerous studies indicate that estrogen is essential to optimal brain function. Estrogen has been shown to increase cerebral blood flow, act as an antiinflammatory agent, enhance activity at neuronal synapses, and exert direct neuroprotective and neurotrophic effects on brain tissue. Through these varied mechanisms, estrogen strongly influences mood and cognition, and the decline of this hormone at menopause can produce significant emotional and cognitive problems in women. Conclusion Pharmacists can educate women about the various mood and memory changes that can occur during peri menopause and how estrogen replacement therapy may lead to improvements in brain function. The potential use of estrogen replacement therapy to reduce the risk of Alzheimer's disease and ease the symptoms of Parkinson's disease could have a profound effect on women, their families, and society as a whole.

Pharmaceutical Care Research and Education Project: Pharmacists' Interventions

Abstract: Objectives: To describe the processes of care used by community pharmacists participating in the Pharmaceutical Care Research and Education Project (PREP) in terms of drug-related problems (DRPs), pharmacists' recommendations, and status of DRPs at follow-up, and to determine characteristics associated with DRPs. Design Descriptive analysis of the treatment group from a larger randomized, controlled cluster design. Setting Five independent community pharmacies in Alberta. Participants One hundred fifty-nine patients who were covered under Alberta Health and Wellness's senior drug benefit plan (i.e., 65 years or older), were taking three or more medications concurrently according to pharmacy records, were able to complete telephone interviews as determined by pharmacists, maintained residence in Alberta for 12 of the 15 study months, agreed to receive their prescription medications only from the study pharmacy during the study period, and provided informed consent. Main Outcome Measures Frequency of DRPs, recommendations, status of DRPs, and analysis of clinical results as determined during pharmacists' follow-up care. Results: In telephone surveys, patients reported taking 4.7 prescription medications per day, but pharmacists documented 8.7 prescription medications per day in their records. Pharmacists documented 559 DRPs, a mean (± SD) of 3.9 ± 3.2 problems per patient. Approximately 39% of problems were actual DRPs, while 60% were potential DRPs. Medical conditions associated most frequently with a DRP involved the respiratory, cardiovascular, and musculoskeletal systems. The most common DRP categories were "patient requires drug therapy" or "patient requires influenza or pneumococcal vaccination." Pharmacists wrote 551 initial clinical notes using the subjective, objective, assessment, plan (SOAP) format, and they recorded 346 follow-up interventions, also using SOAP notes. Counseling, preventive consultations, and clinical monitoring represented 40% of their recommendations. In 80% of situations, the pharmacist made the recommendation directly to the patient. On follow-up, 40% of the 559 DRPs identified were resolved, controlled, or improved. Patients accepted 76% of pharmacists' recommendations, and physicians accepted 72% of pharmacists' suggested resolutions of DRPs. Pharmacists were more likely to follow up about actual DRPs, as compared with potential ones; overall, they followed up on 62% of identified DRPs. Conclusion Pharmacists identified more DRPs for study patients than previous community-based, observational studies have reported. Undertreatment appears to be a prevalent DRP. Community pharmacists' recommendations to prevent and resolve DRPs were made primarily to patients and were we" accepted. More follow-up was needed for a" DRPs. When follow-up occurred, the DRP results generally showed improvement.

Pharmaceutical care in chain pharmacies: beliefs and attitudes of pharmacists and patients.

Abstract: Objective To discuss with pharmacists and patients with reactive airways disease their beliefs about pharmaceutical care and the pharmacist's role in health care, obstacles to providing pharmaceutical care in community pharmacies, and strategies to overcome these obstacles Design Two focus groups of patients, two focus groups of pharmacists Participants Thirteen patients with reactive airways disease and 11 chain pharmacists Main Outcome Measures Qualitative reports on the pharmacist's role in health care delivery and obstacles to implementing pharmaceutical care programs. Results Pharmacists wished to provide pharmaceutical care, and patients were supportive of pharmacists' involvement in their health care. Both viewed counseling as an important role for pharmacists and believed that pharmacists should work with patients' physicians. Reported obstacles included lack of time, inadequate privacy, and pharmacists' lack of direct access to patients' physicians. Pharmacists and patients believed pharmacists should have access to patient-specific clinical data Conclusion Focus groups provided valuable information for designing pragmatic pharmaceutical care. The obstacles and possible solutions identified through the discussions represent fertile ground for designing innovative pharmaceutical care programs.

Improving Drug Therapy for Patients with Asthma-Part 2: Use of Antiasthma Medications

Abstract: Objectives To describe the use of antiasthma drugs among the study patients and to evaluate whether therapeutic outcomes monitoring (TOM) is associated with improved quality of drug therapy. Design Prospective, controlled, multicenter study. Consumption of antiasthma medications was measured as the number of defined daily doses (DDDs) purchased. Data were collected from the pharmacies' computer systems for a period beginning 6 months before the start of the study (period 1) and during its first and second half-years (periods 2 and 3). Treatment changes for TOM patients were classified on the basis of drug regimens at periods 1 and 3. Setting Community pharmacies in Denmark (16 intervention, 15 control). Patients Five hundred patients with asthma aged 16 to 60 years who were being treated in primary health care; this study used data from 350 patients from this sample. Intervention TOM. Main outcome measures Changes in the use of individual drugs and changes in therapeutic patterns--distribution of purchased drugs; proportion of corticosteroid users; frequency of drug regimens used; treatment changes for TOM patients. Results TOM patients' consumption of beta2-agonists decreased by 12% overall from period 1 through period 3, while control patients' consumption of these medications decreased by only 1%. TOM patients' use of inhaled corticosteroids increased by more than 50% compared with 9% among controls. In both groups, about one-half of all purchased DDDs were for inhaled beta2-agonists. The proportion of inhaled corticosteroids increased from 27% to 42% of total DDDs for the TOM group and remained constant for controls. Of patients using beta2-agonists, 68% also used inhaled steroids initially in both the TOM and control groups. The proportion of inhaled steroid users in the TOM group increased to 84%, and to 70% among controls. The most common regimen was inhaled short-acting beta2-agonists and corticosteroids in combination, and the second most common regimen was monotherapy with short-acting beta2-agonists. With time, the regimens changed more toward consensus guidelines among TOM patients. Changes in drug therapy totaled 451, averaging 2.4 changes per TOM patient. The largest number of changes (49%) involved inhaled corticosteroids. Conclusion Changes in medication use among TOM patients were toward improved asthma treatment. Our results show that community pharmacists, physicians, and patients, working together, can improve prescribing, solve drug therapy problems, and improve outcomes for patients with moderate-to-severe asthma.

Evaluation and Management of Premenstrual Syndrome and Premenstrual Dysphoric Disorder

Abstract: Objective To review premenstrual disorders, their varied symptoms, possible etiology, and treatment options. Data Sources: Published articles identified through MEOLINE (1966–2001) using the search terms premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD) and the additional terms treatment and etiology . Additional references were identified from the bibliographies of the retrieved articles. Data Synthesis PMS refers to a group of menstrually related disorders that are estimated to affect up to 40% of women of childbearing age. The varied symptoms of PMS include mood swings, tension, anger, irritability, headache, bloating, and increased appetite with food cravings. PMS symptoms occur during the luteal phase of the menstrual cycle and remit with the onset of menstruation or shortly afterward. Approximately 5% of women with PMS suffer from PMDD, a more disabling and severe form of PMS in which mood symptoms predominate. Because no tests can confirm PMS or PMDD, the diagnosis should be made on the basis of a patient-completed daily symptom calendar and the exclusion of other medical disorders. The causes of PMS and PMDD are uncertain, but are likely associated with aberrant responses to normal hormonal fluctuations during the menstrual cycle. For most women, symptoms can be relieved or reduced through lifestyle interventions, such as dietary changes and exercise, and drug therapy with hormonal or psychotropic agents. For PMDD, selective serotonin reuptake inhibitors have recently emerged as first-line therapy. Certain dietary supplements, including calcium, also may be an option for some women. Conclusion PMS and PMDD are complex but highly treatable disorders. Pharmacists can improve the recognition and management of these common conditions by providing patient education on premenstrual symptoms and counseling women on lifestyle interventions and pharmacotherapy to relieve their discomfort.

Pharmacists' knowledge of and attitudes toward opioid pain medications in relation to federal and state policies.

Abstract: Objective To assess Wisconsin pharmacists' knowledge of and attitudes toward the use of opioid analgesics in the management of chronic cancer and noncancer pain, and to explore the potential for these beliefs to interfere with pharmacist dispensing, the last link of the distribution chain of controlled substances to patients. Design Mail survey. Setting Urban and rural pharmacies, long-term care facilities, hospitals, and outpatient clinics in Wisconsin in 1998. Patients or Other Participants Representative sample of Wisconsin pharmacists. Interventions None. Main Outcome Measures Responses to self-administered questionnaires. Results Although most respondents were knowledgeable about the issues addressed in this study, there were important exceptions. Not all pharmacists knew what constitutes legitimate dispensing practices for controlled substances under federal or state policy in emergencies or for patients with terminal illnesses, and many were unaware of the important distinctions among addiction, physical dependence, and tolerance. Many respondents did not view the chronic prescribing/dispensing of opioids for more than several months to patients with chronic pain of malignant or nonmalignant origin as a lawful and acceptable medical practice; this was especially true when the patient had a history of opioid abuse. Conclusion Pharmacists playa pivotal role in ensuring patient access to medications. Viewed in the context of federal and state controlled substances policies, our findings suggest that the incorrect knowledge and inappropriate attitudes of some pharmacists could contribute to a failure to dispense valid prescriptions for opioid analgesics to patients in pain.

Understanding the Scientific Issues Embedded in the Generic Drug Approval Process

Abstract: Objective To review the major scientific issues embedded in the generic drug approval process. Data Sources Articles indexed initially under terms such as generic medications, generic drugs, bioequivalence, and bioinequivalence. These terms were used to search indexing services such as MEDLINE, International Pharmaceutical Abstracts, CINAHL (a database of nursing and allied health literature), and Science Citation Index. Additional data sources included the Code of Federal Regulations and regulatory guidances from the Food and Drug Administration (FDA) Center for Drug Evaluation and Research. Study Selection Performed by the authors. Data Extraction Not applicable. Data Synthesis Despite the fact that regulations regarding bioequivalence have been in place for more than 20 years, controversies over bioequivalence continue to arise. Consensus on many of these issues is driving the development of new FDA guidances regarding bioequivalence. Still, despite the issuance of new guidance and consensus building among scientists, many clinicians and consumers remain uninformed regarding the scientific basis for establishing bioequivalence and the generic drug approval process in general. Although some have suggested that the generic drug approval process is flawed, overall, it appears that the process works. Conclusion Understanding the generic drug approval process and the issues surrounding bioequivalence is of paramount importance to both clinicians and scientists.

Research: People Vaccinated by Pharmacists: Descriptive Epidemiology

Abstract: Objective To describe the demographic, clinical, and attitudinal characteristics of people vaccinated by pharmacists, using a multistate sample of pharmacists and a more extensive set of parameters than previous studies. Design Cross-sectional survey. Patients and Other Participants 1,730 adults vaccinated at 21 community pharmacies in 17 cities in 10 states. Main Outcome Measures: Vaccinees' age, sex, and selected demographic characteristics; current medications and prescription use patterns; distance traveled to pharmacy; and opinions about vaccine providers. Results 60% of respondents were women; average age was 54 ± 15 years. One-quarter were age 65 years or older. About 9% were younger than 65 and took medication for chronic heart or lung disease or diabetes. Almost half took prescribed medications chronically, and 84% came to the pharmacy intending to be vaccinated. All of the respondents believed they were treated respectfully. Many respondents considered the pharmacy advantageous, compared with other vaccine providers, based on access, proximity, trust, convenience, and/or cost. Conclusion Respondents vaccinated by a community pharmacist were satisfied with the experience and would recommend it to others.

Research: Pharmacists and Immunizations: A National Survey

Abstract: Objectives To obtain information about pharmacists' current involvement in and willingness to provide immunization services, and to assess perceived barriers to providing immunization services. Design Cross-sectional mail survey. Setting National. Patients or Other Participants Random sample of 5,342 pharmacists from chain, independent, mass merchandiser/grocery, primary care clinic, and health maintenance organization settings. Interventions None. Main Outcome Measures Responses to survey on pharmacybased immunization services—current involvement, willingness to get involved, perceived obstacles, and patients' interest. Results Three mailings yielded a response rate of 25.3% (1,348 responses). Only 53.1% of respondents knew correctly whether their state allowed pharmacists to administer immunizations. Although a significant number of pharmacists were involved in immunization activities, such as counseling and promotion, only 2.2% and 0.9% of respondents were involved in actual administration of adult and childhood immunizations, respectively. In general, men, independents, owners/partners, and pharmacists who had attended immunizationrelated educational programs were more willing to provide immunization services than were women, chain and staff pharmacists, and educational program nonattendees. Pharmacists who had attended immunization-related educational programs also perceived pharmacist- and patient-related factors as less problematic for pharmacy-based immunization services than did nonattendees. Conclusion This survey provides a baseline measure of the nature and extent of pharmacist involvement in immunizations that can be used now and in future years. The profession can use the findings on pharmacists' willingness to provide immunization services and their perception of obstacles to such services as a basis for targeted educational and promotional programs and materials.

Comparison of German St. John's wort products according to hyperforin and total hypericin content.

Abstract: Objectives To compare the hyperforin and hypericin content of currently available St. John's wort products and to determine their batch-to-batch reproducibility. Design Representative products were obtained either directly from the manufacturer or purchased from pharmacies in and around Frankfurt, Germany. For five batches from each of the eight manufacturers, 10 individual dosage forms (tablets or capsules) were analyzed for both hyperforin and hypericin content. Setting Laboratories of the Institute of Pharmaceutical Chemistry at Johann Wolfgang Goethe University, Frankfurt, Germany. PRODUCTS: Eight German St. John's wort products containing from 250 mg to 612 mg dry extract were studied. Three of these products are capsules, four are film-coated tablets, and one is a sugar-coated tablet. Two of the products (Jarsin 300 and Neuroplant 300) are also available in the United States. Methods Hyperforin concentrations were analyzed by high-performance liquid chromatography. Total hypericin concentrations were determined by polarography, an electrochemical method. Concentrations were compared among different batches of the same product and among products from different manufacturers. Results The products contained widely differing amounts of hypericin and hyperforin, even after correcting for differences in the amount of extract per dose. Some products demonstrated consistent concentrations of hyperforin and hypericin from batch to batch, others exhibited pronounced interbatch variability. Conclusion The St. John's wort preparations studied exhibited large differences in hypericin and hyperforin content and are not interchangeable for the treatment of mild-to-moderate depression. Pharmacists should take this variability into account when counseling patients on the use of St. John's wort products.

Research: Patients’ Acceptance of Traditional and Nontraditional Immunization Providers

Abstract: Objective To examine patients' acceptance and reported use of traditional and nontraditional immunization providers and settings. Design Survey. Setting: Stratified sample of private family physician clinics, family medicine residency training programs, community pharmacies that provide immunizations under standing order protocols, and nonimmunizing community pharmacies, all located in Iowa. Patients or Other Participants Individuals presenting for medical care or pharmacy services. Interventions Not applicable. Main Outcome Measures Sources of past immunizations, access to immunizations, importance of immunization records, and future use of different health care providers and settings for immunizations. Univariate and multivariate analyses were performed to examine the relationships between patient demographics and recruitment site on the question responses. Results 420 surveys were returned (67% response rate). Respondents frequently received immunizations at sites other than physician offices. Younger patients and those living in smaller towns were more likely to report receiving an immunization from a nonphysician. Patients recruited in immunizing pharmacies more often reported previous immunization by a pharmacist ( P Conclusion Iowans report accessing different health care providers and settings for their routine immunizations. In general, they are more likely to support using traditional immunization providers and settings for childhood immunizations but are less exclusive about where they receive adult immunizations. Pharmacists should consider focusing initial efforts on administering adult immunizations, due to greater patient acceptance of nontraditional immunizers for adult immunizations.

Oral Contraceptives: An Update on Health Benefits and Risks

Abstract: Objective To review the health benefits and risks of oral contraceptives, with an emphasis on emerging noncontraceptive benefits and the pharmacist's role in promoting safe and effective use of these widely prescribed medications. Data Sources Published articles identified through MEDLINE (1995-2001) using the search terms oral contraception, neoplasms, cardiovascular disease, menstrual cycle, and other pertinent subject headings. Additional articles and books were identified from the bibliographies of the retrieved articles. Data Synthesis Combined oral contraceptives (COCs), which contain synthetic estrogen and progestin, are the second most common form of birth control for women after sterilization. When taken properly, COCs are highly effective, with a pregnancy rate of 1% among perfect users. Also, a growing body of evidence points to multiple noncontraceptive benefits of COCs, including protection from several types of cancer and a variety of gynecologic benefits, such as reduced menstrual bleeding irregularities and fewer ectopic pregnancies. COCs are one of the most studied classes of medications, and they have been found to have an excellent safety profile in nonsmoking healthy women. They may be used continuously until menopause. For women with coexisting medical conditions or other special circumstances, the risks and benefits of COCs must be carefully evaluated before use. Conclusion More than 40 years after their introduction, COCs remain the leading form of hormonal contraception. By assessing patients' contraceptive needs, evaluating their risk factors, and providing sensitive and thorough counseling, pharmacists can help ensure the safe and effective use of these medications.

Pharmacologic Management of Epilepsy in the Elderly

Abstract: Objective To review the epidemiology and pharmacologic management of epilepsy in elderly patients. Data Sources Controlled trials, case studies, and review articles identified via MEDLINE using the search terms epilepsy, seizures, elderly, phenobarbital, primidone, phenytoin, carbamazepine, valproic acid, felbamate, gabapentin, lam o trig in e, topiramate, tiagabine, levetiracetam, oxcarbazepine, and zonisamide. Recently published standard textbooks on epilepsy were also consulted. Data Synthesis Epilepsy is a common neurologic disorder in the elderly. Cerebrovascular and neurodegenerative diseases are the most common causes of new-onset seizures in these patients. Alterations in protein binding, distribution, elimination, and increased sensitivity to the pharmacodynamic effects of antiepileptic drugs (AEDs) are relatively frequent, and these factors should be assessed at the initiation, and during adjustment, of treatment. Drug-drug interactions are also an important issue in elderly patients, because multiple drug use is common and AEDs are susceptible to many interactions. In addition to understanding age-related changes in the pharmacokinetics and pharmacodynamics of AEDs, clinicians should know the common seizure types in the elderly and the spectrum of AED activity for these seizure types. AEDs with activity against both partial-onset and generalized seizures include felbamate, lamotrigine, levetiracetam, topiramate, valproic acid, and zonisamide. Other AEDs discussed in this review (carbamazepine, gabapentin, phenobarbital, phenytoin, primidone, and tiagabine) are most useful for partial-onset seizures. Conclusion The provision of safe and effective drug therapy to elderly patients requires an understanding of the unique age-related changes in the pharmacokinetics and pharmacodynamics of AEDs as well as an appreciation of common seizure types and the drugs that are effective for the specific types seen in the elderly.

Onset of Illegal Use of Mind-Altering or Potentially Addictive Prescription Drugs Among Pharmacists

Abstract: Objectives To determine the temporal and descriptive aspects of pharmacists' decision-making processes regarding illegal use of mind-altering or potentially addictive prescription drugs (PAPDs) and to measure the effects of social factors associated with being and becoming a pharmacist on pharmacists' decisions to use PAPDs illegally. Design One-time, written, mailed survey. Setting United States. Participants Random sample of licensed practicing pharmacists who were members of the American Pharmaceutical Association in fall 1996. Interventions Not applicable. Main Outcome Measures Responses to items on the survey. Results Nearly 40% of respondents indicated that they had used a form of PAPD without first obtaining a physician's authorizing prescription. A significant portion of the sample showed signs of repeated use-20% of the respondents reported 5 or more lifetime PAPD-use episodes, and 6% reported more than 10 such episodes. Almost 6% of the respondents identified themselves as being drug abusers at some point during their pharmacy careers. Moreover, a full 88% of these pharmacists began such illegal PAPD use after entering college, 51% used more than one type or class of PAPD, and 69% directly violated their professional code of ethics and state and/or federal laws by either stealing PAPDs from their place of employment (61%) or forging prescriptions (8%) to obtain them. Conclusion A considerable percentage (40%) of the pharmacists surveyed had, on at least one occasion, used some form of PAPD without first obtaining a physician's authorizing prescription, and about one-fifth of respondents reported repeated use. The onset of such illegal PAPD use by pharmacists almost always occurred after the individuals had entered college. Interpersonal factors, such as positive reinforcement of self-medication practices from peers and increased levels of one's own approval for self-medication, appear to increase the likelihood that a pharmacist will engage in such illegal PAPD use.

Research: The Emergency Contraception Collaborative Prescribing Experience in Washington State

Abstract: Objective To describe how prescribers and pharmacists view the Emergency Contraceptive Pills (ECP) program, and to evaluate pharmacists' performance through the use of a consumer survey. Design Self-administered provider satisfaction surveys were mailed 6 months after the program's inception. Consumer satisfaction surveys were distributed at the point of ECP service for return by mail. Setting The program encouraged pharmacists and prescribers in western Washington to enter into collaborative prescribing agreements, increasing consumers' access to ECP. Patients or Other Participants Pharmacists who had attended ECP training sessions, prescribers who had authorized pharmacists to prescribe ECP, and women who had been prescribed ECP by pharmacists. Main Outcome Measures Providers' reasons for participating, attitudes toward the ECP program, and experiences with ECP as a result of the program; feedback from women receiving ECP from pharmacists. Results 309 pharmacist surveys and 55 prescriber surveys were sent, of which 159 (51%) and 27 (49%), respectively, were returned. Meeting patient needs and having a professional responsibility to participate were commonly reported reasons for ECP program involvement. Both pharmacists and prescribers (92%) reported being "satisfied" or "very satisfied" with their prescribing agreements. On the 470 consumer surveys returned out of 7,000 distributed (6.5%), pharmacists were rated highly satisfactory for their interactions with patients and the quality of information about ECP use given, but less satisfactory for information about adverse effects, recognition and follow-up of ECP failure, and regular contraceptive methods. Conclusion All participants expressed satisfaction with the ECP program. This example should support the initiation of similar programs in other states.

Historical overview of generic medication policy.

Abstract: Objective To provide a historical perspective on controversies surrounding the use of generic drugs. Data sources Articles were indexed initially using terms such as generic medications, generic drugs, multisource medications, and multisource drugs. These terms were used to search indexing services such as MEDLINE, International Pharmaceutical Abstracts, CINAHL (a database of nursing and allied health literature), Science Citation Index, Psychological Abstracts, and Wilson Indexes to Journal Articles. Study selection Performed by the authors, with preference given to events from 1951 to the present. Data extraction Not applicable. Data synthesis The history of generic drug use is a history of conflict from a variety of perspectives. The primary conflict is economic, in which manufacturers of brandname pharmaceuticals aggressively seek to protect their patents from a variety of groups (e.g., the federal government, managed care organizations, consumer groups) that want access to less expensive medications. Another conflict is professional, especially for the members of the pharmacy profession who view drug product selection as an important opportunity for pharmacists to use their professional judgment. The most confusing conflict is the scientific discussion of bioequivalence and product quality. The brand manufacturers suggest that not all products are bioequivalent and of the same quality. This position has been opposed by the pharmacy profession, generic drug manufacturers, health care institutions, and the Food and Drug Administration. Conclusion Generic drug use has increased dramatically during the past 50 years and is an accepted part of health care. However, the economic consequences of generic drug use are sufficiently high for this activity to continue as a source of controversy in the future.

Experience: Pharmacy Immunization Partnerships: A Rural Model

Abstract: Objectives To describe the Pharmacy Immunization Project, a pharmacy/county health department (CHO) partnership model for immunizing infants and adults in rural areas, and to develop service procedures and disseminate lessons learned for adapting the model to different settings. Setting Independent community pharmacies in five contiguous rural counties in West Virginia. Practice Description Participating pharmacies varied markedly in space, prescription volume, and population of service areas. Practice Innovation Childhood and adult immunization service. Interventions Pharmacists partnered with nurses from CHOs to offer year-round immunizations at times when other providers were typically closed. Working under standing orders of the CHD medical directors, nurses also conducted routine well-baby examinations in the pharmacy. Promotions involved direct mailings, posters, fliers, direct communication, and ads in newspapers, radio, and TV. Main Outcome Measures Pharmacists' and CHDs' continued willingness to participate, use of the service by local citizens, and feedback from participants and other health care providers and the West Virginia Immunization Program (WVIP). Results All sites except one continued their participation through the life of the project. The one exception was a pharmacy with few infant patients, which discontinued participation during year 4 of the project. Remaining sites were used and well accepted by the community. The WVIP remains a loyal supporter, and no problems arose with local health care providers. Conclusion The model appears adaptable to urban as well as rural practice and to chain as well as independent practice in states not authorizing pharmacists to administer vaccines, for pharmacists who for other reasons prefer not to administer, and for those who prefer to offer adult immunization on a seasonal basis. From the CHD perspective, the partnership model is useful in establishing "satellite" locations to target hard-to-reach patients. Recommendations regarding agreements and responsibilities are available, as are lessons learned during project development.

Reviews: Drug Abuse and Dependency: Understanding Gender Differences in Etiology and Management

Abstract: Objective To review the etiology, consequences, and treatment needs of drug abuse and dependency, especially in women. Data Sources Original studies and literature reviews published primarily since 1990. Data Synthesis Many studies, conducted mostly during the past 10 years, are providing new information regarding the genesis of two separate drug problems: willful abuse (misuse) of drugs and pathological drug dependency. Recent studies have also highlighted important differences between the sexes in the causes, consequences, and management of drug abuse and dependency. The neurobiologic and genetic contributions to the pathological disease of addiction provide important directions for future treatments, as a supplement to existing self-help and structured behavioral therapies. Pharmacotherapy also has an important role in reducing drug craving and relapse in addicted patients. Conclusion Although the precise causes of drug abuse and dependency continue to challenge researchers, important differences have been identified between men and women in terms of how drug use begins, how it progresses, and effective methods of treatment. Pharmacists and other health care professionals need to understand gender differences in the etiology and management of drug abuse and dependency and develop the capacity to recognize and refer women who may be abusing or dependent on drugs.

A Survey of Selected Internet Pharmacies in the United States

Abstract: Objective To determine whether differences in the provision of pharmacy services exist among different types of Internet pharmacies. Design Survey of selected pharmacies with a presence on the Internet. Data were abstracted onto a data collection form for further analysis. Data collection was limited to 3 weeks. Setting U.S.-based Internet pharmacies that allow patients to purchase prescription medications online. Pharmacies were identified using a metasearch engine with the search terms "Internet pharmacy" and "Internet pharmacist." Intervention Survey. Main Outcome Measures Comparisons of availability of 10 commonly used products representing a variety of product categories, prescription verification methods, and privacy issues; and determinations of site navigability, drug information and provider access, and payment methods. Sites were categorized as "chain pharmacy extensions," "mail order pharmacies," "independent pharmacy extensions," and "online pharmacies." Results: Thirty-three sites were reviewed. There was significant variation among the four types of pharmacies selling prescriptions over the Internet. Most pharmacies provided all of the drugs in the survey. Patients were required to provide their own prescription at 88% of the sites, and 75% of sites used mail or fax to verify prescription integrity. More than 50% of sites had privacy policies posted, and 64% used cookies. Chain pharmacy extensions required completion of an average of 10.2 pages to order drugs versus 2.4 to 4 pages for all other site types. Drug information was written at an eighth-grade reading level at 36% of the sites. More than two-thirds of the sites provided a toll-free telephone for a health care professional. Nearly 80% of the sites accepted health insurance, and 95% accepted credit cards; however, only 40% used a secure transmission mechanism for patient or payment information. Conclusion Internet pharmacies provide varying levels of service. Policies regarding the use of the Internet for obtaining medications should focus on improving the privacy of consumer information and ensuring the secure transmission of financial information.

Regulating for Outcomes as a Systems Response to the Problem of Drug-Related Morbidity

Abstract: Objective To describe the evidence that preventable adverse outcomes of drug therapy are prevalent in the United States and Europe, to describe the causes of this problem, to outline a systems response that would correct or improve the problem, to discuss pharmacy's contribution to that solution, and to propose a strategy for implementation. Summary The causes of the widespread problem of preventable drug-related morbidity (PDRM) that have been identified in the literature constitute system failure. Health professionals can understand an individual patient's care system if they organize their thinking about systems as efficiently as they organize their thinking about medical or pharmaceutical problems. Six essential system characteristics are proposed, based on the PDRM literature. Regulations should mandate regular patient and system performance assessments-specifically, that health professionals (1) identify, resolve, and document specific pharmacotherapy problems; (2) assess system performance and identify recurring root causes of problems; and (3) document assessments, problems found, actions taken, and follow-up. These regulations would, in essence, mandate individual quality improvement (QI) programs. QI and pharmaceutical care require similar processes of decisions and actions, one from a practice (multipatient) perspective and the other from a patient perspective. Conclusion Health care accreditation agencies are moving toward regulation for outcomes. Pharmacy managers should embrace and regulatory boards should participate in this movement. Such regulations would clarify pharmacy's role in support of safe and effective pharmacotherapy and would constitute a commitment to pharmaceutical care as public service. A widely adopted system of measuring and improving the quality of medication use and outcomes could eventually lead to quality benchmarks in the community pharmacy setting, which would more firmly establish the value of the pharmacist in pharmacotherapy.