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Interesting Articles in 2002 Jan - Mar


From
American Journal of Health-System Pharmacy
January 15, 2002 (Volume 59, Number 2)

Projecting Future Drug Expenditures

Shah ND, Vermeulen LC, Santell JP, Hunkler RJ, Hontz K
Am J Health-Syst Pharm. 2002;59:131-142

Medications account for a significant portion of pharmacy and total healthcare costs. The ability to accurately predict expected expenditures has an impact on the financial health of an organization. The authors of this article discuss the factors driving increased drug expenditures and offer a forecast of future expenditure patterns. Increases in drug expenditures are related to price inflation, utilization, patient mix, and a blend of both of these factors. Data sources that are used to help predict a forecast of pharmaceutical expenditure patterns include the Producer Price Index (PPI), inflation rate projections, trends in expenditures by practice settings, and hospital expenditure trends.

Editor's Comment

Drugs in development have a tremendous impact on the rise in pharmaceutical expenditures. This article reviews drugs that were expected to receive approval in the last part of 2001 and 2002. Legislative issues, generic drug approvals, and acts of terrorism and their impact on drug expenditures are also addressed. The information presented in the article can be used to help forecast expenditures for an individual organization and must be coupled with data regarding local environment and organizational characteristics that influence the use of medications.

Abstract
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Related Articles:
-- Increase in Drug Expenditures Tied to More Prescriptions, Costlier Brand-Name Products
-- Drugs Take Bigger Slice of Total Health Care Expenditures
-- Dramatic Increase in Drug Spending Largely Attributable to Few Costly Medications
-- Formularies Remain Focus of Cost-Containment Efforts



January 1, 2002 (Volume 59, Number 1)

Relationship Between Direct-to-Consumer Advertising and Physician Diagnosing and Prescribing

Zachry WM III, Shepherd MD, Hinich MJ, et al.
Am J Health-Syst Pharm. 2002;59:42-49

Retrospective data from 2 sources, the National Ambulatory Medical Care Survey (NAMCS) and Competitive Media Reporting (CMR), were used for this study. The National Center for Health Statistics is responsible for maintaining and administering the NAMCS. Data are obtained from surveys of office-based physicians to identify trends in prescribing and treatments. Data pertaining to advertising occurrence and expenditures are collected by CMR and are intended for sale to researchers.

This study included products advertised for at least 19 months between January 1992 and July 1997. The initial sample of 19 specific agents was reduced for several reasons, including the following: (1) identified agents comprised a drug class so broad that associations among variables would be difficult, (2) the identified drug was approved to change status from prescription only to nonprescription, (3) the identified drug had multiple uses (both approved and off-label) associated with multiple diagnosis, (4) the identified drug had disproportionately low advertising expenditure, or (5) administration of the drug required surgical intervention. The remaining 5 drug classes included antihistamines, antihypertensives, acid-peptic disorder medications, benign prostatic hypertrophy medications, and antilipemics. Quasi-experimental time-series techniques were used for the analyses and included dependent variables (eg, monthly frequency of diagnosis for FDA-approved indications, medications prescribed within a class, and medications prescribed for the specific advertised agent) and independent variables (eg, monthly expenditures for advertising each specific agent).

The amount of money spent advertising antihistamines was significantly associated with the monthly number of prescriptions for Seldane (P < .001), Claritin (P = .004), and Hismanal (P = .07). In addition, the monthly number of prescriptions written for Zocor was significantly associated with the advertising spending for antilipemics (P < .001). Other significant associations were also noted.

Editor's Comment

As healthcare practitioners, we struggle with pharmaceutical advertising in general, including direct-to-consumer (DTC) advertising. Although the authors point out that causal relationships are not implied, this study suggests that increasing spending on DTC advertising results in increased prescriptions written for some pharmaceuticals. Whether or not DTC has a negative impact on the overall health of the population is under debate. DTC advertising has made an impact on what is prescribed, but the end result of the prescription and the impact on patient outcome have not been determined.

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Related Articles:
-- Federal and State Laws and Regulations Affecting Managed Care



From
American Journal of Health-System Pharmacy
March 15, 2002 (Volume 59, Number 6)

Prevalence and Cost Savings of Therapeutic Interchange Among US Hospitals

Schachtner JM, Guharoy R, Medicis JJ, Newman N, Speizer R
American Journal of Health-System Pharmacy. 2002;59(6):529-533

Therapeutic interchange (TI) is often used as one method of cost-containment. TI allows for the substitution of a less expensive, equally efficacious medication for a more expensive medication within the same pharmacologic class. This survey was conducted to obtain a detailed description of current TI practices and overall cost impact of TI programs in US hospitals. Surveys were mailed to directors of pharmacy; hospitals greater than 100 beds were targeted for the mailings. Surveys were mailed in December of 1999.

A total of 463 surveys (29.8%) were returned. Both teaching (47%) and non-teaching hospitals (53%) were represented. Close to 90% of all hospitals reported using TI. The majority of hospitals did not require physician consent before a substitution. Histamine h2-receptor antagonists, proton pump inhibitors, antacids, first-generation cephalosporins, and quinolones were among the most common classes of medications included in TI programs. Cost savings was estimated by 36% of teaching hospitals, 38% of non-teaching hospitals, and 50% of investor-owned hospitals.

Editor's Comment

TI is a valuable tool for formulary management and cost containment purposes. According to the results of the survey, most hospitals participate in some form of TI program. TI is most effective when the guidelines for use are developed using a multidisciplinary approach. Hospitals that use TI programs should periodically review the programs to evaluate effectiveness and determine whether the guidelines are being followed. Based on the results of quality improvement reviews, programs should be modified to best suit the needs of the population being served.

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From
American Journal of Health-System Pharmacy
March 1, 2002 (Volume 59, Number 5)

Interdisciplinary Medication Education in a Church Environment

Schommer JC, Byers SR, Pape LL, Cable GL, Worley MM, Sherrin T
American Journal of Health-System Pharmacy. 2002;59(5):423-428

By some estimates, 120,000 lives and $45.6 billion could be saved each year in the United States with successful medication education. Increased and improved communication between patients and their health care practitioners is important for improving patient knowledge, patient recall of directions, patient satisfaction, and medication compliance. Based on this information, the investigators of this study implemented and evaluated a medication education program for ambulatory care patients.

Patients were recruited from a base of 20 church congregations in the central Ohio area. The study was designed to demonstrate the value and acceptance of medication education provided in the church environment by an interdisciplinary team, reduce unscheduled visits to health care providers attributed to improper medication use, identify problems in medication use, increase patient awareness and understanding of medication questions directed at health care providers, and increase patient understanding of the role of the pharmacist.

Participants attended a 2-hour program that included an information session, a one-on-one evaluation of medications with a pharmacist or pharmacy intern, and an exit interview with a parish nurse. The parish nurse exit interview was used to review the study questionnaires, answer questions, set-up follow-up appointments as identified by the pharmacist, and ask the participant to complete a follow-up survey in 6 months.

A total of 200 volunteers participated in the program. One hundred eighty-seven of the 199 patients that agreed to participate in the follow-up survey were successfully contacted at 6 months. Most patients (99.5%) reported that the church environment was a good place to hold the program and that the program was valuable (> 90%). Fourteen percent of the participants felt that the program was too lengthy. After 6 months, only 73% of respondents felt they had learned new medication-related information compared with the 82% response rate obtained at the initial exit interview (P < .05).

After participation in the program, patients took fewer daily medications (4.8 vs 5.5, P < .05). No significant differences in medical visits were noted in the participants after the program. More patients asked questions about their medications after participation in the program, and patients reported feeling more comfortable asking questions after the program (P < .05).

Editor's Comment

Appropriate medication use is important to the overall usefulness of prescribed medication regimens. Patients must be empowered to understand their medications and the need to be comfortable discussing medications with their health care practitioners. The reality of today's medical system limits the availability of any one practitioner to thoroughly educate patients about their medications. Many patients seek avenues to self-learn medication information. Programs that are provided by health care practitioners to deliver education to patients are often well received.

Many patients do not have the financial means to pay for educational programs. This means that these programs must either be provided at no charge or subsidized by the government or health care providers. The onus is on the medical professional to search for ways to provide programs that are not associated with high costs. The use of facilities such as senior centers, community centers, and churches where the cost for space may be minimal is a good way to find ways to offer educational services at a low cost. The ability of a program participant to feel at ease and comfortable during the interview is an important factor that has too often been overlooked.

Abstract

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From
The Annals of Pharmacotherapy
February 2002 (Volume 36, Number 2)

Influence of Standardized Orders on Postoperative Nausea and Vomiting After Gynecologic Surgery

St. Pierre E, Frighetto L, Marra CA
The Annals of Pharmacotherapy. 2002;36(2):210-217

Postoperative nausea and vomiting (PONV) occurs in over 50% of patients who undergo gynecologic surgery. Other studies have demonstrated better efficacy in patients who receive prophylactic antiemetics rather than using a rescue approach once the nausea and vomiting has begun. One large tertiary care teaching hospital developed standardized presurgical orders forms for PONV prophylaxis. Once implemented, this retrospective study was conducted to evaluate the effectiveness of the preprinted order form.

Patients who had undergone gynecologic surgery over a 6-month period before implementation of the standard order forms and similar patients from a 6-month period after implementation served as the study group. There were 400 patient records included in the analysis; 200 in each group. The proportion of patients who experienced PONV decreased after implementation, 77% (pre) vs 68% (post), P = .04. Prophylactic antiemetics were administered in 47% of cases (post) vs 31% (pre), P = .002. Metoclopramide was the most commonly used antiemetic agent. No significant adverse events due to use of antiemetic agents were noted.

Editor's Comment

In this study, patients in the preimplementation group had longer surgeries than patients included in the postimplementation group (P = .09) which could have skewed the results. Still, the improvements observed were significant. Because PONV can have an impact on the cost of a surgical procedure, due to increased complications and longer stays, this approach to standardizing the use of prophylactic antiemetic agents is worth considering.

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From
Journal of Managed Care Pharmacy
January/February 2002 (Volume 8, Number 1)

Effect of Physician Profiles and Academic Detailing on Cost and Utilization of Selective Serotonin Reuptake Inhibitors

Yokoyama KK, Doan QD, Godley PJ, et al.
Journal of Managed Care Pharmacy. 2002;8(1):23-31

Physician profiling has been used as a means of providing feedback to clinicians regarding their use of prescription medications, utilization of clinical procedures and laboratory tests, office visits, hospital admissions, and referrals to specialists. This study evaluates the use of physician profiling and periodic education in a staff-model managed care organization on the cost and utilization of selective serotonin reuptake inhibitors (SSRIs).

Family practice and internal medicine providers associated with this 168,500 member managed care organization were targeted for the intervention. Beginning with year 3 of the study, physicians received a quarterly profile that included information about their use of SSRIs (postintervention phase). In addition to these reports, academic detailing was provided at 13 of the largest regional clinics. Attendance at the group educational sessions was not mandatory but was strongly encouraged. Interventions were targeted at encouraging physicians to consider "non-fluoxetine" SSRIs as the cost to the plan for these medications was less. Pharmacy claims data for the 4-year study period was used to determine utilization.

Over the 4-year period, the per-member-per-month (PMPM) days of therapy rose from 0.535 days PMPM in 1997 to 0.763 days PMPM in 2000. The utilization of SSRIs other than fluoxetine rose from 53.8% to 68%. The cost of SSRI therapy per day declined from $2.43 in 1998 to $2.16 in 2000.

Editor's Comment

The use of physician profiles has not been universally successful at altering physician-prescribing behavior. In this study, the use of profiles was combined with additional academic detailing. Perhaps more education, whether written or verbal, along with the physician profile enhances acceptance and more successfully influences behaviors.



From
Pharmacotherapy
February 2002 (Volume 22, Number 2)

Pharmacist Impact on Posttraumatic Seizure Prophylaxis in Patients With Head Injury

Brophy GM, Tesoro EP, Schrote GL, Garnett WR
Pharmacotherapy. 2002;22(2):251-255

High-risk head injury patients often receive posttraumatic seizure prophylaxis with carbamazepine or phenytoin. Currently, 7 days of therapy is the recommended length of prophylactic treatment. Many patients receive therapy that falls outside this duration. Signs of toxicity or seizure activity may be difficulty to detect in this population, because of their medical condition. In patients receiving phenytoin, keeping trough concentrations at the desired level is a goal of therapy. This study evaluated the impact of a pharmacist on posttraumatic seizure prophylaxis in head trauma patients admitted to a neuroscience intensive care unit. The impact of the pharmacist's involvement on phenytoin dosing and monitoring, cost avoidance, and patient outcome was measured.

Data were collected from patients admitted to the unit over 2 time periods, before a pharmacist routinely participated in the care and monitoring of patients (BP) and after the pharmacists became an active member of the patient care team (AP). Data from 43 patients in the BP group and 66 patients in the AP group were included in the analysis. Patients in the BP group received an average of 13.4 days of phenytoin, whereas patients in the AP group received an average of 7.6 days of treatment. A difference in the average number of phenytoin concentrations measured also differed between the two groups; an average of 10.3 phenytoin levels were collected in the BP group compared with 3.4 in the AP group. Fifty-eight percent of appropriately drawn levels were in the target range in the AP patients compared with 28% in the BP group. Seizures occurred in 4.7% of the BP group and 1.5% of the AP group. The decrease in the number of phenytoin concentrations measured in the AP group translated to a cost savings of approximately $19, 000. A switch to oral therapy in 86% of AP patients was associated with a cost savings of approximately $9000.

Editor's Comment

The presence of a pharmacist on a critical care unit adds continuity to the care of a patient. Oftentimes, the impact of the pharmacist comes from subtle activities, such as monitoring a patient's therapy for appropriate dose, duration, and route of administration. Because of the complexity of critical care patients, prophylactic therapies may fall through the cracks. In this study, the pharmacist was able to successfully impact cost by carefully monitoring posttraumatic seizure prophylaxis.

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From
Journal of Clinical Pharmacology
January 2002 (Volume 42, Number 1)

Pharmacodynamics and Safety of a New Calcium Sensitizer, Levosimendan, and Its Metabolites During an Extended Infusion in Patients With Severe Heart Failure

Kivikko M, Antila S, Eha J, Lehtonen L, Pentikainen PJ
Journal of Clinical Pharmacology. 2002;42(1):43-51

Levosimendan, through its calcium-dependent binding to cardiac troponin C, exerts a positive inotropic effect on the myocardium. It also induces vasodilation by acting as an opener of ATP-dependent K-channels in vascular smooth muscle. Levosimendan itself has a short half-life, approximately 1 hour. Active metabolites of levosimendan that have longer half-lives have been identified. This study was undertaken to assess the pharmacodynamic effects and safety of levosimendan when administered by continuous intravenous infusion over a 7-day period.

A total of 24 patients with New York Heart Association (NYHA) III-IV heart failure and an ejection fraction < 40% were included in this open-label, nonrandomized phase 2 study. Patients were divided into 2 groups for dosing of levosimendan. One group (n = 12) received levosimendan at 0.05 mcg/kg/min for the 7-day period; the other group (n = 12) received levosimendan at 0.1 mcg/kg/min for the study period. Patients were followed up for 10-15 days following dosing.

Eight patients in each group reported adverse events. With one exception, the adverse events were considered mild to moderate and included rhythm disorders, infusion-site reactions, headache, hypotension, rash, swelling in the lower extremities, angina, and dizziness. One patient experienced worsening heart failure 10 days after stopping the levosimendan; this was considered unrelated to treatment.

Mean heart rate increased significantly from baseline in both treatment groups (P < .001); the increase was 18 beats per minute (BPM) in the low-dose group and 26 BPM in the high-dose group. The effects slowly decreased from a peak at the end of the treatment period throughout follow-up. The elimination half-life of levosimendan was 1 hour throughout the infusion period. The half-lives of the metabolites measured were between 70 and 80 hours.

Editor's Comment

Levosimendan represents a new class of therapeutic agents -- the calcium sensitizers -- for treating heart failure. With active metabolites that are not rapidly cleared from the body, it is important to determine if toxicity will limit the duration of levosimendan infusion that a patient will tolerate. This study suggests that at least at the doses used, it is tolerated for a duration of 7 days. Of interest, the effects of levosimendan infusion decreased slowly over the follow-up period. This prolonged effect is probably also due to the long half-lives of the active metabolites.

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From
International Journal of Clinical Pharmacology and Therapeutics
February 2002 (Volume 40, Number 2)

Comparison of Different Reduced Sampling Approaches for the Estimation of Pharmacokinetic Parameters for Long Half-Life Drugs in Patients With Renal or Hepatic Impairment

Mahmood I
International Journal of Clinical Pharmacology and Therapeutics. 2002;40(2):53-59

Estimating pharmacokinetic parameters in patients with renal or hepatic impairment can be difficult and can require multiple plasma samplings over many days. Reduced sampling schemes (48 or 72 hours) may provide adequate information on which to base dosing decisions. This study evaluated 3 different reduced sampling schemes (Bayesian, population analysis, and the truncated area method) to determine half-life, clearance, and Cmax of 2 different drugs. Both drugs used in the study had a half-life of at least 30 hours.

In the first 2 groups, 18 patients received a single dose of Drug A. Drug A is hepatically cleared. Nine of the 18 patients were healthy and 9 had alcoholic cirrhosis. Blood samples were drawn over 120 hours. A second drug, renally cleared Drug B, was given as a single dose to 7 patients in each of 4 groups. Patient assignment to a treatment group was by creatinine clearance. Blood samples in these patients were drawn over 168 hours.

Using only the reduced sampling method, the Bayesian and population analysis schemes provided similar pharmacokinetic parameters to the values obtained when the extended sampling times were used. The truncated area method did not accurately characterize the pharmacokinetics of long-half-life drugs in patients with renal or hepatic impairment.

Editor's Comment

Many patients have complicated medication regimens that are further complicated by disease states that alter the pharmacokinetic parameters of their therapy. Understanding the limitations of different methods of estimating pharmacokinetic parameters is important to clinicians attempting to dose therapy safely and effectively while minimizing the number of sampling points.

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From
Clinical Pharmacology and Therapeutics
January 2002 (Volume 71, Number 1)

Pharmacokinetics of Betamethasone in Twin and Singleton Pregnancy

Ballabh P, Lo ES, Kumari J, et al.
Clinical Pharmacology and Therapeutics. 2002;71(1):39-45

This study was designed to compare the pharmacokinetics of betamethasone in twin and singleton pregnancy. Serial betamethasone levels were measured in 51 patients -- 30 singleton and 21 twin pregnancies. In a subset of these patients, cord and maternal blood levels of betamethasone at birth were measured.

Half-life was significantly shorter in the twin pregnancies: 7.2 +/- 2.4 hours vs 9.0 +/- 2.7 hours (P < .017). Clearance was increased in twin pregnancies: 8.4 +/- 6.4 L/hr vs 5.7 +/- 3.1 L/h (P < .06). Volume of distribution was not affected. Mothers with a longer lag time between the last dose of betamethasone and delivery had higher cord and maternal ratios compared with mothers with a shorter time span between dosing and delivery.

Editor's Comment

This small study offers important pharmacokinetic data regarding betamethasone in twin pregnancies. The increased clearance and shorter half-life of betamethasone in this patient population may necessitate a change in dosing for women with twin pregnancies.

Abstract

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From

Clinical Drug Investigation
February 2002 (Volume 22, Number 2)

Bioavailability of Budesonide Delivered by the Clickhaler and Turbuhaler Dry Powder Inhalers in Healthy Volunteers: A Pilot Study

Godfrey C, Buck H, Ellis S
Clinical Drug Investigation. 2002;22(2):119-124

The pharmacokinetic profile and bioavailability of 1000-mcg budesonide following dry powder inhalation from the Clickhaler and Turbuhaler were compared in this randomized, double-blind, double-dummy crossover study. Six healthy males aged 19-44 years were enrolled in the study. A washout period of 3-7 days was used between study periods. Following inhalations of budesonide, serial blood samples were collected to determine plasma levels of budesonide and cortisol.

The 8-hour mean AUC values for the Clickhaler and Turbuhaler dosing were similar. Plasma budesonide time profiles and plasma cortisol concentration-time profiles were also similar. No significant adverse effects were associated with either budesonide formulation.

Editor's Comment

This small study of budesonide administered via 2 different formulations indicates that the formulations offer similar bioavailability. The study was conducted in a very small group of healthy males and will need to be repeated in a larger group of patients with asthma. If the similarities in bioavailability and systemic activity remain similar, this information can be used to make formulary and therapeutic interchange recommendations.

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From
American Journal of Health-System Pharmacy
February 1, 2002 (Volume 59, Number 3)

Implications of Prion-Induced Diseases for Animal-Derived Pharmaceutical Products

Erstad BL
American Journal of Health-System Pharmacy. 2002;59(3):254-263

Prion-induced disease, bovine spongiform encephalopathy (BSE), is known as "mad cow disease" in the media. Prions are particles that contain proteins but no nucleic acid; prions are found in both humans and animals. Not all forms of prions are pathogenic. Because medications derived from plasma fractionation could theoretically be contaminated with infectious prions, the article discusses the potential for this occurrence.

The article offers a review of transmissible spongiform encephalopathies, the clinical appearance, diagnosis, and natural course of the new variant Creutzfeldt-Jakob disease (CJD); transmission, surveillance, and treatment of CJD; infection control measures aimed at limiting the transmission of prion-induced diseases; and advice for patients concerned about mad cow disease. According to this review, no reported human cases of new-variant CJD from bovine-derived products have been reported. In addition, no well-documented evidence exists that links the use of blood or blood products to the transmission of CJD. While no links exist between prion-induced diseases in humans secondary to medications developed from plasma fractionation, continued surveillance and investigations will continue.

Editor's Comment

This review offers important insight into prion-induced diseases. The author supplies important information that should be reviewed by healthcare practitioners so that they remain well informed and can supply this information to concerned patients.

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From
The Annals of Pharmacotherapy

January 2002 (Volume 36, Number 1)

Correlation Between Activated Clotting Time and Activated Partial Thromboplastin Times

Smythe MA, Koerber JM, Nowak SN, et al.
The Annals of Pharmacotherapy. 2002;36(1):7-11

Data from previous work on the monitoring of unfractionated heparin was reviewed retrospectively to achieve the objectives of this study. Those objectives included determining the correlation between plasma heparin concentration and clotting-time tests and between activated clotting time (ACT) and activated partial thromboplastin time (aPTT) as well as comparing heparin dose adjustment decisions based on ACT with those based on aPTT.

Data from 100 patients were used to establish the correlation between ACT and heparin concentration, 0.72. Bedside and laboratory aPTTs were used in the original study and thus comparison of aPTT and heparin concentration yielded a range of correlation values, depending on the instrument used, 0.74 to 0.86, with the highest correlation associated with the laboratory aPTT. Correlation of the aPTT and the ACT results yielded a correlation of 0.64 to 0.67. Heparin dosing adjustments made using ACT results were different from decisions arrived at using aPTT results 37% to 41% of the time.

Editor's Comment

Although the controversy about the best way to monitor and adjust heparin therapy is not new, it is worth reviewing again. Despite the existence of national guidelines that can guide heparin dosing conditions, it is important that clinicians recognize the limitations of the clotting-time test employed at their unique institution. This study demonstrates that heparin dosing decisions differed when different clotting-time tests were used.

Abstract



From
Journal of the American Pharmaceutical Association

January/February 2002 (Volume 42, Number 1)

Results of a Smoking Cessation Clinic in Community Pharmacy Practice

Kennedy DT, Giles JT, Chang ZG, Small RE, Edwards JH
Journal of the American Pharmaceutical Association. 2002;42(1):51-56

Most healthcare practitioners recognize the hazards of smoking and its implications with regard to patients' health. Despite this knowledge, many clinicians are reluctant to speak to patients about smoking cessation. Pharmacists in community practice are positioned to promote smoking cessation. In this study, results from a demonstration project in chain pharmacies are analyzed.

Pharmacists and fourth-year doctor of pharmacy students were trained both on-site and at off-site locations on the transtheoretical model for change as applied to smoking cessation, charting, behavioral modification techniques, stages of change as applied to smokers, nonprescription and prescription smoking cessation therapies, and patient counseling. Patients serviced at the participating pharmacies were asked if they smoked and whether they would like to quit. Patients could also enter the program by referral from physicians or nurses. An addiction scale score was used to determine a smoker's level of nicotine dependence (6-10 = high level of dependence, < 6 = low level of dependence).

Patients were followed for a 1-year period from the agreed-upon quit date. A total of 48 patients were recruited for participation. Twenty-five percent of these patients abstained form smoking for 12 months or more. These patients had a mean addiction score of 4.2. Smoking cessation rate correlated with sex (F > M) but not with age, number of cigarettes smoked per day, level of nicotine dependence, previous cessation attempts, or method of cessation. Patient satisfaction surveys indicated a high level of satisfaction with the service.

Editor's Comment

As with many patient care activities, it is easy to see how influential the community pharmacist can be in helping a patient achieve positive therapy outcomes. However, the reality of time constraints and lack of reimbursement for activities such as this will prohibit widespread incorporation into daily activities. Recognition of the value of these services outside of the pharmacy community is limited. Reports of successes like this must be shared with administrators and other healthcare providers.

Abstract



From
Pharmacotherapy
January 2002 (Volume 22, Number 1)


Comparison of Risperidone With Olanzapine in Elderly Patients With Dementia and Psychosis

Ellingrod VL, Schultz SK, Ekstam-Smith K, Kutscher E, Turvey C, Arndt S
Pharmacotherapy. 2002;22(1):1-5

Antipsychotic agents are primarily used in the elderly for the treating treatment of psychosis associated with dementia. Typical antipsychotics have a high frequency of drug-induced side effects, leading to increased use of the atypical antipsychotic agents as first-line therapies in this age group. In this study, the effects of risperidone and olanzapine on cognition were compared. Drug-induced side effects in elderly patients were also recorded. The Mattis Dementia Rating Scale was used to measure cognition.

Patients aged >/= 70 years with a diagnosis of Alzheimer-type dementia, multi-infarct dementia, or mixed syndrome and receiving an antipsychotic medication were recruited from 4 rural nursing care facilities. Following a baseline assessment, patients were treated with either risperidone or olanzapine in the single-blind, nonrandomized study. Primary care physicians determined individual patient dosages. Risperidone doses ranged from 0.25 mg/day to 3 mg/day. Olanzapine dosages ranged from 2.5 mg/day to 15 mg/day. A single clinician assessed patients at baseline, 1 month, and 2 months. The clinician, the patient, and the family were blinded to the treatment drug.

A total of 19 patients were enrolled in the study. Eleven patients received risperidone and 8 patients received olanzapine. Social-Adaptive Functioning Evaluation increased in all patients (P = .03). No significant difference in the score was noted between groups. Scores on the Mattis Scale and Mini-Mental State Examination declined in patients receiving risperidone compared with baseline (P < .05). A significant increase in Simpson-Angus Extrapyramidal Symptoms scores occurred in the olanzapine group compared with baseline (P < .05). Blood pressure also decreased in the olanzapine group compared with baseline (P < .07). A significant difference between groups did not occur with any of the measurements.

Editor's Comment

This small study offers an important contribution to the published literature. The incidence of dementia in the elderly and the need to treat psychosis associated with the disease continue to rise. It is interesting to note that no change was observed on the psychosis rating scales during this study, despite improvements in social functioning. Larger groups of patients will need to be studied to determine whether certain patient groups are more apt to suffer adversely from these treatments and whether a difference in response to these agents exists.

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From
British Journal of Clinical Pharmacology
February 2002 (Volume 53, Number 2)


The Effects of Rifampicin on the Pharmacokinetics and Pharmacodynamics of Orally Administered Nilvadipine to Healthy Subjects

Saima S, Furuie K, Yoshimoto H, Fukuda J, Hayashi T, Echizen H
British Journal of Clinical Pharmacology. 2002;53(2):203-206

The oral bioavailability of calcium channel blockers can be decreased by concomitant administration with rifampicin. The interaction occurs because rifampicin is metabolized through the cytochrome p450 enzyme system. An interaction between nifedipine and rifampicin has been established. Nilvadipine is a second-generation calcium channel antagonist used in the treatment of hypertension. Because it is closely related to nifedipine, a drug interaction with rifampicin was expected. This study used 5 healthy volunteers to determine whether coadminstration of rifampicin and nilvadipine resulted in altered pharmacokinetic and pharmacodynamic effects.

All study subjects were considered healthy and were not taking any medications other than study drugs. Pharmacokinetic and cardiovascular effects of nilvadipine were studied prior to the initiation of rifampicin and after a 6-day course of concomitant rifampicin. Serial blood samples were collected and used for pharmacokinetic measurements. Blood pressure was assessed using a sphygmomanometer. Supine and standing blood pressures were assessed at baseline and 1 hour following an oral dose of nilvadipine.

The AUC of nilvadipine was lower following concomitant dosing with rifampicin. The mean AUC of nilvadipine before rifampicin treatment was approximately 30 times greater than the mean AUC following rifampicin administration (P < .05). The mean peak plasma concentration of nilvadipine was approximately 20 times greater before treatment with rifampicin (P < .05). When nilvadipine was administered alone, a significant decrease in diastolic pressure and an increase in heart rate were observed. These effects were not noted with the coadministration of rifampicin and nilvadipine.

Editor's Comment

The results of this small drug interaction study suggest that the coadministration of nilvadipine and rifampicin results in a loss of nilvadipine's therapeutic effect. Although the drug is not currently available in the United States, clinicians in countries where nilvadipine is available should be aware of this drug interaction. When the interaction cannot be avoided, an increase in nilvadipine dose may be warranted.

Abstract

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From
British Journal of Clinical Pharmacology
January 2002 (Volume 53, Number 1)


Distribution of Venlafaxine and Its O-Desmethyl Metabolite in Human Milk and Their Effects in Breastfed Infants

Ilett KF, Kristensen JH, Hackett LP, Paech M, Kohan R, Rampono J
British Journal of Clinical Pharmacology. 2002;53(1):17-22

Venlafaxine is a bicyclic phenylethylamine antidepressant that inhibits serotonin and norepinephrine reuptake. Following delivery, some women develop postpartum depression that may require treatment with an antidepressant medication. This study was designed to determine the transfer of venlafaxine and 0-desmethyl venlafaxine into the breast milk of lactating women. 0-desmethyl venlafaxine has activity that is similar to that of venlafaxine. Plasma concentrations and effects in the breast-fed infants were reviewed.

Six lactating women and their infants participated in the study. The mean age of the infants was 7 months. Following an oral dose of venlafaxine, serial blood and breast milk samples were collected from the mothers. Infant blood samples were collected at a mean of 6.5 hours following maternal dosing. Venlafaxine was detected in only 1 infant sample at a low concentration. 0-desmethyl venlafaxine was detected in 4 of the 6 infants; concentrations ranged from 3 mcg/L to 38 mcg/L. None of the infants experienced adverse effects.

Editor's Comment

The risk vs benefit of any agent used in lactating women needs to be assessed prior to exposure of the infant to the agent. The exposure of the infants to venlafaxine and its active metabolite was relatively low in this study. In many cases, when the risk of adverse effects is low, treating the mother with medication and encouraging breastfeeding will benefit both the baby and the mother.

Abstract

Full text



From
Clinical Therapeutics
January 2002 (Volume 24, Number 1)


Combination Hydrocodone and Ibuprofen Versus Combination Oxycodone and Acetaminophen in the Treatment of Moderate or Severe Acute Low Back Pain

Palangio M, Morris E, Doyle RT Jr, Dornseif BE, Valente TJ
Clinical Therapeutics. 2002;24(1):87-99

This randomized, double-blind, parallel-group, repeat-dose study compared the efficacy and tolerability of combination hydrocodone 7.5 mg and ibuprofen 200 mg (HC/IB) with combination oxycodone 5 mg and acetaminophen 325 mg (OC/AC). Adult patients with a diagnosis of acute low back pain requiring opioid or opioid-nonopioid combination therapy were eligible for the study. Patients were admitted to the study within 48 hours of the onset of pain and completed a baseline self-assessment pain intensity rating. Patients were treated on an outpatient basis. All study participants were required to complete 2 visits within an 8-day period. Day 1 was considered baseline, and day 8 or day of treatment discontinuation was considered the study end point. Patients kept a daily diary and recorded end of day pain relief, number of tablets and doses of supplemental analgesic medications taken, and type and frequency of any prescribed physical therapy. At the end point of the study, patients were asked to make a global assessment of their treatment (poor, fair, good, very good, excellent). A physical examination and Short-Form Health Survey (SF-36) were also completed at the end point.

Patients were randomized; the recommended starting dosage for both treatments was 1 tablet every 4 to 6 hours with a maximum of 5 single tablets per day. Up to 4 daily doses of supplemental analgesic medicine (ibuprofen 200 mg for patients receiving HC/IB and acetaminophen 325 mg for patients receiving OC/AC) were allowed during the study period. No more than 1 supplemental dose of analgesic was allowed between 2 doses of study medication. No other analgesic or anti-inflammatory medications were allowed.

A total of 147 patients entered the study. Sixty-four of 75 HC/IB patients and 61 of 72 OC/AC patients completed the study. Reasons for discontinuation were similar between the two groups and included adverse events, recovery, lack of efficacy, loss to follow-up, and protocol violation. Mean daily pain relief scores improved in both groups from baseline to end point measurement (P < .001). Measurement of efficacy was similar in both groups. Mean daily pain relief scores, mean daily number of tablets and doses of study medication, mean daily doses and tablets of supplemental analgesic medication, and global assessments were similar in both sets of patients. Adverse events were similar for both treatments.

Editor's Comment

The results of this study indicate that the two combination analgesic preparations have comparable efficacy. Larger controlled trials will need to be conducted to determine whether the combination product that contains an anti-inflammatory agent is the better product for acute lower back pain.

Abstract


From
Journal of Clinical Pharmacology

February 2002 (Volume 42, Number 2)


Multiple-Dose, Linear, Dose-Proportional Pharmacokinetics of Retigabine in Healthy Volunteers

Ferron GM, Paul J, Fruncillo R, et al.
Journal of Clinical Pharmacology. 2002;42(2):175-182

Retigabine is a selective M-current potassium channel opener for the KCNQ2/3 and KCNQ3/5 channels under investigation as an antiepileptic agent. This is the first agent in this class of drugs to undergo investigation. Retigabine exerts its activity by opening potassium channels and by potentiating gamma amino butyric acid (GABA). Mutations in KCNQ2/3 and KCNQ3/5 potassium channels have been linked to benign neonatal familial convulsions. Retigabine is being investigated as an antiepileptic agent in the treatment of partial and generalized onset seizures. This study was conducted in 45 healthy adult male volunteers to assess the pharmacokinetics of retigabine and its partially active metabolite, AWD21-360. Assessment was conducted following single and multiple doses of oral retigabine. Safety and tolerability were assessed using a fixed dose and a dose titration schedule.

Study patients participated in only 1 dose group in this double-blind, placebo-controlled, ascending-dose, dose-escalating study. Nine patients were evaluated at each dose level; 6 patients received active study drug and 3 received placebo. Retigabine was dosed at 100, 200, 250, or 300 mg every 12 hours for 15 days. With the exception of the dose titration group, each subject received the same dose level each day. The titration group was started on a dose of 200 mg and increased by 100 mg every 4 days to achieve a 700-mg/day dose on day 15. Study drugs were administered with 250 mL of tap water. Subjects reported to the study center on the day before the first dose and stayed through the morning of day 17. Serial blood samples were collected on days 1 through 15. Physical exams, clinical laboratory values, electrocardiogram reading, vital sign measurements, and spontaneous reports of adverse events were used to assess safety.

Pharmacokinetic parameters were similar throughout the study period. The accumulation ratio with multiple dosing was 1.5. Retigabine was rapidly absorbed and maximum concentrations were reached within 1.5 hours of dosing. The mean terminal half-life was approximately 8 hours; oral clearance was 0.7 L/h/kg in white study patients. Clearance was reduced by 25% in black study patients. Over the range of 100 to 700 mg of retigabine, the pharmacokinetics were linearly dose proportional. Dose-limiting adverse effects were evident in the fixed-dose regimen at 600 mg/day. These patients complained of chills, pain, symptomatic hypotension, dizziness, nausea, myalgia, sweating, and vomiting. Titration allowed for higher doses compared with the fixed-dose regimens.

Editor's Comment

This pharmacokinetic study offers some insight into the challenges that might face clinicians should this medication become available in the United States. The need for titration with any medication often leads to compliance problems. In addition, significant differences in clearance between races may lead to over- or under-dosing in some patients.

Abstract

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