Category Archives: Artikel

Kabar Gembira!!!!! Ada vaksin antimalaria

NEJM telah melaporkan hasil uji klinik vaksin antimalaria. Berita selengkapnya sebagai berikut:
Original Article
A Field Trial to Assess a Blood-Stage Malaria Vaccine

Mahamadou A. Thera, M.D., M.P.H., Ogobara K. Doumbo, M.D., Ph.D., Drissa Coulibaly, M.D., Matthew B. Laurens, M.D., M.P.H., Amed Ouattara, Pharm.D., Abdoulaye K. Kone, M.D., Ando B. Guindo, M.D., Karim Traore, M.D., Idrissa Traore, M.D., Bourema Kouriba, Pharm.D., Ph.D., Dapa A. Diallo, M.D., Issa Diarra, Pharm.D., Modibo Daou, Pharm.D., Amagana Dolo, Pharm.D., Ph.D., Youssouf Tolo, Pharm.D., Mahamadou S. Sissoko, M.D., M.S.P.H., Amadou Niangaly, Pharm.D., Mady Sissoko, Pharm.D., Shannon Takala-Harrison, Ph.D., Kirsten E. Lyke, M.D., Yukun Wu, Ph.D., William C. Blackwelder, Ph.D., Olivier Godeaux, M.D., Johan Vekemans, M.D., Ph.D., Marie-Claude Dubois, M.Sc., W. Ripley Ballou, M.D., Joe Cohen, Ph.D., Darby Thompson, M.S., Tina Dube, Ph.D., Lorraine Soisson, Ph.D., Carter L. Diggs, M.D., Ph.D., Brent House, Ph.D., David E. Lanar, Ph.D., Sheetij Dutta, Ph.D., D. Gray Heppner, Jr., M.D., and Christopher V. Plowe, M.D., M.P.H.

N Engl J Med 2011; 365:1004-1013September 15, 2011

Abstract
Background

Blood-stage malaria vaccines are intended to prevent clinical disease. The malaria vaccine FMP2.1/AS02A, a recombinant protein based on apical membrane antigen 1 (AMA1) from the 3D7 strain of Plasmodium falciparum, has previously been shown to have immunogenicity and acceptable safety in Malian adults and children.

Full Text of Background…
Methods

In a double-blind, randomized trial, we immunized 400 Malian children with either the malaria vaccine or a control (rabies) vaccine and followed them for 6 months. The primary end point was clinical malaria, defined as fever and at least 2500 parasites per cubic millimeter of blood. A secondary end point was clinical malaria caused by parasites with the AMA1 DNA sequence found in the vaccine strain.

Full Text of Methods…
Results

The cumulative incidence of the primary end point was 48.4% in the malaria-vaccine group and 54.4% in the control group; efficacy against the primary end point was 17.4% (hazard ratio for the primary end point, 0.83; 95% confidence interval [CI], 0.63 to 1.09; P=0.18). Efficacy against the first and subsequent episodes of clinical malaria, as defined on the basis of various parasite-density thresholds, was approximately 20%. Efficacy against clinical malaria caused by parasites with AMA1 corresponding to that of the vaccine strain was 64.3% (hazard ratio, 0.36; 95% CI, 0.08 to 0.86; P=0.03). Local reactions and fever after vaccination were more frequent with the malaria vaccine.

Full Text of Results…
Conclusions

On the basis of the primary end point, the malaria vaccine did not provide significant protection against clinical malaria, but on the basis of secondary results, it may have strain-specific efficacy. If this finding is confirmed, AMA1 might be useful in a multicomponent malaria vaccine. (Funded by the National Institute of Allergy and Infectious Diseases and others; ClinicalTrials.gov number, NCT00460525.)

Mana yang lebih menguntungkan Rivaroxaban atau Warfarin pada Nonvalvular Atrial Fibrillation

Non valvular atrial fibrilasis merupakan salah satu faktor risiko stroke iskemia dan embolisme pada pembuluh darah. Selama ini warfarin merupakan salah satu obat pilihan untuk pencegahan strok iskemia maupun pembentukan emboli pada pasien dengan fibrilasis termasuk pasien dengan nonvalvular atrial fibrilasis. Hasil Uji klinis untuk membandingkan kemanjuran rivaroxaban dengan warfarin pada nonvalvular atrial fibrilasis telah dilaporkan oleh NEJM.

rivaroxaban

rivaroxaban

faktor risiko cvd

faktior risiko cvd

Original Article

Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation

Manesh R. Patel, M.D., Kenneth W. Mahaffey, M.D., Jyotsna Garg, M.S., Guohua Pan, Ph.D., Daniel E. Singer, M.D., Werner Hacke, M.D., Ph.D., Günter Breithardt, M.D., Jonathan L. Halperin, M.D., Graeme J. Hankey, M.D., Jonathan P. Piccini, M.D., Richard C. Becker, M.D., Christopher C. Nessel, M.D., John F. Paolini, M.D., Ph.D., Scott D. Berkowitz, M.D., Keith A.A. Fox, M.B., Ch.B., Robert M. Califf, M.D., and the ROCKET AF Steering Committee for the ROCKET AF Investigators

N Engl J Med 2011; 365:883-891September 8, 2011

Comments open through September 14, 2011

Abstract
Article
References
Citing Articles (1)
Comments (3)

Background

The use of warfarin reduces the rate of ischemic stroke in patients with atrial fibrillation but requires frequent monitoring and dose adjustment. Rivaroxaban, an oral factor Xa inhibitor, may provide more consistent and predictable anticoagulation than warfarin.

Full Text of Background…

Methods

In a double-blind trial, we randomly assigned 14,264 patients with nonvalvular atrial fibrillation who were at increased risk for stroke to receive either rivaroxaban (at a daily dose of 20 mg) or dose-adjusted warfarin. The per-protocol, as-treated primary analysis was designed to determine whether rivaroxaban was noninferior to warfarin for the primary end point of stroke or systemic embolism.

Full Text of Methods…

Results

In the primary analysis, the primary end point occurred in 188 patients in the rivaroxaban group (1.7% per year) and in 241 in the warfarin group (2.2% per year) (hazard ratio in the rivaroxaban group, 0.79; 95% confidence interval [CI], 0.66 to 0.96; P<0.001 for noninferiority). In the intention-to-treat analysis, the primary end point occurred in 269 patients in the rivaroxaban group (2.1% per year) and in 306 patients in the warfarin group (2.4% per year) (hazard ratio, 0.88; 95% CI, 0.74 to 1.03; P<0.001 for noninferiority; P=0.12 for superiority). Major and nonmajor clinically relevant bleeding occurred in 1475 patients in the rivaroxaban group (14.9% per year) and in 1449 in the warfarin group (14.5% per year) (hazard ratio, 1.03; 95% CI, 0.96 to 1.11; P=0.44), with significant reductions in intracranial hemorrhage (0.5% vs. 0.7%, P=0.02) and fatal bleeding (0.2% vs. 0.5%, P=0.003) in the rivaroxaban group.

Full Text of Results…

Conclusions

In patients with atrial fibrillation, rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism. There was no significant between-group difference in the risk of major bleeding, although intracranial and fatal bleeding occurred less frequently in the rivaroxaban group. (Funded by Johnson & Johnson and Bayer; ROCKET AF ClinicalTrials.gov number, NCT00403767.)

Dipasang stenting atau terapi obat pada stenosis arteri intracranial?

Telah dilakukan penelitian untuk menilai kemanjuran antara operasi angioplasti dan pemasangan stanting dengan terapi obat pada pasien dengan stenosis arteri intracranial. NEJM edisi Minggu I septem ber 2011 telah melaporkan bahwa terapi obat pada pasien dengan stenosis arteri intracranial lebih menguntungkan jika dibandingkan dengan operasi angioplasti dan pemasangan stenting. Tidak dapat dipungkiri bahwa stenosis arteri intracranial merupakan faktor risiko utama kejadian stroke dan sering berakibat fatal. Makalah selengkapnya silakan baca di:

Original Article

stenosis arteri intracranial

stenosis arteri intracranial

Stenting versus Aggressive Medical Therapy for Intracranial Arterial Stenosis

Marc I. Chimowitz, M.B., Ch.B., Michael J. Lynn, M.S., Colin P. Derdeyn, M.D., Tanya N. Turan, M.D., David Fiorella, M.D., Ph.D., Bethany F. Lane, R.N., L. Scott Janis, Ph.D., Helmi L. Lutsep, M.D., Stanley L. Barnwell, M.D., Ph.D., Michael F. Waters, M.D., Ph.D., Brian L. Hoh, M.D., J. Maurice Hourihane, M.D., Elad I. Levy, M.D., Andrei V. Alexandrov, M.D., Mark R. Harrigan, M.D., David Chiu, M.D., Richard P. Klucznik, M.D., Joni M. Clark, M.D., Cameron G. McDougall, M.D., Mark D. Johnson, M.D., G. Lee Pride, Jr., M.D., Michel T. Torbey, M.D., M.P.H., Osama O. Zaidat, M.D., Zoran Rumboldt, M.D., and Harry J. Cloft, M.D., Ph.D. for the SAMMPRIS Trial Investigators

September 7, 2011 (10.1056/NEJMoa1105335)

Comments open through September 21, 2011

Abstract
Article
References
Comments

Background

Atherosclerotic intracranial arterial stenosis is an important cause of stroke that is increasingly being treated with percutaneous transluminal angioplasty and stenting (PTAS) to prevent recurrent stroke. However, PTAS has not been compared with medical management in a randomized trial.

Full Text of Background…

Methods

We randomly assigned patients who had a recent transient ischemic attack or stroke attributed to stenosis of 70 to 99% of the diameter of a major intracranial artery to aggressive medical management alone or aggressive medical management plus PTAS with the use of the Wingspan stent system. The primary end point was stroke or death within 30 days after enrollment or after a revascularization procedure for the qualifying lesion during the follow-up period or stroke in the territory of the qualifying artery beyond 30 days.

Full Text of Methods…

Results

Enrollment was stopped after 451 patients underwent randomization, because the 30-day rate of stroke or death was 14.7% in the PTAS group (nonfatal stroke, 12.5%; fatal stroke, 2.2%) and 5.8% in the medical-management group (nonfatal stroke, 5.3%; non–stroke-related death, 0.4%) (P=0.002). Beyond 30 days, stroke in the same territory occurred in 13 patients in each group. Currently, the mean duration of follow-up, which is ongoing, is 11.9 months. The probability of the occurrence of a primary end-point event over time differed significantly between the two treatment groups (P=0.009), with 1-year rates of the primary end point of 20.0% in the PTAS group and 12.2% in the medical-management group.

Apakah yang kita ketahui tentang BNP?

gagal jantung

gagal jantung

BNP singkatan dari B type natriuretic peptide sering di sebut juga sebagai brain type natriuretic peptide. BNP merupakan peptida yang dihasilkan oleh tubuh kita, yaitu sel otot ventrikel jantung. Saat ini BNP menjadi penting oleh karena dapat menjadi indikator atau marker, dalam bahasa kito=petanda, yang akan mengarah pada adanya kelainan antara lain untuk kondisi yang mengarah kepada gagal jantung. Marker BNP ini lebih peka, artinya sebelum munculnya kelainan klinik, yaitu meskipun belum memunculkan keluhan ke arah gagal jantung, tetapi keberadaan BNP yang berlebihan telah menunjukkan kondisi jantung yang sedang kepayahan. Dengan memantau kadar BNP dapat memantau kebugaran jantung dan mengantisipasi akan terjadinya gagal jantung yang lebih berat. Cerita selengkapnya tentang BNP silakan baca artikel berikut:

BNP (B-TYPE NATRIURETIC PEPTIDE)

BNP (B-type natriuretic peptide) is a cardiac neurohormone secreted from cardiac ventricular myocyte in response to increased ventricular wall stretch or wall tension, increased ventricular volume or pressure. It is a potent vasodilator and it promotes diuresis. The half-live is short, about 18-22 minutes.

  • Circulating BNP level increases in proportion to the severity of heart failure.
  • Conditions that raise BNP level beside heart failure
    • Age, sex (female), left ventricular hypertrophy, acute coronary syndrome, acute myocardial infarction, cardiac inflammation, arrhythmogenic RV with decrease ejection, primary pulmonary hypertension, worsening of corpulmonale with increased RV pressure and volume, acute pulmonary emboli, Kawasaki disease, advanced renal failure, cirrhosis, hyperaldosteronism, Cushing syndrome, and decreased clearance.
  • Heart failure conditions that may have low BNP
    • Flash pulmonary edema within 1 hour, acute chordal rupture, pulmonary congestion-edema from mitral stenosis, severe end stage heart failure, and heart failure in obese patients (BMI>30 kg/m2).

Potential usefulness are:

1. Diagnosis for HF
      • Utilization of BNP level to help differentiate heart failure from other causes of dyspnea in ER or urgent care setting, using Point of Care measurement technique. BNP level over 100 pg/ml favors the diagnosis of heart failure. The range of BNP level in most heart failure patients is from a few hundreds to >1000 pg/ml. BNP should not be a stand alone test. Clinical judgment is always important, Elevated BNP are seen in other conditions (Table 1). Low BNP may be found in few acute heart failure conditions and in obese patients with heart failure.

Table 1. Common causes of BNP elevation in routine clinical practice

Age. Female
Renal failure (Cr >2) or on dialysis
Myocardial infarction
Acute coronary syndrome
Pulmonary disease with right-side failure
Acute pulmonary embolism
Sepsis
Baseline left ventricular dysfunction


Utilization of BNP level as a diagnostic tool for heart failure with preserved systolic function. A heart failure patient with normal echocardiographic LV systolic function, abnormal diastolic filling abnormalities and elevated BNP should favor this diagnosis.

2. Follow up and Prognosis of heart failure

    • During inpatient treatment of heart failure. Rising of the discharged BNP level from the admission level is a good predictor of poor prognosis and near future unfavorable outcome i.e… early readmission.
    • During outpatient treatment followup, BNP guiding intensity of treatment may be useful.
    • During acute MI, rising of BNP level few days after admission level indicates poorer prognosis
    • Baseline BNP is necessary for comparison.
3. Treatment for acute decompensation
    • Nesiritide (Natrecor) is a human recombinant BNP.
    • Dosage: Intravenous 2 microgram/kg bolus, followed by infusion of 0.01 microgram/kg/min
    • Duration: Up to 7 days (or more?).
    • Action: Hemodynamic effect is observed in an hour or less. There is no tolerance for several days of infusion. Hemodynamic effect resolves by 2-4 hours after cessation of the infusion.
    • Nesiritide promotes diuresis.
    • Use appropriate dose of diuretic. Over diuresing may potentiate hypotension side effect.
    • Side effects: Hypotension (more in cases taking ACEI), nausea, headache.
    • Caution: Volume depletion, aortic stenosis, hypertrophic cardiomyopathy, cardiogenic shock.
    • Usually does not require hemodynamic monitoring.
    • Beware of drug incompatibility in the infusion process.
    • May obtain proBNP but not BNP level during nesiritide infusion.
    • In the responder cases, if the BNP level is checked 2 hours (BNP five halve life time) after stopping the infusion it should be lower than the preinfusion level.

4. Potential outpatient intermittent treatment in severe heart failure

(Waiting for FUSION 2 trial)

5. NT-proBNP (NT = N Terminal)

When cardiac myocyte Pro-BNP enter the circulation it split into BNP which is an active neurohormone and NT-proBNP which is inactive part but with longer half life. Level of NT-proBNP can be used for diagnosis, follow up and prognosis of heart failure the same way as BNP level. The physicians need to know whether the report are BNP or NT-proBNP since the level are significantly different and some laboratory may not label it correctly.

References

Bagaimana berita baru tentang medication error?

FDA memberikan layanan kusus tentang perkembangan terkini kejadian medication error. Kejadian medication error yang masih tinggi di masyarakat telah menjadi isue utama pada sistem layanan kesehatan dan menjadi keprihatinan para pengambil kebijakan bidang kesehatan di dunia.  Gambaran global tentang layanan informasi medication error dari FDA adalah sebagai berikut:

Medication Errors

Introduction

FDA receives medication error reports on marketed human drugs (including prescription drugs, generic drugs, and over-the-counter drugs) and nonvaccine biological products and devices.  The National Coordinating Council for Medication Error Reporting and Prevention defines a medication error as “any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.”

The American Hospital Association lists the following as some common types of medication errors:

  • incomplete patient information (not knowing about patients’ allergies, other medicines they are taking, previous diagnoses, and lab results, for example);
  • unavailable drug information (such as lack of up-to-date warnings);
  • miscommunication of drug orders, which can involve poor handwriting, confusion between drugs with similar names, misuse of zeroes and decimal points, confusion of metric and other dosing units, and inappropriate abbreviations;
  • lack of appropriate labeling as a drug is prepared and repackaged into smaller units; and
  • environmental factors, such as lighting, heat, noise, and interruptions, that can distract health professionals from their medical tasks.

In 1992, the FDA began monitoring medication error reports that are forwarded to FDA from the United States Pharmacopeia (USP) and the Institute for Safe Medication Practices (ISMP). The Agency also reviews MedWatch reports for possible medication errors. Currently, medication errors are reported to the FDA as manufacturer reports (adverse events resulting in serious injury and for which a medication error may be a component), direct contact reports (MedWatch), or reports from USP or ISMP.

The Division of Medication Errors and Technical Support includes a medication error prevention program staffed with pharmacists and support personnel. Among their many duties, program staff review medication error reports sent to the USP Medication Errors Reporting Program and MedWatch, evaluate causality, and analyze the data to provide feedback to others at FDA.

 Campaign to Eliminate Use of Error-Prone Abbreviations

FDA and the Institute for Safe Medication Practices (ISMP) have launched a national education campaign to eliminate the use of ambiguous medical abbreviations that are frequently misinterpreted and lead to mistakes that result in patient harm. The campaign seeks to promote safe practices among those who communicate medical information.

As part of the campaign, FDA recommends that healthcare professionals consider ISMP’s List of Error-Prone Abbreviations, Symbols, and Dose Designations [external link] whenever medical information is communicated. In addition, FDA and ISMP have provided a toolkit of resource materials available at ISMP and FDA Campaign to Eliminate Use of Error-Prone Abbreviations. [external link]

FDA News: FDA and ISMP Launch Campaign to Reduce Medication Mistakes Caused by Unclear Medical Abbreviations.

Federal Regulations and Guidances

Other Resources

Drug Products Associated with Medication Errors

Medication Errors Information from FDA

Contact Us

Division of Drug Information (CDER)

Office of Communications

Feedback Form

10001 New Hampshire Avenue

Hillandale Building, 4th Floor

Silver Spring, MD 20993

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Bagaimana layanan kesehatan yang tepat, dilema layanan kesehatan ke depan

Keberadaan dan peran dokter dalam layanan kesehatan di masyarakat sudah menjadi keniscayaan. Sejak jaman Yunan sampai jaman modern saat ini, peran dokter dalam sistem layanan kesehatan di masyarakat tidak sedikit.  Dalam islam keberadaan dokter maupun profesi kesehatan lainnya agar terselenggara sistem layanan kesehatan yang efektif dan efisien serta mampu meningkatkan derajat kesehatan masyarakat termasuk dalam hukum fardu kifayah. Bagaimana seharusnya menjadi dokter yang sesuai tuntutan jaman tetapi juga sesuai tuntunan etika ternyata tidaklah mudah. Artikel berikut memberikan gambaran bagaimana seharusnya seorang dokter di jaman modern.

Perspective

The Doctor’s Dilemma — What Is “Appropriate” Care?

NEJM | August 17, 2011 | Topics: Comparative Effectiveness, Cost of Health Care

Victor R. Fuchs, Ph.D.

Most physicians want to deliver “appropriate” care. Most want to practice “ethically.” But the transformation of a small-scale professional service into a technologically complex sector that consumes more than 17% of the nation’s gross domestic product makes it increasingly difficult to know what is “appropriate” and what is “ethical.” When escalating health care expenditures threaten the solvency of the federal government and the viability of the U.S. economy, physicians are forced to reexamine the choices they make in caring for patients.

In an effort to address this issue, physicians’ organizations representing more than half of all U.S. physicians have endorsed a “Physician Charter” that commits doctors to “medical professionalism in the new millennium.” The charter states three fundamental principles, the first of which is the “primacy of patient welfare.” It also sets out 10 “commitments,” one of which states that “while meeting the needs of individual patients, physicians are required to provide health care that is based on the wise and cost-effective management of limited clinical resources.” How can a commitment to cost-effective care be reconciled with a fundamental principle of primacy of patient welfare?

The dilemma arises for two main reasons. First, recent decades have witnessed a flood of new, expensive medical technologies (drugs, imaging devices, surgical procedures) that are of varying degrees of value to patients. A few are true breakthroughs, with strong favorable effects on mortality and morbidity. Others make a meager contribution, at best, to health outcomes. Moreover, technologies that may provide high value for carefully selected patients are often used indiscriminately for a much larger cohort of patients. Second, health insurance, private or public, has become so widespread that 90% of the country’s health care bill is paid by third parties, not by the patient receiving the service.

What is a conscientious physician to do? Some new cancer drugs cost thousands of dollars per month for a single patient. The bills for many surgical procedures run to five or even six figures. Noninvasive imaging devices can offer information to assist in diagnosis, at a cumulative cost in the billions of dollars. U.S. patients, on average, get almost three times as many magnetic resonance imaging scans as Canadian patients; there is no evidence that this large differential can be explained by national differences in the medical condition of patients or that it results in significant national differences in health outcomes. So what level of utilization deserves to be called “appropriate”?

If insurance were not widespread, many physicians would be reluctant to order an expensive intervention unless it offered a good chance of substantial benefit — that is, unless it was cost-effective. Indeed, without U.S.-style cost-insensitive insurance, many expensive diagnostic and therapeutic innovations would not be developed and brought to market.1 The insured patient, on the other hand, will usually want any and all care that might possibly be of net benefit, regardless of cost. The physician may recognize that the intervention under consideration is not cost-effective but may recommend it anyway, for a variety of reasons: to keep the goodwill of the patient, to protect against a malpractice suit, or in the belief that the “primacy of patient welfare” makes the denial of such care “inappropriate” and “unethical.”

The doctor’s dilemma is the nation’s problem. Some policy experts think that if patients had “more skin in the game” — that is, had less insurance — the problem would be solved. It would not. Even the most ardent advocates of deductibles and copayments acknowledge the need for an annual cap on patients’ payments, beyond which insurance takes over completely. There is no consensus on the right level for the cap, but it is generally recognized that the average U.S. household, with large debts and minimal financial assets, could not handle much more than $5,000. But the extreme skew in annual health care expenditures, with 5% of individuals accounting for 50% of spending in any given year, means that many health care decisions, and especially those involving big-ticket interventions, will be made by and for patients whose costs have exceeded the cap.

Another popular “solution” is to eliminate care that does more harm than good — that is, “unnecessary” care. Such elimination would be desirable, but the potential savings from this source are smaller than is usually claimed. It is true that after the fact, many interventions turn out to be useless or even harmful for some patients. But the heterogeneity of patient populations and uncertainty about the response of individual patients to an intervention means that it is often difficult or impossible to determine in advance which ones will prove to help particular patients and which will turn out to have been unnecessary.

There is no escaping the fact that many interventions are valuable for some patients even if, for the population as a whole, their cost is greater than their benefit. Under what circumstances are they likely to be ordered, and when are they likely to be withheld? The context within which the physician practices, his or her assumption about the behavior of other physicians, and the economic and health consequences of ordering all the care that might do some good versus practicing cost-effective medicine will affect the physician’s choice. If the physician is paid on a fee-for-service basis and the patient has open-ended insurance, the scales are tipped in favor of doing as much as possible and against limiting interventions to those that are cost-effective. In that setting, who would benefit from the resources that are saved by practicing cost-effective medicine is not obvious to the physician.

In contrast, if the physician is practicing in a setting that has accepted responsibility for the health of a defined population and the organization receives an annual fee per enrollee, the chances of the physician’s practicing cost-effective medicine are substantially increased, even though all patients are insured. The physician’s colleagues are practicing the same way, and the resources saved can be used for the benefit of the defined population, which includes the physician’s patient. In Canada, which has universal insurance, per capita spending on health care is only 55% of the U.S. level because there is a limited overall budget, and all physicians in the system recognize the need for prudence in making decisions about care.

In short, when physicians are collectively caring for a defined population within a fixed annual budget, it is easier for the individual physician to resolve the dilemma in favor of cost-effective medicine. That becomes “appropriate” care. And it is an ethical choice, as defined by philosopher Immanuel Kant, because if all physicians act the same way, all patients benefit.2

Disclosure forms provided by the author are available with the full text of this article at NEJM.org.

Source Information

From Stanford University, Stanford, CA.

References

    1. Weisbrod B. The health care quadrilemma: an essay on technological change, insurance, quality of care, and cost containment. J Econ Lit 1991;29:523-552Web of Science

  1. Kant I. Critique of practical reason and other writings in moral philosophy. Beck LW, trans. Chicago: University of Chicago Press, 1949.

Era baru administrasi layanan kesehatan, Rekam medik elektronik

rekam medik elektronik

sistem rekam medik elektronik

Era baru sistem administrasi kesehatan. Perkembangan IT/TI telah merasuki seluruh sendi kehidupan dan  secara masife merubah cara hidup manusia termasuk pada cara bagaimana meningkatkan derajat kesehatan masyarakat. Salah satu bagian dari proses perubahan dalam layanan administrasi oleh adanya TI adalah layanan administrasi kesehatan. Laporan berikut menunjukkan adanya arus besar menuju perubahan yang mendasar pada sistem administrasi layanan kesehatan.

Special Article

Electronic Health Records and Quality of Diabetes Care

NEJM | August 31, 2011 | Topics: Health IT, Quality of Care

Randall D. Cebul, M.D., Thomas E. Love, Ph.D., Anil K. Jain, M.D., and Christopher J. Hebert, M.D.

Incentives to increase adoption and meaningful use of electronic health records (EHRs) anticipate a quality-related financial return.1,2 However, empirical data showing either quality improvement or cost savings from EHR adoption are scarce. Available studies have shown few quality-related advantages of current EHR systems over traditional paper-based medical-record systems.1-5 Projected cost savings are mostly based on models with largely unsupported assumptions about adherence to and the effect of fully functional EHR systems.6,7 Data are particularly scarce on EHR adoption by “priority primary care providers” — health care professionals practicing in small groups and those serving vulnerable populations, as such providers are defined in the Health Information Technology for Economic and Clinical Health (HITECH) Act.8 EHR adoption by such providers is supported by the national network of Health Information Technology Regional Extension Centers.

Innovations in care delivery as specified in the Affordable Care Act, such as accountable care organizations and patient-centered medical homes (PCMHs), also provide incentives for using information most easily obtained through EHR systems.9,10 Data regarding the benefits of PCMHs have come largely from reports by EHR-based organizations,11-13 and these data support the posited links among EHR use, quality improvement, and cost savings. However, these reports did not compare EHR and paper-based systems.

Regional quality-improvement initiatives, such as those supported by the Robert Wood Johnson Foundation’s Aligning Forces for Quality (AF4Q) program,14 by Medicare and state Medicaid initiatives,15,16 and by multistakeholder collaboratives,17 provide an opportunity to evaluate the effectiveness of EHRs and refinements in national payment policy.15,18 In greater Cleveland, one of 16 AF4Q sites nationwide, diverse EHR-based and paper-based ambulatory practices publicly report on the quality and outcomes of care for patients with chronic medical conditions. Regional achievement of diabetes-related standards has been reported six times to date. The reported data come from practices with high concentrations of priority primary care providers and allow a comparison of quality standards for EHRs and paper records, after adjustment for important patient-level attributes. We examined the independent association of EHR use with achievement of quality standards for the care of patients with diabetes.

Methods

Study Design

We analyzed data from a retrospective cohort of primary care practices of seven diverse health care organizations that publicly reported achievement of quality standards for adults with diabetes between July 2007 and June 2010. Data reported here include the most recent yearlong cross section (July 2009 through June 2010) as well as practice-level trends across three years of reports.

Setting and Subjects

The primary care practice partners of Better Health Greater Cleveland (hereafter referred to as Better Health) are responsible for the majority of medical care for people with chronic disease in Cuyahoga County, an urban area in northeastern Ohio with 1.3 million residents; the county includes Cleveland, one of the nation’s poorest large cities, and its affluent suburbs. Participating practices include 21 sites of large not-for-profit health care organizations, 1 of which serves many vulnerable (“safety net”) patients; 12 sites of a large safety-net public hospital system; 1 safety-net practice of a university hospital; and the safety-net practices of all 3 of the county’s federally qualified health centers. Since the program’s inception in 2007, reporting primary care providers have included physicians in general internal medicine, family practice, and medicine–pediatrics. In July 2009, nurse practitioners and other health care professionals with prescription-writing privileges were added to the list of reporting providers. Patients include all adults (18 to 75 years of age) with diabetes who made at least two visits to the same primary care practice during each yearlong measurement interval.

Care and Outcome Standards

Better Health’s Clinical Advisory Committee approved nine quality standards for diabetes, including four standards of care and five standards of intermediate outcomes. Care standards are reported by standard and as an all-or-none composite19; outcome standards are reported by standard and as a composite indicating achievement of at least four of the five standards. Care standards include receipt of a glycated hemoglobin value, testing for urinary microalbumin or prescription of an angiotensin-converting–enzyme inhibitor or an angiotensin-receptor blocker, an eye examination to screen for diabetic retinopathy, and administration of a pneumococcal vaccination. Intermediate-outcome standards include a glycated hemoglobin value below 8%, a blood pressure below 140/80 mm Hg, a low-density lipoprotein (LDL) cholesterol value below 100 mg per deciliter or documented prescription for a statin medication, a body-mass index (the weight in kilograms divided by the square of the height in meters) below 30, and nonsmoking status. All care and outcome standards pertain to the most recent result documented in the measurement interval, except pneumococcal vaccination (administration at any time is sufficient for meeting this standard).

Covariates

Patient information was collected regarding several sociodemographic variables, including insurance type (Medicare, commercial, Medicaid, or uninsured), race or ethnic group (white, black, Hispanic, or other), age, sex, estimated household income, and educational level, all prespecified for our analyses. Insurance type is the primary insurance reported during the most recent doctor’s visit. Data on race or ethnic group were primarily obtained through self-report. Household income and educational level were estimated by linking each patient’s home address to Census 2000 summaries.

Data Collection and Study Oversight

Clinical practices or health care organizations submitted a unique study code for each patient and health care provider to Better Health’s Data Management Center. EHR-based organizations provided data on all eligible patients. Data from paper-based organizations were gathered by centrally trained chart abstractors for a random sample of patients selected by the Data Management Center. More than 95% of patients in the sample had charts available for review. Each site reviewed summary results for accuracy before publicly reporting data. The MetroHealth System’s Human Privacy Board approved data collection and submission protocols.

Quality-Improvement Assistance

The collaborative supports three types of quality-improvement assistance. First, partner sites receive comparisons with other practices in their organization and regionwide for case mix, achievement of Better Health’s standards, and quality improvement. Practice directors can identify data regarding specific providers. Public reports highlight the top 10% of practice sites with respect to achievement of standards or improvement, by insurance category and overall. Second, Better Health sponsors semiannual daylong summits featuring national speakers and sharing of best practices in quality improvement and management of reported chronic conditions. Third, since mid-2009, all practices have had the opportunity to receive program-sponsored practice coaching. Coaching has principally focused on culture change, workflow redesign, and quality-improvement projects related to specific metrics.

APIXABAN DENGAN ANTIPLATELET PASCA SERANGAN JANTUNG ISKEMIA

Apixaban sebagai inhibitor faktor Xa diduga dapat mencegah serangan ulang jantung iskemia jika ditambahkan pada antiplatelet. Proyek penelitian APPRAISE yang melibatkan lebih dari 7000 relawan, bertujuan untuk mengetahui kemanjuran penambahan apixaban pada terapi standar antiplatelet untuk mencegah serangan ulang pada pasien dengan acute coronary syndroma. Hasil penelitian selengkapnya dapat dibaca di NEJM:

Original Article

Apixaban with Antiplatelet Therapy after Acute Coronary Syndrome

John H. Alexander, M.D., M.H.S., Renato D. Lopes, M.D., Ph.D., Stefan James, M.D., Ph.D., Rakhi Kilaru, M.S., Yaohua He, M.D., Ph.D., Puneet Mohan, M.D., Ph.D., Deepak L. Bhatt, M.D., M.P.H., Shaun Goodman, M.D., Freek W. Verheugt, M.D., Ph.D., Marcus Flather, M.D., Kurt Huber, M.D., Danny Liaw, M.D., Ph.D., Steen E. Husted, M.D., Jose Lopez-Sendon, M.D., Raffaele De Caterina, M.D., Petr Jansky, M.D., Harald Darius, M.D., Dragos Vinereanu, M.D., Jan H. Cornel, M.D., Frank Cools, M.D., Dan Atar, M.D., Jose Luis Leiva-Pons, M.D., Matyas Keltai, M.D., Hisao Ogawa, M.D., Ph.D., Prem Pais, M.D., Alexander Parkhomenko, M.D., Witold Ruzyllo, M.D., Rafael Diaz, M.D., Harvey White, M.D., Mikhail Ruda, M.D., Margarida Geraldes, Ph.D., Jack Lawrence, M.D., Robert A. Harrington, M.D., and Lars Wallentin, M.D., Ph.D. for the APPRAISE-2 Investigators

N Engl J Med 2011; 365:699-708August 25, 2011

Abstract
Article
References

Background

Apixaban, an oral, direct factor Xa inhibitor, may reduce the risk of recurrent ischemic events when added to antiplatelet therapy after an acute coronary syndrome.

Full Text of Background…

Methods

We conducted a randomized, double-blind, placebo-controlled clinical trial comparing apixaban, at a dose of 5 mg twice daily, with placebo, in addition to standard antiplatelet therapy, in patients with a recent acute coronary syndrome and at least two additional risk factors for recurrent ischemic events.

Full Text of Methods…

Results

The trial was terminated prematurely after recruitment of 7392 patients because of an increase in major bleeding events with apixaban in the absence of a counterbalancing reduction in recurrent ischemic events. With a median follow-up of 241 days, the primary outcome of cardiovascular death, myocardial infarction, or ischemic stroke occurred in 279 of the 3705 patients (7.5%) assigned to apixaban (13.2 events per 100 patient-years) and in 293 of the 3687 patients (7.9%) assigned to placebo (14.0 events per 100 patient-years) (hazard ratio with apixaban, 0.95; 95% confidence interval [CI], 0.80 to 1.11; P=0.51). The primary safety outcome of major bleeding according to the Thrombolysis in Myocardial Infarction (TIMI) definition occurred in 46 of the 3673 patients (1.3%) who received at least one dose of apixaban (2.4 events per 100 patient-years) and in 18 of the 3642 patients (0.5%) who received at least one dose of placebo (0.9 events per 100 patient-years) (hazard ratio with apixaban, 2.59; 95% CI, 1.50 to 4.46; P=0.001). A greater number of intracranial and fatal bleeding events occurred with apixaban than with placebo.

Full Text of Results…

Conclusions

The addition of apixaban, at a dose of 5 mg twice daily, to antiplatelet therapy in high-risk patients after an acute coronary syndrome increased the number of major bleeding events without a significant reduction in recurrent ischemic events. (Funded by Bristol-Myers Squibb and Pfizer; APPRAISE-2 ClinicalTrials.gov number, NCT00831441.)

Mana yang lebih unggul untuk pencegahan stroke iskemia, Apixaban atau warfarin?

STROKE

STROKE ISKEMIA

apixaban meta analysisapixaban
apixaban, advocate, anti stroke iskemia
stroke
stroke, atrial fibrilasis

Stroke merupakan masalah kesehatan yang menakutkan. Ada dua jenis stroke, stroke iskemia dan stroke hemoragika. Stroke hemoragika dicirikan dengan adanya perdarahan akibat pecahnya pembuluh darah di otak. Stroke iskemia dicirikan dengan adanya penyumbatan pembuluh darah.

Salah satu faktor risiko pemicu  stroke iskemia adalah atrial fibrilasis. Nejm baru saja mempublikasikan hasil penelitian RCT yang membandingkan kemanjuran apixaban dengan warfarin dalam pencegahan stroke pada pasien dengan atrial fibrilasis. Apixaban sebagai inhibitor faktor Xa diduga merupakan salah satu faktor penting untuk penghambatan proses pembentukan trombus pada pasien dengan atrial fibrilasis. Menghambat kerja faktor Xa diharapkan dapat mencegah terjadinya stroke oleh karena pembentukan trombus pada pasien dengan atrial fibrilasis dapat dicegah.  Outcome utama penelitian RCT pada lebih dari 18.000 pasien  ini adalah kejadian stroke iskemia pada penderita atrial fibrilasis dengan satu atau lebih faktor risiko stroke.

Hasil penelitian menunjukkan bahwa apixaban lebih manjur jika dibandingkan dengan warfarin dalam mencegah kejadian stoke iskemia pada pasien dengan atrial fibrilasis. Apixaban juga lebih aman dalam mencegah terjadinya perdarahan jika dibandingkan dengan warfarin.

Kritik Pengembangan Fakultas dan Pendidikan Farmasi

ahli obat

obat dan ahli obat

A Critical Appraisal of and Recommendations for Faculty Development

B. Joseph Guglielmo, PharmD,a David J. Edwards, PharmD,b Andrea S. Franks, PharmD,c Cynthia A. Naughton, PharmD,d Kristine S. Schonder, PharmD,e Pamela L. Stamm, PharmD,f Phillip Thornton, PhD,g and Nicholas G. Popovich, PhDhaSchool of Pharmacy, University of California San FranciscobEugene Applebaum College of Pharmacy and Health Sciences

cCollege of Pharmacy, University of Tennessee

dCollege of Pharmacy, Nursing, and Allied Sciences, North Dakota State University

eSchool of Pharmacy, University of Pittsburgh

fHarrison School of Pharmacy, Auburn University

gSchool of Pharmacy, Wingate University

hCollege of Pharmacy, University of Illinois at Chicago

Corresponding Author: B. Joseph Guglielmo, PharmD, Professor and Chair, Department of Clinical Pharmacy, School of Pharmacy, University of California San Francisco, San Francisco, CA 94143-0622. Tel: 415-476-2354. Fax: 415-476-6632. E-mail: guglielmoj@pharmacy.ucsf.edu



ABSTRACT Next section

The 2009-2010 American Association of Colleges of Pharmacy (AACP) Council of Faculties Faculty Affairs Committee reviewed published literature assessing the scope and outcomes of faculty development for tenure and promotion. Relevant articles were identified via a PubMed search, review of pharmacy education journals, and identification of position papers from major healthcare professions academic organizations. While programs intended to enhance faculty development were described by some healthcare professions, relatively little specific to pharmacy has been published and none of the healthcare professions have adequately evaluated the impact of various faculty-development programs on associated outcomes.

The paucity of published information strongly suggests a lack of outcomes-oriented faculty-development programs in colleges and schools of pharmacy. Substantial steps are required toward the development and scholarly evaluation of faculty-development programs. As these programs are developed and assessed, evaluations must encompass all faculty subgroups, including tenure- and nontenure track faculty members, volunteer faculty members, women, and underrepresented minorities. This paper proposes AACP, college and school, and department-level recommendations intended to ensure faculty success in achieving tenure and promotion.


INTRODUCTION Previous sectionNext section

Faculty development is considered an essential component in the academic success of individual faculty members as well as that of the institution. Standard Number 26 of the 2007 Accreditation Council for Pharmacy Education (ACPE) Accreditation Standards and Guidelines for the Professional Program in Pharmacy Leading to the Doctor of Pharmacy Degree specifically advocates that colleges and schools of pharmacy have an effective continuing professional-development program for full-time, part-time, and voluntary faculty members, as well as staff members, consistent with their respective responsibilities. While this requirement uses the term “continuing professional development,” the Standard refers to programs intended to ensure faculty development.

Highly effective faculty development programs for colleges and schools of pharmacy have not been created. Complicating progress in this area is the wide range of expectations for faculty members with respect to service, research, and teaching. The scope of faculty development in colleges and schools of pharmacy has not been critically reviewed in the peer-reviewed literature.

The Faculty Affairs Committee of the 2009-2010 AACP Council on Faculty was charged with collecting information and formulating recommendations for faculty development specific to the promotion and tenure process. The initial committee charge was to (1) create an inventory of all colleges and schools of pharmacy that had a “formal” faculty-development program; (2) create a mechanism to characterize and publicize the best practices for faculty development within research-intensive and non-research-intensive colleges and schools of pharmacy; and (3) document the success of these programs.

The committee first identified a sample of colleges and schools of pharmacy and assessed the scope of their faculty development programs by means of telephone interviews, which revealed a wide range of programs, independent of rank and series. In all instances, little to no evaluation of the programs’ effectiveness had taken place. In light of this finding, the committee concluded that a critical review of the literature regarding faculty development was needed and that the review should include faculty-development programs in other healthcare professional schools, including dentistry, medicine, and nursing. Benchmarking programs in other healthcare professional schools were expected to provide valuable information applicable to the development of such programs in colleges and schools of pharmacy.

The specific goals of this review were to: (1) critically assess published programs for faculty development in colleges and schools of pharmacy and other healthcare professions; (2) characterize the most commonly used faculty-development programs and their associated outcomes; and (3) recommend next steps to improve faculty development in colleges and schools of pharmacy.


METHODS Previous sectionNext section

All peer-reviewed literature assessing the scope and outcomes associated with faculty development in healthcare professions were evaluated. Faculty development was defined as programs and activities designed to improve faculty performance in all academic roles, including teaching, research, leadership, and clinical practice.1,2 The methodology for this review included a PubMed search, review of pharmacy education journals, including the American Journal of Pharmaceutical Education (AJPE) and the International Journal of Pharmacy Education, and identification of white papers and position papers from all major healthcare professional academic organizations. We conducted a systematic search of Medline, Cumulative Index to Nursing and Allied Health Literature, Education Resources Information Center, and LexisNexus Academic from inception through August 2010 to identify organization white papers. White papers, guidelines, and position statements regarding faculty development within medical and allied health education were retrieved. A manual search also was conducted at specific academic medicine and allied health associations, including Association of American Medical Colleges (AAMC), National Association of Nurse Practitioner Faculties (NONPF), National League of Nursing (NLN), American Association of Colleges of Nursing (AACN), American Dental Education Association (ADEA), American Academy of Pediatrics (AAP), American Physical Therapy Association (APTA), and American Occupational Therapy Association (AOTA). The search included all relevant publications through September 2010.


RESULTS Previous sectionNext section
Position Papers of Health Care Professions Academic OrganizationsIn its recent position statement entitled, “Clinical Faculty Development,” the American College of Clinical Pharmacy acknowledged the unique requirements and needs of individual institutions3and delineated the need for institutional commitment and identification of necessary components, such as a comprehensive orientation program, mentoring, a sustained faculty-development program, a teaching-abilities development program, and an assessment component to demonstrate program effectiveness. The AACP supports faculty development through its various programs, including the Women Faculty Special Interest Group and the New Pharmacy Faculty Research Awards Program. As described later in the review, development of the clinical scientist has been addressed by both the AACP and ACCP.Professional organizations for medical education, nursing, dentistry, pediatrics, physical therapy, and occupational therapy were researched for position papers or statements regarding junior and mid-level faculty development within their respective disciplines. While there is considerable literature regarding the importance of medical faculty development and mentoring, the Association of American Medical Colleges has no position papers or statements addressing this issue. Despite the absence of official position statements, the importance of faculty development within this organization is evidenced by its creation of a Web-based quarterly publication on faculty development4 focusing on professional and leadership development. No published information on faculty development from physical therapy and occupational therapy associations was found.

The National League of Nursing published a position paper suggesting that mentoring is the primary means of career development for nursing education faculty members.5 This paper highlighted traditional mentoring relationships as well as peer and co-mentoring. While traditional mentoring relationships may have value, the organization cautions that a large cadre of senior faculty members would be needed to fill these roles and argues that these relationships generally involve an expert imparting wisdom to a junior person, with little to no reciprocal sharing of ideas or expertise. Peer and co-mentoring are encouraged with a goal of establishing 2-way sharing of ideas to foster an improved atmosphere of support and empathy. While strongly encouraging mentoring, the National League of Nursing notes that faculty development programs should involve other components as well. Mid-career mentoring was identified as important to improving the rate of promotion to full professorial rank. A less-formal approach, wherein mid-career mentoring would be directed by the faculty member instead of the mentor, was suggested. Development of mentoring workshops is an important recommendation of the organization and has been an area of emphasis at its annual meetings.

The American Association of Colleges of Nursing has published a white paper regarding faculty shortages and commended faculty development as an important step toward faculty retention.6 In response to this white paper, faculty and leadership development materials and information about opportunities (http://www. aacn.nche.edu/Faculty/) were made available on the association’s Web site. The National Organization of Nurse Practitioner Faculties also has published a white paper on faculty development suggesting that colleges and schools provide faculty development opportunities.7 However, no objective evidence was found that this organization has provided such opportunities within its own discipline.

The American Dental Education Association formed the Commission on Change and Innovation in Dental Education to address the need for faculty development, particularly in light of curricular change. The association also developed the Institute for Teaching and Learning to increase the success for promotion and tenure of new faculty members the American Dental Education Association Leadership Institute to improve leadership among mid-career faculty members; and the Academic Dental Careers Fellowship Program to increase entry of dental students into academia. A series of manuscripts also was commissioned by the Commission on Change and Innovation to address environmental concerns and faculty development. Recommendations included provision of clear expectations for faculty members, rewards for excellence in teaching, development of a mentoring program as the cornerstone of faculty development, and maintenance of an environment that supports and encourages enthusiasm within the faculty.8 While these are not truly position papers or statements, they were commissioned and supported by the association.

Faculty Development ProgramsMost of the published programs intended to enhance professional development of college and school of pharmacy faculty members were not associated with clearly measurable outcomes. The University of Tennessee College of Pharmacy9described an approach in which faculty members assessed and identified their specific development needs in 3 programs: (1) Individual Faculty Development Grant, (2) the Seed Research Grant Program, and (3) Technology Support Program. Outcomes associated with these programs were not described and only the Individual Faculty Development Grant program was still in place.The St. Louis College of Pharmacy implemented a Pharmacy Faculty Academy to foster professional growth of new faculty members in an “outcomes-oriented, frames” based manner.10 Key principles of the academy included reinforcing mission, vision, and core values; continuous quality improvement through periodic, timely assessments; modeling best practices; and fostering organizational commitment. Workshops, simulations, reflections, and organized social interactions were all integral components. According to the authors, the program resulted in more highly engaged and productive faculty members who were more likely to have a long-term professional relationship with the college. Objective measures of success included an increase in the average number of publications per faculty member per year; a greater number of invited national lectures, papers, and posters; and a higher percentage of pharmacy practice faculty members with board certification. The authors did not state which aspects of the program were most likely to be associated with the observed benefit.10

The Massachusetts College of Pharmacy11 developed a sustainable formal faculty-mentoring program, including a mentorship committee, faculty mentoring guidelines, orientation, seminars/workshops, and protégé/mentor pairs with regularly scheduled meetings between each protégé and mentor. Self-perceived abilities of both protégés and mentors increased in most areas reviewed, but objective measurable improvement in faculty development was not assessed.

Attitudes and experiences of pharmacy educators toward faculty development programs have been evaluated.12 While many faculty members reported participating in informal faculty development programs, few reported completing formal programs. Many respondents considered the mentoring received in their first academic position to be inadequate. Faculty members pursuing scholarship argued they had insufficient time to devote to research and “an inability to identify a research question and how to answer it.”13

Faculty Development for Tenure-Track Faculty.Many initiatives have been used in both academic medicine and pharmacy to enhance faculty performance for tenure-track research-based faculty members. Mentoring programs, research-development coursework, and start-up funding are commonly used approaches. Some universities offer professional development funds that can be used to attend conferences, pay membership dues, and cover other professional expenses. Provision of protected time for research and financial incentives, eg, the National Institutes of Health (NIH) Loan Repayment Program (http://www.lrp.nih.gov), are commonly used to improve the research productivity of tenure-track junior faculty members. Similarly, new faculty members also can request protected time for the conceptualization, creation, and preparation of new courses or course materials. Short- and long-term sabbaticals allow learning of new techniques in research and teaching as well as exposure to other national and international schools. Relatively few of these approaches to increasing research output and, thus, faculty development have been systematically evaluated to determine whether they are successful.
Faculty Development for the Clinical Scientist.Two AACP task forces have defined the optimal training/skill development program for clinical scientists.14,15 The first task force recommended that doctor of pharmacy students possess a strong foundation in basic sciences and be introduced to basic research principles.14This task force also suggested that clinical scientist training include either a doctorate degree in health professions followed by a doctor of philosophy or a dual clinical doctorate/doctor of philosophy program. The report emphasized the importance of continued clinical skill development in the patient-care setting. One of the suggestions emerging from this task force was that academic pharmacy be involved in the establishment of primary care practice-based research networks in community pharmacies to increase collaboration with health providers in the community.While the first task force was focused primarily on training clinical scientists to conduct bench-to-bedside research (T1), the other explored academic pharmacy and research as a means of preparing the next generation of pharmacist scientists to conduct bedside-to-patient care research (T2).15 The task force recommended strong interdisciplinary research teams to enhance research competitiveness. It also encouraged junior clinical faculty members to enter research-training programs (NIH K awards and similar programs) early in their academic careers, and all pharmacy-practice faculty members to be involved in T2 research as either co-investigators or as part of a practice-based research network.15 Another suggestion was that AACP and colleges and schools of pharmacy promote faculty development pathways to enable/empower faculty members to participate in practice-based translational research, including practice-based research networks.

The ACCP Research Affairs Committee authored a white paper on the State of Science and Research in Clinical Pharmacy.16 This manuscript compared different funding streams and training options, competencies to be achieved, and gaps between the current and project status of clinical scientists in the profession of pharmacy. Because lack of mentorship was identified as a key barrier for junior investigators; enhanced mentoring programs and multidisciplinary collaboration with successful research programs were recommended as strategies for developing successful pharmacy researchers.

The ACCP charged the Research Affairs Committee to recommend optimal pathway(s) for preparing doctor of pharmacy graduates to become competitive clinical and translational scientists.17 Similar to suggestions by other organizations, the committee recommended research-focused postgraduate education, including clinical training (ie, degree-granting fellowships or doctor of philosophy plus residency training), and the NIH as funding sources for junior investigators. This article did not address faculty development for clinical science faculty members.

An NIH-sponsored special conference entitled “PharmD Pathways to Biomedical Research”18 highlighted the importance of exposure to clinical and research training in the doctor of pharmacy and postdoctoral curricula and recommended that doctor of pharmacy graduates complete either a doctor of philosophy degree or a postdoctoral fellowship to prepare for a research career. It also described mechanisms to increase funding opportunities (eg, Clinical and Translational Science Awards, NIH K awards) for research-focused faculty members in the early stage of their careers. Research training was recommended for all pharmacy students, and postdoctoral training, including a doctor of philosophy degree and/or a research-intensive fellowship, was suggested for those interested in research careers. Recommended approaches for developing skills in pharmacist-scientists included mentoring of junior investigators and collaboration between practice- and research-based faculty members. The report did not describe career development programs or expected outcomes.18

Recommendations of the Association of American Medical Colleges Task Force on Clinical Research were similar to those of AACP task forces and included research education in medical school and residency training, followed by attainment of an advanced degree, mentorship, and postdoctoral training.19 The task force also recommended that new junior faculty members receive start-up funds, protected time for research, appropriate resources and infrastructure, and individually focused mentoring. Similar to the AACP’s recommendations, the task force supported collaboration with community-based providers, including the development of practice-based research networks.

A career development program for physician clinical scientist faculty at the University of Toronto includes research faculty, such as clinician-investigators and clinician-scientists, as well as faculty members focused on clinical practice and teaching.20 Program participants demonstrated increased academic rank and improvement in all areas of achievement including research.

A description of the career-development needs of pulmonary and critical care medicine fellows centered on the need for financial support for junior investigators.21 A survey of junior faculty members and physician fellows in pulmonary/critical care medicine and critical care medicine in the United States and Canada demonstrated a desire for formal assistance in career development, mentoring, and a more formal curriculum.22

A description of best practices and innovations in colleges of dentistry highlighted the need to create attainable promotion goals, suggested embracing a broader definition of scholarship, and recommended opportunities for multiple parallel-track career pathways.23 It also recommended creation of appropriate resources as well as mentoring and development of mission statements reflecting dentistry as a scientific and academic profession. It did not describe a specific career development program or focus specifically upon clinical scientists.

Faculty Development for Non-Research (Teaching/Patient Care-Centered) Faculty.While there are no college or school of pharmacy publications related to this topic, literature from medicine and nursing outlines the challenges for clinical faculty members. Unlike the relatively well-known promotion requirements for tenure-track faculty members, little has been published on faculty members focused on teaching and patient care rather than research. This paper elaborates on this important faculty group. Requirements for academic promotion in academia often focus on scholarly activity. However, scholarship is a particular challenge for clinical faculty members with substantial practice and/or teaching commitments, which limit the time that can be allocated for scholarly activity. One medical school study concluded that the odds of holding a higher academic rank were 85% lower for clinical faculty members and 69% lower for teaching faculty compared with research faculty members.24 One study documented that clinical educator faculty members are promoted at a slower rate than are their research faculty counterparts (42% versus 62%, respectively, at 6 years,).25Clinical educators must stay current with knowledge in their respective disciplines, further decreasing the available time needed for scholarly work.26 These faculty members additionally devote substantial time to university and public service. While the quality and quantity of these activities might be high, they may not carry as much weight in promotion decisions as, for example, peer-reviewed publications.26 The nursing literature provides guidelines for these faculty members incorporating quality (ie, expertise as a clinician), governance (ie, ownership of practice), leadership (ie, mentoring and development of standards of practice), and knowledge development (research).27

Some academic medical centers have proposed separate promotion criteria for clinical and research faculty members. Fleming and colleagues suggested incorporating the documentation of teaching, mentoring and supervision, educational administration and service, and scholarship of teaching into the promotion requirements for clinical educators.28 The University of California uses a 5-track system that differentiates medical research faculty members from clinical faculty members.29 The tracks vary with respect to salary sources, tenure eligibility, expectations for clinical service, and membership in the faculty senate. As the faculty member progresses toward promotion, regular merit reviews are conducted for each track. The “salaried clinical” track requires faculty members to participate in teaching and clinical research but does not include a publication requirement. While not explicitly detailed, improved success in the promotion of clinical faculty members was observed using this system.

Faculty development aimed at clinical educators is described in the medical literature.30 Clinical educators must advance their expertise as an educator first, a step that is often overlooked in development programs for clinicians. While formal education or institutional-based faculty-development courses are commonly used mechanisms, peer-review of teaching, publications, and presentations also promote educational skills in clinical faculty members. Mentoring is a key component of faculty development, particularly when the mentor is selected by the individual faculty member rather than being “assigned” by the department chair.31

The Alliance for Academic Internal Medicine recently published a report on development and training for clinical educators.32 The group found that 48% of North American medical schools had medical educational fellowship programs in 2008.33 Programs were considered successful as evidenced by increased numbers of peer-reviewed publications and greater motivation and enthusiasm for teaching.33 The report described a hierarchy of clinical educators, based on the specialization of training in teaching, ranging from clinician-educator to master teacher. The roles of these educators included direct teaching and supervising, role modeling, evaluating, mentoring and advising, and educational leadership and administration.32 To accomplish adequate training of the clinician educator and master teacher, the authors recommended that faculty development be aimed at developing skills in each of the following areas: teaching, networking, mentoring, educational leadership and administration, adult learning theory, curriculum design and evaluation, educational research and scholarship, and career advancement.33 The report stressed the importance of a mentoring program extending beyond research to ensure adequate training of clinician-educators and the success of these programs.

Faculty Development for Women Faculty.Across 1,445 US institutions, including doctoral universities, master’s institutions, baccalaureate colleges, and 2-year colleges, women hold only 31% of tenured positions and 24% of full professorships.34 In medicine, women comprise 19% of tenured faculty members, 17% of full professors, and 12% of medical school department chairs.35According to the AACP’s 2008-2009 profile of pharmacy faculty members, women represent 44% of full-time faculty members, primarily at the assistant-professor rank (54%). Although tenure status was included in the report, it was not broken down by gender.The current search failed to yield results specific to the advancement of women among pharmacy faculty members. The nursing literature included articles pertaining to female faculty members; however, they were descriptive in nature. Most information pertaining to faculty advancement of women originates from medicine and centers more on leadership rather than faculty development.

Formal leadership programs designed for women include those from the Association of American Medical Colleges and the Institute for Women’s Health and Leadership at Drexel University College of Medicine.36,37 To address the shortage of women leaders, the association offers professional development seminars for junior and senior women faculty members.36 These seminars stimulate growth in support and information networks for women and assist in the development of skills, such as negotiating for resources, managing finances, self-promotion, building informal networks, writing for professional journals, procuring grants, building research programs, conflict and time management, and balancing career and family, among others. Longitudinal studies of the effectiveness of these seminars, however, are lacking.

The Executive Leadership in Academic Medicine is a core program of the Institute for Women’s Health and Leadership at Drexel University College of Medicine. It provides executive leadership skill development for women faculty members at the associate or full professor rank at schools of medicine, dentistry, and public health (www.drexelmed.edu/ELAM). Participants meet for three 1-week residential sessions and complete individual and group assignments throughout the program year. Leadership accomplishments (attainment of administrative leadership positions and the rank of full professor) of women who participated in the program were compared with those of women who did not participate.38 Nearly two-thirds (63.5%) of participants in the leadership program reported holding an administrative title of chair or greater compared with only 24.6% of nonparticipants. Although program fellows reported an increase in attaining the rank of full professor from 26 (44.8%) to 37 (69.8%), it was not significantly different from the rate for nonparticipants.38

The effect of participating in the Executive Leadership in Academic Medicine program was assessed in a survey of US and Canadian medical school deans regarding their perceptions of organizational climate and the impact of the program on women advancing into leadership roles.39 A 7-point Likert scale (ie, 1 = strongly disagree, 7 = strongly agree) was used to record the dean’s perceptions of the ability of program fellows to be promoted. Individual means exceeded 5.5/7.0 for perceived advancement for informal (eg, chair of leadership committee or task force) and formal (eg, position in the dean’s office or department chair) leadership positions.39

Fried and colleagues evaluated multiple interventions to overcome career obstacles for women.40 The article identified gender-related career obstacles, interventions implemented to correct obstacles, and the results of the first 5 years of the interventions. Primary outcome measures included promotion rates, career experiences, and identification of gender-related career obstacles for women. Interventions targeted leadership, gender discrimination education, isolation, faculty-member development and mentoring, academic rewards, institutional obstacles, and evaluation. Faculty members reported positive changes in many of the areas targeted for intervention. The proportion of women at the associate professor rank increased from 9% to 41% after 5 years. Although multiple interventions were used, the significant increase in female faculty member promotions was attributed primarily to promotion-committee monitoring of career progress, improved mentoring, and institution of a career development program.

Mentoring is frequently cited as a model to facilitate the advancement of women. A small pilot program used a “facilitated mentoring model” to address the unique needs of women.41 This model involved senior women faculty members serving as mentors to a group of younger women who, in turn, acted as peer mentors to each another. The pilot program was divided into 3 phases: skills acquisition and enhancement, skills application, and group research project development. The applicable outcome measures included published papers and promotions. Three of the 4 mentees coauthored 3 peer-reviewed manuscripts, and each achieved promotion in academic rank from instructor to assistant professor.

Faculty Development of Underrepresented Minorities.The Health Resources and Services Administration defines underrepresented minorities as African and Hispanic Americans, Native Americans, Alaskans, Pacific Islanders (Hawaiians and others), and certain Asians (Hmong, Vietnamese, and Cambodians). Although other faculty development programs have been described in the pharmacy literature, none has focused specifically on the development of URMs. However, the academic medicine literature has examples of such programs.Butts and colleagues reported on a consortium of 4 medical schools that formed centers of excellence for recruitment and development of minority faculty members.42 Albert Einstein School of Medicine created four 1- to 2-year fellowship opportunities for underrepresented minorities. The focus varied from a developmental disabilities fellowship to successful recruitment and training of underrepresented minority faculty members. Notably, a master’s degree in clinical research originated from this effort. The University of Pennsylvania School of Medicine developed a center for excellence on minority health for mentoring of underrepresented minority faculty members.43 The development program focused on the following: (1) career development meetings in which senior faculty members provided advice regarding resources, mentors and mentoring, publishing, teaching activities, and committee memberships; (2) assistance in identifying mentors to provide general assistance regarding external funding requests and manuscript preparation; and (3) assistance in developing research, scientific writing, and medical presentation skills. Although program outcomes were not reported, the authors theorized that it would be beneficial to have a senior underrepresented minority faculty program director and that senior administration should fully support the program. The authors considered it essential to have both clinical as well as tenure-track programs to address the needs of both tenure-track and nontenure-track series for various minority groups. Funding was identified as a significant barrier, and the authors concluded the mentoring process was difficult to fully formalize.

The University of California, San Diego School of Medicine collaborated with the Hispanic Center of Excellence to establish the National Center for Leadership in Academic Medicine housed under the Office of Academic Affairs of the Vice Chancellor for Health Sciences.44 The center designed a formal faculty-development program geared to increasing faculty retention and success. The program was open for campus-wide enrollment to underrepresented minority and non-underrepresented minority faculty. Faculty members were required to attend the following: (1) 12 half-day workshops focused on goal setting, preparation of a faculty portfolio, principles of teaching and learning, leadership styles, negotiation skills, stress management, internal academic resources, internal grant resources, grant writing, conflict resolution, curriculum development, performance evaluation, and presentation skills; (2) a structured 7-month one-to-one mentoring program averaging 12 contact hours per month; (3) a 2-hour academic performance counseling session; and (4) a professional development project. While some pharmacy faculty members participated in this project, it was not possible to identify the impact of the program on underrepresented minority faculty. The percentage of underrepresented minority faculty members remaining in academic medicine increased from 75% to 90%; however, this increase was similar to that observed among center participants who were not underrepresented minorities.

Atlanta’s Morehouse University implemented a formalized faculty development program.45,46 The core structure included a weekly longitudinal program, which was further divided annually into one to two 6-week modules. During the tenth year, an Executive Faculty Development Program was developed and several 4-day intensive sessions provided. The program was staffed by 5 faculty members and 2 support personnel. The courses emphasized 6 areas: teaching, audiovisual skills, research/writing, cultural competency, computer skills, and administrative skills. Over a 10-year period, 120 faculty members enrolled and 113 completed the year-long program. An additional 128 individuals attended 1-day workshops or completed at least 1 module. A postparticipation survey found that 81% of program graduates were full-time or part-time teachers. Faculty members reported a perceived enhanced competence after participation. Major perceived program strengths included small group size, individualized instruction, interactive format, and integration of theory into practice. Suggestions for improvement included: increased opportunities to work on individual projects during the sessions, more discussion of crosscultural issues, increased prerequisite reading, specified blocks of time to focus on writing skills, and provision of handouts. Despite the success of this program, the authors concluded that formal mentoring programs and dedicated research time were still needed and thus recommended advanced programs to develop the skills of senior faculty members.

Faculty Development of Volunteer/Adjunct Faculty.Despite substantial reliance on volunteer/adjunct faculty in colleges and schools of pharmacy,little has been published regarding faculty development in this important group. Our search revealed no publications addressing the advancement of volunteer or adjunct faculty members. Most published manuscripts have investigated incentives and rewards for recruitment and retention of volunteer faculty members, while others have focused on the challenges of mentoring adjunct faculty members. The majority of the articles were from medical schools, a few from nursing schools, and none from colleges or schools of pharmacy. Considering the total lack of publications regarding faculty development of volunteer/adjunct faculty members, we have expanded the current review to assess incentives and rewards for these individuals.Kumar and colleagues examined incentives and rewards offered to nonsalaried clinical faculty teaching medical students in the United States and Canada.47 Over 90% of these faculty members were offered academic appointments. Common incentives included educational opportunities, special recognition events, and appreciation letters, among others. The same investigators subsequently surveyed US volunteer faculty members to determine which incentives were most highly valued by the faculty members.48 Educational opportunities and reimbursement for travel and meeting registration were most commonly cited. Personal satisfaction was the most commonly cited reason for those deciding to participate in volunteer teaching. Kalis and Kirshenbaum49 examined faculty awards at US colleges and schools of pharmacy and reported that 79% provided a teaching-excellence award for adjunct faculty members or preceptors. In their review of the use of adjunct faculty in gerontology programs, Parrott and colleagues50 noted concern among adjunct faculty members regarding the lack of opportunity for professional advancement.

Mentorship programs for volunteer faculty members have been described for medicine and nursing.51,52 Although similar programs are likely available in pharmacy colleges and schools, no publications describing such programs were found.


DISCUSSION Previous sectionNext section

While the peer-reviewed literature offers descriptions of programs intended to enhance faculty development in healthcare professions, relatively little specific to pharmacy has been published. Furthermore, none of the healthcare professions have adequately evaluated the impact of various faculty development programs with associated outcomes, such as promotion and tenure. Although ACPE, AACP, and ACCP offer various white papers and general descriptors of appropriate faculty development programs, there has been no evaluation of the impact of these papers on specific faculty subgroups, including research-based basic science and clinical science faculty members, clinician-teachers, and volunteer faculty members, and additional subgroups, including women and underrepresented minorities. The lack of published information regarding faculty development strongly suggests a lack of evidence-based programs with associated outcomes in colleges and schools of pharmacy. Substantial steps are now required toward the development and scholarly evaluation of faculty development programs in colleges and schools of pharmacy. As these programs are developed and assessed, evaluations must encompass all faculty subgroups, including tenure and nontenure track, volunteer, women, and underrepresented minorities.

Carroll suggests that most faculty members are inherently self-driven learners and thus may be more motivated to participate in programs if the information therein is recognized as “need to know.”53 He argues that the “need to know” factor might be stimulated by student, peer, or administrator evaluation, self-reflection, or observation of others. As adult learners, faculty members should be more motivated to participate when they have the opportunity to direct program content. He suggests that the program design should emphasize adult learning theory that allows attendees to immediately apply the concepts or skills and that workshops and small-group activities are an appropriate format for this program design. Finally, he argues that programs should incorporate various assessment methods.

Our findings suggest that there is minimal assessment associated with faculty-development programs, not only at colleges and schools of pharmacy but at all healthcare professional schools. All faculty development programs should include an evaluation centered on the desired outcomes.2 The first step should be identification of the knowledge, skills, and attitudes that program participants should attain. Subsequently, specific measurable outcomes should be developed, and tools to measure those outcomes should be identified or developed.2

While self-reported outcomes data, such as participant satisfaction or confidence, are easily obtained, it is more challenging to measure higher-level outcomes of a successful faculty development program.2 Validated, reliable evaluation tools should be used in the assessment of faculty development. Kirkpatrick’s model identifies 4 levels to evaluate the effectiveness of an intervention1,2: (1) reaction of participants (satisfaction), (2) learning (knowledge, skills, attitudes), (3) behavioral changes, and (4) results (impact on student, resident, and fellow learners as well as patients and the organization). The optimal evaluation of any faculty development program should assess each of the 4 levels through both quantitative and qualitative measures. Specific approaches include a postprogram evaluation, pre- and post-evaluation, and/or a delayed post-evaluation.1

An important and seldom-observed step is assessing and reporting the reliability and validity of instruments used to evaluate the faculty-development program.2 Academic pharmacy organizations, specifically the AACP, should develop standardized, valid, and reliable instruments to allow for benchmarking and should provide to those charged with faculty development the tools necessary for assessing their programs. Academic pharmacy should look beyond the healthcare professions for successful approaches to faculty development. Many of the programs and methodologies used in the business world to develop productive members of the workforce have potential application to healthcare fields.

We propose applying the concept of shared responsibility to a faculty development plan. Such a plan would mandate a commitment between the administration and faculty members of a college of a college or school of pharmacy to design, implement, monitor, and assess a faculty development plan that would affect specific outcomes for individual faculty members. This model should involve all major transition periods during an academic career, including the initial appointment, promotion to associate and full professor (with or without tenure), the addition of substantial administrative duties, and retirement.

In such a model, in collaboration with college/school administration, the faculty member would identify areas for development through a cafeteria of items, such as teaching (eg, large lecture, small-group discussion) and research (eg, grant writing, manuscript creation). Subsequently, administration would identify and engage one or more individuals from its campus, the university as a whole, and/or within academic pharmacy, to mentor and guide the faculty member. The faculty member and the administration would work on a “matching” process based on the availability of mentors for the faculty member’s specific needs. Depending on the transition point (eg, appointment or promotion), the areas of development and mentor team should be adaptable. The performance of the faculty member and the administration in faculty development would be reviewed annually and, if continued, new goals for the upcoming academic year would be established based on the current annual review. The department/division chair/head, associate dean for academic affairs, and other administrators would have significant responsibilities in this arrangement. Incoming faculty members would be responsible for orienting and directing new faculty members toward available resources to facilitate their ability to meet their academic responsibilities. All faculty members would participate in an orientation individualized according to member status (eg, tenure vs. nontenure track). Campus programs specific to faculty subgroups, including women and underrepresented minorities, would be an integral component of this orientation. Similarly, administrators would be responsible for coordinating a similar process at other important transition points. Schools would need to assess the success of their programs and the performance of individual faculty members through specific outcomes, including but not limited to the number of faculty members achieving promotion and/or tenure.

At the national level, AACP would have substantial responsibilities. For instance, AACP could endorse the concept of a faculty development program and work with ACPE, ACCP, and other pharmacy professional organizations to finalize the definition and concept. AACP could develop a “best practice model” that could be used as a template toward the creation of the optimal faculty development program. Considering the current lack of scholarship associated with faculty development, AACP could develop longitudinal assessment instruments which measure overall satisfaction with existing faculty development programs from an individual and department head perspective. AACP should assume key leadership in the design of multiple outcome-based studies that would identify faculty development programs most likely to ensure success in tenure and promotion.

A final recommendation is the implementation of a “faculty development” section in the Journal that would highlight research accomplished by individual faculty members and colleges and schools, as well as AACP initiatives. Although implementing a faculty-development section in the Journal would require some planning, it would eventually encourage much-needed scholarship in this important domain.

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