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Regulatory Guidelines

 

ACCME Standards for Commercial Support

 

Initially developed in 1992, the ACCME Standards has established a framework for ensuring that CME developed with financial grant support from commercial interests is delivered without bias. Updates to the Criteria in 2006, provide us with rules for evaluating and certifying medical education activities. In addition to the Standards, the ACCME produces guidelines and policies with which accredited providers must comply.

 

ACCME Standards for Commercial Support

 

PhRMA Code on Interactions with Healthcare Professionals

 

The Pharmaceutical Research and Manufacturers Association (PhRMA) developed a voluntary code of ethics that provides pharmaceutical and biotech employees with guidelines for interacting with healthcare providers.

 

PhRMA Code on Interactions with Healthcare Professionals

 

FDA Final Guidance on Industry-Supported Scientific and Educational Activities

 

In 1997, the FDA released a guidance document that distinguished the differences and separation of two distinct those activities managed by pharmaceutical and biotech companies and CME and other activities, supported by companies, that are otherwise independent from the promotional influence of the supporting company.

 

FDA Final Guidance on Industry-Supported Scientific and Educational Activities

 

California Assembly Bill 1195 - Cultural and Linguistic Competency

 

Activity on this website with patient care components are in compliance with California Assembly Bill 1195 which requires CME activities with patient care components to include curriculum in the subjects of cultural and linguistic competency. Cultural competency is defined as a set of integrated attitudes, knowledge, and skills that enables health care professionals or organizations to care effectively for patients from diverse cultures, groups, and communities. Linguistic competency is defined as the ability of a physician or surgeon to provide patients who do not speak English or who have limited ability to speak English, direct communication in the patient’s primary language. Cultural and linguistic competency was incorporated into the planning of this activity. Additional resources on cultural and linguistic competency and information about AB1195 can be found below:

 

Resources

 

1. Kaiser Permanente National Diversity Department
http://kphci.org/resources/links.html 

2. Institute for Medical Quality
www.imq.org

3. On-line dictionary providing translations into 25 different languages
http://www.ectaco.com/English-Multilanguage-Dictionary/

4. Foreign Language Assessment Guide (F.L.A.G.), Produced by Medi-Flag Corporation
www.medi-flag.com

 

Hospital Care

1. National Association of Public Hospitals and Health Systems. “Serving Diverse Communities in Safety Net Hospitals and Health Systems,” The Safety Net 2003; 17(3): Fall.
http://www.naph.org/Template.cfm?Section=The_Safety_Net_Archive&template=/
ContentManagement/ContentDisplay.cfm&ContentID=3407  

2. Andrulis DP. “Study of How Urban Hospitals Address Sociocultural Barriers to Health Care Access”:
http://www.rwjf.org/portfolios/resources/grantsreport.jsp?filename=023299s.htm&iaid=133 

 

Ambulatory Care

1. National Center for Cultural Competence, Georgetown University. “Self-Assessment Checklist for Personnel Providing Primary Health Care Services”
http://gucchd.georgetown.edu/nccc/documents/Checklist%20PHC.pdf

2. National Initiative for Children’s Healthcare Quality (NICHQ), Improving Cultural Competency in Children’s Health Care: Expanding Perspectives
http://www.nichq.org/NR/rdonlyres/5B534B7B-0C38-4ACD-8996-EBB0C4CB2245/0/NICHQ_CulturalCompetencyFINAL.pdf

 

Caring for Individuals with Limited English Proficiency

1. National Council on Interpreting in Health Care
http://www.ncihc.org

2. Hablamos Juntos: Improving Patient-Provider Communication for Latinos
http://www.hablamosjuntos.org

3. Process of Inquiry: Communicating in a Multicultural Environment, Georgetown University National Center for Cultural Competence
http://www.nccccurricula.info/

4. Cross-Cultural Communication in Health Care: Building Organizational Capacity
http://www.hrsa.gov/reimbursement/broadcast/default.htm

 

Health Literacy

1. AMA/AMA Foundation’s Health Literacy toolkits, videos, partnerships
http://www.ama-assn.org/ama/pub/category/8115.html

2. Weiss BD. Health Literacy: A Manual for Clinicians Chicago: American
Medical Association Foundation, 2003

3. Schwartzberg, JG, VanGeest JB, Wang CC: Understanding Health Literacy:
Implications for Medicine and Public Health. Chicago, IL: American Medical
Association Pres., 2004

 

Movies, Videos, and CD-ROM Resources

1. Alexander M. Cinemeducation: An Innovative Approach to Teaching Multi-Cultural Diversity in Medicine. Annals of Behavioral Science and Medical Education 1995; 2(1):23-28.

2. Communicating Effectively Through an Interpreter (1998) (Available from the Cross Cultural Health Care Program, 270 South Hanford Street, Suite 100, Seattle, Washington 98134; Phone (206)-860-0329; Website www.xculture.org).

3. The Bilingual Medical Interview I (1987) and The Bilingual Medical Interview II: The Geriatric Interview, Section of General Internal Medicine, Boston City Hospital, in collaboration with the Department of Interpreter Services and the Boston Area Health Education Center (Available from the BAHEC, 818 Harrison Ave., Boston, MA 02118; Phone (617) 534-5258).

4. The Kaiser Permanente/California Endowment Clinical Cultural Competency Video Series. In 2000, Kaiser Permanente, with funding from The California Endowment, embarked on a project to create "trigger" videos as teaching tools for training healthcare professionals in cultural competence. These now completed videos comprise three sets, each with accompanying facilitator's guide and contextual materials. Each set costs $35.00 or $105 for all 20. The scenarios are from eight to fourteen minutes long.

5. Quality Care for Diverse Populations. Video/CD-ROM/Facilitator's Guide,
Contributors: K. Bullock, L.G. Epstein, E.L. Lewis, R.C. Like, J.E. South Paul, C. Stroebel, et al) This educational program includes five video vignettes depicting simulated physician-patient visits in an office setting as a means to explore ethnic and sociocultural issues found in today's diverse health care environment. Produced by the American Academy of Family Physicians (AAFP), with partial funding by the Bureau of Primary Health Care, Health Resources and Services Administration, June 2002. (Available from the American Academy of Family Physicians, AAFP Order Dept., 11400 Tomahawk Creek Parkway, Leawood, KS 66211; Phone (800) 944-0000; Fax (913) 906-6075; http://www.aafp.org/x13887.xml).

6. Community Voices: Exploring Cross-Cultural Care Through Cancer. Video and Facilitator's Guide by Jennie Greene, MS & Kim Newell, MD (Available from the Harvard Center for Cancer Prevention, Harvard School of Public Health, 665 Huntington Avenue, Bldg 2, Rm 105, Boston, MA 02115; Phone (617) 432-0038; Fax: (617)-432-1722; hccp@hsph.harvard.edu , or Fanlight Productions, www.fanlight.com).

7. Worlds Apart. A Four-Part Series on Cross-Cultural Healthcare. By Maren Grainger-Monsen, MD, and Julia Haslett, Stanford University, Center for Biomedical Ethics (available from Fanlight Productions, www.fanlight.com)

8. The Angry Heart: The Impact of Racism on Heart Disease Among African-Americans, Jay Fedigan. (Available from Fanlight Productions, www.fanlight.com).

9. The Culture of Emotions: A Cultural Competence and Diversity Training Program . Harriet Koskoff, Producer/Co-Coordinator, 415 Noe Street, #5, San Francisco , CA 94114 ; Phone 415-864-0927; Fax 415-621-8969 (Available from Fanlight Productions, www.fanlight.com).

10. Ohio Department of Health and Medical College of Ohio. Cultural Competence in Breast Cancer Care (CD-ROM), 2000.

 

Recent Articles and References on Cultural and Linguistic Competency

1. Brach C, Fraser I, and Paez K. “Crossing the Language Chasm,” Health Affairs 2005 (March); 24(2):424-434.

2. Betancourt, J.R., Green, A.R., Carillo, J.E. et al. (2005). Cultural competency and health care disparities: Key perspectives and trends. Health Affairs, 24(2), 499-505.

3. Brach, C., Fraser, I., Paez, K. (2005). Crossing the language chasm: An in-depth analysis of what language-assistance programs look like in practice. Health Affairs, 24(2), 424-434.

4. Betancourt J.R., Green A.R., Carrillo J.E., et al. (2003). Defining cultural competence:
A practical framework for addressing racial/ethnic disparities in health and health care.
Public Health Reports, 118(4), 293-302.

5. AB 801 Assembly Bill – Chaptered. Official California Legislative Information website.
 http://www.leginfo.ca.gov/pub/03-04/bill/asm/ab_0801-0850/ab_801_bill_20030925_chaptered.html (cited 7 Nov. 2005).

6. AB 1195 Assembly Bill – Chaptered. Official California Legislative Information website.
http://www.leginfo.ca.gov/pub/bill/asm/ab_1151-1200/ab_1195_bill_20051004_chaptered.html (cited 7 Nov. 2005).

7. Youdelman M, Perkins J. “Providing Language Interpretation Services in Health Care Setting: Examples from the Field,” National Health Law Program, May 2002

8. Youdelman M, Perkins J. “Providing Language Services in Small Health Care Provider Settings” Examples from the Field,” National Health Law Program, April 2005

 

 

OIG Compliance Program Guidance for Pharmaceutical Manufacturers and Exclusion List

 

The federal Office of Inspector General (OIG) of the Department of Health and Human Services issued a 2003 document requiring pharmaceutical organizations to fully separate their sales and promotional activities from their education activities. Certified CME is a subset of the educational activities addressed in the guidance, but the OIG clearly states that these activities should be “independent from promotional influence.”

 

OIG Compliance Program Guidance for Pharmaceutical Manufacturers

 



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