Connie L. Barnes, Pharm.D.

SESSIONS:

Full time (minimum 8 hours per day) Monday through Friday for four weeks (160 hours total).

CREDITS:

Four credits.

TEXTBOOK:

None.

REQUIRED OR SUGGESTED READING:

I. Introduction to Drug Information Service Centers

• Chapter 31: Drug Information Services. In: The Handbook of Institutional Pharmacy Practice.
• Dombrowski SR, Visconti JA. National audit of drug information centers. Am J Hosp Pharm 1985;42:819-26.
• Beaird SL, Coley RM, Crea KA. Current status of drug information centers. Am J Hosp Pharm 1992;49:103-6.
• Gong SD, Millares M, VanRiper KB. Drug information pharmacists at health-care facilities, universities and pharmaceutical companies. Am J Hosp Pharm 1992;49:1121-30.
• Hull BL. Managing a drug information center. Hosp Pharm Times 1992;Oct.:4-11.
• Parker PF. The University of Kentucky Drug Information Center. AJHP 1965;22;42-47.
• Anon. Drug Information Service Centers. AJHP 1965;22:3.
• Hutchinson R and Burkholder DF. Clinical Pharmacy Practice- its functional relationship to drug information service. Drug Intell Clin Pharmacy 1971;5:181-185.
• Troutman WG, Wanke LA. Advantages and Disadvantages of Combining Poison Control and Drug Information Centers. AJHP 1983;40:1219-1221.

• Chapter 29: The Literature of Pharmacy. In: The Handbook of Institutional Pharmacy Practice.
• Chapter 30: Literature Evaluation. In: The Handbook of Institutional Pharmacy Practice.
• Cuddy PG, Elenbaas RM, Elenbaas JK. Evaluating the medical literature. Part I: Abstract, introduction, methods. Ann Emerg Med 1983;12:549-555.
• Elenbaas RM, Elenbaas JK, Cuddy PG. Evaluating the medical literature. Part II: Statistical analysis. Ann Emerg Med 1983;12:610-620.
• Elenbaas JK, Cuddy PG, Elenbaas RM. Evaluating the medical literature. Part III: Results and Discussion. Ann Emerg Med 1983;12:679-86.
• Hartzema AG. Guide to interpreting and evaluating the pharmacoepidemiologic literature. Ann Pharmacother 1992;26:96-97.
• Porta MS, Hartzema AG. The contribution of epidemiology to the study of drugs. Drug Intell Clin Pharm 1987;21:741-7.
• International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals. N Eng J Med 1991;324:424-8.
• Anon. Instructions for preparing structured abstracts. JAMA 1991;266:42-44.

• Chapter 8: Drug Use Management. In: The Handbook of Institutional Pharmacy Practice.
• Commentaries: Rethinking the formulary system concept. Am J Hosp Pharm 1986;43:2829-42.
• American College of Physicians. Therapeutic substitution and formulary systems. Ann Intern Med 1990;113:160-3.
• ASHP. ASHP guidelines on formulary system management. Am J Hosp Pharm 1992; 49:648-52.
• American College of Clinical Pharmacy. Guidelines for therapeutic interchange. Pharmacotherapy 1993;13:252-56.
• Chapter 26: Adverse Drug Reactions. In: The Handbook of Institutional Pharmacy Practice.
• Tyler LS, Nickman NA. Hospital pharmacy compliance with JCAHO standards and ASHP guidelines for reporting adverse drug reactions. Am J Hosp Pharm 1992;49:845-50.
• ASHP. ASHP guidelines on adverse drug reaction monitoring and reporting. Am J Hosp Pharm 1989;46:336-7.
• Lesar TS, Briceland LL, Delcoure K, et.al. Medication prescribing errors in a teaching hospital. JAMA 1990;263:2329-34.
• Martucci HJ. Different approach to the formulary needed. AJHP 1987;44:1026.
• ASHP statement on the formulary system. AM J Hosp Pharm 1983;40:1384-5.
• ASHP technical assistance bulletin on the scientific and therapeutic evaluation of drugs for hospital formularies. - Weintraub M. Evolving concerns of the Pharmacy and Therapeutics Committee. Hospital Formulary 1980;29-31
• Zellmer WA. Rethinking the formulary system concept. AJHP 1986;43:2829. - Bell JE. Mission, role and functions of the P&T Committee. Hosp Form 1983;639-646.
• Abramowitz PW and Fletcher CV. Counterpoint: Let's expand the formulary system and renew its vigor. AJHP 1986;43:2834-8.
• Anon. The formulary system: brief history and 1960's perspective. AJHP 1986;43:2838-9.
• Anon. What liability coverage is suggested for P&T committee and dissenters? Drug Utilization Review 1985;14
• ASHP Technical Assistance Bulletin on the Evaluation of Drug for Formularies. Am J Hosp Pharm. 1988;45:386-7.
• ASHP Technical Assistance Bulletin on Hospital Formularies. Am J Hosp Pharm. 1985;42:375-7.
• Chapter 26: Adverse Drug Reactions. In: The Handbook of Institutional Pharmacy Practice.
• ASHP Guidelines on Adverse Drug Reaction Monitoring and Reporting. Am J Hosp Pharm. 1989;46:336-7.
• Sills, JM. Food and Drug Administration monitoring of adverse drug reactions. Am J Hosp Pharm. 1986;43:2764-70.
• FDA MedWatch Form
• ASHP Statement on the Pharmacy and Therapeutics Committee. Am J Hosp Pharm. 1984; 41:1621.
• ASHP Guidelines on the Pharmacist's Role in Drug Use Evaluation. Am J Hosp Pharm. 1988;45:385-6.
• Pierson JF. Physician's attitudes toward drug-use evaluation interventions. Am J Hosp Pharm. 1990;47:388-390
• Donley K. Drug Usage Evaluations: A Medical Staff Responsibility. P&T. 1991:156-61.
• Talley CR. Starting a DUE program that will win medical staff and Joint Commission approval. Am J Hosp Pharm. 1990;47:502-4.
• Grasela TH. Capability of hospital computer systems in performing drug-use evaluations and adverse drug event monitoring. Am J Hosp Pharm. 1993;50:1889-95.
• Chapter 24: Drug Use Evaluation. In: The Handbook of Institutional Pharmacy Practice.

• Chapter 32: Poison Centers. In: The Handbook of Institutional Pharmacy Practice.
• Chapter 23: Investigational Drugs in the Hospital. In: The Handbook of Institutional Pharmacy Practice.
• Chapter 24: Drug Use Evaluation. In: The Handbook of Institutional Pharmacy Practice.
• ASHP. ASHP guidelines on the pharmacist's role in drug use evaluation. Am J Hosp Pharm 1988;45:385-6.
• Myers A, Moore SR. The Drug approval process and the information it provides. Drug Intell Clin Pharm 1987;21:821-6.
• International Committee of Medical Journal Editors. Uniform Requirements for Manuscripts Submitted to Biomedical Journals. JAMA 1993;269(17):2282-2286.
• Fink JL. Liability of the Pharmacist as a therapeutic consultant. AJHP 1981;38:218-222.
• Anon. Jury verdict raises questions about practice standards in poison centers. AJHP 1984;41:1268-9,1272.
• Abood RR. How liability problems apply to pharmacy expanding roles. - Shacknai J. Product Lability: Where the manufacturer stands. US Pharmacist 1987;May:116-7, 120, 129.
• Kelly WN et al. National survey of ethical issues presented to drug information centers. AJHP 1990;47:2245-5
• Harkness R. Beware of the `Expert syndrome' Drug Topics 1987; October 5;18.
• Bergerson SR. More about charting with a jury in mind. Nursing 88; April:516.
• Faust GA. Postmarketing surveillance of prescription drugs: Current status. - Knoben JE. An overview of the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations. AJHP 1990;47:2696-700
• Podell LB. Legal implications of preparing and dispensing approved drugs for unlabeled indications. AJHP 1983;40:111-3.
• Veatch RM. Ethics of drugs for non-approved uses. US Pharmacist 1983;69-72.
• Angorn RA. Standards of Practice: the legal background. US Pharmacist;1989:84-89.

• Frankenfield FM. Computer Hardware and Software. AJHP 1982;39:112-20.
• Perry CA. Online information retrieval in pharmacy and related fields. AJHP 1986;43:1509-24.
• Illsley SS, Sudds TW. Indexing and abstracting services to the primary drug literature. Hosp Form 1982;17:1193-7.
• Lowe HJ, Barnett GO. Understanding and using the medical subject headings (MeSH) vocabulary to perform literature searches. JAMA 1994;271(14):1103-8.
• Stewart GA et al. Pharmacy policy and procedure for processing an order for a nonapproved use of a marketed drug. Hosp Form 1982;708-10.

Students will be evaluated based upon the competencies using the attached Student Evaluation Form.

ASSIGNMENTS:

All assignments and projects must be completed and submitted by the due date. A "0" may result from late submission for that task. To receive a passing grade, all assignments must be completed.

ATTENDANCE POLICY:

Students must complete the 160 hour minimum rotation obligation within the time frame of the rotation or make-up deficiencies within an acceptable time as determined by the preceptor, the Director of Experiential Programs or University policy.

Attendance is mandatory for all scheduled activities (work rounds, attending rounds, preceptor conferences etc.) as directed by the preceptor.

JUSTIFICATION:

Drug therapy information and/or application regarding the proper use of medications has grown in magnitude and sophistication. Appropriate drug information for health professionals and patients provided in an unbiased manner was difficult to obtain until Drug Information Centers (DICs) developed. The provision of "drug information" has always been part of pharmacy service and separate centers have developed throughout the country as a direct result of the need and the expertise available. To better prepare future pharmacists to meet their role as a major source of drug information, it is imperative that each student be properly trained in drug literature retrieval and evaluation.

OVERALL COURSE GOALS:

The student, upon completion of this rotation, should be able to:

1. Demonstrate appropriate and effective use of institutional and extramural library facilities and librarian services.
2. Use appropriate primary, secondary and tertiary reference services in providing answers to information requests.
3. Demonstrate the ability to evaluate current drug information literature and apply the information in a concise, accurate, logical and succinct manner.
4. Communicate effectively with pharmacists, nurses, physicians, patients, and pharmaceutical representatives in solving drug information problems.
5. Obtain appropriate patient, drug, and disease information from an inquirer initiating a patient-oriented drug information request.
6. Write concise, authoritative, grammatically correct, and clinically applicable consultations, drug monographs, and other drug-related manuscripts.
7. Demonstrate an understanding of adverse drug reaction (ADR) reporting including the rationale for ADR reporting, and systems for identifying, evaluating, and reporting ADRs.
8. Demonstrate an understanding of Medication Use Evaluation (MUE) including the rationale behind conducting MUEs, process for establishing MUE criteria, and the process of collecting, analyzing, and conducting follow-up evaluation of MUE data.

The student, upon completion of this rotation should be able to:

1. Apply a systematic approach to drug information retrieval and evaluation to answer questions both in an orderly and timely manner.
2. Use the primary, secondary and tertiary literature appropriately.
3. Format and perform on-line search(s) in an appropriate manner.
4. Develop appropriate responses, both written and oral, that are concise and accurate.
5. Effectively communicate the above noted responses, both orally and in writing.
6. Evaluate the literature appropriately, both clinically and scientifically.
7. Prepare an unbiased drug evaluation.
8. Perform a scholarly effort suitable for publication, e.g., research paper, and/or suitable for implementation in a clinical setting, e.g. a drug use evaluation.
9. Use computer resources appropriately.

The standard CUSP Form Student Evaluation of Preceptor Site must be completed and provided to the preceptor in a sealed envelope in accordance with instructions found in The Campbell University Clerkship Manual. Grades will not be forwarded to the Registrar until the evaluation form is submitted.