Massachusetts General Hospital Department of Pharmacy Guidelines for Pharmaceutical Manufacturers' Representatives
Volume XII, Issue 11


The policies and procedures outlining pharmaceutical company representatives' activities within the Hospital were recently reviewed and updated by the Drug Therapy Committee. These guidelines are meant to supplement the Hospital's overall Vendor Policy, available through the Materials Management Department (GRB BA 010). Pharmaceutical representatives are expected to adhere to both guidelines at all times. Comments and questions may be referred to Bob Hallisey or Mark Kaplan in the Pharmacy Department.


The Massachusetts General Hospital (MGH) has a closed formulary. The purpose of the Formulary is to maintain an adequate supply of cost-effective pharmaceuticals to care for our patients. The Drug Therapy Committee is responsible for the MGH Formulary as well as the Partners Community Healthcare, Inc. (PCHI) Formulary. The PCHI Formulary is a Pharmacy Benefits Management model of pharmaceuticals available to Massachusetts General Hospital physicians on an outpatient basis for patients enrolled in PCHI.

The Drug Therapy Committee is comprised of physicians, nurses, and pharmacists from a variety of specialties and meets approximately 10 times per year.

MGH-Formulary status terminology and regulations

The following terms have been created to reflect a formulary status of a drug.

Available

Available with Restrictions

Unavailable

PCHI-Therapeutic Grid

The PCHI Therapeutic Grid Formulary consists of a co-pay system categorized into three tiers as follows:

Through concurrent and retrospective reviews, MGH and PCHI pharmacists work collaboratively with the physician practice groups to increase compliance with this program. The PCHI Therapeutic Grid is available to all practitioners and patients throughout the MGH outpatient network and pharmacies to assist with appropriate prescribing. All of the agents included have been demonstrated to be effective when used in a clinically appropriate situation.

Pharmaceutical manufacturers' representatives (PMRs) are allowed to promote medications with the Formulary status "Available" and "Available with Restrictions." Informational or promotional material for medications with the Formulary status "Unavailable" is not to be discussed in open forums or left anywhere on the hospital premises. Pharmaceutical representatives may discuss non-formulary medications with attending physicians during private meetings for the purpose of presenting FDA approved information.

 

Vendor Representative Regulations (in addition to Hospital-wide regulations)

1. All industry representatives must wear an identification badge that identifies their employer. Identification badges must be visible at all times while on the hospital premises.

2. Temporary ID stickers will be issued by Materials Management office (Gray Basement, Rm. 010).

3. While in the Hospital, pharmaceutical representatives are permitted in:

4. Pharmaceutical representatives may make appointments with the Director of Pharmacy, Pharmacy Specialist for Finance, Purchasing Manager, Clinical Coordinator or their designees by appointment only. Arrangements can be made with the individual or with the Department Staff Assistant. Appointments with individual pharmacists must be made through one of the individuals listed above.

5. Within the Hospital

House staff - contact with all house staff (including chief residents and fellows) must be conducted through the House Staff's department. The hospital paging system is not to be used for solicitation purposes.

Educational programs and material (outside the Pharmacy) - Educational programs are at the discretion of the area Medical Director and may be used to discuss medications with the Formulary status "Available" or "Available with Restrictions." It is the responsibility of the pharmaceutical representative to notify the Pharmacy Department in advance (at least 48 hours) of such programs, including the topic that is to be discussed. Every attempt will be made to have a pharmacist present at the program. The Department Chairperson is responsible for notifying the Educational Committee on Teaching and Education of the event and abiding to guideline regulations. The Pharmacy Department must approve any written promotional material that identifies the company. This includes dosing charts, color glossy advertisements, and company-sponsored reprints. Ample time should be provided for reviewing of these documents.

Patient Oriented Activities: PMRs may not participate in any patient-oriented activities unless the attending physician has invited them and has received permission from the nurse manager of the area and the Pharmacy Department. In all instances, the PMR must sign a Partners Healthcare Confidentiality Statement, which will be kept on record by the Director of the unit they are visiting. No remuneration will be offered for this participation.

Rounds and Luncheons - Meals and the provision of food are discouraged. Before food can be provided for hospital rounds or meetings, the Chief of Service and the Pharmacy Department must approve both the meeting and the provision of food. Patient information is not to be discussed at these meetings if the PMR is present.

Promotional gifts - The Drug Therapy Committee supports the Pharmaceutical Research and Manufacturers of America's (PhRMA) new marketing code established to govern the pharmaceutical industry's relationships with physicians and other health care professionals. PhRMA guidelines prohibit the distribution of gifts and promotional material that are not primarily associated with the healthcare professionals' scope of practice. Educational and practice-related items may be occasionally offered if they are not of significant value. Please refer to the attachment for details: http://www.phrma.org/publications/policy//2002-04-19.391.pdf

 

 

Drug Distribution Policy

Hospital policy states that the Pharmacy Department must dispense all medication administered to a patient.

Samples are discouraged, but are at the discretion of the area medical director and are allowed in outpatient clinics only. The area medical director is responsible for adhering to state and federal regulations for storage and dispensing. Samples use is not approved to encourage the inappropriate use of drugs not approved by the Drug Therapy Committee "to gain experience" or encourage inappropriate cost ineffective prescribing habits. A procedure is outlined in the Sample Inventory Management System (SIMS) policy. Please refer to the attachment for details: http://www.massgeneral.org/pharmacy/POM/p16-32.htm

The hospital does not allow drug displays or exhibits.

The above vendor representative regulations must be adhered to at all times. Please refer to hospital-wide vendor policies for additional information.

 

Massachusetts General Hospital

Confidentiality Agreement for Partners HealthCare System, Inc., Partners Community HealthCare, Inc. (July 23rd, 1998)

Partners HealthCare System, its affiliates, and Partners Community HealthCare have a legal and ethical responsibility to safeguard the privacy of all patients and to protect the confidentiality of their health information. Additionally, Partners HealthCare System, its affiliates, and Partners Community HealthCare must assure the confidentiality of its human resources, payroll, fiscal, research, computer systems, and management information. In the course of my employment/assignment at a Partners organization/practice, I may come into the possession of confidential information. In addition, my personal access code ["USER ID(s)" and PASSWORD(s)] used to access computer systems is also an integral aspect of this confidential information.

By signing this document I understand the following:

  1. I agree not to disclose or discuss any patient, human resources, payroll, fiscal, research and/or management information with others, including friends or family, who do not have a need-to-know.
  2. I agree not to access any information, or utilize equipment, other than what is required to do my job, even if I don't tell anyone else.
  3. I agree not to discuss patient, human resources, payroll, fiscal, research or administrative information where others can overhear the conversation, e.g. in hallways, on elevators, in the cafeterias, on the shuttle buses, on public transportation, at restaurants, at social events. It is not acceptable to discuss clinical information in public areas even if a patient's name is not used. This can raise doubts with patients and visitors about our respect for their privacy.
  4. I agree not to make inquiries for other personnel who do not have proper authority.
  5. I agree not to willingly inform another person of my computer password or knowingly use another person's computer password instead of my own for any reason.
  6. I agree not to make any unauthorized transmissions, inquiries, modifications, or purgings of data in the system. Such unauthorized transmissions include, but are not limited to, removing and/or transferring data from Partner's computer systems to unauthorized locations, e.g. home.
  7. I agree to log off prior to leaving any computer or terminal unattended.

I have read the above special agreement and agree to make only authorized entries for inquiry and changes into the system and to keep all information described above confidential. I understand that violation of this agreement may result in corrective action, up to and including termination of employment and/or suspension and loss of privileges. I understand that in order for any "USER ID" and/or PASSWORD to be issued to me, this form must be completed. I further understand that computer access activity is subject to audit.

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Signature of Employee / Physician / Student / Volunteer

Date

   

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