Pharmacist- Investigational Drug Services

Responsible for the optimization of drug therapy by identification, resolution, and prevention of drug related problems and improving therapeutic outcomes.

Responsible for providing patient care according to the laws and regulations governing pharmacists and the practice of pharmacy by the appropriate state and federal agencies. When assigned to particular pharmacy service teams, may be responsible for prescribing medications under specific collaborative drug therapy management agreements (CDTM).

Works relatively independently, and within the limits of established pharmacy/ambulatory care practice site's policies and procedures, as a member of the patient care team. Directs and coordinates the activities of a pharmacy service area. Supervises all support personnel during an assigned shift, operating within the limits of pharmacy policy and procedures, and the regulations of the Board of Registration Pharmacy.

1. Leadership

a. Provide direction and guidance to pharmacist and ancillary support including technician staff in following policy and procedure, taking accountability and ownership of job responsibilities, and promoting professional behavior and attitudes.

b. Provide feedback to the pharmacy managers/practice managers/medical directors for the interim and annual performance appraisal of other pharmacists, pharmacy technicians, pharmacy interns, physicians, medical residents, medical interns and medical assistants when appropriate.

c. Participates in resolving personnel management issues, when requested by the management staff.

2. Direct and Indirect Patient Care Services

a. Directs and coordinates the delivery of pharmacy services on the assigned shift, without direct supervision.

b. Supervise and verify the accuracy of all work completed by support personnel assigned to the area.

c. Responsible for the interpretation and implementation of all departmental policies and procedures on the assigned shift.

d. Prepare, compound, and dispense medications to patients according to the laws and regulations of the Board of Registration in Pharmacy, Department of Public Health Food and Drug Administration, and other regulatory agencies when appropriate.

e. Attend and participate in daily medical and multi-disciplinary rounds and participate in specialty rounds as needed and as time allows and collaborate with other healthcare providers when staffing non-rounding services.

f. Interprets, clarifies and evaluates all medication and related laboratory orders for completeness and appropriateness. Communicates with physicians and nurses on medication order discrepancies, possible drug interactions or stability problems. Assures that all patient medication profiles contain the required medication information and clinical data necessary to monitor the patient's pharmacotherapy.

g. Provides prospective evaluation and monitoring of patient drug therapy. Recommend appropriate medication doses and adjustments as indicated by patient conditions. Identifies, documents, resolves, and works to prevent drug therapy related problems.

h. Participates in pharmacokinetic dose monitoring of selected medications and recommends dose adjustments and laboratory monitoring as required meeting patient needs in accordance with approved guidelines and protocols.

i. Recommend drug related labs and interpret results when appropriate.

j. Provide drug information and consultation to patients, physicians, nurses and other health care professionals regarding appropriate drug therapy, including drug interactions, side effects, incompatibilities, allergies, medication order/prescription discrepancies, drug stability problems, and drug administration.

k. Identify, document, resolve, monitor, and prevent drug therapy related problems, including contraindications, duplications of therapy, and drug interactions.

l. Monitors drug therapy to prevent contraindications, duplicate therapy, drug interactions and allergic reactions. Reports and documents all adverse drug reactions to pharmacy leadership and appropriate hospital committees.

3. Quality and Safety

a. Maintain expertise in the departmental policies and procedures.

b. Follow all policies, procedures, laws, and regulations set forth by the Board of Pharmacy and all other applicable regulatory agencies.

c. Ensure compliance with target drug programs, formulary management, medication management initiatives, and adverse drug event monitoring programs.

d. Document and report clinical interventions, medication errors, adverse drug events.

e. Actively participates in the development and performance of drug use evaluations and other drug therapy monitoring initiatives.

f. Maintains skill and competency level to comply with departmental and hospital quality assurance standards.

g. Participates in department quality improvement efforts.

4. Education, Training, and Professional Development

a. Attend and participate in departmental and change of shift staff meetings, M&M rounds, staff development and continuing education activities.

b. Participate in departmental quality improvement committees, programs, and student/resident presentations.

c. Attend, participate in, and conduct continuing education programs and conferences to keep current with developments in the profession.

d. Maintain pharmaceutical care expertise through membership and participation in professional organizations, continuing education, and contributing to peer-reviewed literature.

e. Attend and participate in journal club review, in-services, and case studies for afternoon pharmacist meetings.

f. Assist and contribute to the orientation and training of new personnel as assigned.

g. Serves as a preceptor for pharmacy interns and externs with the Massachusetts Board of Registration in Pharmacy in accordance with 247 CMR 8.01(16) where appropriate.

h. Serves as a preceptor for pharmacist resident and fellows where appropriate

i. Participates in the training of medical, nursing and allied health professionals.

5. Use of Technology and Automation

a. Utilize area-specific technology, including, but not limited to, robotics, automation, software, equipment, and information systems.

b. Troubleshoot and mitigate short-term issues related to the area specific technology.

6. Support research-related patient care and drug therapy by ensuring study protocol medication order compliance when appropriate

7. Participate as a member of the health system Human Research Committee/Institutional Review Board (HRC/IRB).

a. Attends meetings of the Human Research Committee/Institutional Review Board (HRC/IRB) to review new study protocols and annual reports of continuing study protocols.

b. Participate in primary, continuing review, and ancillary reviews of research protocols

. 8. Provides frequent investigational drug and protocol information outside of normal working hours. Shares on-call responsibility with other IDS staff members.

9. Serve as the primary delegated (sponsor or primary investigator) pharmacist for assigned clinical trial

10. Meets frequently with clinical trial sponsors with clinical research.

11. Responds to questions concerning the protocols and investigational drugs as they arise.

12. Communicates directly with nursing, pharmacy, and medical personnel concerning protocol questions.

13. Contacts principal investigators and study coordinators to discuss procurement, storage, anticipated use, and possible problems regarding efficient delivery of investigational drugs.

14. Rotates through additional staffing assignments as needed including 24/7 on-call and weekend / holiday coverage.

1 15. Ensure the proper maintenance of appropriate records for controlled substances and investigational drugs as required.

16. .Supports patient care and drug therapy research by ensuring study protocol medication order compliance.

SKILLS AND ABILITIES REQUIRED

1. Must have exceptional oral and interpersonal communication skills, to communicate effectively with members of other healthcare disciplines, and other Pharmacy staff.

2. Must be able to plan and coordinate the activities of pharmacy staff in accordance with Policy and Procedures.

3. Must be able to properly motivate and supervise support personnel.

4. Priorities and organizes work while under stress and with time constraints. Must pay attention to detail virtually 100% of work time, and have critical thinking and decision-making skills.

5. Must be able to set and change priorities, and accept additional responsibility as needed.

6. Must be able to respond positively to new approaches and changes in the work environment.

7. Evaluates medical information and retrieves biomedical literature using appropriate search strategies and interprets biomedical literature with regard to study design, methodology, statistical analysis, significance of reported data, and conclusions.

8. Must have extensive knowledge and ability in all areas of the department including: IV Admixtures, Drug Information, Ambulatory, Manufacturing, and Drug Distribution.

9. Must be able to train new employees.

10. Must be capable to assume the responsibility for coordinating pharmacy services on an assigned shift.

11. The individual in this position must demonstrate appropriate knowledge of principles of growth and development over the life span of the neonate, adolescent, adult, and geriatric patient. In addition, they must possess the ability to assess patient data relative to age specific needs and provide care as described in the department's policies/procedures.

12. Must have advanced knowledge of Pharmacotherapy.

13. Ability to work collaboratively as a member of the patient care team

14. Ability to develop dispensing procedures for investigational drugs, and randomize and double-blind investigational drug studies.

15. Ability to review submitted investigational drug protocols and present findings and recommendations to the committee for the Protection of Human Subjects from Research Risk.

16. Must have ability to organize, plan, and prioritize work with minimal supervision.

17. Must have current and accurate knowledge of operations in addition to Investigational Drug Service operations.

18. Ability to locate, research, and interpret literature regarding investigational drugs and new drug products. Prior knowledge of investigational drug processes is preferred.

19. Must have basic knowledge of MS Word and Excel programs.

Qualifications

1. Must have a Bachelor of Science degree in Pharmacy or Doctor of Pharmacy from an accredited college of pharmacy. Must be eligible for licensure to practice pharmacy in the Commonwealth of Massachusetts.

a. Post graduate residency/fellowship training is preferred.

b. Board Certification by examination in a specialty is preferred

c. Must meet all Board of Pharmacy requirements to enter into a collaborative drug therapy agreement (if applicable, see appendix)

2. Must complete 20 continuing education credits per year to maintain license

3. When applicable, for each year of a CDTM agreement, pharmacists MUST complete at least 5 additional contact hours (i.e., total of 25 contact hours yearly) that address areas of practice generally related to the specific collaborative practice agreement. If there is more than one specific area of practice, it is recommended to obtain additional contact hours in each area, however only 25 total contact hours per calendar year are required.

4. If prescriptive practices are included in the collaborative practice agreement:

a. Maintain a current controlled substance registration issued by the Department during the term of the agreement, pursuant to M.G.L. c. 94C, §§ 7 and 9 and 105 CMR 700.000: Implementation of M.G.L. c. 94C.

b. Complete pain management training required pursuant to M.G.L. c. 94C, § 18(e) prior to initially obtaining a controlled substance registration and at least biennially thereafter as a condition precedent to renewing his or her pharmacist license

c. Submit an attestation, signed under the pains and penalties of perjury, that the pharmacist participates in, or had applied to participate in, MassHealth as either a provider of services or for the limited purpose of ordering and referring services covered by MassHealth, in accordance with M.G.L. c. 112, § 24B½.

5. Pharmacist is in good performance standing based upon feedback from internal or external references when applicable.

6. Upon department orientation, and annually thereafter, must complete:

a. Institutional level competency assessments:

i. OSHA/Fire safety

ii. Patient and Workplace Safety

iii. National Patient Safety Goal

iv. Infection control

v. HIPPA

vi. Hand Hygiene

b. Pharmacy Department competency assessments are based upon areas of staffing and may include:

i. Process-specific skill

ii. Clinical skill

iii. Population/age specific Pharmacotherapy

iv. Sterile Products Preparation

v. Aseptic Technique

vi. Emergency response/Code training

7. Must have a Massachusetts Controlled Substance Registration license, National Provider Index number, and a Drug Enforcement Administration Registration number, if applicable.

EEO Statement

Brigham and Women's Hospital is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, sexual orientation, protected veteran status, or on the basis of disability.