Formulary Development in a Maritime Environment: A Team Approach

By Domenic A. Sammarco, R.Ph., EMT

Formulary development and utilization must begin and end as a medical healthcare team effort. From standardization to mission objectives, information gathering is paramount to success. Development a standard reporting system allows a streamlined approach for understanding the areas of: essential clinical elements, drug characteristics, medical outcomes, therapeutic selection analysis, drug review and finally decision analysis. A team game play allows intradepartmental discourse, cross-training and education input, and proper pharmacist utilization.

Introduction: As in all maritime operations, the Pharmacy Formulary stands as the ship’s pharmaceutical and therapeutics register. The formulary allows standardization and promises product availability as agreed by the team members of the ship’s medical team. Formulary development must have a team approach and conducted on a periodic basis to ensure an up-to-date operational and efficient mobilization as well as product availability. The unit formulary should be used as your potency and dated item [P+D] reference.

Formulary development and maintenance is one of the essential responsibilities of the Maritime’s companies pharmacy adviser in any level of maritime services whether in a large container ship, cruising class vessel to maritime tugboats or area clinic. The rationale for formulary use may be varied from cost-containment to system availability. Within this article, we shall address the many variables that may come into play in how and why we utilize a uniform drug listing [formulary] in its simplest application. A formulary may be a listing of available pharmaceuticals a practitioner has to use in his/her arsenal of drugs.

However, in time, the evolution of formularies has encompassed many variables beyond simply what we have on our shelf today. As aware to all medical professionals, pharmaceuticals are consumables with specific expiration dates [shelf life], requiring special storage and handling, and form a large part of your medical Unit Basic Loads [UBL]. With these presented facts, one understands that a formulary is a living document constantly in flux. A maritime operations manager must rally his medical think tank to address these changes on a scheduled basis.

Formulary and Pharmacy Objectives: As in all problem-solving modalities, we must define our objectives and understand the, WHO, WHAT, WHEN and WHERE of our mission. Once given a maritime mission with finite objectives and command guidance, we may proceed to start our development.

Our maritime mission should establish:

WHO/WHAT/WHEN/WHERE

• WHO: The level of training of on-board personnel.

• WHAT: The established level of medical care we are to deliver.

• WHEN: Time constraints - departure time and expected arrival.

• WHERE: Next port of call - available medical care.

These factors may seem far reaching from pharmaceutical products but they will affect your problem solving methodology.

Information Gathering:  "ONE IS UNABLE TO PRODUCE THE CORRECT CONCLUSION WITHOUT COLLECTING AS MUCH PERTINENT INFORMATION AS POSSIBLE PRIOR TO MAKING ANY DECISIONS." This corollary holds true to formulary development. Some specific variables in a ship’s operation are:

• People - ship’s cruise based on level of organization, personnel and equipment allowances especially focusing on the level of medical personnel assigned and voyage deployable.

• Plan - maritime operation plan and support annexes stating specific information as mission and assignments and concept of support.

• Time - Time management concerns to include which will specify your ship’s probable time and sequence of departure.

• Source - Available sources of supply in the area of operation either during transit or expected deployments, with considerations for the competitive nature for resources created by multiple ship requests and short suspense dated requisitions.

• Supply -Review the Ship’s Assemblages [SA], products which would be included in health-related field sets, survival kits and lifeboat medical supplies, in order to identify your ship’s medical needs. The SA are primary sources for identifying your formulary items. Scan or check the Common Table of Allowances for any and NDC [National Drug Codes].

• Information -Additional information concerning available pharmaceuticals may be collected from the following:

- US Public Health Service - Ship’s Medicine Chest.

- IMO - Medical Health Standards.

- Both publications need updating and not specific in nature

The SA will change periodically and you must collect the latest version to have the correct data in order to develop an up to date formulary. Now that we have collected some of the preliminary information concerning our potential  formulary we can proceed to address some of the clinical variables in ship’s formulary development. The following checklist will demand input from the clinical staff of the ship’s safety and operation committee. 1

TABLE I

Checklist of essential clinical elements that must be addressed developing a ships’ formulary:

Essential Clinical Elements In Ship’s Formulary Development

• Definition of a Potential Medical Problem:

  - endemic variables (malaria, heatstroke)

                    - quantify and qualify expected casualties

• Qualify Alternative Pharmaceuticals by:

- similar therapeutic index

- availability of multiple sources

- cross-reference all essential items by national drug code and national stock number

• Level of desired patient care

                    - training of onboard medical personnel

                    - historical medical analysis

- level of prepositioned pharmaceutical assets

• Formulary Overall Performance Outcomes:

- specific and measurable pharmacy goals

- supported by or limited by pharmacy services are the standard of medical care

• Cost Component Analysis:

- direct medical cost savings (less costly products of similar therapeutic index)

                    - indirect medical cost savings (ship’s diversions)

In order to further streamline the clinical drug evaluations in the formulary development, it is essential to review and answer some of the following areas of drug characteristics and medical outcomes in order to reduce duplications and select the best possible products as displayed in TABLE II.

TABLE II

DRUG CHARACTERISTICS:

• Routes of administration (by mouth, intravenous, intramuscularly, sublingual)

• Dosing frequency or duration

• Number of FDA approved indications

MEDICAL OUTCOMES:

• Lower incidence of side effects [i.e. nausea, sedation anticholinergic effects]

• The need for laboratory monitoring

• Better cure rate for bacterial, fungal or viral infection

• Better patient compliance factors [i.e. duration of therapy, frequency of dosing, taste and side effect profile]

• Decreased mortality 2

Therapeutic Selection Analysis

Therapeutic selection involves choosing the drug of choice, from among alternatives, for a certain disease state or medical condition. The goal is to select the agent that provides an acceptable level of effectiveness and is system available. 

The ideal drug to select is the one that is least expensive, most effective among alternative agents and accessible in the maritime procurement system. The decision process becomes more complicated when the pharmaceutical product of choice is not available because of cost or production limitations. As we further develop a criteria for product selection, we must develop a uniform reporting system as to truly establish a common denominator for comparison.

TABLE III is a drug review format for our maritime medical committee to review. A listing of SA items specific to pharmacy were given to our pharmacy technicians. They were requested to generate a report per products using the drug review format. 3

TABLE III

DRUG REVIEW REPORT CONTAINED:

• Generic name

• Proprietary name/manufacturer

• Therapeutic class

• Routes of administration

• Formulation[s]

• Requested by

• Pharmacology

• Routes of elimination

• Efficacy [i.e. drug’s ability to achieve its desired effect in a controlled environment]

• Side effects/adverse effects

• Drug/drug and drug/food interactions

• Monitoring parameters

• Alternative medications available

• Current/expected utilization and cost impact

• Availability through supply channels

• References cited/used

Now that we have systematically collected and reported all available products, we have reached the final area of formulary selection called decision analysis. Decision analysis will take into account the probabilities of event occurring or a goal being achieved.

Final Selection Process. Our final selection process shall employ a process entitled decision analysis. Decision analysis encompasses in a summarized format the information we have collected up to this point and arranges the data in the order placed in TABLE IV.

TABLE IV

• Identify the therapeutic or medical problem.

• Define:

                - The perspective

                - The patient population

                - The relevant time frame necessary for receiving product through the military procurement system

• Assessing outcomes with specific primary goals for each decision alternative. A primary usually consists of an easily identifiable and clinically significant desirable therapeutic outcome that relates to the medical or therapeutic problem [i.e. primary goal is a life saved, improvement of chronic disease]

• Listing the therapeutic alternatives under consideration that, with varying degrees of success, could solve the problem by allowing achievement of the primary goal [i.e. [Amoxil] amoxicillin vs [Bactrim] sulfamethoxazole/trimethoprim for treatment of otitis media]

• Specify significant secondary events. Examples of secondary events include drug toxicity, non-compliance with a drug regimen, and the need for second or third-line options when primary therapy fails.

 TABLE V

Definition of Decision Analysis Terminology

Alternative: Two or more therapeutic options—e.g. different drugs—designed to solve a medical problem and accomplish the primary goal.

Primary goal: A positive therapeutic endpoint. What one would traditionally consider the main measurement of effectiveness of an alternative.

Secondary event: An undesirable occurrence—e.g., side effect—associated with a specific therapeutic alternative.

Outcome: The result achieved when one combines a specific alternative with its primary goal and secondary events. Each alternative can result in several outcomes depending on the number of possible combinations of secondary events. 4

Decision analysis can be used both for evaluating first, second and third-line therapies or for determining the costs of treating toxicities on adverse events associated with drug therapy. As in all methods of analysis, limitations are present. However, the use of decision analysis has been useful as the final cut on pharmaceutical selections for our combat support hospital. 

Conclusion.  As in many clinical settings, the start of pharmacy services will focus on both the explicit need and request of the physician. By using our team approach to formulary selection, all members of the health care team have had the opportunity for input and discourse. The advantage of developing and finalizing the formulary prior to the   beginning of an operation allows all members of the maritime medical committee as well as the medical supply department to anticipate and become proactive to potential problems and needs.

TABLE VI

THE VALUE OF A TEAM-DEVELOPED FORMULARY SYSTEM

• Improved clinical communications between medical and non-medical maritime personnel

• A reduction of miscommunication with medical advising services by a prepositioned printed reference formulary

• Improve therapeutic outcomes because of streamlining

• Developing and maintaining a crosslevel educational program between prescriber and ship’s medical officer

• Meeting the perceived need of advising land based physician and on board medical personnel by proper analysis and product availability

• Enhance the value of the maritime pharmacy services among physicians by becoming a part of the solution and not the problem

References:

1 TOE Medical Unit Guidebook For Using Prime Vendor US Army Medical Materiel Agency [USAMMA] August 1996

2 Basskin, L How To Use Cost-Effectiveness Analysis To Select Drugs For Therapeutic Substitution Formulary July 1996

3 Rolon, L & Shoemaker, R Customized Unit Assemblage Listings [USAMMA]

4 Basskin, L How To Use Decision Analysis To Solve Pharmacoeconomic Problems   Formulary June 1997