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Business Proposal

Application to Reach Patients

Abdulelah A. Albukhari

University of San Diego

HCIN-541-01-FA20: Introduction to Health Care Delivery Systems

Dr. Brenda Boone

December 7, 2020
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Executive Summary

Abdulelah Pharma is a pharmaceutical company that provides medical products to patients. Its

organizational structure includes clinical research, regulatory affairs, and medical affairs to achieve the

company’s goals and ensure patient safety. The project’s goals are to improve patients’ health

knowledge and increase the collection of adverse drug reaction (ADR) reports directly from patients.

Increasing ADR reports helps to mitigate patient underreporting, increase awareness of side effects, and

facilitate discovery of additional ADRs. This project is an application to ensure patients have all the

information about their medicine and explore which patients suffer from medication side effects. The

anticipated outcome of the project is to assist the company in improving patient awareness. After

successful implementation, support from government agencies such as the Food & Drug Administration

(FDA) and cooperation with pharmaceutical companies may expand the application usage to help more

patients in the future. The project’s budget is $684,000 to implement three phases until finishing the

project’s evaluation period.

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Application to Reach Patient

At Abdulelah Pharma, we spend every day making the world healthier. The board management

vision is to help people live healthier. From the scientific discovery of our line or product production to

how we reach our customers, we work to provide safe and high-quality pharmaceutical products to

everyone because our responsibility is to ensure we live in a healthy world.

The pharmacovigilance department’s mission aims to improve the care and safety of patients by

providing activities relating to detection, assessment, understanding, and prevention of adverse effects

or any other drug-related problems (Dal Pan et al., 2019). the company’s departments work together

internally and externally with health care authorities, such as physicians, health care practitioners, and

patients.

Board management supervises the entire process to attain patient safety and reach everyone

related to the drug cycle. The end goal for this project is to ensure patients understand the information

presented in the patient package inserts (PPI) (Suwankesawong et al., 2016). Patients should understand

expected side effects and adverse drug reactions from the medication. Moreover, patients should know

how to report ADRs.

ADRs result from errors, misuse, abuse, and expected reactions and are one of the biggest

health care challenges because they increase population morbidity and mortality (Walter et al., 2016). To

avoid misuse and abuse of medication and increase ADR reports, we need to fill the patient education

gap (Coleman & Pontefract, 2016). The company looking for solutions to reach patients and provide

them with necessary information about the use of company products and the process of ADR reporting.

Living in the technology era with the electronic leaflet (PPIs), the company’s business proposal is

to develop a phone application containing the most updated information on each product. The

application will present the information in straightforward language to the patient, accompanied by 24/7

support to answer their questions.

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Problem

Many patients experience difficulties in understanding their medication information or finding

accurate information about their health treatment, such as side effects and routes of administration.

According to Koster et al. (2016), health literacy is defined by the United States Institute of Medicine

(IOM) as the degree to which individuals can obtain, process, and understand health information and

services to make appropriate health decisions.

About 35% of Americans have a lower than an intermediate reading level. To read the

prescription bottle instructions, patients need an intermediate level to read and understand health

literacy (Nikfarjam et al., 2015). The ADR reports from healthcare providers may not capture all ADRs

experienced by the patient. Yen and Leasure (2019) suggest that patients have additional drug ADR

reports, which may contain more detailed information on products, thus leading patients to underreport

their ADRs to healthcare providers. Underreporting limits the effectiveness of spontaneous reporting

systems. Yen and Leasure (2019) estimate that more than 90% of ADRs are underreported.

Objectives

The project objective is to improve patient knowledge about their medicine. By the end of the

first specific duration of the project inception, the objective is to have at least 20% improvement in

patients’ knowledge of medication. This project objective will be measured by monitoring the number of

patients using the company’s drugs who download the application.

The project’s second objective is to ensure that everybody attains knowledge and understands

that developing conditions due to medicinal side effects is not customary. In this case, people will obtain

enlightenment about best ways to cope with treatments they undergo and will understand certain

medicinal effects on their bodies. Patient comprehension will be measured through general multiple-

choice questions the phone app will also monitor physical changes from the use of certain drugs that
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often go undetected by the patient. This objective will help set guidelines to follow in selecting protocols

for studying different patients.

The phone app third objective is to increase collection of patients reported ADRs, comprising at

least 20% of the total ADR report number to increase information and data. The objective is to collect

data directly from the patient to help with patient education and strategies used to handle patients. The

direct patient report will increase patient safety and ADR report numbers.

Scope of Work

The establishment of this project involves many steps and procedures that dictate time

investment and money spent. It is essential to have a clear outline for every planned step to establish

and develop the budget. The most crucial step is selecting a successful company to build the application.

The contracted company must maintain the application and train the Abdulelah Pharma team on its

proper use.

Clinical research, regulatory affairs, and medical affairs/ drug information will work closely with

the application development company to provide the latest updates on medication data in the

application database and follow up to maintain new information updates.

The recruiting phase involves selecting the best-qualified pharmacists who prioritize their

ambition and desire to help others. The pharmacists will be available to reply to patient questions via

online chat. Abdulelah Pharma will train the recruits on application operations and service delivery

methods. In the beginning, there will be a team of four pharmacists to provide 24/7 service. The

marketing team and other departments will work on marketing the application in the field and

monitoring the improvement after launching to reach users' target.

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Timetable and Budget

The project's timetable will be in 3 phases, with a total budget of $634,000 for the first year. The

project will take one year between the build-up to the end of the evaluation period. The 3 phases will

take one year. (see table1)

Table 1

Project Timetable and Budget

Phas Description of Work Start and End Dates Budget

Phase 1 Application build and Jan-04-2021 – June- One payment $250,000

development with all data added 04-2021
(Utility, 2020)
Phase 2 Recruit team and train how to June-07-2021 – Aug- $512,000 per year (pharmacist
operate application (U.S. Bureau 06-2021 salary)
of Labor Statistics, 2020) ($48,000 per month) ($384,000 until
finishing Phase 3)

Phase 3 Launching and marketing Aug-09-2021- Jan-06- $50,000

2020
Total Total budget until evaluation Jan-04-2021 - Jan-06- $684,000
period finished 2020

Key Personnel
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The It is important to include key personnel in the project. To secure funding for project, deal

with policy conflicts and viewpoints among stakeholders, and generally ensure a project's success. (Table

2) illustrate who will be involved in the project and what their duty is.

Table 2

Key personnel

CEO
General manager
Project manager
Clinical Research,
Regulatory Affairs, and
Medical Affairs
departments
Marketing department
The CEO of the company who will approve the project
GM will follow up on the project and who will hire the project manager.
the person who will be responsible for the project
The managers of all of these departments to provide all of the data and
information required.
And help in any regulatory issues.
The regulatory department also is involved by the Qualified person of
pharmacovigilance who will receive ADR reports.
The marketing department is helping in placing marketing plans and ideas.

Team The team will be hired by the project manager and the general manager

Evaluation

When executing every plan to ensure the app’s success, it is essential to have a clear evaluation

plan and performance indicators to determine productivity level. The number of users who download

the application will be the primary evaluation method for measuring patient knowledge. The goal is to

reach 500 users in the first 6 months of application launch.

The second evaluation method will be feedback from people receiving the phone app services

here via questionnaire. It is important to note their reactions and opinions about the service. By

collecting patient views, Abdulelah Pharma will understand its influence and development needs. The

third evaluation method will be ADR report numbers the app receives. Finally, the firm will determine

the need to increase project employees by analyzing project performance. These evaluations will occur

every three months to ensure consistency of details received.

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Next Steps

This project could further develop in the future, involving governmental authority (e.g., FDA).

The phone app could also open up for partnerships with other pharmaceutical companies interested in

listing their products in the phone app. The proposal is open to ideas from anyone with experience in

either the pharmaceutical field or health sector. Therefore, please feel free to share any advice or ideas

to improve the project.

Conclusion

This project’s primary goal is to ensure that patients attain knowledge and understand the

potential information about their medicine and side effects, which can produce certain health

conditions. With this phone APP, the patients can find a trustable channel. To search for the

information, they need. This project’s main objective highlights the importance of seeking and

Understanding crucial information on medical services and products. Health literacy is a critical factor

that we cannot ignore. Moreover, the project objective is to Increase the ADR's reports number by

collected directly from the patient to improve patient safety. Overall, the idea can be more developed,

make a new partnership between the pharmaceutical companies, and cooperate with government

agencies to ensure significant goal achievement.

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References

Coleman, J. J., & Pontefract, S. K. (2016). Adverse drug reactions. Clinical Medicine,  16(5), 481-485.

https://doi.org/10.7861/clinmedicine.16-5-481

Dal Pan, G. J., Raine, J., & Uzu, S. (2019). The role of pharmacoepidemiology in regulatory agencies.

Pharmacoepidemiology, 126–139. https://doi.org/10.1002/9781119413431.ch8

Koster, E. S., Philbert, D., Blom, L., & Bouvy, M. L. (2016). “These patients look lost”–Community

pharmacy staff’s identification and support of patients with limited health literacy. International

Journal of Pharmacy Practice,  24(6), 403–410. https://doi.org/10.1111/ijpp.12272

Nikfarjam, A., Sarker, A., O’Connor, K., Ginn, R., & Gonzalez, G. (2015). Pharmacovigilance from social

media: Mining adverse drug reaction mentions using sequence labeling with word embedding

cluster features. Journal of the American Medical Informatics Association,  22(3), 671–681.

https://doi.org/10.1093/jamia/ocu041

Suwankesawong, W., Dhippayom, T., Tan‐Koi, W. C., & Kongkaew, C. (2016). Pharmacovigilance activities

in ASEAN countries. Pharmacoepidemiology and Drug Safety,  25(9), 1061–1069.

https://doi.org/10.1002/pds.4023

Walter, S. R., Day, R. O., Gallego, B., & Westbrook, J. I. (2016). The impact of serious adverse drug

reactions: A population-based study of a decade of hospital admissions in New South Wales,

Australia. British Journal of Clinical Pharmacology, 83(2), 416-426.

https://doi.org/10.1111/bcp.13124

U.S. Bureau of Labor Statistics. (2020). Pharmacists: Occupational outlook handbook.

https://www.bls.gov/ooh/healthcare/pharmacists.htm 

Utility. (2020). How much does it cost to develop and build an app. https://utilitynyc.com/blog/app-

development-cost 
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Yen, P. H., & Leasure, A. R. (2019). Use and effectiveness of the teach-back method in patient education

and health outcomes.  Federal Practitioner,  36(6), 284-289. Retrieved from

https://pubmed.ncbi.nlm.nih.gov/31258322/