Purpose

The purpose of the pharmacist-run “Tamiflu clinic” is to provide support services to physicians and healthcare providers and alleviate the burden of flu in the community. Introducing this service in the community pharmacy makes oseltamivir (Tamiflu®) accessible to patients that otherwise could not get it.

Summary

A shortage of primary health care providers limits accessibility to oseltamivir in the critically short timeframe when it is most effective. Pharmacists remain the most accessible health care providers in the community. Initiating pharmacy-based clinics that utilize rapid diagnostic tests can help provide quicker access to care, eliminate wait times to see primary care providers, and reduce costs associated with physician appointments and ER/urgent care visits. Pharmacists seeking to implement a “Tamiflu clinic” need to enter into collaborative practice agreements with physicians. This service will allow patients to get necessary care on a walk-in basis. This article provides information on how to implement this type of service in a community pharmacy and discusses the potential impact it can have.

Conclusion

Initiation of this unique service in the community pharmacy will increase accessibility to oseltamivir and thus minimize duration of flu and costs associated with it. Furthermore, it will increase the pharmacists’ presence in the community and their impact in the healthcare arena.

Influenza, commonly known as “the flu”, is a highly contagious respiratory illness that is caused by a variety of influenza viruses that infect the nose, throat, and lungs. It can cause mild to severe illness, and at times, it can lead to death. The Centers for Disease Control and Prevention (CDC) estimates that between 5 to 20% of people in the U.S. get the flu each year [1]. This equates to approximately 31.4 million outpatient visits per year, with more than 200,000 of these visits resulting in hospitalizations due to complications (i.e. pneumonia and myocarditis). 1]Every year, the flu kills between 3,000 to 49,000 people in the US [1 ].The annual costs associated with influenza in the US are estimated to be $10.4 billion in direct medical expenses and an additional $16.3 billion in lost earnings[1].

Studies have shown the effectiveness of the influenza vaccine and indicate that vaccination can reduce the risk of contracting the flu by approximately 50% to 60%.[1]The CDC recommends an annual flu vaccination for all adults and children over 6-months old, as this is the best protection against the influenza virus and its potentially serious complications [2-4].Although vaccination is the best prevention, only 32% of adults aged 18–49 receive a flu vaccine any given year. Vaccination rates are higher for older individuals: 48% for adults 50–64 years and 69% for adults 65 and older [5].Furthermore, vaccine effectiveness varies from season to season and response to the vaccine can depend on the person being vaccinated.[1] For example, during the 2014-15 influenza season, vaccine effectiveness was 19%, while in 2015-16, it was 47% effective [3].

Most people that get the flu do not require anything more than rest and plenty of fluids, but some patients may benefit from an antiviral medication such as oseltamivir (Tamiflu®). Clinical trial data suggests that it is modestly effective at shortening the duration of the flu.6 If taken soon after the onset of symptoms, it may shorten the duration of illness and may help prevent serious complications such as pneumonia or myocarditis[3]. The sooner it is initiated, the more effective it is. Oseltamivir, taken within the first 12 hours of symptom onset, reduced the total duration of illness by greater than three days as compared to one day when treatment was initiated at 48 hours after the onset of symptoms[3]. Early initiation can also lead to a reduction in missed work days and increased productivity at work. Although oseltamivir may help reduce flu symptoms, it does have gastrointestinal side effects that must be considered.

Nausea and vomiting were reported to occur between 3.7 to 4.7% more than placebo.

Oseltamivir increased the risk of nausea (RR 1.60, 95% CI 1.29–1.99; p<0•0001; 9.9% oseltamivir vs 6.2% placebo, risk difference 3.7%, 95% CI 1.8–6.1) and vomiting (RR 2.43, 95% CI 1.83–3.23; p<0•0001; 8.0% oseltamivir vs 3.3% placebo, risk difference 4.7%, 95% CI 2.7–7.3). Other than gastrointestinal side effects, oseltamivir is well tolerated [5-7]. 

Obtaining oseltamivir in a timely manner is challenging for many patients. One barrier to early intervention is the difficulty for a patient to be seen promptly by a primary care provider (PCP). The shortage of PCPs and the long average appointment-waiting period prevents patients from obtaining the medication [8].The average appointment wait time to see a PCP is 19.5 days across most metropolitan areas, which would make it impossible to obtain oseltamivir in the appropriate 36 to 48 hour period after the onset of symptoms [8]. Patients who seek help in the emergency room (ER) may face long wait times as well. The CDC reports average emergency department wait times are about 30 minutes and treatment times are about 90 minutes, which adds up to roughly 2 hours [8-9].These long waits in the ER could also expose other patients to the flu virus thus increasing the rate of transmission. Urgent care clinics can be an alternative to emergency rooms with wait times of about 30 minutes on average, but this can vary depending on how busy the facility is and whether it is appropriately staffed[10].Additional barriers patients face are the costs associated with physician appointments and ER/urgent care visits. Average emergency room costs vary wildly based on treatment, but a 2013 National Institute of Health study put the median cost at $1,233.[11] The patient’s out-of-pocket cost for an urgent care visit depends on the level of treatment that is provided and the patient’s insurance, but the average cost can range from $50 to $150 [10].

Pharmacists remain the most accessible health care professionals.[8] This is particularly relevant in the community setting as nearly 90% of Americans live within 5 miles of a community pharmacy.[8,12] Patients are able to seek help on a walk-in basis at the pharmacy, thus eliminating long waits to see primary health care providers or spending hours in the ER. Offering oseltamivir in the community pharmacy is also a public health benefit, controlling influenza transmission by minimizing duration of the illness and exposure to infected individuals. Currently there is a lack of literature describing this service provided by the pharmacist in the community pharmacy setting.

Description of the Practice Model

 Initiating a “Tamiflu clinic” in a community pharmacy requires pharmacists to establish a collaborative practice agreement, develop a procedure and screening tools, obtain the proper equipment, train staff on use of the equipment and workflow, and implement proper documentation process. A pilot, pharmacy-based “Tamiflu Clinic” was initiated in collaboration with primary care providers at Western University of Health Sciences Patient Care Center Pharmacy (Western PCC) in 2016. Western U PCC engages in collaborative practice amongst various outpatient departments (Pharmacy, Dental Center, Eye Care Center, Foot & Ankle Center, and Family Medicine). The purpose of the pharmacist-run “Tamiflu Clinic” was to provide support services to primary care providers and alleviate the burden of flu in the community. Introducing this service in the community pharmacy makes oseltamivir accessible to patients that otherwise may not have easy access to get it. The steps necessary to implement such a service in the community setting are described in this article.

Collaborative Practice Protocol

The pilot clinic at the WesternU PCC Pharmacy was developed as a part of the policies and procedures of the WesternU PCC health care facility, under a collaborative practice agreement (CPA) with one of the WesternU Family Medicine physicians serving as the authorizing provider. A protocol for the service was developed allowing pharmacists to assess patients who presented to the pharmacy with acute symptoms of influenza. This assessment included a review of signs and symptoms of the illness, duration of the symptoms and performance of a rapid influenza diagnostic test (RIDT) on eligible patients. Results of the test were used as a basis for initiating therapy when indicated.

Under this CPA, the pharmacists, as part of the health care facility and under the supervision of the physician, are not diagnosing the patients. Rather, they are interpreting the results of the RIDT and following a stepwise procedure of the facility to initiate therapy based off these results. Therapy is initiated only if the test result is positive. The CPA should include specifics about the patient population, medication the pharmacist is to use, as well as the communication steps necessary to document and inform the physician of the service that was provided.

Until recently, pharmacists were able to enter into a CPA only under direct supervision of a physician, however, with the passage of SB493 and the creation of the Advanced Practice Pharmacist (APh), the scope of pharmacists’ practice was expanded. Under the new provision this type of service could potentially be implemented in a community pharmacy not operating under a health care facility as long as an APh is performing these activities. Business and Professions code 4052.6 enables an APh to order tests and interpret results, which can include the RIDT, as well as participate in the management of diseases in collaboration with other health care providers. In a community pharmacy setting, an APh could employ a stepwise procedure similar to the one developed by the WesternU PCC Pharmacy. In this case, the APh would not be diagnosing the patient, but would be initiating therapy based off interpretation of the results of the test. The requirements to qualify to be APh are available through the California Board of Pharmacy [13].

​A stepwise procedure was developed in order to provide guidance to the pharmacy staff and to ensure the process was integrated into the workflow. This procedure included how to appropriately identify and screen patients, as well as a process for proper documentation of the results. The clinic’s procedure is described below:

1. Patient who presents to the pharmacy with acute symptoms of influenza described under ‘Clinical Condition’ in the Inclusion/Exclusion Criteria (Table 1), completes Tamiflu® (oseltamivir) Patient Assessment Form (Table 2).

2. Pharmacist reviews the assessment form with the patient, assesses the symptoms, and records patient’s temperature, blood pressure and pulse to determine patient’s eligibility for RIDT.

3. Trained associate (pharmacist/pharmacist intern/technician/clerk) performs RIDT on eligible patients and pharmacist reviews the results with the patient.

4. If test is positive, pharmacist completes a treatment order form for oseltamivir. (Table 3)

5. Pharmacist documents the encounter, including the rest of the test and the outcome (i.e. if treatment was initiated or not).

6. In the event test results are positive and oseltamivir is initiated, documentation is faxed to the PCP provided by the patient and authorizing provider on the CPA. Patient receives a copy of the assessment regardless of the results of the test.

7. All forms are kept in the pharmacy in accordance to the state law.

 

Table 1:  Inclusion and Exclusion Criteria

 

Date:                                                                                            Pharmacist: Patient’s Name: DOB:
Questions (Blue shaded area to be completed by the patient)	Assessment:(Completed by the pharmacist)
What is your age?	18-64 years > 65 years < 65 years with co-morbidity
Have you received a Flu Shot this season? Yes ( if yes when?) No
Do you have any allergies to any medications or food, or herbal supplements)? Yes No
Have you ever had Tamiflu in the past? Yes No
Have you ever had an allergic reaction to any of the Tamiflu products? Yes No	Contraindicated if answer is yes
Are you pregnant or breast-feeding? Yes No	Pregnant or unsure Breast-feeding Plan to get pregnant in the next three months No
When did your symptoms start?	<48 hours >48 hours but <1 week >1 week
What medical conditions do you have?   Are you normally fit and well? 􏰀 Yes No	Any of the following conditions Asthma requiring regular medication COPD Cardio-vascular disease excluding uncomplicated hypertension Immunosuppressed (treatment, illness such as asplenia or splenic dysfunction) Diabetes Mellitus
What medications are you taking?	Respiratory drugs (Asthma/ COPD) Cardiovascular drugs (Blood pressure, heart) Immunosuppressants (including anti-cancer drugs & oral corticosteroids) Drugs for diabetes Chlorpropamide, methotrexate, phenylbutazone, probenecid
What are the symptoms?
Are you feeling hot? 􏰀 Yes No Are you sweating / shivering? 􏰀 Yes No Was it a sudden onset? Yes No	Marked fever of sudden onset
Do you have a cough? Yes No Are you coughing anything up? Yes No What color is the sputum?	Unproductive cough (dry cough) Productive cough (mucus producing) Colored sputum, blood stained
Have you had any difficulty breathing apart from nasal congestion? Yes No	Breathing difficulties Chest pain at the time of consultation
Have you fainted or lost consciousness since the onset of symptoms? Yes No	Loss of consciousness (emergency referral) Delirium
Do you have a rash anywhere on your body that appeared around the time your symptoms began? Yes No	Rash (emergency referral if rash is purpuric with/ without accompanying photophobia)
Have you had any difficulty swallowing? Yes No	Difficulty swallowing
Are experiencing any muscle and joint aches? Yes No Do you have a headache? Yes No	Joint aches and pains Headache
Are you feeling tired and lethargic? Yes No	Lethargy Tiredness
Do have nausea? Yes No Have you vomited? Yes No	Nausea Vomiting
Have you taken any pain killers or cough or cold remedies; e.g. Yes (which ones) No   Have they helped? Yes No	Taken: Analgesics (list if any) Cold remedies (list if any)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ACTION (For the pharmacist to complete)
Influenza test results Temperature Blood pressure Pulse	Positive Negative
BLUE	RED	BLACK
Supply Tamiflu (Oseltamivir) to patients 18-64 y/o who have a positive Influenza result AND: Presented within 48 hours of onset of most of blue symptoms and can start treatment within 48 hours Advise rest and fluids	Patients who fulfill any of the red conditions should be referred to a PCP or Emergency Room for further advice.	Patients in the black category do not fit the criteria for Tamiflu® (Oseltamivir) and do not require referral to the doctor. Advise home care if: There are blue symptoms which suggest cold or flu Advise Rest Adequate fluid intake Analgesics Cough/cold remedies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Table 2: Tamiflu® (oseltamivir) Patient Assessment

 

 

 

Table 3: Tamiflu® (oseltamivir) Treatment Order Form

A procedure that allows for seamless integration into the workflow is essential for a clinical service to be successful in the community pharmacy setting. The time it takes to provide this comprehensive assessment can vary depending on the number of pharmacists or student pharmacists available. In general, workflow for this service is similar to providing immunizations. On average, it takes about 30 minutes to review the assessment form, run the test, dispense the medication if necessary, and document patient interaction. The test itself takes about 15 minutes to perform. Since any trained associate can perform the test, conducting the test may not require additional time from the pharmacist. The actual time the pharmacist spends with the patient might only be a few minutes, making it a possible fit for a community pharmacy practice. At the WesternU PCC Pharmacy, the role of the technicians and student pharmacists is to have the patients complete the Patient Assessment form. They also perform the RIDT. The pharmacist reviews the assessment form to determine eligibility for the RIDT and decides if oseltamivir should be initiated based on the results of the test.

There are more than 10 RIDTs approved by the U.S. FDA for Influenza testing. They vary in sensitivity between 50-70% and specificity between 90-95%. The average cost range for these tests is between $13.00-$15.00 per test [14].

Specimen Collection and Handling

Approved clinical specimens vary by influenza test, so it is recommended to consult the manufacturer’s package insert for each test. All patient samples, controls, and tests should be handled as though they could transmit disease and universal precautions against microbial hazards are indicated.

Space

Additional space in the pharmacy is not required. Existing space used to perform services like vaccinations and private consultations can be utilized for this type of service.

Conducting CLIA- waved Tests

Pharmacists have been conducting CLIA-waived tests for many years [14]. CLIA-waived tests are considered noncomplex and do not require special training or licensures, therefore anyone can administer them. Pharmacy staff members are not required to obtain individual CLIA-waived certificates; only the facility must acquire a certificate. [17] In order to become a CLIA-waived site, a pharmacy must complete a 2-step process. First, the pharmacy must obtain a CLIA certificate followed by an application for laboratory status at the state level. A pharmacist or designated associate will need to serve as the laboratory director.[14,15] Cost of the CLIA- waved application for California is $150.00 biannually.[17] Personnel that is conducting the tests should receive training from the manufacturer on specimen collection and handling, performing the test, and necessary clinical utility for the specific test chosen.

Staffing

The “Tamiflu clinic” can be conducted in the community pharmacy during normal business hours. It would need to be staffed by an APh and other pharmacy-related personnel, which may include other licensed pharmacists, intern pharmacists, technicians, and clerks. Technicians/clerks can provide the patient with the assessment form for the patient to complete in the waiting area. The APh should review the assessment form and establish the need for testing the patient. Any licensed and non-licensed personnel can perform CLIA-waved tests. The APh will interpret the results and write the order if appropriate.

Documentation

Documentation is critical for a successful clinical service. It ensures a standard of care and compliance with laws and regulations. Moreover, proper documentation enhances continuity of care by establishing clear communication among clinicians and providing patients with information about their care. In the event test results are positive and oseltamivir is initiated, documentation is faxed to the PCP provided by the patient and the authorizing provider on the CPA. The patient also receives a copy of the assessment. The original assessment form and Tamiflu Treatment Order form are kept in the pharmacy in accordance to the state law.

Pharmacists are not able to bill directly for CLIA-waived tests at this time in California, so the clinic at the WesternU PCC Pharmacy was strictly a “cash-only” service. The staff determined a fee that was sufficient to cover the cost of the test and the time that the pharmacy spent performing the service. The cost for the service was similar to a physician office visit copayment, but less than the fee of an urgent care or emergency room visit. This cost was similar to the fee the WesternU PCC Pharmacy had established for pharmacist-initiated hormonal contraceptive consultations, which is also operates as a “cash-only” service. Some insurance companies may reimburse patients for these tests, so claim paperwork can be provided to the patient in order to receive reimbursement from the insurance company. Potential billing opportunities might be available once APh services are recognized by third-party payers. In addition to the consultation fee, eligible ​patients pay the copayment for oseltamivir in accordance with their insurance plan. The benefit of starting treatment in a timely manner and reducing the duration of the illness often outweighs the cost of the service to the patient.

Marketing and advertising

For the pilot clinic, the service was advertised to the university student body and staff via mass emails and handing out flyers. In the community pharmacy setting, this service can be advertised via information board and putting flyers in the prescription bags. Additional marketing avenues can include direct mailers, social media, and brochures at the physician’s office.

Cost

Since additional space and personnel are not required, cost associated with implementation of such service is minimal. Initial expense is associated with obtaining the CLIA laboratory certificate and purchasing testing supplies. Training of the personnel is typically done by the manufacturer at no cost. Additional expenses might include marketing materials, and will vary depending on the type of advertisement.

Outcomes of the pilot clinic

Since initiation of the pilot clinic, 10 students presented to the clinic with acute symptoms consistent with influenza. The pharmacist deemed these students eligible for the RIDT, but all patients tested negative for influenza. Results of the tests were not surprising since influenza vaccination is mandatory for all students. Patients that presented to the clinic did not object to the out-of-pocket consultation fee for the assessment and test and were pleased with the option to be seen right away. All patients were given recommendations regarding self-care management to help alleviate the symptoms. Marketing efforts will be escalated in the coming years in order to increase awareness of this service at the pharmacy.

Initiation of this unique service in the community pharmacy will increase accessibility to oseltamivir and thus minimize duration of the flu and the costs associated with it. In addition, it will support providers by decreasing patient load and minimizing exposure to influenza in the primary and urgent care setting. Furthermore, it will allow pharmacists to integrate themselves into a collaborative practice and an interprofessional patient-centered team approach. It will also increase the pharmacists’ presence and impact in the healthcare arena.

1. Influenza statistics (2017).

2. Vaccination Effectiveness Studies (2005-2016).

3. Havers F, Sokolow L, Shay DK, Farley MM, Monroe M et al (2016). Case-Control Study of Vaccine Effectiveness in Preventing Laboratory-Confirmed Influenza Hospitalizations in Older Adults, United States. Clinical Infectious Diseases 63:1304-1311.

4. Key Facts About Seasonal Flu Vaccine (2016).

5. Dobson J, Whitley, RJ, Pocock S. Oseltamivir (2015) treatment for influenza in adults: a meta-analysis of randomized controlled trials. The Lancet 385:1729-1737.

6. Ferdinands JM, Olsho L, Agan A, Bhat N, Sullivan RM et al (2013). Effectiveness of Influenza Vaccine Against Life-threatening RT-PCR-confirmed Influenza Illness in US Children. Journal of Infectious Diseases 210: 674-683.

7. Jefferson T, Jones M, Doshi P, Spencer EA, Onakpoya I et al (2014). Oseltamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments.

8. Healthy People 2020.

9. Wait Time for Treatment in Hospital Emergency Departments.

10. Urgent Care Association of America (2012).Urgent Care Benchmarking Survey. Results. Urgent Care Industry Information Kit.

11. Caldwell N, Srebotnjak T, Wang T, Hsia R. (2013).“How Much Will I Get Charged for This?” Patient Charges for Top Ten Diagnoses in the Emergency Department.

12. National Center for Chronic Disease Prevention and Health Promotion (2012). A program guide for public health: Partnering with the pharmacist in the prevention and control of chronic diseases. Atlanta: Centers for Disease Control and Prevention.

13. California Board of Pharmacy - Regulations. Board of Pharmacy - Regulations. Business and Professions.

14. CLIA-waved Tests.

15. Klepser ME, Dering-Anderson AM, Klepser SA (2014).The Pharmacist Will Screen You Now.

16. Klepser ME, Klepser DG, Dering-Anderson AM, Morse JA, Smith JK et al (2016). Effectiveness of a pharmacist-physician collaborative program to manage influenza-like illness. Journal of the American Pharmacists Association. 56:14-21.

17. Clinical Laboratory Improvement Amendments (CLIA).