American Outcomes Management, L.P. (AOM) considers the safety of our patients and staff our top priority. We are monitoring the situation and will inform our patients if we foresee any impact to normal pharmacy operations due to the virus. Please see the current CDC information here for an up-to-date status on the virus.

What is COVID-19?

The Center for Disease Control (CDC) is responding to an outbreak of respiratory disease caused by a novel (new) coronavirus that was first detected in China and which has now been detected in more than 150 locations internationally, including in the United States. The virus has been named “SARS-CoV-2” and the disease it causes has been named “coronavirus disease 2019” (abbreviated “COVID-19”). As of March 11, 2020, the World Health Organization has declared the situation a pandemic.

What are the symptoms of COVID-19?

Common signs of infection include respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure, and even death. Early information out of China, where COVID-19 first started, shows that some people are at higher risk of getting very sick from this illness. This includes:

• Older adults, with risk increasing by age.
• People who have serious chronic medical conditions like:
• Heart disease
• Diabetes
• Lung disease

How is COVID-19 spread?

Human coronaviruses are usually spread from an infected person to others through the air by coughing and sneezing and through close personal contact, such as touching or shaking hands.

FREQUENTLY ASKED QUESTIONS

Can COVID-19 live on a pill bottle or packaging?

It may be possible that a person can get COVID-19 by touching a surface or object that has the virus on it and then touching their own mouth, nose, or possibly their eyes, but this is not the primary way the virus spreads. In general, coronaviruses do not live well outside of the body and the vast majority of transmission is by droplet from direct contact with infected individuals. Patients can take extra precautions by wiping down the external mailing package with a disinfectant wipe before they open, and always wash their hands after.

Is my medication safe to take?

Does taking my medication put me at higher risk?

Currently, there are no data showing increased risk for patients taking any specific medications. The CDC lists the following populations as higher risk for getting very sick:

• Older adults
• People who have serious chronic medical conditions like:
  • Heart disease
  • Diabetes
  • Lung disease

Will I still receive my home infusions while people are being asked to stay home?

Yes. The health and well-being of our patients is our top priority. We are well prepared to meet the medication needs of our patients so you can stay healthy. We maintain universal precautions regardless of the patient’s illness, and will continue to work with your physician to determine the best course of action. We have an effective Infection Control plan in place, and have stringent processes to protect each patient and nurse.

PREVENTION IS KEY

Consider the following when thinking about symptoms of the common cold vs. the coronavirus:

• If you have a runny nose and sputum, you likely have a common cold.
• Coronavirus pneumonia presents as a dry cough with no runny nose, often accompanied by a fever. If you experience these symptoms, you should call your doctor.
• Stay hydrated and get plenty of sleep.
• You should wash your hands frequently. The virus can only live on your hands for a period of time, but a lot can happen during that time: you can rub your eyes or touch your nose or mouth unwittingly.
• Most importantly, remember that this illness is very mild in 80% of people who have it, and our children do not appear to be getting sick at all except in very rare cases.

It’s important to maintain the steps we’ve recently taken regarding our hygiene and begin to follow new social distancing guidance when working from home or after you leave the workplace:

• No playdates, parties, sleepovers or families visiting each other's houses. This sounds extreme because it is. The idea behind social distancing is to create distance between family units and between individuals across those family units. It is uncomfortable, especially for families with small children or for kids who love to play with their friends. But even if you choose only one friend to invite to your home, you are creating new links and possibilities for the type of transmission that all our school/work/public event closures are trying to prevent. The symptoms of coronavirus take four to five days to manifest. Someone who comes over looking well can transmit the virus.
• Take walks/runs outside, but maintain distance (ideally six feet between people outside your family).
• Try not to use public facilities like playground structures as coronavirus can live on plastic and metal for up to three days, and these structures aren't getting regularly cleaned.
• Do not visit nursing homes or other areas where large numbers of the elderly reside, as they are at highest risk for complications and mortality from coronavirus.
• Reduce the frequency of going to stores/restaurants/coffee shops for the time being. Trips to the grocery store will be necessary but try to limit them and go at times when the store is less busy.
• Take-out meals and food delivery are riskier than making food at home given the links between the people who prepare food, transport the food, and you. It is hard to know how much that risk is, but it is certainly higher than making meals at home.

The wisdom of early and aggressive social distancing is that it can flatten the curve of viral spread, prevent the overwhelming of our health system, and eventually reduce the length and need for longer periods of extreme social distancing later (evidenced by what has transpired in Italy and Wuhan). We all need to do our part during these times, even if it means some discomfort. We will get through this. It is important to practice healthy habits by aiming for the recommended eight hours of sleep, drinking plenty of fluids and eating a well-balanced diet. Be calm, take care of yourself and your family, and follow public health guidelines.

PROTECTIVE MEASURES

• Stocking a two-week supply of water and food.
• Ensuring you have a continuous supply of regularly needed prescription drugs.
• Stocking up on nonprescription drugs and other health supplies. This includes pain relievers, cough and cold medicines and vitamins.
• Locating and storing copies of personal health records from doctors, hospitals, pharmacies and other sources for personal reference.
• Having a plan with family members and other loved ones on how they will receive care if they get sick or what will be needed to care for them in your home. voiding close contact with people who are sick
• When sick, keep your distance from others to keep germs from spreading.
• Covering your mouth and nose with a tissue when coughing or sneezing.
• Avoiding touching your eyes, nose or mouth to prevent infection.
• Getting plenty of sleep, being physically active, managing your stress, drinking plenty of fluids and eating nutritious food.

RESOURCES

DEPARTMENT OF HEALTH OR PUBLIC HEALTH OFFICER

• New York State: 518-474-1142 after hours: 866-881-2809
• New Jersey: Contact the local health department www.localhealth.nj.gov
• Texas: 817-264-4500 (Fort Worth)
• Connecticut: 860-509-7994

For AOM Patients Receiving IVIG

Plasma Protein Therapeutics Association Statement PPTA considers that the SARS-CoV-2 outbreak is not a concern for the safety of plasma protein therapies manufactured by PPTA member companies based on the following information:

• Based on the current epidemiological evidence, the virus is not currently spread widely in the communities in the U.S and Europe (1, 9, 11) and therefore, it is unlikely that the virus is present in U.S. and European populations. Moreover, donor screening procedures are in place to prevent individuals from donating plasma who show typical disease symptoms (raised temperature/ fever, cough, difficulty breathing) of a coronavirus infection, including COVID-19.
• The SARS-CoV-2 is a large sized virus (approximately 120 nm in diameter) (12, 13). The relatively large size and lipid envelope makes it highly susceptible to steps with virus inactivation and removal capacity used during the manufacturing processes, such as solvent-detergent (S/D) (14), low pH incubation, caprylate-, pasteurization- (15) or dry-heat treatments (16), nanofiltration or fractionation processes and others (17). The effectiveness of these processes has been demonstrated on other lipid-enveloped model viruses which are quite similar to 2019-nCoV, e.g. human coronavirus 229E and OC43, SARS-CoV, and porcine coronavirus TGEV (10, 15, 18, 19).
• Based on these data, PPTA is convinced that existing manufacturing methods provide significant safety margins against the SARS-CoV-2.
• Public health bodies in the U.S. (CDC) and in Europe (ECDC), the WHO, as well as Chinese authorities, are continuously monitoring the situation and have put in place proactive measures to monitor SARS-CoV-2 infection in Europe and in the U.S., as well as internationally, including issuing travel guidance for Wuhan City, Hubei Province, China (1, 20, 21, 22), testing (23, 24) and reporting guidance, and adding entry health screening and travel restrictions at major U.S. (25) and international airports for passengers coming from Wuhan City and / or China (26).
• Based on strict screening procedures for plasma donors and the established processes of virus inactivation and removal during manufacturing of plasma-derived products, PPTA concludes that the SARS-CoV-2 is not a concern for the safety margins of plasma protein therapies manufactured by PPTA member companies.
• https://www.pptaglobal.org/media-and-information/ppta-statements/1055-2019-novel-coronavirus-2019-ncov-and-plasma-protein-therapies

IgNS Statement Regarding the Novel Coronavirus (COVID-19 or SARS-CoV-2)

The recent outbreak of the 2019 Novel Coronavirus (COVID-19 or SARS-CoV-2) has raised awareness around the safety of plasma protein therapies in the US and worldwide. COVID-19 (or SARS-CoV-2), initially detected in Wuhan City, China, has now spread to over 37 locations, both internationally and within the US.

This new strand of Coronavirus is similar to, and in the same viral family as the Middle Eastern respiratory syndrome (MERS-CoV) and the Severe Acute Respiratory Syndrome (SARS-CoV).

COVID-19 (or SARS-CoV-2), a large, lipid-enveloped virus, was most likely introduced to the human population through contact with the secretions of infected animals in Wuhan, China.

Due to its morphology (presence of a lipid envelope) and size, COVID-19 (or SARS-CoV-2) is considered to be highly susceptible to viral inactivation and removal processes currently employed by plasma protein product manufacturers. These processes include the use of solvent/detergent treatment, caprylate, nanofiltration, pasteurization, and other dedicated viral inactivation and removal steps.

Further, strict screening processes and ongoing monitoring of qualified plasma donors in the US provides an additional layer of safety around plasma used to manufacture plasma protein therapies.

The Plasma Protein Therapeutics Association (PPTA) has issued an update to address the concerns of plasma safety in the face of a potential pandemic (www.pptaglobal.org). Based on the available data, PPTA does not believe that COVID-19 (or SARS-CoV-2) poses a risk to the plasma supply in the US.

Please visit our website for current information regarding the Coronavirus:

https://ig-ns.org/igns-coronavirus-update/?mc_cid=1c1b740d04&mc_eid=87b6de0f09

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