Have you had any recalls to date? If so, what were the issues?

There have been no recalls and no issues.

What is the expected turnaround time to receive an order?

We use Fed Ex standard two-day shipping, with an overnight delivery option.

How will the products be packaged?

They come in a pack of 10 for vials, and a pack of five for syringes.

Is there a return policy?

We do not typically accept returns unless it was an error made by us.

What would be the BUD for SNAP-N-GO vs DILUTE-N-GO?

We operate on expiry dates, as long as the product is unopened. Once the product is mixed, refer to the package insert or USP <797> guidelines.

Would there be a different BUD for SNAP-N-GO when connected in laminar flow hood vs. nurse connecting?

Yes. Please refer to the appropriate package insert on the vial adapter used for BUD information.

Do products from a 340b facility fall under the Drug Supply Chain Security Act?

No. These products apply to drug manufacturers, not 503B compounding facilities.

How long does it take to deliver your products to me, and is there a cost for shipping?

We use Fed Ex standard two-day shipping. Yes, there are shipping charges for orders and for special needs such as refrigeration or a STAT order. Most times, standard shipping charges can be negated by setting up standing orders or signing a contract.

Are you concerned that your DNG syringe will be incorrectly used such as direct injection?

We have considered this, and that is why we branded the offering as DILUTE-N-GO. The name quite purposely says it all. We have also included multiple warnings that the drug MUST be further diluted in bold red font on all of our labels. We also recommend that the DNG syringe is meant to be used ONLY in the pharmacy and is not meant to be placed in ADMs.

Are SNAP-N-GO® and DILUTE-N-GO® FDA approved?

No. As a Human Drug Compounding Outsourcing Facility, Pentec Health products are exempt from the FDA approval process. However, our manufacturing facilities go through an inspection process for their conformance to the Code of Federal Regulations (CFR). Pentec Health has filed patent applications for SNAP-N-GO and DILUTE-N-GO.

Can you add products that we use locally but are not in your catalog?

We are delighted by the feedback we receive from our customers! If there is enough volume and interest, Pentec Health does have the flexibility to add products to our catalog.

Do you share copies of your FDA-483 with customers after routine and for-cause FDA inspections?

Yes. This information is public and posted on the FDA website.

Can you provide a completed copy of the ASHP Assessment for 503B Compounding Facilities?

Yes. Please contact a member of our Sales Team to receive a copy.

Do you use API for compounding?

Yes. We utilize FDA-approved API manufacturers for compounding our products. Additionally, we have over 30 years of experience in high-risk compounding, giving us the flexibility to provide unique formulations for our customers.

What information is contained in a Certificate of Analysis or a Certificate of Conformity?

We proactively send customers these certificates. Each one features an executive summary highlighting what you need to know and details the results of purity/identity, potency, particulate, sterility and endotoxin testing for every batch sent. These certificates are also available on our e-commerce site.

Do you cycle your cleaning products?

Yes, we utilize multiple cleaning and sanitization agents while cleaning our equipment and areas at regular intervals. These agents are rotated to avoid possible resistance of microorganisms to these agents.

How does Pentec deal with micro/chemistry results outside of established parameters?

In an event of results outside of established parameters, the batch is immediately quarantined and a laboratory investigation is initiated according to standard operating procedures. All the aspects involved in receipt, manufacturing and testing are adequately challenged throughout the investigation to determine the root cause of the failure. Only at the conclusion of this investigation is an appropriate disposition taken on the affected batch.

How do you test products internally?

Each batch that is produced goes through release testing in our in-house Quality Laboratories. The batch is placed into quarantine until testing has been completed by Quality personnel. This testing includes purity/identity, potency, particulate, sterility and endotoxin testing. All sampling and testing methods used are either in accordance with USP compendia testing requirements or have been validated and shown to be equal to or better than the USP methods. Once testing has been completed, results are reviewed by Quality Assurance. The product is then released or rejected depending on the outcome of the testing and complete review of the batch record.

Do you perform your own stability testing on unique concentrations or is it outsourced? Can we obtain that data for TJC/CMS surveys if that data is outside the package insert information?

Testing on concentrations is not outsourced. Our trained and qualified personnel perform stability testing on all our concentrations in our in-house, fully equipped Quality Control Laboratory. Every product ships with a Certificate of Analysis that documents its test results. The certificate is also available to customers on request.

How do I know my product is pyrogen-free?

Every production batch is tested by Quality Control to ensure it meets predetermined Quality specifications, including testing for endotoxins. Every product ships with a Certificate of Analysis that documents its test results.

How do you ensure you have enough products to serve customers?

We have relationships with primary, secondary and tertiary sources of FDA-certified suppliers to ensure we have a seamless material supply. In addition, the raw materials provided by our suppliers typically do not expire for up to three years. Also, we never exceed 70% of our production capacity. This ensures all of our customer needs can be met.

What if there is a shipment delay?

Pentec Health has a Sales Team, consisting of an Account Executive, Account Consultants, Client Liaisons and Customer Service Representatives that will work together to send notifications, as needed, in the event of a delay. We also have a website and an e-commerce site that give us ability to post real-time announcements.

Is testing internally a conflict of interest?

For some organizations, it could be. But at Pentec Health, we are fully compliant with the U.S. FDA 21 CFR 211.22 (a) standards. These require every facility to have a dedicated Quality Control unit. This unit has an independent responsibility and the authority to approve or reject all components, labeling and finished products. The FDA also expects every Quality Control unit to have an independent reporting structure to senior management. This enforces a Quality Culture throughout the organization. Additionally, at Pentec Health, we have our own Enterprise Resource Planning (ERP) software. It enables thorough tracking and traceability of materials and finished product, plus it records all testing of raw materials and finished products at the lot number level. When you choose Pentec Health, you are working with a leader in the industry with more than 30 years of reliable, proven service and solutions.

How does Pentec Health handle recalls? How are customers notified?

If such a situation would arise, Pentec Health is fully committed to remaining compliant with the FDA requirements for conducting any drug recall. Standard operating procedures are in place specifically to address how a recall is to be conducted, including steps to alert the FDA and customers, as needed. Initially, during customer enrollment, we ask for your preferred email to be used in case of a recall. Our validated Enterprise Resource Planning (ERP) system tracks and documents the life span of all products. If a lot number does need to be recalled, we can track each order by its date, time and end user. What makes Pentec Health unique, though, is that our Customer Service and Sales Team will proactively contact you in the unlikely event of a recall.

How do I get help if I have any problems?

Patients served by Pentec Health can contact our nursing and pharmacy personnel 24/7 to address any health-related issues. If the problem you are experiencing is beyond our ability to help, we will contact your physician and work closely with him or her. Pentec Health has more than 15 years of experience managing patients with IT pumps, so chances are good that we can help you immediately.

How do I know if my insurance will pay for your in-home service?

Once you and your doctor decide that our in-home nursing service is right for you, our team of reimbursement specialists will work with your insurance company to determine your coverage level. We will contact you with the information obtained from your health plan about your benefits and out-of-pocket costs before we start caring for you at home.  Pentec Health contracts with many health plans and insurance companies, and each offers different levels of coverage. Medicare and Medicaid are also particularly restrictive about what is covered at home. You will have the final say about in-home treatment, of course. But if you can’t afford your portion of the bill, we may be able to help.

What can I expect during the initial visit from my Pentec Health nurse?

A Pentec Health nurse will call you a day or two before the scheduled appointment to confirm that the date and time still work for you. You can expect your Pentec Health nurse to arrive at your home within 30 minutes of the agreed-upon time. There are some admission forms for you to sign and the nurse will explain the entire refill process to you. The initial visit will last about two hours. A complete medical history and medication profile will be completed along with a physical examination that includes a pain or spasticity assessment. Your nurse will have all the necessary equipment and medication with him or her to perform your pump refill. He or she will also provide you with a copy of the telemetry printout as well as emergency contact information, so you can reach us 24 hours a day, 7 days a week. 
Before your nurse leaves, the two of you can decide on a convenient date for your next visit.

What can I expect during routine visits from my Pentec Health nurse?

A Pentec Health nurse will call you a day or two before your scheduled appointment to confirm that the date and time still work for you. Your nurse will arrive within 30 minutes of the agreed-upon time with all the necessary equipment and medication to perform the pump refill. Your nurse is there for you, so take full advantage of his or her expertise. He or she will ask how you are feeling and if you experienced any changes since the last visit. The nurse will take your vital signs and do a head-to-toe assessment of your bodily functions to uncover any issues you may be having, whether these issues are with the pump or otherwise. If your doctor ordered any changes to your pump medication(s), your nurse will review that with you before performing the refill. You will always be given a copy of your telemetry printout to keep with you in case of emergency. Before leaving, the two of you can decide on a convenient date for your next visit.

Who performs pump refills?

Most patients are forced to go to their doctor’s office or hospital for routine refills because very few companies are qualified to provide this service in the home. Pentec Health is the exception to the rule. Our team of highly trained nurses has years of experience providing in-home care to patients with implanted pumps. We utilize a primary care nursing model to ensure continuity of care. This allows you to develop a long-term relationship with your nurse.

Is in-home care right for me?

Regardless of why you have an implanted pump, in-home care is an attractive option for you. Patients who experience physical discomfort during transportation, who live long distances from the doctor’s office, who require frequent pump refills or who have caregiver support issues all benefit immensely from the convenience of Pentec Health’s in-home nursing service. We don’t replace your doctor, but we act as an in-home extension of your doctor’s office.

How do I sign up for Pentec Health’s in-home nursing service?

You should discuss your situation with your doctor. If your doctor agrees that in-home care is appropriate for you, he or she will refer you to Pentec Health. Once that is done, our team will contact your doctor to obtain necessary medical information and your insurance company to determine your coverage for in-home care. When we have all the information we need and have secured coverage from your health plan, we will assign a Primary Care Nurse to you. He or she will contact you and your doctor to determine a convenient date to begin in-home service.

What is an intrathecal pump?

An intrathecal pump is a medical device that is surgically implanted in your abdomen, with a catheter (a small tube) running from the pump and surgically fixed to the intrathecal space around the spinal cord. The pump has a small reservoir that holds a prescribed medication. This medication is administered very slowly through the catheter to control spasticity and/or pain. The dose is determined by a doctor and then the pump is programmed to dispense that amount by a trained professional. The medication in the pump needs to be replenished regularly to control your condition. The frequency of the refilling is determined by the size of the pump’s reservoir, the concentration of the medication and the rate the medication is being pumped through the catheter.

What is intrathecal drug delivery and why is it beneficial?

Intrathecal drug delivery places medication directly into the area that surrounds the spinal cord. This method of medication delivery allows for lower dosing of drugs than would be needed orally or subcutaneously (under the skin). It also delivers highly concentrated medication directly to where it is needed, thereby minimizing side effects and maximizing effectiveness. The medication does not enter the blood stream and is very beneficial if you have chronic conditions that are difficult to control.

Can a combination of drugs go in the pump?

Yes! For example, if your doctor decides that you would benefit from a combination of pain and spasticity medications, our specialty pharmacy will work with your doctor to determine which combination of drugs is best for you.

Are there any side effects to IPN?

Because Pentec Health’s IPN therapy is individualized and prepared safely based on your patient’s current PD regimen, he or she should not experience any side effects. If dehydration, or any other reported side effect does occur, a Renal Clinical Case Manager or Pharmacist can help determine the cause and treat it accordingly. Sometimes, dehydration can occur if the IPN is providing additional ultrafiltration.

How do I fill out an IPN prescription form?

A Renal Clinical Case Manager will ask the PD nurse to fill out the IPN prescription form once a covered benefit has been established for the therapy. The PD nurse will tell the RCCM what type, size and strength of bags the patient is currently using and together they will determine how to fit IPN in the current PD regimen.

Do you provide IPN in a cycler bag?

Yes, we can provide IPN in a Baxter or Fresenius cycler bag. Most patients receiving IPN with Pentec Health are receiving IPN in the cycler bag.

How much fluid should be calculated in the fluid removal goal to account for IDPN?

Fluid removal should be based on the astute judgment of the RN. However, there is free fluid in the IDPN that can be calculated in the fluid removal goal. For 2-in-1 IDPN, we suggest removing 80% of the total volume. For 3-in-1 IDPN, we suggest removing 75% of the total volume.

What is the source of dextrose used in the IDPN?

The dextrose used is derived from a corn base. If the patient has a true IgE allergy, then dextrose formulations are contraindicated.

What specific lab markers are reviewed quarterly by the Renal Clinical Case Manager?

Renal Clinical Case Managers review various lab markers. They primarily focus on, but are not limited to, albumin, nPCR, BUN, Kt/v, CO2, potassium, phosphorus and PTH. It is very important that they review treatment time and current weight quarterly as well. Anytime there is a major change with a patient, the RCCM should be notified.

How much dextrose is provided in the IDPN?

The amount of dextrose varies per patient based on his or her weight, dialysis runtime and whether or not weight gain is the goal. Patients who are not receiving a lipid formula will receive between 2–3gm/kg/min. For those who are receiving a lipid formula, they will receive 4–8mg/kg/min.

How fast can I expect to see an albumin level increase after receiving IDPN/IPN?

Each patient responds differently to the therapy so the response time will vary. Depending on the goal of therapy, whether it is an increase in albumin level, weight or both, we would typically like to see an increase in albumin level and/or weight after three months of therapy without a break in service.

How long will my patient need to be on IDPN/IPN therapy?

How long a patient needs to receive IDPN/IPN depends on the severity of the malnutrition and why the malnutrition has occurred. A Renal Clinical Case Manager (RCCM) will monitor your patient’s progress closely through lab tests and other evaluations. The patient’s lab results will be reviewed at least quarterly, and more frequently if the clinician alerts the RCCM of a change in nutritional status. Typically, the goal of the IDPN therapy is to see an albumin level increase to 4.0g/dL. Once the albumin level has reached this goal, we will determine when the therapy can be discontinued. The RCCM might suggest to hold the therapy or take a “holiday” from it to see if the patient can maintain nutritional levels on his or her own. Each individual responds differently to the therapy, so the length of time therapy is administered will vary from patient to patient.

How long will I need to be on IDPN/IPN therapy?

You will receive IDPN/IPN therapy during each dialysis treatment. Your doctor and dietitian will monitor your progress closely through lab tests and other evaluations. When your protein returns to normal levels, they will determine when to discontinue therapy. You might take a “holiday” from the therapy to see if you can maintain your nutrition levels on your own. Each individual responds differently to therapy, so the length of time therapy is administered will vary from person to person.

How can IDPN/IPN therapy help me?

Dialysis patients have higher nutritional needs, especially protein. Some dialysis patients may not have a good appetite or find it difficult to tolerate or afford oral nutritional supplements. IDPN/IPN therapies can provide significant amounts of necessary protein without requiring you to drink or eat. Protein is essential for tissue repair and wound healing as well as protecting you against infections. Dialysis patients need approximately 50% more protein than people not receiving treatments.

What is IPN?

Intraperitoneal Nutrition (IPN) is a therapy that provides protein as part of your regular dialysis regimen. Your Pentec Health nurse will add protein to your cycler or CAPD bag by removing some of the dextrose. The IPN will also provide the dialysis that is prescribed. Your doctor and dietitian can determine if you could benefit from IPN therapy.

What is IDPN?

Intradialytic Parenteral Nutrition (IDPN) therapy is a combination of protein and glucose, and sometimes fat, that is provided intravenously during dialysis treatments. It is administered by your dialysis nurse who connects the solution to the venous chamber of the dialysis machine. Your doctor and dietitian can determine if you could benefit from IDPN therapy.