Q&A with Mike Dovidio, PharmD, Pharmacy Director at PharmaLabs
Patients are asking menMD about the safety of their medications in light of the COVID-19 pandemic. We asked Mike Dovidio, pharmacist to help us provide detailed answers.
I am an immunocompromised patient in the danger group for contracting COVID-19. Are the medications I receive from you safe to use?
menMD’s pharmacy partners maintain operations above compliance requirements per the United States Pharmacopeial Convention (USP) chapter <797> for pharmaceutical compounding of sterile preparations. Sterility means lack of contamination from infectious agents including germs and viruses. menMD pharmacy partners follow these guidelines to prevent medicine from being contaminated. The safety measures include, but are not limited to:
- Specialized air-filtered, particle-free rooms designed specifically for sterile compounding
- Multiple layers of head to toe protective garbing—meaning zero skin showing anywhere
- Sterilization of the medication at end of production process
- 28-day ‘challenge’ sterility testing. Preservatives are added to all sterile medications to prevent contamination up to 28-days after first vial puncture
- Quality assurance checks from certified, third-party testing labs to ensure vials are sterile and safe to use before they are dispensed to patients
What safety protocols is the pharmacy staff using when making medication and packaging my order? Also the contact with the USPS and FedEx drivers?
In addition to the safety steps mentioned above, menMD’s pharmacy partners are abiding by all current CDC recommendations. This includes wearing face masks while at work, sanitizing work stations throughout each day, maintaining a six-foot distance, and washing hands multiple times throughout the day.
No one is allowed inside of the pharmacy area, except for pharmacists and pharmacy technicians. Specifically, FedEx and USPS employees are not allowed inside of the pharmacy for package delivery or pick-ups.
Are your products from China?
menMD’s pharmacy partners are only allowed to purchase products from FDA approved wholesalers, also called ‘re-packagers.’ These wholesalers source products from all over the world, perform analytical testing upon receipt of products, and issue products in smaller quantities to our pharmacy partners with documentation. Documentation serves as proof that the products are correct and serves as a way to track product origin.
The pathway from drug manufacturers to US-based compounding pharmacies is specifically designed to provide quality control and ensure traceability. The product pathway includes FDA oversight and testing at every step:
1. Manufacturers make the product. Manufacturers must obtain FDA approval before they can ship a single product. FDA approval is not easy to obtain and requires manufactures to test new medications over a period of years (not months) before approving a drug to be sold to wholesale re-packagers. Once approved for sale, the FDA requires the manufacturer to implement quality assurance testing to validate that the approved drug is manufactured properly every time.
2. The wholesaler re-packages and conducts their own studies on the products they receive from manufacturers. Some tests are the same as the manufacturer’s and some are completely different. The wholesaler must also be inspected and approved by the FDA before they can repackage and resell the product to a compounding pharmacy.
3. Compounding pharmacies have their own set of quality assurance and efficacy and challenge testing that must be conducted on all medications prior to being dispensed to patients.
Medication powders used specifically in our medication preparations are produced by FDA approved manufactures around the world including Europe, Asia (including China), and North America.
Are the medications safe, or could they be carrying COVID19?
Yes, the medications are safe to use. Each pharmacy partner that works with menMD completes quality assurance testing before releasing a product for dispensing. Testing includes sterility, endotoxin, and challenge testing.
What sort of testing does your medication go through to ensure it is safe from COVID19?
Medications do not go through a specific test to ensure it is safe from COVID19. However, every batch of sterile preparations goes through a sterility test from an outside lab before it can be dispensed to patients. If the medication was contaminated in any way, it would fail this test.
Are there exceptions to “Early Refill” of routine medications? For example, Testosterone.
Testosterone products can only be refilled early with authorization from the doctor. If you need to refill a testosterone containing preparation early, please speak with your PSC to start that process.
Can I get a larger quantity of a prescription that I fill monthly?
menMD’s pharmacy partners set quantity limits on prescriptions in accordance with industry standards. Ordering a larger quantity of medication is treated on a case by case basis. Generally, ordering additional quantities is as easy as asking your PSC, with the exception of testosterone containing preparations (which require early refill authorization from a doctor).
Should I do anything with the package I am receiving before bringing it into my home?
As with any packages delivered by hand to your doorstep, you should wear gloves when handling the packaging. If you don’t have gloves, wash your hands with soap for a minimum of 20 seconds immediately after unpacking the contents. It is best to sanitize the package and the contents prior to use.
Should I stockpile my medication and/or supplies like prep pads, syringes, etc.?
No! Stockpiling supplies like prep pads and syringes leads menMD’s pharmacy partners to run out of those supplies faster than normal. menMD’s pharmacy partners work with a very large variety of suppliers and re-packagers and under normal circumstances they rarely stock out.
Is menMD running out of medication and supplies?
At this time, menMD pharmacy partners have no shortages of medication or pharmacy supplies and we do not anticipate any long-term shortages in the foreseeable future.
Does menMD anticipate any type of delays to dispense my prescriptions?
At this time, menMD does not anticipate any type of delay.
What are the benefits of using home delivery during the pandemic?
Two words: social distancing. It couldn’t be more important at this time to practice social distancing. Using home delivery allows you, as the customer, to have the most control over what you are exposed to. As opposed to traveling out to the store or pharmacy, where there are infinite possibilities of being exposed to COVID.
What will happen to my prescription if the pharmacy closes due to the pandemic?
The benefit of using menMD is that we work with multiple pharmacy partners. That being said, if a pharmacy closes because of the pandemic, your prescription would be transferred to the pharmacy of your choice. You would have to request that through your menMD Patient Service Coordinator.
If my medication is coming with a signature required will I still need to sign for it because of the no contact order?
No. Shipping companies, like FedEx and USPS, are not requiring signatures from customers. Instead, delivery men and women are signing in good faith that they delivered the package correctly. This is to avoid contact during their delivery route.
We’re Here to Help
If you have more questions about medication safety or your treatment plan, menMD’s Patient Service Coordinators and Clinical Case Managers are available to help. Please call us at (857) 233-5837 or go online to menMD.com/portal to chat live.