Become your community’s hub for diabetes care
The Compliance Team is out in front once again with a simplified, operations-based, Diabetes Self-Management Training (DSMT) accreditation program that can create a new revenue stream for Part-B DMEPOS providers.
Listen to Sandy Canally, founder and CEO of The Compliance Team, talk about our newest program:
Sandra Canally introduces Diabetes Self-Management Training Accreditation
Yes, you can deliver diabetic supplies!
Competitive bid contracts expired on December 31, 2018. This included the contracts for national mail order diabetic supplies. The current round of bidding, with contracts to take effect on January 1, 2021, does not include diabetic supplies.
What does this mean to you? The restriction on delivery of diabetic supplies, either by mail or in-person, is no longer in place and your business is now able to offer the convenience of delivery of diabetic supplies to your patients.
If you are delivering in person, and already accredited for glucose meters and supplies (non-mail order product category DM05), no action is needed. If you are delivering through the mail, you must also be accredited for mail order glucose meters and supplies (product category DM06).
If your business is not currently accredited for mail order, and you are interested in mail delivery, please contact our home office at 215-654-9110 or submit your request/question via the “Client Services” tab on our website.
The Compliance Team celebrates 25 years!
Preparing your pharmacy operations
By Charles Lager, RPh, MBA, Senior Pharmacy Advisor
In February 2016, the United States Pharmacopeia (USP) published new Chapter <800> standards addressing the handling of hazardous drugs (HD) in healthcare settings. The new standards become enforceable December 1, 2019. Please check with your State Board of Pharmacy, as some states have delayed the implementation.
This is the first enforceable set of standards that protects patients and healthcare personnel from risk of hazardous drugs. Failure to comply with these new standards can not only impact the health of your staff, it can also result in fines for non-compliance.
Note: When USP uses the terms “Shall” or “Must”, what follows is deemed to be a required element. Please pay attention to this throughout this article.
Exposure and Potentials Risks
More than 8 million workers are exposed to hazardous drugs every year and more than 12 billion doses of hazardous drugs are handled by U.S. providers each year. The risks to the healthcare worker are cancer, infertility and reproductive outcomes with symptoms of hair loss, cardiac toxicity, hearing loss, nausea and rashes.
Who is at Risk? Pharmacists, Pharmacy Technicians, Nurses, Physicians, Physician Assistants, Home Health Aides, housekeeping, janitorial and environmental services, veterinarians.
Types of Exposure:
- To workers; dermal absorption, mucosal absorption, inhalation, injection and ingestion.
- How? Receipt, dispensing, compounding & other manipulation, administration, patient care activities, spills, transport and waste.
What is a Hazardous Drug? The Occupational Safety and Health Act of 1970 established NIOSH.
- National Institute of Occupational Safety & Health (NIOSH) List: Anti-neo-plastics, Non-anti-neo-plastics, reproductive only hazards. This was established as a research agency focused on the study of worker safety and health, and empowering employers and workers to create safe and healthy workplaces.
- Any drug identified by at least one of the following criteria: Carcinogenic, Teratogenic or developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxic and similar drugs whose structure and toxicity are similar to existing drugs.
Approach to Compliance
This chart describes the descending steps to protect workers and patients.
Key Steps to Compliance in your Pharmacy:
• Review the NIOSH list to identify any potential hazardous drugs
• Perform an Assessment of Risk (AOR), this will identify any alternative strategies. Note: there are many templates available online to utilize.
• Type of hazardous drug
• Dosage form
• Risk of exposure
• Identify the drugs and dosage forms that are stocked
• Determine your approach to containment strategies
What are the personnel requirements?
• You MUST have a DESIGNATED PERSON assigned to oversee the program.
• If your Pharmacy is compounding the personnel MUST be qualified and trained to:
• Understand fundamental practices and precautions
• Continually evaluate these procedures
• Continually evaluate final HD preparations
• Minimize exposure to personnel
• Minimize contamination of the environment
• Personnel of reproductive capability MUST confirm in writing that they understand the risks on handling hazardous drugs.
• Demonstration of competency MUST be documented every 12 months.
• Appropriate Personnel Protective Equipment (PPE) MUST be worn when handling hazardous drugs including during:
• Spill Control
• Waste Disposal
What are the Community Pharmacy implications for compliance?
• MUST have Policy & Procedures addressing receipt, storage, compounding (if applicable), dispensing, disposal.
• MUST perform an Assessment of Risk (AOR)
• If the drug is on the NIOSH list, no option, MUST treat with all containment strategies
• Identify through assessment of risk the crushing of tablets or opening of capsules to make suspensions
• Splitting of tablets
• Packaging; can you tell from the outside of your packages that a hazardous drug is inside?• Identify the hazardous drugs by unique bins or shelf stickers
• When possible, buy any hazardous drugs in unit-of-use packaging
• Use separate equipment for chemo drugs
• Designated counting tray and spatula
• Wear chemo gloves tested to ASTM D6978
• Decontaminate tray after use
• Store hazardous drugs in separate and identifiable bins
• Clearly note what must be done if manipulation of dose is required
What are the Non-Sterile Compounding Implications for Hazardous Drugs?
• Prepared in a Containment Secondary Engineering Control (C-PEC) room
• Room with fixed walls separate from non-hazardous compounding
• Room MUST be negative pressure
• Vented to the outside
• Have at least 12 air changes per hour
• MUST have a Ducted Containment Ventilated Enclosure (CVE)
• Filtered Exhaust Hood with single HEPA filter
• Personnel Protective Equipment that is required
• Must be disposable
• Must be shown to resist permeability by HD’s
• Should be made of polyethylene-coated polypropylene or other laminate material
• Must close in the back
• Must be long sleeved
• Must have elastic or knit closed cuffs
• Eye & Face Protection
• Required when there is a risk for spills or splashes
• Required when working outside of a C-PEC
• Respiratory Protection
• Use of a N-95 Respirator mask is best practice
• When unpacking HD’s not contained in unit of use packaging
• When attending HD spills
• Best practice for Spill Management
• Personnel MUST receive proper training
• MUST have policies and procedures that address:
• Size and scope of the spill
• Specify who is responsible for spill management
• Determine the type of PPE required
• Address the location and capacity of spill kits
• Spill materials MUST be disposed of as hazardous wasted
• MUST document the spill circumstances and management
USP <800> Handling of Hazardous Drugs in Healthcare Settings becomes effective December 1, 2019. The implementation of USP <795> and USP <797> chapters on Non-Sterile Compounding and Sterile Compounding have been postponed. The Compliance Team will strive to keep all our Pharmacies informed of any changes as they occur. For more information, go to https://www.usp.org/general-chapter-hazardous-drugs-handling-healthcare.
The Compliance Team wins 2019 new product award
For the third year in a row, The Compliance Team has won HME Business’ Product Award for Business Services. The award was granted for The Compliance Team’s new Diabetes Self-Management Training accreditation program. Read the article here. For information on the new program, listen to the podcast above.
Pay invoices online.
There are two ways to get to the payment page on our website:
- Click the Pay Invoice button in the footer of any page on our website
- Click the Pay an Invoice button under the Client Services tab above
If you are having trouble accessing the page, please let us know by calling the office at 215-654-9110.
Exemplary Provider digital logos
We have new Exemplary Provider digital decals that you can add to your website or to your marketing materials. You can choose between generic or custom decals that include the accreditation tracks e.g. DMEPOS, Community Rx + DMEPOS, Long Term Care Pharmacy, Specialty Drug. Contact Marilyn, our communications advisor, for details, firstname.lastname@example.org.