1. provide a copy of their military orders to the licensing board in that state;
2. remain in good standing in their original state of licensure and any other state they are licensed in;
3. ​“submit to the authority of the licensing authority in the new jurisdiction for the purposes of standards of practice, discipline, and fulfillment of any continuing education requirements.”

1. accuracy of a device or drug product, and
2. dosage form of a filled prescription or medication order.

1. accuracy of a device or drug product, and
2. ​dosage form of a prescription or medication selected for stocking into a medication distribution system.​

1. one year of experience in Maryland, and
2. a product verification certificate issued by an approved technician certification program.

Continuing Education Breakfast 2023

Every Continuing Education Breakfast, the Maryland Board of Pharmacy recognizes the licensees who have held a pharmacist license for 50 years or more. Each licensee receives a citation from the governor, thanking them for their service. The citations were presented by the Board’s Executive Director, Deena Speights-Napata. This year we recognized the 2023 recipients. In attendance at the ceremony were six licensees: Cynthia Boyle, Arnie Clayman, Lisa Ann Dudley, Joseph Marrocco, Mark Miller, and Steve Silverman. One was also in attendance via the  webinar: Ellen Yankellow. 

Prescribing Practitioner Enrollment in Medicaid 

At The Maryland Board of Pharmacy board meeting held on November 15,2023 the Maryland Department of Health Office of Medicaid Provider Services and the Office of Pharmacy Services presented  an important update on Medicaid provider enrollment policy.

Beginning January 3, 2024, in order for states to comply with the federal Affordable Care Act requirements, Medicaid programs must deny any pharmacy claim in which the prescriber is not actively enrolled in Medicaid.

Current policy implementation applies to Fee-For-Service (FFS) claims only.

● Phase 1 Denials: (January 2024) Medicaid will deny pharmacy claims for non-behavioral health drug classes if the prescriber is not enrolled. “AS OF JANUARY 3, 2024, CLAIMS WILL DENY FOR UNENROLLED PRESCRIBERS. PRESCRIBER MUST ENROLL WITH MEDICAID."

● Phase 2 Denials: (July 2024) Medicaid will deny ALL pharmacy claims regardless of drug class if the prescriber is not enrolled​

Prescriber Enrollment Options

An individual practitioner may enroll as either: 1) A fully participating (billing or rendering) provider; or 2) An ORP-only Provider - Does not bill for services or sign a full Provider Agreement.

Provider Resources

Prescribers must enroll via ePREP.
● Contact the ePREP hotline for help with applications: 1-844-463-7768.

Enrollment guidance and training: https://health.maryland.gov/mmcp/provider/Pages/eprepresources.aspx

Send ORP enrollment policy questions to mdh.rxenroll@maryland.gov.

Event Corner: Notre Dame of Maryland University School of Pharmacy POD Exercise

On October 10, 2023 ten members from the BOP Emergency Preparedness Task Force (EPTF) conducted a Point of Dispensing (POD) Drill in the gymnasium of the Notre Dame of Maryland University School of Pharmacy.

PODs are where the public would go to receive prophylactic medications/vaccines in the event of an emergency. The scenario employed by the EPTF at Notre Dame Drill involved treating the public after the release of Anthrax by terrorists.

Thanks go to Notre Dame Dean Matthew Shimoda for his encouragement and strong support, Kim Eshleman and Joe White from the Baltimore City Health Department for their engagement and especially Thomas Franklin from the Howard County Health Department who was instrumental in creating the app that was accessed on the “patients" mobile devices. By all accounts this activity was deemed a success and Dean Shimoda has already invited the EPTF back for next fall to conduct another drill. ​

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UMES 10th Annual Point-of-Dispensing (POD) Drill for Students' Training on Disaster and Emergency Preparedness and Response

Hoai-An Truong, PharmD, MPH, FAPhA, FNAP, Professor, Director of Public Health, School of Pharmacy and Health Professions, University of Maryland Eastern Shore

In a continued effort to increase awareness of disaster and emergency preparedness training for future generations of pharmacists and other healthcare professionals, University of Maryland Eastern Shore (UMES) School of Pharmacy and Health Professions celebrated National Preparedness Month in September 2023 with the 10th Annual Point-of-Dispensing (POD) drill on September 12, 2023 as a sustained collaboration with the Somerset County Health Department (SCHD) and with support from the Maryland Board of Pharmacy Emergency Preparedness Task Force (EPTF), the Maryland Department of Health – Office of Preparedness and Response (OPR), and the Eastern Shore Collaborative for Interprofessional Education (ESCIPE). Special thanks to SCHD – Danielle Weber and Christopher Osment, from EPTF – Jennifer Thomas, Don Taylor and Cynthia Anderson, and from OPR – Christopher Kozub.​

Historically, the POD drill exercise was inaugurated in 2013 and continued through 2019 with a focus on mass prophylaxis or dispensing of ciprofloxacin and doxycycline for anthrax. This was a seven-year collaborative partnership of the above-mentioned groups that enabled faculty to convert to virtual POD drill in 2020-2021, as well as prepare students for volunteer roles at mass vaccination clinics during the COVID-19 pandemic. Ongoing interprofessional collaboration among faculty in medical laboratory science, nursing, pharmacy, physical therapy, physician assistant, and respiratory therapy brought together about 100 students for preparedness and response training. This 2023 real-world application- or skills-based training focused on a mass vaccination clinic for the influenza vaccination. Students exchanged roles as providers versus patients in two rounds and rotated through five stations, including: greeting, registration, consultation, vaccination, and observation. Students also received just-in-time-training, which occurred immediately prior to the start of the drill exercise for all students. Overall, it was a positive real-world experience for all those involved and increased awareness among students for disaster and emergency preparedness and response.​

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Inspection Trends- Second Quarter 2023

The Maryland Board of Pharmacy investigates complaints that come to the Board from various sources. Complaints may come from consumers, healthcare professionals, pharmacy boards outside of Maryland, federal agencies, OCSA and from Board inspections of pharmacies, sterile compounding facilities, and distributors in Maryland. The Board requires that all pharmacies be inspected, at a minimum, on an annual basis and distributors be inspected on a biannual basis.

The following represents a breakdown of the issues that have come to the Board from the inspection of pharmacies across the state in the second quarter of 2023.

1. CDS Red Flag      
2. Invalid/Expired CPR Certifications
3. Documents Requested But Not Provided
4. C-II Audit Narcotic Discrepancies
5. Expired Medications
6. Medication Storage Issues
7. No Approved Technician Training Program
8. Not Open During Pharmacy Hours
9. Sterile Compounding Issues
10. Unauthorized Personnel
11. Pharmacy Closed without Notification
12. Pharmacy Signage Not Removed​​

National Association of Boards of Pharmacy

National Pharmacy Compliance News

Reprinted from the National Association of Boards of Pharmacy FOUNDATION​

FDA Delays Enforcement of Certain DSCSA Requirements Until November 2024

Food and Drug Administration (FDA) has published final guidance delaying enforcement of certain Drug Supply Chain Security Act (DSCSA) requirements until November 27, 2024. The extension will give trading partners (drug and device manufacturers, wholesale distributors, dispensers, and repackagers) additional time to further “develop and refine appropriate systems and processes to conduct interoperable, electronic tracing at the package level, to achieve robust supply chain security under the DSCSA while helping ensure continued patient access to prescription drugs," the agency said in the guidance. FDA does not intend to take action to enforce the requirements under Section 582(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act as long as the product is introduced in a transaction into commerce by the product's manufacturer or repackager before November 27, 2024. The final guidance will not impact NABP's plans for providing DSCSA education to its member boards and trading partners, nor will it impact the launch of Pulse by NABP™.

ISMP Launches the 2023-24 Targeted Medication Safety Best Practices for Community Pharmacy

This column was prepared by the Institute for Safe Medication Practices (ISMP), an ECRI affiliate. Have you experienced a medication error or close call? Report such incidents in confidence to ISMP's National Medication Errors Reporting Program online at www.ismp.org or by email to ismpinfo@ismp.org to activate an alert system that reaches manufacturers, the medical community, and Food and Drug Administration (FDA). To read more about the risk reduction strategies that you can put into practice today, subscribe to the ISMP Medication Safety Alert! newsletters at www.ismp.org.

The Institute for Safe Medication Practices (ISMP) has launched the 2023-24 Targeted Medication Safety Best Practices for Community Pharmacy (Best Practices). The purpose of these Best Practices is to identify, inspire, and mobilize widespread, national adoption of consensus-based best practices in community pharmacies to address recurring problems that continue to cause fatal and harmful errors, despite repeated warnings. These best practices, which are reviewed by an external expert advisory panel, represent high-leverage error-reduction strategies, many of which have already been successfully adopted by some pharmacies. While Best Practices might be challenging for some organizations to achieve, they are designed to be practical and realistic. Their value in reducing medication errors is grounded in scientific research and expert analysis of medication errors and their causes. Their implementation can vastly improve medication safety and reduce the risk of significant patient harm.

Each best practice is accompanied by a rationale and references, as well as related issues of ISMP's newsletters for additional background and information. While targeted to the community pharmacy setting, some best practices are also applicable to other health care settings, such as ambulatory, mail order, specialty pharmacy, long-term care, and home infusion.

The 2023-24 Targeted Medication Safety Best Practices for Community Pharmacy include the following:

• Use a standard protocol to verify a patient's identity, utilizing at least two patient identifiers, when receiving a prescription to be filled, responding to patient-specific questions, providing filled prescriptions to patients at the point of sale, when delivering prescriptions to the patient's home, and prior to administering vaccines or other treatments.
• Install and use barcode verification during production (ie, the prescription-filling process) to scan each drug or vaccine package or container (eg, bottle, carton) used to fill a prescription, including manufacturer cartons or bottles that may be dispensed to a patient.
• Use a weekly dosage regimen default for oral methotrexate in electronic systems when medication orders are entered. Require verification and entry of an appropriate oncologic indication in order-entry systems for daily orders. Create a forcing function (for instance, an electronic stop in the sales register that requires intervention and acknowledgment by a pharmacist) to ensure that every oral methotrexate prescription is reviewed with the patient or a family member when a prescription is presented or refills are processed. Provide specific patient and/or family education for all oral methotrexate prescriptions.
• Standardize the use of the milliliter (mL) unit of measure when prescribing, dispensing, and measuring oral liquid medications.
• ​Seek out and use information about medication safety risks and errors that have occurred in organizations outside of your pharmacy, including other affiliated pharmacies, and take action to prevent similar errors.

To best protect public health, ISMP encourages all United States community and ambulatory care pharmacies to focus their medication safety efforts for the next two years on these Best Practices. The Best Practices are fully described on ISMP's website. In addition, there is a worksheet that pharmacies can use to identify gaps in implementation of the Best Practices and develop an action plan to address vulnerabilities. Pharmacies can also view a recording of the NABP educational session Exploring Medication Safety: New ISMP Best Practices for Community Pharmacy to learn more about the new Best Practices. 

FDA Warns of Fraud Pertaining to Distribution of Ozempic, Other Medications  

 Food and Drug Administration's (FDA's) Office of Criminal Investigations has identified cases where wholesalers (licensed and unlicensed) are offering to sell Ozempic^® with large discounts. In some instances, the investigation has revealed it to be a “No-Delivery Scheme," where the purchaser would make payment and not receive the product. In other instances, the product offered for sale is diverted from foreign countries or counterfeit. In some of the transactions currently under investigation, it is suspected that the sellers are involved in account takeover, in which they obtain the licensing, management, and location information from licensed wholesalers and pretend to be employees of such companies. This information is easily accessible online.

The sellers offer sufficient information and documentation to give the appearance that the transaction is legitimate. These transactions often require full or partial payment up front via wire transfer, non-disclosure agreements, establishment of purchase accounts, and on occasion, have involved fraudulent transaction statements (old pedigree). In some cases, the offer comes from a company that doesn't distribute temperature-controlled drug products. It is important to verify the legitimacy of the offer and that the company offering the product for sale and distribution actually distributes Ozempic or other semaglutide drug products.

FDA is also investigating the sale of semaglutide and tirzepatide online. It appears that most of the products offered for sale are counterfeits imported from China. These products, however, are not made to look like legitimate Ozempic pens; they are sold in the form of injectable vials and labeled as semaglutide.

Lastly, FDA has identified several companies importing a salt form of semaglutide (semaglutide sodium and acetate) for distribution and sale to compounding pharmacies. FDA issued guidance indicating the salt form of semaglutide is prohibited from use in compounding human drugs. This bulk active pharmaceutical ingredient is purchased and distributed to compounding pharmacies that then compound semaglutide pursuant to individual prescriptions and in bulk, which has resulted in patients suffering adverse events.

This illicit activity has been detected at both the distributor and pharmacy levels of our supply chains. Any pharmacy that has been approached about the purchase/distribution of Ozempic, semaglutide, tirzepatide, or the salt form of semaglutide (and they haven't spoken to the Healthcare Distribution Alliance Pharmaceutical Cargo Security Coalition already) is advised to contact Chuck Forsaith at cforsaith@hda.org or 401/623-1344.

Final Guidance for Trading Partners to Adopt Secure Electronic Data Exchange System Released by FDA

Food and Drug Administration (FDA) has released a final guidance clarifying the necessary standards to adopt secure, interoperable electronic data exchange among the pharmaceutical distribution supply chain. Specifically, the DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs – Guidance for Industry document offers recommendations for trading partners to adopt the Electronic Product Code Information Services standard to manage transaction information and transaction statements. The document finalizes the revisions added to the July 2022-issued document of the same title. The document can be accessed via the Regulatory Information section of FDA's website.

Over 99% of Health Care System Pharmacists Surveyed Report Experiencing Drug Shortages

Over 99% of health care system pharmacists report experiencing drug shortages, according to a quarterly survey by American Society of Health-System Pharmacists (ASHP). Out of the 1,123 pharmacists who responded to the ASHP survey, nearly a third of participants labeled the shortage as “critically impactful," causing health care professionals to delay, ration, or cancel treatments or procedures. Antineoplastic (chemotherapy) drugs continue to be the most in demand, followed by corticosteroid and hormonal drugs; oral liquids (eg, lidocaine, ibuprofen, amoxicillin); and “crash cart" drugs (eg, prefilled syringes).

With 309 drugs in short supply, patients may seek out other, and sometimes questionable, sources for their medications. Learn more about how pharmacists can help patients find safer alternative medications in the January 2023 issue of Innovations^®.