- Current Topics
WEST VIRGINIA BOARD OF PHARMACY ANNOUNCES STATEWIDE ELECTRONIC HEALTH RECORD INTEGRATION OF PRESCRIPTION DATA
The West Virginia Board of Pharmacy has partnered with Appriss Health to utilize, analyze, and present information from West Virginia’s Controlled Substances Monitoring Program (CSMP) into the clinical workflow of both prescribers and pharmacists via the comprehensive platform NarxCare. All practitioners who dispense Schedule II, III, IV and V controlled substances or opioid antagonists to residents of West Virginia, must provide the dispensing information to the West Virginia Board of Pharmacy CSMP each 24-hour period. RxDataTrack/CSAPP is the online CSMP software (Mahantech Corp.) used by the Board to track these substances. NarxCare will integrate this CSMP information, as well as additional data sources, into Electronic Health Records or Pharmacy Management Systems to empower clinicians to identify patients that may be at risk for prescription drug addiction, overdose and death, and equips those clinicians and care teams with the advanced analytics, tools and technology they need to help those patients. These invaluable insights and tools can be presented and accessed within clinical workflow, up front, for every patient, every time.
NarxCare provides machine learning and artificial intelligence-based patient risk scores, prescription data, patient safety alerts and other information in a visually interactive format to help prescribers and pharmacists quickly identify potential signs of addiction/overdose. NarxCare also helps clinicians connect patients with additional resources within their community if needed, such as medication-assisted treatment. By obtaining CSMP prescription information through PMP Gateway, which can include data from neighboring states, this one-click workflow process eliminates the need for prescribers and pharmacists to manually log into the WV CSMP website separately and then enter a patient’s name and demographics to search for them.
The new NarxCare platform will be made available at no cost to all West Virginia healthcare providers via their electronic health record and pharmacy management system vendors. (It is important to note that not all vendors are currently integrated. Your integration process and duration time is dependent upon your vendor). For more detailed information about the integration process, please visit:
West Virginia Board of Pharmacy
2310 Kanawha Boulevard East
Charleston, WV 25311
An information FAX for WV pharmacies from the Chief Compliance Officer
1. One of the most significant actions the West Virginia Legislature undertook during the 2018 Regular Session was the enactment of The Chronic Pain Clinic Licensing Act of 2018 which will take effect on June 7, 2018. This Act has far reaching limitations on the prescribing of opioid drugs. Pharmacists need to be fully aware of the restrictions it places on most all medical and dental providers. Those limitations are too many to try and list in a one-page fax, but they can be found in the section §16-54-4. Opioid prescription limitations outlined in the code titled:
CHAPTER 16. PUBLIC HEALTH.
ARTICLE 5H. CHRONIC PAIN CLINIC LICENSING ACT.
Below is a link that you can use to find and download a copy of this law:
(You might also find the law by googling WV SB 273 of 2018)
2. Additional action by the Legislature places gabapentin in the list of Schedule V Controlled Drugs and now requires ALL Schedule V drugs to be reported to the monitoring program.
3. A PDF version of the WVBOP Law & Rule Book is now available on the Board website and may be downloaded for your personal use. It may be found by pointing at the LAWS tab on the upper right-hand corner of the Home Page and then clicking on Most Recent Law Editions. The 2018 edition includes actions taking by the Legislature this year. If you have an up to date version of Adobe Reader you should be able to search the book for answers by using key words. Please be advised that your pharmacy must also have a printed copy of the most recent published version (currently 2017).
4. The DEA has won a case in court and CBD Oil (which may contain up to 15% CBD) is now considered a Schedule I drug and should not be stocked or sold in a pharmacy. Hemp Oil or Hempseed oil, which is an extract of hemp seeds, contains less than 25 parts per million CBD may be sold in West Virginia at present.
5. The WVBOP Legislative Rules committee is working on changes in the Rules to permit the employment of non-registered cashiers in the pharmacy area. That change has been submitted to the Legislature but probably will not be approved until the 2019 session.
6. Effective today, May 7, 2018, the medical license of Stephen Scott Brown, M.D. was revoked by the West Virginia Board of Medicine. Accordingly, Dr. Brown is no longer authorized to prescribe. Effective at 11:59 p.m. today, May 7, 2018, the podiatric license of Steven Scott Melek, D.P.M. will be suspended by the West Virginia Board of Medicine. Please be advised that while his license is suspended, Dr. Melek is not authorized to prescribe.
Licensure Information for Pharmacists and Pharmacy Technicians/Trainees
In order to be licensed as a Pharmacist in West Virginia, all applicants will be required to pass the Multistate Pharmacy Jurisprudence Examination (MPJE), administered by NABP.
If you are a new pharmacy school graduate or score transfer applicant, then you will also be required to take and pass the MPJE and/or NAPLEX examination administered by NABP. NABP will then issue you an Authorization to Test for which you will need to schedule an appointment to take the MPJE at a computer testing center.
If you are an applicant for licensure by Reciprocity, or are a Foreign Pharmacy Graduate please see below.
For information on registration as a Pharmacy Technician, or to start as a Pharmacy Technician Trainee see below:
Click here for Applications.
Information for Pharmacist Reciprocity
“Licensure Transfer” and Licensure Transfer Application
Step One - Applicant logs onto www.napb.net, under: Licensure Transfer" and Licensure Transfer Application and follows the directions for Reciprocity and MPJE.
Step Two –After Applicant receives official application from the National Board, please submit the Official Application within 90 days to the West Virginia Board of pharmacy –The applicant must mail the completed Official Application to the West Virginia Board of Pharmacy along with the application fee of two hundred and fifty five dollars ($255.00).
When the West Virginia Board of Pharmacy receives your completed application and fee we will mail you the latest edition of our Law Book “Pharmacy Laws and Legislative Rules of West Virginia” Governing The Practice Of Pharmacy and Controlled Substances Act. You are responsible for any changes made in the statutes or rules after the Law Book was published. All such information is available online. If you have questions regarding the MPJE call the NABP at (847) 391-4406.
In order to be licensed in West Virginia, you will be required to pass the Multistate Pharmacy Jurisprudence Examination (MPJE).
The MPJE is a two-hour, computer-adaptive examination. You will need to familiarize yourself with the specific federal and state pharmacy laws and regulations as they apply in West Virginia. To get information regarding sitting for the MPJE, you will need to get on the NAPB web site at: http://www.nabp.net/. NABP will then issue you an Authorization to Test for which you will need to schedule an appointment to take the MPJE at a computer testing center.
Foreign Pharmacy Graduate
A Foreign Pharmacy Graduate, whose undergraduate pharmacy degree was conferred by a recognized school of pharmacy outside of the fifty (50) United States, the District of Columbia, and Puerto Rico, may establish educational equivalency by obtaining a Foreign Pharmacy Graduate Examination Committee Certificate (FPGEC) from the National Association of Boards of Pharmacy (NABP).
To Obtain an FPGEC Certificate, you must meet all of NABP’s requirements for the program including passing the Foreign Pharmacy Graduate Equivalency Examination (FPGEE), the Test of English as a Foreign Language (TOEEL), and the Test of Spoken English (TSE).
Applicants who receive FPGEC certification meet the educational requirement for licensure and may apply to sit for the licensure exams (NAPLEX and MPJE). Provided they meet all other qualifications for licensure as a pharmacist.
You will need an application for initial license as a registered intern if you plan to work in this State prior to licensure. Upon successfully receiving the FPGE, send a copy of your certificate with your application to become an intern in West Virginia. Fifteen hundred (1500) Intern hours are required by the State of West Virginia prior to taking the NAPLEX and only up to five Hundred (500) of those hours may have been served in a foreign country. After passing the Foreign Pharmacy Graduate Examination (FPGEC), and getting your 1500 Intern hours you may then apply to take the NAPLEX and West Virginia MPJE.
Legislative Rule for Pharmacy Technicians: § 15-7-2. Definitions.
2.3. "Pharmacy Technician" means a person registered with the board to practice certain tasks related to the practice of pharmacist care in this State within the scope of practice permitted by West Virginia Code Section 30-5-12, as provided, permitted, and limited by the laws and rules governing the practice of pharmacist care.
TEN (10) FREQUENTLY ASKED QUESTIONS
1- Since I have to be nationally certified, how I do it, how much does it cost, and where do I had to go to take the certification exam?
ANSWER: We accept either the PTCB or the NHA national certification. They have their own requirements and testing. You can research them at their websites: http://www.ptcb.org (or call 1-800-363-8012), and http://www.nhanow.com/pharmacy-technician.aspx (or call 1-800-499-9092).
2- What type of questions are on the Examinations?
ANSWER: Please refer to their websites for information on their examinations.
3- If I am already nationally certified, or if I get nationally certified, can I go ahead and practice as a PT or PTT in West Virginia?
ANSWER: No. You must first get registered with the State before you start practice, even if nationally certified.
4- So, how do how do I become registered in West Virginia with my national certification?
ANSWER: You must have completed a competency-based pharmacy technician education and training program of a learning institution or training center as approved by legislative rule of the board; or completed a 960 hour pharmacy provided, on-the-job, competency-based education and training program approved by the board. If one of the aforementioned requirements is completed you may then submit an application for pharmacy technician, which includes and state and federal fingerprint based, criminal history background check with the results being released to The West Virginia Board of Pharmacy.
If you have not completed the education and training component then you must register as a PTT and do the training (see Question 6 below) before you can apply to then become a PT.
5- If I am registered in another state how can I become registered in West Virginia (reciprocity or license transfer)?
ANSWER: We don't have reciprocity given our training and national certification requirements. You must have completed a competency-based pharmacy technician education and training program of a learning institution or training center as approved by legislative rule of the board; or completed a 960 hour pharmacy provided, on-the-job, competency-based education and training program approved by the board. Applicants must also be nationally certified via PTCB or NHA. If the aforementioned requirements are completed you may then submit an application for pharmacy technician, which includes and state and federal fingerprint based background check with the results being released to The West Virginia Board of Pharmacy.
6- I'm not nationally certified. How can I become a West Virginia registered pharmacy technician?
ANSWER: You must first apply to the Board (including getting a criminal background check) to register as a trainee, and either complete a school-based pharmacy-technician training program, or do an on-the -job training program where you work 960hours in a pharmacy in its training program within a 15-month period. Upon completion of the training program, you will have 90 days to pass one of the two approved national PT certification examinations to become registered, during which time you can continue to work as a PTT. If you don't pass within the 90-day period, you must request an extension from the Board or stop working until you do. See PTT section below.
7- Do I need continuing education to be a West Virginia registered pharmacy technician?
ANSWER: No (but, yes). The Board does not have a CPE requirement for Pharmacy Technicians. However, to maintain PTCB or NHA CPhT certifications, you must comply with their requirements. PTCB and NHA have their own requirements for maintaining their certifications which include continuing education.
8- If I am not working do I have to renew my registration?
ANSWER: Yes and no, or not necessarily. If you do not renew, this will cause your registration to lapse. See next question.
9- If I do not renew my license in the designated renewal period are there any consequences?
ANSWER: You would have to complete a reinstatement application and pay reinstatement fees, and show proof of ongoing national certification. If you were a PT who was grandfathered-in as a registered PT without national certification prior to the changes in the law, you would have to meet the new requirements and become nationally certified to be reinstated.
10- Do I have to let the Board know where I am working?
ANSWER: You must notify the Board in writing as to your place of employment and any change of address.
Pharmacy Technician Trainee
2.3. "Pharmacy Technician Trainee" means an individual currently engaged in a competency-based pharmacy technician education and training program which has been approved by the Board and who is performing the duties of a pharmacy technician under the direct supervision of a pharmacist.
TEN (10) FREQUENTLY ASKED QUESTIONS
1- Do I have to register with the Board of Pharmacy just to work in the pharmacy?
2- How do I register to work as a trainee?
ANSWER: If you are going to do an on-the-job pharmacy-based 960-hour training course, the pharmacist-in-charge (PIC) must help you complete a Pharmacy Technician Trainee Application. If you are enrolling in a school-based training program, the school must help you fill out the application. As part of the application, you must get a state and federal fingerprint based criminal history background check to be reported to the Board, and have your application approved by the Board prior to beginning.
3- How long can I work as a pharmacy technician trainee?
ANSWER: If enrolled in a school-based program, then, so long as you are enrolled and actively working toward your degree or certificate. If you are doing the on-the-job pharmacy-based 960-hour training course, then you have a maximum of 15-months to complete the training and have 960 hours in the pharmacy. After you complete the training, you have 90 days to continue working while you try to pass a national certification exam. If you don't pass, you can keep trying; you just can't continue to work. However, the law does provide that you can petition the board to continue working if you are taking some approved re-training, or you can petition to start over at the beginning. This petition requires you to complete the pharmacy technician trainee extension request form located on our website under applications/forms.
4- What if I cannot get the 960 hours in a 15-month period.
ANSWER: You can petition the Board for more time provided you can show good cause for the need for the extension (e.g. medical leave during the 15 month period that prevented you from working the needed hours). This petition requires you to complete the pharmacy technician trainee extension request form located on our website under applications/forms.
5- How old do I have to be to work in a pharmacy?
ANSWER: The law does not contain a specific age requirement. It used to require a minimum age of 18, but that provision was removed. However, to become registered as a PT or PTT in West Virginia you must be a high school graduate or you must have a General Education Development Diploma (GED) issued by the Board of Education. So, it is possible to become a PTT or PT prior to reaching the age of 18.
6- What if I have a criminal record (i.e., a misdemeanor or felony conviction in my criminal history)?
ANSWER: You must disclose all convictions on your application, whether a misdemeanor or a felony. To be eligible to be a PT or PTT, the statute requires the Board to find that you are not an alcohol or drug abuser (although you can be in demonstrated recovery), not have been convicted of any felony with the last 10 years prior to application, and not have been convicted of a misdemeanor or felony if the offense bears a rational nexus to the practice of pharmacy. The board will review the nature of the conviction to determine if it precludes you or not. However, if you fail to disclose it on your application, then the board may deny your application for untruthfulness or failure to provide required information.
7- Will my hours count if I change jobs within my training period?
ANSWER: Yes, as long as they can be verified and the new pharmacy/PIC agree.
8- What do I need to wear?
ANSWER: Pharmacy technicians and pharmacy technician trainees shall wear appropriate clean attire and a coat, jacket, or apron of a color other than white, and have a proper name tag.
9- Can I transfer my PT registration from another state?
ANSWER: No. However, if you can show that you completed approved training, and are nationally registered, the Board will grant your WV PT registration based on that information.
10- Can a high school student be a PT or PTT, or can they "shadow" (observe) in a pharmacy?
ANSWER: The law requires that, in order to be a pharmacy technician (PT), or a pharmacy technician trainee (PTT), one must be a high school graduate or its equivalent (GED). The under 18 restriction was removed, but the graduation/GED requirement is still there. (See West Virginia Code § 30-5-11 and Code of State Rules § 15-7-3 and 4.) However, a high school student can go in and “shadow”. They just cannot do any part of the dispensing process (prescription entry, review, filling, dispensing to patient, etc.), or any other duties that are restricted to pharmacists, PTs/PTTs, or pharmacist interns (pharmacy school students in college). The Board has no requirements specifically on “shadowing”, except that the law requires no unauthorized personnel in the pharmacy unless the pharmacist ok’s them, and supervises their presence. Again, no unlicensed/unregistered people can do any part of the dispensing functions, etc., but they can observe.
2017 Law Book: Pharmacy Laws And Legislative Rules of West Virginia (Governing: The Practice of Pharmacy; Controlled Substances Act), 2017Edition.
To Purchase the Law Book, please remit a law book request with your name and address where the book is to be mailed. Fee: $20.00.
The most recent versions of the West Virginia Code and the Rules are available on the Legislature's website and the Secretary of State's website, respectively.
Below are links to current West Virginia Code (on the Legislature's web site) and West Virginia Code of State Rules (on the Secretary of State's web site) governing the practice of pharmacy. To view a particular provision, click on the link and perform the required search on the linked site.
West Virginia Code Sec 30-5-1, et seq., creates the Board of Pharmacy, provides for its powers and duties generally, and sets forth requirements for licensure and permitting of Pharmacists, Pharmacy Technicians, Pharmacy Interns, and Pharmacies.
West Virginia Code Chapter 60A, Uniform Controlled Substances Act.
(a) Board of Pharmacy Rules, Title 15 of CSR, Series 1 through 13, click here: http://apps.sos.wv.gov/adlaw/csr/, and select "Pharmacy" in the Agency drop-down field of the search box.
(b) Board of Medicine, Board of Osteopathy, and Board of Pharmacy Joint Rules for Collaborative Pharmacy Practice, Title 11, Series 8.
West Virginia Code Generally.
DEA law links.
Code of Federal Regulations (CFR) Main Page.
Continuing Pharmacy Education Info
Frequently Asked Questions on CPE Hours Given Recent Changes
Q. By when must I complete the new required 3 CPE hours for best practices prescribing and dispensing for pain (Drug Diversion CPE)?
A. The statute and rules require the Drug Diversion CPE to be completed every reporting period. So, if you are up for renewal on July 1, 2014, then you must have completed the 3 hours as required for your renewal this time around. If you are up for renewal July 1, 2015, you must have completed it for your reporting period for your July 1, 2013 through June 30, 2015, license period. However, if you are a newly licensed pharmacist, you must complete this requirement during your first year of practice, regardless of when you come up for renewal.
Q. Do I still need to complete the "End of Life Care" CPE that was mandatory for all first time license renewals?
A. No, the end of life CPE requirement was deleted from the law. The statute now requires the Drug Diversion CPE each reporting period. So, you will have to get 3 hours of this CPE every 2 years going forward as part of your 30 hours, but end of life care is no longer required.
Q. I am registered as a consultant pharmacist [and/or immunizing pharmacist] and registered pharmacist. Can the CPE hours I've completed for my consultant license [and/or immunizing pharmacist permit] be applied towards the 30 hours needed to renew my pharmacist license?
A. Yes, the hours can count toward your 30 required total CPE hours. The same is also true for the new best practices prescribing and dispensing for pain hours (Drug Diversion CPE).
To find out about CPE programs provided by the WVU School of Pharmacy Office of Continuing Pharmacy Education click here.
Consulting Practice | Application for Continuing Education
CONTINUING PHARMACY EDUCATION IN CONSULTING PRACTICE
Rule 23.3 of the Board's Legislative Rules, 15 CSR 1, requires all pharmacists registered as consultants to have three (3) hours of CPE in the subjects of consulting practice each year.
All programs offered by the American Society of Consultant Pharmacists (ASCP) are acceptable programs to meet this requirement.
Any other program not offered by ASCP must be submitted to the Board's continuing education committee for approval and assignment of a number.
Programs in the subjects of consulting practice may include, but are not limited to, topics related to:
Depression in the Elderly
Nutritional Status in the Elderly
Congestive Heart Failure
Issues with HCFA Regulations
Special Considerations in the Elderly
Prevention and Recognition of Drug Events in the Elderly Population or programs provided by:
WVU Geriatric Education Center Programs
WV Center of Aging Program
West Virginia Board of Pharmacy's Application for Continuing Pharmacy Education Credit
NOTE: (Application only required for general CPE programs not already approved by ACPE or for programs submitted to meet Drug Diversion Training and Best Practice Prescribing of Controlled Substances or consulting practice CPE requirements.)
All applications must be received by the end of each month. Applicants will be notified by the 20th of the following month if the program was approved or disapproved. If approved, continuing education certificates issued to participants must list the title of the program, number of CPE hours awarded, WV Board of Pharmacy Program Number, signature of administrator of the program, and date signed. A record of the participant’s attendance and copy of the CPE certificate must be maintained for a period of 4 years from the program’s date.
PROVIDER / RPH INFORMATION:
Date of Submission:
Applicant (Check One): CPE Provider____ Pharmacist ____
Name of CPE Provider/Pharmacist:
City: State: Zip Code:
Phone Number: Fax Number:
The following 3 items must also be submitted with each application:
Agenda with times of events
Listing of all faculty and brief bio sketch for each faculty member
Learning Objectives for each Session (List the session title followed by at least 3 learning objectives. Each objective should start with a behavioral verb such as describe, list, state and others. Additional sheets may be attached if needed.):
Date of Program: Title of Program:
Location (Facility, City and State):
Number of hours of CPE requested:
Type of CPE credit requested (Check One):
Consulting ____ General ____ Live_____
Drug Diversion Training and Best Practice Prescribing of Controlled Substances____
Pharmacists have a Corresponding Responsibility with the Prescriber to Prevent Drug Diversion
Article after article is out there on preventing drug diversion, and the pharmacists' corresponding responsibility with the prescriber to ensure the prescriptions they dispense are legitimate. Nonetheless, it is worth repeating. So, here is an excerpt from the DEA's Pharmacist Manual, "SECTION IX – VALID PRESCRIPTION REQUIREMENTS", directly on point:
A pharmacist also needs to know there is a corresponding responsibility for the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is an invalid prescription within the meaning and intent of the CSA (21 U.S.C. § 829). The person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.
A pharmacist is required to exercise sound professional judgment when making a determination about the legitimacy of a controlled substance prescription. Such a determination is made before the prescription is dispensed. The law does not require a pharmacist to dispense a prescription of doubtful, questionable, or suspicious origin. To the contrary, the pharmacist who deliberately ignores a questionable prescription when there is reason to believe it was not issued for a legitimate medical purpose may be prosecuted along with the issuing practitioner, for knowingly and intentionally distributing controlled substances. Such action is a felony offense, which may result in the loss of one’s business or professional license (see United States v. Kershman, 555 F.2d 198 [United States Court Of Appeals, Eighth Circuit, 1977]).
West Virginia law incorporates this same duty in Rule Section 15-2-7.4. This is a responsibility that the pharmacist must be aware of, and cannot ignore
Prescritions from Suspended/Revoked Prescribers
Q: A prescriber in my area recently had his/her license to practice suspended/revoked. Can I fill a prescription written by him/her? What about refills?
A. The answer in West Virginia is fairly simple. The law generally requires for a prescription to be valid, it must be written by a properly licensed prescriber, written in the normal or ordinary course of practice, for an actual patient of that prescriber, and be for a legitimate medical reason if necessary. Thus, so long as the prescriber's license was valid when the prescription was written for his/her patient (with whom there was an actual provider-patient relationship), the prescription was written in the usual course of practice, and it is for a legitimate medical reason, then the prescription may be filled. The same analysis applies for refills. For a quick example, Dr. Jones writes a prescription for his patient, Mr. Smith, on April 6, 2010, with three refills. The next day, on April 7, Dr. Jones surrenders his license and DEA registration. If Mr. Smith's presents the prescription and the pharmacist believes it was written in the usual course and for a legitimate medical purpose, the prescription and the refills may be honored. It is recommended that, since the doctor-patient relationship is severed, that the pharmacy direct the patient to get a new prescriber as soon as possible, and that the pharmacy consider limiting the number of refills it will give under the old prescriber.
West Virginia Pharmacists and Buprenorphine-Assisted Therapy: Guidelines for a pharmacist providing pharmaceutical care to patients with opioid addiction and opioid use disorders using buprenorphine medications.
Author: Michael C. LeMasters, Pharm.D.
CDC Releases Guideline for Prescribing Opioids for Chronic Pain
See the CDC's article and guidelines at: http://www.cdc.gov/media/dpk/2016/dpk-opioid-prescription-guidelines.html
This link is to an interesting article entitled "Effects of Illegal Drugs on the Heart".
Floricet and Florinal, and Federal DEA Exempted Products
Q. Does West Virginia honor the DEA’s Exempt Prescription Product list.
A. No. West Virginia has its own controlled substances act and it schedules several things that the DEA exempts. For example, Fioricet and Fiorinal are treated the same here as controlled drugs, whereas the DEA schedules one but exempts the other. The Board has fielded several questions recently on state versus federal scheduling of Chlordiazepoxide and Butalbital products. Federal law has some exemptions for some of these. However, our state law is tighter. To reiterate and flesh things out:
For Butalbital containing products in Schedule III of state statutes, West Virginia Code § 60A-2-208(c)(3) states that any substance which contains any quantity of a derivative of barbituric acid or any salt of barbituric acid is a CIII, and subsection (6) specifically states “Butalbital (including, but not limited to Fioricet)” is included as a CIII. So, we treat Fioricet and Fiorinal the same under state law since they both contain butalbital, which comes from barbituric acid.
For products containing Chlordiazepoxide, regardless of federal exemptions, the state statute for Schedule IV at West Virginia Code § 60A-2-210(c)(8) specifically includes Chlordiazepoxide.
Manufacturers and Wholesale Drug Distributors: In the past, West Virginia licensed non-resident manufacturers as wholesale drug distributors when they distributed their product into the state. Federal law requires a new scheme. Anyone manufacturing prescription-only drugs in West Virginia must be licensed by the state as a manufacturer to do so. Likewise, if you are a drug manufacturer located outside of West Virginia, but distribute any of your product into West Virginia, either yourself or through the use of a Third-Party Logistics Provider (3PL), you must be licensed by this state as a manufacturer (in other words, if you distribute or have your product distributed into West Virginia on your behalf, you must be licensed).
If you are a virtual manufacturer (you own the product, but someone else manufacturers it for you on contract or otherwise at their facility), if any of that product is to be manufactured in West Virginia, or shipped in or into West Virginia on your behalf, you must get a manufacturer's license. Of course, the actual manufacturer will have to be licensed as a manufacturer if it is in West Virginia. If the actual manufacturer is outside West Virginia, it does not need licensed if it never sends the product into West Virginia on your behalf (i.e., it transfers it to a 3PL or wholesaler outside of West Virginia, and it is that other entity that actually sends it into West Virginia). If it is manufacturing the drugs on behalf of a virtual manufacturer, and it sends that product into West Virginia on behalf of the virtual manufacturer or otherwise, it must be licensed as a manufacturer. In other words, if it is located outside of West Virginia and it distributes any of the product into West Virginia, it must get a manufacturers license.
If controlled substances are involved, the actual manufacturer must have a controlled substances handling permit as well. If you are a virtual manufacturer which does not handle the product, then you do not have to also get the CS handling permit since you won't actually touch the product.
If you are a virtual manufacturer and use a 3PL to distribute your product in or into West Virginia, you must have a manufacturer's license, and your 3PL must have a 3PL distributor's license. If controlled substances are involved, the 3PL must have a controlled substances handling permit as well. If you do not handle the product, then you do not have to also get the CS handling permit since you won't actually touch the product.
Wholesale Drug Distributors: If you are a wholesale drug distributor and distribute drugs in or into West Virginia, you must be licensed as a wholesale drug distributor. In the past, West Virginia licensed 3PL's as a wholesale drug distributor. However, federal law requires a new scheme. West Virginia will now have a 3PL distributor's license category to distribute any drug products in or into West Virginia as a 3PL. If controlled substances are involved, the 3PL must have a controlled substances handling permit as well. For any product you are shipping in on behalf of a virtual or actual manufacturer or other party who actually owns title to and control over the drug, that virtual manufacturer, actual manufacturer, or other party must be properly licensed as a manufacturer.
Mid-Level Practitioners Authorization by State: The table available from the DEA Diversion website provides information for the controlled substances authority for Mid-level Practitioner's by discipline and state:
DEA Diversion mid-level Practitioner page: http://www.deadiversion.usdoj.gov/drugreg/practioners/index.html
Download the Table from the page: http://www.deadiversion.usdoj.gov/drugreg/practioners/mlp_by_state.pdf
The Board has been provided a link to a CPE on Naloxone that is extended for another year. It is supported by an educational grant from Adapt Pharma and is ACPE approved for 2 hours.
The CPE is entitled "Naloxone Rescue: The Emerging Role of Pharmacists in Preventing Opioid Overdose"
Download this document in PDF Format
Download Naloxone Tri-fold Brochure
Download Naloxone Administration Tri-fold
The dispensing of opioid antagonists approved by the FDA for use in treating an overdose must be reported to the CSMP. You must work with your software, or, if need be, work with your software provider, to include naloxone as a reportable item.
West Virginia Board of Pharmacy
Protocol for Pharmacist or interns Furnishing
Opioid Antagonist Naloxone Hydrochloride
Developed in Consultation with the DHHR Bureau for Public Health
A pharmacist or intern furnishing an opioid antagonist, naloxone hydrochloride, pursuant to West Virginia Code § §16-46-3a shall satisfy the requirements of this protocol.
(a) As used in this protocol:
(1) “Recipient” means the person to whom naloxone hydrochloride is furnished.
(b) West Virginia Code § 16-46-3a provides that a pharmacist or pharmacy intern under the supervision of a pharmacist may dispense an opioid antagonist without a prescription pursuant to a protocol developed by the Board of Pharmacy in consultation with the Bureau for Public Health. As set forth in subsection (b) of section 16-46-3a,
A pharmacist or intern or pharmacy intern who dispenses [naloxone hydrochloride] without a prescription under this [protocol] shall provide patient counseling to the individual for whom the opioid antagonist is dispensed regarding, but not limited to, the following topics: (1) The proper administration of the opioid antagonist; (2) the importance of contacting emergency services as soon as practicable either before or after administering the opioid antagonist; and (3) the risks associated with failure to contact emergency services following administration of an opioid antagonist. The patient counseling described in this section is mandatory and the person receiving the opioid antagonist may not opt out.
Further, subsection (d) provides: “All pharmacists or pharmacy interns who dispense an opioid antagonist under this section shall provide educational materials to any person receiving such an opioid antagonist on opiate-related overdose prevention and treatment programs, as well as materials on administering the opioid antagonist.” Following is the protocol developed to meet these requirements.
The law clearly requires only a protocol issued by the Board in consultation with the Bureau for Public Health for pharmacists to dispense Naloxone without any prescription from any practitioner. However, although not required, a pharmacy may choose to have a prescribing practitioner sign the protocol set forth in subsection (c) below to treat it as a standing order.
(c) Protocol for Pharmacist or Interns Furnishing Naloxone Hydrochloride.
(1) Before providing an FDA-approved naloxone hydrochloride product, the pharmacist or intern shall screen the potential recipient by asking whether the person to whom the naloxone hydrochloride would be administered has a known hypersensitivity to naloxone. (If the recipient answers yes, the pharmacist or intern may not provide naloxone. If the recipient responds no, the pharmacist or intern may continue.)
(2) When naloxone hydrochloride is furnished:
(A) The pharmacist or intern shall provide the recipient with appropriate counseling and information on the product furnished, including dosing, effectiveness, adverse effects, storage conditions, shelf---life, and safety. The recipient is not permitted to waive the required consultation.
(B) The pharmacist or intern shall provide the recipient with the number to talk with someone about available substance abuse treatment and recovery services near them, 1-844-HELP-4-WV, if the recipient indicates interest in addiction treatment or recovery services at this time.
(C) The pharmacist or intern shall answer any questions the recipient may have regarding naloxone hydrochloride.
(3) Product Selection: A pharmacist or intern may supply naloxone hydrochloride in any FDA- approved product form.
(4) The dispensing shall be documented and labelled as a prescription dispensed per this protocol.
(5) Fact Sheet: The pharmacist or intern shall provide the recipient
(A) a copy of the current Naloxone Administration Tri-fold “I Have Narcan” created and maintained by the West Virginia Department of Health & Human Resources, Bureau for Public Health, Office of Emergency Medical Services (OEMS): http://www.wvoems.org/medical-direction/naloxone-information; or other appropriate patient information for the FDA-approved product dispensed; and
(B) the Naloxone Tri-fold Brouchure concerning recognition of signs of an overdose and other information created and maintained by the OEMS: http://www.wvoems.org/medical-direction/naloxone-information.
(6) Privacy: All pharmacist or interns furnishing naloxone hydrochloride in a pharmacy or health care facility shall operate under the pharmacy or facility’s policies and procedures to ensure that recipient confidentiality and privacy are maintained.
(7) Although not required, a pharmacy may choose to have a prescribing practitioner sign the protocol to treat it as a standing order.
The Opioid Antagonists Act Based on a Practitioner's Prescription
1. Q. Can I dispense Naloxone or other opioid antagonists to an addict pursuant to a prescription?
A. Yes. So long as you have a valid, lawful prescription for it. WEST VIRGINIA CODE Chapter 16, Article 46 is the "ACCESS TO OPIOID ANTAGONISTS ACT." The purpose of the Act is to prevent opioid-related overdose deaths. In §16-46-3(b), the Act provides:
All licensed health care providers in the course of their professional practice may offer to a person considered by the licensed health care provider to be at risk of experiencing an opiate-related overdose, or to a relative, friend, caregiver or person in a position to assist a person at risk of experiencing an opiate-related overdose, a prescription for an opioid antagonist.
2. Q. Q. Can I dispense Naloxone or other opioid antagonists on a prescription to a relative, friend, caregiver or person in a position to assist a person at risk of experiencing an opiate-related overdose?
A. Yes, even though there is no traditional prescriber-patient relationship, §16-46-3(b) permits a practitioner to issue a prescription to these people to help prevent fatalities from opioid-related overdoses.
3. Q. Can I dispense Naloxone or other opioid antagonists to initial (first) responders?
A. Yes, you can do this based on a prescription or the a standing order to do so, or you can do it under the pharmacist's protocol. The Act defines an initial responder as follows:
"Initial responder" means emergency medical service personnel, as defined in subdivision (g), section three, article four-c of this chapter, including, but not limited to, a member of the West Virginia State Police, a sheriff, a deputy sheriff, a municipal police officer, a volunteer or paid firefighter and any other person acting under color of law who responds to emergencies.
In §16-46-3(a), the Act states: "All licensed health care providers in the course of their professional practice may offer to initial responders a prescription for opioid antagonists, including a standing order, to be used during the course of their professional duties as initial responders."
While this would normally be seen as a "for stock" transaction, this statute permits a pharmacy to make this sale based on the prescription or standing order, or the pharmacist's protocol.