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Alabama State Board of Pharmacy
Susan Alverson
Executive Secretary
Cristal Anderson, Pharm.D.
Director of Compliance
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Inspections & Investigations
Chief Drug Inspector
Eddie Braden
Drug Inspector
Richard Lambruschi
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Drug Inspector
Henry Burks
Drug Inspector
Mark Delk
Drug Inspector
Glenn Wells
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Drug Inspector
Scott Daniel
Drug Inspector
Todd Brooks
Drug Inspector
Peyton Zarzour
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Drug Inspector
Mark Hebert
Patty Wright
Case coordinator/Admin. Assistant
WHERE DOES OUR AUTHORITY COME FROM?
• Title 34 Practice of Pharmacy Act 205‐§ 34‐23‐3‐ Each state drug inspector shall have the power to inspect the medicines and drugs or drug products or domestic remedies which are manufactured, packaged, packed, made, sold, offered for sale, exposed for sale or kept for sale in this state, and for this purpose shall have the right to enter and inspect during business hours any pharmacy or any other place in this state where medicines or drugs or drug products or proprietary medicines are manufactured, packaged, packed, made, sold, offered for sale or kept for sale, whether or not licensed by the state board of pharmacy.
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WHERE DOES OUR AUTHORITY COME FROM?
• § 34‐23‐3
‐Drug Inspectors must report to the board all violations of the laws relating to pharmacy and all rules and regulations of the board.
‐As directed by the board, it shall be the duty of the state drug inspectors to issue citations for violations of such laws, rules, and regulations OR institute criminal proceedings against persons for such violations.
WHERE DOES OUR AUTHORITY COME FROM?
• § 34‐23‐3‐When authorized by the board and where there are specific complaints, the state drug inspectors shall have the right to inspect all records, shipping tickets or any other documents pertaining to the transfer of drugs or drug preparations, from or to hospitals, pharmacies, wholesale establishments and manufacturers, or any other place or establishment where said preparations of drugs are kept or stored.
WHERE DOES OUR AUTHORITY COME FROM?
• § 34‐23‐3
‐Drug Inspectors shall have the authority to inspect all prescription files, prescription record books, poison registers, exempt narcotic registers and any other records pertaining to the filling and filing of prescriptions.
‐Drug Inspectors have the duty to take possession of all revoked and/or suspended licenses and permits.
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What Do Board Investigators Do?
• Conduct routine inspections‐Retail pharmacies‐Hospital pharmacies‐Retail oxygen suppliers‐Manufacturer/Wholesaler/Distributors of medical oxygen‐Drug manufacturers/wholesalers/distributors‐Nuclear pharmacies‐Compounding pharmacies‐Wholesalers/distributors of precursor chemicals
What Do Board Investigators Do?
• Conduct Investigations
‐Investigate alleged violations of Title 34 (Practice of Pharmacy Act) and Title 20 (Alabama Uniform Controlled Substances Act) and report our findings to the Board.
What Do Board Investigators Do?
• Provide testimony
‐At Board hearings
‐In court proceedings
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What Do Board Investigators Do?
• Work with Local, State, and Federal law enforcement agencies
What Do Board Investigators Do?
• Work with loss prevention managers in investigating internal thefts
Something to Consider
• Rule 680‐x‐2‐.12 – Supervising Pharmacist• 680‐x‐2‐.12(4)‐The supervising pharmacist shall be
responsible for the following:(a)Supervising of personnel in the prescription department to include ensuring that all licenses and registrations of pharmacists and technicians working in the pharmacy are current and in good standing with the Board
(b)Maintenance of accurate records of all prescription medication received and dispensed
(c)Maintaining the security of the prescription department and its contents
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The Pharmacy Technician
• Rule 680‐x‐2‐.14 Role of Technicians
• 680‐x‐2‐.14(4)‐In order to adequately protect
the public health, technicians shall not:(a)Communicate, orally or in writing, any medical, therapeutic, clinical or drug information, or communicate any information recorded on a patient profile that requires professional judgment.
The Pharmacy Technician
• (b) Document the receipt of a controlled substance.
• (c) Accept by oral communication a new prescription into inventory.
• (d) Prepare a copy of a prescription or read a prescription to another person.
• (e) Provide a prescription or medication to a patient without a pharmacist’s verification as to the correctness of the prescription or medication.
The Pharmacy Technician
• (f) Counsel a patient on medications or perform a drug utilization review.
• (g) Perform any task that requires the professional judgment of a pharmacist.
• (h) Perform any task that is in violation of any federal, state, or local pharmacy regulations.
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Pharmacy Technician Requirements
• (a) Submit a written application on a form provided by the Board of Pharmacy along with a $60 registration fee.
• (b) Have attained the age of seventeen (17).(c) Must wear a name tag identifying them as a pharmacy technician while on duty.(d) Complete 3 hours of continuing education annually, one of which must be live.(e) Notify the Board in writing within 10 days on change of employment (name/registration#/former employer/new employer).
The Investigative Process
A. A complaint is received:
1. From a consumer
2. From a non‐consumer
‐Loss Prevention
‐Law Enforcement
3. Self‐generated/observed
The Investigative Process
B. Perform any preliminary work:
1. Run a query through Prescription Drug Monitoring Program (PDMP)
2. Run a criminal history
3. Check individuals through the Law Enforcement Tactical System.
4. Conduct Interviews
‐obtain verbal and written statements
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The Investigative Process
5. Collect any documentation to support or dispel the allegations:
‐Patient profiles
‐Invoices
‐Copies of prescriptions
‐Witness statements
‐Video evidence
The Investigative Process
6. Prepare an investigative report and submit it to the Chief Investigator along with all supporting documentation.‐After review by the Chief Investigator ‐The case is reviewed by our review committee if circumstances are questionable
or‐The case is sent to the Board’s attorney where a statement of charges and notice of hearing are drafted.
The Investigative Process
• Hearing before the Board
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Cases
BDH Case
BDH Case
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BDH Case
BDH Case
BDH Case
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BDH Case
BDH Case
• BDH ‐ Pharmacist
‐Theft of controlled substances
‐unlawful distribution of controlled substance
‐Possession of crystal meth
‐Possession of drug paraphernalia
Result: Permanent revocation of license to practice pharmacy
Cases
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TB Case
TB Case
T B Case
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TB Case
TB Case
TB Case
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A Closer Look
How Did This Happen?
• 1. Lazy Pharmacist
• 2. Too much trust
• 3. Ignoring the law
• 4. Opportunity
TB Case: Outcome
• Pharmacist ‐ $25,000 fine and 5 years probation.
• Technician – Revocation of technician registration and a plea agreement with the D.A.’s office –Two years in prison.
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Mary Jane Tech
Mary Jane
Mary Jane
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Mary Jane
Mary Jane
Mary Jane
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Mr. Jane
Cases
Question
• What statute gives Board Investigators their authority?
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Answer
• Title 34 – Practice of Pharmacy Act
Question
• What requirement must be met in order to become a Board Inspector?
Answer
• Any applicant for the position of Board Inspector MUST be a certified law enforcement officer.
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Question
• What is the primary goal of the Board Inspectors?
Answer
• Safety of the public.
Questions?