LICENSE PROTECTION HANDBOOK

Transcription

1 LICENSE PROTECTION HANDBOOK Health Care License Protection Services (800)

2 HEALTH CARE LICENSE PROTECTION SERVICES OVERVIEW FOR THE STATE OF CALIFORNIA Welcome to Health Care License Protection Services (HCLPS), the premier resource for protecting your health care license. INTRODUCTION Every pharmacist should be prepared for an audit, whether it s a third party insurance audit, a State Board of Pharmacy audit, or even the infrequent Drug Enforcement Administration (DEA) audit. Many pharmacists believe that audits only happen to other pharmacies, yet unfortunately, the majority of pharmacies will be audited by some entity at some point in time. In any type of audit, something is always at stake. Third party audits generally have a financial repercussion in that a payback to the insurance company is generally required. More importantly and substantial are State Board of Pharmacy and DEA audits. Their outcome may result in the levy of severe fines or civil or criminal legal actions for violations that are discovered. With regulatory agencies overseeing your professional practice and second-guessing your professional judgment, HCLPS provides you with the materials you need so that you ll be prepared for a State regulatory inspection or DEA audit. Members of HCLPS have access to a comprehensive list of professional services including: audit preparation advice, infraction reviews, safe practice policies, procedures, and much more. OVERVIEW OF SERVICES The goal of HCLPS is to safeguard licensed individuals, as well as the pharmacy license itself, from a negative outcome due to a State Board of Pharmacy and/or a DEA inspection. Our services include: A License Protection Handbook that outlines the major areas of pharmacy that are subject to an inspection. Including an Inspection Materials section consisting of the relevant documentation required during an inspection Consulting services prior to and after your inspection Questions you may have that are not addressed in the Handbook, as they relate to the laws governing your practice of pharmacy, can also be answered as part of our Bronze, Silver and Gold levels of our services By taking a preventative approach to potential negative outcomes, not only will you be prepared for the untimely regulatory inspection, but also you will have experts available to assist you in minimizing your potential liability. Even if nothing ever comes from a Board or DEA inspection, there are always the lingering negative effects and stigma of being involved in an investigation. RESOURCES TO HELP YOU PROTECT YOUR LICENSE HCLPS offers several resources to help you protect your license and limit your exposure to the regulatory agencies. License Protection Handbook To avoid a suspension of your license, we recommend that you read our License Protection Handbook and follow the recommendations outlined. The purpose of this Handbook is not to teach you Pharmacy Law, but instead highlight those areas of Pharmacy Law and The Controlled Substance Act where both the Board and DEA are looking for legal compliance. Prevention is your ally when it comes to regulatory involvement, and it is also your best defense to help decrease negative findings resulting from a regulatory inspection.

3 License Protection Quarterly Newsletter Our License Protection Quarterly Newsletter will also help keep you up-to-date on all current regulatory matters that are necessary to keep you and your license in compliance. In addition, this quarterly newsletter will remind you of the necessary timetables to keep your License Protection Handbook current with respect to narcotic inventories, pharmacy selfassessment forms, and much more. THE FORUM: Gold, Silver and Bronze Services HCLPS offers a special FORUM for those who would like the opportunity to ask HCLPS specific questions relating to the laws governing their practice of pharmacy that are not addressed in our Handbook. The FORUM can be especially useful in the event you are inspected by the State Board of Pharmacy and/or the DEA to help you answer questions during the audit, and to help mitigate any findings the State or Federal agency discovers. The FORUM is an added service that is broken down into Gold, Silver and Bronze levels. The level of service to which you subscribe governs the number of questions that we answer for you. Answers to your questions will be personally handled by Jeb Sydejko, Pharm.D., J.D., Registered Pharmacist and Licensed Attorney, and President of HCLPS. In the event that the State Board of Pharmacy and/or the DEA does an inspection, and you have registered for THE FORUM, call HCLPS at , or Jeb Sydejko at jeb@licenseprotection.com We hope you find these materials informative and beneficial to help you understand the proactive actions you can take to protect your license. DISCLAIMER This License Protection Handbook is prepared by HCLPS as a guide and is not all-inclusive. This guide does not constitute legal advice or representation and health care providers are advised to seek legal advice from their own legal counsel for specific situations. Further, this handbook is prepared pursuant to laws and regulations in effect at the time of its preparation. HCLPS recommends that dealers carefully review future HCLPS newsletters and publications for any changes in laws and regulations.

4 TABLE OF CONTENTS The State Board of Pharmacy Inspection... Section Role of the State Board of Pharmacy Inspector... 1-a 1.2 Order of Correction... 1-a 1.3 Explanation of Disciplinary Terms... 1-b 1.4 State Board of Pharmacy Inspection: Events and Checklist... 1-c 1.5 State Board of Pharmacy Inspection Events... 1-c 1.6 State Board of Pharmacy Checklist... 1-c Sample Inspection Report... 1-f Sample Official Receipt... 1-j The Drug Enforcement Administration Inspection... Section Role of the Drug Enforcement Administration Inspector... 2-a 2.2 Drug Enforcement Administration Inspection Checklist... 2-a 2.3 Power of Attorney to Sign an Official Order Form... 2-c Sample Power of Attorney... 2-e Sample Revocation of Power of Attorney... 2-e Perpetual Inventory Log... 2-f Record Keeping Requirements...Section Documentation Needed for a State Board Inspection... 3-a 3.2 Board Waiver to Store Pharmacy Records Off-Site... 3-a Record Keeping Requirements Time-Table... 3-b Controlled Substance Utilization and Review Evaluation System (CURES)...Section CURES Requirements... 4-a Pharmacy Staff Considerations... Section Requirements for Pharmacy Personnel... 5-a Facility and Drug Considerations... Section Pharmacy Layout or Building Structure... 6-a Pharmacy Consultations... Section Consultation Requirements... 7-a Prescription Requirements...Section Verbally Transmitted Prescriptions... 8-a 8.2 Initials on a Filled Prescription... 8-a 8.3 Prescription from a Facsimile Machine... 8-a 8.4 Prescription from the Internet... 8-a 8.5 Written Controlled Substance Prescriptions... 8-b 8.6 Medi-Cal Tamper Resistant Prescriptions... 8-b 8.7 Prescription Expiration... 8-b Erroneous or Uncertain Prescriptions Requirements...Section Legitimate Medical Purpose... 9-a Guideline Questions by The Board... 9-b The Prescription Label...Section Pharmacist Initials a 10.2 Physical Description a 10.3 Expiration Date a

5 Rules Governing Refills... Section Initials on a Refill a 11.2 Refilling Controlled Substances a Day Supply Restrictions a 11.4 Refills Without the Prescriber s Authorization a Quality Assurance and Medication Errors... Section Medication Error Reports a 12.2 Reporting Near Miss Errors a 12.3 Informing Patient and Prescriber of an Error a 12.4 Error Discovered During Consultation Process a 12.5 Medication Error Records a 12.6 Written Plans b 12.7 Documentation of Findings b 12.8 Communicating Quality Assurance Program b 12.9 Contracted Quality Assurance Reviews b Quality Assurance Review Form c Combat Methamphetamine Epidemic Act of Section Introduction a Pseudoephedrine Transaction Logbook b Required Training and Self-Certification... Section Training and Certification a INSPECTION MATERIALS Policy and Procedures... Section A Policy and Procedures for Licensed Employee Theft or Impairment...A-1 Policy and Procedures for a Pharmacy Technician and Duties for a Pharmacy Technician...A-2 Policy and Procedures for Quality Assurance Program Policy...A-3 Policy and Procedures for Compliance with Title 7 Combat Methamphetamine Epidemic Act of A-4 Policy and Procedures for Pharmacy Operations During the Temporary Absence of a Pharmacist...A-5 Policy and Procedures for the Theft or Loss of a Controlled Substance...A-6 Narcotic Variance Report...A-7 FORM DEA A-8 Pharmacy Self-Assessment Form... Section B Controlled Substance Inventory... Section C Previous State Board of Pharmacy Inspection Reports... Section D SubscribetoHCLPSinordertobe preparedforaninspection. Pharmacy Permit, DEA Registration and Sellers Permit...Section E Pharmacy Staff Licenses...Section F Wholesalers Licenses... Section G Master List of Initials... Section H Master List of Pharmacist and Technician Initials... H-1

6 SECTION 1 THE STATE BOARD OF PHARMACY INSPECTION 1.1 Role of the State Board of Pharmacy Inspector It is the role of the State Board of Pharmacy Inspector to inspect during business hours all pharmacies, wholesalers, dispensaries, stores or places where drugs or devices are compounded, prepared, furnished, dispensed or stored. When the inspector is performing the inspection of the pharmacy, the inspector is allowed to remove the pharmacy s files, records, and any documentation that is the subject of the inspection. Upon the completion of the inspection, the inspector must provide a signed receipt to the pharmacy detailing all documentation that is being removed. During the course of the investigation, the licensee may be asked for more documents and/or statements regarding the events that were alleged to have occurred. 1.2 Order of Correction After the inspector reviews the documentation and believes that a violation of Pharmacy Law did in fact take place, then the licensee may be advised of the alleged violation through an Order of Correction. The Order of Correction simply outlines the alleged violations of the law that the inspector believes occurred. The licensee is directed to respond within 30 days by submitting a corrective plan to fix the problem to the inspector. Upon receipt of the response to the Order of Correction, the investigation is fully reviewed by an inspector or enforcement analyst to determine if the law was violated. If a violation is found, then a supervising inspector reviews this violation. If the supervising inspector determines that there was no violation, or the violation is minimal, the action may be closed and the case goes no further. In the event the supervising inspector determines that further action is warranted, the case is referred to the Board s executive officer. Upon review, the executive officer will determine the appropriate course of action, which can include the following: 1) Case Closure: The executive officer may determine that no further action is necessary because of the following: a. There was no violation b. Violation did occur, but was too minimal to warrant further action c. Mitigating circumstances are such that it would be best not to pursue an action 2) Order of Correction: An Order of Correction is sent to the licensee who is required to do one of the following: a. Contest the order by requesting an office conference with the executive officer; or b. Comply with the Order. By complying with the Order, the licensee s action is not an admission of the noted violation. The Order of Correction is not the Board s final determination of the matter. If the licensee complies with the Order, a copy of the Order of Correction and the corrective action plan must be maintained at the pharmacy for at least three years from the date of the Order of Correction. 3) Further Investigation: The executive officer may determine that more information is necessary to conclude there was a violation. By doing so, the matter is returned to the investigational officer for further investigation.

7 4) Letter of Admonishment: After determining that the licensee failed to comply with Pharmacy Law, the executive officer requests that a Letter of Admonishment be issued. The letter will indicate which State statute or regulation was violated and a notice to the licensee of his or her available appeal rights. 5) Citation and Fine: The following factors can be taken into consideration by the executive officer to determine the issuance of citations and fines: a. Severity of the violation b. Good or bad faith of the cited person or entity c. History of previous violations d. Evidence regarding the severity of the intent underlying the violation e. The licensee s cooperation with the Board during the investigation f. Extent to which the licensee or entity has mitigated or attempted to mitigate any damage or injury resulting from the violation g. The number of violations discovered during the investigation h. Other matters as may be appropriate 6) Order of Abatement: The Board can also issue an Order of Abatement in addition to a citation requiring the licensee to submit a corrective action plan to demonstrate how future compliance with Pharmacy Law will be accomplished as well as complete continuing education courses in the subject matter specified in the Order of Abatement. 7) Fine Amount: State Regulations allow the Board to fine up to $5, per licensee for each citation. When the investigation involves multiple licensees, (e.g., the pharmacy, the pharmacist-in-charge, a staff pharmacist, and the pharmacy technician), each licensee may be sited and fined based upon the criteria set forth above. 1.3 Explanation of Disciplinary Terms 1) Effective Date of Action: The date the disciplinary action goes into operation. 2) Revocation or Revoked: The Board revokes the license as a result of disciplinary action and the licensee s right to practice or operate a Board-licensed entity is ended. 3) Revoked, Stayed: The license is revoked, but the revocation is postponed until the Board determines whether the licensee has failed to comply with specific probationary conditions, which may include suspension of the licensee s right to practice. 4) Stayed: The revocation or suspension action is postponed and the licensee is put on probation. 5) Probation: The licensee may continue to practice or operate a Board-licensed entity under specific terms and conditions for a specific period of time. 6) Voluntary Surrender: The licensee has agreed to surrender his or her license and the right to practice or operate a Board-licensed entity is ended. 7) Suspension: The licensee is prohibited from practicing or operating a Board-licensed entity for a specific period of time. 8) Suspension/Probation: The licensee is prohibited from practicing or operating a Boardlicensed entity for a specific period of time, and the right to practice or operate is contingent upon meeting specific terms and conditions during the probationary period.

8 9) PC 23 Order Issued: The licensee is restricted from practicing or operating a Board-licensed entity by a court order that is issued under the provisions of Penal Code section ) Public Reprimand: Resulting from a disciplinary action, the licensee is issued a letter of public reprimand. 11) Accusation Filed: An accusation is the document containing the charges and allegations filed when an agency is seeking to discipline a license. 12) Reinstatement of License: A previously revoked or suspended license is reinstated with specified terms and conditions. 13) Statement of Issues: A legal document that details the factual or legal basis for refusing to grant or issue a license. 1.4 STATE BOARD OF PHARMACY INSPECTION: EVENTS AND CHECKLIST The Board may be prompted to visit the pharmacy for an inspection when certain events happen. The purpose of the inspection is to ensure that the pharmacy is in compliance with all aspects of pharmacy law. 1.5 State Board of Pharmacy Inspection Events Following is a list of events that can prompt the Board to make a visit and a subsequent inspection. 1) New pharmacy permit is issued: A new pharmacy self-assessment form is necessary. 2) New pharmacist-in-charge (PIC) is employed: A new pharmacy self-assessment form is necessary, and the pharmacist-in-charge leaving and PIC arriving MUST notify the Board within 30 days. 3) Complaint: A consumer files a complaint against the pharmacy. While the pharmacy is not aware that a complaint has been filed, most likely the complaint is filed because of a major event occurring at the pharmacy. Dispensing errors qualify as a major event. 4) In the area: The Board of Pharmacy is visiting other pharmacies in the local area. 5) Compliance issues: To confirm or reject a suspicion or report of compliance issues. 1.6 State Board of Pharmacy Checklist Following is a general checklist of the most common policy and procedure items requested and reviewed by the Board during an inspection: SubscribetoHCLPSinordertobepreparedforan inspection. 1) Biennial pharmacy self-assessment: Requires that the pharmacist-in-charge complete a Community Pharmacy & Hospital Outpatient Pharmacy Self-Assessment on Form 17M-13 (Rev 10/08) before July 1 of every odd year SubscribetoHCLPSinordertobepreparedforan inspection. 2) Current controlled substance inventory 3) DEA 222 forms are completed with invoices attached 4) Invoices for Schedule II controlled substances separated from invoices for Schedule III to V controlled substances