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Chapter 8

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Chapter 8

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  1. Chapter 8 State Boards of Pharmacy Jahangir Moini, MD, MPH, CPhT

  2. Overview • Regulation of pharmacy practice is primarily a state function, not federal • Legal responsibilities of pharmacies varyby state • Most states agree on fundamental principles, purposes, aims, and objectives of pharmacy practice

  3. The Board of Pharmacy • State Board of Pharmacy is provided for by state laws (pharmacy practice acts) • They strive to protect health, safety, and welfare of public • Mostly made up of a combination of pharmacists, consumers, and health care professionals

  4. State Board of Pharmacy’s Functions • Board of Pharmacy is sub-agency larger state agency such as Department of Health or Licensing • Charged with enforcement and administration of pharmacy practice laws • Authorized to make rules and regulations for enforcement and administration of pharmacy law

  5. State Board of Pharmacy’s Functions • Board is administrative, not legislative • Grants licenses to qualified pharmacists, pharmacies, technicians, and interns • Can impose sanctions against those who do not follow all applicable laws

  6. State Board of Pharmacy’s Functions • Licensure or registration may be canceled, revoked (withdrawn), or suspended according to statutes or regulations • Offenders may be placed on probation by the Board of Pharmacy or fines may be imposed

  7. State Board of Pharmacy’s Functions • Drug distribution within a state is regulated by Board of Pharmacy • When drug distribution regulations are violated, Board has grounds for refusal, suspension, or revocation of any license or permit issued

  8. State Board of Pharmacy’s Functions • Most states issue licensure permits for pharmacy practice for 1 to 2 years • Pharmacists must be periodically re-licensed • Certificates of licensure must always be prominently displayed in pharmacy

  9. Enforcement Powers • Most situations wherein Board of Pharmacy can institute actions are civil cases • Board’s powers may also include arrest, though warrants are issued by magistrates or judges • FDA and DEA enforce federal drug laws by investigating and turning matters over to U.S. Attorney’s office for prosecution

  10. Activities • State Boards of Pharmacy can enforce statutes, state drug control acts, and their own regulations by suspending, revoking, or withholding licenses or permits, by monetary penalties, or by seeking court injunctions, restraining orders, or other court orders • May also refuse to renew pharmacist’s license or pharmacy’s permit due to infringements

  11. Responsibilities • State Boards of Pharmacy are responsible for: • Licensing by examination or license transfer • Renewal of licenses • Establishment and enforcement of compliance in pharmacy practice • Approval of degree programs to teach pharmacy • Suspension, revocation, or restriction of pharmacy licenses

  12. Responsibilities • Control of training, qualifications, and employmentof pharmacy personnel • Collection of demographic data • Seizure of drugs and devices • Establishing specifications for facilities and equipment • Establishing standards for purity and quality • Manufacturing and distribution licenses • Inspections • Private health information standards

  13. Licensing and Renewal • State Boards of Pharmacy are responsible for granting pharmacist licenses and pharmacy technician certificates • Renewal of licenses can occur after an individual has applied for renewal in a timely manner and completed continuing education since previous licensure

  14. Compliance and Teaching • State Boards of Pharmacy assess penalties against those who do not comply with regulations • They offer accreditation for pharmacy degree programs offered by colleges and universities

  15. License Review and Quality Control • State Boards of Pharmacy review individual cases and can determines if an applicant’s license needs to be suspended, revoked, or restricted • They monitor quality of pharmacies and personnel, requiring specialized training

  16. Data Collection and Seizable Items • State Boards of Pharmacy collect demographic data about staff of pharmacies in their jurisdiction • If they discover a drug or device that may harm the public, they may seize item(s) and prevent continued use

  17. Establishing Specificationsand Standards • State Boards of Pharmacy control types of facilities required in each pharmacy and equipment that can be used within • They establish purity and quality standards for compounding, which may be further regulated by federal standards

  18. Other Licensure and Inspections • State Boards of Pharmacy issue and renew licenses to pharmaceutical manufacturers and distributors as regulated by FDA • They may conduct unannounced inspections of pharmacies and their facilities, equipment, and personnel

  19. Patient Information Standards • Patients’ PHI requires protection • Accomplished by state Boards of Pharmacy, and regulations and standards they establish concerning integrity and confidentiality of information

  20. Examination Requirements • Applicants for pharmacist license must pass all of the following after graduating from state-approved school of pharmacy: • Part I: North American Pharmacist Licensing Exam (NAPLEX) • Part II: Multi-state Pharmacy Jurisprudence Exam (MPJE) • Part III: Written and Practical (Compounding) Exam (currently required by 10 states)

  21. NAPLEX • For NAPLEX, applicants must submit completed licensure application and have completed education documentation approved before taking exam • Once approved, they can apply to take exam online at http://www.nabp.net

  22. Internship Requirements • Most states require pharmacy internships of 400 to 2,500 hours, based on 40 hours per week, under supervision of licensed pharmacist • Internships usually completed both while student is still actively attending courses, and after schooling is completed, but prior to licensure

  23. Internship Requirements • Pharmacy internship means “supervised practical experience working under a licensed pharmacist’s direction” • Purpose is to acquire knowledge and practical experience necessary to function competently and effectively upon licensure

  24. Internship Requirements • Pharmacist must submit practical experience affidavit proving intern’s completion of required clock hours

  25. Major Areas of Instruction during Pharmacy Internships • Receiving and interpreting prescriptions • Compounding • Dispensing • Reviewing patient medication profiles • Communicating with patients • Consulting with health care professionals • Managing the pharmacy

  26. Licensure of the Pharmacist • State Boards of Pharmacies issue licenses to pharmacists and pharmacies • Most states require each applicant to: • Have graduated from accredited pharmacy school • Have completed required internship • Have passed state’s pharmacy licensure exam • Have documentable history of good moral character

  27. Licensure by Transfer • Some states grant licensure by transfer from another jurisdiction (reciprocity), though many states do not allow reciprocity based on a Florida license • Florida only allows reciprocity if applicant took NAPLEX within prior 12 years

  28. Pharmacist Licensure Renewal • Pharmacist must periodically renew license by paying a fee and, in some states, by completing a certain number of continuing education (CE) credits • Renewal usually requires revealing of personal information, CE record forms, pharmacy permit information, verification of any disciplinary actions, and renewal fee

  29. Continuing Education Requirements • Required numbers of credits and hours of CE vary per state, but all states require CE for pharmacy practice and licensure • CE credits may be completed in formal courses from approved providers and self-study courses

  30. Appropriate CE Subjects • Techniques for reducing medication errors • Knowledge of drug interactions • Pharmacology of new/developing drugs • Infection control • Reporting suspected child abuse

  31. Appropriate CE Subjects • Public health issues • Legal and regulatory issues • Proper patient counseling • Sterile procedures

  32. State Board Inspections • Pharmacy Board inspectors conduct routine inspections of pharmacies for compliance with various laws and regulations • All licensed personnel and appropriate records may be inspected, and employees must cooperate with inspectors

  33. Certification of Pharmacy Technicians • Pharmacy Technician Certification Board (PTCB) established to ensure pharmacy technicians in every state have minimum level of skill • PTCB offers Pharmacy Technician Certification Examination (PTCE) 3 times per year

  34. PTCE • Divided into 3 areas: • Assisting pharmacist • Maintenance of medication/inventory control systems • Helping with administration and management of the pharmacy • After certification, pharmacy technicians may use “CPhT” following their names

  35. Renewal of Certification • Renewal of pharmacy technician certification requires continuing education (20 hours of CE every 2 years) • Every year, more states are increasing requirements for and/or requiring certification of pharmacy technicians

  36. ExCPT • The other nationally accredited pharmacy technician certification exam • Given by Institute for the Certification of Pharmacy Technicians (ICPT) • Available to all pharmacy technicians regardless of the type of pharmacy they practice in

  37. Drug Control Regulations • Pharmacists who violate Controlled Substances Act are handled according to whether they knowingly and intentionally violated the act • Federal or state violations involving controlled substances can have severe implications on pharmacist’s licensure and can keep them from practicing pharmacy in the future

  38. Hospital Pharmacy • State regulation of hospital pharmacy is different from regulation of community pharmacy • In most hospital pharmacies, pharmacy technicians cannot accept called-in prescriptions from physicians, check work of other PTs, or transfer prescription orders

  39. Regulation of Long-Term Care Pharmacies • Under current legislation, long-term care facilities may be separately licensed under state law • Pharmacists in these facilities usually required by state law to have special training or expertise

  40. Regulation of Long-Term Care Pharmacies • They supervise all aspects of drugs required by patients and must maintain strict drug control, reviews, cost controls, and detailed policies and procedures

  41. Standards of the Joint Commission • Joint Commission sets certain voluntary standards for hospitals and provides accreditation based on compliance • 6 basic standards • They serve as a guide to proper method of operating a hospital

  42. The 6 Standards • Competent, legally qualified personnel • Separation of internal-use-only drugs from external-use-only drugs • Adequate record keeping and procedures • Pharmacist review of inpatient drug orders before initial dosage is dispensed

  43. The 6 Standards • Automatic cancellation of standing orders when patient goes to surgery • Monitoring and evaluation of pharmacy activities to provide quality assurance

  44. Disciplinary Action • In most states, Board can take disciplinary action if: • Pharmacist’s license obtained through fraud • Pharmacist proven mentally incompetent • Pharmacist has knowingly violated drug laws • Pharmacist has knowingly allowed unlicensed individuals to engage in practice of pharmacy • Pharmacist has compounded or allowed compounding of drugs with incorrect quantities of ingredients

  45. Status of Pharmacy Technicians • Each state has different approaches in how pharmacy technicians are regulated • Traditional pharmacy technician activities include: • Accepting written prescriptions • Checking prescriptions for accuracy • Creating and retrieving patient profiles

  46. Status of Pharmacy Technicians • Determining patient benefit plan information • Entering prescription information on profiles • Obtaining drug products for filling prescriptions • Counting numbers of tablets and other drug forms • Manually filling prescriptions • Using appropriately sized containers

  47. Pharmacy Technicians in Retail Settings • About 7 in 10 pharmacy technician jobs are in retail settings • As population grows and ages, demand for trained individuals will increase dramatically • Many retail pharmacies now open 24 hours

  48. Pharmacy Technicians in Hospital Settings • About 2 in 10 pharmacy technician jobs are in hospital settings • Responsibilities include: • Unit-dose and other medication preparation • Checking patient charts • Preparing, packaging, and labeling medications • Delivering medications to nurses • Managing robotic stocking systems • Organizing 24-hour supplies of medications • Cataloguing information in hospital computer system

  49. Pharmacy Technicians’ Liabilities • Common areas of liability include: • Failing to advise the pharmacist of known drug interactions • Providing incorrect information to patients • Providing advice to patients when state does not allow it