1. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Chapter 8 State Boards of Pharmacy Jahangir Moini, MD, MPH, CPhT

2. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Overview Regulation of pharmacy practice is primarily a state function, not federal Legal responsibilities of pharmacies vary by state Most states agree on fundamental principles, purposes, aims, and objectives of pharmacy practice

3. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. State Board of Pharmacy’s Functions Licensure or registration may be canceled, revoked (withdrawn), or suspended according to statutes or regulations Offenders may be placed on probation by the Board of Pharmacy or fines may be imposed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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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 Responsibilities

12. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Responsibilities  Establishing standards for purity and quality  Manufacturing and distribution licenses  Inspections  Private health information standards –Control of training, qualifications, and employment of pharmacy personnel –Collection of demographic data –Seizure of drugs and devices –Establishing specifications for facilities and equipment

13. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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 Establishing Specifications and Standards

18. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Internship Requirements Pharmacist must submit practical experience affidavit proving intern’s completion of required clock hours

25. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Major Areas of Instruction during Pharmacy Internships 1.Receiving and interpreting prescriptions 2.Compounding 3.Dispensing 4.Reviewing patient medication profiles 5.Communicating with patients 6.Consulting with health care professionals 7.Managing the pharmacy

26. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Appropriate CE Subjects Techniques for reducing medication errors Knowledge of drug interactions Pharmacology of new/developing drugs Infection control Reporting suspected child abuse

31. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Appropriate CE Subjects Public health issues Legal and regulatory issues Proper patient counseling Sterile procedures

32. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. The 6 Standards 1.Competent, legally qualified personnel 2.Separation of internal-use-only drugs from external-use-only drugs 3.Adequate record keeping and procedures 4.Pharmacist review of inpatient drug orders before initial dosage is dispensed

43. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. The 6 Standards 5.Automatic cancellation of standing orders when patient goes to surgery 6.Monitoring and evaluation of pharmacy activities to provide quality assurance

44. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. 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