Rules Hearing - 2006

1. Rules Hearing - 2006 • Pseudoephedrine • Makes it a C-III • Technician education and training • National certification, minimum age and education requirement • Vaccinations/immunizations • Influenza vaccine down to 15 years • Returned drugs • Clarifies what pharmacies can accept

2. LICENSING OF PHARMACISTSOAR 855-019 • Hold an earned degree from an ACPE accredited college of pharmacy • North American Pharmacist Licensure Examination (NAPLEX). • Score of not less than 75 shall be a passing score • 91 days minimum between re-takes • Multistate Pharmacy Jurisprudence Examination (MPJE).

3. General Reciprocity Requirements855-019-0015 • qualified under ORS 689.265 and these rules • pass the computer-based MPJE examination • be registered by written examination in the state on which the applicant bases the reciprocity application and must be in good standing in that state • minimum of 2000 hours of work as a licensed pharmacist • Met the internship requirements of this state within the one-year period immediately previous to the date of such application • application for transfer of pharmaceutic licensure, fee, and • photocopy of state-issued birth certificate must be submitted to and approved by the Board

4. Reinstatement of Licenses855-019-0040 • A pharmacist license that is not renewed by the deadline may be reinstated as follows: • Payment of the annual license fees for all years during which the license has been lapsed and for the current year and the delinquent fees for those years; and • Certification of the continuing education requirement for all years in which the license has lapsed. • Pharmacists in good standing who have retired from the practice of pharmacy after having been licensed 20 years must pay only the annual license fees for the year in which they seek a license but shall be subject to the requirement of certification of continuing education.

5. Petition for Reinstatement of RPh License855-019-0050 • A pharmacist license which has been revoked, suspended or restricted will be reinstated only if the Board finds, upon a presentation made by the petitioner, that there is a reasonable assurance that the public interest will be protected if relicensure occurs.

6. Continuing Pharmacy Education Required forPharmacist License Renewal 855-021-0005 (1) During the period from June 1 through May 31 of each license renewal cycle, each pharmacist must have satisfactorily completed one and one half (1.5) continuing pharmacy education units (CEU's) in an approved continuing pharmacy education program Ten contact hours equals 1 CEU. Fifty minutes equals 1 contact hour. (2) Section (1) does not apply to pharmacists applying for the first annual renewal of their license if they have not been licensed by the Board for at least one year prior to July 1 of the renewal period.

7. Continuing Pharmacy Education Required forPharmacist License Renewal 855-021-0005 • (a) A program shall consist of therapeutics, or pharmacy and drug law or other aspects of health care. At least eleven of the required fifteen hours of continuing education credit must be earned in the areas of therapeutics. At least one hour of continuing education credit must be earned in the area of pharmacy and drug law. • (b) Programs shall provide for examinations or other methods of evaluation to assure satisfactory completion by participants.

8. INTERNSHIP REGULATIONS OAR 855-031 • (1) A "pharmacy intern" means any person who has: • Completed the first professional year and is in good academic standing at an ACPE accredited school or college of pharmacy, or • Is a graduate of an ACPE accredited school or college of pharmacy, or • Holds a certificate from the Foreign Pharmacy Graduate Equivalency Committee, and has passed the Test of Spoken English (TSE) with a score of not less than 50, • And is licensed with the Oregon Board as an intern.

9. INTERNSHIP REGULATIONS OAR 855-031 • Read all of OAR 855-031, please!! • The entire contents of 855-031 will be fair game for the final exam even if we do not discuss specifics in class. • You will need to know this division in preparation for licensure as Pharmacy Intern this Summer.

10. INTERNSHIP REGULATIONS OAR 855-031 • A "preceptor" means a pharmacist licensed and in good standing, registered as a preceptor by the Board to supervise the internship training of an intern. • "Internship" means a professional and practical experience program approved by the Board.

11. Internship Reports855-031-0040 • The Intern Experience Affidavit/Hours Log must list the actual number of hours worked and the dates covered by those hours. • Each Experience Affidavit/Hours Logs must be notarized. • The internship experience Affidavit/Hours Log(s) must be signed by the pharmacy intern and the preceptor(s). • The intern may report to the Board voluntarily the preceptor's aptitude and willingness to perform the duties of a preceptor, or must do so upon request by the Board.

12. Rule Change - 2004 • Allows a non-pharmacist to supervise an intern with prior approval of the Board: • Approved Internship Experience Areas 855-031-0015 • (d) The preceptor must obtain prior approval from the Board if the preceptor wishes to designate a non-pharmacist to be responsible for the direct supervision of the intern during the clerkship experience.

13. Oregon Death With Dignity Act • Ballot measure #16 in 1994 • Passed 51% to 49% • Did not go into effect due to injunction by Federal Judge Michael Hogan (Eugene) • 1997 Legislature • Placed repeal measure before voters (Measure #51) • Repeal defeated 60% to 40% • Appeal to Supreme Court to repeal Act • Supreme Court denied to hear the appeal, law goes into effect in December, 1997

14. Oregon Death With Dignity Act • Very controversial morally and ethically • In 2001, Attorney General Ashcroft rules that Assisted Suicide was not a “legitimate medical purpose” for the use of controlled substances and threatened to suspend or revoke DEA registrations doctors who participated. • Oregon sues John Ashcroft and USDOJ • Federal Judge Robert Jones (Portland) places injunction on Ashcroft ruling • Appealed to Ninth Circuit Court – injunction upheld. • Appeal to US Supreme Court – upheld, January 2006

15. Who May Initiate a WrittenRequest for Medication? An adult who is capable, is a resident of Oregon, and has been determined by the attending physician and consulting physician to be suffering from a terminal disease, and who has voluntarily expressed his or her wish to die, may make a written request for medication for the purpose of ending his or her life in a humane and dignified manner in accordance with ORS 127.800 to 127.897

16. Patient Eligibility • be an adult ( 18 years) • be “capable” (able to make and communicate health care decisions) • be an Oregon resident (> 6 months) • have a terminal illness with less than six months to live • voluntarily request a prescription for lethal drugs

17. Requirements • Two verbal requests to physician, separated by at least 15 days • Written request to physician • Prescribing and a consulting physician confirm the diagnosis and prognosis • Prescribing and a consulting physician must determine whether patient is capable. If either physician believes judgment impaired by a psychiatric or psychological disorder, such as depression, patient must be referred for counseling • Prescribing physician must inform the patient of feasible alternatives to assisted suicide including comfort care, hospice care, and pain control

18. Requirements (Cont’d) • Prescribing physician must request, but may not require, the patient to notify their next-of-kin of the prescription request • Refer the patient for counseling if, in the opinion of either the attending physician or the consulting physician, the patient may be suffering from any mental disorder, including depression, causing impaired judgment; • Request that the patient notify next of kin (the patient does not have to comply); and • Offer the patient the opportunity to rescind the request at any time.

19. The Prescription Oregon Board of Medical Examiners Rule: (1) Dispense medications directly, including ancillary medications intended to facilitate the desired effect to minimize the patient's discomfort, provided the attending physician is registered as a dispensing physician with the Board of Medical Examiners, has a Drug Enforcement Administration (D.E.A.) certificate, and complies with the provisions of ORS 677.089, OAR 847-015-0015 and OAR 847-015-0025; or

20. The Prescription (Cont’d) (2) With the patient's written consent: (a) Contact a pharmacist, and inform the pharmacist of the purpose of the prescription, and (b) Deliver the written prescription personally or by mail to the pharmacist who will dispense the medications to either the patient, the attending physician, or an expressly identified patient's agent.

21. Pharmacist Issues • 10.1 Pharmacists, just as other health care professionals, may choose to not participate, and are under no obligation to participate. If declining to participate when asked by a physician, the pharmacist must inform the physician that they are unwilling. The pharmacist must provide the pharmacy records upon request by the physician and may assist the physician in finding a willing pharmacist, but is under no obligation to do so. The Oregon Death with Dignity Act: A Guidebook for Health Care Professionals

22. Pharmacist Issues • 10.2 Pharmacists must be aware of and respect their employer’s institutional policies regarding the Act before making any decision whether or not to participate. 10.3 Pharmacists need to assess their personal feelings and convictions about physician-assisted suicide in order to appropriately respond to inquiries from physicians, patients, and others. The Oregon Death with Dignity Act: A Guidebook for Health Care Professionals

23. Pharmacist Issues • 10.5 If the pharmacist has any question about the purpose or details of any prescription, it is his/her duty to confer with the prescriber and have those questions answered. • 10.6 The attending physician may obtain the prescribed medication from the pharmacist and present it to the patient personally. The pharmacist can facilitate this by delivering the medication directly to the physician’s office. The Oregon Death with Dignity Act: A Guidebook for Health Care Professionals

24. Pharmacist Issues • 10.7 The participating pharmacist should be prepared to discuss important pharmaceutical information and patient instructions with the physician. The attending physician assumes responsibility for advising on appropriate drug use when providing the medication directly to the patient. • 10.8 Pharmacies should develop policies and procedures to ensure confidentiality for patients, physicians, and pharmacists in handling prescriptions for the purpose of ending life as set forth in the Act. The Oregon Death with Dignity Act: A Guidebook for Health Care Professionals

25. Pharmacist Issues • 10.9 The dispensing health care professional (pharmacist, physician, or health care facility) must report to the Oregon Department of Human Services upon dispensing a lethal prescription pursuant to the Act. A photocopy, submitted by mail or facsimile, of the prescription label including the name of the dispensing health care professional and the phone number of the prescribing physician would meet this requirement. The Oregon Death with Dignity Act: A Guidebook for Health Care Professionals

26. Prescriptions and Deaths 1998-2004

27. Collaborative Drug Therapy Management • Refers to pharmacists writing prescriptions or inpatient orders under a protocol • Written protocol reviewed and agreed to by a prescriber • Prescriber orders protocol to be applied to an individual patient • Common in hospitals and increasing in community and LTC pharmacy practice

28. Collaborative Drug Therapy Management • Widespread practice without specific rule prior to 1996 • Currently described in OAR 855-041-0400 • Rule took about three years to draft and adopt • Opposition from Oregon Medical Association (MDs) and Pharmaceutical Research and Manufacturers of America (PhRMA) • PhRMA concern about “therapeutic substitution” • OMA concern about “turf”

29. Collaborative Drug Therapy Management • Examples: • Therapeutic interchange within specific drug classes (H2 antagonists – famotidine/ranitidine/ cimetidine/nizatidine) • Drug dosing and monitoring (aminoglycosides, anticoagulants, theophylline, TPN) • Weight-based dosing (acetaminophen, antibiotics, pediatrics) • Community pharmacy (diabetes, cholesterol, asthma management)

30. Collaborative Drug Therapy Management OAR 855-041-0400 • A pharmacist shall engage in collaborative drug therapy management only under a written protocol that includes; • The identification, either by name or by description, of the participating pharmacist(s); • The identification, by name,of the participating practitioner(s); • The name of the principal pharmacist and practitioner who are responsible for development, training, administration, and quality assurance of the arrangement;

31. Collaborative Drug Therapy Management OAR 855-041-0400 • A detailed description of the collaborative role the pharmacist(s) shall play, including but not limited to: • Written protocol for specific drugs pursuant to which the pharmacist will base drug therapy management decisions for an individual patient. • Circumstances which will cause the pharmacist to initiate communication with the practitioner, including but not limited to the need for new prescription orders and reports of patients’ therapeutic responses or adverse effects. • Training requirement for pharmacist participation and ongoing assessment of competency, if necessary. • Quality assurance and periodic review by a panel of the participating pharmacist(s) and practitioner(s).

32. Collaborative Drug Therapy Management OAR 855-041-0400 • Authorization by the practitioner(s) for the pharmacist(s) to participate in collaborative drug therapy. • A provision for the collaborative drug therapy arrangement to be reviewed and updated, or discontinued at least every two years; and • A description of the mechanism for the pharmacist(s) to communicate to the practitioner(s) and for documentation of the implementation of the collaborative drug therapy.

33. Collaborative Drug Therapy Management OAR 855-041-0400 • Collaborative drug therapy management is valid only when initiated upon the prescription order of a participating practitioner for each individual patient. • Nothing in this rule shall be construed to allow therapeutic substitution. • The collaborative drug therapy protocol must be kept on file in the pharmacy and made available to the Board of Pharmacy and to the Board of Medical Examiners upon request.

34. All rules start out as somebody’s “bright idea”! This rule actually took a committee of 12 people, including members of the board of Pharmacy, OMA, PhRMA, Board of Medical Examiners, and pharmacists, to draft.

35. FAMILY PHARMACY 4156 Main Street Corvallis, OR 97332 (541) 737-9384 Patient Name___________________ Date____________ Address_______________________ Drug: Quantity: Directions: Refill X_____ Signed:_____________, MD DEA #:_________________ 1 2 3

36. Elements of a Prescription • 1 = Patient information • 2 = Drug therapy instructions/protocol • 3 = Prescriber’s authorization (signature) • 1 + 2 + 3 = complete prescription

37. Administration of Vaccines By Pharmacists • A pharmacist may administer vaccines to persons who are over the age of eighteen as provided by these rules. • A pharmacist may administer vaccines to a person who is over the age of eighteen only if: • The pharmacist has completed a course of training accredited by the Centers for Disease Control and Prevention, the American Council on Pharmaceutical Education or a similar health authority or professional body approved by the Board and the Oregon Health Division; • The pharmacist holds a current basic Cardiopulmonary Resuscitation (CPR) certification issued by the American Heart Association or the American Red Cross;

38. Authority to administer vaccines and immunizations: ORS 689.645 • (1) In accordance with rules adopted by the State Board of Pharmacy under ORS 689.205, a pharmacist may administer vaccines and immunizations only to persons who are more than 18 years of age. • (2) The board is authorized to issue, to licensed pharmacists who have completed training accredited by the Centers for Disease Control and Prevention, the American Council on Pharmaceutical Education or a similar health authority or professional body, certificates of special competency in the administration of vaccines and immunizations to persons more than 18 years of age. • (3) The board shall adopt rules relating to the reporting of the administration of vaccines and immunizations to a patient’s primary health care provider and to the Department of Human Services.

39. Authority to administer vaccines and immunizations: ORS 689.645 • (4) The board shall adopt rules requiring pharmacists to establish protocols for the administration of vaccines and immunizations to persons more than 18 years of age. • (5) The board shall convene a volunteer Immunization Advisory Committee consisting of no more than nine members for the purpose of advising the board in promulgating rules under this section. The committee shall consist of one representative from the Department of Human Services, two representatives from the Board of Medical Examiners, two representatives from the Oregon State Board of Nursing and two representatives from the State Board of Pharmacy and no more than two pharmacists other than the representatives from the State Board of Pharmacy.

40. Authority to flush intravenous lines and to administer drugs and medical devicesORS 689.655 • (1) Only as provided in this section and in accordance with rules adopted by the State Board of Pharmacy under ORS 689.205, a pharmacist may: • (a) In collaboration with and under an order from a physician, nurse practitioner or physician assistant practicing within the scope of practice allowed by law, flush heparin or saline through existing intravenous lines that are connected to a person; • (b) In collaboration with and under an order from a physician, nurse practitioner or physician assistant practicing within the scope of practice allowed by law, attach an infusion pump or enteric feeding pump to existing intravenous lines or enteric feeding lines that are connected to a person, and activate the pump;

41. Authority to flush intravenous lines and to administer drugs and medical devicesORS 689.655 • (c) Administer drugs and devices in a medical emergency within a health care facility in the presence of and under the direction of a physician or nurse practitioner; and • (d) Administer a drug or device to a person in the course of teaching the person to self-administer the drug or device that the person will be required routinely to self-administer as part of a course of therapy ordered by a physician, nurse practitioner or physician assistant practicing within the scope of practice allowed by law. • (2) Nothing in this section shall be construed to allow a pharmacist to establish an intravenous or enteric line or to attach or activate a pump for any intrathecal medication.

42. Administration of Vaccines By Pharmacists OAR 855-041-0500 • (1) A pharmacist may administer vaccines to persons who are over the age of eighteen as provided by these rules. For the purposes of this rule, a person is over the age of eighteen the day following their eighteenth birthday.

43. Administration of Vaccines By Pharmacists (2) A pharmacist may administer vaccines to a person who is over the age of eighteen only if: (a) The pharmacist has completed a course of training accredited by the Centers for Disease Control and Prevention, the American Council on Pharmaceutical Education or a similar health authority or professional body approved by the Board and the Oregon Health Division; (b) The pharmacist holds a current basic Cardiopulmonary Resuscitation (CPR) certification issued by the American Heart Association or the American Red Cross; (c) The vaccines are administered in accordance with an administration protocol approved by the Oregon Health Division; and (d) the pharmacist has a current copy of the CDC reference, "Epidemiology and Prevention of Vaccine-Preventable Diseases".

44. Administration of Vaccines By Pharmacists • Protocols, Policies and Procedures OAR 855-041-0510 • pharmacists must follow written protocols approved by the Oregon Health Division for administration of vaccines and treatment of adverse events following administration of a vaccine(s). • The pharmacy must maintain written policies and procedures for handling and disposal of used or contaminated equipment and supplies. • The pharmacy must give the appropriate Vaccine Information Statement (VIS) to the patient or legal representative with each dose of vaccine covered by these forms. The pharmacist must ensure that the patient or legal representative is available and has read, or has had read to them, the information provided and has had their questions answered prior to administering the vaccine. • The pharmacy must report adverse events to VAERS, and PCP

45. Administration of Vaccines By Pharmacists • Record Keeping and Reporting OAR 855-041-0520 • (1) A pharmacist who administers any vaccine shall maintain the following information in the pharmacy records regarding each administration for a minimum of three years: • (a) the name, address, and date of birth of the patient; • (b) the date of the administration and site of injection of the vaccine; • (c) the name, dose, manufacturer, lot number, and expiration date of the vaccine or immunization; • (d) the name and address of the patient’s primary health care provider, as identified by the patient; • (e) the name or identifiable initials of the administering pharmacist; • (f) the date the pharmacist reported the vaccination information to the patient's primary health care provider, as identified by the patient, and, when required, to the Health Division if different from the date of administration; • (g) documentation of provision of informed consent for administration of vaccines and for transmission of records to a primary care provider, the Oregon Health Division and the Board of Pharmacy; • (h) which Vaccine Information Statement (VIS) was provided; • (i) the date of publication of the VIS; and • (j) the date the VIS was provided.

46. Administration of Vaccines By Pharmacists • (2) A pharmacist who administers any vaccine must report in writing to the patient's primary health care provider, as identified by the patient, the information required to be maintained by OAR 855-041-0520(1). The report shall be made within fourteen days of the date of administration. The pharmacist must also report to the Oregon Health Division as required for vaccines specifically identified by the Division. • (3) A pharmacist who administers vaccines must report to the Board of Pharmacy, on a form provided by the Board: • (a) the vaccine administered, • (b) the age of the patient, and • (c) the zip code of residence of the patient.

47. REMOTE DISPENSINGOAR 855-041-0600 • Definitions • (1) “Automated Pharmacy System” (APS) means a mechanical system that performs operations or activities, including but not limited to, those related to the storage, packaging, dispensing, or distribution of medications, but not including compounding or administration, and that collects, controls, and maintains all transaction information. • (2) “Remote Dispensing Machine” (RDM) means a component of an Automated Pharmacy System that contains prepackaged drugs for dispensing. • (3) “Responsible Pharmacy” means the licensed pharmacy that is responsible for the APS and RDM.

48. REMOTE DISPENSING855-041-0610 • Duties and Responsibilities of the Pharmacist-in-Charge. • Each RDM must be under the supervision of the Pharmacist-in-Charge of the Responsible Pharmacy. The Pharmacist-in-Charge must: • (a) Ensure safety, accuracy, security, and patient confidentiality; • (b) Define access to the RDM and to medications contained within …