2016 Jurisprudence Update. (Phone) (Fax)

Transcription

1 2016 Jurisprudence Update (Phone) (Fax)

2 Goals and Objectives To explain recent law/rule changes which may apply to the pharmacy practice setting. To describe how pharmacists are to use the OARRS program in their practice setting. To interpret current pharmacy compliance trends in the practice of pharmacy. To review recently updated compounding regulations.

3 Recent Board of Pharmacy Changes BOP updated its website and the OARRS website To keep up to date on any changes Subscribe to updates to the Board website: Follow BOP on Monthly E-News Update to all licensees BOP issues licenses electronically Pharmacists and Interns Terminal and Wholesale Distributors BOP moving towards all electronic inspection reports Inspection reports will be ed

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6 To Obtain Answers to Your Questions BOP Website Guidance Documents, Links to Laws/Rules, FAQ section Legal Practice of Pharmacy Selected Points - o This is the document provided to out of state pharmacists who reciprocate into our state Contact your local inspector Contact the BOP via or by phone

7 2016 Jurisprudence Update Recent Law/Rule Changes to the Practice of Pharmacy

8 Law and Rule Changes Recent changes: Proposed changes:

9 Law/Rule Changes HB 4 Naloxone Allows a pharmacist or pharmacy intern under the supervision of a pharmacist to dispense naloxone without a prescription (i.e. by protocol) Pharmacist or pharmacy intern who dispenses naloxone must instruct the person to whom it is dispensed to summon emergency services Pharmacist may document the dispensing of naloxone on a prescription form Prescription form may be assigned a number for record-keeping purposes

10 Law/Rule Changes HB 4 / OAC , Dispensing of Naloxone To assist pharmacies that are interested in dispensing naloxone pursuant to a protocol, the Board has developed a dedicated web page, The site includes the following: o Guidance document, sample protocol and a listing of all participating pharmacies o The Board is also offering printed, no-cost patient educational materials to any participating pharmacy (max 250 per request)

11 Law/Rule Changes , Immunization and vaccine administration, effective 10/5/15 o Guidance document available on website o HB 394 (130 th Assembly), ORC o All CDC/ACIP approved vaccines subject to age restrictions Except for influenza, notification must be made to family physician or health department Includes travel vaccines Includes pre (travel) & post-exposure rabies vaccine o Informed consent required for minors o Immunization can be on a prescription form and assigned a Rx#

12 Law Changes HB 124 Venereal Disease Prescription Authority (effective ) o Regarding the authority to prescribe without examination a drug for a sexual partner of a patient diagnosed with chlamydia, gonorrhea, or trichomoniasis o Prescriber may issue a prescription for a drug to treat chlamydia, gonorrhea, or trichomoniasis, without having examined the individual for whom it is issued the drug is intended, if all of the following conditions are met: The individual is a sexual partner of the prescriber's patient. The patient has been diagnosed with chlamydia, gonorrhea, or trichomoniasis. The patient reports to the prescriber that the individual is unable or unlikely to be evaluated or treated by a health professional.

13 Law Changes HB 124 Venereal Disease Prescription Authority ( ) o A prescription issued under this section shall include the individual's name and address, if known. If the prescriber is unable to obtain the individual's name and address, the prescription shall include the patient's name and address and the words "expedited partner therapy" or the letters "EPT. o A prescriber may issue a prescription under this section for not more than a total of two individuals who are sexual partners of the prescriber's patient.

14 Law Changes HB 188 Pharmacist Consult Agreements (effective ) o Permits one or more pharmacists to enter into a consult agreement with one or more physicians o No longer separate requirements of hospitals versus retail pharmacy settings o Rules under OAC (revisions in process) o Revises ORC , Emergency dispensing Note: By law, consult agreements are with physicians, not mid-level practitioners

15 Law Changes HB Pharmacist Consult Agreements o Authorizes a pharmacist practicing under a consult agreement with a physician to (1) manage a patient's drug therapy for specified diagnoses or diseases and (2) order and evaluate blood and urine tests. o Managing drug therapy includes: o Changing the duration of treatment for the current drug therapy; o Adjusting a drug's strength, dose, dosage form, frequency of administration, or route of administration; o Discontinuing use of a drug; o Administering a drug; o Adding a drug to the patient's drug therapy.

16 Emergency Supply of Medication Without a Prescription ORC , updated per HB 188 o Prescription is expired or prescriber is unavailable o Patient has a chronic medical condition where, left untreated, could endanger the life of the patient o Other than a C-II controlled substance, a pharmacist is permitted to dispense a drug without a written or oral prescription from a licensed healthcare professional Non-controlled substance may be dispensed up to a 30 day supply if the patient has been on consistent drug therapy as documented by pharmacy records If package size is greater than a 30 day supply, pharmacist may dispense the smallest package available Up to a 30 day supply (or smallest package size) can only be provided once to a patient per year. CS III V drugs limited to a 72 hour supply o As always, act in the best interest of your patient

17 Significant Rule Changes Annual controlled substance inventory, OAC (effective 1/1/15) , Requirements for renewal of a pharmacist ID card (effective 1/1/16) Remove requirement for 0.3 CEU s of law to be Board-approved, -03 Add requirement for 0.2 CEU s in patient or medication safety, -05

18 Law and Rule Update

19 OARRS Law Change HB 341- Mandatory OARRS registration (1/1/15) and Requests (effective 4/1/15) o All pharmacists dispensing controlled substances or planning to dispense controlled substances are required to have an OARRS account at time of license renewal (9/15/16). o Prior to prescribing an opioid or a benzodiazepine, exceptions include: o Less than 7 day supply o Hospice, cancer, or end-of-life care o Immediately following surgery or other invasive procedure o Must also request PMP report of neighboring state

20 OARRS Law Change o Allows OARRS report to be included in patient s medical record. o The prescriber must also make periodic requests for patient information from OARRS if the course of treatment continues for more than 90 days. o The requests must be made at intervals not exceeding ninety days, determined according to the date the initial request was made.

21 OARRS Rules Change OAC , Prospective DUR (effective 2/1/16) Prior to dispensing an outpatient prescription for a reported drug, a RPh shall request & review an OARRS report, including a border state s PMP when the pharmacist is practicing pharmacy in a county bordering another state, for a one year period of time, if:

22 OARRS Rules Change A patient adds a different or new reported drug to their therapy that was not previously included 2. OARRS report has not been run > 12 months as indicated on the patient profile 3. A prescriber is outside the pharmacy s usual geographic area

23 OARRS Rules Change A prescriber is outside the pharmacy s usual geographic area 5. RPh suspects patient has received prescriptions for reported drugs from more than one prescriber in the preceding 3 months, unless prescriptions are from prescribers who practice at same physical location 6. Patient is exhibiting signs of potential abuse or diversion

24 OARRS Rules Change Corresponding responsibility language included in this rule: a pharmacist shall use professional judgment when making a determination about the legitimacy of a prescription. A pharmacist is not required to dispense a prescription of doubtful, questionable, or suspicious origin.

25 OARRS Rules Change One hour no-cost jurisprudence CE is available on the new OARRS rule changes.

26 Pharmacist and Prescriber Pocket Card

27 Its OK to Say No To be valid, a prescription must be issued for a legitimate medical purpose by a prescriber acting in the usual course of his/her practice. The responsibility for the proper prescribing is upon the prescriber; however a corresponding responsibility also rests with the pharmacist who dispenses the prescription. (OAC (G) (A) & (A)).

28 Its OK to Say No

29 2016 Jurisprudence Update OARRS Updates and Statistics & Ohio s Prescribing Guidelines

30 New Web Site

31 New Data and Statistics Page

32 # of Solid Doses in Millions Opioids Dispensed to Ohio Patients, by Year Year

33 Number of Doctor Shoppers*, by Year 3,000 2,500 2,493 2,205 2,000 1,500 1,000 1,639 1, Year *In this chart, a doctor shopper is defined as an individual receiving a prescription for 5 or more prescribers in 1 calendar month.

34 Benzodiazepines Dispensed to Ohio Patients, by Year # of Solid Doses in Millions Year

35 Number of OARRS Queries, by Year # of Queries in Millions Year

36 % Opioid Patients Requested in OARRS % Requested Quarter Percentage of opioid prescriptions written by Ohio prescribers where a prescriber or their delegate has run OARRS on the patient in the past 12 months Percentage of 80 MED prescribers written by Ohio prescribers where a prescriber or their delegate has run OARRS on the patient in the past 12 months Source: Ohio Automated Rx Reporting Syst

37 Ohio s Prescribing Guidelines Acute pain management (NEW!) The Ohio Guideline for the Management of Acute Pain Outside of Emergency Departments provides a general approach in the outpatient management of acute pain. Chronic, non-terminal pain The Ohio Guidelines for Prescribing Opioids for the Treatment of Chronic, Non-Terminal Pain use 80 mg morphine equivalency dosing (MED) as a trigger threshold, as the odds of an overdose are higher above that dose. Emergency care settings The Ohio Emergency and Acute Care Facility Opioids and Other Controlled Substances Prescribing Guidelines offer clinical guidance for the acute care environment where there is no established patient-doctor relationship.

38 2016 Jurisprudence Update Pharmacy Practice Topics/FAQ

39 Theft or Significant Loss OAC requires a terminal distributor to notify the Board of any theft or significant loss of dangerous drugs immediately upon discovery of the theft or significant loss.

40 Pharmacy Technicians OAC , Pharmacy Technician Background Check Must be both FBI and BCI&I background check (done by an electronic fingerprint) This must be done prior to technicians performing packaging, labeling, or compounding, ORC (F)(3)(b)

41 Pharmacy Technicians Med reconciliation at hospitals Make sure they don t cross line into areas where professional judgment is required example counseling

42 Electronic Prescription Transmission Systems (EPTS) Prescriptions can be transmitted electronically, even for CS EPCS for controlled substances per DEA E to E transmission only, not E to fax BOP approved for all other prescriptions Resources: E-Prescriptions must be printed and filed per OAC unless otherwise approved by the BOP

43 Repackaging Unless an FDA registered repackager, any drugs repackaged in anticipation of a prescription is for the pharmacy s own use o Exception: In a hospital system, can be repackaged and sold to another hospital under same ownership if the drug is on the drug shortage list USP, General Notices, allows a 1 year beyond use date (unless manufacturer s expiration date is less than 1 year) OAC o A (Label), Name of drug, strength, dosage form, name of repackager, pharmacy control number and pharmacy beyond use date o B (Record), Name of drug, strength, dosage form, and quantity repackaged; manufacturer s name, control number and expiration date; pharmacy s name, control number and beyond use date; positive ID of the pharmacist who checked product

44 Addiction Treatment & Hospitalization 21 CFR Administering or dispensing of narcotic drugs (C) Allows a hospital to administer or dispense narcotic drugs to maintain treatment or detoxify if reason for hospitalization is anything other than addiction Example: Patient in hospital for 2 weeks for surgery may continue their methadone treatment while at the hospital

45 APRN Formulary

46 PA Formulary

47 2016 Jurisprudence Update Compounding OAC

48 Compounding In 2015, OSBP reorganized all the compounding rules into a single chapter, OAC Pharmacies are required to comply with: Section 503A of the Federal Food, Drug, and Cosmetic Act USP <795> for non-sterile compounding USP <797> for sterile compounding Outsourcing facilities, as defined by OAC and under Section 503B of the Federal Food, Drug, and Cosmetic Act, are wholesalers in the State of Ohio

49 Compounding OAC still permits in-state pharmacies to compound small quantities of non-patient specific medications for direct administration by a prescriber for in-office use. No in-state pharmacy shall sell any amount of non-patient specific prescriber administered compounds for human use in excess of five percent of the total amount of compounded drug products sold and/or dispensed from their pharmacy. The five percent limitation shall be calculated on an annual basis and shall reference the number of dosage units. OAC : Before a terminal distributor of dangerous drugs may make a sale of dangerous drugs pursuant to rule of the Administrative Code, the terminal distributor of dangerous drugs must confirm a current certificate of license as a terminal distributor from the purchaser. ALL PRESCRIBERS MUST HAVE A TERMINAL DISTRIBUTOR TO POSSESS COMPOUNDED DRUGS.

50 Compounding Guidance Documents and other resources are available on the BOP website: Compounding in Ohio List of all Outsourcing facilities registered with the BOP Sterile compounding inspection form sample If you are performing compounding, one of the references BOP expects your pharmacy to have access to is USP

51 Compounding, USP <795> For non-sterile compounding inspections: Master formulation for each compound Choose an appropriate beyond use date Compounding record for each compound Prescription label informs patient the drug dispensed is a compound Pharmacy is able to perform a recall for any ingredient If compounding in anticipation of a prescription, do frequent checks of drug stock to remove expired compounds from shelves Environment and equipment are appropriate to compounding Scale Powder hood (not required) Monitoring temperature for temperature-sensitive Rx NOTE: Reconstitution of an oral antibiotic is considered compounding

52 Compounding, USP <797> Sterile compounding inspections will focus on the 4 P s: Policies Personnel Product Property (Environment) Appendixes are great sources of information

53 Compounding, USP <797> Policies Does the pharmacy have a policy and procedural manual? Are they following their policies? 23 recommended policies and procedures listed in USP <797>, Examples: Access to compounding space What is permitted in compounding space Aseptic technique processes How the equipment, apparatus, or devices used to compound are calibrated? Describes in detail: the personnel, the property, and the product Does the pharmacy have a QA program? Can pharmacy do a recall for any ingredient? When a failure occurs, does the pharmacy full investigate?

54 Initial training Compounding, USP <797> Personnel Didactic, written exam, skills evaluation Ongoing competency Skills evaluation Forms filled out at appropriate times and completely for all compounding personnel Garbing/gowning properly and in right order Requires use of sterile gloves Compounding personnel aren t ill, wearing makeup/ nail polish, or jewelry which would affect effectiveness of PPE NOTE: Don t forget competencies of housekeeping staff (garbing/gowning and cleaning/disinfecting)

55 Compounding, USP <797> Product Determining risk level based on source of ingredients Appropriate beyond use dates Packaging, handling, storage, and transport If high-risk, sterilized appropriately through validated method All information about product and equipment used documented on compounding record Finished preparation release checks and tests

56 Compounding, USP <797> Property (Environment) Temperature, humidity, and magnehelic readings at least daily Room design, PEC placement, equipment/ garb, and cleanability of compounding area PEC/SEC use and evaluation Certification done every 6 months By a CETA certified technician? (Recommended) Cleaning procedures, chemicals used, and frequency Sampling program (surface and air) How are action levels handled?

57 Hazardous Drug Compounding Hazardous drug compounding Follow USP <797> Anticipate USP <800> being integrated within BOP rules in future

58 Questions?