Recent COHCA Articles

from_facebook.fw

FDA Guidance Documents Change Compounding Landscape

By Lee H. Rosebush, Cory J…

FDA Guidance Documents Change Compounding Landscape By Lee H. Rosebush, Cory J. Fox, Nita Garg and Dena Kessler o…
Read More

from_facebook.fw

Ohio Senate referrals to committee:

HB 39
INHALER USE (Duffey, M., DeVitis, T…

Ohio Senate referrals to committee: HB 39 INHALER USE (Duffey, M., DeVitis, T.) To permit schools and camps to p…
Read More

from_facebook.fw

Referred to Committee today in the Ohio House of Representatives

Health & Aging…

Referred to Committee today in the Ohio House of Representatives Health & Aging HB 124 STD PRESCRIPTIONS (Jo…
Read More

from_facebook.fw

Introduced today at the statehouse….

HB124 VENEREAL DISEASES-PRESCRIPTION AUT…

Introduced today at the statehouse…. HB124 VENEREAL DISEASES-PRESCRIPTION AUTHORITY (Johnson, T) Regarding the a…
Read More


 

Interprofessional Legislative Update

HPU-LogoBy Lori Herf, MA

The Ohio General Assembly has dedicated much of the winter and spring months to budget (HB 59) deliberations. With the new state fiscal year beginning on July 1st, 2013, legislative leaders will focus most of their attention not only on the fiscal operations of the state of Ohio, but also on the many policy changes made as amendments to state budget provisions.

APRNs and Physician Assistants

Language was considered that would have allowed advanced practice nurses and physician assistants to admit patients to hospitals. That provision is now being considered independently of the budget as HB 139.

Pharmacists

A number of pharmacy provisions remain part of the budget as well. One of the provisions would require that Medicaid managed care organiza-tions provide 90 days notice to pharmacies being terminated as a network provider and extends the notice to all types of health care providers. In the case of pharmacies, similarly the budget would require that 90 days advance notice be given regarding the removal of a prescribed drug from the formulary or preferred drug list used by the organization or administrator or any change in the terms governing access to the drug. The amendment that we are opposing in the budget which is HB 59 dealt with remote dispensing.

The amendment would have allowed a pharmacy that is licensed as a terminal distributor of dangerous drugs to use a remote drug dispensing system at a nursing home or residential care facility. The pharmacist would not be required to be physically present where the system is used to dispense the drugs. COHCA has strong concerns regarding this provision and asked legislators to remove the language from the budget bill. The Ohio Senate did remove the language from the substitute version of the bill; however the bill will be amended next week and then be considered by a conference committee that could reinsert the language into the final version of the bill.

Other Bills:

House Bill 44

HEALTH EMERGENCIES (McClain)
To require the Director of Health to develop protocols regarding the authority to administer, deliver, distribute, or dispense drugs during certain public health emergencies. This is currently pending in

House Health and Aging Committee where it has received two hearings.

Requires the Director of Health to develop one or more protocols that authorize certain licensed health professionals to administer, deliver, or distribute drugs during a public health emergency; requires the Director to develop protocols as well that authorize pharmacists and pharmacy interns to dispense limited quantities of dangerous drugs without a prescription or record of a prescription during a public health emergency; and provides that an individual who administers, delivers, distributes or dispenses a drug or dangerous drug in accordance with one or more of those protocols is not liable for, nor subject to civil damages, criminal prosecution, or professional disciplinary action, unless the individual’s acts of omissions constitute willful, wanton misconduct.

House Bill 60

MATERNITY UNITS (Huffman)
To require that rules governing maternity units, newborn care nurseries, and maternity homes include certain provisions pertaining to the authority to make decisions regarding the transfer of patients to other facilities and to specify procedures for granting variances or waivers of any requirement in the rules governing operation of such facilities.

Currently pending in House Health and Aging where it has received two hearings.

The bill codifies an administrative rule that authorizes the Director of Health to grant a variance from or waiver of any of the requirements of rules regarding the operation of a maternity unit, newborn care nursery, or maternity home; requires the Director to adopt rules regarding application forms to be used and procedures to be followed in applying for a variance or waiver; requires the Director to review all applications for variances and waivers and, not later than 90 days after receipt of an application, to determine whether to grant the variance or waiver and notify the applicant of the decision.

House Bill 83

PSYCHOLOGY LAWS (Hackett)
To make 14 major changes to the law that gov-erns the practice of psychology. Heard in the House Health and Aging Committee; reported out of committee; passed the House 96-1; currently pending in the Senate Medicaid, Health and Hu-man Services Committee.

House Bill 94

HEALTH PLANS (Gonzales)
To require a health insuring corporation, public employee benefit plan, or sickness and accident insurer to reimburse a board of health for any services provided to an individual by the board that is covered by a plan issued to the individual by the health insuring corporation, public employee benefit plan, or sickness and accident insurer upon request submitted by the Board of Health.

Currently pending in House Insurance Committee; has received two hearings.

House Bill 123

TELEHEALTH SERVICES (Gonzales, Wachtmann)
Regarding Medicaid and health insurance coverage of telehealth services.

Currently pending in House Health and Aging Committee where it has received two hearings.

The bill authorizes health care insurers to provide coverage of telehealth services provided by health care professionals and facilities, requires the Office of Medical Assistance to adopt rules establishing standards for Medicaid reimbursement of telehealth services provided by health care professionals and facilities; specifies that coverage of a telehealth service applies only if the service involves an immediate and direct interaction with a patient, is medically appropriate and necessary, and is provided by a licensed health care provider or facility; and requires that a health care provider seeking reimbursement for telehealth service maintain documentation of providing the service as part of the patient records the provider maintains.

House Bill 131

TANNING REGULATIONS (Johnson, Stinziano)
To regulate chemical tanning and prohibit tanning facilities from allowing the use of sun lamps by certain individuals under 18 years of age.

Currently pending in House Health and Aging Committee where it has received three hearings.

Prohibits an operator or employee of a tanning facility from allowing an individual under age 18 to use the facility’s fluorescent sun lamp tanning services unless the individual presents a prescription issued by a physician; and requires the State Board of Cosmetology to regulate chemical tanning facilities.

House Bill 139

HOSPITAL ADMISSIONS (Gonzales)
To permit certain advanced practice registered nurses and physician assistants to admit patients to hospitals.

Currently pending in House Health and Aging Committee where it has received two hearings.

Current law allows only physicians, dentists and podiatrists who are members of the medical staff to admit patients to hospitals. The bill would add clinical nurse specialists, certified nurse midwives and certified nurse practitioners who have a standard care arrangement with a physician or podiatrist who is a member of the medical staff. The bill would also allow physician’s assistants, under the supervision, control or direction of a physician or podiatrist who is a member of the medical staff, to admit patients to hospitals. The bill also would require the APRN or PA to notify the collaborating or supervising physician or podiatrist not later than 12 hours after admitting a patient to a hospital.

House Bill 147

MASTECTOMY GUIDANCE (Patmon, Wachtmann)
To require a surgeon performing a mastectomy, lymph node dissection, or lumpectomy in a hospital to guide the patient and provide referrals in accordance with the standards of the National Accreditation Program for Breast Centers and to name this act the Lizzie B. Byrd Act.”

Currently pending in the House Health and Aging Committee where it has had two hearings.

The bill, in addition to the above would require the sur-geon performing a mastectomy or lumpectomy to refer a patient if breast reconstruction is appropriate, and requires the surgeon to offer the patient a preoperative referral to a reconstructive or plastic surgeon in accordance with NAPBC standards.

House Bill 159

DENTAL SERVICES (Hacket, Schuring)
To prohibit a health insurer from establishing a fee schedule for dental providers for services that are not covered by any contract or participating provider agreement between the health insurer and the dental provider.

Currently the bill is pending in the House Insurance Committee where it has had one hearing.

Prohibits a contracting entity from requiring a dental provider to provide services to plan enrollees at a fee set by or subject to approval by the contracting entity unless certain circumstances are met; makes setting or requiring the insurer’s approval of fees for dental services an unfair and deceptive act in the business of insurance unless certain circumstances are met; and makes the offering of a health benefit plan that sets fees for dental services an unfair and deceptive act in the business of insurance unless certain circumstances apply.

House Bill 165

HYPERBARIC TECHNOLOGISTS (Roegner)
Exempts certified hyperbaric technologists from the laws governing the practice of respiratory care.

Currently pending in the House Health and Aging Committee. Has not been heard.

House Bill 170

DRUG OVERDOSES (Johnson, Stinziano)
To provide that a licensed health professional authorized to prescribe naloxone, if acting with reasonable care, may prescribe, administer, dispense or furnish naloxone to a person who is, or a person who is in a position to assist a person who is, apparently experiencing or who is likely to experience an opioid-related overdose without being subject to administrative action or criminal prosecution, to provide that a person who is in a position to assist a person who is apparently experiencing or who is likely to experience an opiod-related overdose is not subject to actions of professional licensing boards, administrative action, or criminal prosecution for a drug offense or practicing medicine without a license if the person acting in good faith, obtains naloxone prescription from a licensed health professional and administers it to a person for an opioid-related overdose, and to provide that peace officers and licensed emergency responders who are acting in good faith are not subject to administrative action or criminal prosecution for a drug offense or practicing medicine without a license for administering naloxone to a person who is apparently experiencing an opioid-related overdose.

Currently pending in the House Health and Aging Committee. It has not yet been heard by the committee.

Senate Bill 4

NEWBORN SCREENINGS (Manning, Oelslager)
To require a pulse oximetry screening for each newborn born in a hospital or freestanding birthing center.

Received two hearings in Senate Medicaid, Health and Human Services Committee, reported out of Committee; passed the Senate 33-0; referred to House Health and Aging Committee where it has received 5 hearings.

Requires hospitals and freestanding birthing centers to conduct a pulse oximetry screening on each newborn (unless a parent objects on religious grounds) for purposes of detecting critical congenital health defects; requires the Director of Health to adopt rules establishing standards and procedures for the pulse oximetry screenings.

Senate Bill 43

CIVIL COMMITMENT (Burke)
Makes a number of changes to the laws governing the civil commitment of and treatment provided to mentally ill persons.

Currently pending in Senate Criminal Justice Committee. It has received one hearing.

Senate Bill 99

CANCER MEDICATIONS (Oelslager, Tavares)
Regarding insurance coverage for rarely administered cancer medications.

Pending in Senate Insurance and Financial Institutions Committee where it has not received a hearing.

Neurosurgery Physician Assistant at Akron Children’s

Combines the Best of Care and Cure

Holly Zeller, PA-C sits down with Julie Tsirambidis, CNP to go over privilege delineation forms at Akron Children’s Hospital.  This is one of their many overlapping moments where NP and PA practice comes together.  Becoming more frequent is this visibility- that NPs and PAs sit side by side with their physician counterparts to enhance patient care.  After years of working in silos, these disciplines agree the time to work together is long overdue.  Hence, the Center for Advanced Practice at Akron Children’s Hospital was formed in April 2011.  The goals are vast, but include the practice and regulatory oversight of APNs and PAs, on boarding programs, and integration with medical staff leadership to name but a few.

Zeller, who is a board certified physician assistant, works in partnership with Dr. Roger Hudgins, director of the Division of Neurosurgery at Children’s Hospital.  When she is not examining patients during office hours, Holly assists Hudgins in the operating room and shares on-call duties with him for after-hours emergencies.  Additionally, on a daily basis, Zeller rounds on all inpatients, formulates plans of care, interprets imaging, triages new patient referrals, and completes various types of different procedures in the NICU, PICU, patient floors and ER.  At the end of each day, all “Mommy Call” questions which have accumulated throughout the day are addressed by calling the parent of the patient back to address their questions. “Every day is a little bit different,” she says.  Zeller, 44, of Richfield,Ohio, is one of now 18 physician assistants (PAs) who work all across Akron Children’s Hospital.  There are over 150 advanced practice providers at Akron Children’s with a director leading the way.  The center actually oversees and brings together Advanced Practice Nurses (CRNA, CNP, and CNS) and Physician Assistants under one umbrella.  The director, Julie Tsirambidis, CNP, truly believes this is the way of the future.  “We have more in common that we have separate.  Coming together to promote our professional needs, despite our regulatory difference truly sets us apart, and brings improved understanding to our patients, families, and hospital staff.”  “Many years ago, MDs and DOs, would not even work together in the same hospital, and see how far they have come- this journey is a similar beginning, in my opinion.” Tsirambidis said.

As part of their master’s degree program, PAs can elect a surgical track that prepares them to work in the operating room.   After college, Zeller worked in the pharmaceutical field before taking a break to stay home with her children.  When she decided to return to work, she wanted a job in the medical field but didn’t want to travel anymore.  She embarked upon graduate school education and completed the PA program.  The PA education is very similar to that of the medical school model.

Zeller initially practiced with the congenital heart surgical team at Rainbow Babies and Children’s Hospital inClevelandbefore joining Akron.  When Dr. Hudgins joined Children’s two years ago, he requested a PA for his team.  He has especially relied on Zeller to share the patient load since the death this summer of the hospital’s only other neurosurgeon, Dr. Henry Bartkowski.  When Dr. Bartkowski became ill, Dr. Hudgins and Zeller formulated a plan to continue the quality care provided to the neurosurgery patients, by trying to split the evening and weekend call, thus allowing the other some “off time.” The two divide and conquer on office days, with each visiting patients and talking with families.  They frequently huddle to compare notes and examine patients’ images and other test results.  Zeller will assist in the OR on surgery days, and often performs the closing procedures.  This teamwork allows Hudgins to dictate this post-operative notes and get ready for the next patient while Zeller finishes the procedures.  “It really becomes a seamless way for getting a lot more work done than you could by yourself, plus the families love her,” Hudgins said

For information, or to join our neurosurgery team, check us out at

https://www.akronchildrens.org/cms/careers/index.html

COHCA On Facebook

FDA Guidance Documents Change Compounding Landscape

By Lee H. Rosebush, Cory J. Fox, Nita Garg and Dena Kessler of Baker Hostetler March 6, 2015

Almost a year and a half after adoption of the Drug Quality and Security Act (DQSA) in November 2013, which revised federal oversight of drug compounding, the Food and Drug Administration (FDA) continues to roll out guidance documents detailing its view on assorted issues concerning implementation of the statute. The FDA’s most recent offering is four draft guidance documents addressing issues related to compounding. These draft guidance documents address when a facility should consider registering as a so-called “Outsourcing Facility” under the DQSA’s Section 503B, when and how an Outsourcing Facility must report adverse events and policies regarding repackaging human drugs and mixing, diluting and repackaging biological products.

The public is invited to submit comments in response to each draft guidance. Comments are due May 20, 2015.

Each is summarized below:

Draft Guidance for Entities Considering Whether to Register as Outsourcing Facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act

This Draft Guidance was prepared by the FDA in response to questions regarding whether certain entities engaged in limited activities must register as an Outsourcing Facility. The Draft Guidance provides information regarding the regulatory impact of registering as an Outsourcing Facility under Section 503B of the Federal Food, Drug, and Cosmetic Act (FFDCA), as implemented by the DQSA, including recommendations as to whether certain entities should or should not register as Outsourcing Facilities. The FDA specifies that a facility engaged in only certain activities, including repackaging human drugs and compounding non-sterile drugs, should not register as an Outsourcing Facility because its compounded drug products will not qualify for the exemptions provided in Section 503B, including exemptions from the new drug approval requirements. Not surprisingly, the FDA noted that registration as an Outsourcing Facility indicates a compounding facility’s intent for the compounded drugs to be regulated under Section 503B. In this Draft Guidance, the FDA clarified that an Outsourcing Facility must compound at least one sterile product. In other words, an Outsourcing Facility can compound non-sterile products but it must compound at least one sterile product to qualify for the exemptions under Section 503B. It is also worth noting that a compounded drug can only qualify for the exemptions under Sections 502(f)(1) (requiring certain labeling with adequate directions for use), 505 (requiring a New Drug Application) and 582 (the Drug Supply Chain Security Act) if all of the facility’s compounded drugs are compounded in accordance with Section 503B. In other words, the non-sterile product compounded also must meet current good manufacturing practice (cGMP) standards. The Draft Guidance also notes that Outsourcing Facilities are subject to cGMP requirements, among other FFDCA requirements, including inspection by the FDA on a risk-based schedule.

Draft Guidance on Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the FFDCA

Among the requirements applicable to Outsourcing Facilities under Section 503B of the FFDCA is a requirement that Outsourcing Facilities submit adverse event reports to the FDA following any “unexpected, serious adverse drug experience” involving compounded prescription drug products regardless of whether the Outsourcing Facility distributes them pursuant to prescriptions. An adverse drug experience is considered “serious” if it results in death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, or a congenital anomaly or birth defect. Medical events that do not result in death, life-threatening situations, or hospitalization can still be considered “serious” if, based on appropriate medical judgment, they may jeopardize the patient or require medical intervention to prevent such outcomes. Examples of such events include the development of drug dependency or abuse, allergic bronchospasm requiring emergency intervention or convulsions. Such experiences are “unexpected” if they are not listed in the current labeling for the drug product—that is, if they have not been observed as opposed to whether they could be anticipated pharmacologically.

According to the Draft Guidance, Outsourcing Facilities must report these adverse events to the FDA as soon as possible but in no case later than 15 calendar days from first receiving information about the adverse event. Specifically, Outsourcing Facilities should submit a 15-day “Alert report” when they have information regarding any one of the following: an identifiable patient, an identifiable reporter, a suspect drug or a serious adverse event. Information regarding an identifiable patient includes various identifiers, such as names, dates of birth, etc., but also includes general description of a patient, such as “an elderly woman who suffered anaphylaxis.” Information regarding an identifiable reporter includes the name, contact information and/or professional identifier (e.g., “nurse”) of the patient, consumer, family member, healthcare practitioner or other person initiating the report. Outsourcing Facilities must promptly investigate adverse events and attempt to locate information regarding all four elements and submit a follow-up report to the FDA within 15 days of receiving new information about the event or as requested by the FDA. The Draft Guidance also specifies that adverse event reports should be submitted via Form FDA 3500A in hard copy until the FDA completes modifications to its electronic submissions process. If the compounded drug product contains multiple components, each component should be listed in the report along with the component’s manufacturer and any other drug product being taken by the patient at the time of the event. Reports should also include a copy of the current labeling for the compounded drug product that is the subject of the report. Reports should not identify patients by name or address.

Draft Guidance for Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities

This Draft Guidance describes the conditions where the FDA will not take action against facilities repackaging human drug products for violating three sections of the FFDCA: 505 (requiring a New Drug Application), 502(f)(1) (requiring certain labeling with adequate directions for use), and 501(a)(2)(B) (concerning cGMP). The Draft Guidance applies to state-licensed pharmacies, federal facilities and Outsourcing Facilities registered under Section 503B of the FFDCA that take finished drug products from the container in which they were distributed by the manufacturer and put them in different containers without further manipulating the drug. It does not address repackaging non-prescription drugs, those intended for use in animals or biological products. The Draft Guidance also clarifies that repackaged drugs are not eligible for the exemptions provided by FFDCA Sections 503A and 503B.

The FDA makes clear that repackaged drugs typically are not exempt from any provisions of the FFDCA related to the production of drugs. However, improper repackaging can cause serious adverse events. Specifically, the FDA notes that repackaging is of particular concern when it involves sterile drugs, which are susceptible to contamination and degradation. Accordingly, the Draft Guidance spells out 11 requirements, including that the drug be repackaged: by or under the direct supervision of a licensed pharmacist; in a way that does not conflict with the approved drug product labeling (other than an exception for a single-dose vial); and that its beyond-use date (BUD) complies with requirements detailed in the Draft Guidance. The repackaged drug product must be sold only by the entity that did the repackaging, although this does not include administration of a repackaged drug product in a healthcare setting. Certain labeling requirements will apply for drugs repackaged by an Outsourcing Facility.

Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application

This Draft Guidance details the conditions that must be met for the FDA to not take action against certain facilities for violations of Section 351 of the Public Health Service (PHS) Act (mandating a biologics license application (BLA) and certain labeling) and FFDCA Section 501(a)(2)(B) (concerning cGMP) for the dilution, mixing or repackaging of certain biological products without having first obtained a BLA. The Draft Guidance only applies to state-licensed pharmacists, federal facilities and Outsourcing Facilities and does not apply to blood and blood components for transfusion, vaccines, cell therapy products and gene therapy products or for products intended for use in animals.

The Draft Guidance details 10 conditions, some of which are similar to those in the Draft Guidance on repackaging certain human drug products, including: complying with the prescribed BUD requirements; that the product be sold (which does not include administration in a healthcare setting) only by the entity that mixed, diluted or repackaged it; and certain labeling requirements for those products handled by an Outsourcing Facility.

The Draft Guidance also discusses the preparation of licensed allergenic extracts that are mixed and diluted to provide subcutaneous immunotherapy to an individual patient, otherwise known as prescription sets. It notes that the FDA will not take action for violation of Section 351 of the PHS Act or Section 502(f)(1) of the FFDCA if a state licensed pharmacy, federal facility, Outsourcing Facility or physician prepares the prescription sets in accordance with 10 conditions. Conditions include that the prescription set: is prepared from FDA-licensed allergenic extracts and appropriate diluents; is prepared in a way that it does not conflict with approved labeling of the licensed biological products that are part of the prescription set; and is not sold or transferred by an entity other than the one that prepared it. Finally, additional labeling requirements will apply for a prescription set prepared by an Outsourcing Facility.
See MoreSee Less

2 days ago  ·  

Ohio Senate referrals to committee:

HB 39
INHALER USE (Duffey, M., DeVitis, T.) To permit schools and camps to procure and use a metered dose inhaler or dry powdered inhaler used to alleviate asthmatic symptoms in accordance with prescribed policies and to exempt them from licensing requirements related to the possession of these inhalers.


HB 40
MEDICAL BOARD (Gonzales, A., Dever, J.) To authorize the State Medical Board to impose fines rather than licensing suspensions for failure to comply with continuing education requirements, to authorize the Board to impose fines in addition to other actions it may take for violations of the laws it administers, and to authorize the Board to impose additional conditions for restoration of certain certificates to practice.
See MoreSee Less

3 days ago  ·  

Referred to Committee today in the Ohio House of Representatives

Health & Aging
HB 124
STD PRESCRIPTIONS (Johnson, T., Huffman, S.) Regarding the authority to prescribe without examination a drug for a sexual partner of a patient diagnosed with chlamydia, gonorrhea, or trichomoniasis.


Insurance
HB 127
PHARMACY BENEFIT MANAGERS (Brown, T., Cera, J.) To regulate pharmacy benefit managers.
See MoreSee Less

3 days ago  ·  

Introduced today at the statehouse….

HB124 VENEREAL DISEASES-PRESCRIPTION AUTHORITY (Johnson, T) Regarding the authority to prescribe without examination a drug for a sexual partner of a patient diagnosed with chlamydia, gonorrhea, or trichomoniasis.
See MoreSee Less

1 week ago  ·  

 

Health Care Professions…

 

COHCA – Partnering

in Patient Care

COHCA, a interprofessional group, are partners in patient care: better care, lower costs, a partnership that will help improve the quality, safety, and affordability of health care for all Ohioans. Nationally, healthcare initiatives are fostering partnerships in patient care.


 

COHCA Health Policy Update!!  Senate Bill 83  APN Schedule II - Read More…

COHCA’S FIRST SUSTAINING ORGANIZATIONAL SPONSOR - Cleveland Clinic's Zielony Nursing Institute

COHCA Health Policy Update!!  Senate Bill 83  APN Schedule II - Read More…

COHCA’S FIRST GOLD SPONSOR AND A FOUNDING MEMBER - Dr. Jeri Milstead PhD, RN, NEA-BC, FAAN 

COHCA Health Policy Update!!  Senate Bill 83  APN Schedule II - Read More…

COHCA’S FIRST PLATINUM ORGANIZATIONAL SPONSOR - The Southern Ohio Chapter of the American College of Nurse-Midwives 

COHCA Health Policy Update!!  Senate Bill 83  APN Schedule II - Read More…

COHCA PLATINUM ORGANIZATIONAL SPONSOR - Ohio Chapter of the National Association of Pediatric Nurse Practitioners (NAPNAP)

Stop CISPA
X

Forgot Password?

Join Us

Password Reset
Please enter your e-mail address. You will receive a new password via e-mail.