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From the New Jersey Pharmacists Association
Working to Serve the Needs of Our Members
One Profession-One Voice- NJPhA
RENEW YOUR DUES ON-LINE TODAY AT WWW.NJPHARMA.ORG

March 2, 2010

CONTACT MEMBERS OF THE ASSEMBLY HEALTH COMMITTEE IN OPPOSITION TO ASSEMBLY BILL A-1995 (EPILEPSY CARVE OUT)

REQUEST A “NO” VOTE ON A-1995

On Thursday, March 4, the Assembly Health and Senior Services Committee will consider A-1995 sponsored by Assemblyman Herb Conaway MD, (D-Burlington). This bill would require that a separate process take place on all prescription for epileptic patients. Generic substitution would only be permissible with the prior approval of the prescribing physician and the prior notification of the patient or legal guardian and will also be required each time a product from a different generic manufacturer is dispensed.

We are opposed to this unnecessary and burdensome process which mandates the “carve-out” of a special set of circumstance for one disease state, epilepsy. The bill does NOT take into consideration insurance coverage issues or the patient’s financial circumstances. It will place an undue burden on pharmacy practice with no benefit to patient care.

Please call as many of the members listed to register your opposition. When you call, ask to speak to the legislative aide. Let the office know you are calling to register your opposition to A-1995. Identify yourself as a practicing pharmacist and your town. If any of those on the list are your personal legislators, emphasize that fact.

Please make your calls before Thursday am.

Assembly Health and Senior Services Committee Membership
Conaway, Herb - Chair District 7 – (D-Burlington) (856) 461-3997
Wagner, Connie - Vice-Chair District 38 – (D-Passaic) (201) 576-9199
Angelini, Mary Pat District 11 – (R-Monmouth) (732) 974-1719
Green, Jerry District 22 – (D-Union) (908) 561-5757
Greenstein, Linda R. District 14 - (D-Mercer) (609) 395-9911
Handlin, Amy H. District 13 - (R-Monmouth) (732) 787-1170
Munoz, Nancy F. District 21 - ( R-Union) (908) 918-0414
Polistina, Vincent J. District 2 - (R- Atlantic) (609) 677-8266
Quigley, Joan M. District 32 - (D-Hudson) (201) 217-4614
Riley, Celeste M. District 3 - (D-Cumberland) (856) 455-1011
Tucker, Cleopatra G. District 28 – (D-Essex) (973) 926-4320

February 19, 2010

REMINDER TO ALL PHARMACISTS
A NEW LAW GOVERNING CDS PRESCRIPTIONS WILL TAKE EFFECT ON
MARCH 1, 2010

On November 20, Governor Corzine signed into law A 3799 Conaway/ S2550 Weinberg, which will go into effect on March 1, 2010. The new statute will permit a physician to issue up to three prescriptions authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled dangerous substance. Under the following conditions:
· Each separate prescription is issued for a legitimate medical purpose by the physician acting in the usual course of professional practice ;
· The physician provides written instructions on each prescription (other than the first prescription if it is to be filled immediately) indicating the earliest date on which a pharmacy may fill each prescription ;
· The physician determines that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse; and
· The physician complies with all other applicable State and federal laws and regulations.
The purpose of this law is to relieve the burden for patients on maintenance Schedule II controlled dangerous substances if the prescribing physician determines that there is no undue risk of diversion or abuse.
The provisions of this law are not intended to require or encourage physicians to issue multiple prescriptions, or to see their patients only once every 90 days when prescribing Schedule II controlled dangerous substances. Individual practitioners must determine on their own, based on sound medical judgment and in accordance with established medical standards whether it is appropriate to issue multiple prescriptions and how often to see their patients when doing so.
The law also stipulates that a physician must comply with all other applicable State and federal laws and regulations, in recognition of the fact that specific relevant federal requirements with respect to prescribing Schedule II controlled dangerous substances are set forth in regulation rather than in the law.
The law takes effect on the first day of the month next following the date of enactment by 90 days, but the State Board of Medical Examiners may take such anticipatory administrative action in advance thereof as shall be necessary for the implementation of this act.

February 15, 2010

New Medco Contract for New Jersey State Employees

“Equity for Community Pharmacies Requested”

NJPhA has been hard at work attempting to achieve equity and fairness for community pharmacies under the new Medco contract, which went into effect on January 2, 2010. The New Jersey Pharmacy Providers Coalition met with the Director of Pensions and Benefits recently and presented the Director with a detailed letter outlining our concerns.

Many thanks to our membership for keeping us updated about the issues concerning this contract. We will continue to pursue the issue relentlessly with the Christie Administration and the Legislature until we make headway.

In addition, all state employee unions have filed contract grievances with the state concerning the new formulary, which went into effect on February 1.

Please continue to let us know about provider and patient issues involved in the delivery of services under this contract. We will keep you updated as the process continues.

February 15, 2010

Additional Budget Cuts For Current FY 2010 Budget Announced by Governor Christie

Pharmacy Reimbursement for Medicaid FFS, PAAD, SG AND ADDP
Spared the Budget Ax

Governor Christie has announced an additional $1 billion in cuts to the current state budget, which ends on June 30, 2010.

In some good news, we are pleased to report that these proposed cuts do not affect pharmacy reimbursement for the Medicaid, PAAD, SG and ADDP Fee for Service programs.

Preliminary details indicate that eligibility for Family Care for undocumented aliens and parents would be eliminated or capped, and that pharmaceutical manufacturers would be required to pay the state immediately for uncollected rebates.

The Governor’s proposal for the new state budget for FY 2011 will be presented to the Legislature in mid March. We will keep you updated as the process continues.

February 10, 2010

Governor Christie’s transition team has recommended closing the New Jersey Poison Information and Education Services Center. Closing the center will impact your ability to quickly retrieve information for your patients and potentially your own family. I encourage you to send a letter to the governor as well as members of the state senate and assembly asking that this vital service continue to be funded. A sample letter is attached along with backup information.

You can easily identify your local representatives at the following website. http://www.njleg.state.nj.us/members/legsearch.asp

December 20, 2009

NJPhA Chairman of the Board of Trustees, Frank Breve
receives Temple University’s Clinical Practitioner of the Year award.

Frank Breve

Clinical Pharmacist Frank Breve has been named clinical practitioner of the Year by Philadelphia’s Temple University. A Kennedy pharmacist since 1997, Breve received his bachelor of science in pharmacy from Temple University in 1981 and his PharmD in the non-traditional program from the University of Colorado Denver School of Pharmacy in 2006.

Breve, a resident of Blackwood, currently serves as chairman of the board of the New Jersey Pharmacists Association, based in Princeton.

December 20, 2009

NJPHA BOARD MEMBER LORETTA BRICKMAN
APPOINTED TO GOVERNOR-ELECT’S TRANSITION TEAM

GOVERNOR-ELECT CHRIS CHRISTIE ANNOUNCES ADDITIONAL
TRANSITION NEW JERSEY SUB-COMMITTEE MEMBERS

TRENTON, NJ – Governor-Elect Chris Christie announced yesterday additional members of the Transition New Jersey sub-committees, including Corrections and Homeland Security, Energy and Utilities, Environmental Protection, Healthcare, Human Services and Children and Families, Law and Public Safety and Transportation. These sub-committees will conduct a top to bottom review of their respective government department and agency.
 
Congratulations to NJPhA BOT Member, Loretta Brickman on her appointment to the Healthcare Sub Committee!

December 20, 2009

NEW GOVERNMENT WEBSITE

WWW.FLU.GOV

Pharmacists are advised that the Department of Health and Human Services has posted a new web site specifically focusing on influenza and the H1N1 outbreak. The site contains both printed information and video presentations regarding flu, and is suitable for both health professionals and patients.
 
On Wednesday, December 16 at 12 P.M. (noon) E.S.T., experts from HHS, the CDC and the AMA will conduct a one-hour live webcast dealing with the flu. The webcast can be accessed at www.flu.gov. Interested health professionals may also join in the discussion by sending questions or comments to hhsstudio@hhs.gov.

December 20, 2009

MEDICARE PART B

DMEPOS ACCREDITATION

Pharmacies that participate in the Medicare Part B DMEPOS (Durable Medical Equipment, Prosthetics, Orthotics and Supplies) program are reminded that the extended deadline for accreditation as a supplier remains January 1, 2010.  Any pharmacy that does not receive accreditation and subsequent notification to the NSC (National Supplier Clearinghouse) by January 1 will lose its ability to bill for Medicare Part B covered products.
 
As a courtesy to patients, pharmacies that do not intend to continue as Part B suppliers are urged to consider notifying their clients about alternative providers in their area.

December 20, 2009

PHYSICIAN AND PRACTITIONER ENROLLMENT RECORDS

The Centers for Medicare & Medicaid Services has extended the deadline for physicians and other practitioners to establish current enrollment in Medicare until April 5, 2010. Current enrollment requires a physician or practitioner to be registered in PECOS (Medicare Provider Enrollment, Chain and Ownership System) with the appropriate NPI (National Provider Identifier).
 
Pharmacists should be aware of the fact that Medicare Part B claims processed after April 5, 2010 on the orders of a physician or practitioner NOT properly registered in PECOS, will be rejected. A publicly accessible database listing all physicians and practitioners registered in PECOS, along with their proper NPI numbers, will be available on the Internet prior to the April 5 deadline.

December 20, 2009

STATE DELEGATES WANTED!

2010 APHA ANNUAL MEETING

March 12 - 15, 2010

The NJPhA is seeking pharmacists (who are members of both APhA and the NJPhA and who are planning to attend the APhA Annual Meeting and Exposition in Washington, DC next March) to serve as delegates or alternate delegates in the APhA House of Delegates meetings on March 12 and 15.

Please contact Harvey Maldow at 609-275-4246 or at hmaldow@njpharma.org if you are interested. The deadline for applications is February 10, 2010.

 

October 15, 2009

FDA Authorizes the use of Expired Tamiflu®

NABP recently learned that pharmacists in some states are refusing to accept and dispense Tamiflu® from the Strategic National tockpile because it is beyond its labled expiration date. Please be advised, however, that the Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EAU) allowing pharmacists to dispense certain lots of expired Tamiflu® for Oral Suspension as part of the federal government's response to the 2009 H1N1 Influenza public health emergency.

>>Read More

August 6, 2009

NEW PRESCRIPTION LABELING REQUIREMENT EFFECTIVE JANUARY 29, 2010


On July 31, 2009 Governor Corzine signed the new Generic Labeling Requirement into law. Effective January 29, 2010 pharmacists will be required to place both the brand name and generic name of the drug on the label. The information required shall be in the following form with the brand name and generic name inserted as appropriate: “………….. Generic for ………”

It is important that you contact your software vendor as quickly as possible since it may take them some time to implement the label changes. We are working closely with the Board of Pharmacy on some concerns that have been raised with the law including how to provide the “brand” name when the “brand” is no longer commercially available.

Frequently Asked Questions Regarding the Status of CMS’s Medicare Part B DMEPOS Accreditation, Surety Bond, and Competitive Bidding Requirements August 3, 2009

1) What are the basic requirements for me to continue providing and billing for Medicare
Part B DMEPOS?


• After September 30, 2009, all suppliers of Part B Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS), including pharmacies, must obtain both accreditation and a surety bond if they wish to continue providing these supplies to their patients. Even those Pharmacies that are only providing diabetes test supplies must meet these requirements.
• Suppliers providing only Part B drugs and vaccinations do not have to meet the accreditation requirements, but they must meet the surety bond requirements.
• Participation in upcoming Round 1 of the competitive bidding program for certain DMEPOS products is a separate matter, and submitting bids is only required if a supplier wishes to continue supplying those selected products. Those wishing to participate in this competitive bidding program, however, must also have obtained accreditation and the surety bond (see more info in #4).


2) Will CMS or Congress create any exceptions to these deadlines?


• Because we do not know when or if exceptions will be enacted, in preparing for these
deadlines, you should assume that there will be no exceptions available. We are hopeful
that the House and Senate will pass legislation enacting certain exemptions for pharmacies.
• CMS has firmly stated recently that it considers September 30 a firm statutory deadline. The Agency has told NCPA that it believes that all suppliers who have submitted a “completed” application by January 31, 2009, will receive a decision on their application by the September 30 deadline. CMS said that it is regularly consulting with the Accreditation Organizations (AOs) regarding the status of submitted applications. The Agency also told us that it is monitoring this process and could possibly be flexible.
• We have worked to get language included in the House health care reform bill that would exempt pharmacies with clean records from the surety bond requirement; would exempt pharmacies providing only diabetes test supplies, canes or walkers from the accreditation process; and would enable suppliers applying for accreditation by August 1 to have a chance to go through the accreditation process without initial loss of supplier status on October 1. In the Senate, we have received indications that pharmacy accreditation exemption language will be included in the Senate Finance Committee health care reform bill, but that will likely not be agreed to and released until September.
o Pharmacies cannot rely on legislation passing, and should assess their situation
promptly and act prudently, as described in #3.


3) I have not yet received accreditation; what should I do?


• CMS made it clear that those who are working with their AO and have met the January 31, 2009, “completed” application deadline should continue working closely with their AO and they will receive a decision by the September 30 deadline. 7/30/09
• For those suppliers that are currently going through the accreditation process and do not yet know the likely outcome of their application, CMS cautioned against voluntary termination at this time. CMS said that after it consults with the AOs in mid-September, it will be in a better position to provide guidance on the voluntary termination process to these suppliers. Those pharmacies in this category should therefore continue to consult with their AO.
• Those pharmacies that do not want to become accredited or decide, after careful consultation with their AO, that they will not meet the accreditation deadline, should file a CMS-855s voluntary termination application (amendment) to the National Supplier Clearinghouse (NSC) by September 30. CMS said they would begin initiating their revocation letters to suppliers in violation immediately after the September 30 deadline - therefore the importance of filing a voluntary termination amendment before this time. Again, it makes sense for many of you to wait until mid-September to make this decision.
• For those who submit a CMS-855s voluntary termination application (amendment), CMS
would not specify how quickly it would process a subsequent application to reenter the
program. It is clear, however, that the process would be shorter than if you allow CMS to initiate termination of your billing status. You can reenter once you receive accreditation.
• A final option is, of course, to completely terminate and plan not to reenter the program.


4) What should I know about the competitive bidding program, and will it affect me?


• In the summer of 2008, Congress delayed the first round of competitive bidding by about 18 months. CMS recently announced that the 60-day supplier bidding period will begin in late October for the Round One rebid. It is conducting supplier outreach and education: www.dmecompetitivebid.com.
• The restarted first round of competitive bidding will cover 9 product categories (including mail order diabetes testing supplies and oxygen equipment) in only the first 9 Metropolitan Statistical Areas (MSAs). A list of those categories and MSAs is clarified in #5. The winning bid prices in those 9 categories in last year’s round one (aborted after only a couple of weeks) were significantly lower than current pricing schedules (there were actually 10 product categories and 10 MSAs in the discontinued 2008 round 1).
• While bidding requirements and expected low winning bid prices will make it likely that
most pharmacies will NOT want to bid for these products, competitive bidding is important because:
o It sets a precedent for future rounds – and CMS intends for round two, which is likely
to begin in 2011, to commence in 70 additional MSAs.
o Community pharmacy provision of diabetes test supplies is in danger: CMS
stated in the final competitive bidding rule that for round two, it is looking to have
national mail order programs, and it invited comments on the “inconsistency” of
having mail order diabetes test supplies in competitive bidding, but retail diabetes test
supplies outside of competitive bidding. NCPA has of course advocated keeping
retail supplies out of both round one and future rounds of competitive bidding.
• We will continue advocating for fair treatment of community pharmacies and their patients on this issue and other competitive bidding developments.


5) What are the first 9 product categories subject to competitive bidding and what are the 9 MSAs in which it will occur?


The 9 product categories included in the upcoming renewed first round of competitive bidding:


• Oxygen Supplies and Equipment
• Standard Power Wheelchairs, Scooters, and Related Accessories
• Complex Rehabilitative Power Wheelchairs and Related Accessories (Group 2)
• Mail-Order Diabetic Supplies
• Enteral Nutrients, Equipment, and Supplies
• Continuous Positive Airway Pressure (CPAP) Devices, Respiratory Assist Devices
(RADs), and Related Supplies and Accessories
• Hospital Beds and Related Accessories
• Walkers and Related Accessories
• (Miami Only) – Support Surfaces (Group 2 mattresses and overlays)
The first 9 MSAs:
• The first round excludes the top three (3) MSAs - New York, Los Angeles and Chicago.
• Charlotte-Gastonia-Concord, NC-SC
• Cincinnati-Middletown, OH-KY-IN
• Cleveland-Elyria-Mentor, OH
• Dallas-Fort Worth-Arlington, TX
• Kansas City, MO-KS
• Miami-Fort Lauderdale-Miami Beach, FL
• Orlando, FL
• Pittsburgh, PA
• Riverside-San Bernardino-Ontario, CA

6) Where can I find answers to more specific questions?


CMS has a FAQ webpage, and you can review NCPA’s DME Resource Center or contact the
NCPA Government Affairs department at (703) 683-8200.

 

 

July 18, 2009

LEGISLATIVE UPDATE


Dear NJPhA Member:

By now you are probably aware that the New Jersey State Budget for Fiscal Year 2010 was signed by the Governor on June 29, 2009.

Through the incredibly hard work and tenacity of our lobbyist Laurie Clark we were able to reverse a number of the planned cuts in the budget that would have impacted pharmacy in New Jersey. The original proposal imposed a $2.00 Medicaid/ADDP copayment in addition to a reduction in the Medicaid/ADDP reimbursement rate.

While we were unable to eliminate a one percent reduction in the reimbursement rate (now AWP-16%), the copayment was avoided and there was no reduction in dispensing fees. We were also successful in preserving the Long Term Care Capitation fee at the retail pharmacy dispensing level. Given the current financial environment, the final budget was a clear win for pharmacy.

We are also working to assure that current reimbursement rates are preserved if the First Data Bank settlement regarding AWP is implemented. Rest assured that we will remain busy this summer protecting the interests of the pharmacy profession in New Jersey.

It is also important to understand that to assure ongoing success we need a strong NJPhA PAC Fund and we need your help to make this happen.

Please take a few moments today and write a check to NJPhA PAC or make an online contribution at http://njpharma.org/donatepac.html

If you have any questions, ideas or suggestions please do not hesitate to contact me.

Sincerely,


Harvey Maldow R.Ph., MS

 

June 16, 2009

FDA Issues Public Health Advisory Regarding Stolen Levemir Insulin


TheThe U.S. Food and Drug Administration has learned that some stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. have reappeared and are being sold in the U.S. market. Three lots or a total of 129,000 vials of this product were stolen in all. These stolen insulin vials may not have been stored and handled properly and may be dangerous for patients to use.

The FDA has received one report of a patient who suffered an adverse event due to poor control of glucose levels after using a vial from one of these three lots.

The agency is advising patients who use Levemir insulin to:

1. Check your personal supply of insulin to determine if you have Levemir insulin from one of the following lots: XZF0036, XZF0037, and XZF0038. Patients can locate the lot number on the side of the box of insulin and also on the side of the vial.

2. Do not use your Levemir insulin if it is from one of these lots. Replace it with a vial of Levemir insulin from another lot. If you must switch to another brand of insulin for any reason, first contact your healthcare provider as another insulin product may require adjustments in dosing.

3. Always visually inspect your insulin before using it. Levemir is a clear and colorless solution.

4. Contact the Novo Nordisk Customer Care Center at 800-727-6500 for what to do with vials from these lots or if you have any other questions.

June 12, 2009

CALL FOR RESOLUTIONS
And
DELEGATE REGISTRATION


1. The House of Delegates is seeking Resolutions to be acted on at the 2009 House of Delegates Meeting. The House of Delegates Meeting will be held on Wednesday October 7, 2009 during the NJPhA Annual Meeting at Trump Plaza Hotel in Atlantic City. Please fill out the attached Resolution Form and forward it to the NJPhA Office if you have a resolution that you want considered at the House of Delegates

2. If you are interested in serving as a delegate, please fill out the attached application form and forward it to the NJPhA office via email, fax, or mail:

760 Alexander Road
Princeton, NJ 08543
Fax: 609-275-4066
Email: Dallen@njpharma.org

 

All NJPhA members in good standing can submit resolutions for the 2008 meeting of the HOD. Any issue having to do with government regulation of pharmacy, the professional practice of pharmacy in any setting, or the functioning of the Association itself are all categories that can be addressed through a resolution. (A sample resolution showing the format to be used is printed below). Each year at the NJPhA convention a meeting of the HOD is held to debate and vote on the submitted resolutions. Approved resolutions are then added to the NJPhA policy manual, or are submitted to the appropriate committee or the Board of Trustees for action. Any questions that you have for the BOD can be addressed to ASAXPCS@aol.com.

 

NEW JERSEY PHARMACISTS ASSOCIATION
HOUSE OF DELEGATES

 

SAMPLE RESOLUTION

Subject: Pharmacist Hearing Protection Act

Motion: For the safety, comfort, and enjoyment of those attending the NJPHA Convention, the convention committee shall limit the loudness of the band playing at the convention.

Background: According to the website http://www.entnet.org/healthinfo/hearing/noise_hearing.cfm, one in ten Americans has a hearing loss that affects his or her ability to understand normal speech. Excessive noise exposure is the most common cause of hearing loss. Many experts agree that continual exposure to more than 85 decibels is dangerous, but loud music has a decibel level of approximately 115 decibels. There is no reason to expose our members and their guests to the unhealthy levels of sound generated by the band we hire to play at our convention. Not only is it a health hazard but it interferes with conversation. The gala banquet may be the only time each year that we can catch up with old friends and colleagues and discuss the issues that affect pharmacy, which is the whole point of the convention. The sound level from the band makes this impossibility and needs to be corrected.

Submitted by: Alan S. Aronovitz, New Jersey Pharmacists Association – Region 5

Endorsed by: ______________________________________________________

 

NEW JERSEY PHARMACISTS ASSOCIATION
DELEGATE APPLICATION FORM
2009

I, ______________________________________________________________ do
(Print Name)


hereby declare that I will serve as a (you may check one or both):

____ Delegate


____ Alternate


at the NJPhA House of Delegates meeting to be held in October of 2009 in Atlantic City.


Signature: ______________________________________________________



Phone: ________________________________________________________




E-mail: _________________________________

 

 

MAY 27, 2009

 

This Information is Being Provided as a Service to Pharmacists in New Jersey by The New Jersey Pharmacists Association’s Disaster Management Academy


Become a Member of NJPhA and join the Academy at www.njpharma.org

This is an official CDC Health Update...

CDC Guidance on Antiviral Treatment of Patients with Confirmed, Probable, or Suspected Cases of Novel Influenza A (H1N1)

Summary:
As a reminder to clinicians, this Health Update summarizes existing CDC guidance issued on May 6, 2009 on the use of antiviral drugs in novel H1N1 patients and their close contacts. CDC recommends that influenza antiviral treatment be given to all hospitalized patients with confirmed, probable, or suspected novel influenza A (H1N1) and any patient with confirmed, probable or suspected novel influenza A (H1N1) who is at higher risk for seasonal influenza complications. All hospitalized patients should be carefully monitored and treated with antiviral medications as soon as possible after admission, including patients who seek treatment more than 48 hours after onset of symptoms. The drugs recommended for treatment are either oseltamivir or zanamivir. The novel H1N1 viruses are resistant to amantadine and rimantadine.

Background:
Clinical studies indicate that antiviral treatment is safe and effective for seasonal influenza, and that treatment is most effective if started as early as possible, preferably within 48 hours of illness onset. Antiviral susceptibility testing of novel H1N1 viruses indicates that antiviral drugs should be effective for treatment of this new strain of influenza also.

A recent study published in the Morbidity and Mortality Weekly Report (MMWR) described diagnosis, medical conditions, and treatment of 30 patients hospitalized in California with novel influenza A (H1N1) infection during April and May 2009. The report indicated that only 15 of 30 patients hospitalized with novel H1N1 infection received antiviral treatment. Treatment was initiated within 48 hours of symptom onset in only 5 of the 30 patients, although in some instances patients presented for medical care more than 48 hours after onset of illness. Although the majority of hospitalized persons infected with novel influenza A (H1N1) recovered without complications, some patients had severe and prolonged illness, and several remain hospitalized. Among hospitalized patients with n ovel influenza A (H1N1), about half of those who had chest x-rays taken had findings consistent with pneumonia, but few had evidence of bacterial co-infection. Primary influenza virus pneumonia, with or without bacterial co-infection, is a potentially life-threatening illness.

Recommendations:
CDC recommends that antiviral treatment for novel influenza A (H1N1) be given as soon as possible after onset of symptoms for all hospitalized patients with confirmed, probable, or suspected novel influenza A (H1N1) virus infection. All hospitalized patients with novel influenza A (H1N1) infection should be monitored carefully and treated with antiviral therapy, including patients who seek care more than 48 hours after illness onset. Influenza antiviral medicines should be initiated as soon as possible if influenza is suspected, and often before diagnostic test results (RT-PCR) are available, for maximum benefit. If bacterial co-infection is suspected, antibacterials should be directed at likely pathogens (e.g., S. pneumoniae, S. aureus) consistent with existing guidelines for the management of community-acquired pneumonia.* Antibacterial therapy also should be initiated after appropriate diagnostic specimens are obtained, including blood, respiratory secretions (especially for intubated patients), and pleural fluid for culture and urine for pneumococcal antigen testing (in adults).


Patients who are at higher risk for seasonal influenza complications (including people 65 years and older, children younger than five years old, pregnant women, and people of any age with chronic medical conditions) are also recommended for treatment, regardless of whether they require hospitalization.

For More Information:

Additional documents for health care providers, public health officials, and the public are available on www.cdc.gov. Information for the public is posted daily in both English and Spanish. Also, CDC’s toll-free hotline, 800-CDC-INFO (800-232-4636) TTY: (888) 232-6348, is available 24 hours a day, every day.

*Mandell LA, Wunderink RG, Anzueto A, et al. Infectious Diseases Society of America / American Thoracic Society Consensus Guidelines on the Management of Community-acquired Pneumonia in Adults. Clin Infect Dis 2007;44 Suppl 2:S27-72.

April 30, 2009

This information was downloaded from the CDC website www.cdc.gov. . . .

Interim Guidance on Antiviral Recommendations for Patients with Confirmed or Suspected Swine Influenza A (H1N1) Virus Infection and Close Contacts


April 29, 2009 02:45 PM ET

Objective: To provide interim guidance on the use of antiviral agents for treatment and chemoprophylaxis of swine influenza A (H1N1) virus infection. This includes patients with confirmed, probable or suspected swine influenza A (H1N1) virus infection and their close contacts.
Case Definitions for Infection with Swine-origin Influenza A (H1N1) Virus (S-OIV)
A confirmed case of S-OIV infection is defined as a person with an acute febrile respiratory illness with laboratory confirmed S-OIV infection at CDC by one or more of the following tests:

1. real-time RT-PCR
2. viral culture

A probable case of S-OIV infection is defined as a person with an acute febrile respiratory illness who is positive for influenza A, but negative for H1 and H3 by influenza RT-PCR

A suspected case of S-OIV infection is defined as a person with acute febrile respiratory illness with onset within 7 days of close contact with a person who is a confirmed case of S-OIV infection, or
within 7 days of travel to community either within the United States or internationally where there are one or more confirmed cases of S-OIV infection, or resides in a community where there are one or more confirmed cases of S-OIV infection.

Infectious period for a confirmed case of swine influenza A (H1N1) virus infection is defined as 1 day prior to the case’s illness onset to 7 days after onset.

Close contact is defined as: within about 6 feet of an ill person who is a confirmed or suspected case of swine-origin influenza A (H1N1) virus infection during the case’s infectious period.

Acute respiratory illness is defined as recent onset of at least two of the following: rhinorrhea or nasal congestion, sore throat, cough (with or without fever or feverishness)

High-risk groups: A person who is at high-risk for complications of swine influenza A (H1N1) virus infection is defined as the same for seasonal influenza (see MMWR: Prevention and Control of Influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2008).

Special Considerations for Children
Aspirin or aspirin-containing products (e.g. bismuth subsalicylate – Pepto Bismol) should not be administered to any confirmed or suspected ill case of swine influenza A (H1N1) virus infection aged 18 years old and younger due to the risk of Reye syndrome. For relief of fever, other anti-pyretic medications are recommended such as acetaminophen or non steroidal anti-inflammatory drugs.

Antiviral Resistance
This swine influenza A (H1N1) virus is sensitive (susceptible) to the neuraminidase inhibitor antiviral medications zanamivir and oseltamivir. It is resistant to the adamantane antiviral medications, amantadine and rimantadine.

Antiviral Treatment
Confirmed, Probable and Suspected Cases of Swine-origin Influenza A (H1N1) Virus Infection
Recommendations for use of antivirals may change as data on antiviral effectiveness, clinical spectrum of illness, adverse events from antiviral use, and antiviral susceptibility data become available.

Antiviral treatment should be considered for confirmed, probable or suspected cases of swine-origin influenza A (H1N1) virus infection. Treatment of hospitalized patients and patients at higher risk for influenza complications should be prioritized.

Only RT-PCR or viral culture can confirm infection with swine-origin influenza A (H1N1) virus. The test performance of rapid antigen tests and immunofluorescence tests for detection of swine-origin influenza A (H1N1) virus is unknown. Persons who might have swine-origin influenza A (H1N1) virus and who test positive for influenza A using one of these tests should have confirmatory RT-PCR or viral culture testing to confirm the presence of swine-origin influenza A (H1N1) virus. A negative rapid antigen or immunofluorescence test cannot be used to rule out swine-origin influenza A (H1N1) virus infection.

Antiviral treatment with zanamivir or oseltamivir should be initiated as soon as possible after the onset of symptoms. Evidence for benefits from treatment in studies of seasonal influenza is strongest when treatment is started within 48 hours of illness onset. However, some studies of treatment of seasonal influenza have indicated benefit, including reductions in mortality or duration of hospitalization even for patients whose treatment was started more than 48 hours after illness onset. Recommended duration of treatment is five days. Recommendations for use of antivirals may change as data on antiviral susceptibilities and effectiveness become available.

Antiviral doses recommended for treatment of swine-origin influenza A (H1N1) virus infection in adults or children 1 year of age or older are the same as those recommended for seasonal influenza (Table 1). Oseltamivir use for children < 1 year old was recently approved by the U.S. Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA), and dosing for these children is age-based (Table 2).

Note: Areas that continue to have seasonal influenza activity, especially those with circulation of oseltamivir-resistant human A (H1N1) viruses, might prefer to use either zanamivir or a combination of oseltamivir and rimantadine or amantadine to provide adequate empiric treatment or chemoprophylaxis for patients who might have human influenza A (H1N1) infection.

Antiviral Chemoprophylaxis
For antiviral chemoprophylaxis of swine-origin influenza A (H1N1) virus infection, either oseltamivir or zanamivir are recommended (Table 1). Duration of antiviral chemoprophylaxis post-exposure is 10 days after the last known exposure to an ill confirmed case of swine-origin influenza A (H1N1) virus infection. Post exposure prophylaxis should be considered for contact during the infectious period (e.g., one day before until 7 days after the case’s onset of illness). If the contact occurred more than 7 days earlier, then prophylaxis is not necessary. For pre-exposure protection, chemoprophylaxis should be given during the potential exposure period and continued for 10 days after the last known exposure to an ill confirmed case of swine-origin influenza A (H1N1) virus infection. Oseltamivir can also be used for chemoprophylaxis under the EUA (Table 3).

Antiviral chemoprophylaxis with either oseltamivir or zanamivir is recommended for the following individuals:

1. Household close contacts who are at high-risk for complications of influenza (e.g., persons with certain chronic medical conditions, persons 65 or older, children younger than 5 years old, and pregnant women) of a confirmed or probable case.
2. Health care workers or public health workers who were not using appropriate personal protective equipment during close contact with an ill confirmed, probable, or suspect case of swine-origin influenza A (H1N1) virus infection during the case’s infectious period. See guidelines on personal protective equipment.

Antiviral chemoprophylaxis with either oseltamivir or zanamivir can be considered for the following:

1. Household close contacts who are at high-risk for complications of influenza (e.g., persons with certain chronic medical conditions, persons 65 years or older, children younger than 5 years old, and pregnant women) of a suspected case.
2. Children attending school or daycare who are at high-risk for complications of influenza (children with certain chronic medical conditions) and who had close contact (face-to-face) with a confirmed, probable, or suspected case.
3. Health care workers who are at high-risk for complications of influenza (e.g., persons with certain chronic medical conditions, persons 65 or older, and pregnant women) who are working in an area of the healthcare facility that contains patients with confirmed swine-origin influenza A (H1N1) cases, or who is caring for patients with any acute febrile respiratory illness.
4. Travelers to Mexico who are at high-risk for complications of influenza (e.g., persons with certain chronic medical conditions, persons 65 or older, children younger than 5 years old, and pregnant women). (Note: A travel warning is currently in effect indicating that nonessential travel to Mexico should be avoided.
5. First responders who are at high-risk for complications of influenza (e.g., persons with certain chronic medical conditions, persons 65 or older, children younger than 5 years old, and pregnant women) and who are working in areas with confirmed cases of swine-origin influenza A (H1N1) virus infection.

Children Under 1 Year of Age
Children under one year of age are at high risk for complications from seasonal human influenza virus infections. The characteristics of human infections with swine-origin H1N1 viruses are still being studied, and it is not known whether infants are at higher risk for complications associated with swine-origin H1N1 infection compared to older children and adults. Limited safety data on the use of oseltamivir (or zanamivir) are available from children less than one year of age, and oseltamivir is not licensed for use in children less than 1 year of age. Available data come from use of oseltamivir for treatment of seasonal influenza. These data suggest that severe adverse events are rare, and the Infectious Diseases Society of America recently noted, with regard to use of oseltamivir in children younger than 1 year old with seasonal influenza, that "…limited retrospective data on the safety and efficacy of oseltamivir in this young age group have not demonstrated age-specific drug-attributable toxicities to date." (See IDSA guidelines for seasonal influenza.)
Because infants typically have high rates of morbidity and mortality from influenza, infants with swine-origin influenza A (H1N1) infections may benefit from treatment using oseltamivir.

Healthcare providers should be aware of the lack of data on safety and dosing when considering oseltamivir use in a seriously ill young infant with confirmed swine-origin H1N1 influenza or who has been exposed to a confirmed swine H1N1 case, and carefully monitor infants for adverse events when oseltamivir is used. See additional information on oseltamivir for this age group.

Pregnant Women
Oseltamivir and zanamivir are "Pregnancy Category C" medications, indicating that no clinical studies have been conducted to assess the safety of these medications for pregnant women. Because of the unknown effects of influenza antiviral drugs on pregnant women and their fetuses, oseltamivir or zanamivir should be used during pregnancy only if the potential benefit justifies the potential risk to the embryo or fetus; the manufacturers' package inserts should be consulted. However, no adverse effects have been reported among women who received oseltamivir or zanamivir during pregnancy or among infants born to women who have received oseltamivir or zanamivir. Pregnancy should not be considered a contraindication to oseltamivir or zanamivir use. Because of its systemic activity, oseltamivir is preferred for treatment of pregnant women. The drug of choice for prophylaxis is less clear. Zanamivir may be preferable because of its limited systemic absorption; however, respiratory complications that may be associated with zanamivir because of its inhaled route of administration need to be considered, especially in women at risk for respiratory problems.

Adverse Events and Contraindications
For further information about influenza antiviral medications, including contraindications and adverse effects, please see the following:

Antiviral Agents for Seasonal Influenza: Side Effects and Adverse Reactions
MMWR: Prevention and Control of Influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2008
MMWR August 8, 2008 / 57(RR07);1-60
Adverse events from influenza antiviral medications should be reported through the U.S. FDA Medwatch website.

April 27, 2009

Information That You Need to Know About The Swine Influenza Pandemic

RECOMMENDATIONS FOR PUBLIC HEALTH PERSONNEL For interviews of healthy individuals (i.e. without a current respiratory illness), including close contacts of cases of confirmed swine influenza virus (SIV) infection; no personal protective equipment or antiviral chemoprophylaxis is needed. See section on antiviral chemoprophylaxis for further guidance.

For interviews of an ill, suspected or confirmed SIV case, the following is recommended:

1. Keep a distance of at least 6 feet from the ill person; or
2. Personal protective equipment: fit-tested N95 respirator [if unavailable, wear a medical (surgical mask)].

For collecting respiratory specimens from an ill confirmed or suspected SIV case, the following is recommended:

1. Personal protective equipment: fit-tested disposable N95 respirator [if unavailable, wear a medical (surgical mask)], disposable gloves, gown, and goggles.
2. When completed, place all PPE in a biohazard bag for appropriate disposal.
3. Wash hands thoroughly with soap and water or alcohol-based hand gel.

SURVEILLANCE CRITERIA for swine influenza (H1N1) infection: NJDHSS is asking that clinicians report any ill person meeting the following clinical and epidemiologic criteria:

1.*Illness which is clinically compatible with swine influenza. Symptoms can include influenza-like illness (fever, cough, sore throat), mild respiratory illness (nasal congestion, rhinorrhea) with or without fever, vomiting, diarrhea, myalgia, headache, chills, fatigue, dyspnea and conjunctivitis.

* Has had at least one potential exposure within 10 days of symptom onset as listed below:

1.A.) History of travel to an area where swine influenza H1N1 documented in animals and/or humans (i.e., California, Texas); OR

B.) History of travel to an areas where other severe respiratory infections have been identified (i.e., Mexico); OR

C.) Close contact (within 6 feet) of an ill patient who was confirmed or suspected to have swine influenza; OR

D.) Close contact (within 6 feet) of a ill patient who has traveled to one of the areas above; OR

E.) Recent exposure to pigs; OR

F.) Works with live influenza virus in a laboratory.



Providers are reminded to test for other common respiratory pathogens that may be causing illness in the patient (e.g., seasonal influenza, RSV)

Healthcare Providers

Cases meeting the above surveillance criteria should be reported IMMEDIATELY to the local health department (LHD) where the patient resides. If LHD personnel are unavailable, healthcare providers should report the case to the New Jersey Department of Health and Senior Services Communicable Disease Service (CDS) at 609-588-7500, Monday through Friday 8:00 AM - 5:00 PM. On weekends, evenings and holidays, CDS can be reached at (609) 392-2020.

Crisis Criteria

  • The federal government has declared a public health emergency, as the number of confirmed cases of swine flu in the U.S. has risen to 20, with additional suspected cases.
  • The World Health Organization (WHO) met today and decided NOT to change the Pandemic Threat Level from a Stage 3 to a Stage 4. However, they are closely monitoring the situation.
  • CDC EOC remains at Level 1 (full activation) and is closely monitoring the event.
  • Secretary General of the WHO, Margaret Chan has said that the Swine Flu outbreak in Mexico has 'pandemic potential' and an Affiliated Physicians' reports states that WHO Pandemic Stage should soon be raised to 4, with Stage 5 easily accomplishable.
  • The WHO has declared the swine flu outbreak in North America a 'public health emergency of international concern'.

Facts

  • 20 laboratory human infection cases have been confirmed in the U.S. across five states
  • Only one patient has been hospitalized, and all have recovered. However, as the CDC anticipates these numbers to change, they will update the public health community on a daily basis.
  • The current influenza vaccine is not expected to protect against the outbreak. The strain is also resistant to two of the four antiviral drugs licensed in the United States for treatment of influenza, amantadine and rimantadine. The strain, however, is sensitive to oseltamivir (trade name Tamiflu) and zanamivir (trade name Relenza). The CDC has developed a genetically matched “seed stock” for the strain, which would be needed if vaccine production is necessary.

Human Health Impact

  • The current swine influenza outbreak exhibits unusual characteristics of concern:
    The outbreak is affecting adults and spreading through human-to-human transmissions - which is atypical as influenza typically targets young children and elderly individuals, and human contraction of swine influenza is normally associated with close contact with pigs.
  • Although the outbreaks in Mexico and the United States have been genetically linked, the United States has experienced no fatalities related to the outbreak, whereas 22 deaths in Mexico have been confirmed as resulting from the swine influenza, and the Government of Mexico is investigating additional cases.
  • Media reports say that a new strain of influenza has been responsible for the deaths of 86 people, with 22 confirmed from H1N1.
  • Media reports indicate over 1,000 cases of influenza in Mexico, as well as suspected cases in New Zealand, Canada and a number of other countries.
  • According to government reports, confirmed U.S. cases of H1N1 to date are:
    • Mexico – 12 confirmed cases
    • California – 7 confirmed cases
    • Texas – 2 confirmed cases
    • New York – New York City Health Department officials were contacted when approximately 200 students from St. Francis Prep in Queens fell ill. 8 cases confirmed by a New York lab, awaiting CDC confirmation
    • Ohio - 1 case confirmed
    • Kansas – 2 cases confirmed


Government Action

  • CDC has activated its Emergency Operations Center to coordinate this investigation.
  • CDC teams in Mexico are assisting public health authorities in Mexico by testing specimens and providing epidemiological support, and are part of trilateral team of Mexico, US, and Canada, trying to figure out who is ill from this virus, what factors matter for transmissibility, how transmissible it is, instill better capability for Mexican officials to detect and quarantine the virus on site.
  • CDC is working very closely with officials in states where human cases of swine influenza A (H1N1) have been identified, as well as with health officials in Mexico, Canada and the World Health Organization. This includes deploying staff domestically and internationally to provide guidance and technical support.
  • CDC is working with BARDA/FDA on development of vaccine candidates.


FROM THE CDC WEBSITE
Swine Influenza (Flu)
Swine Flu website last updated Sunday, April 27, 2009 10:15 AM ET
U.S. Human Cases of Swine Flu Infection (As of April 26, 2009 9:00 AM ET)

International Human Cases of Swine Flu Infection
See: World Health Organization
Human cases of swine influenza A (H1N1) virus infection have been identified in the United States. Human cases of swine influenza A (H1N1) virus infection also have been identified internationally.

The current U.S. case count is provided below:

  • Investigations are ongoing to determine the source of the infection and whether additional people have been infected with swine influenza viruses.
  • CDC is working very closely with officials in states where human cases of swine influenza A (H1N1) have been identified, as well as with health officials in Mexico, Canada and the World Health Organization. This includes deploying staff domestically and internationally to provide guidance and technical support. CDC has activated its Emergency Operations Center to coordinate this investigation.
  • Laboratory testing has found the swine influenza A (H1N1) virus susceptible to the prescription antiviral drugs oseltamivir and zanamivir and has issued interim guidance for the use of these drugs to treat and prevent infection with swine influenza viruses. CDC also has prepared interim guidance on how to care for people who are sick and interim guidance on the use of face masks in a community setting where spread of this swine flu virus has been detected. This is a rapidly evolving situation and CDC will provide new information as it becomes available.


Related Links: PandemicFlu.gov


WHO - Influenza-Like Illness in the United States and Mexico
What You Can Do to Stay Healthy
There are everyday actions people can take to stay healthy:

  1. Cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it.
  2. Wash your hands often with soap and water, especially after you cough or sneeze. Alcohol-based hands cleaners are also effective.
  3. Avoid touching your eyes, nose or mouth. Germs spread that way.
  4. Try to avoid close contact with sick people.
  5. Influenza is thought to spread mainly person-to-person through coughing or sneezing of infected people.
  6. If you get sick, CDC recommends that you stay home from work or school and limit contact with others to keep from infecting them.

 

April 9, 2009

NJPhA Will be Scheduling Several Immunization Training Programs in the Near Future

IMMUNIZATION REGULATION SUMMARY
WHAT YOU NEED TO KNOW


1. Pharmacists must be pre-approved by the Board of Pharmacy in order to immunize and submit documentation to the Board establishing that they have satisfied specific educational requirements. [Download Form]

2. Pharmacists may administer vaccines and related emergency medications (limited to diphenhydramine and epinephrine) pursuant to:


a. A prescription for the vaccine, related emergency medications and pharmacists administration of the vaccine that is patient specific; and/or

b. A physician’s standing order for the vaccine, related emergency medications above, and administration instructions that are not patient specific

3. A physician must supervise a licensed pharmacist who is participating in an immunization program implemented pursuant to the physician’s standing order.


a. The physician is responsible for formulating or approving a standing order, periodically reviewing the order and the services provided to patients under the order.

b. Must be geographically located to be easily accessible to the pharmacy practice site or immunization location

c. Available through direct telecommunication for consultation, assistance, and direction


4. Educational Requirements


a. Completion of an academic and practical curriculum including instruction on CDC guidelines for vaccine administration by an ACPE accredited provider. The course must include the following topics:


i. Occupational Exposure to Blood Borne Pathogens (OSHA)
ii. CDC Guideline for Infection Control in Health Care Personnel
iii. Basic immunology
iv. Communicable or vaccine preventable disease epidemiology
v. Vaccine characteristics, contraindications, monitoring, proper storage and proper handling
vi. Informed consent
vii. Pre and post vaccine assessment and counseling
viii. Immunization record management
ix. Injection techniques
x. Emergency responses to adverse events
xi. Medical waste disposal
xii. Reporting adverse events


b. Current certification in the American Heart Association Basic Life support (BLS) protocol, the Red Cross Adult Cardiac Pulmonary Resuscitation protocol for heal care providers or a course complying with guidelines created by the International Liaison Committee on Resuscitation.


c. At least two hours of continuing education in immunizations in each biennial renewal period.

 

March 17, 2009

Court Approves First DataBank-Medi-Span Final Settlements


The ruling by Judge Patti B. Saris of the United States District Court for the District of Massachusetts will reduce the average wholesale prices (AWPs) used to set pharmacy reimbursement rates to 120% of wholesale acquisition cost (WAC).

First DataBank and Medi-Span have also announced that they will eventually stop publishing AWPs, which are used as a prescription drug pricing benchmark. The adjustments to Blue Book AWP will become effective in approximately 180 days from the date of the Final Judgment, which is expected to be submitted to the Court within one week. This is a change from the 90 day period in the amended settlement.

Our National organizations are working hard to determine next steps. At NJPhA we will be working closely with all parties both in New Jersey and nationally to mitigate the potential impact of this judgment on community practice.

Drug Fair Group Files for Chapter 11 Bankruptcy Protection and Obtains ‘Stalking Horse’ Bid from Walgreens for 32 Pharmacy Locations


SOMERSET, N.J.--(BUSINESS WIRE)--Drug Fair Group, Inc. ("Drug Fair”) and its parent company CDI Group, Inc., today announced that they filed voluntary petitions for reorganization under Chapter 11 of the U.S. Bankruptcy Code in the United States Bankruptcy Court for the District of Delaware (the “Court”). In connection with the Chapter 11 filing, Drug Fair entered into an agreement with a subsidiary of Walgreen Co. (“Walgreens”) to sell substantially all of its assets associated with 32 of its stores to Walgreens. The proposed transaction remains subject to the marketing requirements of the Bankruptcy Code and the approval of the Bankruptcy Court.

Prior to its Chapter 11 filing, Drug Fair sold various assets at 13 locations to third parties, including Walgreens who purchased prescription files from the following 11 Drug Fair locations:

    • 400 Springfield Ave., Berkeley Heights, NJ
    • 1046 Saint Georges Ave., Rahway, NJ
    • 9 Kennedy Mall, Brick, NJ
    • 175 Locust Ave., West Long Branch, NJ
    • 620 South Ave. E, Cranford, NJ
    • 338 Ramapo Valley Rd., Oakland, NJ
    • 1408 South Ave., Plainfield, NJ
    • 11-15 River Rd., N. Arlington, NJ
    • 1006 US Hwy 46, Clifton, NJ
    • 481 Union Ave., Bridgewater, NJ
    • 51 State Rt. 17, East Rutherford, NJ


Patients previously served by these 11 pharmacies now have access to their prescription histories at any nearby Walgreens, or any of the nearly 6,700 Walgreens locations nationwide.

Drug Fair is committed to continuing to provide quality service and products to its valued customers throughout the course of the Chapter 11 process. Day-to-day operations will be uninterrupted at the locations that are to be sold as part of the proposed transaction with Walgreens.

In connection with the Chapter 11 filing, Drug Fair announced that it has arranged a four-month secured debtor-in-possession financing facility (the “DIP Financing”) in the amount of $40 million. If approved by the Court, proceeds from the DIP Financing will be used by Drug Fair to fund its operations during the Chapter 11 proceedings and should enable it to continue to satisfy its obligations associated with its remaining operations, including payment of employee wages and benefits and post-petition obligations to vendors.

“After exploring alternatives following a thorough consultation with its legal and financial advisors, Drug Fair’s board of directors determined that an orderly sale of the Company’s assets through a Chapter 11 process, together with those assets sold prior to the Chapter 11 filing, would be the most prudent and effective way to maximize value for Drug Fair’s stakeholders.

The Board, Drug Fair’s management and I would like to thank our customers, employees and vendors for their ongoing support in what has been a difficult and uncertain period for us,” said Tim Boates, Drug Fair’s Chief Restructuring Officer. “We have worked very hard to structure a transaction that is in the best interest of all parties, including our employees and the communities they serve. We feel we have identified a great company to carry that service forward into the future.”

“Drug Fair has been a respected pharmacy in this region for more than 50 years,” said Walgreens market vice president for the Northeast, Tim Anhorn. “We’re pleased to be able to keep most of the stores open and continue providing these communities with convenient access to high quality pharmacy services and basic needs. Customers will continue to see many of the familiar faces behind the counter they trust for their health care needs.”

APPROPRIATIONS COMMITTEE ADVANCES BILL TO
REGULATE PHARMACY BENEFIT MANAGEMENT COMPANIES

A-1578 sponsored by Assemblywoman Linda Greenstein to regulate the pharmacy benefits management (PBM) companies that manage prescription drug benefits for health care plans in New Jersey was released by the Assembly Appropriations Committee on February 9, 2009 by a vote of 9-1 with two abstentions. The bill has now cleared two major committees and is ready for a floor vote in the New Jersey General Assembly.

Under the provisions of the bill, PBMs managing the prescription drug benefits for New Jersey health care providers would receive a renewable three-year certification from the New Jersey Department of Banking and Insurance (DOBI), which also would oversee the regulation.

The legislation would define the business activities that a DOBI-certified PBM may conduct, as well as disclosures a PBM would be required to make to individuals whose pharmacy benefits they manage. PBMs also would be required to reveal rebates and discounts to clients as they relate to health benefits plans that have purchased their services.


We urge our members to contact their Assembly representatives to let them know of their support for this important legislation. Please contact headquarters if you need a list of Assembly representatives or for additional talking points.

Important Talking Points

  • This legislation is necessary as a response to a continual problem of harmful, anticompetitive, and fraudulent conduct by PBMs. Numerous suits have been filed against the three major PBMs by a group of state attorneys generals which have challenged fraudulent and deceptive conduct by PBMs and secured over $300 million in penalties.
  • The PBM market is not competitively healthy. There are three major PBMs which dominate the market.
  • Unlike other markets, one can not expect the market to correct itself. The PBMs practices are famous for being opaque, confusing, and hard to decipher. Moreover, the PBMs’ responsibilities to the people they serve – the insurance companies, unions, and employers who buy their services – are unclear and PBMs manipulate that ambiguity to deny services, engage in conflicts of interests, and manipulate the system to “play the spread” and deceive plans about what benefits they receive.
  • Moreover, the ultimate consumers suffer even greater harm, as PBMs arbitrarily switch them to drugs where the PBM gets a higher rebate.
  • The PBMs may suggest the market can be policed by customers. Some PBM customers may be able to spend the money for sophisticated staffs to monitor PBM conduct, but these are only the largest companies. Smaller companies lack the resources and sophistication to police PBMs.
  • The bill provides all PBM customers – both large and small – with sufficient information to police PBMs to make sure these anticompetitive, deceptive, and anticonsumer conduct does not occur.
  • This legislation clarifies that a PBM owes a fiduciary duty to its customers – a concept very clear in the law. And the legislation provides a basic set of information for PBMs to provide so PBM customers can make sure they receive the benefit of their contracts.

2/12/09

Pharmacy Groups Announce Principles to Improve Patient Care, Access to Medications, Promote Technology to Enhance Health Care Delivery

The following information was excerpted from a press release distributed today by the National Association of Chain Drugstores. It is important that the major national pharmacy organizations are working together and have developed one set of principles for Health Care Reform. In New Jersey we will be working with state and national legislative representatives to familiarize them with these principles and the value that pharmacists provide as we move forward with health care reform.
Please contact me if you have any specific legislative contacts or suggestions on how best to move forward with our efforts in New Jersey.

If you are not currently a member of NJPhA, please support our efforts to asssure the future of the pharmacy profession by joining our organization. You can join NJPHA right now.

Washington, D.C.– Amidst a time of rejuvenating the nation’s economic viability and strengthening the nation’s healthcare system, pharmacy organizations officially unveiled Pharmacy Principles for Health Care Reform today at the National Press Club in Washington, DC. The Principles identify what is necessary to fully utilize the medication expertise to address the epidemic of medication misuse. They demonstrate how the nation’s pharmacies and pharmacists can play a critical role in providing accessible, affordable and quality health care for patients.

Twelve pharmacy organizations collaborated to develop the Principles: Academy of Managed Care Pharmacy, American Association of Colleges of Pharmacy, American College of Clinical Pharmacy, American Pharmacists Association, American Society of Consultant Pharmacists, American Society of Health-System Pharmacists, Food Marketing Institute, National Association of Chain Drug Stores, National Alliance of State Pharmacy Associations, National Community Pharmacists Association, Rite Aid Corporation, and Walgreen Co.

The pharmacy organizations outlined three goals related to medication access and use that should be an integral part of any health reform debate:

1) Improve quality and safety of medication use
2) Assure patient access to needed medications and pharmacy services
3) Promote pharmacy and health information technology (HIT) interoperability

Proper use of prescription medications helps improve patient quality of life and health outcomes. However, the health care system incurs more than $177 billion annually in mostly avoidable health care costs to treat adverse events resulting from failure to take medications as prescribed. Proper use of prescription medications helps improve patient quality of life and improve health outcomes.
Pharmacists can help keep those costs down through pharmacist-provided patient care services, such as educating patients on how to take their prescription medications properly and safely, as well as administering health screenings and immunizations. With current costs to the health care system to treat chronic diseases at $1.3 trillion annually, taking medications properly can help prevent the need for catastrophic or emergency care.

Patients can also benefit from the counsel of pharmacists, who are educated and trained as medication experts, to identify cost-effective medication options, such as generics and biosimilars. Pharmacy services such as health screenings can also provide patients with low-cost, preventive care that can lead to better overall health.

Health information technology (HIT) is rapidly becoming an integral part of health care delivery in the United States. The use of electronic health records and electronic prescribing has increased dramatically in recent years. Congress has just passed economic recovery legislation that includes HIT provisions that will help to improve the delivery and quality of health care. HIT interoperability between the pharmacy and other health care providers would enable pharmacists to further assist in ensuring patients adhere to their medication regimens and in reducing medication errors.

Pharmacists are a highly trained and valuable resource, yet they are currently underutilized. As lawmakers continue discussions on how best to reform the health care system, it is critical that pharmacy be a part of that reform. The Pharmacy Principles for Health Care Reform serve as a resource for the ways in which pharmacy can provide cost-effective patient-care services to achieve better health care.

12/24/08

Recently, pharmacists have been receiving notice from the Department of Justice concerning self certification for the sale of pseudoephedrine. We would like to remind you that each pharmacy needs to do a self certification if they are selling pseudoephedrine.

It is on the DEA/Office of Diversion Control webpage, which can be found at: http://www.deadiversion.usdoj.gov/meth/index.html. Scroll down on this page to find the “Required Training and Self Certification” portion.

Once the training has been completed, be sure to make a copy of the certificate and pay close attention to the expiration date at the bottom. You will not receive a renewal notice, but will need to recertify as soon as the certificate expires. Also, be sure to keep a copy of the certificate in the pharmacy. Every pharmacy will have a different date depending on when they did their original certification. We hope that this information helps in maintaining current certificates on file in your pharmacy.

12/22/08

We look forward to a very exciting and successful 2009 as we work together assuring the future success of the pharmacy profession.

Enjoy the Holidays
NJPhA

11/24/08

THE DEPARTMENT OF CONUSUMER AFFAIRS EXTENDED THE DEADLINE FOR TECHNICIAN REGISTRATION LAST FRIDAY.

ALL PHARMACY TECHNICIANS MUST NOW BE REGISTERED BY DECEMBER 31, 2008


We anticipate that inspectors will routinely check to assure that all technicians are registered after December 31, 2008.

Unregistered technicians will not be permitted to work and you may be fined if they are found working in a pharmacy.

Application forms for technician registration can be retrieved from the
New Jersey Board of Pharmacy Website

11/24/08


Dear New Jersey Pharmacy Association Member:

Attached is al copy of a letter that was recently sent to the FDA in an effort to protect our right to compound medications. Our national pharmacy organizations continue to fight for our right as pharmacists to compound prescriptions when medically necessary. You may want to consider sending a letter to the FDA in support of their position.


Enjoy the Thanksgiving Holiday


Harvey Maldow R.Ph., MS
CEO New Jersey Pharmacists Association
760 Alexander Road
Princeton, NJ 08543-0001
609-275-4246
609-275-4066 (fax)
hmaldow@njpharma.org

 



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