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CMS Delays Ban on Faxed Prescriptions
Deadline Moved to Jan. 1, 2012
Physicians who participate in Medicare and depend on computer-generated faxes to transmit prescriptions to pharmacies can breathe a collective sigh of relief. CMS has extended its deadline for banning faxed prescriptions by three years, moving the Jan. 1, 2009, deadline to Jan. 1, 2012.
The deadline change is included in the 2009 Medicare Physician Fee Schedule final rule announced by CMS on Oct. 30. According to CMS’ press release, the agency reversed its position “in the interest of patient care and safety and to encourage prescribers and dispensers to adopt e-prescribing.”
Although many physicians initiate prescriptions through their electronic health record, or EHR, systems, their computers actually generate a fax to the pharmacy.
Had the deadline been imposed on Jan. 1 of next year, many physicians might have reverted back to paper-based prescriptions.
E-prescribing offers proven benefits to physicians, including reductions in medication errors, a reduced call burden from pharmacies and electronic access to formulary information.
Amendment to Add Pharmacists and Pharmacies to MIPPA Language
42 USC § 1395m(a)(20)(F) Application of accreditation requirement
In implementing quality standards under this paragraph--
(i) subject to clause (ii), the Secretary shall require suppliers furnishing items and services described in subparagraph (D) on or after October 1, 2009, directly or as a subcontractor for another entity, to have submitted to the Secretary evidence of accreditation by an accreditation organization designated under subparagraph (B) as meeting applicable quality standards; and
(ii) in applying such standards and the accreditation requirement of clause (i) with respect to eligible professionals (as defined in section 1395w-4(k)(3)(B) of this title), and including such other persons, such as pharmacies, pharmacists, orthotists and prosthetists, as specified by the Secretary, furnishing such items and services--
(I) such standards and accreditation requirement shall not apply to such professionals and persons unless the Secretary determines that the standards being applied are designed specifically to be applied to such professionals and persons; and
(II) the Secretary may exempt such professionals and persons from such standards and requirement if the Secretary determines that licensing, accreditation, or other mandatory quality requirements apply to such professionals and persons with respect to the furnishing of such items and services.
Medicaid Agency Tamper-resistant FAQ's
On April 1, 2008, all hand-written or computer-generated/printed Medicaid prescriptions were required to have at least one approved tamper-resistant feature to prevent: copying; modification or erasure; or counterfeiting. Starting October 1, 2008, all hand-written or computer generated/printed Medicaid prescriptions must contain at least one feature from all three of the previously mentioned categories.
1. Does this requirement pertain to prescriptions received by fax, telephone or electronically?
No. Since fax, telephone, and electronic prescriptions are sent directly to the pharmacy, they are excluded from the new Federal requirements. The direct communication from the physician/prescriber to the pharmacist is considered tamper-resistant.
2. Does this requirement pertain to prescriptions that are written using a computer (Electronic Medical Record - EMR) and printed on paper?
Yes. Any prescription that is entered into a computer, printed on paper and given to the patient/personal representative for filling must contain the required tamper-resistant features.
3. Do prescriptions printed from a computer (EMR) have to be printed on special tamper resistant paper to be compliant?
No. CMS has clarified that while special tamper resistant paper can be used to achieve copy resistance, it is not necessary.
Copy resistance may also be achieved with plain paper; as long as certain features are used and meet your state’s requirements
(see Appendix 1 for examples).
4. Does the Federal requirement affect written Medicaid prescriptions for managed care recipients?
This requirement does not apply to written outpatient prescriptions for those managed care Medicaid recipients whose pharmacy benefits are paid by a Managed Care Organization (MCO). However, there are exceptions to this rule in Illinois and in few plans in California. This is subject to change – check with your State Medicaid program for specific MCO exceptions.
5. Does the tamper-resistant requirement apply to over-the-counter (OTC) products?
Yes. OTC products that require a prescription for reimbursement under Medicaid must be tamper-resistant.
6. Does the tamper-resistant requirement apply to durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) supplies, such as diabetic testing strips?
No. The tamper-resistant requirement only applies to medications.
7. How does this provision apply to discharge prescriptions for a Medicaid patient when they leave an inpatient setting with prescriptions to be filled at an outpatient pharmacy?
If the prescription is written or printed, then it must be tamper-resistant.
8. Does the action of a pharmacist calling back a prescriber and making appropriate documentation on the original non-compliant prescription count as a compliant prescription during a Medicaid audit?
Yes. CMS clarified that documentation by the pharmacist of verbal confirmation of a non-compliant written prescription satisfies the requirement for a compliant prescription. As a best practice you should document the name of the person contacted at the prescriber’s office, the date the prescription was confirmed and the name of the pharmacist who confirmed the prescription.
However, it is recommended that pharmacists check with their state Medicaid agency to confirm this policy. CMS’ clarification can be found in the Frequently Asked Questions on the Tamper-Resistant Law document available on its Web site at:
http://www.cms.hhs.gov/DeficitReductionAct/Downloads/MIPTRPFAQs9122007.pdf.
9. What do I do if I receive a hand-written or printed Medicaid prescription from another state?
You must first determine which state Medicaid program is going to pay for the prescription and then make sure that the prescription meets that state’s tamper-resistant requirements. The National Association of State Medicaid Directors has statespecific materials available on its Web site at: www.nasmd.org/issues/TRPP.asp.
10. If my pharmacy receives a transfer prescription, does the transferred prescription need to be tamperresistant?
Your pharmacy only needs to obtain a phone call or fax from the other pharmacy to confirm the authenticity of the tamperresistant prescription that was previously delivered to the other pharmacy. You do not need to obtain confirmation of the original prescription from the prescriber. If the fax comes across with Void/Illegal/Copy wording across the prescription, see Question #11 below on how to handle.
Medicaid Tamper-Resistant Prescription Requirements FAQs for Pharmacists.
This information was compiled by American College of Physicians, American Pharmacists Association, Centers for Medicare & Medicaid Services (CMS), Computer Sciences Corporation, JenKare, LLC; HP Labs; Medical Group Management Association, MedStar Health, National Association of Chain Drug Stores, National Community Pharmacists Association, National Council for Prescription Drug Programs, North Carolina Division of Medical Assistance, Promex Group – Medi Scripts Services, Standard Register, and Wyoming Department of Health.
This document is provided as a courtesy for informational purposes. It is based on our review of the law and CMS guidance. If you have any questions about your responsibilities, we urge you to contact your state Medicaid agency for clarification and guidance.
11. What do I do if I receive a faxed Medicaid prescription that has Void/Illegal/Copy wording across the prescription?
Prescriptions written on tamper-resistant paper that has the word Void/Illegal/Copy as a background pantograph security feature used to prevent photocopying, may also display Void/Illegal/Copy when faxed. Because it says Void/Illegal/Copy you will need to call the prescriber to verify the prescription and thus reclassify the prescription as a prescription received via telephone. The Drug Enforcement Agency (DEA) and several state Boards of Pharmacy do not recognize prescriptions with the Void/Illegal/Copy wording. Contact your state Board of Pharmacy if you need additional information. You should also educate the prescriber that this particular tamper-resistant paper should not be used to fax prescriptions because of the pantograph – the prescriber should either: write the prescription on plain paper and fax using a cover sheet; call the pharmacy with the prescription; or send an electronic prescription.
12. Sometimes my patients become Medicaid eligible retroactively. If not originally tamper-resistant, will their original prescriptions need to be updated to become tamper-resistant?
Once you are aware of a patient’s retroactive eligibility for Medicaid, all prescriptions, including refills, dispensed on or after that date will need to be compliant with the tamper-resistant requirements. This can be accomplished by verifying with the prescriber the prescription is tamper-resistant, obtaining a new written prescription that is fully compliant with the tamperresistant
requirement, or by obtaining a fax, telephone or electronic prescription.
13. What can I do if a Medicaid patient brings in a prescription that is not tamper-resistant?
Pharmacists can dispense emergency fills of non-controlled or controlled substances when appropriate, for example when the pharmacist is unable to reach the prescriber. The pharmacy must obtain a compliant prescription in writing or by telephone, fax, or e-prescription within 72 hours. Since there is no mandate for prescribers to reply to compliance requests, the pharmacy will be at a financial risk for the amount of the emergency fill. In most states, complaint prescriptions are required within 72 hours of an emergency fill but check with your state if you are unsure of its emergency fill requirement. CMS’ clarification can be found in the Frequently Asked Questions on the Tamper-Resistant Law document on its Web site at:
http://www.cms.hhs.gov/DeficitReductionAct/Downloads/MIPTRPFAQs9122007.pdf.
14. How can I determine if a prescription is compliant with tamper-resistant requirements for my state?
Contact your state Medicaid agency to determine the specific requirements for your state. The National Association of State Medicaid Directors also has state-specific materials available on its Web site at: www.nasmd.org/issues/TRPP.asp. Guidance documents to help pharmacists identify tamper-resistant features and determine if they are compliant were developed by national pharmacy organizations and the National Council for Prescription Drug Programs (NCPDP). In addition, it has been strongly recommended that states require vendors to list the security features on the prescription. This feature will also help pharmacists identify tamper-resistant prescriptions. These documents are available on the NCPDP Web site at: www.ncpdp.org/pdf/Tamper_resistant_07-18-08.zip. Click on Identifying Tamper-Resistant Prescription Pad Features (see attachment) and Best Practices for Medicaid Tamper-Resistant Prescriptions.
15. What can a pharmacist do when a prescriber is routinely issuing non-compliant prescriptions for Medicaid recipients?
After first notifying the prescriber, contact your State Medicaid office for additional direction. Some states request that you report prescribers who fail to comply with the tamper-resistant requirements on a routine basis.
16. Could my pharmacy be audited by State Medicaid for compliant prescriptions?
Yes. This requirement will be one of the auditable categories that could be documented during a State Medicaid audit. The pharmacist is accountable for ensuring that the Medicaid prescription is compliant with the tamper-resistant requirements.
17. What are the audit penalties for non-compliance?
Non-compliance with the new Federal tamper-resistant requirements may result, at a minimum, in the recoupment of the Medicaid reimbursement for the non-compliant prescription.
18. Does the Federal requirement change state requirements regarding record keeping?
No.
19. What if my state already has pre-existing requirements?
The Centers for Medicare & Medicaid Services (CMS) has recognized certain states with existing requirements (California, Florida, Indiana, Kentucky, Maine, Massachusetts, New Jersey, New York, Texas, and Wyoming) and, with one exception, has deemed them to already meet the new Federal requirements. CMS has noted that the existing Idaho requirements comply with the April 1, 2008 deadline only.
20. Where can I view samples of tamper-resistant prescriptions?
Samples of tamper-resistant prescription features are available on the NCPDP Web site at: www.ncpdp.org/pdf/Final_ltr_to_medicaid_directors.pdf. Click on Identifying Tamper-Resistant Prescription Pad Features (see attachment) and Best Practices for Tamper-Resistant Prescriptions.
21. Where can I go to find out more information?
For more information about the tamper-resistant requirements, contact your state Medicaid agency, visit CMS’ Web site at www.cms.hhs.gov/DeficitReductionAct/30_GovtInfo.asp (click on Medicaid Tamper-Resistant Prescription Information, Top Questions about Tamper-Resistant Prescriptions (FAQs), and Medicaid Prescription Resistant Prescription Pad Law - Pharmacist Fact Sheet), or contact your national, state or local pharmacy association. The National Association of State Medicaid Directors also has state specific materials available on its Web site at www.nasmd.org/issues/TRPP.asp.
TRPP Prescriber Education Letter Template (word doc)
TRPP Patient Education (word doc)
Alabama Medicaid Agency Tamper Resistant Update
As the October 1, 2008 Tamper Resistant Prescription deadline is quickly approaching, the Alabama Medicaid Agency wants to provide you with the information you need to ensure Medicaid patients will be able to receive their needed medications and ensure that the transition to these new federally-mandated prescription requirements is as smooth as possible for recipients, pharmacists, physicians, and other prescribers. Please see the below important updated information related to the Medicaid Tamper Resistant requirements. The new law requires all written prescriptions for covered outpatient drugs that are paid for by Medicaid must be executed on a tamper-resistant prescription. The law applies only to written prescriptions for covered outpatient drugs; prescriptions that are transmitted from the prescriber to the pharmacy verbally, by fax, or through an e-prescription are not impacted by the statute. The law applies whenever Medicaid pays any portion of the cost of a prescription. As of April 1, 2008, to be considered tamper resistant, a prescription must contain at least one feature of the following three characteristics:
1. one or more industry-recognized features designed to prevent unauthorized copying of a completed or blank prescription form;
2. one or more industry-recognized features designed to prevent the erasure or modification of information written on the prescription pad by the prescriber;
3. one or more industry recognized features designed to prevent the use of counterfeit prescription forms.
By October 1, 2008, a prescription pad must contain all three of the above characteristics to be considered tamper-resistant. Prior guidance from CMS for printed prescriptions generated from Electronic Medical Records or ePrescribing applications stated that special copy resistant paper would likely be required for printed prescriptions to be in compliance as of October 1, 2008. CMS has clarified this statement, and is now stating the below:
While special paper may be used to achieve copy resistance, it is not necessary. Electronic medical record (EMR) or ePrescribing generated prescriptions may be printed on plain paper and be fully compliant with all three categories of the tamper-resistant regulations presuming they contain at least one feature from each of the three categories. When feasible, any other industry recognized feature that is designed to prevent unauthorized copying of a completed or blank prescription form may also be utilized on a plain paper computer generated prescription. Since issuing its last guidance on this issue, CMS has determined that at least two such features utilized to prevent passing a copied prescription as an original can also be incorporated into plain paper computer generated prescriptions. The first of these is microprinting, which is the use of very small font that is readable when viewed at 5x magnification or greater, and illegible when copied. The second feature is a “void” pantograph accompanied by a reverse “Rx”, which causes a word such as “Void,” “Illegal,” or “Copy” to appear when the prescription is photocopied. Except where state law mandates the word “Void” or “Illegal”, it is recommended that the pantograph show the word “Copy” if the prescription is copied.
Source: FAQ on CMS website http://www.cms.hhs.gov/DeficitReductionAct/Downloads/MIPTRPFAQs9122007.pdf
In order to ensure that patients do not see any adverse impact regarding their access to medications, it is critical for you to meet all three CMS requirements by the October 1 deadline. In an emergency situation, prescriptions written on non-tamper resistant pads will be permitted as long as the prescriber provides a verbal, faxed, electronic, or compliant written prescription within 72 hours after the date on which the prescription was filled. In addition, Alabama Medicaid has developed a Provider Compliance Form (located on the Agency website at http://www.medicaid.alabama.gov/documents/program-RX/Provider_Compliance_Form-1-15-08.pdf ) that can be utilized to submit non-compliant prescribers to the Agency.
Thank you for your efforts to comply with these new federally mandated requirements. Please visit our tamper resistant website for updated information at http://www.medicaid.alabama.gov/programs/pharmacy_svcs/tamper-resistant_Rx_pads.aspx?tab=4.
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QI-1 Program Reinstatement to Benefit Medicare Beneficiaries
On July 29, Medicaid announced that they are reactivating the QI-1 program. Recipient calls should be directed to the call center at 1-800-362-1504. Questions related to Social Security checks and refunds from SSA should be sent to SSA at 1-800-772-1213. They also have a SSA local office locator on their website at https://s044a90.ssa.gov/apps6z/FOLO/fo001.jsp
Here are the key points:
• AL Medicaid terminated approximately 15,500 individuals who were on the QI-1 program June 30.
• Letters went out to qualifying recipients to notify them when they will be reinstated.
• About 11,250 recipients will go back on (effective July 1) because that is all that we received money for. They will receive refunds of any money deducted from their Social Security checks.
• The others will go back on October 1. They will be responsible for paying the premium for 3 months (July, August, September)
• Those individuals awarded on or before March 23, 2007, will be reactivated.
• Federal law requires that states select qualifying individuals on a first come, first serve basis.
• No new application will be necessary for these individuals.
• Medicaid will not accept any new applications until they have written confirmation from CMS that Medicaid will receive funding needed.
Read the Medicaid Press Release( Word doc)
QI-1 Q&A (Word doc)
Special Bulletin from BCBS
Compound Drugs, Effective June 1, 2008
Locally assigned National Drug Codes (NDC) for compound ingredients will no longer be covered. Only compounds unavailable as legend or over-the-counter will be considered for payment. All compound medications must be considered medically necessary and are subject to review.
Unless otherwise prescribed by the physician, compounds should be dispensed for a 30-day supply. All compounds are subject to review.
PEEHIP Law Reminder
Ala.Code 1975 § 16-25A-18
Code of Alabama Currentness
Title 16. Education. (Refs & Annos)
Chapter 25A. Public Education Employees’ Health Insurance. (Refs & Annos)
Article 1. . General Provisions. (Refs & Annos)
§ 16-25A-18. Generic equivalent medications.
As a condition of participation in the Public Education Employees’ Health Insurance Programs (PEEHIP), a pharmacist shall dispense a generic equivalent medication to fill a prescription for a patient covered by PEEHIP when one is available unless the physician indicates in longhand writing on the prescription “medically necessary” or “dispense as written” or “do not substitute.” The generic equivalent drug product dispensed shall be pharmaceutically and therapeutically equivalent and contain the same active ingredient, or ingredients and shall be of the same dosage, form, and strength.
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Check Status of On-line PDP Enrollments
CMS has established a new tool for checking the status of on-line PDP enrollments using the on-line enrollment center (OEC) confirmation number received at the time of enrollment. You can check what plan a beneficiary is enrolled in, when the enrollment was completed and whether the plan has yet downloaded the enrollment for processing.
The url is as follows: https://enrollmentcenter.medicare.gov/AdministrativeConsole/PlanFinder/login.aspx
Login ID: CMS_Readonly
Password: Admin_Read
Enter confirmation number:
Application: Type in the url to get to the on-line enrollment center (OEC) Administrative Console Login Page and then log in using the login ID and password above. Enter confirmation code.
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Emergency Preparedness
Disaster System Notification in Alabama
The Alabama Department of Public Health (ADPH) is signing up as many pharmacists as possible to the emergency Alert system. This system notifies pharmacists immediately if some disaster is imminent that will affect pharmacists in the state. Information about such things as hurricanes, pandemic flu, that affect pharmacists will be sent to you. This is not a list serve and this does not obligate you to do anything. This is the official Public Health Emergency Alert network that will give pharmacists first hand information and put them in first alert status. If the situation arises, ADPH may send out a call for pharmacist volunteers to serve in mass shelters, field medical units etc. only if they are available and want to come and help. ADPH may also send out updates to the disaster as well as test notifications from time to time.
Again, this does not obligate you to do anything but be informed about the situation.
If you wish to be included email your name, address, e-mail, phone, work, home to Charlie Thomas at charliethomas@adph.state.al.us Please respond back and sign on when you get your notification.
Click here for emergency contact information for pharmacists.(word doc)
Flu Shot Promotion
If you are giving flu shots in your pharmacy this season, consider registering at www.findaflushot.com. Significant national promotional efforts to steer patients to this site are underway. It will be good advertising to let the public know you are offering vaccines. The clinic locations can also be accessed toll free at 877-962-9358.
Get 10
Read more about emergency preparedness and the essential items you need to help survive an emergency at the Get 10 web site provided by the Alabama Department of Public Health.
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JOIN THE VOICE OF PHARMACY IN ALABAMA!
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Food and Drug Administration New Label Requirements
FDA clarifies use of 1-800 number for reporting side effects
Pharmacies have until July 1, 2009 to add toll-free number to
medication labels.
Pharmacies must include a 1-800 number for reporting adverse events on the labeling of new and refill prescription and OTC products dispensed in an outpatient setting by the end of this year, according to an FDA interim final rule. The rule was designed to codify the proposed rule titled "Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products" (April 22, 2004) that, under the FDA Amendments Act of 2007 (FDAAA), became effective on January 1. The rule requires that drug products for which applications have been approved come with labeling containing a 1-800 number for reporting adverse events, but not for obtaining medical advice. As mandated by FDAAA, however, the interim final rule does not apply to OTCs if their product packaging already includes a toll-free number for reporting complaints to the manufacturer or distributor.
The required labeling is referred to as the "side effects statement."
Pharmacists and other authorized dispensers may distribute this statement in one of five ways:
* On a sticker attached to the unit package, vial, or container of the drug product
* On a preprinted pharmacy prescription vial cap
* On a separate sheet of paper
* In consumer medication information
* In the appropriate FDA-approved Medication Guide that contains the side effects statement
Although this provision will not be implemented until July 1, 2009, FDA will still publish a final rule to this interim rule based on its ongoing research and comments received on the proposed rule. The effective date and implementation schedule for the final rule will be designed to minimize the burden of any additional regulatory changes for affected entities (such as pharmacies) that must comply with this interim final rule.
APhA will supply updated information on this topic as it becomes available. For complete background about the FDA interim final rule, please visit the Federal Register notice listed below. Web links
* Federal Register Docket No. 2003N-0342
http://a257.g.akamaitech.net/7/257/2422/01jan20081800/edocket.access.gp
o.gov/2008/pdf/E7-25426.pdf
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 201, 208, and 209
[Docket No. 2003N–0342]
RIN 0910–AC35
Toll-Free Number for Reporting
Adverse Events on Labeling for Human
Drug Products
AGENCY: Food and Drug Administration,
HHS.
ACTION: Interim final rule.
SUMMARY: The Food and Drug Administration (FDA) is issuing an interim final rule to codify the
provisions of the proposed rule entitled ‘‘Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products’’ (69 FR 21778, April 22, 2004) (the toll-free number proposed rule or proposed rule) that, under the
Food and Drug Administration Amendments Act of 2007 (FDAAA), became effective by operation of law on January 1, 2008. This interim final rule
requires the addition of a statement on the labeling of certain human drug products for which an application is approved under the Federal Food, Drug, and Cosmetic Act (the act). The added statement includes a toll-free number
and advises that the number is to be used only for reporting side effects and is not intended for medical advice (the side effects statement). As mandated by FDAAA, this interim final rule does not apply to over-the-counter drug products
approved as new drugs under the act if the product packaging includes a manufacturer’s or distributor’s toll-free number for reporting complaints.
DATES: Effective Date: This rule is effective January 1, 2008.
Compliance Date: The agency anticipates that affected entities, including manufacturers, authorized dispensers, and pharmacies, will need time to update labeling and systems to
comply with the new requirements.
Therefore, FDA intends to exercise its enforcement discretion and not take enforcement actions with regard to these regulations until January 1, 2009.
FOR FURTHER INFORMATION CONTACT:
Carol Drew, Center for Drug Evaluation
and Research (HFD–7), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–594–2041.
SUPPLEMENTARY INFORMATION:
I. Background
On September 27, 2007, the President signed into law FDAAA (Public Law 110–85). Among other things, FDAAA reauthorized the Best Pharmaceuticals for Children Act (BPCA). When enacted in 2001, the BPCA (Public Law 107– 109) directed FDA to issue a final rule requiring the labeling of each human drug product for which an application is approved under section 505 of the act (21 U.S.C. 355) to include: (1) A toll-free number maintained by FDA for the purpose of receiving reports of adverse events regarding drugs and (2) a statement that the number is to be used for reporting purposes only, not to receive medical advice. Collectively, we refer to the toll-free number and reporting statement as the ‘‘side effects statement.’’ The BPCA stated that the final rule must reach the broadest consumer audience and minimize the cost to the pharmacy profession. As required, FDA issued a proposed rule entitled ‘‘Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products’’ (69 FR 21778, April 22, 2004). FDA received 22 comments on this proposed rule and was in the process of analyzing the comments and conducting research on consumer comprehension of the side effects statement when FDAAA was enacted.
II. FDAAA Requirements Section 502(f) of FDAAA states that ‘‘the proposed rule * * * ‘Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products’ * * * shall take effect on January 1, 2008,’’ unless FDA issues a final rule before that date.
FDAAA mandates one change to the proposed rule. As described in section III of this document, section 502(f)(2) of FDAAA states that the toll-free number proposed rule shall not apply to over-the-counter (OTC) drugs marketed with an application approved under section 505 of the act (application OTC drug\ products) if these application OTC drug products meet certain labeling requirements. (Neither the BPCA, the proposed rule, nor this interim final rule addresses OTC drugs marketed without approved applications.)
Because the agency’s rulemaking process is ongoing, for the reasons explained in section IV of this document, this interim rule codifies the provisions of the proposed rule as modified by FDAAA. As mandated by FDAAA, these provisions came into effect on January 1, 2008. The agency is publishing this interim final rule to
codify the modified toll-free number proposed rule that has now come into effect.
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Anthrax Preparedness- Liability Issues for Pharmacists
Provisions exempt pharmacists and pharmacies from liability during an Anthrax response in their own pharmacy
On October 1, 2008, Secretary Leavitt issued a declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) that provides liability protection for activities related to developing, manufacturing, distributing, prescribing, dispensing, administering and using anthrax countermeasures in preparation for, and in response to, a potential anthrax attack. This includes entities, such as large “big-box” retail stores, retail pharmacies, and other private sector businesses, that help to deliver and distribute medicines. Providing liability protection to all involved in such efforts will help ensure their full participation and bolster response efforts. For further information on HHS’ emergency preparedness efforts related to anthrax as well as other emergencies in general, please visit http://www.hhs.gov/emergency.
Keep Asthma and COPD Patients Safe, Make Them Aware of the Changes Regarding Their Medication
On May 30, 2008, FDA issued a public health advisory alerting patients, caregivers, and healthcare professionals to important information about albuterol inhalers that are used to treat bronchospasm (wheezing) in patients with obstructive airways disease, such as asthma and chronic obstructive pulmonary disease (COPD). Albuterol inhalers that use CFCs (chlorofluorocarbons) are being phased out and will no longer be available after December 31, 2008. Patients who now use albuterol inhalers containing CFCs will need to transition to alternative albuterol inhalers which contain a propellant called hydrofluoralkane (HFA).
There are currently three approved HFA propelled albuterol inhalers:
• ProAir HFA Inhalation Aerosol
• Proventil HFA Inhalation Aerosol
• Ventolin HFA Inhalation Aerosol.
In addition, an HFA-propelled inhaler containing levalbuterol, an enantiomer of albuterol, is available as Xopenex HFA Inhalation Aerosol. Albuterol HFA inhalers are used in the same way as albuterol CFC inhalers and give the same dose of albuterol as the CFC inhalers.
Any of the three HFA-propelled products containing the active moiety albuterol (ProAir HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol, and Ventolin HFA Inhalation Aerosol) are adequate replacements for CFC-propelled products containing albuterol, but there are differences among these products that healthcare providers and pharmacists should be made aware. These three products are not generic products to CFC-propelled albuterol MDIs.
CFCs and HFAs are the propellants that move the albuterol medicine out of the inhaler so that patients can breathe the albuterol medicine into the lungs. CFCs are harmful to the environment and can have negative effects on health. The national transition from CFC propelled to hydrofluoralkane (HFA) propelled albuterol inhalers is due to an international environmental treaty. Under this treaty, the United States has agreed to phase out production and importation of Ozone Depleting Substances (ODS), including CFCs. Healthcare professionals have already started transitioning patients to the HFA-propelled albuterol inhalers.
Because Albuterol HFA inhalers have to be cleaned and primed to work in the right way and give the right dose of medicine, it is important to note the following:
• HFA inhalers may taste and feel different than the CFC inhalers. Notably, the force of the spray of an HFA-propelled inhaler may feel softer than that of a CFC-propelled inhaler.
• Patients should be reassured of the drug’s effectiveness, even though the spray may taste different or not feel as strong as that from a CFC inhaler.
• The actuator of an HFA inhaler must be cleaned under warm running water once a week; if it is not kept clean, it can become clogged and the albuterol will not be delivered to the lungs. Each HFA inhaler has different cleaning and drying instructions. Therefore, it is important to read and understand the instructions that come with each of the HFA inhalers before using.
• The HFA inhaler needs to be “primed” before initial use. Each HFA inhaler has different priming instructions. Therefore, it is important to read and understand the instructions that come with each of the HFA inhalers before using.
The labeling for Proventil-HFA Inhalation Aerosol, Ventolin-HFA Inhalation Aerosol, Pro Air-HFA Inhalation Aerosol, and Xopenex HFA Inhalation Aerosol may be found at:
DRUGS@FDA: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Additional information, including a Podcast, question and answer sheet, consumer article, and public service announcement can be found on FDA’s website at http://www.fda.gov/cder/mdi/albuterol.htm. The question and answer sheet and consumer article are available in both English and Spanish. To learn more about the transition and get answers to many frequently asked questions, you may also visit the Environmental Protection Agency (EPA) website at http://www.epa.gov/Ozone/title6/phaseout/mdi/.
If you have questions, please contact the Division of Drug Information’s toll free number 1-888-INFO-FDA (1-888-463-6332), or by email at druginfo@fda.hhs.gov.
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