PART I ELECTRONIC PRESCRIBING OF CONTROLLED SUBSTANCES (“NEW” REGS) (and its relation to current...

PART I

ELECTRONIC PRESCRIBING OF CONTROLLED SUBSTANCES (“NEW” REGS)

(and its relation to current regulations)

--------------------------------------------PART II

PHARMACY LAW UPDATE

Email: [email protected] :(978) 884-2140Fax: (978)418-8255

Laurence E. Sweeney, R.Ph., Esq.© 2013

When was the first court case to determine the validity of an electronic signature……….

3

In Howley v. Whipple, the New Hampshire Supreme Court determined that the traditional method of signing is not the only way to make a document binding in the absence of additional proof

This 1869 case dealt with the telegraph as the means for forming a signature in a contract

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“It makes no difference whether [the telegraph] operator writes the offer or the acceptance in the presence of his principal and by the principal’s express direction, with a steel pen an inch long attached to an ordinary penholder, or whether his pen be a copper wire a thousand miles long. In either case the thought is communicated to the paper by the use of the finger resting upon the pen. Nor does it make any difference that in one case common record ink is used, while in the other case a more subtle fluid, known as electricity, performs the same office.”

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ELECTRONIC PRESCRIBING OF CONTROLLED SUBSTANCES

(NEW REGS) (as of 2010)

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3 Federal Laws affect the practice of pharmacy with respect to controlled substances signatures (NOTE: State Law Must Also Allow) : 1. New federal regulations regarding electronically

prescribing CII-CV Rxs (21 CFR 1311) 2. Current federal regulations regarding

prescriptions (21 CFR 1300 et seq.) 3. The E-Sign law of 2000 (and State UETA laws) 4. State Laws also apply.

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Title 21 CFR, Part 1300-1399 As of April 1, 2011 PART 1300 - DEFINITIONS PART 1301- REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF

CONTROLLED SUBSTANCES PART 1302- LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES PART 1303 - QUOTAS PART 1304- RECORDS AND REPORTS OF REGISTRANTS PART 1305- ORDER FORMS PART 1306- PRESCRIPTIONS PART 1307- MISCELLANEOUS PART 1308- SCHEDULES OF CONTROLLED SUBSTANCES PART 1309- REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND

EXPORTERS OF LIST I CHEMICALS PART 1310- RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES PART 1311- DIGITAL CERTIFICATES PART 1312- IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES PART 1313- IMPORTATION AND EXPORTATION OF PRECURSORS AND ESSENTIAL

CHEMICALS PART 1314- RETAIL SALE OF SCHEDULED LISTED CHEMICAL PRODUCTS PART 1315- IMPORTATION AND PRODUCTION QUOTAS FOR EPHEDRINE,

PSEUDOEPHEDRINE, AND PHENYLPROPANOLAMINE PART 1316- ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES PART 1321-DEA MAILING ADDRESSES

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21 CFR 1311 et seq.Requirements for Electronic Orders and

Prescriptions∞

Published in Federal Register 05-31-2010∞

Effective 06-01-2010

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PART 1311 DIGITAL CERTIFICATES Subpart A General Section 1311.01 Scope Section 1311.02 Definitions Section 1311.05 Standards for technologies for electronic transmission of orders Section 1311.08 Incorporation by reference Subpart B Obtaining and Using Digital Certificates for Electronic Orders Section 1311.10 Eligibility to obtain a CSOS digital certificate Section 1311.15 Limitations on CSOS digital certificates Section 1311.20 Coordinators for CSOS digital certificate holders Section 1311.25 Requirements for obtaining a CSOS digital certificate Section 1311.30 Requirements for storing and using a private key for digitally signing orders Section 1311.35 Number of CSOS digital certificates needed Section 1311.40 Renewal of CSOS digital certificates Section

1311.45 Requirements for registrants that allow powers of attorney to obtain CSOS digital certificates under their DEA registration

Section 1311.50 Requirements for recipients of digitally signed orders Section 1311.55 Requirements for systems used to process digitally signed orders Section 1311.60 Recordkeeping

+ 11

Subpart C—Electronic Prescriptions §1311.100 General §1311.102 Practitioner responsibilities §1311.105 Requirements for obtaining an authentication credential--Individual

practitioners §1311.110 Requirements for obtaining an authentication credential--Individual

practitioners eligible to use an electronic prescription application of an institutional practitioner

§1311.115 Additional requirements for two-factor authentication §1311.116 Additional requirements for biometrics §1311.120 Electronic prescription application requirements §1311.125 Requirements for establishing logical access control--Individual practitioner §1311.130 Requirements for establishing logical access control--Institutional

practitioner §1311.135 Requirements for creating a controlled substance prescription §1311.140 Requirements for signing a controlled substance prescription §1311.145 Digitally signing the prescription with the individual practitioner's private

key§1311.150 Additional requirements for internal application audits

§1311.170 Transmission requirements §1311.200 Pharmacy responsibilities §1311.205 Pharmacy application requirements §1311.210 Archiving the initial record §1311.215 Internal audit trail §1311.300 Application provider requirements--Third-party audits or certifications §1311.302 Additional application provider requirements §1311.305 Recordkeeping 12

Background: DEA has previously never allowed electronic signatures on prescriptions for controlled substances.

Originally 3 Methods: Oral, written, faxed. Faxed prescriptions: Have been are still are

allowed, but it must be “a facsimile of a signed paper prescription transmitted by the practitioner or the practitioner's agent to the pharmacy.” 21 CFR 1306.21

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The DEA considers faxed prescriptions PAPER prescriptions and, therefore, they MUST be MANUALLY signed.

“A faxed prescription is a paper prescription and, therefore, must be manually signed by the prescribing practitioner

registered with DEA to prescribe controlled substances.” 75 FR 16264 March 31, 2010 (interim final rule on elec. Rxs) A signature created by a stylus on an electronic

device is digital and is NOT a manual signature!!! Manual Signature = PEN TO THE PAPER!

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21 CFR 1311 (The New Regs) NOW Electronic OK – BUT must be in compliance with new regs.

WRITE --- RECEIVE --- ARCHIVE Providers can write for controlled substances

electronically, including schedule II substances. Pharmacies can receive electronic prescriptions

for controlled substances in schedule II-V. Pharmacies must archive the records

electronically (if electronic rx it must be maintained electronically) (nothing prevents paper record but it MUST be maintained electronically)

15

Specific software and other requirements and procedures must be met for valid transmittal of electronic controlled substance prescriptions .

The new electronic prescribing regs do NOT mean electronic signatures FAXED to a pharmacy are valid.

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NO (but, c.f., NY) Physicians have the option of writing

electronically for controls. Pharmacies have the option of accepting

electronically prescribed controls. The DEA considers the use of electronically

prescribed controls as strictly voluntary Prescribers may still write for controls as

before, or fax or call in C III, IV and V Rxs.17

YES. “Nothing in this chapter shall be construed as authorizing or permitting any person to do any act which such person is not authorized or permitted to do under other Federal laws or obligations under international treaties, conventions or protocols, or under the law of the State in which he/she desires to do such act nor shall compliance with such parts be construed as compliance with other Federal or State laws unless expressly provided in such

other laws.” 21 CFR 1307.02 [i.e., no preemption] This is why some states do not allow oral CIII, IV and V Rxs

even though the DEA does. Generally, the more restrictive law applies. If state law is

more restrictive, must follow state law (unless preempted – e.g., See E-Sign Law)

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NOW.

However, both the prescriber’s computer system AND the pharmacy’s computer system must be compliant with the stringent requirements in the interim final rule.

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The application provider must either hire a qualified third party to audit the application or have the application reviewed and certified by an approved certification body.

The auditor or certification body will issue a report that states whether the application complies with the DEA’s requirements and whether there are any limitations on its use for controlled substance prescriptions.

The application provider must provide a copy of the report to the practitioners or pharmacies to allow them to determine whether the application is compliant.

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YES, BUT A practitioner may use an existing electronic prescription or Electronic

Health Record (EHR) application that doesn’t yet comply with the interim final rule to prepare and print a controlled substance prescription so that the other electronic prescribing functionality may be used, but until the application is compliant, the practitioner will have to print the prescription for manual signature. Such a prescription is a paper prescription and subject to existing rules. It may then be handed to the patient or faxed to the pharmacy.

A pharmacy cannot process electronic prescriptions until the application is compliant, but it may use the application to store data from printed, manually signed prescriptions or oral prescriptions entered or scanned into the computer as they currently do, and the paper records from controlled substances must be retained

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BEFORE the application is used to sign or transmit electronic prescriptions (practitioners)

BEFORE the application is used to process controlled substance prescriptions (pharmacies)

AFTER the applications are being use by practitioners or pharmacies WHENEVER a FUNCTIONALITY as it relates to controlled substances is ALTERED, or EVERY TWO(2) YEARS, whichever occurs first

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Third-Party Audits and Certifications apply to the application provider, NOT to the individual practitioner, institutional practitioner or the pharmacy

UNLESS, the application is proprietary (i.e., developed by the individual practitioner, institutional practitioner or pharmacy)

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NEED 2 OUT OF THE 3: 1. Something you know (e.g., a password) 2. Something you have (a hard token – e.g., a

smart card or USB device) – must be stored or kept separate from the computer being accessed with only prescriber control

3. Something you are (a biometric – e.g., a fingerprint, iris scan)

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PRACTITIONER: sole possession of hard token or password! Notification in 1 business day if lost or stolen!

If not compliant, can lose DEA registration 2 PEOPLE assigned to issuance and control of

application and one must be a DEA registrant Requirements for obtaining an authentication

credentials complex - Section 1311.105. The credential service provider or certification

authority must issue the authentication credential using two channels ( e.g., e-mail, mail, or telephone call).

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The practitioner will use the two-factor credential to sign the prescription; that is, using the two-factor credential will constitute the legal signature of the DEA-registered prescribing practitioner.

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NO A practitioner is not permitted to issue prescriptions for

multiple patients with a single signature. May sign multiple prescriptions for a single patient at

one time as long as he/she indicates each rx is ready to be signed

Each controlled substance prescription will have to be indicated as ready for signing, but a single execution of the two-factor authentication protocol can then sign all prescriptions for a given patient that the practitioner has indicated as being ready to be signed.

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NO. Signing and transmitting an electronic controlled

substance prescription are two distinct actions. Electronic prescriptions for controlled substances

should be transmitted as soon as possible after signing, however, it is understood that practitioners may prefer to sign prescriptions before office staff add pharmacy or insurance information, therefore, DEA is not requiring that transmission of the prescription occur simultaneously with signing the prescription.

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YES. Electronic prescription application may print copies of

the transmitted prescription(s) if they are clearly labeled: “Copy only – not valid for dispensing.”

List of prescriptions transmitted may be printed for patients if the list indicates that it is for informational purposes only and not for dispensing.

**The copies must be printed after transmission. If an electronic prescription is printed prior to attempted transmission, the electronic prescription application must not allow it to be transmitted. **

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IF TRANSMISSION FAILS, MAY INTERMEDIARY CONVERT TO A DIFFERENT

FORMAT (I.E., CHANGE IT TO A FAXED PRESCRIPTION)?

NO.

Electronic prescription must be transmitted from the practitioner to the pharmacy in its electronic form. If an intermediary cannot complete a transmission of a controlled substance prescription, the intermediary must notify the practitioner.

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Under such circumstances, if the prescription is for a schedule III, IV, or V controlled substance, the practitioner can print the prescription, manually sign it, and fax the prescription directly to the pharmacy. **This prescription must indicate that it was originally transmitted to a specific pharmacy (and name the pharmacy), the date and time of transmission, and the fact that the electronic transmission failed.** [see pharmacy responsibility below if they receive such a faxed prescription]

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The DEA-required contents of a prescription shall not be altered during transmission between the practitioner and pharmacy.

However, this requirement only applies to the content (not the electronic format used to transmit the prescription).

This requirement applies to actions by intermediaries. It does not apply to changes that occur after receipt at

the pharmacy. Changes made by the pharmacy are governed by the same laws and regulations that apply to paper prescriptions. [see below, pharmacy annotations and

alterations]

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• What must a pharmacy application do? (21 CFR 1311.205)• Accurately and consistently:

• Import• Display • Storeall the required contents of a controlled substance prescription, indication of signing, digital signature, and number of refills

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The pharmacy must determine which employees are authorized to enter information regarding the dispensing of controlled substance prescriptions and annotate or alter records of these prescriptions (to the extent such alterations are permitted under this chapter). The pharmacy must ensure that logical access controls in the pharmacy application are set so that only such employees are granted access to perform these functions

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When a pharmacist receives a paper or oral prescription that indicates that it was originally transmitted electronically to the same pharmacy, the pharmacist must check its records to ensure that the electronic version was not received and the prescription dispensed. If both prescriptions were received, the pharmacist must mark one as void.

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When a pharmacist receives a paper or oral prescription that indicates that it was originally transmitted electronically to another pharmacy, the pharmacist must check with that pharmacy to determine whether the prescription was received and dispensed. If the pharmacy that received the original electronic prescription had not dispensed the prescription, that pharmacy must mark the electronic version as void or canceled. If the pharmacy that received the original electronic prescription dispensed the prescription, the pharmacy with the paper version must not dispense the paper prescription and must mark the prescription as void.

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What changes can be made by the pharmacy AFTER receipt of an electronic prescription?

Changes made by pharmacies are subject to the same rules that apply to all prescriptions for controlled substances. 75 FR 16281, No. 61

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CHANGES TO CII vs. CHANGES to CIII,IV, & V

Same rule applies to electronic rxs and paper rxs for changes to the prescription. Prohibition to changes of content of electronic rx applies only to intermediaries.

But what changes can be made?

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CII Changes: Previous DEA policy allowed changes to

CII prescriptions the same as a CIII-V (see below for such changes that may be made)

On November 19, 2007, DEA issue rule on Issuance of Multiple Prescriptions for Schedule II Controlled Substances.

PRAMBLE to that rule created problem…..

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…Preamble to Multiple CII Rxs regulation stated that: "the essential elements of the [schedule II] prescription written by the practitioner (such as the name of the controlled substance, strength, dosage form, and quantity prescribed)…may not be modified orally.“

This contradicted previous policy of allowing changes to a CII prescription.

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DEA recognized resulting confusion and plans on resolving in future with additional rule….. Until then…

DEA states: Until that time, pharmacists are instructed to adhere to state regulations or policy regarding those changes that a pharmacist may make to a schedule II prescription after oral consultation with the prescriber.

What if state law is silent?????? 41

Changes to a CII made by the pharmacy AFTER receipt of an electronic prescription are governed by the same laws and regulations regarding paper prescriptions.

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MASSACHUSETTS – CII changes MAY CHANGE OR ADD after consultation with

prescriber: Date Written Directions for use Prescribers address Dosage form Drug strength Quantity prescribed ***Patient Address***Can ADD patient address if not

on Rx without consultation; can CHANGE patient address with consultation with prescriber OR agent!

***DEA#*** DEA number may be added to Rx without consultation with prescriber or agent.

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True Statement: A pharmacist can add the patient’s address on a controlled substance prescription if missing and legitimately dispense that prescription (assuming all other requirements of a valid prescription are met)

Question: If a prescriber issues a prescription to a patient without the patient’s address on the prescription, that prescriber has issued a prescription in violation of the federal law and action against that prescriber can be taken by the DEA.

TRUE or FALSE????

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Answer:

TRUE.Really???

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Registrant Actions - 2012 [Federal Register Volume 77, Number 148 (Wednesday, August 1,

2012)] [Notices] [Pages 45675-45688] From the Federal Register Online via the Government Printing Office [www.gpo.gov] [FR Doc No: 2012-18749]

DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 11-57] Margy Temponeras, M.D.; Decision and Order On December 15, 2011, Administrative Law Judge (ALJ) Timothy

D. Wing issued the attached recommended decision. Neither party filed exceptions to the decision.

Having considered the entire record, I have decided to adopt the ALJ's recommended rulings, factual findings, and his legal conclusions, except as discussed below.\1\ I further hold that the record establishes that Respondent engaged in acts which are sufficiently egregious to warrant the revocation of her registration and that she has not rebutted this conclusion.\2\

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“Among the allegations raised by the Government were: (1) That Respondent had failed to include required information on various prescriptions (such as a patient's address) in violation of 21 CFR 1306.05”

“That Respondent frequently issued prescriptions for controlled substances that did not contain all of the information required by 21 CFR 1306.05(a) \3\”(FOOTNOTE 3)

\FOOTNOTE3\ The section requires in relevant part that "[a]ll prescriptions for controlled substances shall * * * bear the full name and address of the patient * * * [and] directions for use * * *."

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Accordingly, I find by a preponderance of the evidence that Respondent issued approximately eleven prescriptions between August and November 2006 for controlled substances without providing a patient address, in violation of applicable federal regulations.

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What does this all mean????? Physicians are required to put patient’s address

on the rx. Failure to do so increases risk of diversion

because adding address at pharmacy does not confirm what practitioner has on file as address… could be different, possible diversion issue.

Example of not doing what you’re supposed to do can come back to bite you even if it’s not something normally enforced (i.e., accepting electronic signatures on faxed rxs for controls (e.g., Robitussin w/ Codeine, Vicodin, Valium, etc.) Those are NOT valid if faxed Rx has electronic signature.

LAW UPDATES

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THE “LEARNED INTERMEDIARY DOCTRINE”

Traditionally, the learned-intermediary doctrine has been used to insulate drug manufacturers from liability in products-liability lawsuits. The physician becomes the intermediary between the drug manufacturer and the patient.

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Under the learned-intermediary doctrine, a drug manufacturer is immune from liability to a patient for “failure to warn” so long as the manufacturer has provided the patient's doctor with all relevant safety information for that drug.

It is then up to the patient's doctor—who has the benefit of knowing the patient's specific situation—to convey to the patient any information that the doctor deems relevant. That is, the doctor is in the “best position” to warn the patient. Thus, he is the “learned intermediary” best suited to provide a warning.

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EXCEPTIONS: Exemptions began to emerge beginning

with birth control pills where the doctor takes almost a passive role, prescribing the BC to patients at their request. Drug manufacturers thus were required to provide additional warnings to the patient by patient package inserts

Also, with newer “direct-to-consumer” advertising in TV, magazines, radio, greater warnings DIRECT to consumers is required

But the general rule still applies.54

Jurisdictions adopting the learned-intermediary doctrine in the context of pharmacist/customer tort litigation have put forth a similar rationale: that between the doctor and the pharmacist, the doctor is in the best position to warn the customer of a given medication's generalized risks

Or, viewed more pragmatically, the doctrine prevents pharmacists from constantly second-guessing a prescribing doctor's judgment simply in order to avoid his or her own liability to the customer.

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CASES THAT CHIP AWAY AT THE DEFENSE

A TROUBLESOME CASE!

Klasch v. Walgreen Co., Supreme court of the State of Nevada, 54805, Nov. 23, 2011.

This case raises concern for the continued viability of the learned intermediary defense and, indeed, for the extent of liability imposed even when a pharmacist takes reasonable steps to avoid injury.

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Klasch v. Walgreen, Co. (cont’d) Background: Helen Klasch visited Fredrick

Tanenggee, M.D., for the first time in December, 2005. On her paperwork she indicated that she might have a sulfa allergy.

After discussion, it was recorded in her medical file under allergies as “Sulfa?”

In July, 2006, Klasch returned to Dr. Tanenggee complaining of “abdominal fullness.”

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Klasch v. Walgreen, Co. (cont’d) Klasch was diagnosed with a urinary tract

infection. Dr. Tanenggee told Klasch that under normal circumstances, her infection could be treated most effectively with Bactrim.

Given the notation in her chart, however, Dr. Tanenggee asked Klasch to clarify how certain she was of her sulfa allergy. After some further discussion, Klasch downplayed the previous notation and asked Dr. Tanenggee to write her a prescription for Bactrim.

Dr. Tanenggee complied, and Klasch dropped off the prescription at Walgreens Pharmacy on her way home from Dr. Tanenggee's office.

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Klasch v. Walgreen, Co. (cont’d) Later that day, Klasch’s caretaker

returned to the pharmacy to pick up the prescription, and a pharmacy employee told the caretaker the prescription was not ready because it had been “flagged” because of the possible sulfa allergy.

The caretaker asked the pharmacy to call Klasch directly to discuss the issue. The employee called Klasch.

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Klasch v. Walgreen, Co. (cont’d) Klasch reportedly indicated that she had

taken Bactrim in the past and that she had not experienced any adverse reaction to it.

Based on this information and clarification provided by the patient, the pharmacist overrode the “flag” and filled the prescription and released it to the caretaker.

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Klasch v. Walgreen, Co. (cont’d) Later that day, after taking the medication,

Klasch complained that she felt "itchy." The following day, Klasch called Dr. Tanenggee's office and left a voice mail in which she stated that she was wrong about not having a sulfa allergy.

Klasch's condition continued to worsen, and she was taken to the emergency room. After being diagnosed with SJS/TEN, Klasch was transferred to a burn center, where she eventually lapsed into a coma and passed away.

At the time Klasch was removed from life support, she had burns covering 40 to 50 percent of her body.

61

Klasch v. Walgreen, Co. (cont’d) Klasch's two children brought a wrongful-

death action against Walgreens, alleging that its pharmacist breached the duty of care owed to their mother. Specifically, the Klasches contended that Walgreens' pharmacist breached her duty of care by failing to adequately warn Klasch of the prescribed medication's risks in light of her allergy to it or, alternatively, by failing to call Dr. Tanenggee to clarify whether he really meant to prescribe a medication to which she was allergic.

62

Klasch v. Walgreen, Co. (cont’d) At the trial level, Walgreen’s filed a

motion for summary judgment, using the “learned intermediary” defense, claiming that it had no duty to warn.

The trial court, following what it perceived to be the “majority rule” allowed Walgreen’s motion and dismissed the case.

Klasch’s estate appealed.63

Klasch v. Walgreen, Co. (cont’d) On appeal, the appellate court for the first

time in that state “adopt[ed] the learned-intermediary doctrine in the context of pharmacist/customer tort litigation and [held] that pharmacists have no duty to warn of a prescribed medication's generalized risks.”

BUT, the court went on to address whether the doctrine applies when there is a “known customer-specific risk.”

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Klasch v. Walgreen, Co. (cont’d) Despite the fact that there was a

discussion between the pharmacy and the patient about the possible allergy, and despite the fact that the patient said she had taken the drug with no problems before, and despite the fact that the doctor had the same information as the pharmacy and prescribed the drug, the court still denied the learned intermediary doctrine defense in this case!

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Klasch v. Walgreen, Co. (cont’d) In denying the learned-intermediary defense

to Walgreens, the court stated it rational. The Klasch court adopted the reasoning of

Happel v. Wal-Mart Stores, Inc., 199 Ill.2d 179, 262 Ill.Dec. 815, 766 N.E.2d 1118 (2002) (an Illinois case).

Happel involved a specific known risk to a patient – an allergy to aspirin and prescribed toradol.

66

Klasch v. Walgreen, Co. (cont’d) The Klasch court reasoned:▪ “We find the analysis of the Happel court

persuasive. Consistent with the Supreme Court of Illinois and what we perceive to be the modern trend of case law, we hold that the learned-intermediary doctrine does not insulate a pharmacist from liability when he or she has knowledge of a customer-specific risk. Instead, when a pharmacist has such knowledge, the pharmacist has a duty to warn the customer or to notify the prescribing doctor of the customer-specific risk.”

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Klasch v. Walgreen, Co. (cont’d)

THE COURT’S HOLDING: “By insulating pharmacists from liability for failing to warn

their customers of a medication's generalized risks, the learned-intermediary doctrine prevents pharmacists from interfering with the doctor-patient relationship. Because the public-policy considerations behind this doctrine are sound, we adopt it in the context of pharmacist/customer tort litigation. These public-policy considerations are less persuasive, however, when a pharmacist has knowledge of a customer-specific risk with respect to a prescribed medication. Accordingly, in such circumstances, the learned-intermediary doctrine does not insulate a pharmacist from liability, and the pharmacist instead has a duty to exercise reasonable care in warning the customer or notifying the prescribing doctor of this risk.” (Emphasis added).

68

Klasch v. Walgreen, Co. (cont’d) The Klasch court holding itself makes sense, that

if a pharmacist knows of a specific risk to a specific patient (such as a drug interaction or drug allergy) he should warn the patient or doctor, BUT, in the Klasch case the pharmacist took reasonable steps to ascertain whether or not there even was a risk, and relied on the patient’s information provided BY the patient :That she wasn’t allergic, that she had had it before! She even got the doctor to prescribe it knowing of the initial statement that she might have been allergic. WHAT’S A PHARMACIST TO DO?

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Who is really to blame????

Owner? Staff Pharmacists with knowledge?

Technicians? State inspectors?

State Board? FDA?

CONGRESS? THE UNITED STATES SUPREME

COURT?

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The Federal Food and Drug Administration Modernization Act of

1997

1997 FDAMA did many things: Expediting study/approval of “fast track” drugs Addressed the pediatric study of drugs Eliminated “batch certification” of insulin and

antibiotic products Lifted some restriction on “off-label” use of

meds

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The Federal Food and Drug Administration Modernization Act

of 1997

THE FDAMA ALSO ADDED TO THE FOOD, DRUG AND COSMETIC ACT OF 1938 THE FOLLOWING SECTION:

SECTION 503A – PHARMACY COMPOUNDING

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FDA issued Compliance Policy Guide (CPG) on compounding in 1992. Pharmacy industry disturbed by how the FDA would exercise its enforcement discretion, so looked to congress

Congress enacted 503A to ensure the availability of pharmacy compounding for individuals based on the traditional physician-patient-pharmacist relationship, WITH some restrictions…………….

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503A exempted compounding pharmacies from the adulteration, misbranding and new drug application sections of the FDCA if: Unsolicited Prescription from physician for

specific patient Small scale (i.e., not manufacturing scale) Limited interstate sale Follow certain FDA & USP compounding

regs/guides

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“such drug product is compounded in a State-- (i) that has entered into a memorandum of understanding

with the Secretary which addresses the distribution of inordinate amounts of compounded drug products interstate and provides for appropriate investigation by a State agency of complaints relating to compounded drug products distributed outside such State; or

(ii) that has not entered into the memorandum of understanding described in clause (i) and the licensed pharmacist, licensed pharmacy, or licensed physician distributes (or causes to be distributed) compounded drug products out of the State in which they are compounded in quantities that do not exceed 5 percent of the total prescription orders dispensed or distributed by such pharmacy or physician.”

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SECTION 503A – PHARMACY

COMPOUNDING LAWStruck Down by Supreme

Court in 2002(why?)

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SECTION 503A – PHARMACY COMPOUNDING LAW

Struck Down by Supreme Court in 2002

WHY: First Amendment – Free Speech“(c) Advertising and Promotion.--A drug may be compounded

under subsection (a) only if the pharmacy, licensed pharmacist, or licensed physician does not advertise or promote the compounding of any particular drug, class of drug, or type of drug. The pharmacy, licensed pharmacist, or licensed physician may advertise and promote the compounding service provided by the licensed pharmacist or licensed physician.”

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Struck Down by Supreme Court in 2002 November 1998, solicitation and advertising provisions of

section 503A challenged by seven compounding pharmacies as an impermissible regulation of commercial speech.

The U.S. District Court for the District of Nevada ruled in the plaintiffs’ favor. FDA appealed to the U.S. Court of Appeals for the Ninth Circuit. On February 6, 2001, the Court of Appeals declared section 503A to be invalid in its entirety (Western States Medical Center v. Shalala, 238 F.3rd 1090 (9th Cir. 2001)). The government petitioned for a writ of certiorari to the U.S. Supreme Court for review of the Ninth Circuit’s decision that the solicitation and advertising provisions of section 503A were unconstitutional restrictions on commercial speech. The Supreme Court granted the writ and issued its decision in the case on April 29, 2002.

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The Supreme Court affirmed the Ninth Circuit’s decision that section 503A of the FD&C Act was invalid in its entirety because it contained unconstitutional restrictions on commercial speech (i.e., prohibitions on soliciting prescriptions for and advertising specific compounded drugs). The Court did not rule on, and therefore left in place, the Ninth Circuit’s holding that the unconstitutional restrictions on commercial speech could not be severed from the rest of section 503A. Accordingly, all of section 503A is invalid. (c.f. 5th circuit (district court case in TX) severable, new-drug issue)

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503A struck down in 2002, and complaints about NECC to the FDA began in 2002.

Feb. 2003 FDA & MA state officials met: FDA staff emphasized "the potential for serious public consequences if NECC's compounding practices, in particular those relating to sterile products, are not improved."

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The VALID ActA bill introduced in the

House by Representative Markey of Mass.

‘‘Verifying Authority and Legality In Drug Compounding Act of

2012’’

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The VALID Act

The VALID Act is basically a re-introduction of Section 503A with some modifications AND the elimination of the offending portions of

the original section 503A (the solicitation and advertising sections struck down)

Currently pending in congress

States may pass laws and regs also

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The VALID Act

Some new provisions:

LABELING: “this drug has not been tested for safety and effectiveness and is not approved by the FDA. Serious adverse

reactions to this drug should be reported to the pharmacy where it was received

and to the FDA at XXXXX”

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The VALID Act

Some new provisions:

MANUFACTURERING : exemption for compounding pharmacies won’t apply “to the extent to which the pharmacy is, in effect, manufacturing such drugs, as determined by the Secretary, taking

into consideration the extent to which such pharmacy sells the drugs across state lines, the quantities of drugs sold, and any other factors

deemed appropriate by the Secretary.”

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New Massachusetts laws regarding controlled substances:

Massachusetts Acts of 2012, Chapter 244 AN ACT RELATIVE TO

PRESCRIPTION DRUG DIVERSION, ABUSE AND ADDICTION.

There are 29 Sections to this Act.

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Massachusetts Acts of 2012, Chapter 244

Section 1. [Added Sec. 7A of M.G.L. Ch. 94C] Practitioners (except veterinarians) upon

obtaining or renewing controlled substance registration from the State (not their DEA registraton) shall automatically and without further action be registered as a participant in the prescription monitoring program (PMP) established in section 24A.

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Section 2. [Added a paragraph to Sec. 15 (Record Keeping) of M.G.L. Ch.94C] If you have a controlled substance registration from the state

(e.g., practitioners, pharmacIES) and are required to submit a DEA form 106 (loss or theft of controlled substance) to the DEA, you must simultaneously file a copy of the form to the State Police AND local police of the location of the loss or theft

NOTE: individual pharmacists do not obtain a controlled substance registration – the pharmacies they work in do – BUT remember Manager of Record responsibilities with recordkeeping (does corporate submit 106 form??? Rx Manager responsibility!)

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Sections 3 and 4. [changed Sec. 18(d) of M.G.L. Ch.94C and added Section 18(d½ ).

COMMON TO SECTION 18(d) AND 18(d½)

MGLCh.94C,Sec. 18(d) AND (d½):▪ authorize out of state prescribing of CII rxs but only if

issued within preceding 5 (FIVE) days, and must be verified by telephone or other means or cannot be filled. No liability for not filling if document good faith attempt to verify.

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Sections 3 and 4. [changed Sec. 18(d) of M.G.L. Ch.94C and added Section 18(d½ ) cont’d.

COMMON TO SECTION 18(d) AND 18(d½)

MGLCh.94C,Sec. 18(d) AND (d½):▪ Requires pharmacist to send copy of CII rx from

out of state to department of public health with patient’s name and address redacted. [Is corporate doing this??]

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Sections 3 and 4. [changed Sec. 18(d) of M.G.L. Ch.94C and added Section 18(d½ ) cont’d.

DIFFERENCES BETWEEN SECTION 18(d) AND 18(d½)

Sec. 18(d):▪ Allows out of state prescriptions for NON-NARCOTIC CIIs (e.g.,

Adderall, Concerta, Daytrana, Ritalin) from ANY STATE

Sec. 18(d½): [Note: Delayed until Dec. 1, 2013]▪ Allows out of state prescriptions for NARCOTIC CIIs (e.g.,

Percocet, Oxycodone, Fentanyl) only from the STATE of MAINE and all contiguous states (RI, CT, NY, VT, and NH)

▪ So no more of those Florida Oxycodones!!! Finally.

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Section 5. [Added a paragraph to Sec. 21 (Labeling) of M.G.L. Ch.94C] Requires the department of public health to produce/provide pamphlets

(written or electronic) relative to narcotic drugs to pharmacies for distribution to a patient picking up a presctiption for a NARCOTIC in EITHER Schedule II or III.

information about: (i) pain management; (ii) misuse and abuse by adults and children; (iii) risk of dependency and addiction; (iv) proper storage and disposal; (v) addiction support and treatment resources; and (vi) the telephone helpline operated by the bureau of substance abuse services

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Section 6. [Added Sec. 21B (Lock Boxes) to M.G.L. Ch.94C] Pharmacies in MA (but not institutional pharmacies) registered to

dispense drugs in Schedule II, III, IV and V must make “LOCK BOXES” for medication available for sale to the public.

Must inform public by a sign “on or near” pharmacy counter. Sign must be at least 4” x 5” and say “lock boxes for securing your

prescription medications are available at this pharmacy.”

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Section 7. [Amended Sec. 23(g) (written rx requirements) to M.G.L. Ch.94C]

Effective July 1, 2013 – TAMPER RESISTANT PAPER FOR ALL RXS Added the words “on a tamper resistant form

consistent with federal requirements for Medicaid” in the language describing the requirements for written prescriptions. So after July 1, 2013 (unless delayed) ALL rxs written in MA

(control and non-control rxs) must be on tamper resistant paper

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Section 8. [Adds a paragraph to Sec. 24A(c) (PMP program) of M.G.L. Ch.94C] Requires the Dept. of Public Health to promulgate regulations

REQUIRING participants in the PMP (practitioners) to utilize the PMP program PRIOR to seeing a new patient, even where it would normally not require use of the PMP prior to seeing a new patient.

Requires pharmacists to be trained in the PMP program by way of Continuing Education requirements (according to the Board of Pharmacy, this will be a one-time CE).

Authorization for support staff to be able to use the PMP on behalf of the PMP registrant.

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Other Sections: Physicians, Nurse Practitioners and Hospitals treating patients under 18 years of age for alcohol

or drug overdose must notify parent and provide pamphlet on drug/alcohol abuse to parent upon discharge and provide access to social worker if available. SECTION 10

MassHealth enrollees who use excessive drugs (“frequent flyers”), shall be restricted by the Division of Medical Assistance to one primary pharmacy. SECTION 11

Provides for training for judges, other court employees, and lawyers in substance abuse and to identify substance abuse treatment resources for those charged with or convicted of crimes. SECTIONS 12 and 13.

Provides for a study to be conducted on drug diversion, abuse and addiction among SENIOR CITIZENS. SECTION 25

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FEDERAL LAW Hydrocodone Combo Products (Vicodin, Vicoprofen, Tussionex, Hycodan)

--- Push to RE-SCHEDULE into Schedule II FDA Advisory Panel on January 24 and 25 of 2013 conducted hearings. Voted 19-10 in favor of placing Hydrocodone combo products into Schedule II FDA has not yet determine weather or not to follow recommendation. Testifying were law enforcement (DEA, police), pain specialists, addiction specialists,

pharmacist, industry advocates, and bereaved families who lost children to pain prescription medication.

NEW YORK STATE has already placed hydrocodone combo products in Schedule at the state level.

MASSACHUSETTS Chapter 244 of the Acts of 2012 initially had a provision that would have moved hydrocodone combo products into schedule II, but it did not find its way to the final bill that was signed into law by Governor Duval Patrick and became effective August 18, 2012.

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FEDERAL LAW

PLAN B: Federal court orders FDA to make Plan B

available to all consumers without a prescription regardless of age.

No decision

PART I ELECTRONIC PRESCRIBING OF CONTROLLED SUBSTANCES (“NEW” REGS) (and its relation to current...

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