Tag Archives: controlled substance

Alabama’s Proposed Action to Reschedule Seven Controlled Substances

by admin on January 11th, 2017 at 6:57 am

The Alabama Department of Public Health recently filed a “Notice of Intended Action” to amend Alabama’s current Controlled Substance List by rescheduling seven substances to a higher schedule due to the potentials of abuse as recommended by the Alabama Board of Medical Examiners.

The seven substances the Alabama Department of Public Health proposes to reclassify are:

1. Alprazolam – Reschedule from Schedule IV to Schedule II,

2. All other benzodiazepines (Clonazepam, Diazepam, Lorazepam, and Temazepam) from Schedule IV to Schedule III,

3. Pregabalin – Reschedule from Schedule V to Schedule IV,

4. Zolpidem – Reschedule from Schedule IV to Schedule III

The comment period ended on January 4, 2017, and Baer Law will keep you informed on when there is a final ruling as health care providers, pharmacists, pharmacies and wholesalers will have to change their practices to address such changes, especially if alprazolam is reclassified to Schedule II. 

 

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Colorado Senate Bill 16-158: Physician Assistant’s Performing Functions Delegated by a Physician

by admin on September 2nd, 2016 at 5:47 am

 

On June 1, 2016, Colorado Governor John Hickenlooper signed Senate Bill 16-158: Concerning the Ability of a Physician Assistant to Perform Functions Delegated by a Physician that are within the Physician Assistant’s Scope of Practice. The bill, which went into effect on August 10, 2016, requires that a physician assistant prescription order meet the following three requirements:

1. The order must be within the scope of the physician assistant’s supervising physician;

2. If for a controlled substance, the order must contain the name of the supervising physician in addition to the other information required for a prescription; and

3. If for a controlled substance, the order must contain the physician assistant’s own DEA registration number.

Pharmacists filling prescription orders from physician assistants should ensure all three requirements are met prior to performing their final check. Failure to do so could result in disciplinary action.

Contact Baer Law with any questions.

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Analyzing Colorado 2014 Prescription Drug Outlet Disciplinary Actions: Repeated Deficiencies

by admin on March 21st, 2015 at 10:58 am

Baer Law recently completed an analysis of thirty-two (32) separate disciplinary actions against Colorado Prescription Drug Outlets (PDOs) by the Colorado State Board of Pharmacy (Board).

The Board registers and licenses pharmacy businesses, both in-state and out-of-state, including:

  • Prescription Drug Outlets;
  • Wholesale distributors of prescription drugs;
  • Manufacturers of prescription drugs;
  • Other outlets; and
  • Limited licenses.

The Board has jurisdictions over PDOs, or in-state pharmacies, pursuant to provisions of the Pharmacists, Pharmacy Businesses, and Pharmaceuticals Act at Title 12, Article 42.5, C.R.S (Article 42.5) and Board of Pharmacy Rules and Regulations (3 CCR 719-1).

PDOs failure to timely address repeated deficiencies and not promptly reporting changes in the status of a pharmacist-in-charge are of particular interest, not only because over fifty percent of the disciplinary cases analyzed involved one or both of these issues and resulted in fines ranging from $1000 to $10,000, but that, in most instances, the fines could have been avoided had the PDOs promptly addressed the prior documented deficiencies.

Issues addressing changes in the status of a pharmacist-in-charge will be discussed in the next Baer Law blog.

Baer Law identified three recent cases that resulted in probation and large fines simply because repeated deficiencies were never addressed or corrected. Again, it is important to note that had these deficiencies been promptly addressed each PDO could have avoided fines, probation and the burden of continued monitoring.

In the first case, during a routine inspection, the Board discovered six repeated deficiencies from previous Board inspections, including:

  1. Vaccine administration records not in compliance;
  2. Casual sales records that were not in compliance;
  3. Labeling on non-sterile compounded products made in anticipation of orders not in compliance with Board Rules;
  4. Return of stock records not in compliance;
  5. A compounded product was assigned a beyond use date that exceeded the expiration date of the individual component; and
  6. Compounding records did not accurately reflect the date a compounded product was prepared.

Additionally, the Board found five dispensing errors and discrepancies between what the prescriber’s directions for use were and what was placed on the patient’s prescription label. Ultimately, the Board placed the Pharmacy on five years probation with numerous strict stipulations on monitoring.

In the second case, the Board identified seven repeated deficiencies from previous inspections which included:

  1. Invoices not in compliance with Board rules;
  2. Notice of initial interpretation and final evaluation posting not in compliance with Board rules;
  3. Prescription files were not maintained in three (3) different prescription files: Schedule II, Schedule III-V, and non-controlled substance prescription orders;
  4. Beyond use dating for non-sterile compounded products were not in compliance with Board rules;
  5. The labeling non-sterile compounded products did not comply with Board rules; 
  6. The labeling of anabolic steroid prescriptions were not in compliance with Article 42.5 rules; and
  7. Four prescriptions orders were filled without valid DEA numbers on the orders.
As a result of these repeated deficiencies, the Pharmacy was fined $5000 and placed on probation with stipulations.

In the final case, a pharmacy was fined for nine repeated deficiencies including:

  1. Pharmacist manager immunization training documentation that could not be located;
  2. Prepack records for cassettes that did not include the name or initials of the pharmacist responsible for packaging;
  3. Vaccine records that did not include, among other things, the site of administration;
  4. Invoices for prescription drugs that were not dated upon receipt;
  5. Compounding records for non-sterile compounded products that did not contain appropriate beyond-use dating;
  6. A compounding record for a non-sterile aliquot preparation that did not include the date of preparation; 
  7. The policy and procedure manual for central processing could not be located;
  8. Electronic storage of controlled substance prescriptions is not allowed; and
  9. Transferred prescription orders did not include, among other things, the phone number of the transferring outlet, first fill date and last fill date.

For these repeated violations, the Board fined the Pharmacy $3000 and placed the Pharmacy on probation.

Colorado PDOs must take notice when the Board identifies a deficiency. PDOs must make a conscious effort to promptly address all documented Board deficiencies to avoid any future fines or disciplinary actions. Failure to do so, as documented in these three cases, could result in probation, significant fines and continued close monitoring by the Board.

In conclusion, by ignoring the Board’s recommendations, each PDO is placing the health, safety and welfare of the citizens of Colorado at risk, which is clearly unacceptable.

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Analyzing Colorado Pharmacist 2014 Disciplinary Actions: Controlled Substances, Red Flags and Pharmacist Corresponding Responsibility

by admin on March 12th, 2015 at 12:29 pm

Baer Law recently completed an analysis of thirty-three (33) separate 2014 disciplinary cases against Colorado pharmacists by the Colorado State Board of Pharmacy (Board).

Certain cases, especially those involving controlled substance dispensing errors and pharmacists dispensing controlled substances when no valid patient-prescriber relationship existed, should be of particular interest to all licensed Colorado pharmacists.

Out of the thirty-three cases analyzed, twenty-four (24) letters of admonition were issued to pharmacists. A letter of admonition is a public reprimand issued to a pharmacist in the form of an actual letter or as part of a stipulation, which is an agreement between the Board and the pharmacist prior to a formal hearing. With a stipulation, both parties agree to facts, sanctions and the terms and conditions for continued practice, if applicable. Though a stipulation resolves the case both a letter of admonition and stipulation are public records.

Of the twenty-four letters of admonition issued to pharmacists in 2014, Baer Law identified eleven cases involving controlled substances.

In some instances, the pharmacist dispensed the wrong controlled substance medication as cited by the Board. In these cases, the pharmacist:

  • “Performed the initial interpretation on an order for Fentanyl 25 mcg transdermal patches but dispensed fentanyl 75 mug patches;”
  • “Performed the initial interpretation and final evaluation on an order for Fiorinal/Codeine #3 which was dispensed as butalbital/acetaminophen/caffiene/codeine;”
  • “Performed the initial interpretation on a prescription of Butalbital/ASA/Caf when the order was written for Butalbital/ASA/Caf/Codeine;”
  • “Performed the initial interpretation on an order for MS Contin 30mg, but dispensed morphine sulfate ER 100mg tablets;”
  • “Admittedly dispensed a prescription with 20 tablets of methadone 5mg on an order for 720 methadone 10mg tablets;”
  • “Performed the initial interpretation on an order for Oxycontin 15mg tablets which was dispensed with oxycodone 15mg immediate release tablets.”

In another case, the pharmacist was cited for filling “a prescription for Adderall 20mg tablets, a schedule II controlled substance, before the filling date authorized by the prescriber.”

In the last four cases, pharmacists were cited for dispensing controlled substances when no valid patient-prescriber relationship existed or when a pharmacist dispensed controlled substances after an out-of-state prescriber had lost his license to prescribe controlled substances.

In the first case, multiple pharmacists, and their pharmacy, were disciplined for performing the initial interpretation on controlled substance orders for oxycodone, Soma, and Xanax after it was later determined during a routine Board inspection that:

  • No valid preexisting patient-prescriber relationship existed between an out-of-state prescriber and a patient residing in Colorado and
  • At the time these orders were dispensed, the out-of-state prescriber was prohibited from prescribing any Schedule II-IV controlled substances.

In another case that was previously cited on the Baer Law Blog, Pharmacists Must Ensure Prescription Orders are Issued for a Legitimate Medical Purpose by an Authorized Prescriber and Have a Recognized Medical Utility or Application, a pharmacy manager was disciplined after her pharmacy filled orders for controlled substances for patients of a California based prescribing practitioner who the pharmacist mistakenly believed, after investigation, had a valid, pre-existing patient-practitioner relationship with the patients.

The final four cases should be a learning experience for all pharmacists as the disciplinary actions may have been avoided had the pharmacists involved exercised corresponding responsibility and proactively identified certain “red flags” that could have assisted them in identifying prescriptions that are not legitimate.

As previously discussed on the Baer Law Blog, Corresponding Responsibility: A Pharmacist’s Obligation to Understand, pharmacists must exercise sound professional judgment with determining the legitimacy of a controlled substance prescription. When a pharmacist is presented with a doubtful, questionable or suspicious prescription, the law does not require a pharmacist to dispense the prescription. On the contrary, a pharmacist who deliberately ignores a questionable prescription when there is reason to believe the prescription was not issued for a legitimate medical purpose may be prosecuted along with the prescribing physician for knowing and intentionally distributing controlled substances.

All pharmacists should be able to identify certain “red flags” that could assist in identifying prescriptions that are not legitimate.

Common red flags include but are not limited to:

  • Pattern prescribing (i.e. prescriptions for the same drugs and the same quantities from the same doctors);
  • Irregularities on the face of the prescription itself;
  • Nervous patient demeanor;
  • Multiple or duplicative therapies (i.e. Oxycontin and MS Contin);
  • Prescribing of combinations or “cocktails” of frequent abused controlled substances;
  • Geographic anomalies;
  • Shared Addresses;
  • Filling a larger percentage of cash prescriptions;
  • Customers with the same diagnosis code from the same doctor;
  • Prescriptions written that are not consistent with their area of specialty;
  • Prescriptions for medications with no logical connection to diagnosis or treatment;
  • Consistent requests for early refills; and
  • (Re)filling prescriptions of patients or doctors located hundreds of miles away

While there are no clear and concise answers or guidelines, a pharmacist should always exercise his or her independent judgment when determining whether a prescription was issued for a legitimate medical purpose by a prescriber in their normal course of professional practice. Failure to do so could result in disciplinary action by the Board.
Please contact Baer Law with any questions.

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Colorado Pharmacy Legislation Update: Modifying the PDMP

by admin on February 24th, 2015 at 6:42 am

HB14-1283: Modify Prescription Drug Monitoring Program

HB14-1283 modifies the electronic prescription drug monitoring as follows:

  • The dissemination of automatic reports to prescribers and pharmacies when a patient meets a defined threshold that takes into account the number of prescribers and pharmacies visited within a certain timeframe. Reports started in September 2014.
  • Allows a prescribing practitioner or a pharmacist to delegate authority to access the database to up to 3 designees acting for the practitioner or pharmacist, and requires each designee to register with the program under a sub-account of the practitioner or pharmacist. Delegated Access started in January 2015.
  • Requires prescribing practitioners and pharmacists to register and create user accounts with the program by a deadline established by the Director of the Division of Professions and Occupations.
  • Allows the Colorado Department of Public Health and Environment (CDPHE) to access data from the PDMP for public health research. CDPHE access began in the late 2014.
  • Allows an out-of-state pharmacist to obtain Colorado PDMP data in connection with a current patient to whom the pharmacist is dispensing a controlled substance or is providing clinical patient care services. This ability to obtain such data is already available.
  • Adds individual pharmacies as an eligible subject for information requests by law enforcement officials if the request for information is accompanied by a court order or subpoena beginning immediately.
  • Allows federally owned and operated pharmacies to submit data to the database beginning immediately.
  • Authorizes the executive director of the department of regulatory agencies to create a prescription drug monitoring program task force, or to request assistance from the team assembled by the governor’s office to develop a plan to reduce prescription drug abuse, to study the program and make recommendations to the executive director on ways to ensure that the program is effective at reducing prescription drug abuse and misuse. The Executive Director has requested the Governor’s Consortium for Prescription Drug Abuse serve as the task force.

 

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Designer Anabolic Steroid Control Act of 2014 (H.R. 4771)

by admin on January 20th, 2015 at 6:51 am

In December 2014, President Obama signed into law H.R. 4771, the Designer Anabolic Steroid Control Act (DASCA) of 2014. The DASCA amends the Controlled Substance Act and adds over 20 specified substances to the list of those included within the definition of “anabolic steroid” and provides that a drug or hormone substance (other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone) that is not listed and that is derived from, or has a chemical structure substantially similar to, an anabolic steroid that is listed, shall be considered an anabolic steroid for purposes of such Act if it:

  1. Has been creased or manufactured with the intent of producing a substance that either promotes muscle growth or otherwise causes a pharmacological effect similar to testosterone; or
  2. Has been, or is intended to be, promoted in any manner suggesting that consuming it will promote any pharmacological effect similar to that of testosterone.
The DASCA excludes a drug or hormonal substance from the above definition if it is:
  1. An herb or other botanical, a concentrate, metabolite, or extract of, or a constituent isolated directly from, an herb or other botanical, or a combination of two or more such substances; or
  2. A dietary ingredient for purposes of the Federal Food, Drug, and Cosmetic Act (FDCA) and is not anabolic or androgenic.
The DASCA authorizes the Attorney General to issue an order adding a drug or other substance to the definition of “anabolic steroid” upon finding that: (1) the substance satisfies the criteria for being considered an anabolic steroid, and (2) such addition will assist in preventing abuse or misuse of the substance. Such an order by the Attorney General is in effect 30 days following the publication of the temporary scheduling notice, and will be in force for 24 months.

The DASCA authorizes fines of up to $500,000 per violation for importing, exporting, manufacturing, distributing or dispensing anabolic steroids.

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Pharmacists Must Ensure Prescription Orders are Issued for a Legitimate Medical Purpose by an Authorized Prescriber and Have a Recognized Medical Utility or Application

by admin on October 6th, 2014 at 11:41 am

 

As discussed previously on the Baer Law Blog, corresponding responsibility remains one of the most misunderstood or unknown concepts found in the Drug Enforcement Administration’s (DEA) regulations. The DEA’s regulations (21 CFR 1306.04) regarding corresponding responsibility state:

A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.

Many states, including Colorado, have incorporated similar language into their own Board of Pharmacy Rules and Regulations. The Colorado State Board of Pharmacy (Board), for example, uses the following language addressing both medical need and corresponding responsibility issues:

3.00.20  Medical Need. No license or registrant shall compound, dispense, deliver or distribute any drug to any person in such quantity or in any situation where the licensee or registrant knows or reasonably should know said drug has no recognized medical utility or application. Violation of this rule shall constitute prima facie proof of violation of CRS 12-42.5-123, or unprofessional conduct and ground for discipline.

3.00.21 A pharmacist shall make every reasonable effort to ensure that any order, regardless of the means of transmission, has been issued for a legitimate medical purpose by an authorized practitioner. A pharmacist shall not dispense a prescription drug if the pharmacist knows or should have known that the order for such drug was issued on the basis of an internet-based questionnaire, an internet-based consultation, or a telephonic consultation, all without a valid preexisting patient-practitioner relationship.

In a recent Colorado case, both issues were addressed. Pharmacists did not make reasonable efforts to ensure prescriptions for Schedule III controlled substances or other compounds were issued for a legitimate medical purpose by an authorized prescriber and had a recognized medical utility.

The facts of the case are as follows:

During a routine inspection of a registered, in-state prescription drug outlet (Pharmacy) in mid-2014, the Board identified over 20 prescriptions that were dispensed pursuant to orders based on Skype internet-based consultations from a Naturopathic Doctor (ND) in California.

The identified prescriptions included the following:

  1. Human Chorionic Gonadotropin (HCG), a schedule III Controlled Substance in the State of Colorado;
  2. “B Lipo,” a vitamin B supplement compounded as a sterile product at the Pharmacy
  3. “Garcinia,” a plant that is presumed to control appetite and fat storage in the body when properly compounded and ingested.

In California, a ND can prescribe a legend and Schedule IV-V controlled substances under MD/DO supervision and prescribe Schedule III drugs under a patient-specific protocol checked by a supervising MD or DO.  In this case, pharmacists did not verify the ND was practicing under a supervising MD/DO or that a valid patient-practitioner relationship existed as the relationship appeared to be based only on an internet-consulatations. Due to the many Federal and State violations, the Pharmacy was cited by the Board and the has since voluntarily relinquished its license to practice pharmacy. Cases against the pharmacists involved are still pending and could be severe.

This case should remind all pharmacists to use due diligence when verifying all prescription orders, especially in light of the reclassification of hydrocodone containing products (HCPs) as Schedule II controlled substances.

Pharmacists are expected to exercise sound professional judgment when making a determination about the legitimacy of all prescriptions, not just controlled substance prescriptions. It is no longer sufficient for a pharmacist to accurately fill a prescription if the prescription is unreasonable on its face.  In fact, under the corresponding responsibility rule, a pharmacist who deliberately ignores a questionable prescription where there is reason to believe the prescription was not issued for a legitimate medical purpose may be prosecuted along with the issuing practitioner for knowingly and intentionally distributing controlled substances.

Ultimately, pharmacists should continue to monitor prescriptions for “red flags,” closely scrutinize all prescriptions, and ensure that valid MD/DO supervisory relationships exist when checking any controlled substances, especially Schedule II HCPs as there will likely be much confusion over the next few weeks as practitioners adjust to the new rule.

 

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Countdown to October 6, 2014: Hydrocodone Containing Product Reclassification

by admin on September 30th, 2014 at 7:31 am

As discussed previously here on the Baer Law Blog, after more than a decade of debate, hydrocodone containing products (HCPs) are being reclassified from Schedule III to the more restrictive Schedule II controlled substances category starting October 6, 2014.

HCPs are the most prescribed drug in the United States, second only to levothyroxine, a thyroid medication commonly sold under the brand name Synthroid or Levoxyl. In 2012, over 135 million prescriptions for HCPs were sold. Levothyroxine was the only other medication to surpass the 100 million prescription mark.

What does the reclassification of HCPs to Schedule II mean for health care providers, specifically pharmacists?

Here are some key points for pharmacists (and other health care providers):

1. Refills are not allowed for prescriptions that are written beginning Monday, October 6, 2014. New Schedule II hard copy prescriptions or certified electronic Schedule II prescriptions should be issued for all HCPs. Pharmacists must use extra due diligence when addressing all HCP prescriptions starting on October 6, 2014, as this will likely be an area of immense focus during future State Board of Pharmacy audits.

2. Prescriptions issued before Monday, October 6, 2014 will not necessarily qualify for refills, so plan on obtaining new prescriptions for HCPs. The new rule allows refills to be issued on prescriptions issued before October 6, 2014, and until April 8, 2015 (i.e., the six-month rule for Schedule III refills), but more strict state specific laws could prevent patients from receiving those refills since some states have proactively published notices that they will treat HCP prescriptions issued before October 6, 2014, in the same manner as prescriptions issued after the new rule’s implementation date. Thus, the more stringent state pharmacy law will govern and the refills for a prescription written prior to October 6, 2014 should not be honored.

3. Schedule II prescriptions cannot be faxed or called in, though some emergency circumstances may apply.  Pharmacists are generally prohibited from filling Schedule II prescriptions delivered verbally or via fax, so new hard copy prescriptions will need to be written by providers. An exception is the emergency treatment rule which allows physicians to call in a limited quantity of the medication to cover the emergency period, generally up to seventy-two hours only. Pharmacists are required to report prescribers if the prescribers of emergency Schedule II controlled substance do not provide the pharmacist with a written prescription within seven days.

4. Some non-physician health care professionals (physician assistants or nurse practitioners) may not be able to write prescriptions for Schedule II controlled substances.  Pharmacists should verify that the prescribers of HCPs have the appropriate prescriptive authority to issue prescriptions for Schedule II controlled substances. Again, all pharmacists must use due diligence to ensure  all prescribers have Schedule II prescriptive authority as this will likely be another area of focus for all State Boards of Pharmacy in the near future.

5. Multiple prescriptions may be issued at one time under certain circumstances. Under the new rule, a patient may receive new prescriptions totaling a 90-day supply if the prescriber, in his or her professional medical opinion and in accordance with medical standards, determines that it is appropriate to see the patient once every three months. However, each prescription must be written with instructions specifically detailing the earliest refill date.

6. Educating all patients on the new HCPs requirements and processes. All health care providers should make sure each patient understands that HCPs cannot be refilled due to the new DEA rule. Pharmacists, however, will likely be the primary educators when patients have questions regarding prior HCP prescription refills and HCP requirements and processes going forward.

While pharmacies have had forty-five days to prepare for the new rule, there is bound to be confusion for the first few days or even weeks after implementation of the new rule. Pharmacists, however, should take extra precautions to ensure that all HCPs are filled under the strict Schedule II controlled substance requirements and any applicable more stringent state laws, if needed.

Contact Baer Law with any questions or issues.

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Updated Controlled Substances Disposal Requirements: Effective October 9, 2014

by admin on September 22nd, 2014 at 9:32 am


The Drug Enforcement Administration’s Updated Controlled Substance Disposal Requirements Take Effect October 9, 2014.

Historically, under the Controlled Substance Act (CSA), patients could only dispose of unused controlled substances themselves or deliver the controlled substances to law enforcement officials.

In October 2010, the Secure and Responsible Drug Disposal Act (Disposal Act) of 2010 was enacted with the goal of facilitating more convenient and secure disposal options. The Disposal Act amended the CSA and authorized “ultimate users” or persons who have  ”lawfully obtained, and who possesses, a controlled substance for his own use or for the use of a member of his household or for an animal owned by him or a member of his household,” to deliver their controlled substances to a broader range of entities for disposal in accordance with the requirements of the Drug Enforcement Agency (DEA).

Earlier this month, the DEA published a rule which broadens the range of permissible collection and disposal methods for unused, unwanted, or expired controlled pharmaceutical substances while also further clarifying the roles of “collectors” and “reverse distributors.”

Authorized Collectors. The new rule allows authorized collectors, or those entities who have submitted a written request to the DEA Registration Unit, to conduct mail-back collection programs and maintain collection receptacles at authorized collection locations. Under the rule, hospitals and clinics with on-site pharmacies may register as collators.

Reverse Distributors. As defined by the rule, reverse distributors can acquire controlled substances from another DEA registrant or law enforcement for the purpose of destruction or return to the registered manufacturer or an entity authorized to accept returns on a registered manufacturer’s behalf. All controlled substances must be stored securely at the reverse distributor’s location until destruction or return to the registered manufacturer.

Disposal. Under the Rule, all controlled substances must be destroyed and rendered non-retrievable under all Federal, State, tribal and local regulations. A controlled substance is deemed to be non-retrievable when it cannot be transformed into a physical or chemical condition or state as a controlled substance or controlled substance analogue. While the method of destruction is not specified, any registered entity that destroys controlled substances must (1) maintain a complete and accurate record of all destroyed substances on a DEA Form 41 and (2) include the signature of two employees who witnessed the controlled substance distraction.

Again, the updated Controlled Substances Disposal Requirements become effective on October 9, 2014.

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Corresponding Responsibility: A Pharmacist’s Obligation to Understand

by admin on July 30th, 2014 at 10:58 am

Why is understanding corresponding responsibility important to me as a practicing pharmacist?

In short, enforcement actions against pharmacies occur most often when pharmacists fail to exercise their corresponding responsibility as addressed by the Drug Enforcement Agency (DEA) in its regulations (21 CFR 1306.04) which state:

“A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of Section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.”

Thus, in interpreting the regulations, a pharmacist’s position is nearly identical to the practitioner who issued the prescription, though the pharmacist did not examine the patient or review their medical records. Therefore, the pharmacist filling a controlled substance prescription should proceed with caution and use their professional judgment to determine if a prescription for a controlled substance was issued for a legitimate medical purpose during the course of his or her usual professional practice.

Ultimately, a pharmacist is required to exercise sound professional judgment with determining the legitimacy of a controlled substance prescription. When a pharmacist is presented with a doubtful, questionable or suspicious prescription, the law does not require a pharmacist to dispense the prescription. On the contray, a pharmacist who deliberately ignores a questionable prescription when there is reason to believe the prescription was not issued for a legitimate medical purpose may be prosecuted along with the prescribing physician for knowing and intentionally distributing controlled substances.

In 2010, the DEA published a decision that addressed a pharmacist’s corresponding reliability, the East Main Street Pharmacy (EMS) Case, and identified certain “red flags” that could assist pharmacists in identifying prescriptions that are not legitimate.

Common red flags include but are not limited to:

  • Pattern prescribing (i.e. prescriptions for the same drugs and the same quantities from the same doctors);
  • Irregularities on the face of the prescription itself;
  • Nervous patient demeanor;
  • Multiple or duplicative therapies (i.e. Oxycontin and MS Contin);
  • Prescribing of combinations or “cocktails” of frequent abused controlled substances;
  • Geographic anomalies;
  • Shared Addresses;
  • Filling a larger percentage of cash prescriptions;
  • Customers with the same diagnosis code from the same doctor;
  • Prescriptions written that are not consistent with their area of specialty;
  • Prescriptions for medications with no logical connection to diagnosis or treatment;
  • Consistent requests for early refills; and
  • (Re)filling prescriptions of patients or doctors located hundreds of miles away
While there are no clear and concise answers or guidelines, a pharmacist should always exercise his or her independent judgment when determining whether a prescription was issued for a legitimate medical purpose by a prescriber in their normal course of professional practice. And, pharmacists should always document all correspondences with any providers and/or their offices. 
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