Tag Archives: DEA
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.
Earlier this year, CVS paid $8 million for alleged violations of the Controlled Substance Act in its Maryland pharmacies.
Last week, the US Attorney’s Office for the District of Massachusetts announced that CVS has agreed to pay $3.5 million to settle allegations that its pharmacists filled forged prescriptions, mostly for addictive painkillers, between 2011 and 2014.
CVS also entered into a three-year agreement with the Drug Enforcement Agency (DEA) to make sure its pharmacies work more diligently to detect and prevent the diversion of controlled substances.
In a press release, US Attorney Carmen M. Ortiz stated, “Pharmacies have a legal responsibility to ensure that controlled substances are dispensed only pursuant to valid prescriptions. When pharmacies ignore red flags that a prescription is fraudulent, they miss a critical opportunity to prevent prescription drugs from entering the stream of illegal opiates on the black market.”
The CVS investigation started after the DEA began receiving a high volume of calls about forged oxycodone prescriptions in the Massachusetts CVS stores. Ultimately, the DEA found that 403 forged prescriptions were filled at 40 stores in Massachusetts and New Hampshire and that 120 forged prescriptions were filled at 10 CVS stores in the Boston area.
One of the major forgers, according to the DEA allegations, was a patient known as “PR,” who used a dentist’s name to fill 56 of 59 oxycodone prescriptions. CVS pharmacists continued to dispense the medications to “PR” despite having detailed computer warnings and notes regarding “PRs” history of trying to fill forged prescriptions.
“PR” allegedly was able to circumvent the CVS ban by creating a new patient profile with her Arizona driver’s license and using a different last name.
The attorney’s office press release stated, “The government alleged that CVS should have known that the new profile was really PR’s, and that the quantities and frequency of PR’s oxycodone prescriptions were excessive, especially coming from a dentist. Moreover, the government alleged, even if CVS had believed the prescriptions to be real, there were red flags that PR was doctor shopping, including the fact that PR presented oxycodone prescriptions from 2 different providers during a single week at 1 CVS store.”
Finally, the attorney’s office noted that pharmacists should continue to use diligence in identifying red flags to ensure that forged prescriptions are not filled.
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.
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:
- Human Chorionic Gonadotropin (HCG), a schedule III Controlled Substance in the State of Colorado;
- “B Lipo,” a vitamin B supplement compounded as a sterile product at the Pharmacy
- “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.
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.
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.
In early October, disposing of unused medications, including controlled substances, will likely get much easier as the Drug Enforcement Agency (DEA) is expanding the options to collect medications with the hopes that the rule expansion will discourage individuals from simply flushing drugs down the toilet, throwing drugs away or leaving drugs in medicine cabinets.
With the expansion of Secure and Responsible Drug Disposal Act of 2010 (The Disposal Act), consumers will now be allowed to drop off unwanted medications, including controlled substances, at authorized pharmacies, hospitals, long-term care facilities and police stations that maintain collection receptacles. The new rule also allows people to mail back unused medications.
Specifically, the new regulations:
- Allow authorized pharmacies; hospitals and clinics with on-site pharmacies; manufacturers; distributors; reverse distributors; and narcotic treatment programs to place collection receptacles inside their establishments and to permit people to mail back unwanted controlled medications;
- Expand the authority of authorized pharmacies and hospitals to place collection receptacles inside long-term care facilities; and
- Allow law enforcement agencies to place collection receptacles inside their stations, conduct drug take-back events and administer mail-back programs.
Registrants interested in collecting controlled substances will need to become authorized by the DEA, though it remains to be seen how many pharmacies, hospitals, and clinics will initially participate in the program because historically pharmacies have not been allowed to legally take medications back and some pharmacies, including CVS and Walgreens already participate in drug take-back programs and work closely with local police departments and the DEA. More to come as the information is available.
On August 22, the Drug Enforcement Agency (DEA) published a final rule to move hydrocodone combination products (HCPs) from Schedule III to Schedule II. The change takes effect on October 6, 2014.
Under the finale rule, all Schedule II requirements with respect to security, labeling and packaging, inventory, record keeping and reporting, etc., will apply to “all pharmaceuticals containing hydrocodone currently on the market in United States.”
While the DEA does state that a practitioner may issue multiple Schedule II prescriptions to provide up to a 90-day supply of medication, all pharmacists should be on high alert and must continue to use due diligence when checking prescriptions for HCPs to ensure only a thirty day supply is dispensed per prescription. Additionally, pharmacists should continue to watch for any “red flags,” and use their best judgment when determining whether to fill multiple (Schedule II) HCP prescriptions for a specific patients at one time.
All Colorado licensed pharmacists and registered DEA prescribing practitioners are required to register an individual user account with Colorado’s Prescription Drug Monitoring Program (PDMP) pursuant to CRS 12-42.5-403 of the Pharmacy, Pharmacy Businesses and Pharmaceuticals Practice Act. The following due dates for each profession are:
- Pharmacists and DEA-registered Advanced Practice Nurses: September 30, 2014
- DEA-registered Dentists, Veterinarians, Optometrists and Podiatrists: October 31, 2014
- DEA-registered Medical Board licensees: November 30, 2014
For more information pharmacists and practitioners should use the following link to create a PDMP account prior to the above due dates: http://www.hidinc.com/copdmp
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