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.
On June 21, 2016, the Department of Justice announced that two Alabama pharmacists were sentenced to prison terms of 12 and 10 months for their roles in the distribution of adulterated drugs. The drugs in question were compounded at the now-defunct compounding pharmacy Advanced Specialty Pharmacy (dba: Meds IV.)
Meds IV allegedly compounded numerous drugs for human use, including intravenous drugs known as Total Parenteral Nutrition (TPN) which is a liquid nutrition for patients who cannot or should not receive medications orally, without taking the legally required precautions to ensure the sterility of its products.
Allegedly, in early 2011, Meds IV began compounding its own amino acid solution which was then mixed with other intravenous medications to create patient specific TPNs. The amino acids used in compounding the TPNs were adulterated as the amino acids were found to be contaminated with the highly resistant bacteria Serratia marcescens (S. marcescens) which can cause bloodstream infections if introduced into the bloodstream through contaminated medications.
According to documents, the amino acid was prepared by Meds IV outside a laminar airflow workbench and kept unrefrigerated in a non-sterile room in a large pot sitting on the floor before it was sterilized and used.
Nine patients, with other serious underlying medical conditions, who developed bloodstream infections caused by S. marcescens died while many others developed infections but survived.
David Allen of McCalla, Alabama, the former pharmacist-in-charge of Meds IV, was responsible for reviewing and approving TPN formulations, and William Timothy Rogers, of Hoover, Alabama, the former president of Meds IV, pleaded guilty in March 2016 to two misdemeanor violations of the Federal Food, Drug and Cosmetic Act (FDCA). Allen and Rogers received 12 month and 10 month prison terms, respectively, and also received a one year of supervised release following their imprisonment and a $5,000 fine.
The Department of Justice and the Food and Drug Administration continue to work aggressively to protect consumers from drugs compounded under insanitary conditions.
On June 6, 2016, Colorado Governor John Hickenlooper signed into law Senate Bill 16-135 which amends the Colorado Pharmacy Practice Act and the Colorado Insurance Code to expand practice opportunities for pharmacist and provide a pathway for reimbursement of pharmacy services. The Bill is expected to go into effect in early August 2016.
The Bill includes the following:
- Providers reimbursement opportunities for pharmacies that provide healthcare services otherwise provided by a physician or advanced practice nurse;
- Calls on insurance plans to include pharmacists in their network of providers;
- Expands collaborative practice agreements to one or more patients cared for by the collaborative physician or advanced practice nurse;
- Expands collaborative practice agreements to treat a protocol rather than a single drug;
- Provides for the development of Statewide Drug Therapy Protocols to be jointly developed by the Boards of Medicine, Pharmacy and Nursing in collaboration with the Colorado Department of Public Health and Environment.
Baer Law will continue to keep you updated.
On April 15, 2016, the FDA issued draft guidance on the Prescription Requirement Under 503A (Prescription Guidance). The Prescription Guidance sets forth the FDA’s policy concerning prescription requirements for compounding human drug products for identified individual patients under Section 503A of the Federal Food, Drug and Cosmetic Act (FDCA) and addresses:
- Compounding after the receipt of a prescription for an identified individual patient,
- Compounding before the receipt of a prescription for an identified individual patient (anticipatory compounding) and
- Compounding for “office use”
The Prescription Guidance notes that a valid prescription order for a compounded product must be received from a licensed physician or other licensed practitioner authorized by state law to prescribe drugs before dispensing a compounded drug.
In addition, the policy notes that a pharmacist may consult with the prescriber to determine whether the patient needs a compounded drug and make appropriate notations on the prescription order. Such notations, which would serve as the basis for compounding under Section 503A, must include the prescriber’s determination that a compounded drug is necessary for the identified patient.
The FDA recommends using the following statement:
“Per [type of communication] with [name of prescriber] on [date], [name of prescriber] has advised that compounded [name of drug] for the treatment of [name of patient].”
The Prescription Guidance does recognize the statutory authority to engage in “anticipatory compounding,” or the practice of compounding drugs in advance of receiving a valid prescription order based on the historical needs and relationship between a licensed pharmacist and the prescriber.
However, FDA notes that the “limited quantity” restriction regarding anticipatory compounding would likely be interpreted as a limit of a 30-day supply based on the relationship.
Finally, the Prescription Guidance addresses office use, or the practice of shipping compounded drugs to hospitals, clinics and physician offices in advance or without first obtaining a prescription for an individual patient.
The FDA acknowledges that hospitals, clinics and health care practitioners have valid needs for office stock and office use compounded drug products to administer to patients who present with an immediate need for a compounded drug product. However, the the FDA notes that such compounded products can be obtained from FDA outsourcing facilities registered under Section 503B or via anticipatory compounding in a limited quantity provided a patient-specific prescription order is presented for the compounded drug product.
Up next: Analysis on the third FDA draft guidance which clarifies the definition of “Facility” under Section 503B.
Last week the Food and Drug Administration (FDA) announced three new Draft Guidance documents related to drug compounding under the Sections 503A and 503B of the Food, Drug and Cosmetic Act (FDCA):
- Hospital and Health System Compounding
- Prescription Requirement Under Section 503A
- Clarifying the definition of “Facility” under Section 503B
This article will focus on the Draft Guidance on Hospital and Health System Compounding (Hospital Draft Guidance). The Hospital Draft Guidance explains how Section 503A and 503B apply to hospitals and health systems.
Traditional compounding pharmacies, covered under 503A, are required to obtain valid prescription orders prior to distributing any drug products, amongst other specific requirements.
The new Hospital Draft Guidance clarifies that pharmacies which are part of a hospital or health systems are treated the same under federal law as other traditional compounding pharmacies and are required to comply with the requirements of 503A, unless they are registered as outsourcing facilities.
However, the FDA states it may refrain from enforcing the prescription requirement against hospital-based pharmacies if the compounded drug product is distributed only to facilities under the same ownership and control within a one-mile radius of the pharmacy and administered within the facility pursuant to a patient-specific prescription or order.
The intent of the “one-mile radius” exception is to accommodate centralized drug compounding at a single hospital campus with multiple facilities, but not larger and more geographically diffuse health systems as the FDA remains concerned that distributing compounded drugs across a larger health system is more similar to drug manufacturing.
Hospital pharmacies that wish to distribute compounded drugs outside the one-mile radius without receiving a valid prescription order should, according to the Hospital Draft Guidance, comply with 503B, and register with the FDA as an outsourcing facility or outsource production to an FDA registered outsourcing facility.
Baer Law will have updates on the next two FDA draft guidances shortly.
Last month the Food and Drug Administration (FDA) alerted health care professionals and patients not to use drug products intended to be sterile that are produced and distributed by IV Specialty of Austin, Texas, due to lack of sterility assurance.
The FDA found numerous safety issues during its February 2016 which prompted them to recommend that IV Specialty (1) cease sterile production until appropriate corrective action are implemented and (2) recall all non-expired drug products intended to be sterile.
IV Specialty is a small pharmacy that reportedly only compounds in response to physician orders and does not provide medicines for office use or ship out of state. The FDA’s inspection report, Form 483, lists IV Speciality as a “Producer of Sterile Drug Products” and not as a licensed “Outsourcing Facility.” Therefore, some question whether the FDA has authority to force IV Specialty to halt production or issue a recall.
In response to the FDA alert a consumer advocacy group, Public Citizen, urged the Texas State Board of Pharmacy (Texas Board) to suspend IV Specialty’s compounders license since the FDA “uncovered multiple egregious, life-threatening problems in the company’s processes for making sterile drugs.”
In response to the FDA alert and Public Citizen’s pleas, the Texas Board sent one of its inspectors to IV Specialty and ultimately determined that there was not an immediate danger to the public or anything that would prompt the Texas Board to immediately close the pharmacy.
The Texas Board, however, acknowledged that while state regulations are not as stringent as FDA regulations, they are closely monitoring the case since the Texas Board recently issued five warning notices to IV Specialty for different violations. Additionally, the Texas Board has been in close contact with the FDA regarding their concerns.
As discussed previously on the Baer Law Blog, historically, state boards of pharmacy regulated compounding pharmacy. However, after the New England Compounding crisis of 2012, the Drug Quality and Security Act was passed and granted the FDA authority to inspect facilities and enforce regulations.
Figuring out how state and federal compounding rules and regulations are going to work together remains to be seen as sterile compounding regulations vary in many states.
Stay tuned to the Baer Law Blog for more updates on sterile compounding.
State boards of pharmacy continue to have primary responsibility of the day-to-day oversight of state-licensed pharmacies that compound drugs in accordance with Section 503A of the Food and Drug Cosmetic Act (FDCA) while the FDA regulates and inspects registered outsourcing facilities licensed under Section 503B of the FDCA.
While the exact definition of compounding may vary slightly state by state, in general terms, compounding is a practice in which a licensed pharmacist, a licensed practitioner, or in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist combines two or more drugs to create a tailored medication to address the needs of an individual patient.
Currently, Section 503B only applies to human compounding and the veterinary medicine community continues to explore pharmacy related legislation changes that would specifically address the unique needs of their animal patients.
According to the American Veterinary Medical Association (AVMA), nine states have laws or regulations that permit licensed veterinarians to administer and dispense compounded products, in some cases under specified conditions. In the past few months, at least four more states have introduced bills or regulations that would permit or place limitations on compounding for animal patients in specified situations.
Maryland recently introduced SB 614 which provides an exception to state pharmacy law, specifying that it does not prohibit a licensed veterinarian from dispensing a sterile or non sterile compounded preparations, provided by certain pharmacies, for use in a companion animal, under specified circumstances. Additionally, under SB 614, a pharmacy would be authorized to provide certain compounded preparations without a patient-specific prescription to a certain licensed veterinarian under certain circumstances.
Massachusetts introduced HB 3989 which would authorize a veterinarian to dispense a compounded drug, distributed from a pharmacy, when the animal is his own patient within the valid veterinarian-client-patient relationship (VCPR), as defined by the Principles of Veterinary Medical Ethics of the AVMA provided that:
- The animal is a companion animal;
- The quantity dispensed is no more than a 120 hour supply;
- The compounded drug is for the treatment of an emergency condition; and
- Timely access to a compounding pharmacy is not available as determined by the prescribing veterinarian.
The Massachusetts bill would also allow a veterinarian to compound for individual patients within a valid VCPR provided that the veterinarian (1) does not compound from bulk substances, (2) does not duplicate proprietary products, (3) does not wholesale compounded medications and (4) does not compound from federally controlled substances for dispensing.
New York is considering a bill that would allow pharmacists to compound strictly limited amounts of substances for veterinary facilities which in turn could then dispense, under certain limited circumstances, to animals with which the veterinarians have a valid VCPR. Interestingly, the New York bill addressed the uniqueness of veterinary medicine:
- “Unlike human medicine, veterinary medicine has a unique service model. In many cases there is no ready alternative to a veterinarian having compounded medicines on had at all times. This is especially true in emergency situations and at night and on weekends and holidays where there is no practical alternative but the animal hospital and its staff veterinarians for the purposes of filling a prescription for an animal with which a veterinary client patient relationship exists. The alternative to the safe and proper use of these safe substances would in many cases be suffering and possible death for the animal in need of them.”
The New York bill provides additional safeguards by strictly limiting the quantities of compounded pharmaceuticals that a veterinary practice may have on hand to a short term supply of 100 doses or twelve ounces of liquid medications, twelve ophthalmic, topical or inhaled preparations and 100ml of sterile injectable solutions.
Last week in Colorado, HB 16-1324 was introduced to the House Health, Insurance, & Environment committee. HB 1324 would authorize:
- A compounding pharmacy to compound and distribute a drug to a veterinarian without a specific patient indicated to receive the compounded drug and
- Allow a veterinarian to dispense a compounded drug, maintained as part of the veterinarian’s office stock, in an amount not to exceed 5 days worth of doses, if a patient has an emergency condition that the compounded drug is necessary to treat and the veterinarian cannot access, in a timely manner, the compounded drug through a compounded pharmacy.
Patient safety remains paramount while states continue to address veterinary compounding, office use and office stock in an effort to protect the health, safety and welfare of the animal population.
Baer Law will continue to keep you updated on veterinary compounding issues.
The FDA recently issued two warning letters to compounders in California and Kentucky for violating current good manufacturing practices related to sterility.
- Producing sterile drug products and putting patients at risk,
- Not receiving valid prescriptions for individually identified patients,
- Misbranded drug products; and
- Poorly written guidelines.
Ionia, in response to the FDA’s noted deficiencies, stated that it would cease all operations and close. The FDA, however, has not received confirmation of Ionia closing.
Inspections at Spoonamore revealed that Spoonamore did not use a sporadical agent as part of its disinfection program in its cleanroom. Additionally, FDA inspectors found that Spoonamore produced domperidone, a medication commonly used to treat nausea and vomiting, that has not been approved by the FDA for use in the United States and therefore should not be used in compounding. Spoonamore reportedly has stopped producing domperidone.
Stay tuned to the Baer Law Blog for more compounding updates.
As previously discussed on the Baer Law Blog in August, the Colorado Medical Board (Medical Board) adopted Guidelines for the Appropriate Use of Telehealth Technologies in the Practice of Medicine (Guidelines).
The Medical Board defined telehealth as:
“‘a mode of delivery of health care services through telecommunications systems, including information, electronic, and communication technologies, to facilitate the assessment, diagnosis, consultation, treatment, education, care management, or self-management of a person’s health care while the person is located at an originating site and the provider is located at a distant site. The term includes synchronous and store-and-forward transfers.’
The Colorado Board of Pharmacy (Pharmacy Board) is considering amending some of its rules to improve the administration and enforcement of the Pharmacists, Pharmacy Business and Pharmaceuticals Act.
Presently, the Pharmacy Board Rule 3.00.21 states, in part the following:
- 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.
The proposed 3.00.21 rule is as follows:
- 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 know that the order for such a drug was issued without a valid preexisting patient-practitioner relationship. Such relationship need not involve an in-person encounter between the patient and practitioner if otherwise permissible under Colorado law.
In 2016, groundbreaking laws in California and Oregon will allow women to obtain hormonal contraceptive pills, patches and rings directly from pharmacists without a doctor’s prescription — a change many say is more convenient and likely a less expensive option than going to the doctor.
Presently, a doctor’s prescription for hormonal contraceptive products is required, but over the next few months, pharmacists in Oregon and California will be authorized to prescribe contraceptives after a quick screening process where women fill out a questionnaire about their health and medical histories.
As noted on the Baer Law Blog previously, Oregon and California laws differ in that California’s law has no age restriction, whereas Oregon law requires teenagers under 18 obtain their first contraceptive prescription from a doctor. Also, California pharmacists will likely have to take a women’s blood pressure if filling a contraceptive containing estrogen.
Advocates of the new law, including some pharmacists’ organizations and reproductive health experts, plan to actively lobby for a nationwide change, provided they can be assured that pharmacists can safely dispense contraception without a doctor’s prescription and that women’s health risks can be can be safely and accurately assessed via questionnaires.
As the role of the pharmacist continues to expand and the strong push to recognize pharmacists as health care providers continues, a big unanswered question is whether insurers will pay for the time pharmacists spend reviewing the health questionnaires to ensure all patient safety issues are appropriately addressed.
Stay tuned to the Baer Law Blog for more updates.
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