Recently, the whole pharmacy community was watching how an Albertsons pharmacy technician in Boise was the first in the nation to administer an immunization. This was possible thanks to a new Idaho law addressing a shortage of healthcare providers in the state.  Under the new law, pharmacy technicians willing to increase the scope of their responsibilities undergo a board-approved training for administering immunizations to pharmacy patients. The pilot program was developed with the help of Washington State University College of Pharmacy, which is currently monitoring immunizations provided by Idaho technicians, their effect on improving access to care, and any adverse effects. The data will be used to better utilize the skills of pharmacy technicians and help ease the time burden on pharmacists.

Other states are interested in similar programs for their technicians; however, California is not one of them. Under the current California law, pharmacy technicians are not allowed to perform any tasks in excess of express provisions of the Board of Pharmacy’s regulations. Technicians’ duties should be limited to packaging, manipulative, repetitive or other nondiscretionary tasks. Also, technicians in California must always be directly supervised and controlled by a pharmacist (that means that when a pharmacist is absent, pharmacy technicians should not be performing any professional tasks, but may still perform pharmacy clerk duties, such as working at a cash register or answering the phone). The pharmacist remains responsible for any acts performed by the technicians. The ratio in California remains two technicians per pharmacist (does not apply for inpatient facilities).

If you decide to give your technicians more responsibilities, consider whether these additional tasks involve discretionary duties. Our firm has defended numerous pharmacies and pharmacists in similar matters (i.e. allegations regarding tasking technicians with compounding or consulting patients). It is understandable that pharmacists are overwhelmed with the number of tasks that need to be performed, however – unless you live in Idaho – giving your technicians more responsibility may subject you and your pharmacy to unnecessary issues with the Board of Pharmacy.

The Drug Supply Chain Security Act (DSCSA) is also known as Track-and-Trace law. It creates a system to identify and trace certain prescription drugs to improve detection and removal of potentially dangerous products from the pharmaceutical distribution supply chain.  The DSCSA has two parts.
 
Phase I is product tracing. Manufacturers, wholesalers, repackagers, and many dispensers (primary pharmacies) must provide information about a drug and who handled it each time it was sold in the US market. Dispensers are defined as retail pharmacies, hospital pharmacies, or any other persons or entities authorized by law to dispense or administer prescription drugs (prescribers are exempt).
 
Some transfers are exempt:

  • If the transfer is among entities under common control
  • If an entity is purchasing a product from a Group Purchasing Organization or from another entity that is a member of the GPO
  • Transfer by a charitable organization to a non-profit affiliate.
  • Does not apply to drug samples
  • Minimal quantity transfer by a retail pharmacy to licensed practitioner for office use.

Every time a product is transferred, certain transactional data must be recorded and exchanged between the parties.  This includes Transactional information, Transactional history, and Transactional statement – known as the “3Ts.”
 
Phase II requires manufacturers and repackagers to put a unique product identifier on certain prescription drug packages. For example, a bar code that can be easily read electronically. Unlike phase one (product tracing) this section expressly applies to prescribers.
 
The DSCSA outlines a ten-year plan to build an electronic interoperable system to identify and trace prescription drugs through distribution.
 
All manufacturers, wholesalers, repackagers, and dispensers must have policies and procedures describing proper procedures to quarantine and promptly investigate a drug that had been identified as “suspect” meaning that it maybe counterfeit, unapproved, or potentially dangerous.

SMLXL

 More information from the FDA

Oregon became another state to further increase its oversight over PBMs. Oregon has required PBM registration since 2013, however, it had no actual oversight over PBMs operating in the state. The new law – coming in effect on January 1, 2018 – grants Oregon Department of Consumer Services (DCS) the authority to deny, revoke, or “suspend a PBM registration for specified conduct, including engaging in dishonesty, fraud or gross negligence in the conduct of business as a pharmacy benefit manager and refusing to be examined or to produce accounts, records or files for examination by the department.” In addition, pharmacies may file a complaint with the DCS alleging misconduct by a PBM. The full text of the bill.

Express Scripts has announced further cuts on a number of reimbursed drugs to make its formularies more clinically appropriate and cost effective. Currently, Express Scripts covers approximately 3,791 drugs and the 2017-2018 exclusions would remove 159 drugs out of coverage. According to Express Scripts, most patients will not see any changes but a small percentage of patients will start using different medications with the same therapeutic outcomes. If a medication is not part of the patient’s formulary, it would be covered only with prior authorization. Express Scripts claims that the exclusion will save approximately $2.5 billion to the payors. Further reading.

Biologics are the fastest growing and the most expensive class of drugs on the market. The current cost of biologics is between $50,000 to $250,000 for one year of treatment. FTC Press Release. The numbers are expected to increase even further. Congressional Research.

Biosimilars –on the other hand – are less expensive due to their generic-like nature. Biosimilars are marketed after patents have expired on the original biopharmaceutical product. They are, however, not generic versions of biologics, which are complex, large molecules that are genetically engineered in a highly controlled environment. Because different cells are used to produce a biosimilar version, the end product is different. And in biologic medicine, even a small difference can be crucial to the end product’s clinical effect and safety. Yet, biosimilars are chemically close enough to already approved biopharmaceuticals and their cost of manufacturing is lower (the manufacturers can rely on the already existing scientific knowledge about the safety and effectiveness of the biopharmaceutical).

Therefore, the idea of expediting and increasing availability of biosimilars is very attractive for the policymakers. In addition, a recent U.S. Supreme Court decision held that a biosimilar manufacturer may enter the market faster than a biopharmaceutical manufacturer and may use various shortcuts in a long path of a new drug application process. Sandoz v. Amgen.

Specialty pharmacies are definitely affected by the introduction of biosimilars because most biologics are dispensed through a specialty pharmacy system. Specialty pharmacies’s four largest biopharmaceuticals are erythropoietin, recombinant DNA insulin, human growth hormone, and granulocyte colony stimulating factors. But the transition to biosimilars might not be all smooth for specialty pharmacy. First of all, the availability of biosimilars will depend upon the prescriber’s determination of whether to switch the patient to a biosimilar product. A pharmacist may substitute a generic drug when presented with a prescription for its brand equivalent, unless a physician or patient specifically requests the brand name drug. However, these state substitution laws do not apply to biosimilars. Some states have enacted such substitution provisions, including Florida, North Dakota, Oregon, Utah, and Virginia (Fla. Stat. § 465.0252; N.D. Cent. Code § 19-02.1-14.3; Ore. Rev. Stat. § 689.522; Utah Code § 58-17b-605.5; Va. Code § 54.1-3408.04.) California’s biosimilar substitution law was subsequently vetoed by the governor (but the law allows for interchangeable biologics substitution). Therefore, pharmacies should  work closely with the prescribers to determine whether a biosimilar may suit the patient.

Improved availability and lower cost may reduce pharmacies’ acquisition costs and increase sources of revenue. Patients are also likely to have more options of the products available as well as the number of pharmacies that can serve their needs. Currently, biologics manufacturers supply their products only to very limited distribution channels. Biosimilar manufacturers are likely to make products available to a wider network of specialty pharmacies. But ultimately, time will show how biosimilars affect pharmacies, payors, and patients.

An excellent overview of Biosimilars: “Where are all the Generic Biopharmaceuticas (Follow-op Biologics)? (And how much money will they save?)” by Laura A. Carpenter, RPh, JD.

Last week, the U.S. Department of Justice announced the largest ever healthcare fraud enforcement action by the Medicare Fraud Strike Force. Fraud charges were filed against 115 licensed professionals and payment suspension actions were initiated against 259 providers. DOJ’s announcement.

A particular focus is on medical professionals involved in the excessive prescribing and distribution of opioids; mostly tramadol, hydrocodone, and oxycodone. The primary reason behind these extensive investigations is the extreme use of opioids and questionable prescribing practices. HHS OIG Data Brief on Opioid Use.

The Office of Inspector General (OIG) announced that it will continue targeting medical providers who prescribe or dispense large numbers of opioids. Keep in mind that during an investigation of one provider, federal agencies have access to all business records of that provider and often investigate other providers whose names come up during the investigation. (For example, our firm is currently involved in a federal investigation of a pharmacy that served patients of a prescriber accused of illegal opioid prescribing. The investigation of the prescriber  commenced two years ago and only recently the agencies started their investigation of the pharmacy).

If you prescribe, administer, or dispense controlled substances, you must keep a few things in mind:

  • Strictly comply with your state and federal laws on controlled substances. Sometimes you encounter situations outside of the topics covered by state or federal law. In such situation, you must consult your counsel and document your analysis and decisions.

  • If you are a subject of an investigation, engage your counsel as soon as possible. If the U.S. Department of Justice contacts you, retain a criminal attorney, in addition to your healthcare counsel.

  • Train your staff on the DEA manuals, your licensing board’s precedential decisions, and any issued guidance on the topic.

  • Make sure to verify and report to CURES (PDMP).

  • If you work with a controlled substance inventory, always make sure you have an accurate perpetual inventory and strictly comply with recordkeeping and storage requirements. Keep an eye on the numbers. (Is your stock too large for the industry? Are you ordering a disproportionate amount of control substances? Any notifications of the wholesalers that you are approaching your threshold?)

  • I encourage you to read the attached article describing some additional business practices that can help you in your compliance with controlled substances laws.

Article on Minimizing the Risk in Prescribing, Dispensing, and Administering Controlled Substance prepared for the ABA Health Law Section conference.

Data accumulated in CURES[1] is available to appropriate state and federal agencies, law enforcement, and regulatory boards for disciplinary, civil, or criminal purposes. But when should CURES be reviewed for such purposes? When a government suspects overprescribing? May it be used against a prescriber or a pharmacist when no controlled substances are involved in the underlying disciplinary, civil, or criminal case? California Supreme Court answered these questions yesterday in a case challenging actions of the Medical Board of California when it obtained data from CURES during a disciplinary investigation not involving controlled-substances.[2]

In Lewis case, Medical Board began investigating Dr. Lewis based on a patient’s complaint unrelated to prescribing controlled substances. While the Board found no issues with Dr. Lewis’ treatment of the complaining patient, it did discover instances of improper prescribing by accessing and reviewing CURES. Dr. Lewis argued that the Board had violated his patients’ informational privacy rights in their controlled substances prescription records when it obtained them without a justifiable reason.

Dr. Lewis argued that the Board must obtain a warrant or an administrative subpoena demonstrating a good cause prior to searching and reviewing the records of his patients. The court of appeal decided – on balancing patients’ right to privacy against state’s interest in protecting public health – that state’s practice of reviewing CURES to pursue an individual does not amount to an impermissible invasion of patients’ state constitutional right to privacy, as there are sufficient safeguards to prevent unwarranted public disclosure and unauthorized access to CURES data. California Supreme Court affirmed holding that Medical Board didn’t have to show good cause to access the database because that would hamper efforts to prevent abuse: “Delays … would impede the board’s ability to swiftly identify and stop dangerous prescribing practices.” The decision does not come as a surprise at a time of a nationwide epidemic of opioid abuse.

Note: Louisiana Supreme court also tackled a similar issue – but in a criminal context – and held that the Fourth Amendment requires a search warrant before a search of prescription and medical records for criminal investigative purposes.[3]

The 9th U.S. Circuit Court of Appeals weighed in on a related issue when it said the DEA does not need a court order to subpoena Oregon’s prescription drug database. The case ultimately did not resolve whether DEA’s administrative subpoenas violate constitutional protections against unreasonable search and seizure.

[1] Controlled Substance Utilization Review and Evaluation System (CURES) is California’s Prescription Drug Monitoring Program (PDMP).

[2] Lewis v Superior Court of Los Angeles County, 226 Cal.App.4th 933 (2014).

[3] State v. Brock, 210 So. 3d 276, 277 (La. 2017), State v. Skinner, 10 So. 3d 1212, 1218 (La. 2009)

 

In 2016, California enacted End-of-Life Option Act. The Act specifically exempts pharmacist and physicians from liabilities for participating in the medically-assisted suicide. Approximately 504 California patients requested the prescriptions last year.

From the inception of the bill, a group of healthcare providers voiced a strong opposition to the Act. Last year, the group and the American Academy of Medical Ethics filed a law suit challenging medically-assisted death. The case, in the opinions of many, had very little chances of surviving the initial stage due to the nature of the Act (it does not give any right to the doctors to bring a legal challenge in the first place). The judge, however, allowed the suit to proceed, ruling that the doctors alleged enough information to ultimately succeed on the merits.The state – defending the Act – argued that the law merely offers patients a choice and does not confer any rights and therefore should be dismissed. Nevertheless, the judge ruled that the doctors may proceed on the constitutional grounds (under equal protection and due process).

To read more about the suit: from U.S. News

Note:

A pharmacist may receive a prescription for a life-ending drug – usually secobarbital or pentobarbital – through electronic means and must consult the patient on the proper intake of the drug. The pharmacist should assure that the patient understands the purpose of the medication, its side effects (vomiting, prolonged suffering, etc.), and the procedure to take if the patient changes his mind (the medication should not be flushed down the toilet, and if a patients changes his mind after taking the drug, he should know how to prevent the drug from taking its effects).

More on procedures and compliance when dispensing life-ending drugs, from PharmacyTimes.

More information on life-ending drugs and recommended dosage and usage, from MedScape.

The federal government reported that in 2016 the healthcare industry experienced 106 hacker-attributed data breaches. Around $2.8 billion was spent on cleaning up hacking incidents. Nowadays medical devices are connected to the internet (and therefore are prone to cyberattacks)  but are they keeping pace with cybersecurity developments?

The issue was first brought up when potential security vulnerabilities in St. Jude’s pacemakers and defibrillators were discovered. To read more on the controversy of St. Jude’s medical devices, go here. The FDA investigated the vulnerabilities and issued a Safety Communication confirming vulnerabilities of St. Jude’s cardiac devices. Shortly after, Johnson & Johnson started to warn its patients about a cyber vulnerability of its older model insulin pump, which could potentially be hacked and cause injury or death to patients (overdose).

The hacking potential is huge in the medical devices field. Not only we are talking about hacking individual devices that can cause harm or death to patients but also accessing hospital networks through them. And hospital databases have been a lucrative target for hackers. TrapX – a cybersecurity defense firm – released a report describing how hackers can gain access to hospital networks through medical devices (and how they can hack a hospital drug pump to modify the amount of medical to a fatal dose!).

Healthcare providers selling, maintaining, or working in any way with medical devices must be aware of the potential risks associated with cybersecurity. Potential breaches can cause millions to clean up (including ransoms in bitcoins), injuries to patients (read: potential suits against providers), and reputational harm.

The FDA issued guidance on cybersecurity in medical devices. Accessible here.

The FTC also issued guidance on best practices in preventing cybersecurity breach in medical devices. You may access here.

 

The new administration has vowed to lower drug prices. The new importation bill maybe exactly the solution to that. The bill – pending in Congress – proposes to remove importation barriers and enable Americans to purchase foreign drugs. In 2003, we came pretty close to drug importation through the Medicare Modernization Act. The Secretary of HHS, however, could not assure the quality of these drugs and did not present the numbers on how much such measure would save. The FDA was also vocal about opposing the measure arguing possible serious harm from the use of adulterated, substandard, or counterfeit drugs.

A recent proposal from the Democrats (including Bernie Sanders) may possibly overcome this concern by setting up a regulatory system where Canadian pharmacies who purchase their supply from manufacturers inspected by the FDA would be licensed to sell to the U.S. patients. The bill also allows drug wholesalers and pharmacies to buy from Canada. The bill provides that HHS could eventually allow importation from other countries that meet standards comparable with the U.S. standards.

Trump has publicly announced that he supports the measure. The bill, however, faces serious opposition form the Pharma (surprise!) claiming that the measure presents threats to public health.

According to Kaiser Health News (KHN) about 8% of Americans have bought medicines outside of the U.S. A report by KHN also noted that PharmacyChecker.com helps Americas buy expensive medications in Canada (legal?). For a comparison on U.S. and Canada drug prices, go to KHN’s article covering the bill by clicking here.

Potentially this bill could be a game-changer for pharmacies, since they would have to compete with foreign pharmacies but potentially could buy cheaper products from foreign suppliers.

The summary of the bill can be accessed here.