add, ads, automated dispensing device, automated dispensing system, auxiliary medication inventory, emergency kit, ancillary drug cabinet, patient care unit, nursing home, long-term care, limited service permit, controlled substance
Goto Lianhe Aigen to know more.
If controlled substances are placed an auxiliary medication inventory, that storage must comply with 10A NCAC 26E., which allows skilled nursing facilities, intermediate care facilities, and combination facilities licensed by the Department of Health and Human Services to have a controlled substance emergency kit. 21 NCAC 46.(d)(7) This requirement applies equally when an automated medication system is being used as an auxiliary medication inventory.
A controlled substance emergency kit (whether contained in an automated medication system or other inventory) can contain no more than seven (7) controlled (II-V) drug entities, as determined by the medical staff and as approved by the pharmaceutical service committee. Controlled substances for emergency use shall be obtained through purchase orders from the licensed pharmacist who regularly provides medications to the facility. If CIIs are purchased, DEA order forms must be used. The controlled substances must be provided in unit-dose form. “A facility shall not be permitted to possess more than 5 doses of each controlled substance entity for each 50 licensed beds or fraction thereof.”
Any emergency kit containing controlled substances must be locked and stored with access limited to authorized personnel. Only those designated by the director of the facility shall have access to these controlled-substance-containing emergency kits. The facility must be registered with the DEA, or have received an exemption, to use controlled substances in this manner, as would be required for any other use.
The primary responsibility for the proper control and accountability of such drugs in the facility belongs to the “pharmacist-supplier” of the controlled drugs used in the emergency kit.
compound, compounding, commercially available product, federal food drug cosmetic act, shortage, usp
In general, no. The federal Food Drug & Cosmetic Act prohibits pharmacies from compounding “drug products that are essentially copies of a commercially available drug product.” FD&C Act § 503A(b)(1)(D)
FDA has issued enforcement guidance on how the “essential copy” restriction is interpreted and applied: Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act
FDA does not consider a drug to be “commercially available” if it appears in FDA's Shortage Database. On April 27, , FDA officials clarified that a drug is considered in shortage by the FDA if it is listed in the database and its “status” is described as “currently in shortage.”
When compounding any drug product, the substances used to compound must: (1) comply with the standards of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph, if a monograph exists, and the USP chapter on pharmacy compounding; (2) if such a monograph does not exist, then the substances used must be components of drugs approved by the Secretary [of HHS]; or (3) if such a monograph does not exist and the drug substance is not a component of a drug approved by the Secretary [of HHS], appear on a list developed by the Secretary through regulation. FD&C Act § 503A(b)(1)(A)(i)
The pharmacy must ensure that the API used in compounding is a pharmaceutical grade product, accompanied by a valid certificate of analysis, and is sourced from an establishment registered with FDA under Section 510 of the FD&C Act. FD&C Act § 503A(b)(1)(A)(ii) – (iii)
controlled substances, csrs, nccsrs, controlled substances reporting system, gabapentin, veterinary
The CSRS requires (GS § 90-113.73(b)) dispensers to report the following information for all dispensed controlled substances and (effective March 1, ) gabapentin:
(1) The dispenser's DEA number.
(2) The name of the patient for whom the controlled substance is being dispensed, and the patient’s:
a. Full address, including city, state, and zip code,
b. number, and
c. Date of birth.
(3) The date the prescription was written.
(4) The date the prescription was filled.
(5) The prescription number.
(6) Whether the prescription is new or a refill.
(7) Metric quantity of the dispensed drug.
(8) Estimated days of supply of dispensed drug, if provided to the dispenser.
(9) National Drug Code of dispensed drug.
(10) Prescriber’s DEA number.
(11) Prescriber's national provider identification number, for any prescriber that has a national provider identification number. A pharmacy shall not be subject to a civil penalty for failure to report the prescriber's national provider identification number when it is not received by the pharmacy.
(12) Method of payment for the prescription.
The North Carolina Drug Control Unit has specific guidance on gabapentin reporting, including instruction on how a pharmacy that does not hold a DEA registration may register with the CSRS.
Effective March 1, , state law requires all veterinary dispensations of gabapentin to be reported to the CSRS. Some veterinarians may lack a Drug Enforcement Agency (DEA) or National Provider Identifier (NPI) number. To facilitate CSRS reporting of veterinary gabapentin dispensations in that circumstance, the Drug Control Unit (“DCU”) will enable a failover allowing submissions using the veterinarian’s North Carolina license number. DCU has updated its Dispenser and Veterinarian Dispensers Guides (found here) to include the veterinary license failover process. DCU has also published a Gabapentin Veterinary State License Failover Reporting FAQ (found here). Anyone with questions or concerns about DCU’s veterinary gabapentin reporting processes should contact Savannah Simpson or the CSRS inbox.
controlled substances, csrs, nccsrs, controlled substances reporting system, dispenser, dispenser definition
The act defines (GS § 90-113.72(4)) a dispenser as “a person who delivers a Schedule II through V controlled substance to an ultimate user in North Carolina, but does not include any of the following:
a. A licensed hospital or long-term care pharmacy that dispenses such substances for the purpose of inpatient administration.
b. A person authorized to administer such a substance pursuant to Chapter 90 of the General Statutes.
c. A wholesale distributor of a Schedule II through V controlled substance.”
DHHS advises that, in determining whether a particular facility is a “dispenser”, facility personnel should ask themselves whether the dispensing will occur for administration to a patient population that is resident at, or confined within, the facility. If so, then the facility is not likely to be considered a “dispenser” for reporting purposes. If not, then the facility is likely a “dispenser” for reporting purposes.
Some specific examples:
Emergency Departments. Dispensing of controlled substances to emergency department patients, including the dispensing of 24-hour “send home” packs, would not trigger a reporting requirement.
Hospital patients. Dispensing of controlled substances to hospital patients while receiving care at the hospital does not trigger a reporting requirement. This includes outpatient surgery.
Dispensing controlled substances to a hospital patient for administration outside the hospital on an outpatient basis does trigger a reporting requirement.
Long-Term Care Facility, Assisted Living Facility, Group Homes, Hospice Facility. These facilities are expressly excluded from the definition of a “dispenser” unless the facility has its own pharmacy that dispenses medications for administration outside the facility.
Health Departments, Mental Health Facilities, Free Clinics. Dispensing controlled substances to outpatients of these facilities does trigger a reporting requirement.
Prisons or Jails. Dispensing to inmates confined to the facility does not trigger a reporting requirement.
controlled substances, treatment of substance use disorder, substance use, methadone, buprenorphine, data-waiver, mate act, dea
Methadone may be used for the treatment of pain, and any pharmacy may dispense methadone if the prescription is for a legitimate medical purpose and prescribed in the ordinary course of medical practice. This would include using methadone as part of a formal pain management program in which a patient is switched from other licit drugs to methadone to control or gradually reduce dosage of pain medication.
Methadone may only be prescribed and administered to maintain narcotic addiction or to detoxify a patient when the prescriber is registered by Drug Enforcement Administration (DEA) as a narcotic treatment facility (NTF). In such cases, the drug may only be administered by the NTF.
On December 29, , with the signing of the Consolidated Appropriations Act of (the Act), Congress eliminated the “DATA-Waiver Program”, under which prescribers were required to obtain an “X” DEA number to prescribe medications like buprenorphine for the treatment of opioid use disorder ("OUD"). All practitioners who have a current DEA registration that includes Schedule III authority may prescribe buprenorphine for OUD in their practice if permitted by applicable state law. North Carolina rules and laws do not conflict with this authority to prescribe buprenorphine for opioid use disorder with a current DEA registration.
Accordingly:
A DATA-Waiver registration is no longer required to treat patients with buprenorphine for opioid use disorder. Prescriptions for buprenorphine only require a standard DEA registration number. The previously used DATA-Waiver registration numbers are no longer needed for any prescription.
There are no longer any limits or patient caps on the number of patients a prescriber may treat for opioid use disorder with buprenorphine.
Separately, the Act also introduced new training requirements for all prescribers. These requirements went into effect on June 21, . The DEA has outlined the requirements for DEA-registered practitioners to meet the new, one-time Medication Access and Training Expansion Act (MATE Act) training requirement that will be tied to their initial or renewal DEA registration. This requirement applies to practitioners holding individual DEA registrations. A pharmacist who is not an individual DEA registrant – i.e., practice pharmacy under the DEA registration of the employing pharmacy – is not required to obtain this training. But pharmacists such as Clinical Pharmacist Practitioners who are individual DEA registrants that prescribe controlled substances are subject to the requirement.
There are three ways that practitioners may meet this training requirement, which are outlined in DEA's letter. The letter also defines which accredited groups may provide training to meet the requirement, key points related to the training, and a list of practitioners who have been deemed to satisfy the training.
The DEA’s letter is found here: DEA MATE Training Letter. Recommendations for curricular elements in substance use disorders training is also available from the Substance Abuse and Mental Health Services Administration. If you have any additional questions on this issue, please contact the DEA Diversion Control Division Policy Section at or (571) 362-.
drug disposal, disposing drugs, controlled substances
The NCBOP Drug Disposal Form can be found by logging into the facility portal. The Drug Disposal Form Tab is located at the bottom of the facility page.
1. Complete the form making sure a current address is listed. The form can be saved to be completed later; a confirmation number will be provided to access the form again. Once the form is submitted, you will not be able to access the form to make changes.
Community/retail pharmacies are to use this form for controlled or non-controlled medications; however, when listing controlled substances, a separate form(s) must be used. Do not combine controlled and non-controlled medications.
Hospitals, clinics and nursing homes (see #3) may use this form for non-controlled medications only. Duplicate/multiple forms are permitted. These forms shall be retained by the pharmacy for a period of three (3) years.
2. Once the form is submitted and reviewed by staff, an will be sent to notify the permit that approval for drug disposal has been given. The should be retained in the pharmacy for (3) years.
3. Contact the NC Department of Health & Human Services, Drug Control Unit at (919) 733- for disposal or destruction of controlled substance medications in:
- Hospitals
- Nursing homes that are skilled facilities with a ten (10) bed limit. Note: this does not include assisted living facilities.
- Clinics include: EMS, Veterinary clinics, Methadone clinics, outpatient surgery clinics, weight loss clinics and physician practices with more than one (1) practitioner using common stock of controlled substance medications.
The Drug Control Unit has more information available here: NCDHHS Drug Control Unit FAQs.
pseudoephedrine, controlled substance, sale of pseudoephedrine containing products, pse
North Carolina law requires all sellers of pseudoephedrine containing products to participate in a real-time electronic program for the purpose of tracking illegal pseudoephedrine purchases -- the National Precursor Log Exchange (NPLEx).
This October 27, letter to Pharmacy Managers from then-NC SBI Director Gregory S. McLeod outlines those requirements.
This November 16, follow-up letter to Pharmacy Managers from then-NC SBI Director Gregory S. McLeod includes NPLEx account login, training, and support instructions and information.
To avoid double record keeping, the North Carolina Mental Health Commission has deemed reporting into the NPLEX system as a "form approved by the commission," thus eliminating the requirement for keeping two logs and obtaining two signatures. By reporting in to the NPLEX system, NPLEX is essentially keeping your log for you and electronically storing it. Law enforcement may retrieve the information from NPLEX. If the system is down, you must keep the log and obtain the signature as previously required.
A pharmacy must still post a sign visible in 10-point bold face print near the place where the electronic signature is obtained that says the following:
"North Carolina law strictly prohibits the purchase of more than 3.6 grams total of certain products containing pseudoephedrine per day, and more than 9 grams total of certain products containing pseudoephedrine within a 30-day period. This store will maintain a record of all sales of these products which may be accessible to law enforcement officers."
This should be called to the customers' attention at the time the signature is obtained.
The PSE restrictions apply only to the retail sales of ephedrine and pseudoephedrine products sold behind a pharmacy counter and do not apply to valid prescriptions dispensed to a consumer.
pain management, end of life care, palliative, terminal illness
Through dialogue with members of the healthcare community and consumers, a number of perceived regulatory barriers to adequate pain management in end-of-life care have been expressed to the Boards of Medicine, Nursing, and Pharmacy. The following statement attempts to address these misperceptions by outlining practice expectations for physicians and other health care professionals authorized to prescribe medications, as well as nurses and pharmacists involved in this aspect of end-of-life care. The statement is based on: the legal scope of practice for each of these licensed health professionals; professional collaboration and communication among health professionals providing palliative care; and a standard of care that assures on-going pain assessment, a therapeutic plan for pain management interventions; and evidence of adequate symptom management for the dying patient.
It is the position of all three Boards that patients and their families should be assured of competent, comprehensive palliative care at the end of their lives. Physicians, nurses and pharmacists should be knowledgeable regarding effective and compassionate pain relief, and patients and their families should be assured such relief will be provided.
Because of the overwhelming concern of patients about pain relief, the physician needs to give special attention to the effective assessment of pain. It is particularly important that the physician frankly but sensitively discuss with the patient and the family their concerns and choices at the end of life. As part of this discussion, the physician should make clear that, in some end-of-life care situations, there are inherent risks associated with effective pain relief. The Medical Board will assume opioid use in such patients is appropriate if the responsible physician is familiar with and abides by acceptable medical guidelines regarding such use, is knowledgeable about effective and compassionate pain relief, and maintains an appropriate medical record that details a pain management plan. Because the Board is aware of the inherent risks associated with effective pain relief in such situations, it will not interpret their occurrence as subject to discipline by the Board.
With regard to pharmacy practice, North Carolina has no quantity restrictions on dispensing controlled substances including those in Schedule II. This is significant when utilizing the federal rule that allows the partial filling of Schedule II prescriptions. In these situations, it would minimize expenses and unnecessary waste of drugs if the prescriber would note on the prescription that the patient is terminally ill and specify the largest anticipated quantity that could be needed for the next two months. The pharmacist could then dispense smaller quantities of the prescription to meet the patient’s needs up to the total quantity authorized.
Government-approved labeling for dosage level and frequency can be useful as guidance for patient care. Health professionals may, on occasion, determine that higher levels are justified in specific cases. However, these occasions would be exceptions to general practice and would need to be properly documented to establish informed consent of the patient and family. Federal and state rules also allow the fax transmittal of an original prescription for Schedule II drugs for hospice patients. If the prescriber notes the hospice status of the patient on the faxed document, it serves as the original. Pharmacy rules also allow the emergency refilling of prescriptions in Schedules III, IV, and V. While this does not apply to Schedule II drugs, it can be useful in situations where the patient is using Xanax for anxiety.
The nurse is often the health professional most involved in on-going pain assessment, implementing the prescribed pain management plan, evaluating the patient’s response to such interventions and adjusting medication levels based on patient status. In order to achieve adequate pain management, the prescription must provide dosage ranges and frequency parameters within which the nurse may adjust (titrate) medication in order to achieve adequate pain control. Consistent with the licensee’s scope of practice, the RN or LPN is accountable for implementing the pain management plan utilizing his/her knowledge base and documented assessment of the patient’s needs. The nurse has the authority to adjust medication levels within the dosage and frequency ranges stipulated by the prescriber and according to the agency’s established protocols.
However, the nurse does not have the authority to change the medical pain management plan. When adequate pain management is not achieved under the currently prescribed treatment plan, the nurse is responsible for reporting such findings to the prescriber and documenting this communication. Only the physician or other health professional with authority to prescribe may change the medical pain management plan.
Communication and collaboration between members of the healthcare team, and the patient and family are essential in achieving adequate pain management in end-of-life care.
Within this interdisciplinary framework for end-of-life care, effective pain management should include:
-
thorough documentation of all aspects of the patient’s assessment and care;
-
a working diagnosis and therapeutic treatment plan including pharmacologic and non-pharmacologic interventions;
-
regular and documented evaluation of response to the interventions and, as appropriate, revisions to the treatment plan;
-
evidence of communication among care providers;
-
education of the patient and family; and,
-
a clear understanding by the patient, the family and healthcare team of the treatment goals.
It is important to remind health professionals that licensing boards hold each licensee accountable for providing safe, effective care. Exercising this standard of care requires the application of knowledge, skills, as well as ethical principles focused on optimum patient care while taking all appropriate measures to relieve suffering. The healthcare team should give primary importance to the expressed desires of the patient tempered by the judgment and legal responsibilities of each licensed health professional as to what is in the patient’s best interest.
supplements, cbd, cannabidiol, epidiolex, hemp, farm bill, fda, cannabis, thc
No. On December 20, , FDA Commissioner Scott Gottlieb issued a statement explaining that while the Farm Bill of removed hemp from the federal Controlled Substances Act, "Congress explicitly preserved the [FDA's] authority to regulate products containing cannabis or cannabis-derived compounds under the FD&C Act." Hence, the FDA "treat[s] products containing cannabis or cannabis-derived compounds as [it does] any other FDA-regulated products." Importantly, FDA reminded the regulated community that it is "unlawful under the FD&C Act . . . to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as . . . dietary supplements." The full statement is found here:
FDA CBD Statement.
In late February , the North Carolina Department of Agriculture -- which directly regulates industrial hemp products in North Carolina -- began sending letters to businesses that manufacture or sell CBD-containing products emphasizing that "North Carolina has routinely adopted by reference the federal Food, Drug & Cosmetic Act and implementing regulations. The violation of these federal laws and regulations would equally be a violation of state laws and regulations." The Department of Agriculture's letter -- like Commissioner Gottlieb's statement -- emphasizes that "CBD is the active ingredient in the approved drug product Epidiolex" and that "[s]ince CBD is the active ingredient in the approved drug product Epidiolex, it is currently excluded from being a dietary supplement under section 210(ff)(3)(B)(i) and (ii) of the FD&C Act."
The North Carolina Department of Agriculture further emphasized that "CBD products marketed with claims to prevent, mitigate, diagnose, treat or cure diseases" make those products "drugs under the FD&C Act." Accordingly, "CBD in products other than the approved drug Epidiolex and which make health claims would be a new drug that cannot legally be introduced into interstate commerce."
The full text of the Department of Agriculture letter is found here: NC Department of Agriculture CBD Statement.
rapid diagnostic, tests, clia, clia-waived tests, clinical laboratory improvement amendments act
Board staff have received numerous questions about pharmacies' ability to perform "rapid diagnostic" and other "CLIA-waived" tests. Some point-of-care tests for things like streptococcus infection, blood glucose levels, and cholesterol levels are approved by the FDA as so-called “CLIA-waived” tests.
CLIA refers to the Clinical Laboratory Improvement Amendments Act, a federal statute that, as the name suggests, governs clinical laboratories. When FDA approves an in vitro diagnostic device, it may designate the device as approved “for home use or that, as determined by the Secretary, are simple laboratory examinations and procedures that have an insignificant risk of an erroneous result, including those that . . . employ methodologies that are so simple and accurate as to render the likelihood of erroneous results by the user negligible, or . . . the Secretary has determined pose no unreasonable risk of harm to the patient if performed incorrectly.”
42 USC § 263a(d)(3). If so deemed by the FDA, these tests may be performed in a laboratory that has applied for a waiver of CLIA requirements. 42 USC § 263a(d)(2). CLIA-waived tests don’t require, as a condition of FDA approval, any sort of “prescription” or medical order.
Unlike some states, North Carolina law does not impose a separate layer of regulations on top of CLIA: If a facility – including a pharmacy – meets the criteria to perform CLIA-waived tests and obtains from the federal Centers for Medicare and Medicaid Services a CLIA waiver, then that facility may perform any CLIA-waived tests.
A pharmacy performing a CLIA-waived test cannot allow its pharmacists to use the results of a CLIA-waived test to prescribe drug therapy independently, or to do anything with the test results besides provide them to the patient and/or communicate them to the patient’s provider of choice. (The exception would be a CPP whose agreement with the supervising physician authorizes the CPP to act on test results.)
transfer, transferring prescriptions, patient request
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On a semi-regular basis, Board staff receive calls from pharmacists raising concerns or complaints about prescription transfer practices. Typically, the concern or complaint takes one of the following forms: (a) the pharmacist complains that another pharmacy (or, more frequently, a particular pharmacist) refuses to transfer prescriptions upon request; (b) the pharmacist complains that another pharmacy (or pharmacist) agrees to transfer prescriptions, but takes a long time to do so; (c) the pharmacist complains that another pharmacy (or pharmacist) is “tricking” or “coercing” patients into transferring prescriptions.
Board Rule . authorizes the transfer of prescriptions among pharmacies, and it sets forth procedural and recordkeeping requirements for doing so. Pharmacists seldom have questions about these procedural or recordkeeping requirements. Instead, most of the focus in these situations is one word in the rule – “permissible.” The introductory language of Rule . says that the “transfer of original prescription information for the purpose of refill dispensing is permissible between pharmacies . . . .” Pharmacies or pharmacists who have refused to transfer a prescription typically respond to a complaint by saying that the rule makes transfers “permissible,” and not “mandatory.” What tends to get lost in this blinkered argument is the most important factor – the patient.
Patients have the right to select their pharmacy provider. Patients have many reasons for choosing a particular pharmacy in the first instance or deciding that they wish to change to a different pharmacy. Whatever those reasons, the patient is the decision maker. A patient’s wishes must be respected not only because it’s the right thing to do, but also to avoid interruption of care that could well prove harmful to the patient.
With this background in mind, this is how Board staff approach transfer complaints:
1. Pharmacists are expected to consult with one another professionally and politely to resolve transfer issues. Staff often find that the root of a transfer dispute is a personal or business conflict among pharmacists or pharmacies. These sorts of disputes are not a reason to involve the Board, nor are they a reason to delay (or deny) a patient’s care.
2. In some cases, a pharmacist alleged to have wrongly refused a transfer will state that he/she simply wants to confirm the request with the patient. That, in and of itself, doesn’t necessarily raise an issue. But “I’m checking with the patient” must not become a pretext for denying a transfer or delaying one to such a degree that the patient’s continuity of care is jeopardized. And pharmacy policies and procedures that incentivize staff pharmacists to delay or deny transfers place those pharmacists, the pharmacist-manager, and the pharmacy permit in potential jeopardy.
3. Board staff treats a transfer complaint from a patient as a higher priority matter than a transfer complaint from a pharmacist. This is because, as noted above, transfer complaints relayed by pharmacists are often rooted in personal or business conflicts. Direct patient complaints are more typically rooted in potential harm resulting from interrupted drug therapy. A patient who alerts the Board that his/her transfer request is not being honored, or is not being honored in a timely fashion, will find a ready ear and a helping hand from Board staff.
4. If, after a patient complaint, neither professional consultation among the pharmacists nor informal intervention of Board staff (usually by way of a call to both pharmacists with a suggestion that the patient’s request be met without further delay), Board staff will open a case and pursue it as a disciplinary matter focusing on potential negligence in a pharmacist’s/pharmacy’s outright refusal to transfer or a dilatory transfer.
5. Pharmacies are expected to have adequate staff on hand to fulfill a patient’s transfer request in a timely fashion. As noted in Item of the July Newsletter, in recent months some pharmacies have abruptly closed without adequate (and legally required) notice to patients. Predictably, this results in the pharmacy receiving the prescription files getting bombarded with transfer requests. The pharmacist-manager of the receiving pharmacy must staff it sufficiently to accomplish timely transfers. Failure to do so will lead to a Board staff investigation and potential discipline.
6. If a pharmacy or pharmacist complains to the Board that it believes a patient was “tricked” or “coerced” into transferring prescriptions, Board staff needs, at a minimum, the patient’s name and contact information and strongly prefers to receive the complaint from the patient directly. In Board staff’s experience, most often the patient explains that he/she did authorize a transfer but was uncomfortable admitting this to his/her now-former pharmacy. But if a patient directly alleges that he/she experienced a transfer that he/she did not authorize, that is a serious matter that could involve not only the Board of Pharmacy, but also law enforcement agencies or the North Carolina Attorney General’s office.
In , the Oregon Legislature passed the Prescription Drug Price Transparency Act (House Bill ) to increase transparency in how prescription drugs are priced. The act established the following:
- Oregon's Drug Price Transparency program in the Division of Financial Regulation, part of the Department of Consumer and Business Services, to provide transparency for prescription drug pricing through reporting of specific drug price information from consumers, health insurers, and prescription drug manufacturers.
- The Task Force on Fair Pricing of Prescription Drugs within the Oregon Legislature charged with examining and developing transparency strategies for the entire pharmaceutical supply chain.
Reporting requirements for drug manufacturers were modified in by
House Bill to require a 60-day notice of price increases meeting certain criteria.
The department receives reports from consumers, health insurers, and pharmaceutical manufacturers. Different information on prescription drug pricing is reported from each stakeholder:
Consumers – May notify the department and report on drug price increases.
Health insurers – Report on the top 25 drugs for various categories including most frequently prescribed, most costly, and those causing the greatest increase in plan spending.
Prescription drug manufacturers – Report on price increases and new prescription drugs above specific thresholds on wholesale acquisition cost. Reports include pricing data, reasons for increases, publicly funded research and development costs, marketing costs, sales revenue and net profit data, prices paid in other countries, and patient assistance program data.
A prescription drug is a substance used to treat, cure, or prevent diseases and is required to have a doctor or health practitioner’s approval for someone to purchase it. Prescription drugs can be either a brand name or generic drug. Brand name prescription drugs are protected by a patent, which provides protections to the drug developer for a set period of time when no one else can produce the same drug. A generic drug is considered to be the same as a brand name drug and competes with the brand name drug once the patent has expired. Generic drugs typically cost less. A specialty drug is a high-cost drug (brand name or generic drug) that exceeds a certain price threshold.
The pharmaceutical supply chain is a complex structure that includes several types of entities working to supply consumers with drug products. Manufacturers, wholesale distributors, pharmacies, pharmacy benefit managers (PBM), health insurance companies, medical providers, and consumers make up the majority of the pharmaceutical supply chain.
The Prescription Drug Price Transparency Act currently requires prescription drug manufacturers and health insurance companies to report on prescription drug prices. Additionally, consumers are provided the opportunity to notify the department of a prescription drug price increase.
For more information on the transparency strategies for the pharmaceutical supply chain, refer to the Joint Interim Task Force on Fair Pricing of Prescription Drugs –
Report on Transparency Strategies for the Pharmaceutical Supply Chain.
Figure 2: Pharmaceutical supply chain for brand name drugs dispensed through retail pharmacies
Source: RAND Corp. and U.S. Department of Health and Human Services; Mulcahy, Andrew W. and Kareddy, Vishnupriya. “Prescription Drug Supply Chains: An Overview of Stakeholders and Relationships." RAND Corporation, . Accessed Sept. 19, .
The price you pay at the pharmacy is determined through a complex set of factors throughout the pharmaceutical supply chain. If you are uninsured, you typically are paying the list price of the drug set by the drug manufacturer as well as supply chain costs.
If you have health insurance, prescription drug costs are typically regulated through placement on a tier determined by your insurance company or their pharmacy benefit manager (PBM). Placement on a higher tier typically results in a higher cost. Many health insurance companies will require a copay or coinsurance payment when you pay for the prescription drug at the pharmacy. A copay is a flat fee, such as $5 per prescription, and coinsurance is a percentage of the drug cost, such as 20 percent of the drug price, that you pay when you get a prescription drug. The negotiated reimbursement between the pharmacy and your health insurance carrier or their PBM can affect the cost.
The Joint Interim Task Force examined the supply chain and the cost factors that may affect the price paid by Oregonians for pharmaceutical products. The figure below from their report displays the interactions and the cost factors involved with the different entities within the pharmaceutical supply chain.
No, only reporting manufacturers who have new drugs or price increases that exceed the reporting thresholds are required to submit reports. A “reporting manufacturer" is defined in administrative rule (OAR 836-200-) as an entity:
- Required to be registered with the Oregon Board of Pharmacy as a drug manufacturer;
- That engages in the manufacture of prescription drugs sold in this state as defined by
ORS 646A.689(1)(d); and
- That sets or changes the wholesale acquisition cost of the drugs it manufactures.
Reporting manufacturers include entities that identify as virtual manufacturers or contract out the act of manufacturing to another entity. Each entity that is a reporting manufacturer (even subsidiaries of a parent company that is also a reporting manufacturer) are required to create their own separate account with the department. If a parent company is setting the price, then the account creation and reporting responsibility is with the parent company.
Manufacturers identifying as animal or veterinary drug or durable medical equipment manufacturers are not subject to the current Oregon law.
The Drug Price Transparency program reviews information claimed by prescription drug manufacturers to be a trade secret under ORS 192.345(2).
Under ORS 192.345(2), a trade secret is defined as including but not limited to “any formula, plan, pattern, process, tool, mechanism, compound, procedure, production data, or compilation of information which is not patented, which is known only to certain individuals within an organization, and which is used in a business it conducts, having actual or potential commercial value, and which gives its user an opportunity to obtain a business advantage over competitors who do not know or use it.
For data elements claimed to be trade secret under ORS 192.345(2), the website will show that the data is under review. The department will review all information received including information claimed to be trade secret. If in disagreement with any trade secret claim, a determination will be issued and the manufacturer will have an opportunity to appeal the department's decision. Once the review process is completed, the data that is not considered trade secret will be publicly available on the department website. Information that is considered a trade secret will not be published unless public interest requires disclosure. If the department determines that information must be withheld as a trade secret, any person may petition the attorney general to review the determination, as provided in ORS 192.411.
See the user guide on the
webpage for manufacturers for more information.
Data reported to the department will be available to the public as soon as possible and can be viewed on the
data webpage. Once data is reported from prescription drug manufacturers, it is published to the website, unless the manufacturer claims it is a trade secret.
Data reported by prescription drug manufacturers can be claimed to be a trade secret under ORS 192.345(2).
For data elements claimed to be trade secret under ORS 192.345(2), the website will show that the data is under review. The department will review all information received, including information claimed to be trade secret. If in disagreement with any trade secret claim, a determination will be issued and the manufacturer will have an opportunity to appeal the department's decision.
Once the review process is completed, the data that is not considered trade secret will be publicly available on the department website. Information that is considered a trade secret will not be published unless public interest requires disclosure. If the department determines that information must be withheld as a trade secret, any person may petition the attorney general to review the determination, as provided in ORS 192.411.
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