Tag Archives: prescription
Last week, New Jersey Governor Chris Christie signed into law Assembly Bill 3, which, among other things:
1. Limits doctors’ ability to issue first-time opioid prescriptions for more than five days;
2. Mandates that doctors create a pain-management treatment plan regarding the use of opioids and review prescriptions every three months; and
3. Requires doctors to obtain a written record that the doctor and patient have discussed the risks of taking opioids.
The prescription drug limit would not apply to cancer and chronic pain patients or end-of-life care.
Ohio House Bill 188 (HB 188), which passed last year, greatly expands the role of the Ohio pharmacist by streamlining the collaborative practice agreement paperwork and allowing physicians to enter into an agreement with multiple pharmacists to manage drug therapy for their patients.
Under an Ohio collaborative practice agreement, pharmacists can order blood or urine tests, analyze the results and then, add, modify or discontinue a drug without requiring a qualified physician to cosign, provided the pharmacist’s work is done within the scope of the collaborative practice agreement.
Additionally, HB 188 allows pharmacists to order a 30-day supply of a prescription refill for patient if the prescription has expired and a physician cannot be reached.
With the passage of HB 188, Ohio joins other states such as California, North Carolina, Oregon and Washington, that have recently updated their collaborative practice agreements. Ultimately, the goal is to have pharmacists become more involved in nondispensing, hands-on patient care.
On April 15, 2016, the FDA issued draft guidance on the Prescription Requirement Under 503A (Prescription Guidance).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.
How often are pharmacy prescription label instructions translated incorrectly?
Should pharmacists who are fluent only in English be required to fill prescriptions with instructions in a foreign language?
Who counsels the non-English speaking patients regarding their prescription(s) and/or side effects of the medication(s)?
Who is ultimately liable for the incorrect translated instructions in the event there is an error?
As discussed previously on the Baer Law Blog, California is reviewing legislation that would require pharmacies to provide prescription instructions in languages other than English. The proposed legislation is currently under consideration by the California Board of Pharmacy (Board) and a decision may be available in early 2015.
Proponents argue that English only prescription labels contribute directly to medication nonadherence and poor patient outcomes in the estimated forty-four percent of California residents who speak a language other than English at home.
Presently, the Board’s website offers prescription label translations for the most common medication instructions in Spanish, Chinese, Vietnamese, Korean, and Russian. The language translations assist pharmacists in clarifying medication instructions for non-English speaking patients, but are not presently required on prescription labels.
While translated labels may improve adherence and outcomes, pharmacists remain concerned with the accuracy of translated labels and numerous liability issues surrounding such translations.
One of the strongest pharmacist arguments is: If I cannot read what is on the prescription label, how can I be certain the patient is receiving the correct directions or instructions.
All in all, if pharmacists are directed to use board approved translations on prescriptions labels, waiver of liability provisions will be a topic of discussion as pharmacists and pharmacies want to ensure they are not liable for third-party translation errors in the event that there is a mistake that can be traced back to incorrect instructions or information on the label.
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.
While many consumers continue throw away medications in the trash or flush medications down the toilet, consumers should be aware of a much safer disposal alternative: community-based “take-back” programs.
In February 2007, the Office of National Drug Control Policy (ONDCP), working together with the Food and Drug Administration (FDA), issued the first consumer guidance for proper disposal of prescription medications. Last updated in 2009, the federal guidelines recommend patients should:
- Follow any specific disposal instructions on the medication label or patient information that accompanies the medication. Flushing prescription medications down the toilet is not recommended unless the disposal instructions specifically instruct you to do so.
- Take advantage of community drug take-back programs that allow the public to bring unused medications to a central location for proper disposal.
- If no instructions are given on the medication label and no take-back program is available in your area, you can throw the medications in the household trash, but first you should:
- Take the medication(s) out of their original containers and mix them with an undesirable substance such as used coffee grounds or kitty litter to make the medications less appealing to children, pets and other individuals who may intentionally go through your trash.
- Consider putting the medications in a sealable bag, empty can or other container to prevent the medications from leaking or breaking out of a garbage bag.
- To protect the identity and privacy of your personal health information, strongly consider scratching out all identifying information on the prescription labels prior to throwing a medication container away.
- Never give medications to another family member or friend as the patient specific medication that was prescribed for you could be extremely harmful to another individual.
- Whenever you have any questions about medication disposal, consult your pharmacist.