A Guide to State Opioid Prescribing Policies

Pain Policy and Regulation: South Dakota

Summary

This summary is intended to serve as a general reference for South Dakota practitioners on the use of controlled substances to treat pain. Make sure you read all of your licensing board materials and check board Websites for updates.

Many of these rules can be found at: http://legis.state.sd.us/rules/DisplayRule.aspx?Rule=44:58:08 and http://legis.state.sd.us/rules/DisplayRule.aspx?Rule=20:51:05. A link to state board of pharmacy summary on prescribing authority can be found at: http://doh.sd.gov/boards/pharmacy/PDF/PrescribingAuthority.pdf.

South Dakota law prohibits practitioners from issuing a prescription to obtain controlled substances for general dispensing to patients.

South Dakota law prohibits practitioners from issuing any prescription for a controlled substance, and from dispensing or administering a controlled substance, to a drug dependent person for the purpose of continuing the person's dependency. It does not prohibit the legitimate medical treatment of a drug-dependent person with controlled substances for a medical condition other than dependency. The direct administering or dispensing of a controlled substance listed in any schedule to a drug-dependent person for the purpose of controlled withdrawal while in treatment in a drug treatment or rehabilitation program must be within the meaning of the term, "in the course of professional practice or research."

A practitioner may not issue a prescription for a controlled substance for his or her own use. All controlled substance prescriptions must be dated and signed on the day when issued to the patient, and the prescription must bear the full name and address of the patient; the drug name, strength, dosage form, quantity prescribed, and directions for use; and the name, address, and registration number of the practitioner.

A prescription must be signed in the same manner as a legal document would be signed. If an oral order is not permitted, prescriptions must be written with ink, indelible pencil, or typewriter and must be manually signed by the practitioner. The prescriptions may be prepared by a secretary or agent for signature, but the prescribing practitioner is responsible if the prescription does not conform in all essential respects to the law.

The pharmacist who fills a controlled substance prescription that is not prepared in the form required by South Dakota law has a corresponding liability.

Prescriptions for schedule III and IV controlled substances may be transmitted directly from the practitioner's office to the pharmacy by facsimile.

An individual practitioner, in the course of professional practice only, may directly administer or dispense a controlled substance without a prescription to other persons. An individual practitioner or institutional practitioner may not order a controlled substance for direct administration or dispense a controlled substance, including any controlled substance sample, for the practitioner's use.

Emergency Oral Prescriptions for Schedule II Controlled Substances

In an emergency situation, a pharmacist may dispense a schedule II controlled substance after oral authorization if:

1. The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period;
2. The prescription is immediately reduced to writing by the pharmacist and contains all information required by South Dakota law (patient name, etc), except the signature of the prescribing practitioner;
3. If the practitioner is not known to the pharmacist, the pharmacist must make a reasonable effort to determine that the oral authorization came from a registered practitioner by returning the prescriber's call using the phone number listed in the telephone directory or through other good faith efforts to assure the practitioner's identity; and
4. Within 7 days after authorizing an emergency oral prescription, the practitioner must supply the pharmacy with a written prescription for the emergency quantity prescribed. In addition to conforming with the general requirements of controlled substance prescriptions, the emergency prescription must have "authorization for emergency dispensing," written on it and the date of the oral order. Upon receipt, the dispensing pharmacist should attach this prescription to the oral emergency prescription that had earlier been reduced to writing. If the emergency prescription is sent by mail, the carrier envelope must be postmarked within the 7 days. The pharmacist must notify the department if the prescribing practitioner fails to deliver a written prescription within 7 days. Failure to notify the department voids the authority to dispense the controlled substance without a written prescription.

Refills of Schedule III or IV Controlled Substances

A prescription for a schedule III or IV drug or substance may be refilled up to 5 times within a 6-month period if the refills are authorized by the practitioner who wrote the original prescription. Each refill dispensed must be entered on the prescription or on a patient medication record and must include the date, quantity dispensed, and initials or name of the dispensing pharmacist. If the pharmacist merely initials and dates the prescription, the pharmacist is assumed to have dispensed a refill for the full amount of the prescription. Additional quantities of controlled substances listed in schedule III or IV may only be authorized by a practitioner through issuance of a new prescription. As an alternative to the record procedures required by this section, an automated data processing system that complies with South Dakota law may be used for the storage and retrieval of refill information for prescription orders for controlled substances in schedules III and IV.

Refills of Schedule II Controlled Substances

Refills of schedule II controlled substances are prohibited. However, South Dakota allows the issuance of multiple prescriptions for schedule II controlled substances according to the federal rule and the "Issuance of Multiple Prescriptions for Schedule II Controlled Substances," published in the Federal Register.^[1]

South Dakota refers practitioners to the DEA Office of Diversion Control's Website for an explanation on the federal rule relating to the issuance of multiple prescriptions for schedule II controlled substances. The Website is at: http://www.deadiversion.usdoj.gov/faq/mult_rx_faq.htm

Multiple Prescriptions for Schedule II Controlled Substances

The federal rule became effective December 19, 2007. Under the federal rule, a practitioner may provide individual patients with multiple prescriptions for the same schedule II controlled substance to be filled sequentially. The combined effect of these multiple prescriptions is to allow the patient to receive, over time, up to a 90-day supply of that controlled substance.

The rule requires practitioners to issue each prescription for a legitimate medical purpose and to do so while acting in the usual course of his or her professional practice. Written instructions must be included on each prescription indicating the earliest date on which a pharmacy may fill each prescription. The practitioner must comply fully with all other applicable requirements under the Controlled Substances Act and implementing regulations, as well as any additional requirements under state law. The practitioner must consider each patient individually and must conclude that for that patient using prescriptions in this format will not present an undue risk for abuse or diversion of the controlled medications prescribed.

The rule does not require or mandate a practitioner to issue multiple prescriptions for schedule II controlled substances. The rule does not require a practitioner to see a patient only once every 90 days.

The federal law does not set a limit on the number of schedule II dosage units a practitioner can prescribe to a patient. However, if multiple schedule II prescriptions are issued, the federal rule limits the total amount prescribed to a 90-day supply of a particular schedule II controlled substance.

The federal rule does not set a limit on the number of separate prescriptions per schedule II controlled substance that may be issued for the 90-day supply. The rule does not stipulate how many separate prescriptions per schedule II controlled substance may be issued for the 90-day supply. It is up to the practitioner to determine how many separate prescriptions to be filled sequentially are needed to provide adequate medical care. For example, the practitioner may issue three 30-day schedule II prescriptions to cover a 90-day supply or the practitioner may issue 9 prescriptions for the same schedule II controlled substance, each for a 10-day supply, having the combined effect of a 90-day supply.

The federal rule allowing the use of multiple prescriptions for schedule II controlled substances does not violate the federal law prohibiting refills of schedule II controlled substance prescriptions. Instead, the rule allows the use of multiple prescriptions for the dispensing of schedule II controlled substances, under the conditions set forth in the final rule, thereby ensuring that the prescriptions are treated as separate dispensing documents, not refills of an original prescription. Each separate prescription must be written for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. Each separate prescription must contain written instructions indicating the earliest date on which a pharmacy may fill each prescription.

The proper dating of each prescription is still required. Schedule II prescriptions cannot be postdated. Important: A prescription's fill date is not the same as its issuance date. Each prescription in the multiple schedule II prescription format must be dated and signed on the date it is issued to the patient.

The Pharmacist's Role in Filling Multiple Prescriptions for Schedule II Controlled Substances. Prescriptions containing instructions from the prescribing practitioner indicating the date on which a prescription may be filled may not be filled by a pharmacist before that date. In addition, when filling any prescription for a controlled substance, a pharmacist who fills multiple prescriptions issued in accordance with this regulation has a corresponding responsibility to ensure that each sequential prescription was issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.

Partial Filling of Schedule II Controlled Substance Prescription

A pharmacist may partially fill a prescription for a controlled substance listed in schedule II if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription and he or she makes a notation of the quantity supplied on the face of the prescription. The remaining portion of the prescription may be filled within 72 hours of the partial filling; however, if the remaining portion is not filled within the 72-hour period, the pharmacist must notify the practitioner. No further quantity may be supplied beyond 72 hours without a new prescription.

Exception for Patients in Nursing Facility or Hospice Care. A pharmacist may partially fill a prescription for a substance listed in schedule II written for a patient in a nursing facility or for a patient with a medical diagnosis documenting a terminal illness. The pharmacist must record on the prescription whether the patient is "terminally ill" or is a "nursing facility patient." For each partial filling, the pharmacist must record on the back of the prescription the date of the partial filling, the quantity dispensed, the remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist. Before any subsequent partial filling, the pharmacist must determine that the additional partial filling is necessary. The total quantity of the schedule II controlled substance dispensed in all partial fillings may not exceed the total quantity prescribed. The prescription is valid for not more than 60 days from the date of issue unless it is terminated sooner by the discontinuance of medication.

The use of a computerized system for schedule II prescription information is authorized for nursing facility or terminally ill patients.

Faxes

The use of a facsimile of a written prescription for a schedule II controlled substance is permitted only if the original written, signed prescription is presented to the pharmacist for review prior to the actual dispensing of the controlled substance. State law allows the facsimile to serve as the original schedule II controlled substance prescription when the medication is intended for direct administration to a patient by parenteral, intravenous, subcutaneous, or intraspinal infusion or when the prescription is for a resident in a long-term care facility or properly certified hospice. Read the entire rule, which can be found at: http://legis.state.sd.us/rules/DisplayRule.aspx?Rule=44:58:08:18.03&Type=Rule.

South Dakota Model Guideline

South Dakota adopted the Federation of State Medical Board's 1998 Model Guidelines for the Use of Controlled Substances for the Treatment of Pain, which is summarized below. Read the guideline at: http://www.fsmb.org/pdf/2004_grpol_Controlled_Substances.pdf.

1. Evaluation of the Patient. Obtain a medical history and perform a physical examination. Document these items and the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, and history of substance abuse. The medical record also should document the presence of one or more recognized medical indications for the use of a controlled substance.
2. Treatment Plan. Use a written treatment plan to state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function. The plan should also indicate whether any further diagnostic evaluations or other treatments are planned. After treatment begins, the physician should adjust drug therapy to the individual medical needs of each patient. Other treatment modalities or a rehabilitation program may be necessary depending on the cause of the pain and the extent to which the pain is associated with physical and psychosocial impairment.
3. Informed Consent and Agreement for Treatment. The physician should discuss the risks and benefits of the use of controlled substances with the patient, persons designated by the patient, or with the patient's surrogate or guardian if the patient is without medical decision-making capacity. The patient should receive prescriptions from one physician and one pharmacy whenever possible. If the patient is at high risk for medication abuse or has a history of substance abuse, the physician should consider the use of a written agreement between physician and patient outlining patient responsibilities, including:
   • urine/serum medication levels screening when requested;
   • number and frequency of all prescription refills; and
   • reasons for which drug therapy may be discontinued (eg, violation of agreement).
4. Periodic Review. The physician should periodically review the course of pain treatment and any new information about the cause of the pain or the patient's state of health. Continuation or modification of controlled substances for pain management therapy depends on the physician's evaluation of progress toward treatment objectives. Satisfactory response to treatment may be indicated by the patient's decreased pain, increased level of function, or improved quality of life. Objective evidence of improved or diminished function should be monitored and information from family members or other caregivers should be considered in determining the patient's response to treatment. If the patient's progress is unsatisfactory, the physician should assess the appropriateness of continued use of the current treatment plan and consider the use of other therapeutic modalities.
5. Consultation. The physician should be willing to refer the patient as necessary for additional evaluation and treatment to achieve the treatment objectives. Special attention should be given to those patients with pain who are at risk for medication misuse or diversion. The management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder may require extra care, monitoring, documentation, and consultation with or referral to an expert in the management of such patients.
6. Medical Records. The physician should keep accurate and complete records to include:
   • the medical history and physical examination;
   • diagnostic, therapeutic and laboratory results;
   • evaluations and consultations;
   • treatment objectives;
   • discussion of risks and benefits;
   • informed consent;
   • treatments;
   • medications (including date, type, dosage, and quantity prescribed); and
   • instructions and agreements; and periodic reviews.
   Records must be kept current and must be accessible and readily available for review.
7. Compliance With Controlled Substances Laws and Regulations. Practitioners must be licensed in the state and must comply with applicable federal and state regulations. Read the DEA Practitioner's Manual of 2006, which is available at: http://www.deadiversion.usdoj.gov/pubs/manuals/pract/index.html.

Reference

1. Drug Enforcement Administration. Issuance of multiple prescriptions for schedule II substances. Federal Register. 2007;72:64921-64930. Abstract

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Author Information

Jennifer Bolen, JD, Jennifer Bolen, JD, Founder, The Legal Side of Pain, Lenoir City, Tennessee http://www.legalsideofpain.com

Disclosure: Jennifer Bolen, JD, has disclosed no relevant financial relationships.