A Guide to State Opioid Prescribing Policies

Pain Policy and Regulation: South Carolina

When prescribing controlled medications, South Carolina requires registrants to keep records and inventories pursuant to federal law requirements.

General Requirements for All Schedules

• You cannot preprint any controlled substance prescription. You may only distribute or dispense controlled medications for a legitimate medical purpose. You must also have a bona fide practitioner-patient relationship when you prescribe controlled substances.
• All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall 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 practitioner shall sign a prescription in the same manner as he or she would sign a check or legal document (eg, J. H. Smith or John H. Smith).
• Where an oral order is not permitted, prescriptions shall be written with ink or indelible pencil or typewriter or other mechanical means of printing and shall be manually signed by the practitioner.
• A secretary or agent may prepare the prescriptions, but the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations.

Valid Practitioner-Patient Relationship Required

• A valid relationship is one where the practitioner can demonstrate sufficient knowledge of the medical need of the patient for the controlled medication, a benefit to risk ratio in favor of the use of the controlled medication, and a good faith determination of the identity and address of the patient.

Practitioner-Patient Relationship Required

• Prior to the issuance of a prescription for or the direct dispensing of any schedule II controlled substances, the prescribing practitioner shall have a valid practitioner-patient relationship established with the recipient of the prescription. Such relationship must include, but not be limited to, a sufficient knowledge of the medical need of the patient for such schedule II controlled substance, determination of the benefit to risk ratio of the use of such substance, good faith determination of the identity and address of the patient, a determination of the physical condition of the patient, and such practitioner shall be in personal attendance of the patient at the time of issuance of the prescription.
• Any prescription issued by any practitioner for any person outside of the reasonable bounds of a practitioner-patient relationship shall be deemed issued other than in the course of professional practice required by the Act.

Pharmacist Has Corresponding Responsibility

• The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding liability rests with the pharmacist who fills and ultimately dispenses the prescription. Also, a corresponding liability rests upon the pharmacist who fills a prescription not prepared in the form prescribed by this regulation.

Dispensing Practitioner Must Know or Identify the Person Receiving the Controlled Substance Prescription Medication

• When dispensing, the state requires the dispenser to know the recipient or ask him or her to produce government identification. The dispensing practitioner must also note the identification source and identification number on the prescription or in a readily retrievable log, and must include the following information:
  1. prescription number;
  2. date prescription filled;
  3. number and type of identification;
  4. initials of person obtaining and recording information.

Schedule II Prescriptions

• There are no refills on schedule II controlled substance prescriptions. With the exception of transdermal patches, supply limitation is thirty-one (31) days and must be dispensed within ninety (90) days of the date of issue. After 90 days, a schedule II controlled substance prescription is void. No practitioner may dispense a schedule II narcotic controlled substance for the purpose of maintaining the addiction of a narcotic-dependent person outside of a facility or program approved by the state.

Partial Filling of Schedule II Medication

• Partial filling of schedule II medication is permitted and subject to the 72-hour rule, as stated in South Carolina Controlled Substances Act (CSA) and rules. These rules should be read in their entirety.
• Prescriptions for schedule II controlled medications for patients in long-term care facilities are subject to special rules, as stated in South Carolina CSA and rules.

Schedule III Through V Prescriptions

• The life of a schedule III through V prescription is six (6) months. The state limits the quantity of each prescription for a schedule III through V controlled medication to a ninety (90)-day supply and refills are limited to five (5). If authorized for refill, no prescription shall be refilled sooner than 48 hours prior to the time that the prescription should be consumed if the prescribed daily dosage is divided into the total prescribed amount. (Example: 4 daily divided into 100 dosage units = 25 days.) Carry over time shall not accrue between refills. In the event that the practitioner does not specify an exact daily dosage, the dispenser shall calculate date of refill from the usual daily dosage recommended by the manufacturer of the controlled substance.

Dispensing of Narcotic Drugs for Maintenance Purposes – Special Issue

• The administering or dispensing directly (but not prescribing of) narcotic drugs listed in any schedule to a narcotic drug-dependent person for the purpose of continuing his or her dependence on such drugs in the course of conducting an authorized clinical investigation in the development of a narcotic addict rehabilitation program shall be deemed to be within the meaning of the term "in the course of his or her professional practice or research" in the Act, provided that approval is obtained prior to the initiation of such a program by submission of a Notice of Claimed Investigational Exemption for a New Drug to the Food and Drug Administration. The submission will be reviewed concurrently by the Food and Drug Administration for scientific merit and by the Drug Enforcement Agency for drug control requirements, and the clinical investigation must thereafter accord with such approval.

Prescribing to a Drug-Dependent Person

• An order purporting to be a prescription issued to a drug-dependent person not in the course of generally accepted medical treatment but for the purpose of providing the user with controlled substances sufficient to maintain his or her dependence on the substance, or to provide him or her with quantities of controlled substances in great excess of normal dosage ranges as recommended by the manufacturer of the substance, is not a prescription within the meaning and intent of this article; and the person filling or dispensing such an order, as well as the person issuing it, shall be deemed in violation of this section.
• There should be no self-prescribing and no prescribing to family members unless there is a documented emergency.

Prescription Monitoring Program

• The state has a prescription monitoring program and the records are confidential and subject to very specific laws. The entire law should be read before using the program. The data are controlled by the state "drug control" unit. The data are available to the following persons or for the following reasons:
  1. a practitioner or pharmacist who requests information and certifies that the requested information is for the purpose of providing medical or pharmaceutical treatment to a bona fide patient;
  2. an individual who requests the individual's own prescription monitoring information in accordance with procedures established pursuant to state law;
  3. a designated representative of the South Carolina Department of Labor, Licensing and Regulation responsible for the licensure, regulation, or discipline of practitioners, pharmacists, or other persons authorized to prescribe, administer, or dispense controlled substances and who is involved in a bona fide specific investigation involving a designated person;
  4. a local, state, or federal law enforcement or prosecutorial official engaged in the administration, investigation, or enforcement of the laws governing licit drugs and who is involved in a bona fide specific drug-related investigation involving a designated person;
  5. the South Carolina Department of Health and Human Services regarding Medicaid program recipients;
  6. a properly convened grand jury pursuant to a subpoena properly issued for the records;
  7. personnel of drug control for purposes of administration and enforcement of this article;
  8. qualified personnel for the purpose of bona fide research or education; however, data elements that would reasonably identify a specific recipient, prescriber, or dispenser must be deleted or redacted from such information prior to disclosure. Further, release of the information only may be made pursuant to a written agreement between qualified personnel and the department to ensure compliance with this subsection.

South Carolina Board of Medical Examiners Pain Management Guidelines

• February 7-10, 1999, Board meeting
  • Inadequate pain control may result from physicians' lack of knowledge about pain management or from an inadequate understanding of addiction. Fears of investigation or sanction by federal, state, and local regulatory agencies may also result in inappropriate or inadequate treatment of patients with chronic. Guidelines clarify the Board's position on pain control.
  • The medical management of pain should be based on current knowledge and research and should include the use of both pharmacologic and non pharmacologic modalities. Pain should be assessed and treated promptly and the quantity and frequency of doses should be adjusted according to the intensity and duration of the pain. Physicians should recognize that tolerance and physical dependence may be seen as a result of sustained use of opioid analgesics and are not synonymous with addiction.
  • Physicians should be diligent about preventing the diversion of drugs for illegitimate purposes.
  • The Board will consider prescribing, ordering, administering, or dispensing controlled substances for pain to be for a legitimate medical purpose if it is based on accepted scientific knowledge of the treatment of pain or if based on sound clinical grounds.
  • The Board requires clear documentation of unrelieved pain in compliance with applicable state or federal law. Each case of prescribing for pain will be evaluated individually.
  • The Board will not take disciplinary action against a physician for failing to adhere strictly to the provisions of these guidelines if good cause is shown for such deviation. The physician's conduct will be evaluated to a great extent by the treatment outcome, taking into account whether the drug used is medically and/or pharmacologically recognized to be appropriate for the diagnosis, the patient's individual needs including any improvement in functioning, and recognizing that some types of pain cannot be completely relieved.
  • The Board will judge the validity of prescribing based on the physician's treatment of the patient and on available documentation, rather than on the quantity and chronicity of prescribing.

  These are guidelines, not absolutes.

Evaluation of the Patient

• A complete medical history and physical examination must be conducted and documented, including:
  1. the nature and intensity of the pain,
  2. current and past treatments for pain,
  3. underlying or coexisting diseases or condition,
  4. the effect of the pain on physical and psychological function and history of substance abuse, and
  5. the presence of one or more recognized medical indications for the use of a controlled substance.

Treatment Plan

• A written treatment plan, which can be an informal note, must be used as part of the office or emergency department visit should state objectives that will be used to determine treatment success. Goals may include: pain relief and improved physical and psychosocial function. The treatment plan should indicate whether any further diagnostic evaluations or other treatments are planned. After treatment begins, drug therapy should be adjusted 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.

Informed Consent

• 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 incompetent.
• Note: The patient should receive prescriptions from one physician and one pharmacy where possible.
• Treatment agreement language pertains to high-risk patients or those with history of substance abuse. For any patient on chronic opioid therapy, or if the patient is determined to be at high risk for medication abuse or has a history of substance abuse, the physician may employ the use of a written agreement between physician and patient outlining patient responsibilities including:
  1. urine/serum medication levels screening when requested,
  2. number and frequency of all prescription refills, and
  3. reasons for which drug therapy may be discontinued (ie, violation of agreement).

Periodic Review

• A periodic review must be conducted at reasonable intervals based on the individual circumstance of the patient. The physician should review the course of treatment and any new information about the etiology of the pain. Continuation or modification of therapy should be based on evaluation of the patient's progress toward stated treatment objectives such as improvement in patient's pain intensity and improved physical and/or psychosocial function, such as ability to work, need for healthcare resources, activities of daily living, and quality of social life.
• If the patient is not meeting treatment goals despite medication adjustments, the appropriateness of continued treatment must be reevaluated. The physician must monitor the patient for compliance related to medication usage and related treatment plans.

Consultation

• The physician must be willing to refer the patient as necessary to help the patient meet treatment objectives. Special attention must be given to patients with pain who are at risk for misusing their medications and those whose living arrangements pose a 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.

Medical Records

• The following should be included in the chart of each patient being treated for chronic pain with controlled medications:
  1. the medical history and physical examination,
  2. diagnostic, therapeutic, and laboratory results,
  3. evaluations and consultations,
  4. treatment objectives,
  5. discussion of risks and benefits,
  6. treatments,
  7. medications, including date, type, dosage, and quantity prescribed,
  8. instructions and agreements, and
  9. periodic reviews.
• The record must be kept current and in a manner that allows it to be readily retrieved for review. Records relating to acute pain management are understood to be less Involved than those involving the management of chronic illnesses.

Compliance With Controlled Substances Laws and Regulations

• Physicians must be properly licensed and comply with applicable federal and state regulations. Read the DEA Practitioner's Manual (available at http://www.deadiversion.usdoj.gov/pubs/manuals/pract/index.html) and other materials. Read your state materials.

Definitions

South Carolina uses the following definitions relating to pain management and controlled substances:

• "Acute pain" is the normal, predicted physiologic response to an adverse chemical, thermal, or mechanical stimulus and is associated with surgery, trauma, and acute illness. It is generally time-limited and is responsive to opioid therapy, among other therapies.
• "Addiction" is a neurobehavioral syndrome with genetic and environmental influences that results in psychological dependence on the use of substances for their psychic effects and is characterized by compulsive use despite harm. Addiction may also be referred to by terms such as "drug dependence" and "psychological dependence." Physical dependence and tolerance are normal physiologic consequences of extended opioid therapy for pain and should not be considered addiction.
• "Analgesic tolerance" is the need to increase the dose of opioid to achieve the same level of analgesia. Analgesic tolerance may or may not be evident during opioid treatment and does not equate with addiction.
• "Chronic pain" is a pain state that is persistent and in which the cause of the pain cannot be removed or otherwise treated. Chronic pain may be associated with a long-term incurable or intractable medical condition or disease.
• "Pain" is an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage.
• "Physical dependence" on a controlled substance is a physiologic state of neuroadaptation that is characterized by the emergence of a withdrawal syndrome if drug use is stopped or decreased abruptly or if an antagonist is administered. Physical dependence is an expected result of opioid use. Physical dependence, by itself, does not equate with addiction.
• "Pseudoaddiction" is a pattern of drug-seeking behavior of patients with pain who are receiving inadequate pain management. Pseudoaddiction can be mistaken for addiction.
• "Substance abuse" is the use of any substance(s) for nontherapeutic purposes or use of medication for purposes other than those for which it is prescribed.
• "Tolerance" is a physiologic state resulting from regular use of a drug in which an increased dosage is needed to produce the same effect or a reduced effect is observed with a constant dose.

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Author Information

Jennifer Bolen, JD, Founder, The Legal Side of Pain, Lenoir City, Tennessee

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