An analysis of safety regulations of online pharmacies and self prescription

Abstract Background Amidst the rise of e-commerce, there has been a proliferation of illicit online pharmacies that threaten global patient safety by selling drugs without a prescription directly to the consumer. Despite this clear threat, little is known about the key risk characteristics, central challenges and current legal, regulatory and law enforcement responses.

An analysis of safety regulations of online pharmacies and self prescription

Registration of nonresident establishments. Such establishments shall include, but not be limited to, pharmacies that transact business through the use of the internet.

The provisions of this subdivision shall apply solely to nonresident establishments and shall not affect any other provision of this article. As a condition of registration, a nonresident establishment shall comply with the following requirements: Nonresident pharmacies registered pursuant to this section shall: Except in emergencies that constitute an immediate threat to public health, the department shall not prosecute a complaint or otherwise take formal action against a nonresident establishment based upon delivery of a drug into this state or a violation of law, rule, or regulation of this state if the agency having jurisdiction in the state where the nonresident establishment is based commences action on the violation complained of within one hundred twenty days from the date that the violation was reported; provided however, that the department may prosecute a complaint or take formal action against a nonresident establishment if it determines that the agency having jurisdiction in the state where the nonresident establishment is based has unreasonably delayed or otherwise failed to take prompt and appropriate action on a reported violation.

A nonresident establishment that fails to comply with the requirements of this section shall be subject to revocation or suspension of its registration and other applicable penalties in accordance with the provisions of article one hundred thirty of this chapter. The department shall promulgate rules and regulations to implement the provisions of this section.

No drug for which a prescription is required by the provisions of the Federal Food, Drug and Cosmetic Act or by the commissioner of health shall be distributed or dispensed to any person except upon a prescription written by a person legally authorized to issue such prescription.

All labels shall conform to such rules and regulations as promulgated by the commissioner pursuant to section sixty-eight hundred twenty-nine of this article. The prescribing and dispensing of a drug which is a controlled substance shall be subject to additional requirements provided in article thirty-three of the public health law.

The words "drug" and "prescription required drug" within the meaning of this article shall not be construed to include soft or hard contact lenses, eyeglasses, or any other device for the aid or correction of vision.

Nothing in this subdivision shall prevent a pharmacy from furnishing a drug to another pharmacy which does not have such drug in stock for the purpose of filling a prescription.

A prescription may not be refilled unless it bears a contrary instruction and indicates on its face the number of times it may be refilled. A prescription may not be refilled more times than allowed on the prescription.

The date of each refilling must be indicated on the original prescription. Prescriptions for controlled substances shall be refilled only pursuant to article thirty-three of the public health law.

An analysis of safety regulations of online pharmacies and self prescription

For the purposes of this section, consent may be obtained in the same manner and process by which consent is deemed acceptable under the federal Medicare Part D program Pharmacy providers who deliver medication without patient or authorized individual consent will be required to accept the return of the medication from the patient, provide that patient credit for any charges they may have paid, and will be required to destroy those medications sent without consent on delivery in accordance with applicable state and federal law.

Nothing in this section shall be deemed to interfere with the requirements for refill reminder or medication adherence programs. Nothing in this section is intended to apply to long-term care pharmacy dispensing and delivery.

A copy of a prescription for a controlled substance shall not be furnished to the patient but may be furnished to any licensed practitioner authorized to write such prescription. Copies of other prescriptions shall be furnished to the patient at his request, but such copies are issued for the informational purposes of the prescribers only, and shall be so worded.

Oral prescriptions for controlled substances shall be filled pursuant to article thirty-three of the public health law. A pharmacist may fill an oral prescription for a drug, other than a controlled substance, made by a practitioner legally authorized to prescribe drugs.

An oral authorization for the refill of a prescription, other than a prescription for a controlled substance, may be made by a practitioner legally authorized to prescribe drugs. The pharmacist receiving such oral authorization for the refill of a prescription shall write on the reverse side of the original prescription the date, time, and name of the practitioner authorizing the refill of the prescription.

An oral prescription or an oral authorization for the refill of a prescription for the drug, other than a controlled substance, may be communicated by an employee of the prescribing practitioner; provided, however, the pharmacist shall: Oral prescriptions for patients in general hospitals, nursing homes, residential health care facilities as defined in section twenty-eight hundred one of the public health law, hospitals as defined in subdivision ten of section 1.

Such agent shall be a health care practitioner currently licensed and registered under this title. Records of all prescriptions filled or refilled shall be maintained for a period of at least five years and upon request made available for inspection and copying by a representative of the department.

Records of prescriptions for controlled substances shall be maintained pursuant to requirements of article thirty-three of the public health law.

Imprinted conspicuously on every prescription written in this state in eight point upper case type immediately below the signature line shall be the words: No other letters or marks in such box shall prohibit substitution.

Such box shall be placed directly under the signature line and shall be three-quarters inch in length and one-half inch in height, or in comparable form for an electronic prescription as may be specified by regulation of the commissioner. Immediately below such box shall be imprinted in six point type the words "Dispense As Written".

Notwithstanding any other provision of this section or any other law, when a generic drug is not available and the brand name drug originally prescribed is available and the pharmacist agrees to dispense the brand name product for a price that will not exceed the price that would have been charged for the generic substitute had it been available, substitution of a generic drug product will not be required.

If the generic drug product is not available and a medical emergency situation, which for purposes of this section is defined as any condition requiring alleviation of severe pain or which threatens to cause disability or take life if not promptly treated, exists, then the pharmacist may dispense the brand name product at his regular price.Dec 06,  · To manage the increased use of online pharmacies, however, more regulations are being proposed, including the Online Pharmacy Safety Act and the development of state-run online pharmacy programs [22,23].

As part of its goal to support a culture of patient safety and quality improvement in the Nation's health care system, the Agency for Healthcare Research and Quality (AHRQ) sponsored the development of patient safety culture assessment tools for hospitals, nursing homes, ambulatory outpatient medical offices, community pharmacies, and ambulatory surgery centers.

An analysis of safety regulations of online pharmacies and self prescription

Every state regulates driver's license eligibility of persons with certain medical conditions. The most common requirement for people with epilepsy is that they be seizure free for a specific period of time and submit a physician's evaluation of their ability to drive safely.

Another common. A pharmacist is required to label any prescription dispensed with the expiration date of the effectiveness of the drug dispensed. (B&P § ) the health and safety of the public, worker and environmental safety, and increasing analysis, and documentation.” This change permits a pharmacist, using professional judgment, to extend the.

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