Nevertheless, the MHRA receives reports of patients experiencing adverse events on switching between different levothyroxine products. The MHRA has conducted a review of the available data and sought advice from the Commission on Human Medicines (CHM) as to whether any regulatory action is needed to minimise the risk of adverse events on switching between different levothyroxine products.
Advice for New Prescribers
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There is international interest for consensus advice for prescribers working in the field of drug resistant epilepsy intending to trial potential therapies that are nonregistered or off-label. Cannabinoids are one such therapy. In 2017, the New South Wales State Government (Australia) set up a cannabinoid prescribing guidance service for a wide variety of indications, based on known pharmacology together with the relevant new literature as it became available. Increasing interest in cannabis medicines use outside this State over the following 5 years together with a paucity of registration-standard clinical trials, lack of information around dosing issues, drug interactions and biological plausibility meant there remained a large unmet need for such advice. To address the unmet need in epilepsy, and until medicines were registered or regulator quality data were available, it was agreed to bring together a working group comprising paediatric and adult epilepsy specialists, clinical pharmacists., clinical pharmacologists and cannabis researchers from across Australia to develop interim consensus advice for prescribers. Although interim, this consensus advice addresses much of the current practice gap by providing an informed overview of the different cannabis medicines currently available for use in the treatment of epilepsy in paediatric and adult settings, with information on dose, drug interactions, toxicity, type of seizure and frequency of symptom relief. As such it supplements the limited evidence currently available from clinical trials with experience from front-line practice. It is expected that this consensus advice will be updated as new evidence emerges and will provide guidance for a subsequent Guideline.
Risk Evaluation and Mitigation Strategy (REMS) for Opioid AnalgesicsEssential safety information for prescribers of these medications, includes basic information that prescribers can use when counseling patients.
The Centers for Disease Control and Prevention (CDC) yesterday published the final version of its newly revised advice about prescribing opioids for pain, which aims to ameliorate the damage done by the guidelines it issued in 2016. The new guidelines, which are similar to the draft that the CDC published in February, emphasize individualized treatment and include warnings against "rigid standards," "rapid tapers," "abrupt opioid discontinuation," and "patient abandonment," which give you a sense of the disastrous impact that the 2016 version had on patient care.
The CDC blames that fiasco on "misapplication" of its advice by clinicians, pharmacists, insurers, regulators, and legislators. Because all those people misunderstood what the CDC was recommending, it says, patients across the country experienced "untreated and undertreated pain, serious withdrawal symptoms, worsening pain outcomes, psychological distress, overdose, and suicidal ideation and behavior."
When patients respond to CDC-inspired medical practices by killing themselves, it might be time to concede that the agency issued its advice without sufficiently considering the potential for unintended but foreseeable consequences. The CDC never quite admits that, and its new guidance has similarly malignant potential.
Is this presentation less likely than the 2016 version to encourage the "rigid application of opioid dosage thresholds" that the CDC officially eschews? Probably not, especially given six years of adaptation to the agency's original advice.
Even while retaining the warnings about crossing the 50 MME/day line, the CDC tries to limit the harm that advice might cause. "Payers, health systems, and state medical boards," it says, "should ensure that policies based on cautionary dosage thresholds do not result in rapid tapers or abrupt discontinuation of opioids."
Although the 2016 guidelines ostensibly were limited to chronic pain treatment, they included a recommendation regarding opioid prescriptions for acute pain. "Three days or less will often be sufficient," the CDC said. "More than seven days will rarely be needed." Like the warnings about exceeding specified daily doses, that advice predictably resulted in arbitrary limits on prescriptions, including statutory restrictions.
This new advice is less likely to be read as supporting arbitrary limits on the length of prescriptions. But as with the MME thresholds, the damage already has been done, and reversing it will not be easy. Since 2016, according to a tally by the National Conference of State Legislatures, at least 20 states have imposed restrictions on initial prescriptions for acute pain, typically ranging from three to seven days.
The new guidance, available for the public to review and comment on over the next 60 days, is for doctors and non-physician prescribers who treat three categories of patients: adults with acute pain lasting less than one month; "subacute" pain for one to three months; and chronic pain for three months or longer. It does not apply to sickle cell disease, cancer, palliative or end-of-life care.
For patients who have not taken opioids before, doctors should prescribe the lowest dosage. For patients with chronic pain, prescribers should be cautious about recommending opioids and gauge the risks and benefits, the guidance says.
The internet has now become a significant resource for patients to obtain supplies of prescription medicines from overseas. When these medicines are held at the New Zealand border prescribers are usually asked to provide a prescription to enable their release.
The Department of Health presents the information on this Web site as a service to the public. The Department has attempted to ensure that the information is as accurate as possible. However, the Department makes no warranty or guarantee concerning the accuracy or reliability of the content of this Web site. No posted information or materials provided are intended to constitute legal or medical advice. Before considering taking any action, confirm information by contacting OPMC.
This document is intended to help physicians interpret their obligations as set out in the Prescribing Drugs policy and to provide guidance for how these obligations can be effectively discharged. This document also seeks to provide physicians with practical advice for addressing common issues that arise in practice.
Physicians must also complete the training necessary to ensure they have the knowledge, skill, and judgment to appropriately prescribe and manage patients through MMT. As with all care and prescribing, physicians will need to exercise sound clinical judgment, taking into consideration the specific needs of their patients. Physicians prescribing methadone for opioid use disorder must do so in accordance with the Prescribing Drugs policy and practice in a manner that is informed by relevant opioid use disorder guidelines.1 In particular, the Centre for Addiction and Mental Health (CAMH) has developed the Canadian Opioid Use Disorder Guideline, a national clinical guideline that standardizes guidelines for Canadian prescribers of opioid agonist therapy, including using methadone.
Regular communication and collaboration between MMT prescribers, pharmacists, and other health-care providers will help ensure patient care is safe and of high quality. This collaboration may include the development of policies and procedures to ensure continuity of patient care and secure custody and storage of methadone.
Information provided in Yale Medicine articles is for general informational purposes only. No content in the articles should ever be used as a substitute for medical advice from your doctor or other qualified clinician. Always seek the individual advice of your health care provider with any questions you have regarding a medical condition.
New York State (NYS) requires all licensed prescribers and pharmacies who serve Medicaid members to be enrolled with the Medicaid fee-for-service program. This includes prescribing practitioners identified on pharmacy claims per the Centers for Medicare & Medicaid Services (CMS) and federal regulations.However, under the Medicaid Provider Enrollment Compendium there are two exceptions to the provider enrollment requirement:
Any information provided on this Website is for informational purposes only. It is not medical advice and should not be substituted for regular consultation with your health care provider. If you have any concerns about your health, please contact your health care provider's office.
PLEASE NOTE: CCHP is providing the following for informational purposes only. We are not providing legal advice or interpretation of the laws and regulations and policies. CCHP encourages you to check with the appropriate state agency for further information and direction. This information should not be construed as legal counsel. Consult with an attorney if you are seeking a legal opinion.
(IV) The prescribing of a non-opioid controlled drug classified in schedule II through IV by means of telemedicine shall be limited to prescribers as defined in RSA 329:1-d, I and RSA 326-B:2, XII(a), who are treating a patient with whom the prescriber has an in-person practitioner-patient relationship, for purposes of monitoring or follow-up care. A provider shall not be required to establish care via face-to-face in-person service when:
The prescribing of a non-opioid controlled drug classified in schedule II through IV by means of telemedicine shall be limited to prescribers as defined in RSA 329:1-d, I and RSA 326-B:2, XII(a), who are treating a patient with whom the prescriber has an in-person practitioner-patient relationship, for purposes of monitoring or follow-up care. A provider shall not be required to establish care via face-to-face in-person service when: 2ff7e9595c
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