Mike Bereza – Online Prescribing https://onlineprescribing.com Online Prescribing Best Practice Fri, 11 Apr 2025 06:45:43 +0000 en-US hourly 1 https://wordpress.org/?v=6.8 https://i0.wp.com/onlineprescribing.com/wp-content/uploads/2022/08/cropped-android-chrome-512x512-1.png?fit=32%2C32&ssl=1 Mike Bereza – Online Prescribing https://onlineprescribing.com 32 32 209681591 Australian Online Prescribing Requirements https://onlineprescribing.com/australian-online-prescribing-requirements/ https://onlineprescribing.com/australian-online-prescribing-requirements/#respond Wed, 09 Apr 2025 02:16:03 +0000 https://onlineprescribing.com/?p=2066 The rise of digital health services in Australia has transformed how patients access healthcare—including prescriptions. As online consultations and e-prescriptions become more common, healthcare providers must stay informed about the legal, clinical, and technical requirements governing online prescribing.

This guide outlines the key regulations, frameworks, and best practices for safe and lawful online prescribing in Australia.


1. Key Regulatory Bodies

Online prescribing in Australia is governed by a mix of federal and state/territory laws, supported by various regulatory bodies:

  • Australian Health Practitioner Regulation Agency (AHPRA) – Oversees the registration and conduct of prescribers (doctors, pharmacists, nurse practitioners, etc.).
  • Therapeutic Goods Administration (TGA) – Regulates the safety and availability of medicines and medical devices.
  • Medical Board of Australia – Issues professional standards and guidelines for medical practitioners.
  • State/Territory Health Departments – Set local laws, especially around controlled substances and pharmacy operation.
  • Australian Digital Health Agency (ADHA) – Oversees digital health infrastructure, including My Health Record and electronic prescribing systems.

2. Who Can Prescribe Medications Online?

To prescribe medications online in Australia, the prescriber must:

  • Be a registered medical practitioner (e.g., GP, specialist, nurse practitioner) with AHPRA.
  • Prescribe within their scope of practice.
  • Be located in Australia, and in many cases, licensed in the same state or territory as the patient (especially for Schedule 8 medicines).
  • Use secure, appropriate telehealth platforms for consultations.

3. Online Prescribing Standards

The Medical Board of Australia and Pharmacy Board have issued clear expectations for safe online prescribing. Key requirements include:

a. Sufficient Clinical Information

  • Prescribers must collect adequate information to make a safe clinical decision.
  • This may involve reviewing medical history, current medications, allergies, and patient concerns.
  • A video consultation is preferred over text-based questionnaires alone.

b. Informed Consent

  • Patients must receive information about the medication, potential risks, side effects, and alternatives.
  • Consent must be voluntary and documented.

c. Proper Record-Keeping

  • Prescribers must maintain accurate and complete records of consultations and prescriptions.
  • Integration with My Health Record is encouraged where appropriate.

4. Electronic Prescribing (eRx)

Australia officially rolled out electronic prescribing in 2020. This allows prescribers to issue paperless prescriptions via a token system (SMS or email) that patients can use at participating pharmacies.

Key points:

  • ePrescriptions are legal and valid across Australia.
  • Prescribers must use compliant clinical software (e.g., Best Practice, MedicalDirector).
  • Pharmacies must be enabled to dispense from tokens.

5. Controlled Drugs and Schedule 8 Medicines

Prescribing Schedule 8 drugs (e.g., opioids, stimulants, benzodiazepines) online is tightly regulated:

  • Some states require prior approval or permits (e.g., NSW, QLD).
  • Prescribers may need to notify or obtain consent from the patient’s regular GP.
  • Video consultation is typically mandatory, and prescribing based solely on an online form is not permitted.

6. Pharmacy Regulation for Online Dispensing

Online pharmacies must:

  • Be registered with the Pharmacy Board of Australia.
  • Operate from a licensed premises in a specific state/territory.
  • Adhere to Professional Practice Standards and Good Dispensing Practice.
  • Follow the Therapeutic Goods Advertising Code—POMs (Prescription Only Medicines) cannot be advertised to the public.

7. Advertising and Commercial Restrictions

Australian law strictly regulates how medicines and prescribing services can be advertised:

  • Prescription medicines cannot be promoted to consumers by name or therapeutic claim.
  • Health practitioners must not make misleading or exaggerated claims online.
  • All marketing must comply with the TGA’s advertising code and AHPRA’s advertising guidelines.

8. Common Pitfalls and Enforcement Trends

The Medical Board and Pharmacy Council have taken disciplinary action against practitioners and businesses for:

  • Prescribing without a proper consultation
  • Using automated systems to issue prescriptions
  • Failing to check a patient’s medical history or medication use
  • Issuing high-risk medicines without clinical justification

Increased scrutiny is being placed on weight loss clinics, men’s health platforms, and mental health services that prescribe medications online without adequate safeguards.


9. Best Practices for Online Prescribers

To stay compliant and ensure safe patient care:

  • Use video consultations wherever possible
  • Implement secure systems for identity verification and record-keeping
  • Develop clear SOPs and clinical guidelines for prescribing decisions
  • Ensure all staff are trained in telehealth and regulatory compliance
  • Stay updated on state-specific rules for controlled drugs and telehealth provision

Conclusion

Online prescribing in Australia offers a flexible and patient-centred model of care—but it must be practiced responsibly. With increasing regulation and oversight, prescribers and businesses must ensure they are not only meeting legal requirements, but also upholding the highest clinical standards.

By combining robust technology, thoughtful patient engagement, and ongoing regulatory awareness, online prescribing can remain a safe and sustainable part of Australia’s healthcare future.

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US Online Prescribing Requirements https://onlineprescribing.com/us-online-prescribing-requirements/ https://onlineprescribing.com/us-online-prescribing-requirements/#respond Wed, 09 Apr 2025 02:11:19 +0000 https://onlineprescribing.com/?p=2064 The landscape of healthcare in the United States has shifted dramatically with the rise of telehealth and online prescribing services. From mental health treatment to chronic condition management, more patients than ever are accessing medical care—and prescriptions—through digital platforms.

However, online prescribing in the U.S. is tightly regulated. Providers and telehealth companies must navigate a complex mix of federal laws, state-specific regulations, and clinical best practices. This article outlines the key requirements, challenges, and opportunities surrounding online prescribing in the U.S.


1. Federal Regulations and Oversight

Online prescribing is governed by several federal laws and agencies. These include:

a. The Ryan Haight Online Pharmacy Consumer Protection Act (2008)

This landmark law was designed to combat the illegal sale of controlled substances online. It prohibits the prescribing of controlled substances over the internet without at least one in-person medical evaluation.

b. DEA (Drug Enforcement Administration)

The DEA enforces controlled substance laws and regulates how they can be prescribed and dispensed. A practitioner must be registered with the DEA to prescribe controlled substances, and online services must comply with strict recordkeeping and reporting requirements.

c. FDA (Food and Drug Administration)

The FDA oversees drug safety and labeling, ensuring that medications prescribed online are approved and used appropriately.


2. Telehealth and State-by-State Licensing

In the U.S., medical licensure is state-based, meaning a provider must be licensed in the state where the patient is located at the time of the consultation.

Key considerations:

  • Providers offering services across multiple states need to be licensed in each.
  • Some states participate in the Interstate Medical Licensure Compact (IMLC) to streamline multi-state licensing.
  • Telehealth prescribing laws vary by state—some allow a prescription after a video consultation, while others may require a physical exam or referral.

3. Controlled Substances and the Telehealth Rule Changes

During the COVID-19 Public Health Emergency (PHE), the DEA temporarily relaxed certain requirements to allow for prescribing controlled substances via telehealth without an initial in-person visit. These flexibilities were extended multiple times, but are now transitioning under a proposed “Special Registration Rule” that would establish a permanent framework for telehealth prescribing of controlled substances.

As of 2025:

  • In-person visits may again be required for certain medications.
  • Providers must stay updated on DEA rulemaking for compliance.

4. Clinical Guidelines and Best Practices

Prescribers—whether physicians, nurse practitioners, or physician assistants—must adhere to accepted clinical standards when prescribing medications online. This includes:

  • Conducting a thorough assessment via secure video or audio platforms.
  • Accessing patient history and medication records, when available.
  • Ensuring informed consent and discussing risks/benefits with the patient.
  • Documenting consultations and prescriptions in a secure EHR system.

5. Online Pharmacies and Verification

Online pharmacies must be registered with the NABP (National Association of Boards of Pharmacy) and preferably carry the VIPPS (Verified Internet Pharmacy Practice Sites) accreditation.

Consumers are advised to use pharmacies listed on the NABP’s “.Pharmacy” domain or “Safe Pharmacy” list to avoid counterfeit or unsafe medications.


6. Data Privacy and HIPAA Compliance

Any telehealth or online prescribing service must comply with HIPAA (Health Insurance Portability and Accountability Act) regulations, ensuring:

  • Patient data is stored securely
  • Video consultations are encrypted
  • Access is restricted to authorized personnel only

Failure to maintain HIPAA compliance can result in substantial fines and legal consequences.


7. Advertising and Direct-to-Consumer Services

Telehealth providers offering prescriptions directly to consumers (e.g., for acne, hair loss, ED, or mental health) must ensure that marketing is truthful and not misleading. The Federal Trade Commission (FTC) and FDA regulate healthcare advertising, particularly when involving prescription medications.


8. Enforcement and Penalties

Violations of online prescribing regulations—particularly involving controlled substances—can result in:

  • DEA license suspension or revocation
  • Civil or criminal penalties
  • Loss of medical license
  • Exclusion from federal programs like Medicare or Medicaid

Conclusion

Online prescribing is a powerful tool in expanding access to care in the U.S.—but it comes with serious responsibilities. Whether you’re a healthcare provider, pharmacist, or telehealth entrepreneur, compliance with federal and state regulations is non-negotiable.

Navigating the U.S. online prescribing landscape requires staying informed, implementing robust clinical protocols, and maintaining patient safety as the top priority. With careful attention to evolving rules and ethical practice, online prescribing can be both safe and transformative for American healthcare.

If you need help in your online prescribing journey, get in contact with one of our dedicated consultants.

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UK Online Prescribing Requirements https://onlineprescribing.com/uk-online-prescribing-requirements/ https://onlineprescribing.com/uk-online-prescribing-requirements/#respond Wed, 09 Apr 2025 02:08:43 +0000 https://onlineprescribing.com/?p=2062 In recent years, online healthcare services in the UK have grown significantly, with more patients opting for digital consultations and prescription services. While this transformation offers greater convenience and access to care, it also raises serious considerations around patient safety, clinical governance, and regulatory compliance.

Online prescribing in the UK is governed by a combination of national legislation, professional standards, and regulatory oversight. This article outlines the key requirements and responsibilities for clinicians, pharmacists, and businesses involved in online prescribing.


1. Legal Framework and Regulatory Bodies

Online prescribing in the UK is subject to the same legal and ethical standards as face-to-face prescribing. Key regulatory bodies include:

  • General Medical Council (GMC) – Regulates doctors who prescribe.
  • General Pharmaceutical Council (GPhC) – Regulates pharmacists and pharmacy premises.
  • Care Quality Commission (CQC) – Regulates independent healthcare providers in England, including some online services.
  • Medicines and Healthcare products Regulatory Agency (MHRA) – Regulates medicines, medical devices, and advertising standards.

Pharmacies dispensing medicines via online prescriptions must be registered with the GPhC and display the EU/UK Distance Selling Logo on their website to prove legitimacy.


2. Clinical Requirements for Online Prescribing

a. Patient Assessment

Prescribers must ensure that they have gathered sufficient information about the patient before issuing a prescription. This typically includes:

  • Medical history
  • Current medications
  • Allergies
  • Relevant symptoms or conditions

Online forms and questionnaires must be robust, but cannot replace clinical judgment. In many cases, a video or phone consultation may be required, especially when prescribing high-risk medications.

b. Informed Consent and Communication

Patients must be fully informed about the treatment, risks, benefits, and alternative options. A prescriber must ensure that:

  • The patient understands the nature of the medication.
  • The consent is voluntary and based on accurate information.
  • There is a clear opportunity to ask questions.

3. Medicines That Require Extra Caution

The GPhC and GMC have emphasized extra scrutiny for high-risk or controlled drugs. These include:

  • Opioids
  • Benzodiazepines
  • Weight loss medications
  • Hormonal treatments
  • Antibiotics

Prescribing such medicines without direct contact, access to a patient’s full medical record, or coordination with the patient’s GP can be considered unsafe and lead to regulatory action.


4. Record-Keeping and Data Protection

All online prescribers must maintain accurate records of:

  • Consultations
  • Assessments
  • Prescriptions issued
  • Patient communications

Additionally, online services must comply with UK GDPR and Data Protection Act 2018 requirements. Patient confidentiality and data security must be maintained at all times.


5. Advertising and Promotion Restrictions

Medicines cannot be advertised to the public in a misleading or promotional way, particularly prescription-only medicines (POMs). The MHRA and Advertising Standards Authority (ASA) closely monitor online advertising practices, and breaches can result in fines or suspension of services.


6. Prescribing from Outside the UK

If a prescriber is based outside the UK but offers services to UK patients, they must still adhere to UK prescribing laws and standards. It is illegal to prescribe POMs to UK patients from unregulated or unregistered services, even if the prescriber is licensed in another country.


7. Recent Updates and Enforcement

In 2022 and 2025, the GPhC published guidance reinforcing its commitment to patient safety in online prescribing. Notably:

  • Over 30% of Fitness to Practise cases involved online pharmacy services.
  • Common concerns included prescribing high-risk medicines based on incomplete patient data and lack of GP coordination.
  • Several interim suspensions were issued to pharmacists involved in unsafe online services.

8. Best Practices for Online Prescribers and Providers

To meet UK requirements and maintain patient trust, providers should:

  • Establish clear SOPs for prescribing and dispensing.
  • Use secure platforms for consultations and data management.
  • Maintain a quality assurance process.
  • Ensure ongoing training for staff in clinical and regulatory updates.
  • Encourage GP collaboration where appropriate.

Conclusion

Online prescribing in the UK presents a promising model for accessible healthcare—but only when done within the boundaries of clinical safety, regulatory compliance, and ethical practice. Whether you’re a clinician, pharmacist, or entrepreneur launching an online pharmacy, understanding and adhering to these requirements is critical to protecting patients and sustaining trust in digital health.

If you need help with your online prescribing venture, get in touch with one of our consultants.

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List of Controlled Drugs on Ships https://onlineprescribing.com/list-of-controlled-drugs-on-ships/ https://onlineprescribing.com/list-of-controlled-drugs-on-ships/#respond Tue, 08 Apr 2025 00:59:13 +0000 https://onlineprescribing.com/?p=2018 In maritime healthcare, the management of medications—especially controlled drugs—is critically important for ensuring the safety and well-being of crew members during long voyages. Ships often carry a limited but essential stock of medical supplies in accordance with international maritime regulations, including a carefully monitored inventory of controlled substances.

Controlled drugs are medications that carry a higher risk of abuse, dependence, or harm, and their possession, storage, and administration are subject to strict legal oversight. Onboard vessels, these drugs are typically included in the ship’s medical chest and are managed by the Ship’s Medical Officer or a trained, designated crew member.

The types of controlled drugs permitted at sea are regulated by the flag state under which the vessel is registered. Below is a list of the most common controlled substances found on ships, especially those used for pain management, anxiety, sleep disorders, and emergency medical situations. If you would like a full list of controlled drugs on ships as a pdf to use onboard, use the links provided in our Ship’s Controlled Drug Register article.

🚢 Common Controlled Drugs on Ships

These medications are typically authorized for emergency medical use onboard and must be stored securely and recorded in a Controlled Drugs Register.


💊 1. Opioid Analgesics (Pain Relief)

Used to manage moderate to severe pain, especially in trauma or post-surgical scenarios.

Drug NameCommon BrandUse Case
Morphine SulfateVariousSevere pain, injury, burns
Codeine PhosphateVariousModerate pain, cough suppressant
Fentanyl (Patch or Injection)DuragesicSevere pain, rapid relief
Tramadol (controlled in some jurisdictions)UltramModerate pain management

🧠 2. Benzodiazepines (Sedatives & Anxiolytics)

Useful for acute anxiety, seizures, and as pre-medication before certain procedures.

Drug NameCommon BrandUse Case
DiazepamValiumAnxiety, seizures, muscle spasms
LorazepamAtivanAcute anxiety, sedation
ClonazepamKlonopinSeizure control

😴 3. Hypnotics (Sleep Aids)

Used short-term for insomnia, particularly in situations where sleep is critical.

Drug NameCommon BrandUse Case
ZopicloneImovaneInsomnia, sleep disorders
ZolpidemAmbienShort-term sleep aid

⚡ 4. Controlled Stimulants (Rare on Ships)

Occasionally included for conditions like narcolepsy or severe fatigue, but generally limited.

Drug NameCommon BrandUse Case
ModafinilProvigilFatigue, narcolepsy (rare use)

🛡 5. Emergency or Special Use Drugs

Drug NameCommon BrandUse Case
KetamineKetalarEmergency anesthesia
BuprenorphineSubutexOpioid detox (if licensed)

⚠ Important Notes:

  • All controlled drugs must be stored in a locked and secured cabinet, with restricted access.
  • Each administration must be recorded in the Controlled Drugs Register, including dosage, reason, and signature of the person administering.
  • Disposal of expired or unused controlled substances must follow flag state and port authority regulations.
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Ships Controlled Drugs Register https://onlineprescribing.com/ships-controlled-drugs-register/ https://onlineprescribing.com/ships-controlled-drugs-register/#respond Tue, 08 Apr 2025 00:25:50 +0000 https://onlineprescribing.com/?p=2009

Introduction: A Complete Guide for Maritime Compliance

In the maritime industry, safety and compliance are paramount. One crucial area that requires strict regulation is the management of controlled drugs on ships. To ensure proper handling, documentation, and accountability, a Ship’s Controlled Drugs Register is mandatory under international maritime laws. This article covers everything you need to know about this vital document—what it is, why it’s important, and how to maintain it correctly.


What Is a Ship’s Controlled Drugs Register?

A Ship’s Controlled Drugs Register is a formal log used on board vessels to record the receipt, use, and disposal of controlled drugs, such as morphine or other opioid analgesics, which may be carried in the ship’s medical chest. These medications are often required for emergency treatment during long voyages where medical facilities are not immediately accessible. You can download a sample of a generic register here:


Why Is the Register Necessary?

Controlled substances have the potential for misuse, theft, or unintentional harm. Maritime regulations such as those enforced by the International Maritime Organization (IMO) and local flag state authorities require ships to:

  • Maintain proper records of all controlled drugs onboard.
  • Track quantities dispensed, administered, or disposed.
  • Ensure accountability and reduce the risk of diversion or abuse.

This applies to a list of controlled drugs on ships, including morphine, oxycodone, amphetamines and some sleeping aids. Failure to comply can result in severe legal consequences, fines, and vessel detention during port inspections.


Key Components of the Register

The flag state is legally responsible for prescribing exactly what the register must contain and how it should be maintained. However, in general, a compliant Controlled Drugs Register should include:

  1. Date of entry
  2. Name and strength of the drug
  3. Quantity received or issued
  4. Balance remaining
  5. Name and signature of the person issuing/administering the drug
  6. Name of the patient (if applicable)
  7. Reason for administration
  8. Witness signature (where required)

If you would like a flag state-compliant register just click on the individual link to download:


Who Can Administer Controlled Drugs on Ships?

Controlled drugs must be administered by a qualified Ship’s Medical Officer or an authorized crew member trained in medical care. Administration should always be justified and documented, with another crew member acting as a witness when possible.


Storage and Security

Controlled drugs must be:

  • Stored in a locked, secure cabinet
  • Accessible only to authorized personnel
  • Inspected regularly to ensure there are no discrepancies

The register should also be kept in a secure location and retained onboard for a specified period—usually two years, depending on the flag state’s regulations.


Best Practices for Maintaining the Register

  • Use permanent ink for all entries
  • Make entries immediately after drug administration
  • Never leave blank lines or use correction fluid
  • If a mistake is made, cross it out with a single line and initial it
  • Reconcile the register during regular audits

Digital Registers: Are They Accepted?

While some modern vessels are transitioning to digital controlled drug registers, their acceptance and legal standing still depend on the regulations of the vessel’s flag state. Regardless of digital adoption, it remains best practice to maintain a physical, hard-copy register, as international pharmaceutical and maritime laws continue to uphold the standards established before the digital era.


Legal and Regulatory References


Conclusion

Maintaining a Ship’s Controlled Drugs Register is not only a legal requirement but a crucial safety protocol that protects the health of crew members and ensures compliance with international and flag state regulations. Ship operators, captains, and medical officers must stay informed and diligent in keeping accurate, up-to-date records. By doing so, they promote a safer, more accountable maritime environment.

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What Is the Special Access Scheme? How to Request Unavailable Medications Legally https://onlineprescribing.com/what-is-the-special-access-scheme-how-to-request-unavailable-medications-legally/ https://onlineprescribing.com/what-is-the-special-access-scheme-how-to-request-unavailable-medications-legally/#respond Sat, 05 Apr 2025 10:37:58 +0000 https://onlineprescribing.com/?p=2002 In certain medical situations, conventional treatments may not be suitable, effective, or even available. This is where the Special Access Scheme (SAS) comes into play. In Australia, the SAS provides a legal pathway for healthcare professionals to access unapproved therapeutic goods, such as medicines, biologicals, and medical devices, for individual patients when necessary.

In this article, we’ll explore what the Special Access Scheme is, how it works, who is eligible, and how patients or healthcare providers can legally request access to unavailable medications.


What Is the Special Access Scheme (SAS)?

The Special Access Scheme is a regulatory framework governed by the Therapeutic Goods Administration (TGA) in Australia. It allows for the supply of unapproved therapeutic goods to patients on a case-by-case basis, under the supervision of a qualified healthcare provider.

These unapproved products may include:

  • Medications not registered in Australia
  • Experimental treatments
  • Medical devices still undergoing evaluation
  • Medications that have been discontinued or are in short supply

The SAS is not an alternative to clinical trials or registered treatments—it is only used when there are no viable alternatives and the treating practitioner believes the potential benefit outweighs the risks.


Why Might a Patient Need Access Through the SAS?

There are several circumstances in which a patient may benefit from accessing medications through the SAS:

  • They have a rare disease with no approved treatment
  • They are undergoing palliative care and need symptom relief not provided by registered products
  • They require access to a life-saving drug not yet available on the Australian market
  • They have tried all approved treatment options without success

Categories of the Special Access Scheme

There are three categories under the SAS, depending on the level of risk and urgency:

1. SAS Category A – Life-Threatening Conditions

This is a notification pathway (not approval-based). It applies to patients who are seriously ill or terminally ill, and whose condition is life-threatening. The healthcare provider must notify the TGA after the product has been supplied.

2. SAS Category B – Non-Life-Threatening Conditions

This is an application pathway. A registered medical practitioner must apply to the TGA for approval to supply the unapproved product. This includes providing clinical justification and supporting evidence.

3. SAS Category C – Pre-Approved Products

This is a notification pathway for specific medicines that the TGA has deemed suitable for certain patient groups. The healthcare provider must notify the TGA but doesn’t require formal approval beforehand.


How to Request Unavailable Medications Legally via the SAS

Here’s a step-by-step guide on how healthcare professionals can legally request access:

Step 1: Clinical Assessment

The treating doctor evaluates the patient’s condition and determines that an unapproved medicine is necessary and justifiable.

Step 2: Check the SAS Category

Identify the correct SAS category (A, B, or C) based on the patient’s condition and the medicine involved.

Step 3: Submit the Application or Notification

  • Category A: Complete the SAS Category A form and notify the TGA within 28 days of supply.
  • Category B: Submit an application to the TGA, including clinical justification and relevant documentation. Await TGA approval before supplying the product.
  • Category C: Notify the TGA using the SAS Category C form and proceed with the supply.

Step 4: Supply and Monitor

Once approval or notification is complete, the product may be supplied to the patient. The healthcare provider must monitor for safety and effectiveness.


Important Considerations

  • Patient Consent: Informed consent is essential. The patient must be made aware that the product is not approved by the TGA.
  • Product Sourcing: The product must be sourced through legal supply chains (e.g., from overseas manufacturers who meet TGA requirements).
  • Record Keeping: Documentation of supply, consent, and outcomes should be retained for compliance and patient safety.

Commonly Accessed Medications via SAS

Some examples of medications commonly accessed under SAS include:

  • Medicinal cannabis products
  • Treatments for rare cancers or neurological disorders
  • Certain biologics and gene therapies
  • Overseas-registered medications for drug-resistant infections

Final Thoughts

The Special Access Scheme is a vital part of the Australian healthcare landscape, enabling ethical and legal access to life-changing medications that are not otherwise available. While the process is highly regulated, it ensures that patients with serious or unmet medical needs can still receive potentially life-saving treatment when all other options have been exhausted.

If you’re a healthcare provider, it’s essential to stay informed about SAS pathways and TGA requirements. For patients, understanding this process empowers you to have open, informed discussions with your healthcare team about all possible treatment options.


FAQs

Q: Is the SAS the same as participating in a clinical trial?
A: No. SAS is for individual patient use, while clinical trials involve multiple patients and controlled research protocols.

Q: Can patients apply for SAS access themselves?
A: No. Only registered healthcare professionals can apply on behalf of a patient.

Q: Are SAS medications covered by Medicare or private insurance?
A: Not usually. Most SAS medicines are accessed at the patient’s own cost unless other funding options are available.

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How to Use Telehealth for Off-Label Prescriptions Safely and Legally https://onlineprescribing.com/how-to-use-telehealth-for-off-label-prescriptions-safely-and-legally/ https://onlineprescribing.com/how-to-use-telehealth-for-off-label-prescriptions-safely-and-legally/#respond Sat, 05 Apr 2025 10:36:52 +0000 https://onlineprescribing.com/?p=2001

Telehealth has transformed the way we access healthcare, offering convenience, speed, and expanded access to medical expertise. One emerging area of interest is off-label prescriptions via telehealth. While off-label prescribing is legal and common, doing it safely and legally—especially through digital platforms—requires patients and providers to follow best practices.

In this article, we’ll explore how to use telehealth for off-label prescriptions, the legal landscape, and how to stay safe and informed as a patient or practitioner.

What Is Off-Label Prescribing?

Off-label use refers to the prescribing of a medication for a condition, age group, dosage, or route of administration not specifically approved by the FDA (or equivalent regulatory body in other countries). Although it’s not approved for that specific use, many off-label prescriptions are supported by scientific evidence and clinical experience.

Common Examples of Off-Label Use

  • Using antidepressants to treat chronic pain
  • Prescribing beta-blockers for anxiety
  • Using antipsychotics for insomnia

Can Telehealth Providers Prescribe Off-Label Medications?

Yes—telehealth providers can prescribe medications off-label, just like in-person physicians. However, the same standards of care, clinical justification, and documentation apply.

How to Use Telehealth for Off-Label Prescriptions Safely

Here’s how patients and healthcare providers can ensure that off-label prescribing via telehealth is safe, legal, and ethical:

1. Choose a Licensed and Reputable Telehealth Platform

Always use a board-certified healthcare provider through a registered and compliant telehealth service. Ensure the platform:

  • Verifies practitioner credentials
  • Operates within your state or country’s legal guidelines
  • Follows secure data and privacy regulations (e.g., HIPAA in the U.S.)

2. Understand the Medication’s Off-Label Use

Ask your provider:

  • Why is this medication being prescribed off-label?
  • Is there clinical evidence to support this use?
  • What are the potential risks or side effects?

Being informed empowers you to make safer decisions.

3. Get a Proper Evaluation

A legitimate telehealth consultation should involve:

  • A thorough review of your medical history
  • Discussion of symptoms and concerns
  • A well-documented clinical rationale for off-label use

Avoid services that prescribe without a proper assessment.

4. Ensure Informed Consent

Doctors are legally and ethically required to obtain your informed consent for off-label use. This means explaining:

  • That the use is off-label
  • Known risks and benefits
  • Alternative treatments

This documentation should be part of your telehealth record.

5. Check State and National Regulations

Some states and countries may have specific restrictions on prescribing certain medications or off-label uses. Both patients and providers must be aware of:

  • Controlled substances regulations
  • Special licensing or DEA registration for prescribing remotely
  • Telehealth prescribing laws (e.g., Ryan Haight Act in the U.S.)

6. Follow Up and Monitor

Off-label use often requires close monitoring. Make sure your telehealth provider offers:

  • Follow-up appointments
  • Medication adjustments if needed
  • Clear communication channels for questions or side effects

Legal Considerations for Providers

If you’re a healthcare provider prescribing off-label via telemedicine, ensure:

  • Compliance with local medical board rules
  • Documentation of clinical justification
  • Use of evidence-based guidelines
  • Appropriate malpractice coverage for telehealth and off-label use

Red Flags to Watch Out For

Avoid telehealth services that:

  • Promise miracle cures or guaranteed results
  • Skip over clinical assessments
  • Provide off-label medications without informed consent
  • Lack transparency in their provider qualifications

Final Thoughts

Telehealth is a powerful tool that can increase access to innovative treatments, including off-label prescriptions. However, both patients and providers must uphold high standards to ensure the process remains safe, legal, and effective. Get in contact if you would like further information or specialist help finding a medicine.

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Why Cognitive Enhancers Like Piracetam Are So Hard to Get — and What to Do About It https://onlineprescribing.com/why-cognitive-enhancers-like-piracetam-are-so-hard-to-get-and-what-to-do-about-it/ https://onlineprescribing.com/why-cognitive-enhancers-like-piracetam-are-so-hard-to-get-and-what-to-do-about-it/#respond Sat, 05 Apr 2025 10:28:56 +0000 https://onlineprescribing.com/?p=1999 In an era where productivity and mental performance are prized more than ever, cognitive enhancers—or nootropics—have garnered massive interest. One of the most discussed nootropics in the community is Piracetam, a substance that has shown promise in improving memory, focus, and learning capacity. Despite its popularity and long history, Piracetam is notoriously difficult to obtain in many countries. But why is that the case? And if you’re interested in using it, what can you do about the restrictions?

What Is Piracetam?

Piracetam is one of the earliest nootropics ever synthesized, developed in the 1960s by Romanian chemist Dr. Corneliu E. Giurgea. It’s part of the racetam family of compounds and is often touted for its potential to enhance cognitive function without being a stimulant or sedative. It’s believed to work by influencing the brain’s neurotransmitters, particularly acetylcholine, and by improving blood flow to the brain.

Why Is Piracetam So Hard to Get?

1. Lack of FDA Approval (in the U.S.)

Piracetam is not approved by the FDA for any medical use in the United States. It’s not illegal, but it’s also not classified as a dietary supplement, making it difficult to market or sell through standard health channels. This regulatory gray area means most U.S.-based vendors avoid it.

2. Unregulated Market

In many countries, Piracetam exists in a legal limbo. It’s not scheduled or controlled, but it’s also not officially approved for use, creating barriers for sellers and confusion for consumers. In the EU, regulations vary widely by country—some require prescriptions, others allow over-the-counter sales, while some have banned it outright.

3. Pharmaceutical Industry Pressure

Cognitive enhancers threaten to disrupt traditional pharmaceutical markets. Substances like Piracetam, which are often off-patent and inexpensive, pose little financial incentive for big pharma companies. As a result, there’s limited push for clinical trials or approval, despite decades of anecdotal use and international research.

4. Association with Biohacking Culture

Piracetam is popular among biohackers, students, and professionals looking for an edge. This association with “DIY brain enhancement” makes regulators cautious. There’s concern about unsupervised use, dosage inaccuracies, and the potential for misuse or overuse, despite its relatively safe profile.

What to Do If You Want to Try Piracetam

1. Research Local Laws

Before attempting to buy or import Piracetam, check the laws in your country or state. In some places like the UK or Canada, you may need a prescription. In others, personal importation for personal use might be allowed—but always proceed with caution.

2. Look for Reputable International Suppliers

Some online vendors, especially those based in countries where Piracetam is legal and regulated, may still ship internationally. Always vet suppliers carefully. Look for third-party lab testing, clear sourcing, and a strong reputation in the nootropics community.

3. Consider Legal Alternatives

There are other cognitive enhancers with similar effects that are more easily accessible, including:

  • Citicoline (CDP-Choline) – Supports acetylcholine and brain health.
  • Aniracetam or Oxiracetam – Other racetams that may be easier to obtain.
  • Bacopa Monnieri and Rhodiola Rosea – Herbal supplements with cognitive benefits.
  • L-Theanine + Caffeine – A safe, synergistic combo for focus and calm.

4. Consult a Medical Professional

Even though Piracetam is often described as safe, individual responses vary. If you have underlying health conditions or take other medications, it’s best to consult a doctor or functional medicine practitioner—preferably one familiar with nootropics.

Final Thoughts

Piracetam and other nootropics represent a fascinating frontier in cognitive enhancement. But regulatory barriers, legal ambiguity, and lack of clinical endorsement have made access challenging. By staying informed, researching alternatives, and proceeding responsibly, you can still explore ways to optimize mental performance without breaking the law—or compromising your health.

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Can You Bring Prescription Drugs on a Plane? https://onlineprescribing.com/can-you-bring-prescription-drugs-on-a-plane/ https://onlineprescribing.com/can-you-bring-prescription-drugs-on-a-plane/#respond Sat, 05 Apr 2025 10:27:38 +0000 https://onlineprescribing.com/?p=1996

If you’re planning to fly and need to take prescription medication with you, you’re not alone. Millions of travelers bring essential medicines when traveling by air — but many wonder: Can you bring prescription drugs on a plane? The short answer is yes, but there are specific rules you need to follow to ensure a hassle-free journey. In this article, we break down everything you need to know about flying with prescription medications, plus helpful travel tips to keep your meds safe and accessible.


Can You Bring Prescription Drugs on a Plane?

Yes, You Can — With Some Conditions

According to the Transportation Security Administration (TSA) and most international travel authorities, passengers are allowed to bring prescription medications on board both in carry-on and checked luggage. However, certain guidelines must be followed to avoid issues at security checkpoints.


TSA Guidelines for Prescription Medications

To travel smoothly through airport security in the U.S., keep these TSA medication rules in mind:

  • ✅ Medications are allowed in pill, liquid, or cream form.
  • ✅ There is no limit on the number or volume of medications (including liquid medications over 3.4 oz/100 mL).
  • ✅ You do not need to store medications in their original prescription bottles, though it’s strongly recommended.
  • ✅ Declare liquid medications to TSA officers and remove them from your bag for separate screening.
  • ✅ Bring documentation, such as a prescription or a doctor’s note, especially for injectable or controlled substances.

International Travel with Prescription Drugs

Flying internationally? Rules can vary by country.

  • 🌍 Always check the destination country’s regulations on prescription medications.
  • 🚫 Some countries prohibit or strictly regulate certain drugs, including common ones like Adderall or codeine.
  • ✈ Bring a translated copy of your prescription and a letter from your doctor stating your medical need.
  • 🧾 Carry only the quantity needed for personal use, typically no more than a 30- to 90-day supply.

Tips for Traveling with Prescription Medications

1. Keep Medications in Your Carry-On

Always pack your medications in your carry-on bag. Checked luggage can be lost or delayed — and you don’t want to be without your vital meds.

2. Use Original Packaging

While not required by TSA, original packaging with pharmacy labels can help avoid suspicion or delays at security checks — especially for controlled medications.

3. Bring a Doctor’s Note

If you’re carrying injectable meds, syringes, or drugs that may raise red flags, a signed doctor’s note explaining your medical condition and prescription can be a lifesaver.

4. Pack a Travel-Size Medication Kit

Include a list of your medications, dosages, and the times you take them. Keep this list separate from your meds in case of emergency.

5. Be Time-Zone Aware

Plan how to take your medications when crossing time zones. Some travelers use alarms to maintain regular dosing intervals.


Special Considerations: Controlled Substances

If you’re traveling with narcotics or controlled medications, additional precautions apply:

  • 🔒 Keep them in original containers with your name and prescription info.
  • 📄 Bring supporting documents (doctor’s note, recent prescription).
  • 🛂 Declare them at customs if required, especially when entering countries with strict drug laws.

Final Thoughts

So, can you bring prescription drugs on a plane? Absolutely — as long as you follow the appropriate regulations. A little preparation goes a long way when it comes to traveling with medications. From keeping drugs in your carry-on to carrying proof of prescription, these simple steps can ensure a smooth and stress-free trip.

Whether you’re flying domestically or internationally, staying organized and informed is the best prescription for safe travels.

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Importing Medications Into USA: What’s Allowed and What Gets Seized https://onlineprescribing.com/importing-medications-into-usa-whats-allowed-and-what-gets-seized/ https://onlineprescribing.com/importing-medications-into-usa-whats-allowed-and-what-gets-seized/#respond Sat, 05 Apr 2025 10:22:36 +0000 https://onlineprescribing.com/?p=1992

When it comes to importing medications into the United States, the rules can be complex and confusing. With the rising cost of prescription drugs in the U.S., many individuals consider buying medications from abroad. However, the U.S. Food and Drug Administration (FDA), Customs and Border Protection (CBP), and the Drug Enforcement Administration (DEA) have strict regulations in place. This article breaks down what’s permitted, what gets confiscated, and how to stay compliant.


What’s Generally Allowed

  1. Personal Importation Policy (PIP): The FDA allows the import of unapproved medications under limited circumstances through its Personal Importation Policy. These include:
    • The drug is for a serious condition with no effective treatment available in the U.S.
    • It’s not being promoted to U.S. residents.
    • It’s for personal use (generally a 90-day supply or less).
    • There’s no known risk associated with the drug.
    • The individual provides a doctor’s note or documentation of treatment.
  2. FDA-Approved Medications: If a medication is FDA-approved and manufactured in a foreign country, it may be imported if:
    • It is for personal use.
    • It’s not controlled by the DEA.
    • The quantity is reasonable (again, usually a 90-day supply).
  3. Over-the-Counter (OTC) Drugs: Many OTC medications may be imported for personal use as long as:
    • They are not banned or restricted in the U.S.
    • They are in reasonable quantities.

What Gets Seized at the Border

  1. Controlled Substances:
    • Medications containing controlled substances like narcotics, stimulants, or benzodiazepines are typically seized unless the importer has prior approval from the DEA.
    • Even if prescribed abroad, these drugs require specific documentation and clearance.
  2. Unapproved Drugs:
    • Any drug not approved by the FDA, regardless of whether it is approved elsewhere (like Canada or Europe), may be seized.
    • This includes some generic medications that are equivalent in other countries but lack FDA approval.
  3. Counterfeit or Mislabeled Products:
    • Medications that are not properly labeled, have no identifiable manufacturer, or appear counterfeit will be confiscated.
    • Packaging without English labeling may also raise red flags.
  4. Large Quantities:
    • Bringing in bulk supplies of medications, even OTC drugs, can signal intent to resell, which is illegal without proper licensing.
  5. Biological Products & Injectables:
    • Insulin, vaccines, and injectable medications often require special handling and approvals. Improper storage or documentation may lead to seizure.

Best Practices for Importing Medication Legally

  • Consult Your Doctor: Get a prescription or letter stating the medical necessity.
  • Carry Proper Documentation: Always include prescriptions, invoices, and usage details.
  • Stick to Small Quantities: Limit to a 90-day personal supply to avoid suspicion.
  • Use Reputable Sources: Purchase from licensed, well-known international pharmacies.
  • Check the DEA and FDA Lists: Confirm if your medication is on any controlled or restricted list.

Special Note on Traveling With Medications

When traveling to the U.S.:

  • Keep all medications in original packaging.
  • Carry a copy of your prescription.
  • Declare medications to Customs if required.

Conclusion

Importing medication into the U.S. is not as simple as ordering online from abroad. While some personal use cases are allowed under the FDA’s discretion, the risk of seizure is high for controlled or unapproved substances. Understanding and following the legal pathways can save you from legal trouble, delays, and financial loss.

If in doubt, consult with a licensed pharmacist, attorney, or the FDA directly before attempting to import medication.

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