Webinar: Special Access Scheme (SAS) Portal Update

Source: Australian Department of Health

A walk-through of the changes to the SAS and Authorised Prescriber Online System.

Background

The SAS and AP Online System is being upgraded and as a result there will be some minor changes to the look and feel, as well as some new enhancements. The SAS Category B online form has been updated to reflect the legislative changes made in NSW, ACT, VIC and QLD. The AP dashboard now includes a streamlined application for nicotine prescribing and the ability to submit six monthly patient data reports.

How do I register?

Webinar session 1

  • Date: Wednesday, 10 March 2021
  • Time: 10am-11am
  • Where: Online webinar

Register for webinar

Webinar session 2

  • Date: Thursday 11 March 2021
  • Time: 2pm-3pm
  • Where: Online webinar

Register for webinar

Haimex International Pty Ltd fined $53,280 for alleged unlawful importation of medical devices

Source: Australian Department of Health

The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued four infringement notices totalling $53,280 to Sydney-based company Haimex International Pty Ltd (Haimex International) for the alleged unlawful importation of infrared thermometers, rigid strapping tapes and iodine prep pads under the Therapeutic Goods Act 1989 (the Act).

Haimex International allegedly imported the products, which had not been included in the Australian Register of Therapeutic Goods (ARTG), and were neither exempt nor excluded from the operation of the Act. Unless a specific exemption, approval or authority applies, therapeutic goods must be entered in the ARTG before they can be lawfully imported into Australia. The TGA notified Australian Border Force that the goods should be seized.

Demand for thermometers in Australia has increased due to the COVID-19 pandemic. The TGA has published regulatory guidance to support business with submitting their applications for thermometers to be included in the ARTG.

Unapproved therapeutic goods imported unlawfully are of unknown reliability, and their importation in the context of the pandemic is of significant concern to the TGA.

The TGA’s highest priority is to protect the health and safety of the Australian public through the regulation of therapeutic goods.

The TGA takes action against breaches of the Act

The regulatory scheme is critical to the safety of Australian consumers, and the TGA investigates suspected illegal activity in relation to therapeutic goods. A range of compliance and enforcement tools are available and may include criminal or civil court proceedings, which can result in substantial penalties, fines or imprisonment.

If you suspect non-compliance, you can report illegal or questionable practices online to the TGA.

NMI Mask Testing Forum 2.0

Source: Australian Department of Health

TGA encourages sponsors and manufacturers of medical device facemasks and respirators to join the Mask Testing Forum.

The National Measurement Institute (NMI) established a Mask Testing Forum in 2020 as an informal technical discussion group. The primary focus of the group was to solve technical questions of mutual relevance with the intention to accelerate the development of Australia’s mask testing capabilities. These discussions included, but were not limited to, ensuring confidence in mask testing results and understanding how they compare between jurisdictions or laboratories.

The NMI are looking to expand this forum in 2021. Through the Forum, NMI hopes to facilitate the development of collaborative solutions to pre-/non-commercial technical issues of mutual concern across the industry including:

  • Interpretation of standards
  • requirements from regulators,
  • industry questions and
  • policy issues that are relevant to technical questions being considered by the forum.

The NMI would like to see a broad range of interested parties join the forum, including manufacturers and major suppliers of masks and respirators, Government representatives, public and private PPE testing laboratories and researchers.

To join the forum or for more information, please see mask testing forum or email COVID19@measurement.gov.au.

The TGA’s risk management approach

Source: Australian Department of Health

Version 5.0, February 2021

About this guidance

This guidance outlines the broad approach adopted by the Therapeutic Goods Administration (TGA) to identify and manage risk associated with therapeutic goods.

Role of the TGA

We regulate and monitor therapeutic goods through:

  • pre-market assessment
  • post-market monitoring and enforcement of standards
  • licensing of Australian manufacturers and verifying overseas manufacturers’ compliance with the same standards as their Australian counterparts
  • compliance and enforcement activities to address alleged breaches of the regulatory requirements.

We also play a role in the Australian Government’s implementation of the National Medicines Policy.

For more information refer to:

Medicines

Australia has a two-tiered system for the regulation of medicines:

  • Higher risk medicines must be registered in the Australian Register of Therapeutic Goods (ARTG), which involves individually evaluating the quality, safety and efficacy (effectiveness) of the product.
  • Lower risk medicines containing pre-approved, low-risk ingredients and that make limited claims can be listed in the ARTG.

The different types of medicines that must be registered or listed are set out in the Therapeutic Goods Regulations 1990.

Regardless of whether a medicine is registered or listed in the ARTG, it must be manufactured in a licensed or approved facility in accordance with the principles of good manufacturing practice (GMP).

For more information refer to:

Risk management options

Having identified and evaluated the risks associated with a new medicine we consider options to determine the most appropriate means to manage potential risks.

The legislative framework provides the risk management options available to us. These options include:

  • Refusal of entry in the ARTG where the risks of a medicine outweigh the benefits.
  • Application of conditions on registration for products intended for supply in Australia.
  • Application of conditions relating to the manufacture of products, such as allowing only certain manufacturers to manufacture a product.
  • Requirement of the sponsor to adhere to an agreed Risk Management Plan for products intended for supply in Australia.
  • Requirement of the sponsor to meet all pharmacovigilance reporting responsibilities for listed or registered medicines supplied to the Australian market.
  • Scheduling decisions to control how medicines are made available to the public.
  • Labelling requirements where we stipulate particular information that must be included in the packaging or on the label of a medicine, this might include a health warning.
  • Specific conditions on supply such as restricting supply and use of the medicine to hospitals only.
  • Require information to be included in the Product Information (PI) and Consumer Medicines Information (CMI) leaflet for a given product.

Manufacturing medicines

We apply risk management practices to risks posed through the manufacture of a medicine. We do this through licensing, inspections and good manufacturing (GMP) compliance assessments of manufacturers.

Our focus is on ensuring that manufacturers build quality into their manufacturing processes to minimise risk. For medicines, we do this by requiring manufacturers to comply with the Code of Good Manufacturing Practice (GMP).

GMP is used internationally to describe a set of principles and procedures which, when followed by manufacturers of therapeutic goods, helps ensure that each batch of a therapeutic good is safe, reliable and of consistent high quality.

Licensing of Australian manufacturers

With certain exceptions, Australian manufacturers of medicines are required to hold a manufacturing licence.

Before licensing a manufacturer, we assess the manufacturer’s compliance with the relevant code of good manufacturing principles (GMP) through an on-site inspection. We undertake a detailed risk assessment of the manufacturer’s facilities, equipment, practices and processes. This enables us to determine the appropriate action (or treatment option). Actions we can take include:

  • Refusing to issue a manufacturing licence until the manufacturer has demonstrated that they have comprehensively designed and correctly implemented systems of quality assurance that incorporate GMP principles and which build a high level of quality control into each batch of their product.
  • Issuing of a manufacturing licence subject to conditions, for example, conditions may be applied so that the manufacturer may only undertake certain steps in the manufacturing process or may only manufacture certain products.

For more information refer to Manufacturing medicines.

Assessment of overseas manufacturers

Overseas manufacturers of therapeutic goods supplied to Australia are required to meet an acceptable standard of good manufacturing practice (GMP) comparable to that required by Australian manufacturers.

Australian sponsors of products manufactured overseas must also obtain TGA approval for overseas manufacturers wishing to supply therapeutic goods to the Australian market.

While our GMP inspectors will conduct on-site inspections of the overseas manufacturers where required, we have entered into various international arrangements with other countries and regulatory authorities that allow us to use inspections conducted by these regulatory authorities as part of the GMP clearance process in lieu of performing our own on-site inspections.

Blood and haematopoietic progenitor cells (HPCs)

Blood, blood components and haematopoietic progenitor cells (HPCs) are regulated as medicines under the Therapeutic Goods Act 1989. However, they are not required to be entered into the Australian Register of Therapeutic Goods (ARTG).

Plasma derivatives are regulated as prescription medicines subject to full regulation under provisions requiring standards, licensing of manufacture and inclusion in the ARTG after review of manufacturing, pre-clinical and clinical data.

Some blood, blood components and haematopoietic progenitor cells are exempt from TGA oversight to allow for autologous and directed donations under the supervision of a medical practitioner.

Manufacturing blood and haematopoietic progenitor cells (HPCs)

The potential risks relating to blood, blood components and HPCs are managed through good manufacturing (GMP) inspections and licensing of manufacturers. These processes include the evaluation the Technical Master File (TMF) against relevant standards. The technical and scientific information in a TMF is expected to demonstrate the safety and quality of the product.

The risk assessment and risk management processes for ensuring compliance with good manufacturing practice (GMP) requirements are essentially the same as those described for the manufacture of medicines and the same options to refuse to issue a licence or to issue a licence subject to conditions apply.

Biologicals

Biologicals are a distinct group of therapeutic products.

For more information refer to:

Once we have reviewed of all risks associated with the different aspects of a biological product, a senior officer of the TGA will review the reports and determine what action is appropriate. The advice of independent expert advisory committees may also be sought on key issues such as for new products or major extensions of clinical indications.

Manufacturing biologicals

We also evaluate and manage risks that may be posed through the manufacture of biologicals. The requirements are equivalent to those discussed for manufacturing medicines, except that the requirements for a biological are contained within the Australian code of good manufacturing practice for human blood and blood components, tissues and human cellular therapy.

Medical devices and IVDs

The regulation of medical devices and IVDs incorporates accepted best practice relating to safety, quality and risk management procedures and adopts the principles of the International Medical Device Regulators Forum (IMDRF).

Medical devices including in vitro diagnostic medical devices (IVD) are assessed against the Essential Principles and in line with their intended purpose and risk-based classification.

For more information refer to:

Monitoring and review

We share responsibility for post-market risk management with sponsors, manufacturers, healthcare providers and consumers.

Each participant has a role in monitoring and evaluating adverse events associated with therapeutic goods as well as taking appropriate corrective action.

For more information refer to Post market monitoring.

Monitoring and review of medicines

Our post-market monitoring activities enable us to identify and evaluate any risks associated with the formulation, manufacture, labelling, safety monitoring and advertising of medicines once they have entered the market-place.

Under the Therapeutic Goods Act 1989, sponsors of medicines on the Australian Register of Therapeutic Goods (ARTG) also have mandatory pharmacovigilance responsibilities.

Some of the ways we monitor compliance include:

  • monitoring of adverse events reports and recalls
  • sample testing by the Laboratories Branch
  • review of safety-related information submitted by sponsors or published in scientific literature
  • random and targeted desk-top reviews of selected listed products
  • full safety and efficacy reviews of products and substances
  • review and response to intelligence and tip-offs.

We also work to ensure that Australian and international manufacturers operate in a way that results in their products meeting required standards. We conduct regular inspections of manufacturers, both in Australia and overseas, to ensure they continue to meet these standards. Where inspections or other GMP compliance signals identify that manufacturing standards are not being met, we may take compliance actions including suspending or revoking manufacturing licences of Australian manufacturers or conditioning or cancelling GMP Clearances for overseas manufacturers.

As a result of this monitoring, information might be identified that leads to a re-evaluation of the risks posed by a particular therapeutic product.

Monitoring and review of medical devices

Once a medical device has been approved for supply in Australia we undertake post-market monitoring to ensure that products continue to meet all the regulatory, safety, and performance requirements and standards that were required for the approval.

For more information refer to Post-market reviews.

The Australian Regulatory Guidelines for Medical Devices (ARGMD) provides detailed information for sponsors and manufacturers about their post-market responsibilities including:

  • procedures to collect information from users
  • procedures for reporting incidents and performance issues
  • evidence that appropriate conformity assessment procedures have been applied
  • reporting of adverse events (including threshold criteria for adverse events reporting)
  • reporting exemption rules.

Compliance

Our post-market compliance activities relate to the monitoring of the continuing safety, quality and efficacy of therapeutic goods once they are on the market.

We use a combination of monitoring strategies to support our compliance programs. Our monitoring programs are both proactive and responsive and include acting upon signals and reports of non-compliance from a number of external sources.

For more information refer to Compliance management.

Communication and consultation

All participants in the development and delivery of therapeutic goods have a role to play in maintaining a benefit-risk balance by making sure that products are developed, tested, manufactured, labelled, prescribed, dispensed and used in a way that maximises benefit and minimises risk, when used as intended.

Communication and consultation are important at each step of the risk management process. We actively consult with our stakeholders to promote understanding and improve the efficiency and effectiveness of the regulatory framework.

Effective internal and external communication ensures that those responsible for implementing risk management, and those with a vested interest, understand the basis on which decisions are made and why particular actions are required.

For more information refer to the Stakeholder engagement framework.

Internal stakeholders

The effective management of both product and compliance risks depends on the collection, collation and analysis of information from all regulatory areas of the TGA.

Communication and collaboration between our different regulatory areas are facilitated by TGA being structured along functional responsibilities. This allows us to identify existing interdependencies to maximise our ability to identify and manage product safety risks and regulated entity compliance risks. This is supplemented by collaboration within the Regulatory Compliance and Risk Committee (RCRC).

Applying a whole-of-regulatory-cycle view of therapeutic goods and regulated entities allows us to identify risks and tailor appropriate risk management strategies.

External stakeholders

Communication with stakeholders is also critical for effective risk management:

  • we provide guidance and information that is up to date, clear, accessible and concise through media appropriate to the target audience
  • we consider the impact on the regulated entities and engage with industry groups and representatives of affected stakeholders, including consumer representatives where appropriate, before changing our policies, processes and service standards
  • we establish cooperative and collaborative relationships with stakeholders to improve the efficiency and effectiveness of the regulatory framework.

Key external stakeholders

Communication and consultation with external stakeholders ensures that there is a continuous feedback loop and that information from a wide variety of sources is available to assist us in our role in risk assessment and management of therapeutic goods.

Our key external stakeholders are:

  • consumers
  • healthcare practitioners
  • industry (sponsors and manufacturers of therapeutic goods)
  • other government agencies including state and territory governments
  • international regulatory bodies.

Communication and consultation mechanisms

We have a number of measures in place to ensure our stakeholders are kept informed about developments within the TGA, are well educated about the regulatory requirements and are provided the opportunity to provide feedback. These measure include, but are not limited to:

  • the TGA website which is a primary source of information for consumers, healthcare practitioners and industry
  • use of social media to share links and information about safety alerts, recalls, current issues and events
  • a variety of email lists to which stakeholders can subscribe to receive updates
  • public consultations
  • industry, healthcare professionals, state and territory government health departments and consumer representation on a number of TGA committees
  • regular meetings with industry, health practitioner and consumer representatives through our involvement in a variety of conferences, forums and other events
  • collaboration with state and territory governments. For example, each state and territory has a State Recall Co-ordinator that assists us with the recall of products
  • we survey our stakeholders each year to help evaluate our performance
  • we work collaboratively with several international agencies and regulators.

For more information refer to About consultations.

Version history

Version Description of change Author Effective date

V1.0

Original

Deloitte

20/07/2004

V2.0

Update to reflect regulatory changes

Office of Regulatory Integrity

06/05/2011

V3.0

Update to include Biologicals Regulatory Framework

Office of Regulatory Integrity

01/09/2011

V4.0

Update to Risk Management Standards

Office of Regulatory Integrity

09/09/2011

V5.0

Rewrite and update

Regulatory Guidance

23/02/2021

Advertising COVID-19 vaccines to the Australian public

Source: Australian Department of Health

There are rules that you must follow if you wish to advertise COVID-19 vaccines

The advertising of prescription medicines (including vaccines) to consumers is generally prohibited in Australia. However, the use of specific promotional materials to advertise COVID-19 vaccines has been authorised to support the roll-out of the vaccines across Australia.

As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates the advertising of therapeutic goods in Australia. This fact sheet explains how vaccine providers and other parties may lawfully advertise the COVID-19 vaccine without risking penalties for breaching the prohibition on advertising prescription medicines.

Advertisers must not:

  • use self-developed advertising about COVID-19 vaccines

Advertisers can:

  • use Australian Government produced materials to promote COVID-19 vaccines
  • use materials produced by Australian state or territory governments to promote COVID-19 vaccines
  • provide factual information to assist the public in obtaining the vaccine such as:
    • the location of the COVID-19 vaccination service
    • times vaccines are administered or opening hours of the service provider
    • whether there is a need for an appointment to receive the vaccination and how to make one

When using government materials, advertisers must:

  • ensure that the materials are:
    • genuine
    • not altered or added to, other than to record the factual information described above i.e. logistical information
    • not used in a way that may alter the take-home message for consumers, through either placement of the materials or proximity to other promotional materials

Government produced materials may be used in all communication channels including on websites, as flyers, or as posters as well as in the windows and on the walls at vaccine providers, clinics, pharmacies, and other businesses. Businesses with an interest in disseminating information about the availability of the vaccine may also use the materials in their newsletters, social media and emails.

In using government materials to promote COVID-19 vaccines, advertisers must be careful not to add:

  • the tradename and/or active ingredient of the specific vaccine or other information that might enable consumers to identify the particular vaccine or the manufacturer of the vaccine
  • statements or the implication that harmful effects will result from not receiving the vaccine
  • statements or the implication that the vaccine offered is superior to other vaccines (e.g. a statement about the efficacy against a particular strain)
  • incentives to encourage a consumer to obtain the service or vaccine
  • any comparisons between vaccines (even if supported by evidence)

The TGA has powers to issue directions to advertisers, impose fines or pursue court action for breaking the advertising laws.

Further information

  • The Australian Government materials on COVID-19 vaccines are available from:
  • You should use the appropriate Australian Government or Australian state or territory government materials in the same way to promote influenza and other vaccines.
  • If you have questions about the legal requirements regarding advertising of therapeutic goods including vaccines, please lodge an advertising enquiry online with the TGA.

Examples

Facebook post

Downtown Medical Centre

You can now get vaccinated against COVID-19 at the Downtown Medical Centre. Available Monday to Friday from 9am – 9pm. Call 9999 9999 for an appointment.

Facebook post (all content self developed)

Downtown Medical Centre

A COVID-19 vaccine is the best way to protect you and your family from falling seriously ill!

You can now get your COVID-19 vaccination at the Downtown Medical Centre. Available Monday to Friday from 9am – 9pm. Just walk-in and enjoy a free cappuccino while you wait.

Video of patient receiving a vaccine and saying “Wow that didn’t hurt at all!”.

Facebook post

Downtown Pharmacy

You can now get the COVID-19 vaccine at Downtown Pharmacy. Available Monday to Friday from 9am – 9pm. Call 9999 9990 for an appointment.

vaccine is free>

Other regulatory requirements

Advertising to consumers, whether for a product or service, is regulated under the Australian Consumer Law.

Registered health professionals are also subject to the Australian Health Practitioner Regulation Agency’s Guidelines for advertising a regulated health service.

Webinar presentation: Australian Dental Industry Association (ADIA), 16 February 2021

Source: Australian Department of Health

Presentation: Personalised Medical Devices Framework: Regulatory changes to custom-made medical devices

Disclaimer

This presentation paper is provided on the TGA’s website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The paper is not legislative in nature and should not be taken to be statements of any law or policy in any way.

The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation paper should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.

Presentation

  • Presented by: Rebecca Bateson
  • Presented at: Online
  • Presentation date: 16 February 2021
  • Presentation summary: Personalised Medical Devices Framework Presentation for Australian Dental Industry Association (ADIA)

Webinar presentation: Australian Orthotic Prosthetic Association (AOPA), 16 February 2021

Source: Australian Department of Health

Presentation: Personalised Medical Devices Framework: Regulatory changes to custom-made medical devices

This presentation paper is provided on the TGA’s website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The paper is not legislative in nature and should not be taken to be statements of any law or policy in any way.

The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation paper should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.

Presentation

  • Presented by: Rebecca Bateson
  • Presented at: Online
  • Presentation date: 16 February 2021
  • Presentation summary: Personalised Medical Devices Framework Presentation for Australian Orthotic Prosthetic Association (AOPA)

Webinar: Information session about a proposed standard for vaporiser nicotine

Source: Australian Department of Health

Background

Vaporiser nicotine products are nicotine-containing products intended to be used in vaping devices such as e-cigarettes, e-cigars and other electronic nicotine delivery systems (ENDs).

Suggested audience

  • Health professionals
  • Consumers
  • Government
  • Academics

How do I register?

  • Date: Thursday 4 March 2021
  • Time: 12pm-1pm
  • Where: Online webinar

Register for webinar

Consultation: Standard for vaporiser nicotine (TGO 110)

Source: Australian Department of Health

This consultation closes on 31 March 2021.

The Therapeutic Goods Administration (TGA) is seeking comments on a standard for vaporiser nicotine products.

Vaporiser nicotine products are nicotine-containing products intended to be used in vaping devices such as e-cigarettes, e-cigars and other electronic nicotine delivery systems (ENDs). This includes vape liquids, e-liquids and e-juices that contain nicotine and/or nicotine salts. This does not include nicotine replacement therapies (NRTs) containing nicotine, such as patches, gum, lozenges, mouth spray and inhalators nor nicotine-containing products that are not intended for use in ENDs, such as chewing tobacco and snuff.

This standard relates only to unapproved goods – that is, medicines that have not been approved by the TGA and are not registered in the Australian Register of Therapeutic Goods (ARTG).

We invite you to provide feedback on our proposed standard using the online survey on the Department of Health consultation hub.

Enquiries

Please email any questions relating to the proposed standard to nicotine.standard@health.gov.au.

Shortage of sertraline tablets

Source: Australian Department of Health

The Therapeutic Goods Administration (TGA) is advising health professionals and consumers that there are shortages of multiple brands of sertraline 50 mg and 100 mg tablets. Shortages are expected to continue until at least late February and potentially until April 2021.

Sertraline tablets are used to treat depression, social anxiety disorder or social phobia, and pre-menstrual dysphoric disorder. Sertraline tablets are marketed in Australia under multiple brand names such as Zoloft, Eleva, Sertra, APO-sertraline, Sertraline Sandoz and Setrona.

Dates for anticipated return to supply of sertraline tablets are published on our website. Sponsors of these medicines can update the information about the shortage at any time.

In order to reduce the impact of these shortages on patients, the TGA has authorised the supply of overseas-registered products under Section 19A of the Therapeutic Goods Act 1989. However, given the high demand volume for sertraline tablets, the s19A products may not be sufficient to ensure all Australian patients have access to medicines they need.

For this reason, the TGA has also issued a Serious Shortage Substitution Notice (SSSN) for sertraline tablets. The notice will allow pharmacists to dispense an alternative strength of sertraline tablets, with the consent of the patient, without requiring a new prescription.

The SSSN must be given effect under state or territory law before pharmacists can supply according to the specified substitution. The patient’s consent is required, but the pharmacist does not require prior approval from the prescribing doctor. Pharmacists should notify the prescriber of the substitution as soon as possible.

The SSSN will be effective from 16 February 2021 until 30 June 2021. However, the TGA may lapse it prior to this date, if it becomes evident that normal supplies become available to meet demand in Australia.

Information for consumers

Talk to your doctor or pharmacist if you have any questions regarding the above information.

If you are considering substituting 100 mg tablets for your usual 50 mg tablets, ask your pharmacist for advice on how to break the tablets. You may need to ask them to cut the tablets for you to get the prescribed dose.

Information for prescribers

Bear in mind the current shortage of sertraline tablets when prescribing. Any changes to treatment should be carefully discussed with your patients, including any possible adverse effects.

Information for pharmacists

Use your professional and clinical judgement to determine whether a patient is suitable for substitution under the SSSN. Ensure the patient is fully informed and consents to the change.

Please refer patients to their doctor if substitution is not appropriate or where alternative treatments may be more appropriate.

For patients who are suitable for and consent to substitution:

  • counsel them thoroughly, including about how to cut unscored 100 mg tablets for a 50 mg dose
  • advise them to monitor for any side effects and to contact a doctor or pharmacist immediately if they have any concerns
  • recommend that they discuss alternative treatment options with their doctor where appropriate.

The SSSN must be given effect under state or territory law before you can supply. States and territories may also apply specific conditions to the pharmacist substitution, such as keeping a record of the substitute medicine and communication with the prescriber.