Australian Sponsors Therapeutic Goods Administration · Role of sponsors . Sponsors maintain...

Medicine Shortages Information Initiative

PRPROTOTOCOLOCOLffor all or all

AuAusstralian Sponsorstralian Sponsorsand thand thee

Therapeutic Goods Therapeutic Goods AdministrationAdministration

Better communication and management of medicine shortages in Australia

SPONSOR

Histor

ical

doc

umen

t


PROTOCOLfor all

Australian Sponsorsand the

Therapeutic Goods Administration

To be read in conjunction with the

BUSINESS SPECIFICATIONSand GUIDANCE SUPPLEMENT

May 14


Histor

ical

doc

umen

t

Medicine Shortages Information

© Commonwealth of Australia 2014This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to <[email protected]>.

Histor

ical

doc

umen

t

Protocol for Australian Sponsors and the TGA

Contents

Overview.......................................................................................................1

Purpose and scope .....................................................................................1

The role of prescription medicine supply chain stakeholders .............3

Principles of the Protocol .........................................................................6

The assessment framework ....................................................................7High impact level medicine shortages .......................................................................... 7

Medium impact level medicine shortages ................................................................... 7

Low impact level medicine shortages ........................................................................... 8

The Medicine Shortages Information website .................................... 11

Communication and education ............................................................. 11

Histor

ical

doc

umen

t

Medicine Shortages Information

Histor

ical

doc

umen

t

Protocol for Australian Sponsors and the TGA 1

OverviewThe Medicine Shortages Information Initiative has the goal of improving the communication and management of medicine shortages in Australia and is being led by the Therapeutic Goods Administration (TGA), Medicines Australia (MA) and the Generic Medicines Industry Association (GMiA). This partnership has developed the Protocol for Australian Sponsors and the TGA (the Protocol). Participation by sponsors in the Initiative is voluntary.

The Protocol describes the roles of sponsors and the TGA in the communication and management of medicine shortages and is premised on the principles of:

• timely notification about changes in supply in the Australian market

• structured assessments of the likely impact when supply will not, or is anticipated not to, meet consumer demand1

• coordinated responses and communication in collaboration with other medicine stakeholders.

The Protocol also sets out the arrangements for the Medicine Shortages Information website <http://www.tga.gov.au/hp/information-msi.htm>. Hosted by the TGA, it is the key tool for delivering consolidated information to support health professionals and consumers when there is a medicine shortage.

This Protocol does not alter or replace current responsibilities of parties in managing medicine shortages.

Purpose and scopeThe purpose of the Protocol is to guide implementation of the Initiative to deliver:

• a mechanism to communicate timely, consistent, current and coordinated information about medicine shortages and discontinuations to health professionals and consumers, in addition to the channels that already exist

• an effective shared assessment and response process, based on graduated activities which correspond to the impact on the timely access to medicines by Australians.

The Protocol can apply to:

• all prescription medicine sponsors and the TGA

• all prescription medicines on the Australian Register of Therapeutic Goods (ARTG) when there is a:

Ì temporary medicine shortage (current or anticipated)

Ì medicine discontinuation (permanent medicine shortage).

Consumerdemandistheoverallvolumeandtimingneedsoftheconsumertoaccessaspecificmedicine.Forthepurposeofmedicineshortages,the assessment of the demand is limited to:

• the availability to the overall Australian market and not the separate distribution points

• thesupplyof thespecificproductandexcludesconsiderationsabouttheexistenceandavailabilityofsubstitutemedicinesor therapeuticalternatives.

1

Histor

ical

doc

umen

t

2 Medicine Shortages Information

For this purpose, a medicine shortage occurs when the supply of a medicine is not likely to meet the normal or projected consumer demand for the medicine within Australia for a period of time. There are three time related types:

• Anticipated shortage means the shortage is anticipated to commence at a future date

• Current shortage means the shortage has commenced

• Resolved shortage means the supply of the medicine is now meeting normal demand.

A decision by a sponsor to cease the supply of a medicine (discontinuation) has been included in the Protocol because from a health professional and consumer perspective it has a similar impact and also requires timely information to be provided. This Protocol builds on the Ensuring Best Practice in the Notification of Prescription Medical Product Discontinuation’s – TGA and Medicine Australia Conjoint Best Practice Guidelines Oct 2007.

The separate Business Specification and Guidance Supplement to the Protocol sets out the details of the:

• roles and responsibilities of the TGA and sponsors in undertaking each of the four activities (as defined in the Protocol)

• data specifications for:

Ì the website

Ì the electronic notification form

• business specifications, guidance and enabling systems for the notification and publishing of:

Ì temporary shortages (anticipated and current)

Ì permanent shortages (discontinuations) with additional information about stakeholder communications.

This is available to sponsors on the eBusiness Services website.

Histor

ical

doc

umen

t


The role of prescription medicine supply chain stakeholdersA range of stakeholders perform roles in the timely access to medicines that Australians need and therefore also have a role in the management of medicine shortages, as described below.

Broader role of the Australian Government Department of HealthThe Australian Government Department of Health has a role in coordinating responses to medicine shortages, where there is a significant public health impact, through the Office of Health Protection and the Chief Medical Officer.

It is a condition of listing on the Pharmaceutical Benefits Scheme (PBS) that sponsors have stock available across the supply chain, and they must report any supply disruption with a PBS listed medicine to the Department of Health (Division 3C of Part VII (sections 99AE to 99AEL) of the National Health Act 1953).

The Protocol is not intended to replace the ‘Guarantee of Supply’ form, to be used when a ‘Responsible Person’ wishes to advise of a failure to supply a brand of an item listed on the PBS, or a belief that a supply disruption has, or is likely to occur.

Role of the state and territory departments of healthState and territory health departments are also involved in policy and operational aspects of timely access to medicines through, for example, contractual purchasing arrangements, and through therapeutics committees for hospital networks. They also have a role in coordinating responses to medicine shortages where there is a significant public health impact within their jurisdiction.

Role of health professionals and professional organisations Health professionals perform roles as prescribers or dispensers across various healthcare settings including primary care and hospitals. When a medicine shortage occurs, health professionals are often required to identify substitute medicines or therapeutic alternatives for their patients. With accurate information about medicine shortages, the health professional will also work to assist the consumer to manage potential issues that arise with quality use of medicines, for example, the safety and compliance considerations needed when a substitute of different dose forms or strength is used.

The health professional receives medicine supply information through a range of channels, including notices from the wholesaler, letters from sponsors, newsletter articles in professional media, health professional colleagues and consumers.

In the majority of cases, it is expected that the health professional has the knowledge and expertise to prescribe substitute medicines or therapeutic alternatives. However, there are high risk cases when it is not reasonable for the health professional to know about substitute medicines or therapeutic alternatives and additional information is required. In these cases medical colleges and clinical guidelines experts may become involved in providing advice on the appropriate treatment regimens.

SPONSOR

SPONSOR

Histor

ical

doc

umen

t


Role of wholesalersWholesalers are the central coordinating point between the sponsor and the pharmacy. Wholesalers, through the directions of the sponsor, may impose strict allocations on medicines that are experiencing a shortage to appropriately direct the supply of a medicine to the areas of need.

Role of sponsors Sponsors maintain continuity of supply for a medicine through accurate demand forecasting, maintenance of appropriate levels of safety-stock, and identification of backup supply routes. When a disruption to the supply arrangements for a medicine occurs, sponsors routinely:

• assess supply and demand gaps and develop a response

Ì implement contingency planning to reduce the supply disruption

Ì assess the supply disruption to determine if and when the supply is reasonably likely to impact on consumers

Ì implement management activities to secure supply, including applying to the TGA for regulatory options for the supply of substitute medicines or therapeutic alternatives.

• publish and update information within the supply chain

Ì implement communication activities to the supply chain that are proportionate to the impact on consumers, which may include:

� publishing of information on sponsor websites

� activating public/health professional information hot lines

� communicating directly with:

� wholesalers

� prescribers and pharmacists (for example ‘Dear health professional' letters)

� the Australian Government Department of Health/state and territory health departments

� state medicine information hot lines

� health professional peak bodies (for example to discuss therapeutic options)

� health professional media, public media channels.

Role of consumers and consumer organisationsConsumers need timely access to medicines. They also require access to information to support their access to and quality use of their medicines from their health professional and other sources. In the case of a medicine shortage, consumer organisations, particularly disease specific consumer groups, may be involved in supporting consumers with information and/or advising medical experts of considerations when setting alternate regimens or considering substitute medicines or therapeutic alternatives.

Role of the TGA The TGA can approve the temporary supply of a substitute medicine or therapeutic alternative during a medicine shortage. The chosen option will depend on the nature of the medicine, and the circumstances surrounding the shortage (see Table 1).Hist

oric

al d

ocum

ent


Table 1: Regulatory options for TGA’s response to a medicine shortage

Provisions of the Therapeutic Goods Act 1989 Description

Section 18(1) and section 19(1)

Special Access Scheme (SAS)

The TGA regulates the import and supply of the unregistered medicine for use by individual patients through the Special Access Scheme (SAS).

Section 14 Under section 14 of the Act the TGA can consent to the importation and supply of prescription medicines that do not comply with a standard that would otherwise be applicable.

Section 19A Under section 19A of the Act the TGA can grant approval to a sponsor to import and supply an unregistered medicine that could substitute for a registered medicine that is in short supply.

In addition, the TGA can undertake additional communication activity in relation to particular medicine shortages where justified because of the public health impact. The TGA also collaborates with sponsors to streamline the notification of medicine shortages, and to enable consistent communication and management. This may include:

• escalation to a public health response, such as advice from the Commonwealth Chief Medical Officer or state and territory health departments of cases assessed as high impact level medicine shortages

• provision of an additional communication channel to inform health professionals and consumers about the details of the shortage (via the website)

• coordination of expert advice and information about substitute medicines and therapeutic alternatives (where appropriate)

• the publication of information about a medicine shortage in the public interest.

Histor

ical

doc

umen

t


Principles of the Protocol The Protocol is founded on a commitment, by sponsors and the TGA, to the communication and management of medicine shortages in Australia in accordance with the following principles:

1. Not all supply disruptions result in a medicine shortage.

2. The scope and timing of the communication and management activities are informed by a shared impact assessment and response plan.

3. The assessment of demand is initially limited to the supply of a specific medicine and is separate to considerations about the existence and availability of substitute medicines or therapeutic alternatives.

4. The information on the website supports the roles of sponsors and the TGA and all prescription medicine supply chain stakeholders in the event of a medicine shortage.

5. The assessment of and response to high impact medicine shortages may involve the coordination of advice and activities by a range of stakeholders, experts and authorities.

6. The information and duration published on the website is based on business specifications that are informed by the assessment framework, which is applied flexibly on a case-by-case basis.

7. The sponsor will notify and update the TGA about shortages and discontinuations in accordance with the business specifications.

8. The TGA will publish information provided by a sponsor on the website at the date nominated by the sponsor and agreed with the TGA, at a time that coincides with the sponsor’s communication activities within the supply chain.

9. The processes to notify, assess/respond, publish and update are supported by the TGA eBusiness systems that manage the minimum required information to be notified to the TGA.

10. The TGA will publish information about any medicine shortage when in the public interest.

Histor

ical

doc

umen

t


The assessment framework The assessment framework provides a mechanism for the assessment of the potential impact of a medicine shortage and assists sponsors to manage the shortage consistently with the assessed impact level. This impact level informs the appropriate roles and responsibilities for sponsors and the TGA, and recognises that:

• not all supply disruptions result in a medicine shortage

• not all medicine shortages will result in the publication of information

• not all published information about medicine shortages will require additional supply or related information.

The output of the assessment is assignment of an impact level of HIGH, MEDIUM, or LOW. This level defines a graduated set of required response activities, performed by the sponsor and TGA across four steps:

1. Notify – submission of information from sponsors to the TGA as soon as a medicine shortage is anticipated or known. The minimum information is determined by the agreed business specifications

2. Assess/Respond – collaboration between the TGA and sponsors to assess impact (by using the framework) and agree on responses, which may include escalation for public health responses and/or additional communication activities

3. Publish – publication of standardised information via the Medicine Shortages Information website

4. Update – sponsors provide updated status information to the TGA.

High impact level medicine shortages The required response is based on the assumption that health professionals require highly specific and urgent information on the nature and anticipated duration of the shortage as well as details about supply arrangements and clinical guidance on substitute medicines or therapeutic alternatives. This information is provided on, or through links from, the website, in addition to direct communication by sponsors through the supply chain and, if appropriate, from the TGA and the Department of Health.

An example is an unexpected batch failure of heparin-based products. This product has NO therapeutic alternative, and the post-surgical population group would potentially experience life-threatening impacts if this medicine was not available.

Medium impact level medicine shortages The required response is based on the assumption that health professionals are reasonably able to manage if they have access to timely information about supply arrangements and, if appropriate, clinical guidance on substitute medicines or therapeutic alternatives linked from the website, in addition to direct communication by sponsors through the supply chain.

An example is an ACE Inhibitor for hypertension where a doctor would need to change their prescribing to another ACE inhibitor, or other anti-hypertensive medicine. In these cases, publicly available information for doctors and pharmacists would assist this process.

Histor

ical

doc

umen

t


Low impact level medicine shortages The required response is based on the assumption that health professionals are well able to manage through access to simple supply status information. This is supported by communication of information about the shortage status through the website.

An example is a shortage of a generic amoxicillin 250 mg oral product, where another generic product (either tablet or capsule) is easily substitutable with little effect on the doctor, pharmacist and consumer. In this case, information would simply inform and assist doctors and pharmacists if queries are received about availability.

The figure and tables below illustrate the application of the assessment framework.

Figure 1: Assessment framework

Substitute medicines or therapeutic alternatives ranking• Registered for use for the indication in Australian market?• Available in adequate quantities to meet demand?

Exact Similar Appropriate Possible None

Patient population ranking• Medical condition?

Mild Low Low Medium Medium High

Moderate Low Medium Medium High High

• Unique population concerns? Severe Low Medium High High High

Histor

ical

doc

umen

t


Table 2: Categories of substitute medicine or therapeutic alternative assessment and rankingThe table below provides the description of the categories for each dimension of the impact assessment.

Substitute medicine or therapeutic alternatives – ranking Examples

Determined by taking into EXACT – same active ingredient, strength • Generic medicines account: and route of administration. • Liquid/tablet/capsule • Types of substitute substitutable

medicines or therapeutic alternatives that exist

• The approved indications for the substitute

SIMILAR – same active ingredient but different strength.

• Injection in different strength

APPROPRIATE – • Angiotensin Converting Enzyme medicines or therapeutic alternatives • Different active ingredient but same

pharmacological class and adverse •

(ACE) Inhibitors

Antibiotics• Likelihood of available

substitute medicines or therapeutic alternatives being available in quantities to meet demand

reaction profiles when administered to patients in therapeutically equivalent doses.

• Same active ingredient but different dose form that may require consideration of care setting

• Substitute oral for intravenous route of administration (care setting assessment is required)

Note: When ranking implications.a medicine shortage, consideration is also given to the feasibility of the medicine being substituted in the context of the patient population and the care setting.

POSSIBLE – different active ingredient yet different but comparable pharmacological class or mode of action that manages patient symptoms.

Management of chronic diseases e.g. essential hypertension, diabetes.

NONE – unique pharmacology no substitute medicine or alternative treatment options exist.

Table 3: Categories of patient population assessment and rankingThe table below provides the description of the categories for each dimension of the impact assessment.

Patient population – ranking Examples

Determined by taking into account: MILD Simple dermatological conditions

• The different patient population group for the product and their unique needs.

• The consequences of a medicine

MODERATE Vulnerable patient population groups where dose forms may not be appropriate e.g. paediatric

shortage on the likelihood that the medical condition, if left untreated, will

SEVERE Oncology patients in mid cycle regimen

progress from a less serious condition to a more serious condition and impact on:

Ì day to day functioning Ì survival.

Histor

ical

doc

umen

t


Table 4: Activities by shortage types

Shortage types Activity steps1. NOTIFY

Anticipated shortages YesCurrent shortages YesDiscontinuations Yes

2a. ASSESS

Anticipated shortages YesCurrent shortages YesDiscontinuations Yes

2b. RESPOND

Anticipated shortages HIGHYes

Public health escalation

MEDIUMOptional

LOWOptional

Current shortages HIGHYes


MEDIUMYes

LOWOptional

Discontinuations HIGHYes


MEDIUMYes

LOWOptional

3. PUBLISH

Anticipated shortages HIGHYes

With information about supply arrangements for substitute

medicines or therapeutic alternatives linked to website, as appropriate

MEDIUMOptional

LOWOptional

Current shortages HIGHYes



MEDIUMYes



LOWYes

Discontinuations HIGHYes



MEDIUMYes



LOWYes

4. UPDATE(Noting that the information in the update may result in a different impact level and hence response plan)

Anticipated shortages YES regardless of impact level

Current shortages YES regardless of impact level

Discontinuations YES regardless of impact level

Histor

ical

doc

umen

t


Detailed information on the roles of the TGA and sponsors in undertaking each activity is available in the business specifications.

The Medicine Shortages Information websiteThe website provides health professionals and consumers with information about medicine shortages. The site includes information about medicines that are:

• prescription medicines registered in the ARTG

• currently or anticipated to be in short supply either temporarily or permanently (discontinued) (the medicine may be available from pharmacies as this will depend on stock and use levels)

• notified to the TGA for the purposes of inclusion in the website by the sponsor, as part of its communication and management activities.

The information available on the website for each medicine shortage includes:

• sponsor name and contact details

• product active ingredient and trade name, strength, dose form and ARTG number

• reason for shortage (from drop-down menu)

• estimated duration of shortage

• shortage type

• additional supply details about the medicine as appropriate

• information about substitute medicines or therapeutic alternatives as appropriate.

By subscribing to the alert service, subscribers can elect to receive email or RSS feed notification of new and updated medicines shortage information.

The information will normally be published with the consent of the sponsor. It is recognised that there may be situations where consent is not given or is not possible. The TGA is able to publish information about medicine shortages under a legislative instrument under section 61 of the Therapeutic Goods Act which provides the TGA with authority to release information to the website regardless of this consent (see http://www.tga.gov.au/industry/legislation-tg-information-specifications.htm).

Communication and educationWhen a medicine shortage is notified to the TGA, the sponsor will normally have begun the process of assessing the impact and considering the appropriate activities for communicating to the stakeholders within the supply chain.

The majority of shortages are assessed as low or medium risk. In accordance with the Protocol, the ‘ASSESS/RESPOND’ activity is simple and routine, for both the sponsor and the TGA. The response plan will only need:

• sponsors to develop and implement their routine communication activities based on the impact assessment, decide on the website publication date (that aligns with the commencement of supply chain communication) and notify the TGA of updates as required

Histor

ical

doc

umen

t


the TGA to validate the assessment and manage the publication of the shortage information (including updates) in accordance with the sponsors nominated publication date, as well as working with the sponsor to implement any agreed regulatory response.

High impact shortages will involve a range of stakeholders that work together, sharing expertise and information, to conduct the following steps:

• determine response options (for example, convening expert advisors to develop clinical guidance for the transfer from one therapeutic regimen to another or to consider the impact on specific population groups)

• assess the viability of response options (for example, import action, rationing, determining new therapeutic treatment regimens, coordinate patient clinics etc. The availability and supply timing of alterative products)

• decide on communication messages, channels, schedule, and overall communication plan

• decide on additional information for publishing on the website to support patient care

• monitor and respond to shortage status changes and issues that emerge.

As the public health response within the ‘ASSESS/RESPOND’ activity may involve a range of stakeholders, experts, sponsors and occasionally the sponsors of substitute medicines or therapeutic alternatives, a coordinated response may be required.

From time to time health professional and public media outlets are interested in reporting on specific medicine shortages. In developing the response, sponsors and the TGA will have considered this and decided on appropriate action. It is normally the sponsor’s role to discuss the details of their products and the reasons for the shortages with the media.

Education about the protocol and the purpose of the website is important. The broad education and communication activities include:

• information about medicine shortages in Australia:

Ì why they occur, the types, and how they are managed

Ì the different categories of shortages, and what information to expect when a high impact medicine shortage occurs in Australia

• what to expect from sponsors and the TGA in terms of their responsibilities

• the purpose and content of the website, how to access and use the available information, and how to subscribe to alerts and notifications.

Further information, including on the enabling systems and processes, is available in the business specifications.

•

Histor

ical

doc

umen

t



SPONSORPROTOCOL

for all Australian Sponsors

and theTherapeutic Goods

Administration

PROTOCOLfor all

Australian Sponsorsand the

Therapeutic Goods Administration

Histor

ical

doc

umen

t

Australian Sponsors Therapeutic Goods Administration · Role of sponsors . Sponsors maintain...

Documents

Transcript of Australian Sponsors Therapeutic Goods Administration · Role of sponsors . Sponsors maintain...