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poison and drug info.pdf
1. BASIC CONCEPT
OF MEDICINE &
POISON
INFORMATION
SERVICES
Submitted By,
Ameena Kadar K A
First Sem M Pharm
Clinical Pharmacy Practice
Sanjo College of Pharmaceutical Studies
Submitted To,
Soumya Ma’am
Assistant Professor
Dept. of Pharmacy Practice
2. 1
DRUG INFORMATION SERVICES
INTRODUCTION
Providing drug information is a fundamental responsibility of all pharmacists.
Drug information means providing clinically relevant information on any
aspect of drug use relating to individual patients, or general information on
how best to use drugs for populations.
Pharmacists have a unique range of knowledge and skills which are required for
drug information practice. These include knowledge of pharmaceutics,
pharmacology, pharmacokinetics and pharmacotherapy. All of these are
required to optimize the use of drugs in the treatment and prevention of disease.
Drug information can be challenging but also exciting. It requires much of the
knowledge that pharmacists acquire as students and allows them to apply these
skills to improve health outcomes.
Providing a drug information service is a professional activity which carries the
same responsibilities as direct patient care. Information provided to support
policy decisions can affect many people (hospital, regional or national
populations) and poor-quality information can cause as much damage to public
health as inadequate quality control in pharmaceutical manufacturing.
The term ‘Drug Information Service’ can be applied to any activity where
information about drug use is transferred, and includes patient-related
aspects of pharmaceutical care.
A ‘Drug Information Centre’ is an area where pharmacists (or other health
professionals) specialize in providing information to health professionals or
the public.
3. 2
The term ‘medicines information’ can be used to avoid confusion with services
which are limited to problems relating to drugs of abuse.
Drug information centres were first established in the USA in the early 1960s
and developed in parallel with clinical pharmacy services.
Drug information centres can limit their services to health professionals but
some also offer a service to the public, there are also centres which specialize in
information for the public.
DRUG INFORMATION RESOURCES
Information sources have traditionally been categorized as primary, secondary or
tertiary, according to the nature of the content and speed of publication. However,
the most important point is to distinguish primary sources (original reports) from
all other sources (reviews). Electronic formats, and ready access to updates, have
blurred the divisions previously applied to secondary and tertiary sources.
PRIMARY RESOURCES
Primary literature describes unique experiences which change the world in
terms of available knowledge.
Primary reports include the results of research at all levels (from molecular
science to controlled clinical trials) and also clinical experience in the form of
individual responses to drugs and small case series.
Primary literature is published principally in scientific journals in the form
of research results, concise reports and letters to the editor.
Adverse drug reaction reports are an example of primary literature and these
can be published in journals or contributed to pharmacovigilance centres.
4. 3
Primary literature can be seen as the building block on which medical science
(and therefore clinical practice) is based.
It is essential to understand its nature and to be able to critically analyze its
content using the full text of reports.
Primary literature provides a ‘first look’ at how clinical practice may evolve but
it must be constantly monitored and interpreted carefully.
Eg: Journal of Clinical and Hospital Pharmacy, Journal of Pharmaceutical
Sciences.
SECONDARY RESOURCES
It consists of reviews of primary reports.
Journals often publish a mixture of primary and secondary reports but there are
also journals which are devoted to reviews of previously published material.
Reviews can be informal, often by a single author recognized as a specialist in
the field.
These provide a personal perspective of the literature and can include comments
on how the author might apply the information in practice.
This type of report is sometimes called a ‘narrative review’ and this term may
appear in the title to distinguish it from a more formal analysis, referred to as a
‘systematic review’
In a systematic review, the authors (usually a team) use a rigorous (and defined)
method to search for all relevant information (including unpublished studies)
and select those studies which meet criteria for scientific quality.
The selected studies are then analyzed and conclusions drawn.
In many cases, the results of a number of studies are merged using a process
called ‘meta-analysis’, this process aims to create the equivalent of one large
study with greater statistical power than the separate studies.
5. 4
Secondary sources provide a condensed and refined view of primary data and
are often used in drug information practice to provide rapid responses to
clinical questions.
However, published reviews may not include recent primary reports, and
narrative reviews may reflect the authors’ clinical perspective and limited
access to the relevant information.
Eg: Index Medicus, MEDLINE, PubMed, Ovid, SEDBASE, Toxline, Cochrane
Database.
TERTIARY RESOURCES
Tertiary resources are summaries of the primary and secondary published
literature.
Printed textbooks are the main example and these are characterized by a slow
rate of revision compared to secondary sources.
Although they are revised less frequently, these texts tend to be more
comprehensive and should undergo a more thorough review and editing process
than secondary sources.
Many major textbooks are now published electronically as well as in print, so
sections can be updated progressively rather than waiting for a complete
revision at the time of printing (usually every 3–5 years).
In drug information practice, a tertiary text will usually be consulted first
as a quick reference and, if necessary, secondary and primary sources are
then checked for a more complete response.
Eg; Harrisons Principles of Internal Medicine, Martindale, Pharmacopoeias,
Merck index, Merck manual etc.
6. 5
OTHER SOURCES OF DRUG INFORMATION
The internet has enhanced our access to information from reputable organizations.
National libraries offer reliable information and links to useful sites, including
openaccess journals. Many clinical guidelines and drug assessments are not
indexed in bibliographical databases but can be located on recognised sites or
using search engines which focus on reputable sources of information.
Examples of specific sites include:
National Institute for Health and Clinical Excellence, UK (www.nice.org.uk)
National Prescribing Centre, UK (www.npc.co.uk)
National Prescribing Service, Australia (www.nps.org.au)
Canadian Agency for Drugs and Technologies in Health (www.cadth.ca)
Search tools for clinical guidelines include:
National Guideline Clearinghouse, USA (www.guidelines.gov)
National Library for Health, UK (www.library.nhs.uk).
Product information is available for approved drugs in many countries including:
DailyMed, USA (dailymed.nlm.nih. gov/dailymed)
European Medicines Agency (www.emea.europa.eu)
Medicines.org.uk, UK (www.medicines.org.uk).
Drug information about understands all available information resources, selecting
and using the most useful, and being able to retrieve and interpret that information
in a clinical or public health context.
7. 6
FUNCTIONS OF DIC
1. Promoting rational drug evaluation and therapeutics
o It can evaluate the information on products available in the market and prepare
rationalised drug monographs that may overcome the imbalance between
commercially oriented and purely scientific sources of drug information.
o Drug product oriented stored at also includes data on product availability,
manufacturer, package strength, cost, OTC products, and identification of
foreign drug products.
2. Patient specific consultations
o Drug information specialist may actively disseminate information related to
patient care where he attends ward rounds or reviews a patient’s chart along
with physicians.
o Specialist may passively participate in patients care by responding to queries
received at the DIC.
3. Adverse reaction reporting:
o The drug information specialist plays an important role by following up such
patients filling and analysing the forms needed for detection and reporting
adverse reactions.
4. Drug interaction monitoring:
o Multiple drug therapies have resulted in growing incidence of drug-drug
interaction. The DIC services may evaluate reports on drug interactions and
suggest ways to detect interactions and to determine their clinical significance.
5. Drug interaction with diagnostic tests:
o Many diagnostic and pathological test results are found to be modified due to
concurrent drug administration. DIC service can provide manual or
8. 7
computerised information on such interferences and saves the patients of under
surgical procedures and wrong diagnosis based on altered test result.
6. Drug utilisation review
o The pharmacist at the drug information centres can be actively involved in
conducting drug utilisation reviews to determine patterns of drug usage in the
hospital.
7. Pharmacy and therapeutics committee related function
o This is the most important non patients’ specific activity of the DIC to provide
specific drug reports for evaluations by the committee.
8. Investigational drug information
o The drug information specialist can participate in clinical investigations to
establish safety and efficacy of new drug. He can assist in preparation of
protocols, applications & literature reports & investigational drugs.
9. Publication of news letters
o DIC can publish newsletters, news bulletins or periodic reports; subject matter
in such publications includes all the topics of current interest to staff.
o E g : news products , drug reviews , new drug policies , specific diseases ,
comparative therapies.
10. Teaching and education activities
o Educational functions include developing continuing education programmes for
staff pharmacist, a resident doctor, intern nurses etc… DIC can organise
seminars, conference, workshops and guest lectures by eminent scientist.
11. Consumer awareness programmes & community pharmacy based activity
o The DIC can create awareness for safe drug usage.
o It can prepare attractive sheets for consumers for audio-visual aids such as
cassette tapes called media messages for counselling of ambulatory patients.
12. Literature retrieval services
o Drug literature is defined as any published paper on preparations with the
potential therapeutic or diagnostic activity.
o A DIC can be at the interference of this literatures and the user who seeks it.
o Having up to date information alone does not automatically ensure information
of high quality but the effective communication of this information to the
person who requested for it is also important.
9. 8
APPROACH TO ANSWERING DRUG INFORMATION QUERIES
The major steps involved are:
Step 1: Secure demographics of requester
Step 2: Obtain background information
Step 3: Determine and categorise the ultimate questions
Step 4: Develop search strategy and conduct search
Step 5: Perform evaluation, analysis and synthesis
Step 6: Formulate and provide response
Step 7: Conduct follow up & documentation.
Step 1: Secure demographics of requester
o The requesters name, position, training and anticipated knowledge are
important to determine the approval and final response to the question.
Step 2: Obtain background information
o The ability to obtain background information is essential for effectively using
the modified systematic approach.
o The background question should be specific for the nature of the request.
o When a question involves a patient, the patient’s age, weight and sex are
usually needed. On addition, the patients’ diagnosis, other comorbidities, and
hepatic & renal function are often important to assess.
o It is also advisable to find out if the requester has checked any resources
previously so as to avoid duplication of work.
Step 3: Determine & categorise the ultimate question
o The ultimate question may differ significantly from the if the requester posed a
general question.
10. 9
o Adequate background information is needed to determine the ultimate question.
Thereafter the question should be categorised, as it will help in developing
search strategy.
Step 4: Develop search strategy and conduct search
o The information resources are selected based on the probability of containing
the desired information on data.
o If query is about any drug interactions, standard reference on drug interactions
is first line resources. However, if one of the drugs was a recently introduced
drug a Medline search would be more appropriate.
Step 5: Perform evaluation, analysis and synthesis
o The information retrieved must be reviewed for the response to be analysed and
synthesised with the consideration of the background information obtained
previously.
o Analysis and synthesis together assist in forming opinions, arriving at
judgements and ultimately drawing conclusions.
Step 6: Formulate & provide response
o This involves a series of steps that must be performed completely objectively
and in a logical sequence.
o The way in which answers are communicated plays a major role in determining
how drug information accepted by physicians.
o Conflicting viewpoints or considerations should be clear stated. Specific
recommendation must be scientifically sound & clearly justified.
11. 10
o In the hospital setting the majority of questions will be answered verbally and
responses should be brief, concise and accurate and provided in a timely
manner.
Step 7: Conduct follow up & documentation
o Follow up is the process of verifying the appropriateness, correctness, and
completeness of a response after it has been given.
o When recommendations are made, follow up should always be done in a timely
manner. This follows pharmacist to know if the recommendations were
accepted and implemented.
o In a hospital setting this may involve visiting the ward and offering additional
advice & information.
o Documentation of DI query is essential for purpose of quality assurance, budget
allocation, promotion of the DI service & to minimise liability.
PREPARATION OF WRITTEN AND VERBAL RESPONSES:
Preparation of written response:
Goal:
Is to prepare a document that is clear, concise, complete and correct.
General rules:
Organize the information before starting to write (what and how to write)
Use proper spelling and grammar
Preferably avoid passive voice throughout
12. 11
Avoid writing in the first person and second person wherever possible.
Prepare a document in a presentable manner (neat)
Keep things as simple and direct as possible
Consider whether tables or graphs or figure would make the document
simpler
Avoid using abbreviations or acronyms (or quote at first instance in
parentheses)
If the document is long , use sub headings
Present it in correct order as required
Write in your own words
At first make sure that all of the information is down on paper. Once that
occurs go back, revise, and perhaps reorganize the document.
Specific document sections:
It should contain
Introduction
Body
Conclusion
Introduction: Should inform what the remainder of the document is to cover
Body: Should contain all the details of the document.
Do not include unnecessary information (even if it is interesting)
13. 12
Do not stray from the subject
Subdivide the document further in a logical order and as appropriate when
necessary.
Always focus end point
Conclusion:
Should be placed at the end of the document
Avoid extrapolating beyond the information available
Readers need something to bring their thoughts together at the end
Preparation of verbal response:
Verbal communications are most frequently used in practice setting
Need to use good verbal communication skills
Deliver the information at an ideal place
Deliver the content confidently
Make analogous to the delivery to the delivery of a presentation or lecture
Use appropriate language with good grammar
Use correct pronunciation all of terms of the document
Listen carefully when clarification is sought
Clarify all doubts confidently
Must be prepared for additional questions
Show evidence where necessary or appropriate.
16. 15
POISON INFORMATION SERVICES
The number of chemicals, poisonous household products and medicines on the
Indian market is increasing day by day, which consequently increases the risk of
misuse of these products and leads to greater incidence of intentional and
unintentional poisoning. The impact of poison information services on the quality
of healthcare is very significant, and hence there is an increased need for poison
information services to prevent and manage the morbidity and mortality caused by
poisoning. Such services are designed to provide immediate, round-the-clock
toxicity assessment and treatment recommendations for the effective management
of poisoning cases.
Poison information (PI) is a specialized area of drug information which
includes information about the toxic effects of chemicals and pesticides,
hazardous material spills, household products, overdose of therapeutic
medicines, plants including mushrooms, animal toxins from the bites of
snakes, spiders and other venomous creatures, and stings.
A poison information service deals with the risk assessment, diagnosis,
management and prevention of exposure to any poison, in patients of any age
irrespective of type (intentional or accidental) and route of exposure.
The goal of poison information services is to reduce the morbidity and
mortality caused by poisoning and improves the patients’ health-related
quality of life.
These services are mainly provided to the general public as well as to healthcare
professionals. Specialist pharmacists with knowledge of clinical toxicology and
with the skills required for provision of drug and poison information can contribute
17. 16
to the management of poisoning cases. Pharmacists can acquire the required
knowledge and skills through appropriate training in the area of poison information
which enables them to evaluate poisoning cases with in-depth understanding, and
thereby provide valuable information.
Poison information services are provided by a specialized center known as a
poison information center (PIC) or poison control center (PCC).
It provides immediate information on poisoning management through
well trained poison information specialists.
A PIC functions 24 hours a day, round the year with the objective of
continually improving health outcomes by providing a timely, safe information
service appropriate to the needs of the enquirer related to poisoning, suspected
poisoning and prevention of poisoning.
It also aims to prevent unnecessary visits to doctors and hospitals and to ensure
that patients who are poisoned receive the most effective treatment promptly.
The size of the PIC may vary depending on call volumes and should ideally be
located adjacent to the emergency department.
A PIC may operate locally, providing services to populations of a specific
geographical location, or may extend its service to the regional/national level.
Role of the Poison Information Centre
To minimize poisoning deaths due to accidental or intentional poisoning or
overdose among the general public.
Providing the general public and healthcare professionals with information on
poisoning prevention and management (identification/ assessment and
management) by providing rapid access to poisoning information.
18. 17
Educational programs for healthcare professionals of the hospital where the PIC
is located, and outreach programs at smaller hospitals may also be developed.
The identification of the poisoning substance, first aid measures and the
treatment and prevention of poisoning cases.
PIC staff can also assist with rationalization of antidote stocks.
Healthcare professionals have access to up-to-date and relevant information
about poisoning management.
Functions of a poison information center
Patient management
Toxicological analytical services
Toxic vigilance
Education and training of healthcare professionals and public
Prevention of poisoning
Research in poisoning
Development of therapeutic guidelines/protocols for poison management.
Organization
The organization pattern of a PIC should be based on the anticipated ‘ideal human
exposure call volume’ (average number of queries that the poison information
center receives regarding the management of poisoning cases in humans). The
majority of PICs are connected with hospitals and to some extent to universities
and with the public health service of the country at national or regional level.
Networking with all other existing PICs at a regional, state or national level in a
systematic way is essential not only for maintaining uniformity of services but also
to ensure better utilization of available resources. This also allows the development
19. 18
of a national database on poisoning and the formulation of expert management
advice.
Personnel
An adequate number of staff is essential for effective and round the-clock
functioning of the Centre. The PIC is usually staffed by a physician (medical
director), a pharmacist (technical director), an administrator, at least one
clinical toxicologist and a poison information specialist with the required
secretarial assistance. Personnel working in PICs should have unique qualifications
and distinct responsibilities.
The responsibility of medical and technical directors is to promote research, raise
funds, ensure quality service and undertake further development of the information
service.
The poison information specialists should be trained properly to carry out the basic
functions of the Centre. The responsibilities of the poison information specialist
include:
Provide poison information
Prepare standard protocols
Maintain an accurate record of all queries
Participate in continuing education
Update and maintain information resources
Carry out research activities.
Facilities
Location: A feasible location for the PIC is within a hospital or an area closely
associated with a hospital providing emergency and intensive care services.
20. 19
Ideally, the PIC should be co-located with a hospital clinical toxicology service
which is concerned with the identification, treatment and prevention of the harmful
effects of chemicals, including natural substances, on humans.
This type of setup will provide ready access to a network of medical disciplines
that will support and enhance the work of the Centre.
Other locations include a medical library, medical university, pharmacy
department and medical or pharmacy college. Regardless of the location, it is wise
to have a liaison with a hospital/ university medical library.
Space: The PIC should be placed in a spacious facility to accommodate the
service’s staff and needs. A work area of 200 square feet per workstation is
recommended, with a separate office for the medical director and manager/
supervisor. The working area should have adequate lighting and ventilation.
Equipment: The PIC should be well equipped with the necessary basic facilities,
including furniture, to allow it to function effectively. Communication equipment
is vital for the Centre. As most communication with the enquirer is over the phone,
at least two telephones with sufficient incoming lines with toll-free numbers should
be reserved to receive the queries. It is essential to have other fast and reliable
communication options such as fax and e-mail. It is also important to be equipped
adequately with computers, printers, a photocopying machine and uninterrupted
power supply (UPS). Book shelves and filing cabinets for storage of case records
and documentation files for systematic storage and easy retrieval of data are also
essential. A lockable cabinet should also be available to store confidential data. For
toxicological screening purposes, either the required facilities need to be created or
the center can liaise with a well-equipped laboratory which carries out
toxicological analysis.
21. 20
Information resources: Information pertaining to the management of poisoning
cases is available from a wide range of information sources including primary,
secondary and tertiary resources and the internet
Tertiary Resources:
Medical and general toxicology: Murray L, Dary F, Little M and Cadogan M
(eds). 2007. Toxicology Handbook. Churchill Livingstone, Elsevier: Australia.
Goldfrank LR, Flomenjbaum NE and Lewin NA (eds).2006. Goldfrank’s
Toxicologic Emergencies, 6th ed. Appleton and Lange: Norwalk.
Secondary resources:
POISINDEX
WikiTox / http://curriculum.toxicology.wikispaces.net/
Toxbase
MEDLINE
Toxicology abstracts
Toxline
Excerpta medica
Index medicus.
Primary resources
Human and experimental toxicology. Published by Macmillan, Basingstoke,
England.
On-line journal scanning services, for example, AMEDEO, Current Awareness
in Clinical Toxicology
Clinical toxicology. Published by Informa Healthcare.
Neurotoxicology. Published by Raven Press, New York, USA
22. 21
Legal and ethical prerequisites: It is recommended that the PIC be officially
reIntoxcognised either by government authorities or the WHO. To carry out the
functions effectively, the Centre should have independent status, stability and
neutrality. The Centre should maintain confidentiality of the data it handles.
Usually the Centre is required to provide the information free of cost to enquirers.
But, occasionally, the Centre may charge for the services being offered for its own
viability. In such instances, it should be on a ‘no loss–no profit’ basis.
Policies and procedures: For the effective functioning of the Centre, it should
have well-defined policies and procedures. The policies and procedures may vary
from one Centre to another depending on the scope of service, financial support
and the Centre’s requirements. The PIC should develop policies for personnel,
methods of operation, documentation of services and quality assurance programs,
staff training, confidentiality, and ethical and legal aspects. Policies pertaining to
personnel should indicate the mode of recruitment of personnel, qualifications and
training required if any, and the position of staff with distinct responsibilities. The
method of operation should detail the handling of poisoning cases starting from
receipt of the query until final documentation.
Training of staff: Adequate training to site personnel is essential especially for
newly recruited and inexperienced staff. The PIC should provide either internal or
external training to the staff in the various areas of poison information. The PIC
should develop and implement a needs-based staff training manual. This would
assist in training new and inexperienced staff in various areas and ensure that
uniformity in training is maintained. Training components may include updating of
knowledge in clinical toxicology, communication skills, handling of databases,
retrieval of information, interpretation and analytical skills, and handling of
equipment such as computers, telephones and other instruments.
23. 22
Systematic Approach in Handling Poison Information Queries
Step 1: Obtain the Requester’s Demographics
Receive and accept the query related to the service either over the phone or in
person. Establish the identity of the enquirer by gathering contact details. Also
obtain all required information from the requester that will allow you to reply to
the query. If the enquirer is a healthcare professional, the position and anticipated
knowledge of the enquirer should be determined. If it takes time to obtain
information, ask the enquirer to call back or note their contact number. Queries
relating to potentially serious poisoning cases need to be answered immediately,
and for a query with minimal toxicity an appropriate deadline for a response should
be established.
Step 2: Collect Background Information
It is important to collect all the required background information to provide
appropriate information. Obtaining relevant information often requires targeted
questioning, and additional care is required to accurately identify the poisoning
substance. However, all critical information should be obtained in a short time to
maximize the patient outcome as otherwise it may be counter-productive.
Step 3: Assess the Patient’s Condition
Appropriate background information about the patient’s condition allows for better
understanding of the actual query to be answered. Firstly, the urgency of the
situation should be assessed in terms of whether it is an emergency, serious, not
serious or no problem. Assess the likelihood of toxicity associated with the
exposed toxins based on the nature of the substance, type of exposure and quantity
consumed. Assessment of signs and symptoms of toxicity and analytical testing of
24. 23
the compound may greatly aid in determining appropriate patient management and
whether first aid, observation, medical treatment, home treatment or no treatment
is appropriate.
Step 4: Develop and Conduct a Search Strategy
Select and prioritizes the information resources based on the probability of locating
the desired information. It is ideal to locate the information based on the probable
efficiency of information sources in the literature hierarchy. Although in many
instances the information can be provided with the use of tertiary resources, it is
worthwhile to consider other information sources, as appropriate.
Step 5: Evaluate and Provide Information
The retrieved information should be thoroughly and critically evaluated.
Comprehensive information needs to be provided to ensure the recommended line
of management is based on all of the current evidence available. The response
should be generated only after critically evaluating all the information available.
However, consistency of information among the resources used should be ensured.
Interpretation of the information available in various resources should be patient
specific and made considering all relevant factors. In case of lack of information or
conflict of information in the available sources, a decision may be taken based on
professional knowledge and previous experience. Information may be provided
verbally/written/printed form/through fax or e mail, as appropriate. However,
timely or immediate delivery of the response is critical. If more time is required to
evaluate and formulate the response, minimum vital information is to be provided
at the earliest possible time.
25. 24
Step 6: Conduct Follow-up and Document
Follow-up of the case is vital to assess the patient outcome and also to ascertain
whether provision of any additional information is useful in the management of the
poisoning. A personal visit may be more useful and is possible only when the
victim is admitted to a hospital where the poison information Centre is co-located.
In other cases, follow- up can be made through other modes including telephone
enquiry and e-mail. Documenting the details of enquirer, query and response.
Step 7: Maintain Confidentiality
All issues relating to the query are to be kept confidential by the Centre for socio-
legal reasons. The details of the enquirer should not be disclosed to anyone,
including family members and healthcare professionals, without the consent of the
enquirer.
COMPARISON OF PIC AND DRUG INFORMATION CENTRE
26. 25
Conclusion
Skilled pharmacists can play an important role as poison information specialists.
This role is most effective when the PIC is co- located with a clinical toxicology
service within a hospital treating poisoning cases. Experienced pharmacists may
also serve as advisors to analytical toxicology laboratories, as expert witnesses in
legal proceedings, and may also work in the safety offices of the pharmaceutical
industry.
There is a need for a centralized database and expert advice on toxicological cases
to assist physicians, and to educate the public in the prevention and the overall
management of poisoning in India.
REFERENCES:
A Textbook of Clinical Pharmacy Practice: Essential Concepts and Skills. By G Parthasarathi,
Karin Nyfort-Hansen, Milap C Nahata. 2nd
Edition, Page No. 534-584.
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