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HealthQ International HemoStatis Current Treatment Practices

Hemostasis Current Treatment Practices – XX Country Country Report Qualitative Market Research

Prepared for: Prepared by: HealthQ International

HealthQ International HemoStatis Current Treatment Practices 2

Methodology and Sample


Methodology and Screening Criteria

• Sixteen respondents were interviewed in XX Country using the in-person individual-depth interview (IDI) methodology.

• On average, each interview took 45 minutes to complete.

• All respondents were recruited from research vendor databases, and all met the following screening criteria:

• More than 40 beds in hospital; • >50% of time devoted to see patients; • At least 25 procedures (physicians) required the use of a topical hemostatic agent, specifically

thrombin (with or without a sponge or other mechanical); • Use of thrombin in at least 5 procedures per month; • 35% of their patients had private insurance or paid out of pocket.

16 Neuro Surgeons

• Average 4 years in practice

• All perform surgeries at teaching hospitals

• Range of 5 to 50 surgeons on staff at hospitals

• Many also have private practices

16 General Surgeons

• Average 8.5 years in practice

• 5 performing surgeries at teaching hospitals

• 1 from Major Academic Center

• Range of 5 to 50 surgeons on staff at hospitals

• Many also have private practices

14 Pharmacy Directors

• Average 9 years in position • All from teaching hospitals

• Range of 15 to 50 pharmacists on staff

• All serve on procurement committees and all have responsibility in new products evaluation and selection


Sample Description

16 Neuro Surgeons

• Hospitals bed size:

Average: 153 beds

Range: 40 – 400 beds

• Number of surgical procedures requiring topical hemostats (per month):

Average: 39

Range: 25 – 80

• Number of surgical procedures requiring thrombin* products (per month):

Average: 11

Range: 5 – 27

16 General Surgeons


Average: 175 beds


• Number of surgical procedures requiring topical hemostats (per month):

Average: 31

Range: 25 – 60

• Number of surgical procedures requiring thrombin* products (per month):

Average: 8

Range: 5 – 20

14 Pharmacy Directors


Average: 119 beds


• All respondents’ hospitals stock thrombin* products

• Thrombin-JMI is not stocked in hospitals

* In XX Country, this sample of respondents (MDs and Pharm Directors) do not distinguish between active thrombin or “pure thrombin,” e.g., Thrombin-JMI and thrombin-containing products, e.g., Xseal, Tisseel.


Current Perceptions and Practices


Surgeries performed depend on surgeons’ specialties

• Surgeons mention the following as most common surgeries performed:

• Many of the most common surgeries mentioned above were associated to bleeding, additional examples include:

• Cerebral vascular disease, spleen laceration, malformations of the spine, lumbar and cervical spine, open heart surgeries, partial kidney tumor resections, radical prostatectomy, and prosthesis replacement.

• Pharmacy Directors mentioned that “all types” of surgeries are performed in their hospitals.

Most Common Neurosurgeries

• Craniotomy due to aneurism and tumor removal/resection,

• Laminectomy fusion,

• Discectomy,

• Microdiscectomy,

• Meningiomas and

• Hypophysis/pituitary gland tumors

Most Common General Surgeries

• Abdominal and colorectal surgery,

• Arteriovenous graft,

• Cholecystectomy (Gall bladder) and

• Appendix


Hemostatic agents are often used only after all other means of hemostasis have been tried

In most cases, surgeons feel they use surgical techniques to manage bleeding during the surgical procedure.

Means to avoid bleeding include:

Performing less invasive surgeries to limit the damage.

Using specific techniques to limit contact with the surrounding structure.

Using strong sutures to close the incision.

Using bipolar/monopolar radio frequency and ultrasound knives.

When hemostasis is required, compression, gauze and cauterization tend to be options prior to topical hemostatics.

Few mentioned that in liver surgeries normal cauterization is not used because it can cause more damage.

Some exceptions seem to exist for the Neurosurgeons, who use topical hemostatics before the other specialties since the tissue involved in their procedures calls for greater caution in the use of cautery.

“A good hemostasia and precise closing is my best ally to have a successful surgery and recovery.”

- Neurosurgeon, XX Country

1) Surgeons first try to avoid excessive

bleeding

2) If bleeding

continues, other ways to stop the

bleeding are tried

3) Topical Hemostatic agents are used as

a “last resort”


Surgeons manage bleeding in surgical procedures with various topical Hemostasis products

• Most common spontaneously mentioned hemostatic products are:

• In this sample, just one or two respondents in XX Country mention:

• When prompted about ZZZZ none of the surgeons in this sample knew or had used the product. • One respondent mentioned that in XX Country that ZZZZZ is no longer available;

thrombin is currently used in combination products only.

SurgX (Fibrillar

/nu-knit)

xfoam Tisxl xflow xseal xplast

XXX Xcel xclot

“I can manage bleeding with all of the good

products there are on the market, from XXfoam to XXgicel and reach up to

XXX or XXXX.”

- General Surgeon, XX Country


Perceived advantages and disadvantages of Hemostasis Products

Non-Thrombin-containing Hemostasis Products Product Advantages Disadvantages

Xoam

• Cheaper • Easy to use/ preserve • Most hospitals have it available • No need to prepare

• Needs a lot to cover bleeding • Has less hemostasia • It is seen in the CT scan and confuses surgeons • Does not stick very well • The material density is uncomfortable for delicate areas

XXgicel

• Easier to apply than foam • Covers more bleeding area • For more regular areas • Not seen in the CT scan • It can be left inside the patients- does not produce mass effects • Available and easy to manipulate • Different presentations

• It becomes loose and it needs to be discarded and reapplied • Not as potent as products with thrombin • Can not be applied in irregular surfaces • Need to apply pressure to gain hemostasia • Not great for artery bleeding

(XXX)

• Improved hemostasia • Can be easily separated into pieces • Can be applied as cotton • Used for important vascular bleeding

• It tears apart very easily • It is often wasted

(XX)

• Can be rolled and molded • Easy to apply in difficult to reach areas • Easy to manipulate • Dense knit material, more dense than SurgX and faster • Its good as a suture

• Not good for artery bleeding • Can only be used for defined sections


Nearly all XX Country surgeons have experience with thrombin-containing products

• It is important to note that in this sample, XX Country surgeons do not distinguish between active/pure thrombin versus thrombin-containing topical hemostats.

• All surgeons in this sample describe the preparation methods correctly for each of the three thrombin products (when compared to available on-line information), thus indicating that they are speaking about the proper product(s).

• XX Country-specific summary of pros and cons are as follows:

Product Advantages Disadvantages

TissX

• Faster and greater hemostasia (than non-thrombin containing products)

• Seals fistulae better • Administration is convenient • Useful for difficult areas to reach • Used in brain; Often used as a sealant in dura mater

• More expensive • Cannot easily manipulate tissue after application; may

require re-application thus leading to waste and increased cost

• Needs 20 minutes to be prepared

Xseal

• More specifically for vascular hemorrhage, specifically blood vessel and artery bleeding and vascular anastomosis

• More adherence property than Tissucol • Coagulated slower in the syringe (more time to use) • Has adapters for laparoscopy

• Needs to be prepared • Its needs to be in the freezer • The syringe can be tampered • The most expensive in the market

Xplast

• Used for pediatric surgeries due to smaller presentation • Similar to Tissucol • Good hemostasia and sealant action • More liquid than the other Xseal or Tissucol • Most representative support/presence • Less expensive than the other thrombin-containing

products

• None mentioned

“ I use Xseal for venous bleeding when I do not

know were its coming from as it stops hemorrhage

rapidly.”


“The Xplast drops are very convenient as they can be used

in small quantities.”



- Cost is the primary complaint associated with thrombins.

- While some respondents say that thrombins are easy to apply, others claimed that they are more difficult to prepare.

- The pressure leaks in the syringe so the product is activated and coagulates inside the syringe, thus sealing the conduit.

- Some mentioned that the products containing fibrins coagulate faster and thus wastes more product.

Thrombin-containing agents have specific advantages over non-thrombin containing hemostatic agents

+ Faster time to achieve hemostasia as fast as 5 minutes.

+ Less quantity needed to achieve hemostasia and surgeons use what they need without leaving solid waste.

+ Mode of application allows it to be introduced in small and difficult to reach places.

+ Absorbs adequately so it can be left inside the body tissues without the worry of generating adverse events.

Advantages of Thrombins*

Disadvantages of Thrombins

“What I really like about thrombins is that its application allows it to enter into the

smallest places where we need hemostasia.”


*According to this sample of respondents, pure thrombin, i.e., Thrombin-JMI is not longer available in XX Country.


Product Selection and Availability


Availability in the hospital

Surgeon’s experience with product, ease of use, & colleague

endorsement

Type of surgery – amount of

bleeding expected or seen*

Patient-specific factors, e.g., age

and comorbidities (rare mention)

Cost

(Primary concern for Pharmacy Directors)

Surgeons select hemostatic products based on a variety of factors

• Overall, selection of hemostatic product selection is based on the following, in order of importance:

• In general all respondents agreed that their colleagues at the hospital share the same general approach to technique/product selection.

• XX Country General Surgeons in this sample, indicate that if Xseal was too expensive to the patient or to the hospital, they are happy to use SurgX or foam.

• Surgeons report hemostatic products they require are generally available at their hospitals.

• Some respondents mention manufacturer supply issues has caused temporary switches.

• In public hospitals, it is more common that the desired product is not available, but there are adequate substitutes.

“I have found myself asking for SurgX and they would only

have foam, or ask for SurgX Fibrillar and they would

only have SurgX.” -General Surgeon, XX Country

*See discussion on p10.

“I really use what is available at the hospital, the chief of nurses and the chief of surgery are the ones that may know better the options as they are the ones that know which products are used the

most.” - General Surgeon, XX Country

All respondents state vehemently that the nurses only participate in preparing the product and never in making a product

selection.


Cost and manufacturer availability are main “guidelines” for hemostatic product use

• Both surgeons and pharmacy directors report that, overall, no formal guidelines exist for the selection of hemostatic products for surgical use.

• Pharmacy directors give the following, additional reasons for product availability and selection within their hospitals: Hemostat

Selection

Cost

Surgeon preference

Manufac-turers’ product

availability

Relation-ships and

contracting with suppliers

Hospital committee consensus

US FDA, COFEPRIS

“Our hospital does not have specific guidelines, the main

guideline is efficacy and cost.” - Pharmacy Director, XX

Country


Physicians select hemostatic products mostly during surgery; exceptions are for “cash-paying” patients

• Most respondents interviewed from XX Country report that they decide on the specific hemostatic product at the time of surgery, based on the general criteria discussed previously.

• Surgeons in XX Country’s public hospitals many times are able to suggest a better product for a patient, and thus they need to plan in advance so patients can buy it before the surgery.

• Respondents from XX Country stated that their timing for asking for a product could range from 24 to 48 hours in advance, but most of them did not worry as their hospitals could provide additional product in few minutes.

• The chief of department or the chief of nurses in conjunction with the PD (administrative department) are the ones that make the request of the hemostatic products.

“If I have a craniotomy where I know I might need additional hemostasia, I can call the administrative department 24 in advance to let them know the products I will be using” - Neurosurgeon, XX Country “We make the request of the hemostatic products and either the Pharma Company or the distributor will provide them to our hospital so that we have always on stock” - Pharmacy Director, XX Country

• Few mentioned that in emergency surgeries such as trauma accidents, they may not have enough product in the operation room - but they would have it as soon as the general pharmacy would provide it from their stock.

• Similarly, pharmacy directors state that they always try to have an advanced stock of the products that surgeons will need for their surgeries. They mentioned that they had the smaller pharmacy and the bigger warehouse pharmacy were they can ask for more product if needed.

“This is my work, I need to provide what the surgeon will use, and that is why we are continuously revising our stocks and the surgeons needs” - Pharmacy Director, XX Country


Respondents report a relatively standardized process for adopting new products (see appendix for details)

Surgeon

Chief of Surgery

Medical Committee Admin. Committee Nurses Committee

Pharmacy Director Chief of Operation Rooms

Surgeon’s Product Presentation

Evaluation Form or Letter

• Committee’s VOTE • Cost-Benefit Analysis • Contact Pharma Company

Acceptance Buy and Stock

Surgeon

Evaluation Form or Letter

Pharmacy Director

Contacts Pharma Company to have

samples and presentation

Cost-benefit analysis Buy and Stock

Option 1

Option 2

Origination

Identification

Decision

Origination Identification Decision

Option 1

Option 2


Current Unmet Needs


Surgeons and pharmacy directors express a concise list of current hemostatic unmet needs

Current Unmet Needs (In order of priority)

Reasons

• Faster and more efficiently in diminishing bleeding

• Promote better surgical outcomes and faster patient recovery

• Reduce surgical time • Reduce hospital cost • Avoiding blood loss and transfusions

• Product cost • More emphasis by Pharmacy Directors

• While hemostat products may play a small role in most surgeries, they can be very costly

• Would like to save patients’ money • Reduce hospital cost

• Multiple application methods • Need ability to be adapted for laparoscopy surgeries • Less product waste

• Easier preparation and storage • No need to freeze/defrost • Longer expiration date

• Less nursing time and training • Less product waste • Faster usability

• Training by manufacturers • Would be a distinguishing feature for manufacturer • Save physicians’ time in training nursing staff

“My main unmet need is that SurgX and foam is not enough to stop the bleeding in

some surgeries, so I need to use much product, therefore I would be more than willing to use

a product with greater hemostasia.”


“I really would need a product for my brain

surgeries that could be liquid because it can seal

faster and that it can cover the layer bleeding at

100%.” - Neurosurgeon, XX

Country

“If a new and better product is on the market and its also cheaper I would push myself to stock it!! That is for

sure.” - Pharmacy Director, XX Country


Potential adoption of new hemostatic agents driven by satisfying unmet needs & current “guiding principles”

• Nearly all surgeons interviewed are not aware of any new hemostatic products on the horizon.

• A few mention that they never actively research the area of hemostats.

• Two XX Country surgeons have had heard of “Xseal” but have not used it.

• One XX Country surgeon mentioned he had heard about “growth factors” being used in hemostasia.

• For adoption of a new hemostat product, respondents cite the following factors:

Faster onset of action

Greater efficacy in stemming

bleeds

“New” biotech-nology

Low side effects

No risk of infections (human

products)

US FDA, COFEPRIS

& Secretaria de Salud approved

Equivalent or superior pricing to current

products

Pharma-ceutical

company presence/

presen-tation

KOL endorse-ment, Dr. Guindo,

Societies

“I can change the products I use if the new one is really faster to achieve

hemostasia and does not cause adverse events.”

-General Surgeon, XX

Country

“I think that Dr. Evandro de Oliveira and Dr. Ali Krisht are the top Neurosurgeons that can make a good recommendation about a

new product.” - Neurosurgeon, XX Country

“The Pharmaceutical Company is key in presenting to us a new product in this area.”



Reactions to Product X Profile


Product Profile

Hypothetical Product

Indication Product X Thrombin, topical (Recombinant) is indicated as an aid to hemostasis whenever oozing blood and minor

bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical. May be used in conjunction with an absorbable gelatin sponge, USP.

Characteristics Product X Thrombin, topical (Recombinant), is human thrombin produced via recombinant DNA technology from a

genetically modified Chinese hamster ovary (CHO) cell line, a commonly used expression system for producing recombinant proteins. Product X is identical in amino acid sequence to naturally occurring human thrombin

Efficacy

In a randomized, double-blind phase 3 clinical trial, 401 patients at 34 study sites undergoing spinal, vascular, or liver surgery received either Product X (1000 IU/mL) or bovine thrombin (1000 IU/mL, Thrombin-JMI). Product X promotes rapid, reliable hemostasis:

Dosing and Administration

Product X is supplied as a white lyophilized powder in 5,000-unit and 20,000-unit vials and can be stored at room temperature for up to 24 months. Lyophilized Product X is reconstituted with normal saline using a needle-less transfer device (diluent in a pre-filled syringe provided in the kit) Product X may be topically applied directly to a bleeding site or in conjunction with an absorbable gelatin sponge, USP. Multiple application methods via: Absorbable gelatin sponge, Absorbable gelatin powder, absorbable gelatin matrix, Pump and Syringe spray devices.

Side Effect Profile

The safety and immunogenicity observations from 8 completed Product X clinical trials (n=583) were pooled for analysis. The most commonly reported adverse event were incision site pain (51%), procedural pain (30%), and nausea (28%), which are consistent with those commonly observed in surgical patients Product X has a favorable immunogenicity profile <1% (n=5/552) of all patients developed antibodies to Product X. Rates of antibody formation to Product X across these clinical trials ranged from 0 to 1.6% at day 29. None of the antibodies neutralized to native human thrombin


Respondents point to a number of benefits: onset of action & novel recombinant technology as greatest attributes


Benefits of Product X (in order of importance)

• Faster and more efficiently in diminishing bleeding

• Many respondents are impressed by the percentage of patients who achieve hemostasis at three minutes.

• However, many do not feel that the time to hemostasis is strongly different from currently available products.

• Can be combined with other hemostatic products and thus have even greater efficacy.

• [Product Safety was not a stated unmet need, but is the 2nd most important benefit of Product X]

• The fact that it is obtained from a recombinant DNA technology which in turn generates less immunogenicity and other adverse events is seen as a definite advantage.

• However, some questioned the side effects listed in the product profile, noting that they do not have similar concerns with other agents.

• Product cost • More emphasis

by Pharmacy Directors

• Not immediately seen as a strength of Product X: • Respondents assume that a new product would be more expensive.

“I am really impressed on how this thrombin was

produced- its identical to human thrombin but its

recombinant.” - Neurosurgeon, XX

Country


Overall, Product X immediately satisfies 3 out of 5 top unmet needs…


Benefits of Product X (in order of importance)

• Multiple application methods

• Several application advantages are noted: • The different application methods offer flexibility in use with

different types of surgeries/surgeons. • The ability to be applied directly to the bleeding site. Other

products need to have dry tissue to be applied. • When prompted about the application method most surgeons

mentioned they would prefer the pump and syringe spray devices followed by the absorbable gelatin sponge. They thought that the spray presentation helps to reach larger areas with smaller amounts of product.

• Easier preparation and storage

• No need to freeze/defrost • Longer expiration date

• The no refrigeration requirements and up to 24 months storage are likewise

viewed positively.

• Training by manufacturers • Not immediately seen as a strength of Product X

“I can save a lot of money for my hospital if the product that I am

buying can be stored up

to 24 months at a room temperature.”

- Pharmacy Director, XX Country

“Having all of this application forms makes me think of

Product X as four different products for many surgeries.”


“What I really like most is that it activates when it contacts the bleeding site - and not

before, and that leads me to think that it does not adhere to the tissue and works perfectly

for Hemostasia.”



Surgeons envision a number of different applications for Product X

Surgeons foresee the most value for surgeries with excessive bleeding. They feel they can control minor bleeds themselves.

Examples of surgeries mentioned (partial list)

Tumors, meningiomas

Open heart surgeries; bypass, valve replacement

Aneurysms

Vascular malformations/surgeries

Brain tissue

Some pediatric procedures

Malformations of the spine

Transsphenoidal surgeries (hypofisis)

A number of surgeons also mentioned laparoscopic surgeries.

Given the formulation, they believe the application is well suited for these procedures.

A few patient driven factors were identified:

Age was not as important in considering the use of Product X but some surgeons were more worried about co-morbidities such as heart and blood conditions.

Patients who use antiplatelet products (aspirin) would not be suitable candidates.

“I would use it in craniotomy as it could be used in advance to

prevent bleeding- as we do it with Tissucol.”


“It is easy to prepare and has that many methods, then it would be ideal in laparoscopic surgeries” - General Surgeon, XX Country


Cost is perceived to be the primary potential drawback of the product; and availability is a potential concern

Surgeons and Pharmacy Directors point to cost as the main barrier for product acceptance, particularly in public hospitals in XX Country.

However, a number of Pharmacy Directors in XX Country indicated that the cost of $810 pesos for a 5ml vial is a reasonable price for a thrombin product.

Just one Pharmacy Director from a lower income hospital considered it somewhat more expensive than what they had, as they got special stock prices for certain contracts with Pharmaceutical Companies.

There were some questions and concerns surrounding product availability.

Some surgeons questioned the availability of the product, especially those in XX Country who mentioned that some hemostatic products have been not available for certain periods of time.

Other concerns were the possibility to find it in every pharmacy or that most distributors would have them for delivery to all hospitals.

“I hope that the product is not very expensive, that way it can be stocked faster

in my hospital once we have analyze its benefits.”

- Pharmacy Director, XX Country

“I need to know that I will have access to the product and that my hospital will always

have it when I decide to use it- if it is not like that, I will continue to use the products I

trust.” -Neurosurgeon, XX Country

“I believe $810 pesos is much lower than what we

pay for Xseal- this is a great option if its going to cost

this.” - Pharmacy Director, XX

Country


Experience, education, and exposure are critical to product acceptance.

Manufacturer training for the surgeons and nurses was voiced by many of the respondents in order to gain exposure to the product. Some suggested a workshop organized by the Pharmaceutical Company specially dedicated to the preparation and administration methods- as well as the devices needed.

Many respondents mentioned that they would like to see the sales reps visit them and leave them samples.

Various respondents, mainly from XX Country, envisioned themselves as the ones introducing Product X to their hospital.

Several suggested increasing awareness by finding a professor who defends the adoption of the new product to increase the impact on the decision of standardizing a new material.

Presence at meetings and lectures is important to create familiarity with the product.

Manufacturer training ad

support

Experience is important

A number of surgeons would want to evaluate the product for themselves prior to fully adopting it.

Some respondents said that at the beginning they would use it in surgeries that have low risk of heavy bleeding. From there, they would evaluate use in riskier surgeries with greater risk of heavy bleeding.

Expert endorsement would raise awareness

“The best way that I will find out that the product exists is from a

sales rep who will show it to me.” – General Surgeon, XX Country


Additionally samples and scientific literature would “kick-start” adoption

Many respondents ask for free samples out-right, such that they can gain personal and first-hand experience of Product X

As well, personal experience will also translate into personal endorsement of Product X, thus feeding into “expert endorsement” and overall awareness in hospitals.

Engaging senior surgeons, department heads, and professors with samples would be worthwhile.

Several physicians also request scientific information from manufacturers, in addition to sale rep presentations.

Important sources of reliable information mentioned include:

Neurosurgery Society

Neurosurgery (journal)

Academy of Surgery

Availability of Samples

Availability of Research

Information/ Monographs “In order to use a new product, I

would need to see medical publications from an international,

independent researcher.”

– Neurosurgeon, XX Country

“Try it and see it for myself – that is the best recommendation I can

have!” – Neurosurgeon, XX Country


Conclusions & Recommendations


Surgeons immediately saw uses for Product X for specific types of surgeries

Product X

Perceptions

Product X is viewed positively in XX Country

The primary points of interest appear to be the novel recombinant DNA technology and the multiple application methods. These attributes are perceived as having definite advantages over current products.

Other benefits include: - Fast onset of action: comparisons should be made to

the hemostatics currently used in the country rather than other thrombins.

- Easy to stock: This point is especially important to the Pharmacists

Strongly communicate the primary benefits and reasons to use Product X in order to motivate use over current modalties.

Product X Use

Physicians point out that this agent would be most useful in surgeries where heavier bleeding is anticipated.

At present, many do not use topical hemostatics for minor surgeries or bleeding unless the bleeding cannot be stopped. As such, this product is preceived as intended for serious and extreme cases, not for routine surgeries.

Surgeons tend not to give much forethought to the hemostatic product used and will make decisions based on what is currently available to them in the operating room.

The perception that minor bleeding does not require the use of topical hemostatics should be corrected by calling attention to the possibility of even more effective results than are currently being achieved.

Invest in educating surgeons on the

differeces between hemostatic agents and utility of Product X over current modalities.

Items for Consideration


Perceived cost and product awareness are the two potentially greatest obstacles Product X will face

Cost Barrier

Perceive cost is a primary driver of adoption of new hemostatic agents and may present a barrier to the uptake of Product X initially.

However, specifically in XX Country, respondents (MDs and pharmacy directors) agree that Xseal is extremely expensive, and any product that provides greater safety, efficacy, and convenience at a parity or lower price, would be a winner

Develop a strong materials showing mainly the possible cost and time gained with the adoption of the new hemostatic.

Product X Use and

Perceptions

Generating a level of comfort and familiarity will be essential.

Surgeons and pharmacy directors perceived that a good presence/training from sales reps and distributors/ pharmaceutical companies would driver a higher likelihood of selection of the product.

Key Opinion Leaders have a great importance in the adoption on new materials.

Approval from US FDA as well as local XX Country authorities is essential in considering a new product in the XX Country

Actively approach hospitals to provide in-service training to raise awareness and level of comfort about the product.

Associate at least one renowned surgeon (or team) with the product to boost its credibility and awareness.

Items for Consideration


Appendix: Additional Details


Stocking Decision Tree Details

• The first requirement to obtain a product is that it has to be previously authorized by the FDA and have proven experience.

• Surgeons mentioned that in order to obtain a product that is not stocked in their hospital they need to write a proposal mentioning the benefits of the product and why they want it. • Some may even need to present the results from a Study or Protocol. • Others need to make a presentation themselves to convince the different committees.

• Few mentioned that there was a formal format to ask for new products.

• These are product evaluation sheets that have different parts were the benefits are mentioned and then the product is compared to the ones already stocked. The administrative department makes the decision to substitute another product or add to the stock.

• Other respondents from XX Country mentioned that they would need to pose the requirement to their

chief of surgery/department so that together they can write to the administrative department. • Few respondents mentioned that the first one in charge of submitting the letters was the chief of nurses or the person

in charge of all the operation rooms.

• Then these would need to be presented to the different committees (Administrative, Medical and Nurses)

so they can evaluate the product, vote, and make the authorization.

“If I know there exists a new product I just need to write a letter stating the benefits and why I want it, then present it to the Pharmacy Director or Administrative Department and they start the process to stock the product.” - General Surgeon, XX Country


• Pharmacy Directors mentioned that they are constantly evaluating new products and their analysis is based mainly in a cost-benefit approach. Generally, they belong to an administrative committee that meets periodically (every 1~3 months) to review new products, make procurement decisions, as well as to discuss other issues pertaining to products kept at their pharmacy.

• The administrative department together with the chiefs of surgery/nurses or medical department evaluate the product and then an outcome is given to buy or not the specific product.

• Some surgeons and Pharmacy Directors from both countries mentioned that certain Pharmaceutical Companies were close to them and that they gave them samples and presentations so they were more keen in getting their attention and require their product. • They also mentioned these same companies trained them and their nurses in order to be more knowledgeable of their

product and thus that would make them chose it more frequently.

• Respondents from XX Country and PR stated that their private hospitals could take 5 to 10 days to

authorize a new product and as long as 1 to 3 months. For the public sector in XX Country it could range from 1 month to 6 months.

• Few surgeons from XX Country mentioned that as their hospital was private, the responsibility was theirs so they just needed to ask for it and they would have the supply.

“I am open to any suggestion a surgeon would have to stock a new product, but their presentation has to be convincing and at the end we would stock the product if the cost is worth the benefits.” - Pharmacy Director, XX Country “I am the only responsible of prescribing or using a certain product, so my hospital would stock what I ask for as long as it is approved by the FDA.” - Neurosurgeon, XX Country

Stocking Decision Tree Details


Perceived advantages and disadvantages of Hemostasis Products

Thrombin-containing Hemostasis Products

Product Advantages Disadvantages

Surgiflo • Has good hemostasia • Can be used as a spray • Can be used easily for the hepatic area/gall bladder

• Not mentioned

Tissucol

• Faster and greater hemostasia • Seals fistulae better • Administration is convenient • Useful for difficult areas to reach • Used in brain • Used to isolate bleeding areas • Its is absorbed in the tissue • Often used as a sealant in dura mater

• Coagulates so fast that product is wasted, it gets stuck in the syringe and not useful after a while

• More expensive • As it is liquid it can flow to unintended areas • Its wasted because they do not have the equipment on

hand to apply it • Needs to be prepared

Xseal

• For blood vessel bleeding • Great for artery bleeding • Coagulates less faster in syringe • Effective • Has adapters for laparoscopy • Good for open heart surgeries • Effective in brain surgeries

• Needs to be prepared • Its needs to be in the freezer • The syringe can be tampered • The most expensive in the market

Xplast • Similar to Tissucol • Good hemostasia and sealant action • More liquid than the other Xseal or Tissucol

• Less expensive than the other thrombin-containing products

Perclot

• Useful in brain (craniotomy) surgeries • Its a powder and its very manageable • Good for difficult to access areas • Good for hypophysis • It adheres good to the gall bladder walls

• Expensive • Not always available

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