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By:
Dr.Lavanya.S.A
2nd Year P.G.Scholar
Dept of RS & BK
T.G.A.M.C, Ballari.
Under the guidance of:
Dr.M.S.Doddamani
HOD & Professor
Dept of RS & BK
T.G.A.M.C, Ballari
Pre-Launch Ads.
Launch/Product
release.
Active Marketing.
Pre-launch ads:
• Pique interest in a new product
• Introduce logos and color schemes
• Introduce the brand name
A product release is the launch of a new product or a
combination of features that will provide value to customers
or users.
A product release program ensures that only
compliant products are released to the market. The facility
should prepare a procedure outlining the responsibility and
protocols for the release of products and effectively
implement that procedure.
Product release also applies to the procedures for
releasing quarantined or held product.
The product release procedure not only applies to
positive release of compliant products, the supplier should
also outline the procedure for releasing products from
quarantine or hold status.
In all cases, the facility should identify those staff
positions with responsibility for releasing products and
indicate the action they will take when results are outside
specification, including references to other procedures for
holding, reworking or disposing of product.
The facility should ensure that:
All products are confirmed as compliant before
release to the market.
All staff is familiar with the product release
procedures and that personnel authorized to
release product are aware of their responsibilities.
All products under quarantine or authorized personnel only
release hold status after the product has successfully passed
inspection. All products released for distribution should have
records maintained. These records should record the product
name and identification, confirmation of product checks, and the
product disposition. Products released from hold should also be
recorded.
Records should include the amount of product that was held and
the reason for the hold. Records should be reviewed routinely to
ensure that holds are closed out. Any product that is still on hold
should be physically or visually verified.
Active
Marketing:
• Brand name
• Generic name
• Use/indications
• Summary of side effects
• Contraindications
• Effectiveness
MARKETING:
Marketing is the business function that identifies customer
needs and wants, determines which target markets the
organization can serve best, and designs appropriate products,
services, and programs to serve these markets.
Marketing is a proven approach for stimulating consumers to
purchase new services.
An understanding of patient needs and wants is
essential for developing and implementing a successful
plan for marketing pharmacy services.
To be successful, a pharmacy can incorporate a
marketing management process as a basic component
of their operation
A marketing management process should include 3 primary steps:
*Evaluating a market.
*Planning marketing strategies and tactics.
*Implementing and controlling marketing effort.
A market can be viewed as containing buyers and sellers that react to each
other and to other influences acting in the market.
In this case, the actors in the market for pharmacy services usually include
service providers, patients, payers and employers.
Evaluating a market:
It entails consideration of both a macro-environment and a micro-
environment.
A macro-environment refers to forces that effect the parties in a
market, and encompasses 5 sectors:
Economic
Competitive
Technological
Social
Regulatory
Economic:
These consideration can effect the likelihood that patients will
be able to pay for a pharmacy service.
Ex:- The closing of a large local employer can greatly limit the demand
for services, perhaps by eliminating health insurance coverage.
Competitive Factors:
Such as consolidation of ownership can be important. For
instance, the presence of a large chain usually affects pricing levels
and could affect supply of pharmacists.
Technology:
It can support new services. For example, some pharmacists are
incorporating personal digital assistants(PDAs) into their service provision.
Social:
Social factors should be considered, such as the percentage of elderly
without family support in the community.
Regulatory:
It can include state or federal regulations. For example, many states allow
collaborative practise agreements between pharmacists and physicians.
Planning of marketing
The second phase of marketing management process is to plan marketing
strategies and tactics.
A marketing plan should contain key elements that are essential for
successful implementation.
The marketing plan should be consistent with the mission of the practise
and should incorporate analyses performed during the evaluation phase,
especially the SWOT analysis.
From the analyses, target markets may be identified, the marketing mix
can be determined, and the marketing strategies can be developed.
The key elements of a marketing plan
include:
SWOT analysis.
Goals and
Objectives.
Target
markets.
Marketing
mix.
Control processes.
SWOT Analysis:
S = Strengths of the practise
W = Weaknesses of the practise
O = Opportunities for the practise
T = Threats to the practise
Goals and Objectives:
After the SWOT analysis is written, a set of goal statements can be
prepared. These statements lead to objectives that a pharmacy want to
accomplish. They should reflect the mission statement for the practise,
which is the underlying philosophy of the pharmacy.
Goal statements are general and provide direction for the practise to meet
the mission of the pharmacy. Each goal statement has its own specific
objectives that are the outcomes needed to meet the goals.
The objectives that are developed for the practise should be clearly
stated, realistic, and measurable. It is through the objectives that pharmacists
can determine the success or failure of their marketing plan.
Target markets:
Target markets are those customers who behave in similar patterns and
can benefit from the pharmacy care services offered by the practise.
Marketing mix:
The term for the variables that are under the pharmacists control is
marketing mix. The variables are selected strategically to increase the
likelihood of successful marketing.
The elements of the marketing mix, also called the 4 P’s of marketing
include:
• Product
• Price
• Promotion
• Place
Implementing and Controlling
Marketing Activities
2 components can be considered:
•Rollout of the service
•Monitoring of activities.
Pharmacy service rollout:
It should be guided with an action plan that identifies the activities that need to
be performed when each activity will occur, and who will be responsible for getting it
done.
A starting place is to generate a task list for the service rollout. Tasks can address
a variety of areas that are likely to require some change to accommodate a new
pharmacy service. Such areas include :
Workflow and staffing
Staff training
Materials and systems for service provision and documentation.
Pharmacy layout
Marketing materials
Monitoring of marketing activities:
To monitor the marketing activities, an information system should be
utilized. The system should allow the evaluation of performance at achieving
marketing objectives.
Performance indicators should be identified, and processes for
collecting and reporting this information can be established. Then, regular
reports can be used to assess service quality and other marketing
performance objectives.
A number of performance indicators can be monitored.
These indicators should be established before implementation and
processes are in place to collect the data. The outcomes may
include:
*No of services or programs sold
*Increase in pharmacy service revenue
*Increase in referrals
*No of contracts with employers
*Improved patient satisfaction surveys
*Quality of the services
By assessing these outcome data from the marketing
efforts, one can make decisions about future marketing
efforts and the cost effectiveness of certain strategies.
For example, low patient satisfaction with a service
can be used to guide improvements in the service delivery.
Any performance shortfalls should lead to
identification for the cause of the shortfall. All of the
marketing mix should be considered.
Once a potential cause is found, adjustments can be
made in the marketing effort to address it.
Budgeting for the marketing plan will need to be
addressed at this time as well .Several strategies can be
used to determine the appropriate amount that should be
spent for marketing and advertising.
One common approach is to determine a fixed
percentage of sales to set aside for advertising . Although
this method is easily applied, it has some inherent
problems. Its major shortcoming is the implication that
sales cause advertising. Instead, marketing and advertising
should be seen as increasing sales.
A second method is to establish a marketing budget
based on the competition or industry norms. This is not an
optimal approach because the competition may be reaching
a different target market or may not have appropriated
sufficient funds for marketing. In addition, these figures
may not be readily available.
The next approach is the affordable method. This
strategy takes the marketing budget into consideration only
after funds have been allocated to other important
operations or projects to the pharmacy. The remaining funds
then are applied to the marketing budget.
The last strategy, objective and task approach, is the most
cost-effective method for determining a budget. This bottom-up
method determines the goals and objectives of the marketing
plan, the tasks that need to be completed and the costs
associated with each task.
The marketing budget is created by determining what
investment is needed to implement the marketing strategies
developed during the planning process. Assessments of the
effectiveness of each strategy allow adjustments to be made in
the plan and budget.
Decisions about the amount spent on marketing should be
evaluated routinely by looking at the return on investment.
Another key part of monitoring marketing effort is
to seek feedback from patients. Receiving feedback from
patients and stakeholders regarding promotional
materials before market testing helps in the
development of these marketing tools.
One approach is to recruit a small group of
patients and stakeholders to preview materials regularly.
During the market testing, carefully evaluate
patient and stakeholder response to the marketing
strategies.
A product recall is a request to return a product
after the discovery of safety issues or product defects
that might endanger the consumer or put the
maker/seller at risk of legal action.
The recall is an effort to limit ruination of the
corporate image and limit liability for corporate
negligence, which can cause significant legal costs.
There are approximately 200 pharmaceutical
recalls every year.
The reasons for recalls and withdrawals range from
life-threatening situations to situations where there is no
health hazard or risk, but simply, the product does not
measure up to the quality control standards that the
pharmaceutical community wishes to present to the public.
There are mainly 3 sections to deal with namely;
1. Recall procedures
2. Action when a recall happens
3. Background information, Future directions, and
implication of recalls.
Elements of recall procedures:
Communication
Product handling
Record keeping
A pharmacist may discover that for a particular
pharmacy institution, facility, or type of pharmacy practice,
there needs to be additional elements. There is probably no
one right answer.
After becoming aware of a product recall or
withdrawal, one of the first things a pharmacist will
probably need to do is to communicate the recall to
someone else. It may be helpful to think in terms of:
oWhom to contact?
oWhat to communicate?
oWhen to send out communication?
oHow to communicate?
Establishing written procedures for how product is to
be handled should address such items as:
Identifying the recalled product
Locating the product in the pharmacy
Quarantining and returning the product
The reasons that a pharmacists would want to
document the actions in a recall range from the simple
determination of fact to lessening of legal liabilities.
Documenting a pharmacists actions during a recall
can be greatly facilitated by forms and checklists.
In addition to using forms to establish documentation
of a pharmacists own actions, copies of documents created
by others should also be kept.
Once a recall event has begun, the pharmacist should proceed
in a step-by-step manner. A good outline that the pharmacist may
wish to customize may include:
Receiving the initial information
Listing further action steps
Carrying out further notification
Responding to the initial notification
Product handling
Reimbursement
Initial Notification:
The first thing that will occur in any particular recall is
that the pharmacist will learn about that recall for the first
time. This may be by one of several methods. Most common is a
notice from a pharmaceutical manufacturer, a wholesaler or a
community chain headquarters. This can be by letter or
automated telephone voice message.
Action steps:
If there are no written recall procedures for the
pharmacist’s particular facility, it is recommended that the
pharmacist should first simply write down all the action steps
that he/she can think of.
Further Notification:
It is also called as sub-recall. In the case where patient
notification is required, the pharmacist will have to identify any
patients who may have received the recalled product and then
communicate the recall instructions to them.
Response to notification:
An important aspect of the recall is responding back to
the manufacturer, wholesaler, or whomever initiated the recall
notification. The pharmacist should promptly respond that the
notice was received and that the pharmacist is carrying out the
actions instructed in the recall communication.
Product handling:
The recalled product must be identified, located, quarantined,
and returned.
Reimbursement:
The pharmacist will want to monitor when reimbursement is
received from the manufacturer. Although the product is not an urgent
health- related issue, many patients may be understandably anxious
about how much and when they will be reimbursed. Pharmacist should
attempt to ascertain what the manufacturer’s reimbursement policy
will be, and, failing that, at least, reassure the patient that some form
of reasonable compensation could be expected from most major
manufacturers.
Importance of lot number:
Pharmaceuticals are manufactured in batches.
Each lot manufactured is coded with a specific lot
number so that if there is any need, then that
particular lot can be traced back to discover such
things as which raw materials were used, what
equipment was used, and which personnel were on
duty during the manufacture of that lot.
Classes of recalls and withdrawals:
The difference between a recall and a withdrawal is
that the word recall applies if the product in question could
potentially violate the FD & C Act.
RECALL WITHDRAWAL
A recall is defined as “
a firm’s removal or
correction of a marketed
product that the FDA
considers to be in violation
of the laws it administers
and against which the
agency would initiate legal
action.”
A withdrawal is defined
as “a firm’s removal or
correction of a distributed
product which involves a
minor violation that would
not be subject to legal
action by the FDA or which
involves no violation”
Level of recalls and distribution channels:
When a recall is announced by a manufacturer, there
should be a statement about at what level the recall is being
carried out. In its simplest form, the levels of
pharmaceutical distribution system can be charted as
Pharmaceutical
Manufacturer
Drug wholesaler
Pharmacy
Patient
Reasons for recalls:
REASON DESCRIPTION % ALL DRUG
RECALLS
Potency Failure to maintain potency at
certain time points during the in
date period
20
Labelling/ packaging
mixups
Incorrect strength on label;
wrong product in bottle etc.
25
Misc.Product problems Discoloration; leaking bottles;
particulate matter etc.
5
Dissolution Failure to dissolve at certain time
points during the in date period
5
Manufacturing
discrepancies
Deviations from official
manufacturing procedures
5
Contamination Contamination with bacteria or
general lack of sterility
45
Future directions and implications:
Some potential legal developments may affect
pharmacists directly in coming years. Legislation changes
constantly, and pharmacists must be aware of new
regulations. One possible legislative initiative may require
pharmacists to notify patients in the case of certain recalls.
One outgrowth of recalls that may affect pharmacists
practise is the topic of tracking dispensed drugs by lot
number. Tracking by lot number is an enormous data
management burden for manufacturers.
To successfully implement pharmacy-care services, pharmacists
can market their services. The 3 steps of the marketing process
provide a basic framework that can be applied to any practise.
Each step of the marketing process may be individualised to a
particular practise site, demographic area, patient base,
competitive environment and financial constraint.
A thorough analysis of one’s environment is essential to identify
key targets and stakeholders, recognize opportunities and
threats to the practise’s success, and ensure that marketing
resources are used in the most cost effective manner.
Important steps for a pharmacist to take to handle
recalls effectively are as follows:
Establish procedures
Document what is performed
Use good judgement.
Dr.Lavanya.S.A- Pharmaceutical marketing

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Dr.Lavanya.S.A- Pharmaceutical marketing

  • 1. By: Dr.Lavanya.S.A 2nd Year P.G.Scholar Dept of RS & BK T.G.A.M.C, Ballari. Under the guidance of: Dr.M.S.Doddamani HOD & Professor Dept of RS & BK T.G.A.M.C, Ballari
  • 2.
  • 4.
  • 5. Pre-launch ads: • Pique interest in a new product • Introduce logos and color schemes • Introduce the brand name
  • 6. A product release is the launch of a new product or a combination of features that will provide value to customers or users. A product release program ensures that only compliant products are released to the market. The facility should prepare a procedure outlining the responsibility and protocols for the release of products and effectively implement that procedure. Product release also applies to the procedures for releasing quarantined or held product.
  • 7. The product release procedure not only applies to positive release of compliant products, the supplier should also outline the procedure for releasing products from quarantine or hold status. In all cases, the facility should identify those staff positions with responsibility for releasing products and indicate the action they will take when results are outside specification, including references to other procedures for holding, reworking or disposing of product.
  • 8. The facility should ensure that: All products are confirmed as compliant before release to the market. All staff is familiar with the product release procedures and that personnel authorized to release product are aware of their responsibilities.
  • 9. All products under quarantine or authorized personnel only release hold status after the product has successfully passed inspection. All products released for distribution should have records maintained. These records should record the product name and identification, confirmation of product checks, and the product disposition. Products released from hold should also be recorded. Records should include the amount of product that was held and the reason for the hold. Records should be reviewed routinely to ensure that holds are closed out. Any product that is still on hold should be physically or visually verified.
  • 10. Active Marketing: • Brand name • Generic name • Use/indications • Summary of side effects • Contraindications • Effectiveness
  • 11.
  • 12. MARKETING: Marketing is the business function that identifies customer needs and wants, determines which target markets the organization can serve best, and designs appropriate products, services, and programs to serve these markets. Marketing is a proven approach for stimulating consumers to purchase new services.
  • 13. An understanding of patient needs and wants is essential for developing and implementing a successful plan for marketing pharmacy services. To be successful, a pharmacy can incorporate a marketing management process as a basic component of their operation
  • 14. A marketing management process should include 3 primary steps: *Evaluating a market. *Planning marketing strategies and tactics. *Implementing and controlling marketing effort. A market can be viewed as containing buyers and sellers that react to each other and to other influences acting in the market. In this case, the actors in the market for pharmacy services usually include service providers, patients, payers and employers.
  • 15. Evaluating a market: It entails consideration of both a macro-environment and a micro- environment. A macro-environment refers to forces that effect the parties in a market, and encompasses 5 sectors: Economic Competitive Technological Social Regulatory
  • 16. Economic: These consideration can effect the likelihood that patients will be able to pay for a pharmacy service. Ex:- The closing of a large local employer can greatly limit the demand for services, perhaps by eliminating health insurance coverage. Competitive Factors: Such as consolidation of ownership can be important. For instance, the presence of a large chain usually affects pricing levels and could affect supply of pharmacists.
  • 17. Technology: It can support new services. For example, some pharmacists are incorporating personal digital assistants(PDAs) into their service provision. Social: Social factors should be considered, such as the percentage of elderly without family support in the community. Regulatory: It can include state or federal regulations. For example, many states allow collaborative practise agreements between pharmacists and physicians.
  • 18. Planning of marketing The second phase of marketing management process is to plan marketing strategies and tactics. A marketing plan should contain key elements that are essential for successful implementation. The marketing plan should be consistent with the mission of the practise and should incorporate analyses performed during the evaluation phase, especially the SWOT analysis. From the analyses, target markets may be identified, the marketing mix can be determined, and the marketing strategies can be developed.
  • 19. The key elements of a marketing plan include: SWOT analysis. Goals and Objectives. Target markets. Marketing mix. Control processes.
  • 20. SWOT Analysis: S = Strengths of the practise W = Weaknesses of the practise O = Opportunities for the practise T = Threats to the practise Goals and Objectives: After the SWOT analysis is written, a set of goal statements can be prepared. These statements lead to objectives that a pharmacy want to accomplish. They should reflect the mission statement for the practise, which is the underlying philosophy of the pharmacy.
  • 21. Goal statements are general and provide direction for the practise to meet the mission of the pharmacy. Each goal statement has its own specific objectives that are the outcomes needed to meet the goals. The objectives that are developed for the practise should be clearly stated, realistic, and measurable. It is through the objectives that pharmacists can determine the success or failure of their marketing plan. Target markets: Target markets are those customers who behave in similar patterns and can benefit from the pharmacy care services offered by the practise.
  • 22. Marketing mix: The term for the variables that are under the pharmacists control is marketing mix. The variables are selected strategically to increase the likelihood of successful marketing. The elements of the marketing mix, also called the 4 P’s of marketing include: • Product • Price • Promotion • Place
  • 23. Implementing and Controlling Marketing Activities 2 components can be considered: •Rollout of the service •Monitoring of activities.
  • 24. Pharmacy service rollout: It should be guided with an action plan that identifies the activities that need to be performed when each activity will occur, and who will be responsible for getting it done. A starting place is to generate a task list for the service rollout. Tasks can address a variety of areas that are likely to require some change to accommodate a new pharmacy service. Such areas include : Workflow and staffing Staff training Materials and systems for service provision and documentation. Pharmacy layout Marketing materials
  • 25. Monitoring of marketing activities: To monitor the marketing activities, an information system should be utilized. The system should allow the evaluation of performance at achieving marketing objectives. Performance indicators should be identified, and processes for collecting and reporting this information can be established. Then, regular reports can be used to assess service quality and other marketing performance objectives.
  • 26. A number of performance indicators can be monitored. These indicators should be established before implementation and processes are in place to collect the data. The outcomes may include: *No of services or programs sold *Increase in pharmacy service revenue *Increase in referrals *No of contracts with employers *Improved patient satisfaction surveys *Quality of the services
  • 27. By assessing these outcome data from the marketing efforts, one can make decisions about future marketing efforts and the cost effectiveness of certain strategies. For example, low patient satisfaction with a service can be used to guide improvements in the service delivery. Any performance shortfalls should lead to identification for the cause of the shortfall. All of the marketing mix should be considered. Once a potential cause is found, adjustments can be made in the marketing effort to address it.
  • 28. Budgeting for the marketing plan will need to be addressed at this time as well .Several strategies can be used to determine the appropriate amount that should be spent for marketing and advertising. One common approach is to determine a fixed percentage of sales to set aside for advertising . Although this method is easily applied, it has some inherent problems. Its major shortcoming is the implication that sales cause advertising. Instead, marketing and advertising should be seen as increasing sales.
  • 29. A second method is to establish a marketing budget based on the competition or industry norms. This is not an optimal approach because the competition may be reaching a different target market or may not have appropriated sufficient funds for marketing. In addition, these figures may not be readily available. The next approach is the affordable method. This strategy takes the marketing budget into consideration only after funds have been allocated to other important operations or projects to the pharmacy. The remaining funds then are applied to the marketing budget.
  • 30. The last strategy, objective and task approach, is the most cost-effective method for determining a budget. This bottom-up method determines the goals and objectives of the marketing plan, the tasks that need to be completed and the costs associated with each task. The marketing budget is created by determining what investment is needed to implement the marketing strategies developed during the planning process. Assessments of the effectiveness of each strategy allow adjustments to be made in the plan and budget. Decisions about the amount spent on marketing should be evaluated routinely by looking at the return on investment.
  • 31. Another key part of monitoring marketing effort is to seek feedback from patients. Receiving feedback from patients and stakeholders regarding promotional materials before market testing helps in the development of these marketing tools. One approach is to recruit a small group of patients and stakeholders to preview materials regularly. During the market testing, carefully evaluate patient and stakeholder response to the marketing strategies.
  • 32.
  • 33. A product recall is a request to return a product after the discovery of safety issues or product defects that might endanger the consumer or put the maker/seller at risk of legal action. The recall is an effort to limit ruination of the corporate image and limit liability for corporate negligence, which can cause significant legal costs. There are approximately 200 pharmaceutical recalls every year.
  • 34. The reasons for recalls and withdrawals range from life-threatening situations to situations where there is no health hazard or risk, but simply, the product does not measure up to the quality control standards that the pharmaceutical community wishes to present to the public. There are mainly 3 sections to deal with namely; 1. Recall procedures 2. Action when a recall happens 3. Background information, Future directions, and implication of recalls.
  • 35. Elements of recall procedures: Communication Product handling Record keeping A pharmacist may discover that for a particular pharmacy institution, facility, or type of pharmacy practice, there needs to be additional elements. There is probably no one right answer.
  • 36. After becoming aware of a product recall or withdrawal, one of the first things a pharmacist will probably need to do is to communicate the recall to someone else. It may be helpful to think in terms of: oWhom to contact? oWhat to communicate? oWhen to send out communication? oHow to communicate?
  • 37. Establishing written procedures for how product is to be handled should address such items as: Identifying the recalled product Locating the product in the pharmacy Quarantining and returning the product
  • 38. The reasons that a pharmacists would want to document the actions in a recall range from the simple determination of fact to lessening of legal liabilities. Documenting a pharmacists actions during a recall can be greatly facilitated by forms and checklists. In addition to using forms to establish documentation of a pharmacists own actions, copies of documents created by others should also be kept.
  • 39. Once a recall event has begun, the pharmacist should proceed in a step-by-step manner. A good outline that the pharmacist may wish to customize may include: Receiving the initial information Listing further action steps Carrying out further notification Responding to the initial notification Product handling Reimbursement
  • 40. Initial Notification: The first thing that will occur in any particular recall is that the pharmacist will learn about that recall for the first time. This may be by one of several methods. Most common is a notice from a pharmaceutical manufacturer, a wholesaler or a community chain headquarters. This can be by letter or automated telephone voice message. Action steps: If there are no written recall procedures for the pharmacist’s particular facility, it is recommended that the pharmacist should first simply write down all the action steps that he/she can think of.
  • 41. Further Notification: It is also called as sub-recall. In the case where patient notification is required, the pharmacist will have to identify any patients who may have received the recalled product and then communicate the recall instructions to them. Response to notification: An important aspect of the recall is responding back to the manufacturer, wholesaler, or whomever initiated the recall notification. The pharmacist should promptly respond that the notice was received and that the pharmacist is carrying out the actions instructed in the recall communication.
  • 42. Product handling: The recalled product must be identified, located, quarantined, and returned. Reimbursement: The pharmacist will want to monitor when reimbursement is received from the manufacturer. Although the product is not an urgent health- related issue, many patients may be understandably anxious about how much and when they will be reimbursed. Pharmacist should attempt to ascertain what the manufacturer’s reimbursement policy will be, and, failing that, at least, reassure the patient that some form of reasonable compensation could be expected from most major manufacturers.
  • 43.
  • 44. Importance of lot number: Pharmaceuticals are manufactured in batches. Each lot manufactured is coded with a specific lot number so that if there is any need, then that particular lot can be traced back to discover such things as which raw materials were used, what equipment was used, and which personnel were on duty during the manufacture of that lot.
  • 45. Classes of recalls and withdrawals: The difference between a recall and a withdrawal is that the word recall applies if the product in question could potentially violate the FD & C Act. RECALL WITHDRAWAL A recall is defined as “ a firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action.” A withdrawal is defined as “a firm’s removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the FDA or which involves no violation”
  • 46. Level of recalls and distribution channels: When a recall is announced by a manufacturer, there should be a statement about at what level the recall is being carried out. In its simplest form, the levels of pharmaceutical distribution system can be charted as Pharmaceutical Manufacturer Drug wholesaler Pharmacy Patient
  • 47. Reasons for recalls: REASON DESCRIPTION % ALL DRUG RECALLS Potency Failure to maintain potency at certain time points during the in date period 20 Labelling/ packaging mixups Incorrect strength on label; wrong product in bottle etc. 25 Misc.Product problems Discoloration; leaking bottles; particulate matter etc. 5 Dissolution Failure to dissolve at certain time points during the in date period 5 Manufacturing discrepancies Deviations from official manufacturing procedures 5 Contamination Contamination with bacteria or general lack of sterility 45
  • 48. Future directions and implications: Some potential legal developments may affect pharmacists directly in coming years. Legislation changes constantly, and pharmacists must be aware of new regulations. One possible legislative initiative may require pharmacists to notify patients in the case of certain recalls. One outgrowth of recalls that may affect pharmacists practise is the topic of tracking dispensed drugs by lot number. Tracking by lot number is an enormous data management burden for manufacturers.
  • 49. To successfully implement pharmacy-care services, pharmacists can market their services. The 3 steps of the marketing process provide a basic framework that can be applied to any practise. Each step of the marketing process may be individualised to a particular practise site, demographic area, patient base, competitive environment and financial constraint. A thorough analysis of one’s environment is essential to identify key targets and stakeholders, recognize opportunities and threats to the practise’s success, and ensure that marketing resources are used in the most cost effective manner.
  • 50. Important steps for a pharmacist to take to handle recalls effectively are as follows: Establish procedures Document what is performed Use good judgement.

Editor's Notes

  1. PIQUE-AROUSE OR CREATE INTEREST
  2. FD & C ACT – Food, drug and cosmetic act