The FDA makes sure the medicines we take are secure







The FDA makes sure the medicines we take are secure. Numerous separate medications are accessible within a country. Once a medication is up for selling, the health supervisors and the medication creators observe it for any unexpected problems Should a problem occur, or the protection of drugs comes into query, the organization has the power to remove that drug or item from the market.

According to (Danford , 2013). He discussed that FDA works closely with the Western regulator, the Western Medicines Agency (EMA), which permits medicines and healthcare gadgets across Europe, They issue alerts to doctors and medical centers, to inform them when a medication is being removed or when there are problems about the quality that will influence its protection or efficiency Producers and importers are obliged to report to the FDA any excellence shortcomings in a medicinal product, which might probably result in a recall or constraint on its distribution. All the other users and distributors of medicinal products are encouraged to act on the same way as well as any person, body, organization or firm that is engaged in the dealership or in the manufacture of any medicinal product,(Danford), (2013).

(Shaw, 2012). Stated that where a defect is thought to be or pose a health risk to public health and to patients the marketing authorization holder withdraws the affected product from use and the FDA issues a ‘drug alert’ letter. This alert is classified on a scale of 1 to 4 depending upon the risk presented to the public health by the defective product. The signals are evaluated according to the scale of the threat on the public’s wellness. For example, category 1 needs immediate recall because the item presents a serious or life-threatening threat to health. Class 2 identifies a recall within 48 hours since the fault may well damage the individual but is not life-threatening. Class 3 needs action to be taken within five days because the problem is unlikely to harm patients and is being done for factors other than individual protection. Class 4 says caution to be worked out when using the item but indicates the item presents no threat to individual protection (Shaw), (2012).

Reasons for recalling drugs

According to ( Steinberge, 2013). Many issues can cause drugs to be recalled. A recall may be released if a drug is a threat to wellness of the patients. This happens when a drugs or item has already been used and unfortunately, some health hazards associated with that certain medicine are noticed although too late because the harm may already have been done (Steinberge),(2013).

Mislabeling or poor wrapping and casing is another cause of recall of drugs. At times, drugs recalled for lack of ideal dosing guidelines or a problem with the dose instruction that accompany the medications. A medication might be potentially impure. During production or submission, drugs may become infected with a dangerous or harmful material. Badly manufactured and bad Production process affecting quality, cleanliness, and efficiency may be the reason for drugs recall. All these are designed towards defending the individual and to ensure individual safety requirements are met.

The recent drug recall relate to the THURSDAY PLANTATION TEA TREE MOUTHWASH Due to Bacterial Contamination On the 3rd of April, 2014 – Natural Organics, Inc., voluntarily recalled THURSDAY PLANTATION TEA TREE MOUTHWASH after they were informed by its contract manufacturer INTEGRIA Healthcare (Australia) Pty Ltd. that one lot of Tea Tree Mouthwash had not passed the microbial contamination testing. The bacterial contaminant, identified as Pseudomonas aeruginosa, may possibly pose a health risk to users. While a health hazard is unlikely, this recall was important because Pseudomonas can cause serious illness in immune compromised individuals. It was distributed countywide to retail outlets and to other countries as Trinidad and the Philippines. The mouthwash is packed in clear plastic bottles with green and white labeling bearing the following product code and lot number shown at the back panel of the product label: Thursday Plantation, Tea Tree Mouthwash, 8.45 floz. / 250mL ℮, Product No. 6710, (Centers for Disease Control and Prevention, 2014)Background Information

According to (Seger, 2012). In the title are we heeding the vital signs he argues that The general understanding of pseudomonas infection is that it’s an infection widely suspected to be to be caused by bacteria strains that are found mostly in the environment, in humans the most type causing infection is the pseudomonas aeruginosa,it then important to understand the type of infection that pseudomonas aeruginosa causes this will help bring out the understanding of the background about the recall of plantation tea (Seger), (2012).

According to (Nanji, 2012). the publication are we heeding the vital signs he explains and describes that the infections usually occur to people in the hospitals those with a weakened immune systems in the blood and especially after surgery and this can lead to serious complications and even death, (Nanji), (2012).

Healthy individuals can also develop mild pseudomonas aeruginosa especially after being exposed to water ,the infection is characterized by ear infection in children as well as a general skin rash after exposure to water that is inadequately chlorinated could be in swimming pools

According to (Atwater, 2013). Individuals at danger of the infection are patients in health institutions especially those who are on breathing support equipment, patients with catheters and burns unit patients.

Pseudomonas infections are spread by health workers hands of those who are not adequately equipped and cleaned, however the infection can be prevented through proper control procedures as simply having hand hygiene. The treatment involve the use of antibiotics, however it is becoming extremely difficult to treat with antibiotics because the increasing antibiotics ressistance,it is a challenge to hospital personnel to effectively choose the right antibiotic for this requires that a specimen is got from a patient and analyzed at the laboratory.(Atwater), (2013).

The CDC usually conducts surveillance as well as outreach activities to help prevent and reduce infections or help avoid the infections so as to avoid the spread and resistance to antibiotics, the CDC centre works closely with the health institutions, to educate people on the dangers of this infection the centre will rapidly dispatch information to health institutions and to the public at large in the event that there is a problem or any scenario that increases the presence of this infection.The FDA as a shield protection to people will undertake all the measures necessary to prevent, inform or educate the general public or create awareness of any drug information.The Thursday plantation tea tree mouthwash was found to have failed a particular bacterial test and because of this natural organics did a recall. This recall was important so as to help reduce and avoid the spread of pseudomonas aerungosa for the general benefit of the entire nation. The chosen health institution is Hope Hospital and For the purpose of this project, the personnel assigned this task are;

Prof. Peter Jenkins-Project coordinator

Miss.KulipahDoh-Systems Analyst

Dr. Dinks Tiyiza-Dental Consultant

Mr. CyrilSamino-Safety Manager

The various roles of the team members are analyzed as below



Leads the work plan process activities

Coordinate activities of project team

Ensure adherence to the project management process Prof. Peter Jenkins-Project coordinator

Ensure the system design is well operational

Ensure the warning system is effective

Look into possible human error element in the system Miss.KulipahDoh-Systems Analyst

To determine the effects to affected patients

Offer referral advice

Keep clinical data

Advise on side effects Dr. Dinks Tiyiza-Dental Consultant

Ensure safety measures are put in place

Determine the relevant safety procedures

Ensure safety guidelines were followed Mr. Cyril Samino-Safety Manager

As a project coordinator with a PHD in project management Professor Jenkins is supposed to lead this team that is expected to create a plan for dissemination of this information to the rural population served by the healthcare system. Mr.KulipaDoh has a master in systems design from the University of Michigan and will bring valuable experience on this task by helping on the advice and use of health information using computers. As the principle dental specialist for the hope Hospital Dr.Tiyiza is leading the charge in employing health information technology (HIT) to improve patient safety and reduce medication errors he has a wide understanding of bacterial infections. Based on their experience these team members will perform a consultative role by providing advice and guidance as subject-matter experts.And mainly to perform a RCA in response to all sentinel happenings and based on the results of the RCA, the health institution to develop and implement an action plan that consists of improvements designed to trim down future risk of events and to scrutinize the effectiveness of those improvements.

Lastly the RCA team will attempt to know what happened, how it happened and why it happened and come out with recommendations to improve the situation. The aim of RCA is to unearth the principal cause(s) of an error by looking at enabling factors (e.g., lack of education), latent conditions (e.g., not checking the patient’s ID band) and situational factors (e.g., two patients in the hospital with the identical last name) that contributed to or enabled the adverse event. The team involved in the investigation asks a progression of key questions, e.g. what happened, why it happened, what were the most immediate factors causing it to happen, and why those factors happened.(Van der Sijs), (2013).

Safety warning

The Key principles of a good health Warning System is that it must be; timely i.e. this can be achieved by prioritization of safety concerns and timely evaluation and communication of these concerns throughout the regular vigilance time. It must also be sustainable, this involves the process, procedures and thresholds for communication that have been designed to ensure the scheme will be sustainable. The warning system need also be responsive and be able to spot and communicate safety concerns appropriate to stakeholders and integrate stakeholder opinion and finally it must be engaging so as to present functional advice targeted for diverse stakeholders.

The chosen patient safety warning is email alerts and SMS alerts, email alerts involve the use of the internet to disseminate information to the population through the individual email addresses of the patients, in addition to this the other alert system is through the SMS system where information is sent directly to the individual phone number these two systems allow for immediate passing of information.

According to (Backer, 1995).In integrating behavioral and systems strategies to change clinical practice. He argues that As SMS technology is the simplest and still the most resourceful technique to communicate. SMS messages become a principally appropriate means for communication in healthcare industry, as well. This functionality is the greatest answer for cases when patients fail to remember their appointments, the administration is not efficient, disabled people cannot communicate efficiently, etc. SMS messages are so easy and accessible for everyone but this simplicity gives its recognition and suitability. (Backer), (1995).

As (Borenstein, 2006) explains in his book, the Physician attitudes toward strategies to promote the adoption of medical evidence into clinical practice. He explains the operational ways how SMS works and he says that The SMS gateway forwards messages to the mobile network either through GSM or IP SMS interconnectivity. On the onset, there is a GSM modem attached to the PC by a data cable. The IP SMS connection basically means that the SMS gateway connects straight to the SMS hub of the mobile service provider of the Internet. If one wants to increase capacity one needs to just attach more than one GSM modem to the computer or switch to IP SMS connection and in this way dependable data is sent to all would be recipients(Borenstein), (2006).

Today clinicians, healthcare workers or administrators can employ SMS technology to improve healthcare services for patients and reduce their workload. As SMS messages are targeted messages, they are the exceptional ways for passing information (for example, campaign for smoking cessation), notification (e.g. about appointments), sending health information this has been indicated by (Rosenheck, 2009) Because SMS messages are sent only to the intended person, they ensure discreet messaging. Basically it means that only the intended person will get the information that is being passed over or about his health. Furthermore, SMS messages can be seen and read at any time and at any place, for that reason, they are by no means intrusive compared to telephone conversations.(Rosenheck), (2009).

The advantages and disadvantages of this are;

Medical alerts are instant and the information is relayed on a real-time basis this has the advantage of enabling the patients to instantly stop taking any of the recalled medication, there is no restriction of the time and place of receiving the text messages for they can be received at any place or time without any restrictions The other advantage being that the e mail alerts are detailed and pass the relevant information. The SMS alert system has the advantages of individual personal delivery of information and as well as instant delivery of the information. It is also a personalized message delivery system because access to email information is also restricted to the use of passwords

As a disadvantage email alerts and SMS alerts may fail because of system failure, as we are aware network services sometimes do fail, there is also the disadvantage of the individual mobile phones or the email accounts being switched off and therefore the information is not passed over to the intended recipient.

Patient confidentiality

It important to maintain patient confidentiality, patient confidentiality respects the patients’ rights. Individual who are not certified to the right of use of patient information are not supposed to be allowed to access that patients information. On approach one, the patient confidentiality will be maintained by allowing only authorized personnel to send the required information to the intended recipients .on approach two while for the SMS alerts the confidentiality could be maintained through having a proper individuals number verification system so that the information is sent to the intended recipient.

Dissemination Work Plan

The objective of a dissemination work plan is that the plan ought to provide information on the activities that are carried out and the benefits to society, patients and to the health community in general. Such a plan will define and detail the strategy and procedures necessary to reach the Intention of stakeholders, including participation in relevant international conferences. Communication with national agencies (including health management and health

Intervention, civil protection, environmental monitoring) will be established; below is the dissemination work plan for the patient safety warning about the Thursday plantation tea tree alert.

The Table displays how tools can be linked to the goal. Two ticks signifies “interested”, while one tick signifies “possibly interested

The table shows the Correlation of Target Audience and Products.

Primary Primary Secondary Tertiary Tertiary

(Public Health



Hospitals Regional,

Provincial and



Bodies Government


Agencies and


companies or

Health funds General




Associations Universities,






posters √√ √√ √√ √√


release √ √√ √√ √


papers √√ √ √√ √


articles √ √√ √ √ Web site √√ √√ √√ √√ √√

Events √√ √ √√

As described above, The Project members come from different specialization sectors the Hospital sector, information technology sector, Governmental Health institution organization, Universities, and Research Centers.

Every partner has its own group of contacts and links with individuals and organizations that could be interested (at every level) in the Project activity and product. It’s very essential to share these contacts to optimize the dissemination.

The effectiveness of this plan is that it will enable the patient population be able to know the actions that has been taken, the intended timeframe for this action and as well they would be able to know the person responsible for any action that they may require or any guidance and direction they may seek, by knowing about the interested parties and the other parties who are possibly interested it is easier to know where to concentrate on so as to effectively receive the desired results. The distribution of information must be effectively undertaken through the proper understanding of the dissemination plan.

According to( Zullig, 2013).In the Association between perceived life2013, the recommended approach to the executive leadership team is the SMS alert system for it is much more reliable. This is an electronic system on health record management it’s a real-time, point-of-care; patient-centric information resource for all health staffs it represents a major domain of health information technology (HIT). Of recent times, an electronic medical records system (EMR) or electronic health record (EHR) has been described as “a longitudinal electronic documentation of patient health details. “Information about the patient as a health difficulty list, orders, and medications, vital signs, past medical history, notes, lab results, and X- ray reports, among others are aptly described and well stored. The will generate a complete record of clinical patient encounter or episode of care and underpins care-related activities such as decision making, better management, and clinical reporting (Zullig), (2013).

Why the electronic notification system is recommended.

The choice of this method of electronic system is best because once the data is captured the system will be able to disseminate any information to the patients, at any time, additionally the SMS System and the E-Mail system will help in better health care by improving all aspects of patient care, i.e. including safety, effectiveness, patient-centeredness, communication, and education, more so by encouraging healthier lifestyles in the entire population, including increased physical activity, enhanced nutrition, evading of behavioral risks, and wider use of preventative care.

According to Clinton, (2004) he suggests that the system will provide improved efficiencies and lesser health care expenditure by promoting preventative medicine and improved coordination of health care services as well as help in superior clinical decision making by integrating the patient information from various sources. (Clinton), (2004)

More advantages abound i.e. the Electronic Health Records (EHR) and the capacity to exchange health information electronically can help supply elevated quality and safer care for patients while creating concrete enhancements for the hospital. EHRs help provider’s good managed care for patients and provide better health care by:

Providing true, up-to-date, and full information about patient safety the point of care

Steadily sharing electronic information with patients and other clinical staff.

Helping provide more effective patient diagnostics and reduction in medical errors

Enabling better, more reliable prescriptions to inpatients and outpatients

Helping encourage complete legible documentation and correct, modernized coding and billing of patient details

Improvement of patient data security and patient confidentiality

Fewer discrepancies in records and better health records management.

Patient confidentiality could be maintained through the following;

According to (Barrows, 1996). In his article Privacy, confidentiality, and electronic medical records the Journal of American Medical Informatics Association, pages3 (He argues that Electronic medical records require comprehensive shield at the national level. There is definitely a need for access to medical information and guard patients’ information from secondary users. Adding to that, patients should be given the alternative to place a disclosure restraint on their health records, (Barrows), (1996).

According to (Clinton, 2004).In his publication now is we ready to talk about health care? New York Times, He argue that legislation or an amendment to the patient protecting policy the doctor-patient relationship would make better the access and quality of care because without the assurance of privacy, patients may avoid medical care. Security and ensuring the integrity of healthcare data by preventing modification of information enables patient confidentiality. (Clinton), (2004).

According to (Michael, 2002). in Final Privacy Rule amendments he says that timely notifications, this will help ensure that patients discharged by from hospitals receive the exact care, at the correct time and in the precise place, so they can stay healthy and avoid return trips to the hospital, Ensure that all staff are aware of the confidentiality policy, Store all service users’ information in a locked place where only care staff can access. Not sharing service user’s information with any other individuals other then health staff. Unless there is an urgent situation where medical practitioners may need to access the information. Family and friends are not allowed to access this information without the service users express authority. As a priority Permission needs to be sought first. Maintaining privacy of patient information is an essential part of the health care profession. (Michael), (2002).


It is recommended that safety measures should be on a three level basis so as to incorporate all the healthcare stakeholders, government, clinics, hospitals, health staffs as follows

A Stage One “warning” alert issued to ensure healthcare personnel are made aware of the potential health issues at the earliest opportunity. This will allow healthcare organizations to assess similar risks in their own organizations, and take urgent action.

In the event that Stage One alert requires further action, the Stage Two “resource” alert ought to come next, with more in-depth information and advice. Stage Two alerts will include examples of good practice to tone down the risk that have been shared by providers following a Stage One alert; being allowed to access resources to help initiate new measures to lessen risks; and access to appropriate training programs.

If need be, a third stage “directive” alert ought to be issued, that requires organizations to verify that they have undertaken relevant actions and set up detailed steps to ease the risk. health givers ought to be issued with a checklist of intended actions, customized to the individual patients

Drug safety alerts do have a big potential to decrease the adverse drug effects and improve patient safety when properly implemented and utilized, this needs to be enhanced at Hope Hospital. The SMS and e- mail alert systems will effectively work with certainty to inform patients of any drug related recalls or alerts.

There should be a well functioning information technology system design that is effective and working properly so as to achieve the desired health information development and when all these is done the Competency 744.2.2: Leadership in Information Technology will be achieved, The knowledge of technology and nursing initiatives will be substantially improved, professional organizations, and the leadership must form strategies for enhancing the nursing information technology. Competency 744.2.5: about Information Security will me within reach. Competency 744.2.6: on Technology Supporting Quality Improvement must be greatly enhanced.


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