Section 1: Introductory Concepts
1. Discuss the roles of the Therapeutic Goods Administration (TGA) and the Pharmaceutical Benefits Scheme (PBS) in the provision of drugs.
The role of the Therapeutic Goods Administration (TGA) is to assess the therapeutic goods available in Australia, monitoring them and measuring the standards in which they are being made (PBS, 2011). Furthermore, the TGA ensures that therapeutic advances are made accessedible to the public quickly but safely. The Pharmaceutical Benefits Scheme (PBS) is a scheme that enmakes sures that Australians throughout the country are provided access to the medicines that they need, through the administration of health care plans and subsidisation of medications benefits. The PBS uses only TGA-approved drugs in its list of approved medications (PBS, 2011).
2. Discuss three issues that are currently impacting on the continued viability of the Pharmaceutical Benefits Scheme.
The viability of the PBS is being impacted upon by several factors at this time. Currently, the PBS costs nearly $6.5 billion a year to run, of which only $1.3 billion is being provided from co-payments sent by patients and the remainder being funded by the government (PBS, 2011) . Not only that, the government appears to be introducing random price cuts to the PBS services and medications, potentially making it harder for pharmaceutical companies to remain financially viable while selling these drugs to Australian health care providers (PBS, 2011). Finally, the PBS has been decreasing in value due to the lack of regular reviews on cost-effectiveness, thereby failing to keep up with shifting prices and costs of operation (PBS, 2011).
Section 2: National Medicines Policy and the Quality Use of Medicines
3. Discuss the key components of a national drug policy.
The key components of a national drug policy are equality and ease of access, medication quality and rational use of medicationsmany. The primary three things needed are access, quality and rational use –The overriding focus is that patients must be able to get the medicines they need at a price they can afford, those medicines must be made safely and cost effectively, and they must be used with effective instruction and promotion from health care professionals and the government (WHO, 2003). The quality assurance process is primarily undertaken by the TGA in Australia. The PBS scheme is designed to ensure that the financial status of the patient does not limit their access to the essential medications for them to maintain health. The rational use of medications is designed to ensure that the medications prescribed are used for the approved purposes and that there is no unnecessary prescribing of medications. This particularly applies to antibiotic prescription due to the increase in resistant strains of pathogens. The rational use of medication also ensures that the medication regimes are appropriate and that combination therapies are used to optimise patient outcomes. These strategies are designed to optimise patient outcomes which will, in the long term, decrease the burden on the health care system as a whole.
4. As a paramedic, identify your responsibilities relating to three NMP objectives regarding:
(a) The rational use of medicines.
(b) The regulation and quality assurance.
(c) The monitoring and evaluation.
A) As a paramedic, the my responsibilities regarding the rational use of medicines involves educating patients as to the responsible ways tocorrect use ofe medicines, including pointing out potential negative interactions, overdoses, and the risks inherent in using the medicines that they have. In emergencies, the patient has often taken the drugs already, in which case Ithe paramedic must learn how the medicines were used improperly in order to adequately treat them. It is also important to check that the patient understands what they are taking and why they are taking it. (National Medicines Policy, 20100).
B) As for rWith regards to regulation and quality assurance, the paramedicI must enmake sure that all medications utilised by their ambulance service are stored and their use recorded in accordance with the legislative requirements. This may take the form of completing a drug register for the use of an S8 category drug, like morphine, or completing a daily drug count of the S4 medications.the It is also the responsibility of the paramedic to complete an incident report if there are adverse reactions to the drugs administered to the patient or if drug errors occur. Adherence to drug checking procedures ensures the patient safety is maximised. Checking the medication of the patient to ensure thatmedicines that the patient has taken are it is not expired, are the correct dosage, and whether they should have been disposed instead of administered is another way in which paramedics can ensure quality medication use. The use of properly regulated medicines can help to diminish instances in which my expertise is needed (National Medicines Policy, 2000).
C) With monitoring and evaluation, mythe responsibilities of the paramedic are very similar to the first two objectives; as contact with the patient is usuallyI can only see the patient after they have take the drugs, The paramedicI hasve a responsibility to report to the receiving facility any concerns about the patient’s medication regime.no say over the monitoring and evaluation process. The only thing I can do in these instances is to talk to the patient (if possible) and diagnose or possible adverse drug reactions that could have been prevented through a post-market monitoring system. The paramedic also has a responsibility to report any medication errors or near-miss events. (National Medicines Policy, 2000).
5. From your paramedic experience, discuss current work related practices that support the Quality Use of Medicines. Identify areas which you consider do not currently promote QUM and discuss strategies you will try to put in place to support the Quality Use of Medicines.
The responsibilities of key partners in the Quality Use of Medicines (QUM) include determining the source of problems and their contributing factors, as well as contributing to the discussion of what risks and benefits are inherent to all medicines (National Strategy for Quality Use of Medicines, p. 10). As a paramedic, there are many of these responsibilities that are not being fulfilled in their particular way. Many instances exist in my field where paramedics are not consulted by health care providers and pharmaceutical companies in order to learn more about the situations that patients are in when they take a certain drug, especially one that has not been regulated properly. I could contribute to these discussions by providing instances where paramedics such as myself could bring our expertise to those who create and regulate medication; for example, contacting pharmaceutical representatives after having experienced an unexpected side effect in a patient of a drug that they manufacture and informing them. This would allow all sides of the discussion to contribute to QUM.
Another responsibility involves helping people know as much about their medicines as possible by informing them in all aspects of what they are taking (National Strategy for Quality Use of Medicines, p. 10). During my paramedic care process, once I have patients stabilized and it is determined they do not need to go to the hospital immediately, I learn as much as possible about the drug that they took and the circumstances surrounding it. From there, I can determine where the patient may have gone wrong in their dosage, and inform them appropriately. There is potentially more I could do, including providing a greater level of warning regarding possible hazards and negative drug interactions.
Section 3: Drug Information Resources for Australian Health Care Professionals
Using a suitable online database accessed through Page (preferably PubMed or Medline):
Determine the MeSH term for your profile drug.
Record the outcome by incorporating a screen capture of the entered search and its result in your workbook (you can copy and paste the search or send a page copy from the screen )
Identify all subheadings (e.g. classification) that you may usefully incorporate in a search for your profile drug. Also note any restrictions that you may apply to this search. Record the outcome by incorporating a screen capture of the selected subheading and the result in your workbook.
In the same search window:
Enter the MeSH term for one of the major therapeutic indications for your profile drug as a second search term.
Record the outcome by incorporating a printout of the selected subheadings and result in your workbook.
MeSH term: Albuterol
Possible Classifications: Receptors, Adrenergic, beta-2
7. As a paramedic, it is essential to have a personal list of appropriate drug information resources. These may include textbooks, practice guidelines, journals and online material.
In your workbook:
List the drug information resources that you have identified and consider appropriate (e.g. Therapeutic Guidelines).
Provide an explanation of the reasons for including each resource in your personal list.
Identify the possible limitations of each of these drug information resources.
Resources that I use to determine drug information on what I need are those I consider comprehensive, convenient and readily available to me. An online information resource I typically use is the Australian Drug Foundation’s DrugInfo website (druginfo.adf.org.au), a service that provides the adequate information on illegal drugs (alcohol, heroin, cocaine) when I need them. When a patient has taken illegal drugs and is having problems with them, I can use this website (and its appropriate mobile application) to instantly pull up relevant detailed information on how it metabolizes, what constitutes an overdose, and potential treatments in an emergency.
The Ambulance Victoria Paramedic Guidelines have always been a good-to resource for me, as they provide a comprehensive list of the various prescription drugs that are typically found in the vast majority of medical emergencies (Ambulance Victoria, 2008). Information like each drug’s pharmacology, metabolism, primary emergency indication, and the like are available in a simple, easy-to-read format, allowing for quick absorption of the information required. (Ambulance.vic.gov.au). If anything, there could stand to be more drugs included in the list, so as to provide for rarer drug complications that could be encountered, but as it stands now it is a very comprehensive resource in its own right.
Section 4: Over-the-Counter & Complementary and Alternative Medicines
8. Locate an Australian licensed CAM preparation of melatonin either in your own medicine cupboard, local pharmacy, or health food shop. Record the name of the product, its melatonin content, the sponsor and any Aust L/R number.
Determine and record whether melatonin is an ‘over the counter’ medication, ‘complementary alternative medicine’, or ‘prescription only’ medication in Australia.
Determine and record the trade name(s) for this product, the melatonin content and the manufacturer.
Determine and record the regulatory classification (schedule) for this product.
Determine and record whether the information provided by the manufacturer concerning safe and efficacious use is acceptable in terms of paramedic practice.
Product Name: Melatonin 5mg (Fast Dissolve) 90 Strawberry Flavoured Tablets
Melatonin Content: 5mg
No Aust L/R number (homeopathic)
Melatonin is a complementary alternative medicine in Australia, due to its status as a homeopathic supplement.
Regulatory ClassificationDrug Schedule: 1 dose per 24 hours
Given the product information, and the nonspecific nature of that information, I would not recommend this particular product in a paramedic practice, particularly as it states there is no recommended dosage and it is not used for the management of any emergency condition that a paramedic is likely to encounter (BioVEA, 2011).
In the instance of the exhausted parent, I would first attempt to see if they can develop non-medicated methods of managingcuring the insomnia in the baby, such as decreasing external stimuli or certain kinds of food or activity scheduling. EvenOnly if those failed I would I not consider the Circadin route; my decision is based on the uncertain nature of how such a dose of melatonin would affect the child, and whether or not the sleep disorder was affecting the child negatively, or just the exhausted parent.There is insufficient evidence relating to melatonin administration in children to ensure this practice is safe. If it is just the parent that is being affected, I would instead seek out ways to help the parent address their own insomnia and presumed sleep disorder.
9. List the conditions for which the herb is used.
List a summary of the recommendations you would give a patient who consults you about the advisability of using this herbal medicine:
In the general case as a dietary component.
In the situation where the patient has a condition for which the herb is advocated.
St. John’s wort is typically used for patients who are dealing with anxiety and depression, as well as nervous unrest (De Smet, 2002).
If I were to give advice to a patient who wanted to use St. John’s wort as a dietary component, I would make sure that they were educated on the real uses for the drug (anxiety, depression), so that they are sure that their insistence on using St. John’s wort is founded on fact. I would also explore what other strategies they are using to manage their anxiety or depression and recommend other resources, like psychologists or counsellors.
For those patients who want to use St. John’s wort, for anxiety, depression or nervous unrest, I would ask them questions as to the level of their condition, and how it is affecting them. I would ask them what other supplements or medicines they are taking, and advise them not to take it for more than 8 days at a time. I would warn them about the potential loss of efficacy inof their conventional medicines that may occur with St. John’s wort, as well as the statistically insignificant levels of effectiveness in treating its advocated condition, especially when compared to placebo (De Smet, 2002).
11. Karli is a 22-year-old asthmatic woman (using a preventive DPI and a reliever MDI) who has decided to use CardiprinR in an attempt to prevent travellers' DVT on an 18-hour plane trip.In your response you should identify all considerations in regard to the potential risks and benefits of Karli's decision to use CardiprinR in this setting.
In Karli’s situation, she must consider the 21% chance of aspirin induced asthma that could occur as a result of taking Cardiprin along with her asthma medication (Jenkins & Costello, 2004). The risks include the onset of an asthma attack as a result of taking the aspirin; however, given the likelihood of travel provoked deep vein thrombosis (DVT), there is sufficient cause to want to take the Cardiprin to diminish the chances of that occurring, particularly given the hazardous nature of DVT (Jenkins and & Costello, 2004). Since she uses a preventive inhaler as well, there will perpetually be some asthma medication in her system, thus deincreasing her risk of aspirin induced asthma (Jenkins & Costello, 2004). I would r4ecommend the use of alternative strategies to prevent the occurrence of DVT rather than take the risk of aspirin induced asthma mid-flight.
Ambulance Victoria, 2008, November 19. Drug Interaction Guidelines. Ambulance Victoria. Retrieved September 20, 2011, from www.ambulance.vic.gov.au/Media/docs/Drugs2-a279be3d-9808-4a8d-9047-7117f5e7b6a2-0.pdf
De Smet, P., 2002. Herbal Remedies. National English Journal of Medicine, 347(25), 2045.
Jenkins, C., & Costello, J. (2004). Systematic review of prevalence of aspirin induced asthma and its implications for clinical practice. BMJ, 328, 434.
MELATONIN 5mg (Fast Dissolve) 90 Strawberry Flavoured Tablets by BIOVEAÂ® - BIOVEA AUSTRALIA., 2011. BIOVEA. Retrieved September 20, 2011, from http://www.biovea.com/au/product_detail.aspx?NAME=MELATONIN-5mg-Fast-Dissolve-90-Strawberry-Flavoured-Tablets&PID=2561&OS=204#tab-content-1
Medicines Australia, 2009. PBS Reforms - Are They Working? The Evidence. Medicines Australia.
National Medicines Policy, 20100. Australian Department of Health and Aging, 1, 1-10.
Pharmaceutical Benefits Scheme (PBS), 2011, January 6. Department of Health and Ageing. Retrieved September 20, 2011, from http://www.health.gov.au/pbs
The national strategy for quality use of medicines, 2002. Canberra: Commonwealth Dept. of Health and Ageing.
WHO, 2003. How to develop and implement a national drug policy. WHO Policy Perspectives on Medicines, 6, 1.