Welcome to the December edition of i2P-Information to Pharmacists.
As we wind down in 2013 for the holiday period we will be filing some updates, but at a little more leisurely pace.
Where has the year gone?
Certainly the rate of change for 2013 has been more than hectic and there has been little time to organise thoughts and set appropriate directions.
This is the season for hard negotiations for the 6CPA but there is little left to squeeze.
Pharmacy has had the equivalent of bariatric surgery.
Government has taken it all, as usual.
As current price changes work their way through the pharmacy cash flow cycle, for some there will be insufficient- and heartburn.
Crunch time is that there will be more bankruptcies over 2014.
Media reports that some pharmacies have received free shop refits as a form of payment for purchasing a specific generic drug range is certainly not obvious, as the average pharmacy is in need of some renovation or repair and looking a bit jaded.
Volume 1 Number 1
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Volume 1 Number 5
Volume 1 Number 6
Volume 1 Number 7
Volume 2 Number 1
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Volume 2 Number 4
Volume 2 Number 5
Volume 2 Number 6
Volume 2 Number 7
Volume 2 Number 8
Volume 2 Number 9
Volume 2 Number 10
Volume 2 Number 11
Volume 3 Number 1
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Volume 3 Number 3
Volume 3 Number 4
Volume 3 Number 5
Volume 3 Number 6
Volume 3 Number 7
Volume 3 Number 8
Volume 3 Number 9
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Volume 3 Number 11
Volume 4 Number 1
Volume 4 Number 2
Volume 4 Number 3
Volume 4 Number 4
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Volume 4 Number 7
Volume 4 Number 8
Volume 4 Number 9
Volume 4 Number 10
Volume 4 Number 11
Volume 5 Number 1
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Volume 5 Number 6
Volume 5 Number 7
Volume 5 Number 8
Volume 5 Number 9
Volume 5 Number 10
Volume 5 Number 11
Editing and Researching news and stories about Australian and International Pharmacy Issues
Daniel Hussar publishes a newsletter in the US called the Pharmacist Activist and is very involved with pharmacy issues and direction.
In his March edition he discusses a submission presented to government supporting a wider range of drugs be available without prescription, but under pharmacist supervision.
This process has only just begun here in Australia, with "statins" and emergency contraception selected as the first two items.
Alarmist press releases by the Australian Medical Association as well as political lobbying to remove this useful extension is being conducted, along with moves to have non-medical prescribing banned.
It is interesting to note how similar doctor attitudes in the US and Australia are, and readers are referred to the comments in the last paragraph about not tolerating "turf battles".
Return to home
I commend the Food and Drug Administration (FDA) for convening this hearing to receive comments and opinions on a topic that I believe represents a very important opportunity to improve health care for millions of individuals. The perspectives and recommendations I am providing are based on my responsibilities as a pharmacist and faculty member at the Philadelphia College of Pharmacy that include teaching our required Nonprescription Therapeutics course, having taught every area of drug therapy, and having written and spoken about every new drug marketed in the United States in the last 40 years.
As stated in the Federal Register announcement of this public hearing, "Undertreatment of many common diseases or conditions in the United States is a well recognized public health problem." Millions of Americans do not see a physician or other prescriber unless they are experiencing symptoms they can no longer tolerate. Millions of Americans use unregulated herbal and other natural products, as well as dietary supplements, for which there is no evidence of effectiveness and safety. It is my strong conviction that there are actions that can be taken that will greatly increase access to, effectiveness, and safety of a significantly larger number of medications. These actions will result in better health care that is provided in an efficient manner, and will also reduce the burden on emergency rooms and many physician providers.
The responsibilities of pharmacists currently include the assessment of the type and severity of symptoms described by patients, decisions whether to refer a patient to a physician/emergency department or to recommend the use of nonprescription medications, and, in the latter situation, to provide the counseling and monitoring needed to assure the appropriate management of the condition. Pharmacists have the knowledge and accessibility to assume a greatly expanded role in the appropriate use of medications. The topics being addressed at this hearing are particularly important and timely with respect to their relationship to the recent Report to the Surgeon General, Improving Patient and Health System Outcomes through Advanced Pharmacy Practice.
My comments will primarily focus on the identification of medications that currently require a prescription, but which I would recommend for availability without a prescription in a pharmacy with the consultation of a pharmacist. The following medications are examples of those that I recommend for nonprescription availability from a pharmacist.
1. Epinephrine auto-injector for severe allergic reactions.
2. Albuterol for oral inhalation for acute asthma attacks.
3. Naloxone for narcotic overdosage.
Epinephrine, albuterol, and naloxone are used for the treatment of very serious and even life-threatening experiences. These events require emergency treatment and often occur in an area and/or at a time in which the local pharmacy is more accessible than a physician or a hospital.
4. Triptans (e.g., sumatriptan) for migraine headache.
Migraine attacks can be severe and disabling for some patients. The sooner the use of effective treatment can be initiated, the greater the likelihood of relieving symptoms on a timely basis and preventing worsening of the migraine attack.
5. Oseltamivir for influenza.
Oseltamivir is one of a very small number of medications that is effective for the treatment of influenza. However, for this drug to be optimally effective, it is very important that treatment be initiated as soon as possible following the onset of symptoms (within two days). Patients who experience influenza symptoms should be provided the fastest access possible to medication that might be of significant benefit.
6. Statins (e.g., atorvastatin, pravastatin, simvastatin) for hyperlipidemia.
Many individuals, rather than seeing a physician and receiving prescribed medications for high cholesterol concentrations, are purchasing dietary/nutritional supplements such as red yeast rice in which a statin is the primary active ingredient. These products have not been evaluated in clinical studies, there are little or no safety data, and there is often no assurance of standardization of active ingredients. In these situations, it is highly preferable to have nonprescription pharmacy availability of statins that have been extensively studied, have a known safety profile, and will be monitored by a pharmacist.
7. Diuretics (e.g., hydrochlorothiazide) for edema and high blood pressure.
8. Tamsulosin for benign prostatic hyperplasia.
9. Agents for overactive bladder (e.g., tolterodine).
10. Celecoxib for pain and inflammation.
11. Cyclobenzaprine for musculoskeletal symptoms.
12. Ramelteon for insomnia characterized by difficulty in falling asleep.
13. Corticosteroids (e.g., fluticasone propionate) for intranasal administration for allergic rhinitis.
14. Montelukast for allergic rhinitis.
15. Agents for smoking cessation (nicotine nasal spray, nicotine inhalation system, varenicline).
More than 440,000 Americans die each year as a result of smoking-related illnesses. Although some smokers have been successful in quitting with the use of nonprescription nicotine replacement therapy (gum, lozenge, patch) or other strategies, others have not had a successful experience with these products. There are many smokers who want to quit but who will not set up an appointment with a physician to discuss other options. For these individuals, the nonprescription availability from a pharmacist of nicotine nasal spray, nicotine inhalation system, and varenicline will provide a pharmacist-monitored opportunity for a successful effort to stop smoking. It is an unacceptable irony that only proof of age is required to purchase a dangerous product like cigarettes whereas a prescription is required to obtain certain of the products that will help individuals stop smoking.
Attention should also be given to revision of the labeling of the nicotine replacement therapy formulations that are currently available without a prescription. For example, the labeling for these products contains the statement, "Do not use if you continue to smoke..." Although the goal is for the individual to not smoke at all, some are not able to resist the craving to smoke but do so on a less frequent basis. Because they have not followed the specific instructions, they may conclude that the treatment has not been successful and discontinue it. However, a substantial reduction in the number of cigarettes smoked should also be considered a positive result and a source of encouragement to stop smoking completely. The labeling for the nonprescription nicotine replacement therapies also includes a statement that individuals should not use a second nicotine-containing product concurrently. However, this statement may actually preclude the use of what, for some individuals, may actually be the best strategy to stop smoking, that is to use the patch to provide a sustained low concentration of nicotine and the lozenge or gum to provide a prompt, but brief, action when cravings to smoke are experienced.
In addition to these examples, there are also other prescription medications that can be considered for nonprescription availability from a pharmacist. With certain of the agents identified, there will be a need for specific parameters and guidelines to assure appropriate use and these will vary depending on the medication. However, this should not be reason to delay consideration of medications for which a change in status can be made quickly.
The increase in the number of nonprescription medications that are available from a pharmacist will not only result in increased patient access to helpful medications, but will also make them available on a more cost-effective basis. I also anticipate that there will be increased communication, collaboration, and referrals between pharmacists and prescribers as they fulfill their individual responsibilities for the patients being served.
Neither the FDA nor the public should tolerate "turf battles" among the health professions as these issues are addressed. There is much more to be done in improving the scope and quality of health care and preventing drug-related problems than all of the health professions are doing now. We can and must do much better. The opportunities that the FDA is considering are ones in which all participants can "win," and I urge your bold and prompt action.