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Written By: Abier Hamami. RPH. CPHQWhat are Bisphosphonates?
Bisphosphonates are a family of drugs used to prevent and treat Osteoporosis, and other bone diseases as Paget¢s disease. Among them are Alendronate (Fosamax ®), Etidronate (Didrocal ®) and Risedronate (Actonel ®). Also they are used in bone metastasis (with or without hypercalcemia) and in multiple myeloma as Pamidronate (Aredia ®) or Clodronate (Bonefos ®).

How do they work?
Bisphosphonates bind to the surfaces of the bones and slow down the Osteoclasts (bone-eroding cells). This allows the Osteoblasts (bone-building cells) to work more effectively. Thus increase bone density and prevent fractures.

Who can take them?
Bisphosphonates are used for many indications, among them prevention and treatment of Osteoporosis in: postmenopausal women, and men and women of any age who are using steroid medications.

What are the instructions for their use?
They should be taken early in the morning 1/2 hour before eating or 2 hours after with a full glass of water( avoid drinking juice, mineral water, and coffee). Taking the pill sitting or standing minimizes the chances of the pill being lodged in the esophagus. Patients should also remain upright and avoid lying down for at least 30 minutes after taking the pill to avoid reflux of the pill into the esophagus.

What is their frequency of use?

Bisphosphonates are available in 2 forms; oral and injectable, and could be used daily, weekly, monthly, or every 3 months according to their strength, form, and clinical condition.

What are their side effects?
The most common side effects are nausea, abdominal pain and loose bowel movements. There is a small risk of ulcers in the esophagus especially if taken incorrectly. They can also cause bone, joint &/or muscle pain and sometimes severe enough to stop taking the drug.

In extremely rare cases, some have been linked to a breakdown of the jaw bone following dental work (Osteonecrosis of jaw bone).

What are their contra indications?

They are contraindicated in:

Women who are pregnant or planning pregnancyRenal insufficiency Low serum calciumOsteomalacia/Rickets ( Vitamin D deficiency)Patients with serious esophageal diseasePatients at bedrest who can't stay upright for an hour

They should be used with caution in:

Patients with abnormal white blood cells Patients with high parathyroid hormone PTHChildren (no long-term safety data)

What about taking other medications?

Calcium, iron supplements, vitamins with minerals, or antacids containing calcium, magnesium, or aluminum can reduce the absorption of Bisphosphonates, thereby resulting in loss of effectiveness. Therefore, it is very important that your doctor knows if you are taking any other medicine. This includes prescription and non-prescription medicines as well as vitamins and herbal supplements.

August 16 -2005

References:

http://courses.washington.edu/bonephys/opbis.html
http://www.aafp.org/afp/20000501/2731.html
http://www.osteoporosis.ca/english/About%20Osteoporosis/Drug%20Treatments/Bisphosphonates/default.asp?s=1
http://www.webmd.com/hw/osteoporosis/hw130875.asp
http://www.medscape.com/viewarticle/448205

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Category: English Contents

Prepared by: Wafaa Shwaiky. RPH

 

Introduction:
For thousands of years, ethics have been recognized as an essential requirement for any profession. The ancient codes of ethics have to some extent stressed this requirement.
The Western medical code of ethics have evolved from the ancient Hippocratic Oath and western principles of gentlemanly honor. Standards of professional behavior were codified in the late17th century and officially adopted by medical associations as early as the mid-19th century.

The Islamic medical ethics are primarily based on the Qur'anic ethics which stand out a perfect model for all mankind, all professions, and in all time.

The origins of medical and research ethics are examined below:

Hippocratic Oath (400 BC)
Hippocrates (Born in Greece 460 BC) is known as the Father of Medicine. He founded a medical school and developed an Oath of Medical Ethics for physicians to follow.

The Hippocratic Oath has formed the basis of more recent healthcare oaths taken by graduates as they begin their practice.

The chief tenants of this Oath are:

  1. Honour the instructors of the medical arts.
  2. Pass on the Art only to those bound by the Oath.
  3. Practice for the benefit of patients, "do no harm".
  4. Avoid deadly medicine or substance to produce abortion
  5. Enter homes for the benefit of the patient.
  6. Abstain from mischief and corruption.
  7. Respects the Doctor-patient confidential relationship.

Thomas Percival (1740-1804)
An English physician established in 1794 a code of medical ethics for physicians that were adopted by American doctors and later by the American Medical Association (AMA). This was the first code of ethics to be adopted by a professional organization replacing the variously interpreted ethics of gentlemanly honor and thus providing a standard of behavior for medical professionals.

American Medical Association ( AMA) Code of Ethics (1846)
The (1980) version of AMA code of ethics has seven articles, while the updated version (2001) contains nine articles. The additional articles in the current version stress physician’s responsibility, and support of universal access to medical care. In addition, the latest version added all required provisions regarding a commitment to medical education and a responsibility for the improvement of public health. The AMA code has some other features like:

  1. The respect of the law.
  2. The respect of the patient’s rights.
  3. The respect of colleague’s rights.
  4. The respect of patient’s privacy and confidentiality.
  5. The dedication, competence, and compassion.
  6. The honesty and duty to report fraud or deception.
  7. The continued education, study, and consultation with other professionals.
  8. The freedom of association and environment in the practice of the Art.
  9. The responsibility to make efforts to improve the community

Nuremberg Code (1947)
Nuremberg code is a result of the post World War II (WWII) trial of a group of Nazi doctors, for crimes against humanity committed in the name of research. This code represents the starting point in discussions about the ethical treatment of human subjects.

German doctors, performed macabre medical experiments under the disguise of scientific research in Nazi concentration camps where prisoners were used without concern for their welfare.

The Nuremberg Code is a set of ten principles outlining the ethics of medical research and ensuring the rights of human subjects.

The principles include the following:

  1. Informed, voluntary consent.
  2. Research must be purposeful and necessary for the benefit of society.
  3. Research must be based on animal studies or other rational justification
  4. Avoidance and protection from injury, and unnecessary physical and mental suffering
  5. Risks to the subject shall not be greater than the humanitarian importance of the problem
  6. Investigators must be scientifically qualified.
  7. Subject may terminate the experiment at any time.

Declaration of Geneva (1948)
The World Medical Association adopted this oath after the atrocities committed in the name of research in Nazi concentration camps. Key features of this code are:

Service to humanity, respect and gratitude for instructors, conscience and dignity in the practice of the Art, dutiful attention to the health of the patient, colleagues and traditions of the Art , practice in accordance with the laws of humanity, respect for human life from conception , and duty takes precedence over racial, religious, political or social prejudices.

Declaration of Helsinki (1964)
The first publication of this declaration was in 1964, as a response to unethical medical experiments of the Nazis during WWII. It has been revised several time since 1964, the latest revision of the document was in 2000 and states the following principles :

  • The well being of the human subject should take precedence over the interest of science 
    and society.
  • The doctor should only act in the patients best interest and that the health of the patient is 
    the first concern.

Many of declaration’s principles are incorporated in national research regulations. On the other hand the revised document discusses the use of placebo, recommends that ethics committees have the obligation to monitor ongoing trials, and requires that researchers disclose to subjects details of funding and possible conflicts of interest. Finally, there is a recommendation that publishers decline studies not carried out in accordance with the declaration.

Islamic medical Ethics 
The Qur'anic ethics stand out as a perfect model for all mankind, all professions, and all time. It guidelines for mankind’s behaviour and attitude, both at the personal and professional levels.

This standard of moral and ethical values should guide the Muslim health care practitioners in their private life and while conducting their professional life as well.

Muslim pharmacists must believe in God and in Islamic teachings and practice, both in private and public life. They must be grateful to their parents, teachers, and elders. They should be humble, modest, kind, merciful, patient, and tolerant, and they must follow the paths of the righteous and always seek God's support.

Pharmacists equipped with the above-listed virtues are capable of complying with the following professional requirements needed:

1- Knowledge: Muslim pharmacists must acquire, maintain, abreast of current medical knowledge, and continuously improve their skills.  God makes it clear in the Qur'an" … Say: Are those equal, those who know and those who do not know?… "  Qur'an: 39/9.

Therefore the believer is encouraged to always seek knowledge.

"... Say: O my Lord. Advance me in knowledge." Qur'an: 20/114.

2- Respect of the law: Muslim pharmacists must respect law, order and legal rules regulating their profession. The following verse reflect this concept "Oh you who believe: Obey God and obey the Apostle, and those charged with authority among you..." Qur'an: 4/59.

3- Professional commitment to the health and well-being of patients life:  As a health care providers, pharmacists must understand the importance of patient’s health and well-being. God states this issue clearly in the Qur’an in the following verse:  " ... Whoever kills a human being not in lieu of another human being nor because of mischief on earth, it is as if he has killed all mankind; and whoever saves the life of a human being, it is as if he has saved the life of all mankind..." Qur'an: 5/32.

4- Pharmaceutical advices: Pharmacists should offer all pharmaceutical advices needed with consideration for patient educational level and age.

5- Communication: Pharmacist must adopt an appropriate manner of communication with patients and colleagues.

6- Patient confidentiality: Pharmacists must protect the patient's confidentiality, reflecting God's description of the believers: "Those who faithfully keep their trusts and their covenants." Qur'an: 23/8.
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Written By: Abier Hamami.RPH. CPHQWhat is Isotretinoin?

Isotretinoin ( trade names : Accutane/ Roacutane and more) is an oral derived form of vitamin A. used for the treatment and prevention of severe (Nodular) acne that is resistant to more conservative treatments such as creams, drying agents, and topical or oral antibiotics. The Food and Drug Administration approved isotretinoin for nodular acne in 1982.

What is the most important information you should know about Isotretinoin?
Isotretinoin can cause serious side effects. Before starting it, discuss with your prescriber how bad your acne is, the possible benefits of Isotretinoin, and its possible side effects, to decide ifIsotretinoin is right for you. Your prescriber will ask you to read and sign a form or forms indicating you understand some of the serious risks of it.

Women must NOT become pregnant while taking Isotretinoin, or for 1 month after stopping it to allow the body to get rid of it. Isotretinoin can cause severe birth defects in babies of women who take it while they are pregnant, even if they take it for only a short time

What should you discuss with your physician before taking isotretinoin?

Before taking isotretinoin, tell your physician if you have:A plan to become pregnant or actually are pregnantA personal or family history of mental problems including depression, suicidal behavior, or psychosis (loss of contact with reality, hearing voices, or seeing things that are not there);Diabetes;Asthma;Heart disease;Osteoporosis (bone loss) or weak bones;Anorexia nervosa;High cholesterol or triglyceride levels (types of fat) in the blood; orLiver disease.

You may NOT be able to take isotretinoin, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

How does it work?
The exact mechanism of action of isotretinoin is not known; however, it may reduce acne by reducing the secretion of sebum (the oily substance secreted by The sebaceous glands which found in the skin of mammals). If less sebum is secreted it is likely that there will be less inflammation and keratinization.

How well does Isotretinoin work?

Most dermatologists believe it is a remarkable acne medication .For severe acne, isotretinoin cures approximately 35%-38% of patients after one course of treatment, and 70% of those who takeisotretinoin experience long-term remission. Adult women have higher relapse rates than teenagers. Also if you have very oily skin and giant blackheads, are a younger teenager, or have acne on your chest and back, then you have a greater chance of having a relapse of your acne.
Most dermatologists believe it is a remarkable acne medication.

What is the recommended dose?
The recommended dose of isotretinoin is 0.5 to 2 mg per kg of body weight daily. The daily dose usually is administered in two divided doses.

What is the duration of treatment?
One course of treatment will take on average, 4-6 months. Some people's acne clears quickly while in others improvement is gradual. Multiple courses can be taken.

How should you take it?
Isotretinoin should be taken with a meal. Swallow the capsules with a full glass of liquid to prevent the medication inside the capsule from irritating the lining of your esophagus (connection between mouth and stomach). For the same reason, do not chew or suck on the capsule.

What should you avoid while taking Isotretinoin?

1. For women:

Do not get pregnant. Isotretinoin is harmful to the fetus and therefore should not be used during pregnancy. Women of childbearing age must have two negative pregnancy test results before therapy is started, and a pregnancy test must be conducted during each month of therapy. Effective forms of birth control( 2 methods) must be used during therapy, and pregnancy should be avoided until at least one month after stopping isotretinoin.Do not breast feed while taking isotretinoin and for 1 month after stopping it.Do not use birth control pills that do not contain estrogen ("minipills"). They may not work while you take isotretinoin. Ask your physician or pharmacist if you are not sure what type you are using.Do not take drugs or herbal products while using birth control pills before consulting your physician. Because certain drugs or herbal products may make birth control pills not work as effectively. Example: St. John’s Wort (a herbal supplement )

2. For general:

Do not give blood while you take isotretinoin and for 1 month after stopping it. If someone who is pregnant gets your donated blood, her baby may be exposed to isotretinoin and may be born with birth defects.Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, while you are using isotretinoin and for at least 6 months after you stop. It can increase your chance of scarring from these procedures. Check with your physician for advice about when you can have cosmetic procedures.Avoid sunlight and ultraviolet lights as much as possible. Tanning machines use ultraviolet lights. isotretinoin may make your skin more sensitive to light.Do not share isotretinoin with other people., and do not advice others to take it without consulting their physicians.Use caution when driving a vehicle at night. Isotretinoin can cause decreased night vision. The onset of decreased night vision may be sudden.

What are the possible side effects of Isotretinoin?

Accutane can cause serious side effects as:

Birth defects, premature births, and death in babies.Serious mental health problems. Stop taking Isotretinoin if you have depression including feelings of sadness, crying spells, irritability, changes in sleep patterns, unusual tiredness, trouble concentrating, loss of appetite, and/or suicidal thoughts or other mental problems;Serious brain problems. It can increase the pressure in your brain. This can lead to permanent loss of sight, or in rare cases, death. Stop taking isotretinoin and call your prescriber right away if you get any of these signs of increased brain pressure: bad headache, blurred vision, dizziness, nausea, or vomiting. Also, some patients taking isotretinoin have had seizures (convulsions) or stroke.Abdomen (stomach area) problems. Stop taking isotretinoin and call your prescriber if you get severe stomach, chest or bowel pain, trouble swallowing or painful swallowing, new or worsening heartburn, diarrhea, rectal bleeding, yellowing of your skin or eyes, or dark urine.Bone and muscle problems. isotretinoin may affect bones, muscles, and ligaments and cause pain in your joints or muscles. Tell your prescriber if you develop pain, particularly back pain or joint pain or muscle pain.Hearing problems. Stop using isotretinoin and call your prescriber if your hearing gets worse or if you have ringing in your ears.Vision problems. Stop taking isotretinoin and call your prescriber right away if you have any problems with your vision or dryness of the eyes that is painful or constant.Lipid (fats and cholesterol in blood) problems. Return to your prescriber for blood tests to check your lipids and to get any needed treatment. These problems generally go away when isotretinoin treatment is finished.Allergic reactions. Stop taking isotretinoin and get emergency care right away if you develop hives, a swollen face or mouth, or have trouble breathing, fever, rash, or red patches or bruises on your legs.

Also isotretinoin may cause other problems. Tell your prescriber if you have trouble breathing (shortness of breath), are fainting, are very thirsty or urinate a lot, feel weak, have leg swelling, convulsions, slurred speech, problems moving, or any other serious or unusual problems. Frequent urination and thirst can be signs of blood sugar problems.

Less serious side effects are:

The common less serious side effects of isotretinoin are dry skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds. People who wear contact lenses may have trouble wearing them while taking isotretinoin and after therapy.

Sometimes, people’s acne may get worse for a while. They should continue taking isotretinoin unless told to stop by their prescriber.

What about taking Isotretinoin with other drugs?

Do not take vitamin supplements containing vitamin A. This may increase your chance of getting side effects.Do not take tetracycline antibiotic such as tetracycline, minocycline, doxycycline, demeclocycline, or troleandomycin . Use of both drugs together can increase the chances of getting increased pressure in the brain.Do not take other acne medications unless otherwise directed by your doctor. They may interfere with the treatment or increase irritation of the skin.Tell your doctor if you are taking carbamazepine (a drug for seizures named: Tegretol, Carbatrol, Epitol). You may require a dosage adjustment or special monitoring during treatment.Tell your doctor if you are using steroids. These drugs may weaken your bones.

In general, drugs other than those listed here may also interact with isotretinoin. Talk to your doctor or pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

What should be done if a dose is missed?
If a dose is missed, just skip that dose. Do not take 2 doses the next time.

What happens if you overdose?

Seek emergency medical attentionSymptoms of an isotretinoin overdose include vomiting, abdominal pain, flushing of the face, inflammation of the lips, headache, dizziness, and clumsiness.

How should you store Isotretinoin?

Store isotretinoin at room temperature, between 59° and 86°F. Protect from light.Keep isotretinoin and all medicines out of the reach of children.

References:

http://www.fda.gov/CDER/DRUG/infopage/accutane/medicationguide.htm
http://www.rocheusa.com/products/accutane/
http://www.medicinenet.com/isotretinoin/article.htm
http://www.drugs.com/accutane.html
http://www.skinsite.com/info_accutane.htm
http://www.aocd.org/skin/dermatologic_diseases/accutane.html
http://www.acneguide.com/acus_treat/isotretinoin/isotretinoin_accutane.html

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Category: English Contents

Prepared by: Wafaa Shwaiky. RPH.

The Pharmaceutical code of ethics is generally evolved from the medical code of ethics. They include guidelines for the pharmacist’s behaviour and attitude both at the personal and professional levels. The same standard of moral and ethical values should guide the pharmacists in their private life and while conducting their professional business as well.

Any lack of moral values in private life may lead to a lack in trust at the professional level, even with the highest professional or technical qualifications.

We can categorize the pharmacists’ moral values into three groups based on their professional relationship as the following:

A. The Pharmacist- Patient relationship.
B. The Pharmacist- Colleagues relationship.
C. The pharmacist’s self-improvement at the professional level.

A. The Pharmacist- Patient relationship:

This relationship is considered as a covenant, which means that the pharmacists have moral obligations in response to the trust received from society, based on that, pharmacist promises to: 

  1. Respect the professional relationship with the patient and act with integrity compassion and honesty.
  2. Help patients achieve optimum benefit from their medications.
  3. Provide a competent care to the patient.
  4. Respect the patient needs, values and dignity.
  5. Support the patient's right to receive competent and ethical health care.
  6. Support the patient’s right to make his choice about pharmacy care.
  7. Provide information to the patient in an understandable way.
  8. Aid the patient to be an active participant in his pharmaceutical care.
  9. Provide pharmacy care with consideration of the patient’s personal privacy, and maintain practices that protect patient confidentiality.
  10. Ensure continuity of care under any circumstances.
  11. Protect the patient's right of confidentiality.
  12. Maintain the patient’s trust.
  13. Avoid discriminatory practices and behavior.

B- The Pharmacist- Colleagues relationship: 

  1. All pharmacists must accept responsibility to work with colleagues, health care professionals, and others, to promote safe and effective pharmacy care.
  2. Pharmacists should first consider the welfare of the patient when they suspect incompetence or unethical conduct by a health care professional. They should engage in direct discussion with the health care professional involved, if a situation can be resolved without peril to the patient.
  3. Pharmacists must honour the teamwork.

C- The pharmacist’s self Improvement at the professional level. 

 

  1. Each pharmacist from his site must endeavour to ensure that the practice environment contributes to safe and effective pharmacy care.
  2. The pharmacist must commit to lifelong learning designed to maintain relevant knowledge and skills.
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  1. Clinical Pharmacy
  2. Abeer Hammami
  3. Mission/Vision/Values
  4. Introduction

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