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A Project by:
The OPL Scientific Committee
Prepared by:
The Health Promotion Sub-Committee
Authors:
Ahmad DIMASSI, BSc, RPh, PharmD, MSc
Aline HAJJ, PharmD, PhD
Ghada EL-KHOURY, PharmD, BCACP
Hala SACRE, PharmD
Hind HAJJ, BS Pharm, MBA
Iqbal FAHS, PharmD
Marguerita EL-HACHACH, PharmD
Marwan AKEL, PharmD, MPH
Myriam BECHWATI, PharmD
Nathalie LAHOUD, PharmD, MS, PhD
Souheil HALLIT, PharmD, MSc, MPH, PhD
Souraya DOMIATI, PharmD, PhD
Edited by:
Aline HAJJ, PharmD, PhD
Hala SACRE, PharmD
Nathalie LAHOUD, PharmD, MS, PhD
Souheil HALLIT, PharmD, MSc, MPH, PhD
FOREWORD
Dear colleagues,
It is our pleasure to present this “Health Promotion Counseling Tips” booklet. Simple and clear, it
includes the most commonly used guidelines for therapeutic management and patient’s related
counseling pertaining to diseases frequently encountered in pharmacy. In addition, the last two
chapters, include guidelines regarding medications storage and pharmaceutical waste management.
This booklet was carefully prepared by the Scientific Committee – Health Promotion Sub-Committee
We hope that you will find it useful in your daily practice, together for “Excellence in Patient Care”
TABLE OF CONTENTS
SUBLINGUAL TABLET
1. Sit down.
2. Take a sip of water to moisten the mouth if it is dry.
3. Swallow or spit out the water.
4. Place the tablet under the tongue.
5. Close the mouth and do not swallow until the tablet has dissolved
completely. Do not hasten the process by moving the tablet around the
mouth with the tongue. Do not chew or swallow the tablet and do not eat
drink or smoke while the tablet is dissolving.
6. Do not rinse out the mouth for several minutes after the tablet has
dissolved.
ORAL POWDERS
1. Ideally powders should be taken while standing or sitting upright.
2. Open the powder carefully on a flat surface then either:
(a) empty the contents of the sachet directly onto the back of the tongue
and swallow with a glass of water or
(b) empty the contents of the sachet into about a third of a tumbler of
water. Stir to disperse and swallow resulting solution/ suspension.
3. Do not lie down flat for at least 2 minutes after taking the powder.
TOPICAL APPLICATIONS
Emollient creams or ointments
1. Wash area (preferably with an emollient wash) and pat dry gently with a
towel (do not rub).
2. Five to ten minutes after washing apply the emollient liberally (the skin
will have cooled and the water content of the skin will be highest).
3. Repeat as necessary during the day.
Steroid creams or ointments
1. Wash hands.
2. Wash area (preferably with an emollient wash) and pat dry gently with a
towel (do not rub).
3. Apply the cream or ointment sparingly (thinly) to the affected area.
4. Gently massage the cream or ointment into the skin.
5. After application wash hands again, unless the hands are the area being
treated.
Reference
Christopher A Langley and Dawn Belcher (2009). “Patient counselling and communication 2 –
Product-specific counselling points”. In: Applied Pharmaceutical Practice. Pharmaceutical Press.
London. pp227-270
Definitions
⦁ Drug abuse: Any use of a legal or illegal drug in a way that is detrimental to health or well-being.
⦁ Alcohol abuse: Unhealthy or dangerous drinking habits, such as drinking every day or drinking
too much at a time.
Alcohol and drug abuse, and their related harms, cost our society hundreds of millions of dollars
every year, and have therefore been identified as significant public health and social issues.
Drug-Alcohol Interactions
Drug Effect Risk
Alcohol may enhance the hepatotoxic effect of
Acetaminophen Risk C: Monitor therapy
acetaminophen
Alcohol may enhance the risk of gastro- Risk D: Consider therapy
Aspirin
intestinal bleeding of aspirin modification
Alcohol may enhance the CNS depressant
CNS Depressants Risk C: Monitor therapy
effect
Alcohol may enhance the CNS depressant
Gabapentin Risk X: Avoid combination
effect of gabapentin
Alcohol may diminish the therapeutic effect of
Melatonin Risk X: Avoid combination
melatonin
Alcohol may enhance the CNS depressant
Mequitazine Risk X: Avoid combination
effect of mequitazine
Alcohol may potentiate the risk of lactic
Metformin Risk X: Avoid combination
acidosis
Alcohol may increase the serum concentration
Methylphenidate Risk X: Avoid combination
of methylphenidate
May enhance the adverse/toxic effect of
Metronidazol Risk X: Avoid combination
Alcohol. A disulfiram-like reaction may occur
Alcohol may enhance the CNS depressant
Mirtazapine Risk X: Avoid combination
effect of mirtazapine
Alcohol may diminish the therapeutic effect of
Modafinil Risk X: Avoid combination
modafinil
Alcohol may enhance the CNS depressant Risk D: Consider therapy
Opioid Analgesics
effect of opioid analgesics modification
Alcohol may enhance the CNS depressant
Orphenadrine Risk X: Avoid combination
effect of orphenadrine
May enhance the CNS depressant effect of CNS
Oxomemazine Risk X: Avoid combination
depressants
Alcohol may enhance the hypotensive effect of
PDE5 Inhibitors Risk C: Monitor therapy
phosphodiesterase 5 inhibitors
Alcohol may enhance the risk of psychomotor Risk D: Consider therapy
SSRIs and SNRIs
impairment modification
Alcohol may enhance the CNS depressant
Topiramate Risk X: Avoid combination
effect of topiramate
Alcohol may enhance the CNS depressant Risk D: Consider therapy
Zolpidem
effect of zolpidem modification
Alcohol may enhance the adverse/toxic effect
Zopiclone Risk X: Avoid combination
of zopiclone
Abbreviations
CNS: Central Nervous System
PDE5: PhosphoDiEsterase type 5 inhibitor
SNRI: Serotonin and Norepinephrine Reuptake Inhibitors
SSRI: Selective Serotonin Reuptake Inhibitors
References
1. Fox TP, Oliver G, Ellis SM. The destructive capacity of drug abuse: an overview exploring the
harmful potential of drug abuse both to the individual and to society. ISRN addiction. 2013 Jul
17; 2013.
2. Volpicelli JR. Alcohol abuse and alcoholism: an overview. The Journal of clinical psychiatry. 2001;
62:4-10.
3. Schuckit MA. Drug and alcohol abuse: A clinical guide to diagnosis and treatment. Springer
Science & Business Media; 2006 Jun 8.
4. Freese TE, Miotto K, Reback CJ. The effects and consequences of selected club drugs. Journal of
substance abuse treatment. 2002 Sep 1; 23(2):151-6.
5. White A, Hingson R. The burden of alcohol use: excessive alcohol consumption and related
consequences among college students. Alcohol research: current reviews. 2013.
6. Moore AA, Whiteman EJ, Ward KT. Risks of combined alcohol-medication use in older adults.
The American journal of geriatric pharmacotherapy. 2007 Mar; 5(1):64.
Occasionally:
- Senna
- Bisacodyl
Gastroesophageal reflux - Aluminum, calcium, or Avoid sodium bicarbonate and
disease magnesium antacids magnesium trisilicate.
- Sucralfate
- Cimetidine
- Ranitidine
- Famotidine and nizatidine
(limited information)
- Proton pump inhibitors
(mainly omeprazole and
lanzoprazole)
Hemorrhoids - Topical hydrocortisone
- Topical anaesthetics
Gestational diabetes - Insulin
- Glyburide
- Metformin
Infections - Penicillins Nitrofurantoin should not be
- Cephalosporins used after week 37 in patients
with glucose-6-phosphate
dehydrogenase deficiency due to
concern for hemolytic anemia in
the newborn.
Sulfa-containing drugs may
increase the risk for kernicterus in
the newborn and should be
avoided during the last weeks of
gestation.
Folate antagonists, such as
trimethoprim, are relatively
contraindicated during the first
trimester because of their
association with cardiovascular
malformations.
Fluoroquinolones and
tetracyclines are contraindicated.
References
1. Ward, Kristina E. Chapter 78: Pregnancy and Lactation: Therapeutic Considerations. In: DiPiro JT,
Talbert RL, Yee GC, Matzke GR, Wells BG, Posey L. DiPiro J.T., Talbert R.L., Yee G.C., Matzke G.R.,
Wells B.G., Posey L Eds. Joseph T. DiPiro, et al. eds. Pharmacotherapy: A Pathophysiologic
Approach, 10th ed. New York: McGraw-Hill. 2017.
2. Le Centre de Référence sur les Agents Tératogènes (CRAT). http://lecrat.fr
According to this definition, the functioning of a particular patient is constituted by a dynamic and
complex interaction between his state of health and contextual factors (environmental and personal).
These factors include concomitant pathologies and their medicinal treatments. Indeed, in all these
patients, particularly with endocrine (diabetes), cardiovascular and chronic pulmonary diseases and
eligible for physical activity, drug therapy is ubiquitous.
Therefore, in order to set the goals and the treatment plan, it would be wise to analyze the patients’
cases from a broader standpoint: the clinical reasoning and the integration of the medicinal
treatment data in patient care. Clinical reasoning can be defined as a cognitive process in which the
pharmacist interacts with the patient and family members, as well as with all health care team, in
order to clearly define the patient management strategies based on clinical data, scientific knowledge
(recommendations or guidelines), professional judgment (personal knowledge and experience), and
above all, patient choices (patient-centered care).
Therefore, pharmacology has a prominent role in this process of critical thinking for decision making
at different levels.
The pharmacist and the health care team should systematically review the prescribed medications
and evaluate the consequences of their interactions, in order to consider modifications when
necessary, i.e. adapting doses, substituting medications, stopping treatments or possibly adapting
interventions and physical activity to medications intake.
⦁ If the patient does not take the medication, the exercise intensity is limited to a heart rate of 20
beats/min above resting value
⦁ Fluid replacement needs to be provided during the exercise session
⦁ If nitroglycerine is prescribed, the patient should carry it at all time
⦁ In nitroglycerine patch is prescribed, some guidelines should be noted:
- Exercise increases nitroglycerin uptake per patch
- Check and recognize signs of overdose (hypotension, headache, etc.)
- Avoid exercising/ application of heat the muscle where the patch is applied
- Avoid water sports (decrease absorption) or heated pool (increase absorption)
- Beware of and prevent orthostatic hypotension (postural hypotension) especially when
nitroglycerine is taken concomitantly with other anti-hypertensive drugs: slowly move from
laying down/sitting to standing, maintain a good hydration, etc.
- Individualize the exercise to avoid risk of falls.
References:
1. Organisation mondiale de la santé (OMS). L'activité physique des personnes âgées. OMS.
http://www.who.int/dietphysicalactivity/factsheet_olderadults/fr/.
2. Organisation mondiale de la santé (OMS). Stratégie mondiale pour l'alimentation, l'exercice
physique et la santé: Recommandations mondiales en matière d'activité physique pour la santé.
OMS. http://www.who.int/dietphysicalactivity/publications/9789241599979/fr/.
3. American Diabetes Association (ADA). Standards of medical care in diabetes. ADA; 2017
http://www.care.diabetesjournals.org/content/diacare/suppl/2016/12/15/40.
Supplement_1.DC1/DC_40_S1_final.pdf.
4. Colberg SR, Sigal RJ, Yardley JE, Riddell MC, Dunstan DW, Dempsey PC, et al. Physical
activity/exercise and diabetes: a position statement of the American Diabetes Association.
Diabetes Care 2016; 39(11):2065–79. http://dx.doi.org/10.2337/dc16-1728 [PubMed PMID:
27926890].
5. American Association of C, Pulmonary R, American College of Cardiology F, American Heart
Association Task Force on Performance M, Thomas RJ, King M, et al. AACVPR/ACCF/AHA 2010
Update: performance measures on cardiac rehabilitation for referral to cardiac
rehabilitation/secondary prevention services endorsed by the American College of Chest
Physicians, the American College of Sports Medicine, the American Physical Therapy Association,
the Canadian Association of Cardiac Rehabilitation, the Clinical Exercise Physiology Association,
the European Association for Cardiovascular Prevention and Rehabilitation, the Inter-American
Heart Foundation, the National Association of Clinical Nurse Specialists, the Preventive
Cardiovascular Nurses Association, and the Society of Thoracic Surgeons. J Am Coll Cardiol 2010;
56:1159–67. http://dx.doi.org/10.1016/j.jacc.2010.06.006 [PubMed PMID: 20863958].
6. Kraal JJ, Vromen T, Spee R, Kemps HMC, Peek N. The influence of training characteristics on the
effect of exercise training in patients with coronary artery disease: systematic review and meta-
regression analysis. Int J Cardiol 2017. http://dx.doi.org/10.1016/j.ijcard.2017.07.051 [PubMed
PMID: 28735757].
7. American Association of Cardiovascular, Pulmonary Rehabilitation (AACPR). Guidelines for
pulmonary rehabilitation programs, 7th ed., 2011.
8. Global Initiative for Asthma (GINA). Guide de poche pour le traitement et la prévention de
l'asthme. GINA; 2016, http://www.ginasthma.org/wp-content/uploads/2016/09/WMS-French-
Pocket-Guide-GINA-2016.pdf.
9. Organisation mondiale de la santé (OMS). Classification internationale du fonctionnement, du
handicap et de la santé, version complète. OMS; 2001, http://www.dcalin.fr/fichiers/cif.pdf et
http://apps.who.int/classifications/icfbrowser/Default.aspx.
Asthma is a chronic disease of the airways, characterized by reversible airflow obstruction, with
variable and recurring symptoms. Many risk factors are correlated with asthma, including airborne
substances (pollen, dust mites), respiratory infections, physical activity (exercise-induced asthma),
cold air pollutants and irritants (smoking, pesticides), certain medications (beta blockers, ACE
inhibitors, aspirin, ibuprofen, naproxen), strong emotions and stress, sulfites and preservatives added
to some types of foods and beverages (shrimps, dried fruits, processed potatoes, beer and wine),
disease states (gastroesophageal reflux disease, chronic sinusitis or rhinitis, obesity), and genetics.
Asthma can present as shortness of breath, coughing, wheezing, and excess bronchial secretions.
COPD (Common Obstructive Pulmonary Disease) is a common, preventable, and treatable disease
that is characterized by persistent respiratory symptoms and airflow limitation that is due to
airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or
gases. Chronic inflammation causes structural changes, small airways narrowing, and destruction of
lung parenchyma. A loss of small airways may contribute to airflow imitation and mucociliary
dysfunction, a characteristic feature of the disease.
Etiology of COPD comprises many factors environmental factors (cigarette smoking (90%),
occupational exposure to allergens, air pollution), age, gender, genetics.
Staging of Asthma
Characteristics
Mild Persistent > 2 times a < 1 time a day > 2 times a FEV1>80% predicted
Exacerbation may affect activity month FEV1 variability 20-30%
Abbreviations
SABA: Short-Acting Beta Agonists
LABA: Long-Acting Beta Agonists
LTRA: LeukoTriene Receptor Antagonists
ICS: Inhaled CorticoSteroids
PRN: as required or as needed
EIB: Exercise-Induced Bronchoconstriction
Stepwise Approach for Managing Asthma in Youths ≥ 12 Years of Age and Adults
Available treatments
Inhaled Beta-2 agonists:
Short-acting: Salbutamol
Long-acting: Salmeterol, Formoterol
Ultra-long-acting: Indacaterol, Olodaterol, Vilanterol
Anticholinergics:
Short-acting: Ipratropium
Long-acting: Tiotropium
Ultra-long: Glycopyrrolate, umeclidinium
References
1. National Asthma Education and Prevention Program, Third Expert Panel on the Diagnosis and
Management of Asthma. Bethesda (MD): National Heart, Lung, and Blood Institute (US); 2007
Aug. https://www.ncbi.nlm.nih.gov/books/NBK7223/
2. National Asthma Education and Prevention Program. Expert Panel Report II: Guidelines for the
Diagnosis and Management of Asthma. Bethesda, MD: National Institutes of Health; 1997.
Publication No. 97- 4051:12–18.
3. Global Strategy for Asthma Management and Prevention. Bethesda, MD: National Institutes of
Health, National Heart, Lung, and Blood Institute; 2002. NIH publication No. 02-3659.
4. W Nystad. Asthma. Int J Sports Med. 2000; 21:S-98–S-102. (suppl) [PubMed]
5. Balatbat JH. Asthma: an overview from prevalence to plan. J Contin Educ Top Issues. 2002; 2:80–
92.
6. Rundell KW, Im J, Mayers LB, Wilber RL, Szmedra L, Schmitz HR. Self-reported symptoms and
exercise-induced asthma in the elite athlete. Med Sci Sports Exerc. 2001; 33:208–213
7. Hallit, S., Raherison, C., Waked, M., & Salameh, P. (2017). Association between Caregiver Exposure
to Toxics during Pregnancy and Childhood-onset Asthma: A Case-control Study. Iran J Allergy
Asthma Immunol, 16(6), 488-500.
8. Hallit, S., & Salameh, P. (2017). Exposure to toxics during pregnancy and childhood and asthma
in children: A pilot study. J Epidemiol Glob Health, 7(3), 147-154. doi:10.1016/j.jegh.2017.04.004
9. Pascale Salameh, Mirna Waked, Isabelle Baldi, Patrick Brochard, and Bernadette Abi Saleh.
Respiratory diseases and pesticide exposure: a case-control study in Lebanon. J Epidemiol
Community Health. 2006 Mar; 60(3): 256–261. doi: 10.1136/jech.2005.039677. PMCID:
PMC2465555. PMID: 16476757
10. Pesticides in Lebanon: a knowledge, attitude, and practice study. Salameh PR1, Baldi I, Brochard
P, Abi Saleh B. Environ Res. 2004 Jan; 94(1):1-6.
11. Global Initiative for Chronic Obstructive Lung Disease (GOLD): global strategy for the diagnosis,
management and prevention of COPD. 2017. www.goldcopd.org
12. Busse WW, Boushey HA, Camargo CA, Evans D, Foggs MB, Janson SL. Expert panel report 3:
Guidelines for the diagnosis and management of asthma. Washington, DC: US Department of
Health and Human Services, National Heart Lung and Blood Institute. 2007:1-417.
https://www.nhlbi.nih.gov/files/docs/guidelines/asthgdln.pdf
In the 2015 World Health Organization report on the global tobacco epidemic, the smoking
frequency in Lebanon reached 36.2%, the highest in the Middle East and North Africa region.
Cigarette smoking is the principal risk factor for the damaging consequences on the respiratory and
cardiovascular systems, acute exacerbations of respiratory illness, and associated morbidity and
mortality. Relative to a single cigarette (about 500 ml of smoke), a single waterpipe use episode
(about 90,000 ml of smoke) is associated with 1.7 times the nicotine, 8.4 times the CO, and 36.0 times
the tar.
Three scales can be used to assess nicotine dependence; two for cigarettes (The Fagerstrom and the
Lebanese Cigarette Dependence Scale) and one for waterpipe (the Lebanese Waterpipe Dependence
Scale).
In this document, regarding dependence to cigarettes, we will only disclose the Fagerstrom scale as
it is shorter than the Lebanese scale and easier to use by the Lebanese pharmacists.
Successful intervention begins with identifying users and appropriate interventions based upon the
patient’s willingness to quit. The five major steps to intervention are the “5 A’s”: Ask, Advise, Assess,
Assist and Arrange.
Lebanese Waterpipe Dependence Scale - 11 items (please circle the right answer)
1. Number of times you
Several It always
could stop waterpipe for None (3) Once (2)
times (1) happens (0)
more than 7 days
more than
2. Percent of income you 1% or less of 2%-10% of your 11%-50% of
50% of your
would spend on waterpipe your monthly monthly income your monthly
monthly income
smoking? income (0) (1) income (2)
(3)
3. Number of days you could One day or less More than 7
2-3 days (2) 4-7 days (1)
spend without waterpipe? (3) days (0).
7 or more
4. Number of water pipes 1 waterpipe/ 1-2 waterpipes/ 3-6 waterpipes/
waterpipes/
you usually smoke per week? week (0) week (1) week (2)
week (3)
5. You smoke waterpipe to Yes, absolutely yes, maybe
yes, probably (2) No (0)
relax your nerves. (3) (1)
6. You smoke waterpipe to Yes, absolutely yes, maybe
yes, probably (2) No (0)
improve your morale. (3) (1)
7. Do you smoke waterpipe Yes, absolutely yes, maybe
yes, probably (2) No (0)
when you are seriously ill? (3) (1)
8. Are you ready not to eat in Yes, absolutely yes, maybe
yes, probably (2) No (0)
exchange for a waterpipe? (3) (1)
9. You smoke waterpipe for Yes, absolutely yes, maybe
yes, probably (2) No (0)
pleasure. (3) (1)
10. You smoke to please Yes, absolutely yes, maybe
yes, probably (2) No (0)
others (for conviviality). (3) (1)
11. Do you smoke waterpipe Yes, always (3) yes, most of the yes, sometimes
No, never (0)
alone? times (2) (1)
A score of ≥10 indicates high dependence, whereas a score <10 indicates low dependence.
Treatment Options
The treatments listed below are the most common ones used to help smokers quit. They include
different kinds of counseling and medications.
Medical treatments are only available in specialized centers except for the nicotine replacement
therapy that is available in community pharmacies.
References
1. World Health Organization. Report on the global tobacco epidemic. WHO Web Site; 2015;
Available at: http://www.who.int/tobacco/surveillance/policy/country_profile/lbn.pdf?ua=1
2. Doll R, Peto R, Wheatley K, Gray R, Sutherland I. Mortality in relation to smoking: 40 years'
observations on male British doctors. BMJ. 1994; 309: 901-11.
3. World Health Organization. WHO report on the Global Tobacco Epidemic: Warning about the
dangers of tobacco. Geneva: WHO; 2011.
4. World Health Organization. Toolkit for delivering the 5A’s and 5R’s brief tobacco interventions
in primary care. Available at:
http://apps.who.int/iris/bitstream/handle/10665/112835/9789241506953_eng.pdf?sequence=1
5. Layoun N, Saleh N, Barbour B, Awada S, Rachidi S, Al-Hajje A, et al. Waterpipe effects on
pulmonary function and cardiovascular indices: a comparison to cigarette smoking in real life
situation. Inhal Toxicol. 2014; 26: 620-7.
6. Caroline Cobb, Kenneth D. Ward, Wasim Maziak, Alan L. Shihadeh, Thomas Eissenberg.
Waterpipe Tobacco Smoking: An Emerging Health Crisis in the United States. Am J Health Behav.
2010 May-Jun; 34(3): 275–285.
7. HYPERTENSION
Souheil HALLIT, PharmD, MSc, MPH, PhD
Stages of hypertension
Blood pressure category Systolic BP Diastolic BP
Normal < 120 mm Hg and <80 mm Hg
Elevated 120-129 mm Hg and <80 mm Hg
Hypertension Stage 1 130-139 mm Hg or 80-89 mm Hg
Hypertension Stage 2 ≥140 mm Hg or ≥90 mm Hg
Lifestyle modifications
⦁ To be followed in case of antihypertensive medication intake or not
⦁ Losing weight in case of overweight or obesity
⦁ Stop smoking
⦁ Eating a healthy diet, including the DASH diet (eating more fruits, vegetables, and low fat dairy
products, less saturated and total fat)
⦁ Reducing the amount of sodium in your diet to less than 1,500 milligrams a day; healthy adults
should try to limit their sodium intake to no more 2,300 milligrams a day (about 1 teaspoon of
salt).
⦁ Exercise (such as brisk walking at least 30 minutes a day, 5 days a week)
⦁ Limit alcohol to two drinks a day for men, one drink a day for women
References
1. https://www.acc.org/~/media/Non-Clinical/Files-PDFs-Excel-MS-Word-
etc/Guidelines/2017/Guidelines_Made_Simple_2017_HBP.pdf
2. Weber MA, Schiffrin EL, White WB, et al. Clinical practice guidelines for the management of
hypertension in the community: a statement by the American Society of Hypertension and the
International Society of Hypertension. J Clin Hypertens (Greenwich) 2013 Dec 17. doi:
10.1111/jch.12237.
Hypertension treatment
8. DYSLIPIDEMIA
Souheil HALLIT, PharmD, MSc, MPH, PhD and Hala SACRE, PharmD
Definition
Dyslipidemia is defined as elevated total or low-density lipoprotein (LDL) cholesterol levels, or low
levels of high-density lipoprotein (HDL) cholesterol.
Implementation of Risk Assessment Work Group Recommendations. ACC indicates American College of
Cardiology; AHA, American Heart Association; ASCVD, atherosclerotic cardiovascular disease; CV, cardiovascular;
and NHLBI, National Heart, Lung, and Blood Institute.
Pharmacological treatment
Statins
⦁ Statins are competitive inhibitors of HMG-CoA reductase, the rate-limiting step in hepatic
cholesterol synthesis is conversion of hydroxymethylglutaryl coenzyme A (HMG-CoA) to
mevalonate by HMG-CoA reductase.
⦁ The intensity of the statin therapy is determined according to the coronary heart disease (CHD)
risk obtained from the ASCVD score.
High-intensity statins Moderate-intensity statins Low-intensity statins
CHD risk ≥7.5% CHD risk 5% to <7.5% CHD risk <5%
Lower LDL-C by Lower LDL-C by approximately Lower LDL-C, on average, by less
approximately 50% or more 30% to less than 50% than 30%
Atorvastatin 40–80 mg Atorvastatin 10–20 mg Fluvastatin 20–40 mg
Rosuvastatin 20–40 mg Fluvastatin 40 mg twice daily Lovastatin 20 mg
Fluvastatin XL 80 mg Pitavastatin 1 mg
Lovastatin 40 mg Pravastatin 10–20 mg
Pitavastatin 2–4 mg Simvastatin 10 mg
Pravastatin 40–80 mg
Rosuvastatin 5–10 mg
Simvastatin 20–40 mg
Counseling about statins
⦁ The patient should do a baseline liver function tests (SGPT, SGOT, bilirubin, alkaline phosphatase
and Gamma Glutamyl Transferase-GGT) then 4 weeks after initiating a statin therapy. Also, check
the creatine phosphokinase (CPK) levels.
⦁ Patient should stop drug and contact physician in case of severe myalgia, muscle weakness or
dark urine.
⦁ Symptomatic management: Coenzyme Q10 100 mg orally daily reduces myalgia by 40%.
⦁ Conversion of statins in terms of potency:
- 5 mg simvastatin = 15 mg lovastatin = 15 mg pravastatin = 40 mg fluvastatin
- 20 mg simvastatin = 10 mg atorvastatin
- 20 mg atorvastatin = 10 mg rosuvastatin
⦁ Metabolism of statins
Generic name Metabolism Protein bound Counseling
Lovastatin CYP3A4 95% With food; at night
Simvastatin CYP3A4 95% With food; at night
Pravastatin NOT metabolized 50% With food; at night
Fluvastatin CYP2C9 95% With food; at night
Atorvastatin CYP3A4 95% With food; anytime of the day
Rosuvastatin CYP3A4 95% With food; anytime of the day
Pitavastatin CYP3A4 95% Anytime of the day
Niacin
⦁ Water soluble B complex vitamin; Hypolipemic effects of niacin require larger doses than those
required for its vitamin effects
⦁ Indicated in case of hypertriglyceridemia with low HDL-C levels and elevated LDL-C; Best agent
for increasing HDL-C (30-40%). Lowers TG by 35-45% within 4-7 days and LDL-C level by 20-30%
within 3-6 weeks.
⦁ Extended-release niacin formulations have a better tolerability than immediate-release
formulations.
⦁ Counseling:
- Take aspirin 325 mg, 30 minutes before the niacin dose, at bedtime, with food.
- Flush occurs when drug is taken with hot beverages or alcohol.
⦁ Side effects: dry skin (use moisturizers), hepatotoxicity, hyperglycemia, increased uric acid levels,
myopathy when combined with statins.
Ezetimibe
⦁ Inhibition of diet cholesterol uptake; reduced cholesterol absorption by more than 50%.
⦁ Adjunctive therapy for statins.
⦁ Side effects are mainly gastro intestinal (diarrhea, stomach or abdominal pain), back pain,
numbness or tingly feeling, tired feeling.
Bile acid sequestrants
⦁ Cholestyramine, cholestipol, colesevelam.
⦁ Maximal doses can reduce LDL-C by up to 25% but are associated with gastrointestinal side
effects (bloating, flatulence, constipation, dyspepsia) that limit compliance.
⦁ No effect on triglycerides.
⦁ They are probably the safest because they are not absorbed from the intestine.
⦁ Any medication must be administered 1 hour before or 3-4 hours after a dose of any bile acid
sequestrants.
⦁ The resin-induced increase in bile-acid production is accompanied by an increase in hepatic
triglyceride synthesis.
⦁ Contraindicated in patients with significant hypertriglyceridemia (≥400 mg/dL).
Fibrates
⦁ Indicated in case of elevated triglyceridemia, severe hypertriglyceridemia with risk of pancreatitis,
high TG with low HDL-C levels.
⦁ Side effects: severe stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes or skin
(jaundice), increased liver function tests, dark urine, unusual muscle pain, tenderness, or
weakness especially if accompanied by fever or flu-like symptoms.
References
1. Hermansson J, Kahan T. Systematic Review of Validity Assessments of Framingham Risk Score
Results in Health Economic Modelling of Lipid-Modifying Therapies in Europe.
PharmacoEconomics. 2018 Feb 1:1-9.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5805819/pdf/40273_2017_Article_578.pdf
2. Fodor G. Primary prevention of CVD: treating dyslipidaemia. BMJ clinical evidence. 2010;2010.
https://www.aafp.org/afp/2011/0515/p1207.html
3. Stone NJ, Robinson JG, Lichtenstein AH, Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D,
Levy D, Lloyd-Jones DM, McBride P. 2013 ACC/AHA guideline on the treatment of blood
cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American
College of Cardiology/American Heart Association Task Force on Practice Guidelines. Journal of
the American College of Cardiology. 2014 Jul 1;63(25 Part B):2889-934.
https://www.ahajournals.org/doi/pdf/10.1161/01.cir.0000437738.63853.7a
4. Goff DC, Lloyd-Jones DM, Bennett G, Coady S, D’agostino RB, Gibbons R, Greenland P, Lackland
DT, Levy D, O’donnell CJ, Robinson JG. 2013 ACC/AHA guideline on the assessment of
cardiovascular risk: a report of the American College of Cardiology/American Heart Association
Task Force on Practice Guidelines. Journal of the American College of Cardiology. 2014 Jul
1;63(25 Part B):2935-59.
https://www.ahajournals.org/doi/pdf/10.1161/01.cir.0000437741.48606.98
5. ASCVD Risk Calculator.
https://professional.heart.org/professional/GuidelinesStatements/ASCVDRiskCalculator/UCM_4
57698_ASCVD-Risk-Calculator.jsp
6. Eckel RH, Jakicic JM, Ard JD, et al. 2013 AHA/ACC guideline on lifestyle management to reduce
cardiovascular risk: a report of the American College of Cardiology/American Heart Association
Task Force on Practice Guidelines. Circulation. 2014;129(suppl 2):S76–S99.
https://www.ahajournals.org/doi/pdf/10.1161/01.cir.0000437740.48606.d1
7. Smith SC Jr., Benjamin EJ, Bonow RO, et al. AHA/ACCF secondary prevention and risk reduction
therapy for patients with coronary and other atherosclerotic vascular disease: 2011 update: a
guideline from the American Heart Association and American College of Cardiology Foundation.
Circulation. 2011;124:2458–73.
https://www.ahajournals.org/doi/pdf/10.1161/CIR.0b013e318235eb4d
8. Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC,
Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K,
Wilson PWF. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce
atherosclerotic cardiovascular risk in adults: a report of the American College of
Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation.
2014;129(suppl 2):S1–S45.
https://www.ahajournals.org/doi/pdf/10.1161/01.cir.0000437738.63853.7a
9. Jensen MD, Ryan DH, Apovian CM, et al. 2013 AHA/ACC/TOS guideline for the management of
overweight and obesity in adults: a report of the American College of Cardiology/American Heart
Association Task Force on Practice Guidelines and The Obesity Society. Circulation.
2014;129(suppl 2):S102–S138.
https://www.ahajournals.org/doi/pdf/10.1161/01.cir.0000437739.71477.ee
10. Expert Panel on Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children
and Adolescents, National Heart, Lung, and Blood Institute. Expert panel on integrated guidelines
for cardiovascular health and risk reduction in children and adolescents: summary report.
Pediatrics. 2011;128(Suppl 5):S213–56.
https://www.nhlbi.nih.gov/files/docs/peds_guidelines_sum.pdf
Diabetes symptoms:
Check symptoms of Diabetes Mellitus (DM): polyuria, polydipsia, polyphagia, fatigue, dryness of the
mouth.
Lifestyle modifications:
⦁ Stop smoking.
⦁ Decrease caffeine intake.
⦁ Exercise 30 minutes per day for 5 days a week (150 minutes per week).
⦁ Limit alcohol intake: 1 glass of alcohol for women and 2 glasses for men per day.
Vaccinations:
⦁ Annual influenza vaccine.
⦁ Pneumococcal vaccine (PPCV13, PPSV23).
⦁ Hepatitis B vaccine.
⦁ Tetanus-diphteria boosters.
Hypertension treatment:
⦁ Goal: Systolic Blood Pressure (SBP) < 130 mmHg; Diastolic Blood Pressure (DBP) <80 mm Hg.
⦁ Regardless of the blood pressure value, Angiotensin Converting Enzyme Inhibitors (ACEI) or
Angiotensin Receptor Blockers (ARB) should be started in all diabetic patients for their
nephroprotective effects.
⦁ If not at goal, dual antihypertensive therapy is preferred with ACEI or ARB. Recommend lifestyle
modifications and assess every 2-3 months.
⦁ Caution: Patient should check the baseline serum creatinine and potassium levels, then 7-10 days
after starting the treatment. If there is an increase in serum creatinine and/or potassium levels,
treatment should be stopped and patient referred to a physician.
Pharmacologic therapy:
⦁ Metformin: minimal effective dose is 1500 mg, titrated over 3 weeks: 500mg QD on the first
week, then 500mg BID on the second week, then 500mg TID on the third week.
Maximum dose: 2550mg/day
Contraindications: hypersensitivity to metformin, renal disease (eGFR<30ml/minutes/1.73m2)
Administration: with a meal
Adverse effects: renal impairment, GI symptoms
Monitoring parameters: eGFR, Vitamin B12, serum glucose levels, HbA1C
Insulin types:
Insulin Onset of Peak Duration of Patient’s
Examples
Type Action Action Action Counseling
Lispro
Rapid acting Aspart 5-15 min 30-90 min <5h Inject 15 min before eating
Glulisine
Regular Bolus insulin to control post
Short acting 30 min 2-4 hrs 5-8 hrs
Insulin prandial glucose
Intermediate NPH Cloudy insulin: roll and rotate
1-2 hrs 4-10 hrs 10-18 hrs
acting Insulin vial before filling syringe
Glargine Do not mix in the same syringe
Long acting 1-2 hrs None Up to 24 hrs
Detemir with other insulins
Ultra long Do not mix in the same syringe
Degludec 1-2 hrs None Up to 40 hrs
acting with other insulins
Rapid-, short-, and intermediate-acting insulins may be mixed together in one syringe, or may be available
pre-mixed.
References
1. American Diabetes Association. Standards of medical care in diabetes—2016. Diabetes Care.
2016; 39(suppl 1):S1-S10
2. Lexi-Drugs. Lexicomp. Wolters Kluwer Health Inc. Hudson, OH. Available at:
http://online.lexi.com.
3. American College of Radiology. ACR manual on contrast media. Version 10.3. Reston (VA): ACR;
2018. https://www.acr.org/-/media/ACR/Files/Clinical-Resources/Contrast_Media.pdf#page=47
Antiplatelets
Contraindications: hypersensitivity; active bleeding
⦁ Clopidogrel 75 mg once daily
Duration: 12 months if drug-eluting stent (DES), 1-2 months if bare-metal stent (BMS)
Adverse reactions: pruritus, GI hemorrhage, hematoma
Monitoring parameters: signs of bleeding, hemoglobin, hematocrit
⦁ Prasugrel 5 mg once daily if < 60 kg, 10 mg once daily if > 60 kg
⦁ Ticagrelor 90 mg twice daily
Beta-blockers
Contraindications: 2nd/3rd degree AV block, shock, left ventricular failure with CHF, bradycardia
Duration: lifelong
Adverse reactions: bradycardia, hypotension, AV block, edema, dizziness, headache
Monitoring parameters: HR (target < 55 - 60 bpm); BP (target < 140 / 90 mmHg)
⦁ Bisoprolol starting 1.25 mg QD, maximum 10 mg QD
⦁ Atenolol starting 25 mg QD, maximum 100 mg QD
⦁ Metoprolol succinate starting 25 mg QD, maximum 200 mg QD
Note: may consider non-DHP CCB (verapamil, diltiazem) if beta-blocker not tolerated or CI, although
there is no mortality benefit
Vaccines
⦁ Yearly influenza vaccine
⦁ Tetanus and diphtheria booster every 10 years
⦁ Pneumococcal vaccine if 65 years old or more
References
1. 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction: A Report
of the American College of Cardiology Foundation/American Heart Association Task Force on
Practice Guidelines. Circulation. 2013; 127:00-00.
2. Recommended Adult Immunization Schedules 2016. Available at:
http://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf
Despite the public and medical pressure to “stay fit”, the incidence of obesity has doubled over the
past two decades, particularly among children and adolescents. It is a chronic metabolic disorder
caused by excessive accumulation of body fat secondary to poor appetite regulation and decreased
energy metabolism.
3 Classes of Obesity
Class I BMI 30-34.9 kg/m2
Class II BMI 35-39.9 kg/m2
Class III BMI ≥ 40 kg/m2
Different causes can be identified behind obesity including overconsumption of high-fat, energy-
rich foods, unhealthy snacking between meals, more food choices at restaurants, snack bars, and
grocery stores, readily available inexpensive food 24 hours a day, larger sized portions of food and
drinks, increased advertising of high-fat/high-carbohydrate foods and drinks and lack of physical
activity and sleep.
Patients with obesity usually present with waist circumference >102 cm (40 inches) in men or >88
cm (35 inches) in women and waist-to-hip ratio >1 in men or 0.8 in women, in addition to skin-fold
thickness.
According to the National Heart, Lung, and Blood Institute guidelines, weight loss treatment should
be initiated in overweight patients with increased waist circumference and two or more risk factors
or in obese patients with BMI ≥30 kg/m2. Non-pharmacological therapy for obesity includes
behavioral modification programs (Using support groups, nutritional education, exercise, cognitive
restructuring, self-monitoring), balanced diet and exercise (Weight loss program, counseling for
lifestyle changes / trained staff / coping strategies for stressful times / weight loss maintenance /
flexible and appropriate food choices / exercise) and surgery. Surgery is used only for morbidly obese
individuals (BMI ≥40 or ≥35 kg/m2 with comorbid conditions) in whom behavioral or pharmacologic
treatments have failed. Surgical procedures include gastric banding, vertical banded gastroplasty,
Roux-en-Y gastric bypass, biliopancreatic diversion and gastric bypass.
⦁ Guarana. Guarana is a diuretic and also stimulates the nervous system and helps fighting
depression and coping with stress. Guarana thus helps to avoid emotional eating, one of the
chief causes of weight gain.
⦁ Ginseng. Ginseng increases stamina and helps to combat fatigue. It increases your capacity to
do physical activity. It’s also responsible for reducing blood sugar levels and helps losing weight.
⦁ Ginger. Ginger cleanses the body by reducing the stomach’s acidity and purging the digestive
system of food lodged in it. This lodged food can cause weight gain, and the purging helps lose
it.
⦁ Senna. It shouldn't be used for more than two weeks because in the long term it can cause the
bowels to stop functioning normally and might cause dependence on laxatives.
⦁ Conjugated Linoleic Acid (CLA). There are claims that it may help reduce body fat. It also seems
to be associated with feelings of fullness that reduce hunger. But results of studies are mixed,
and some research suggests no benefit. Some researchers have raised safety issues about the
long-term use of CLA, especially in obese people, where it may increase insulin resistance.
⦁ Chromium Picolinate. Chromium is a mineral that enhances the action of insulin. It's also critical
to the storage of carbohydrates, fats, and proteins. There are claims that chromium supplements
can decrease appetite, increase number of calories burned, reduce body fat and increase muscle
mass but a recent review of 24 studies examining the effects of 200 to 1,000 micrograms (mcg)
of chromium a day found no significant benefits. Also, small studies have indicated the potential
for kidney failure and liver failure.
⦁ Bromelain. Found in pineapple, it absorbs fat and helps in digestion of proteins. It has serious
side effects like increased heart rate, drowsiness and abnormal uterine bleeding or heavy
menstruation.
⦁ Aloe. It aids in removal of extra water in the cells, build enough supply of vitamins and minerals
which help in burning excessive fats, and promotes a lean body. It reduces body mass index: this
results in less energy demanded leading to less food intake.
⦁ Acai. The acai berry diet pill works in the sense that the antioxidants and minerals found in the
acai berry pills add fuel to muscle and aids in weight loss with its high content of fiber. Acai
berries being an appetite suppressant and speed up metabolism is a myth.
⦁ Caffeine. Caffeine may reduce the desire to eat for a brief time, but there's not enough evidence
to show that long-term consumption aids weight loss. Caffeine may stimulate thermogenesis,
but this probably isn't enough to produce significant weight loss. In some people, caffeine can
act as a diuretic. This increase in urine output, mostly water loss, may temporarily decrease body
weight, but it doesn't result in the loss of body fat.
References
1. Heymsfield S, and Wadden T. Mechanisms, Pathophysiology, and Management of Obesity. N Engl
J Med 2017; 376:254-266.
2. Kaila B, and Raman M. Obesity: A review of pathogenesis and management strategies. C J
Gastroenterol. 2008;22(1):61-68.
3. Schwartz MW, Seeley RJ, Zeltser LM, et al. Obesity Pathogenesis: An Endocrine Society Scientific
Statement. Endo Rev. 2017; 38 (4): 267–296.
4. Lagerros YT, Rössner S. Obesity management: what brings success? Therapeutic Advances in
Gastroenterology. 2013;6(1):77-88.
"Dietary Supplements", "nutritional ergogenic aids", "sports supplements", "sports foods" and
"therapeutic nutritional supplements”, these are some of the terms used to describe the range of
products which together form the industry of sports supplements. Supplement use is widespread
and accepted practice by athletes, with a high prevalence of use and a wide range of different types
and brands. The current objective of the industry of sports supplements is to create compounds and
nutrients that act as cofactors, intermediate metabolites or stimulants for major reactions during
exercise. The rationale for supplementation is that if the system is "surcharged" with additional
amounts of these compounds, the metabolic processes will proceed faster or for longer, thereby
improving athletic performance. But a scientific theory or hypothesis should be developed before
the establishment of a supplementation.
Sports supplements have many advantages and disadvantages. Some products directly improve
performance (ergogenic effect) or aid in achieving the nutritional goals and thus allow the athlete to
achieve optimum performance. For example, many studies have confirmed the benefits of consuming
sports drinks to provide carbohydrates and fluid during exercise.
Despite these benefits, sport supplements are mostly expensive. Moreover, like most supplements,
they are considered by regulators to be relatively safe. Consequently, in many countries there is no
formal or mandatory accounting that report adverse side effects from the use of these products. In
addition, reliance on sport supplements is shifting priorities of the athlete, where successful athletic
performance is the product of superior genetics, long-term training, optimal nutrition, adequate
sleep and recovery that cannot be replaced by the use of supplements. Furthermore, a number of
ingredients that can be found in supplements are considered prohibited by the codes of “the World
Anti-Doping Agency (WADA)” and other sports organizations. These include pro-hormones and
stimulants. Education programs drugs have highlighted the need for athletes to read the labels of
supplements and sports foods carefully to ensure they do not contain such prohibited substances. It
is a responsibility that athletes must master to avoid doping. However, even when athletes take such
precautions, the incidental catch of prohibited substances from products supplements may still
occur. This is because some supplements contain prohibited goods without declaring them as
ingredients, this is the result of contamination or mislabeling. Another major concern is the use of
sport supplements among young athletes where various expert groups have made strong statements
against the use of supplements in young athletes. For example, the American College of Sports
Medicine recommends that creatine should not be used by people under 18 years.
Since 2000, the Australian Institute of Sport (AIS) has implemented a program of supplements for
athletes. AIS program is an ABCD ranking system that classifies sports foods and supplement
ingredients into four groups based on scientific evidence and other practical considerations that
determine whether a product is safe, legal and effective in improving sports performance. These
decisions are regularly re-evaluated.
Group A supplements provide a useful and timely source of energy or nutrients in the athlete's diet
and have been shown in scientific trials to benefit performance, when used according to a specific
protocol in a specific situation in sport. They include caffeine, creatine, citrate and bicarbonate and
glycerol.
Caffeine:
⦁ Increased catecholamines, and direct effect of caffeine on Cyclic AMP, can both increase lipolysis in
adipose tissue and muscle, causing an increase in plasma concentrations of fatty acids and increased
availability of intramuscular triglycerides.
⦁ An obvious benefit of athletes is to find the dose of caffeine that stimulates the greatest benefit to the
performance and the minimum level of risk and side effects.
⦁ Overall, it appears that, for the execution of the exercises for 1 hour or more, the performance benefits
are observed at low doses of caffeine (1-3 mg/kg), and no other benefits at higher doses.
⦁ The effects of caffeine supplementation differ between individuals. Some people are non-responders
and some people experience negative side effects such as tremors, increased heart rate, headaches, and
sleep disturbances that are more common at higher doses. These side effects may cause direct
impairment of performance.
Creatine:
⦁ The main advantage of creatine supplementation appears to be an increase in creatine phosphate re-
synthesis during recovery between sets of high intensity exercise. So it can lessen the normal production
decline of force or power.
⦁ 4-6 doses of 5 g creatine for 5 days increase the concentration of creatine in muscle by 20%, and achieve
an apparent threshold muscle ~ 150-160 mmol / kg dry weight.
⦁ The response for creatine loading varies between individuals, with approximately 30% of individuals
that are "non-responders".
⦁ The creatine loading is associated with increase in body weight of about 0.6 to 1.0 kg.
⦁ There are side effects of long term use of creatine such as nausea, gastrointestinal disorders, headaches
and muscle cramps.
⦁ Creatine supplementation should be limited to well-developed athletes.
Bicarbonate and citrate:
⦁ Anaerobic glycolysis provides the main source of fuel for exercise. The lactate and hydrogen ions diffuse
into the extracellular space and therefore increase the acidity and reduce performance.
⦁ The alkalosis therapies improve performance. The use of bicarbonate or citrate is a useful strategy to
improve maximum intensity sporting events for the duration of 1-7 minutes.
⦁ Ingestion of 0.3 g of sodium bicarbonate/ kg body weight, 1-2 hours before exercise, which is equivalent
to 4-5 teaspoons of baking powder is required.
⦁ Bicarbonate is not considered to pose a major health risk. Although some people suffer from
gastrointestinal disorders such as cramps or diarrhea.
Glycerol:
⦁ Athletes are not interested in glycerol for its energy potential, but it is taken for hydration.
⦁ When a large amount of liquid is consumed simultaneously with glycerol, there is a retention of the
liquid. What is needed is 1 to 1.5 g/ kg of glycerol with addition of 25-35 ml/kg of fluid.
⦁ Glycerol can be useful for high-intensity exercise and / or in hot, humid environments where sweat
losses are high, therefore minimizes water loss.
⦁ Over hydration with glycerol is associated with increased performance, especially in well-trained athletes.
Group B supplements are considered for provision to AIS athletes only under a research protocol or
clinical monitoring activity. They have received some scientific attention, sometimes in populations
other than athletes, or have preliminary data which suggest possible benefits to performance. They
include colostrum, ribose, carnitine, HMB and glutamine.
Colostrum:
⦁ It is a substance that is rich in protein secreted in the breast milk the first days after birth that is rich in
immunoglobulins and IGFs (Insulin-like Growth Factors).
⦁ There is no scientific proof to consider it a beneficial supplement.
⦁ In any case, this supplement is expensive. It costs $ 70 / week if a daily dose of 60g is administered.
Colostrum was associated with:
⦁ Increase in plasma IGF and endogenous IGF production and salivary IgA
⦁ Decrease in respiratory tract infections
⦁ Improvement in the performance of the athlete
However, other studies had other negative results, where colostrum was associated with:
⦁ Increase in body mass and subcutaneous fat
⦁ No apparent benefits of resistance during training
Ribose:
⦁ It increases regeneration of ATP (post-exercise), but other studies have shown the opposite.
⦁ Ribose supplementation is not very effective for improving the performance. Only one study of 6 studies
showed an improvement in performance.
⦁ It is an expensive product that costs $ 700 / kg.
Carnitine:
⦁ Carnitine is derived from an amino acid that is found in nearly all body cells.
⦁ Carnitine is the generic term for a number of compounds that include L-carnitine, acetyl-L-carnitine,
and propionyl-L-carnitine.
⦁ It plays a critical role in energy production. It transports long-chain fatty acids into the mitochondria so
they can be oxidized to produce energy. It also transports the toxic compounds generated out of this
cellular organelle to prevent their accumulation.
⦁ Some athletes take carnitine to improve performance.
Twenty years of research finds no consistent evidence that carnitine supplements can improve exercise or
physical performance in healthy subjects—at doses ranging from 2–6 grams/day administered for 1 to 28
days.
HMB:
⦁ It is β-hydroxy-β-methylbutyrate that improves strength, increases muscle mass and improves energy
post-exercise recovery.
⦁ HMB is an anti-catabolic agent (reduce protein degradation).
⦁ It is Effective in athletes just starting a physical activity or in an athlete changing exercise. Once the body
adapts to exercise, HMB has no effect. Hence the positive effect of HMB during exercise of short
duration and not those of long duration.
Glutamine:
This is the most abundant free amino acid in muscle and plasma. It has numerous functions:
⦁ Transfer of nitrogen between organs.
⦁ Maintain acid-base balance during acidosis.
⦁ Regulation of the synthesis and degradation of proteins.
⦁ Energy source for epithelial cells and cells of the immune system.
The main effect of glutamine is increasing blood buffering.
Group C supplements have little proof of beneficial effects and are not provided to AIS athletes. This
category includes the majority of supplements and sports products promoted to athletes. These
supplements, despite enjoying a cyclical pattern of popularity and widespread use, have not been
proven to provide a worthwhile enhancement of sports performance. Although we can't categorically
state that they don't work, current scientific evidence shows that either the likelihood of benefits is
very small or that any benefits that occur are too small to be useful. They include ginseng, coenzyme
Q10, inosine, chromium picolinate, and Medium Chain Triglyceride (MCTG).
Ginseng:
⦁ In athletes, ginseng can reduce fatigue and muscle damage, improve aerobic conditions, performance,
and immune function and increase psychomotor performance and well-being.
⦁ The majority of studies have not been able to prove all these advantages mentioned.
⦁ Ephedrine was found in some ginseng supplement, and therefore the doping effect cannot be entirely
due to the active ingredient (Ginsenosides).
Coenzyme Q 10:
It is a part of the mitochondrial antioxidant system that decreases free radicals’ formation and increases ATP
production. Research on Coenzyme Q10 supplementation have revealed the following:
⦁ No effect on lipolysis or performance.
⦁ No effect on the release of free radicals.
⦁ Increase in production of free radicals (pro-oxidant).
⦁ Increase in plasma concentration of Coenzyme Q10.
⦁ No increase in mitochondrial concentration (in striated muscle) Coenzyme Q10.
Inosine:
⦁ It is a precursor of IMP (inosine mono-phosphate).
⦁ Inosine supplementation increases muscle ATP content and has an antioxidant and vasodilator effect.
Research conducted on athletes has revealed the following:
⦁ No improvement of the performance.
⦁ No beneficial metabolic changes.
⦁ Decrease in performance level.
⦁ Increase in fatigue.
Chromium:
⦁ Low chromium levels are associated with insulin resistance and reduced growth.
⦁ Physical exercise increases urinary excretion of chromium, which is why the athlete is recommended to
take a supplement chromium.
⦁ The most biologically active form of chromium supplements is: chromium picolinate.
⦁ Chromium supplementation causes iron deficiency because the iron and Cr bind to transferrin.
Research has shown that chromium supplements are associated with:
⦁ No changes in muscle mass and in body mass.
⦁ No improvement in performance.
Medium Chain Triglyceride (MCTG):
⦁ MCTG supplementation provides athletes with a source of fat during endurance exercise thus saving
glycogen.
⦁ Research has shown that MCTG increases level of endurance performance.
⦁ The dose is critical for MCTG where doses > 30g are associated with gastrointestinal disorders.
Group D supplements should not be used by AIS athletes. These supplements are banned or are at
high risk of being contaminated with substances that could lead to a positive drug test. They include
stimulants (ephedrine, sibutramine, methylhexanamine, dimethylbutylamine, strychnine…) and
prohormones and hormone boosters (Androstenedione, DHEA, Maca root powder, Tribulus
terrestris…).
Exaggerated advertising on sports supplements claim to have miraculous effects for the athletes.
However, athletes should be cautious towards these products that should be well documented based
on scientific research to avoid falling victims of these evil claims.
References
1. Sports Supplements. Dietitians of Canada. 2018. Available at: https://www.dietitians.ca/Your-
Health/Nutrition-A-Z/Sports-Nutrition-(Adult)/Sports-Supplements.aspx
2. Classification: AIS: Australian Sports Commission. Ausportgovau. 2018. Available at:
https://www.ausport.gov.au/ais/sports_nutrition/supplements/classification
3. Thomas D, Erdman K, Burke L. Position of the Academy of Nutrition and Dietetics, Dietitians of
Canada, and the American College of Sports Medicine: Nutrition and Athletic Performance. J
Acad Nutr Diet. 2016; 116(3):501-528
3-Beta-lactams (Cefdinir 300mg bid; Cefuroxime 500mg bid; Cefixime 400mg qd; Amoxicillin-
clavulanate 1g bid 3-7days) (Diarrhea, nausea, vomiting, rash, urticaria)
OR
4-Fluoroquinolones (Ofloxacin 200mg bid; Ciprofloxacin 250-500mg according to body weight;
Levofloxacin 500mg qd; Prulifloxacin 600mg qd 3-5days) (Quinolones side effects: Nausea/vomiting,
diarrhea, C. difficile colitis, headache, drowsiness, insomnia, photosensitivity with skin rash,
prolongation of QT interval, hypo/hyperglycemia, hepatic dysfunction, Achilles tendon rupture)
Complicated UTI (Refer): functional or anatomical abnormality of the urinary tract, pregnancy, old
age, diabetes mellitus, immunosuppression, presence of an indwelling urinary catheter, urinary tract
instrumentation or surgery, hospital-acquired infection, presence of a urolithiasis, symptoms for
more than 7 days at presentation, renal failure, renal transplant, and an infection with a pathogen
resistant to broad-spectrum antibiotics.
Acute Pharyngitis
Treatment Algorithm
Diagnosis NO ANTIBIOTIC!!
Swabbing the throat and testing for
Group A Streptococcus by rapid
antigen detection test and/or culture
Treatment
Amoxicillin 50mg/kg once daily (max 1000mg) or 25mg/kg (max 500mg) bid for 10days - Adjunctive
therapy (Acetaminophen/NSAID)
If penicillin allergy:
Clindamycin 7mg/kg/dose tid (max=300mg/dose) for 10days (diarrhea, C. difficile colitis, skin rashes,
metallic taste)
Azithromycin 12mg/kg qd (max=500mg) for 5days (GI upset, hepatotoxicity); take 1 hour before or 2 hours
after meal
Clarithromycin 7.5mg/kg/dose bid (max=250mg/dose) for 10days (GI upset, hepatotoxicity, cardiac
arrhythmias); the extended release should be taken with food
IDSA 2012
Infectious Diarrhea
Diarrhea: passage of 3 or more loose or liquid stools per 24 hours, or more frequently than is normal
for an individual.
Acute diarrhea: <7days (acute watery or acute bloody or acute gastroenteritis)
Prolonged diarrhea: 7-13 days
Persistent diarrhea: 14-29 days
Chronic diarrhea: ≥ 30 days
Management
⦁ If the diarrhea is accompanied by fever, bloody or mucoid stools, severe abdominal cramping or
tenderness, or signs of sepsis
- Stool testing should be performed for Salmonella, Shigella, Campylobacter, Yersinia, C.
difficile, and STEC (Shiga toxin-producing E. coli)
- Empiric antimicrobial treatment is not recommended
- Campylobacter: 1- Azithromycin / 2-Ciprofloxacin
- C. difficile: 1- Oral vancomycin / 2- Métronidazole (reddish brown urine, headache, nausea,
dry mouth, metallic taste, disulfiram-like effect)
- C. Nontyphoidal Salmonella enterica: antibiotics usually not indicated for uncomplicated
infection
- Salmonella enterica Typhi or Paratyphi: 1- Ceftriaxone (induration after IM injection,
eosinophilia, pancreatitis, hemolytic anemia, nephrotoxicity) or ciprofloxacin / 2- Ampicillin or
trimethoprim/sulfamethoxazole (TMP-SMX) or azithromycin
- Shigella: 1- Azithromycin or ciprofloxacin or ceftriaxone / 2- TMP-SMX or ampicillin
⦁ In the absence of signs and symptoms to suggest inflammatory bacterial infection, viral infection
becomes significantly more likely
- Antimicrobial therapy is ineffective and potentially harmful
Acute Rhinosinusitis
Inflammation of the mucosal lining of the nasal passage and paranasal sinuses
lasting up to 4 weeks.
Infection by viruses, bacteria, or fungi
Allergens, Environmental irritants
Diagnosis of rhinosinusitis based on the presence of at least 2 major or 1 major and ≥ 2 minor
symptoms
Major symptoms Minor symptoms
Purulent anterior nasal discharge Headache
Purulent or discolored posterior nasal discharge Ear pain, pressure, or fullness
Nasal congestion or obstruction Halitosis
Facial congestion or fullness Dental pain
Facial pain or pressure Cough
Hyposmia or anosmia Fever (for subacute or chronic sinusitis)
Fever (for acute sinusitis only) Fatigue
Viral infection (90-98%) Bacterial infection (2-10%)
⦁ Nasal symptoms (discharge and ⦁ Onset with persistent symptoms or signs
congestion/obstruction) and/or cough compatible with acute rhinosinusitis, lasting for
⦁ Scratchy throat ≥10days without any evidence of clinical
⦁ The nasal discharge begins clear and watery to improvement
become thicker and more mucoid/ purulent for ⦁ Onset with severe symptoms or signs of high
several days. Then the situation reverses with the fever (≥39°C) and purulent nasal discharge or
purulent discharge becoming mucoid and then facial pain lasting for at least 3-4 consecutive
clear again, or simply drying days at the beginning of illness
⦁ The fever and constitutional symptoms (if ⦁ Onset with worsening symptoms or signs
present) disappear in the first 24-48hours and characterized by the new onset of fever,
the respiratory symptoms become more headache, or increase in nasal discharge
prominent following a typical viral upper respiratory
⦁ Respiratory symptoms last 5-10days infection that lasted 5-6days and were initially
improving (“double-sickening”)
Treatment of bacterial sinusitis First-line (Daily dose) Second line (Daily dose)
Initial empirical therapy Amoxicillin-clavulanate Amoxicillin-clavulanate
(5-7days) (500mg/125mg PO tid, or (2000mg/125mg PO bid)
(consider adjunctive therapy: 875mg/125mg PO bid) Doxycycline (100mg PO bid or
intranasal saline irrigations/intranasal 200mg PO qd) (Epigastric burning,
corticosteroids) abdominal discomfort, nausea,
vomiting, diarrhea, photosensitivity
reactions, hepatotoxicity)
β-lactam allergy Doxycycline (100mg PO bid or
200mg PO qd)
Levofloxacin (500mg PO qd)
Moxifloxacin (400mg PO qd)
Risk for antibiotic resistance or failed Amoxicillin-clavulanate
initial therapy (Age>65, prior (2000mg/125mg PO bid)
antibiotics within the past month, prior Levofloxacin (500mg PO qd)
hospitalization past 5 days, Moxifloxacin (400mg PO qd)
comorbidities, immunocompromised)
IDSA 2011, LSID 2017, IDSA 2012, IDSA 201, CDC, WHO, IDSA 2012
References
1. Gupta K, Hooton TM, Naber KG, Wullt B, Colgan R, Miller LG, et al. International Clinical Practice
Guidelines for the Treatment of Acute Uncomplicated Cystitis and Pyelonephritis in Women: A
2010 Update by the Infectious Diseases Society of America and the European Society for
Microbiology and Infectious Diseases. Clin Infect Dis. 2011 Mar 1; 52(5):e103–20.
2. Husni R, Atoui R, Choucair J. The Lebanese Society of Infectious Diseases and Clinical
Microbiology: Guidelines for the Treatment of Urinary Tract Infections. Lebanese Medical Journal.
2017 Dec; 65(4):208–19.
3. Shulman ST, Bisno AL, Clegg HW, Gerber MA, Kaplan EL, Lee G, et al. Clinical Practice Guideline
for the Diagnosis and Management of Group A Streptococcal Pharyngitis: 2012 Update by the
Infectious Diseases Society of America. Clin Infect Dis. 2012 Nov 15; 55(10):e86–102.
4. Shane AL, Mody RK, Crump JA, Tarr PI, Steiner TS, Kotloff K, et al. 2017 Infectious Diseases Society
of America Clinical Practice Guidelines for the Diagnosis and Management of Infectious Diarrhea.
2017; 65(12):e45–e80
5. Diarrhoeal disease [Internet]. World Health Organization 2017. Available at:
http://www.who.int/news-room/fact-sheets/detail/diarrhoeal-disease
6. Travelers’ Diarrhea - Chapter 2 - 2018 Yellow Book | Travelers’ Health | CDC. Available at:
https://wwwnc.cdc.gov/travel/yellowbook/2018/the-pre-travel-consultation/travelers-diarrhea
7. Chow AW, Benninger MS, Brook I, Brozek JL, Goldstein EJC, Hicks LA, et al. IDSA Clinical Practice
Guideline for Acute Bacterial Rhinosinusitis in Children and Adults. Clin Infect Dis. 2012 Apr 15;
54(8):e72–112.
8. Goodman and Gilman’s. The pharmacological basis of therapeutics 12th edition. Mc Graw Hill
2011.
Prevention:
⦁ Adequate calcium intake (supplementation with 1200-1500mg, if needed)
⦁ Adequate vitamin D intake (supplementation with 600-800 IU, if needed to maintain serum 25-
hydroxyvitamin D [25(OH)D] between 30 and 60 ng/mL)
⦁ Limit alcohol intake (≤ 2 servings per day)
⦁ Limit caffeine intake (<3 per day)
⦁ Smoking cessation
⦁ Active lifestyle: Weight-bearing exercises for 30 minutes daily
⦁ Adequate protein intake
References
1. Watts, Nelson et al. "American Association of Clinical Endocrinologists Medical Guidelines for
Clinical Practice for The Diagnosis and Treatment of Postmenopausal Osteoporosis: Executive
Summary of Recommendations". Endocrine Practice 16.6 (2010): 1016-1019. Web.
2. Lexi-Drugs. Lexicomp. Wolters Kluwer Health Inc. Hudson, OH. Available at:
http://online.lexi.com.
References
1. Garber, Jeffrey R. et al. "Clinical Practice Guidelines for Hypothyroidism in Adults: Cosponsored
by The American Association of Clinical Endocrinologists and The American Thyroid Association".
Thyroid 22.12 (2012): 1200-1235.
2. Lexi-Drugs. Lexicomp. Wolters Kluwer Health Inc. Hudson, OH. Available at:
http://online.lexi.com.
Overview
Objective: of this paper is to have standard operating procedure for storage of medicines.
Scope: All products that within the drugstore. Should be under specific temperature for other
temperature-sensitive drugs and proper categorized.
Responsibility: Pharmacist, Owner/Manager, Pharmacy Assistant
Procedure:
⦁ After initially checking the medicines delivered, all products should be wrapped by a clear plastic
to avoid accumulation of dust particulates.
⦁ Transfer the goods to their respective areas.
⦁ Store the goods in an organized and orderly manner with the label bearing the name of the
product in front.
⦁ First-Expire-First-Out will be the basis of disposing drugs.
⦁ Avoid direct contact to the sun or on the walls to avoid moisture accumulation.
⦁ Store controlled drugs substances and other potent drugs in the designated. Access this area
should only be allowed to the pharmacist and owner.
⦁ Store expired goods in the storage room, marking it with “Expired” to prevent use.
⦁ Store medicines at stipulated temperature areas, protected from excessive light, dust and
humidity. The temperature should be checked by the pharmacist daily and recorded in the
monitoring sheet if necessary for cold chain drugs.
⦁ Store the other stock in a separated area. Maintain all sales invoice records for return or exchange
of products to the supplier.
⦁ Clean and maintain the storage areas neat and tidy all the times.
Introduction
Maintaining proper storage conditions for health commodities is vital to ensuring their quality.
Product expiration dates are based on ideal storage conditions and protecting product quality until
their expiration date is important for serving customers and conserving resources.
The Guide to Good Storage Practices for Pharmaceuticals is a practical reference for those managing
or involved in setting up a storeroom or warehouse. The guide contains written directions on
receiving and arranging commodities; special storage conditions; tracking commodities; maintaining
the quality of the products; constructing and designing a medical store; waste management; and
resources. It was written to meet the needs of any storage facility, of any size, in any type of
environment, provided that the desired standards of quality are still achieved.
These guidelines are issued, according to the guidelines and instructions of the World Health
Organization and the International Pharmaceutical Federation (FIP), by the Order of Pharmacy in
Lebanon, which stresses the importance of adhering to it by all parties involved in any aspect of the
storage of pharmaceutical products, as relevant to the particular role that they play, from the
premises of the manufacturer of the product to the person dispensing or providing pharmaceutical
products directly to a patient.
Glossary
The definitions given below of some of the terms used in this document take into account the
terminology of current regulations and recommendations.
⦁ Active pharmaceutical ingredient (API): Any substance or mixture of substances intended to
be used in the manufacture of a pharmaceutical dosage form and that, when used in the
production of a drug, becomes an active ingredient of that drug. Such substances are intended
to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation,
treatment or prevention of disease, or to affect the structure and function of the body.
⦁ Distribution: The division and movement of pharmaceutical products from the premises of the
manufacturer of such products, or another central point, to the end user thereof, or to an
intermediate point by means of various transport methods, via various storage and/or health
establishments.
⦁ Container: The material employed in the packaging of a pharmaceutical product. Containers
include primary, secondary and transportation containers. Containers are referred to as primary
if they are intended to be in direct contact with the product. Secondary containers are not
intended to be in direct contact with the product.
⦁ Contamination: The undesired introduction of impurities of a chemical or microbiological
nature, or of foreign matter, into or onto a starting material, or intermediate or finished product
during production, sampling, packaging or repackaging, storage or transport.
⦁ Counterfeit: A counterfeit medicine is one which is deliberately and fraudulently mislabeled with
respect to identity and/or source. Counterfeiting can apply to both branded and generic
products and counterfeit products and may include products with the correct ingredients or with
the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake
packaging.
⦁ Cross-contamination: Contamination of a starting material, intermediate product or finished
product with another starting material or product during production.
⦁ Excipient: A substance, other than the active ingredient, which has been appropriately evaluated
for safety and is included in a drug delivery system to:
- Aid in the processing of the drug delivery system during its manufacture
- Protect, support or enhance stability, bioavailability, or patient acceptability
- Assist in product identification; or
- Enhance any other attribute of the overall safety and effectiveness of the drug during
storage or use.
⦁ Expiry date: The date given on the individual container (usually on the label) of a drug product
up to and including which the product is expected to remain within specifications, if stored
correctly. It is established for each batch by adding the shelf-life to the date of manufacture.
⦁ Labelling: The action involving the selection of the correct label, with the required information,
followed by line clearance and application of the label.
⦁ Manufacture: All operations of purchase of materials and products, production, quality control,
release, storage and distribution of finished products, and the related controls.
⦁ Material: A general term used to denote starting materials (active pharmaceutical ingredients
and excipients), reagents, solvents, process aids, intermediates, packaging materials and labeling
materials.
⦁ Packaging material: Any material, including printed material, employed in the packaging of a
pharmaceutical product, but excluding any outer packaging used for transportation or shipment.
Packaging materials are referred to as primary or secondary according to whether or not they
are intended to be in direct contact with the product.
⦁ Pharmaceutical product: Any medicine intended for human use or veterinary product
administered to food-producing animals, presented in its finished dosage form or as a starting
material for use in such a dosage form, that is subject to control by pharmaceutical legislation in
both the exporting state and the importing state.
⦁ Production: All operations involved in the preparation of a pharmaceutical product, from receipt
of materials, through processing, packaging and repackaging, labelling and re-labelling, to
completion of the finished product.
⦁ Product recall: Product recall is a process for withdrawing or removing a pharmaceutical product
from the pharmaceutical distribution chain because of defects in the product or complaints of
serious adverse reactions to the product. The recall might be initiated by the
manufacturer/importer/ distributor or a responsible agency.
⦁ Quality assurance: Quality assurance is a wide-ranging concept covering all matters that
individually or collectively influence the quality of a product. It is the totality of the arrangements
made.
⦁ Quality control: Quality control covers all measures taken, including the setting of specifications,
sampling, testing and analytical clearance, to ensure that starting materials, intermediates,
packaging materials and finished pharmaceutical products conform with established
specifications for identity, strength, purity and other characteristics.
⦁ Quarantine: The status of starting or packaging materials, intermediates, or bulk or finished
products isolated physically or by other effective means while a decision is awaited on their
release, rejection or reprocessing.
⦁ Shelf-life: The period of time during which a finished pharmaceutical product, if stored correctly,
is expected to comply with the specification as determined by stability studies on a number of
batches of the product. The shelf-life is used to establish the expiry date of each batch.
⦁ Standard operating procedure (SOP): An authorized, written procedure giving instructions for
performing operations not necessarily specific to a given product but of a more general nature
(e.g. equipment operation, maintenance and cleaning, validation, cleaning of premises and
environmental control, sampling and inspection).
⦁ Storage: The storing of pharmaceutical products and materials up to their point of use.
⦁ Supplier: A person providing pharmaceutical products and materials on request. Suppliers may
be agents, brokers, distributors, manufacturers or traders. Where possible, suppliers should be
authorized by a competent authority.
⦁ Retest date: The date when a material should be re-examined to ensure that it is still suitable
for use.
⦁ Validation: A documented program that provides a high degree of assurance that a specific
process, method or system will consistently produce a result meeting pre-determined
acceptance criteria.
Personnel
⦁ At each storage site (e.g. that of a manufacturer, distributor, wholesaler, community or hospital
pharmacy) there should be an adequate number of qualified personnel to achieve
pharmaceutical quality assurance objectives. National regulations on qualifications should be
followed.
⦁ All personnel should receive proper training in relation to good storage practice, regulations,
procedures and safety.
⦁ All members of staff should be trained in, and observe high levels of, personal hygiene and
sanitation.
⦁ Personnel employed in storage areas should wear suitable protective or working garments
appropriate for the activities they perform.
bulk and finished products, products in quarantine, and released, rejected, returned or recalled
products.
⦁ Storage areas should be designed or adapted to ensure good storage conditions. In particular,
they should be clean and dry and maintained within acceptable temperature limits. Where special
storage conditions are required on the label (e.g. temperature, relative humidity), these should
be provided, checked, monitored and recorded. Materials and pharmaceutical products should
be stored off the floor and suitably spaced to permit cleaning and inspection. Pallets should be
kept in a good state of cleanliness and repair.
⦁ Storage areas should be clean, and free from accumulated waste and vermin. A written sanitation
program should be available indicating the frequency of cleaning and the methods to be used
to clean the premises and storage areas.
⦁ There should also be a written program for pest control. The pest-control agents used should be
safe, and there should be no risk of contamination of the materials and pharmaceutical products.
⦁ There should be appropriate procedures for the clean-up of any spillage to ensure complete
removal of any risk of contamination.
⦁ Reception areas should be designed and equipped to allow containers of incoming materials
and pharmaceutical products to be cleaned, if necessary, before storage.
⦁ Where quarantine status is ensured by storage in separate areas, these areas must be clearly
marked and their access restricted to authorized personnel. Any system replacing physical
quarantine should provide equivalent security. For example, computerized systems can be used,
provided that they are validated to demonstrate security of access.
⦁ There should normally be a separate sampling area for starting materials in a controlled
environment. If sampling is performed in the storage area, it should be conducted in such a way
as to prevent contamination or cross-contamination. Adequate cleaning procedures should be
in place for the sampling areas.
⦁ Physical or other equivalent validated (e.g. electronic) segregation should be provided for the
storage of rejected, expired, recalled or returned materials or products. The materials or products,
and areas concerned should be appropriately identified.
⦁ Highly active and radioactive materials, narcotics and other hazardous, sensitive and/or
dangerous materials and pharmaceutical products, as well as substances presenting special risks
of abuse, fire or explosion, (e.g. combustible liquids and solids and pressurized gases) should be
stored in a dedicated area that is subject to appropriate additional safety and security measures.
⦁ Materials and pharmaceutical products should be handled and distributed according to GMP as
defined in this document.
⦁ Materials and pharmaceutical products should be handled and stored in such a manner as to
prevent contamination, mix-ups and cross-contamination.
⦁ Materials and pharmaceutical products should be stored in conditions which assure that their
quality is maintained, and stock should be appropriately rotated. The “first expired/first out”
(FEFO) principle should be followed.
⦁ Rejected materials and pharmaceutical products should be identified and controlled under a
quarantine system designed to prevent their use until a final decision is taken on their fate.
⦁ Narcotic drugs should be stored in compliance with international conventions, and national laws
and regulations on narcotics.
⦁ Broken or damaged items should be withdrawn from usable stock and separated.
⦁ Storage areas should provide adequate lighting to enable all operations to be carried out
accurately and safely.
Storage conditions
⦁ Storage conditions for pharmaceutical products and materials should be in compliance with the
labelling, which is based on the results of stability testing (see Appendix).
⦁ Comprehensive records should be maintained showing all receipts and issues of materials and
pharmaceutical products according to a specified system, e.g. by batch number.
Labelling and containers
⦁ All materials and pharmaceutical products should be stored in containers which do not adversely
affect the quality of the materials or products concerned, and which offer adequate protection
from external influences. In some circumstances, this could include bacterial contamination.
⦁ All containers should be clearly labelled with at least the name of the material, the batch number,
the expiry date or retest date, the specified storage conditions and reference to the
pharmacopoeia, where applicable. Unauthorized abbreviations, names or codes should not be
used.
Receipt of incoming materials and pharmaceutical products
⦁ On receipt, each incoming delivery should be checked against the relevant purchase order and
each container physically verified, e.g. by the label description, batch number, type of material
or pharmaceutical product and quantity.
⦁ The consignment should be examined for uniformity of the containers and, if necessary, should
be subdivided according to the supplier’s batch number should the delivery comprise more than
one batch.
⦁ Each container should be carefully inspected for possible contamination, tampering and damage,
and any suspect containers or, if necessary, the entire delivery should be quarantined for further
investigation.
⦁ When required, samples should be taken only by appropriately trained and qualified personnel
and in strict accordance with written sampling instructions. Containers from which samples have
been taken should be labelled accordingly.
⦁ Following sampling, the goods should be subject to quarantine. Batch segregation should be
maintained during quarantine and all subsequent storage.
⦁ Materials and pharmaceutical products should remain in quarantine until an authorized release
or rejection is obtained.
⦁ Measures should be taken to ensure that rejected materials and pharmaceutical products cannot
be used. They should be stored separately from other materials and pharmaceutical products
while awaiting destruction or return to the supplier.
Stock rotation and control
⦁ Periodic stock reconciliation should be performed by comparing the actual and recorded stocks.
⦁ All significant stock discrepancies should be investigated as a check against inadvertent mix-ups
and/or incorrect issue.
⦁ In manufacturing facilities, partly used containers of materials and pharmaceutical products
should be securely reclosed and resealed to prevent spoilage and/or contamination during
subsequent storage. Materials and pharmaceutical products from containers which have been
opened or partly used should be used up before those in unopened containers.
⦁ Damaged containers should not be issued unless the quality of the material has been shown to
be unaffected. Where possible, this should be brought to the attention of the person responsible
for quality control. Any action taken should be documented.
Control of obsolete and outdated materials and pharmaceutical products
⦁ All stocks should be checked regularly for obsolete and outdated materials and pharmaceutical
products. All due precautions should be observed to prevent the issue of outdated materials and
pharmaceutical products.
Returned goods
⦁ Returned goods, including recalled goods, should be handled in accordance with approved
procedures and records should be maintained.
⦁ All returned goods should be placed in quarantine and returned to saleable stock only after this
has been approved by a nominated, responsible person following a satisfactory quality re-
evaluation.
⦁ Any stock reissued should be so identified and recorded in stock records. Pharmaceuticals
returned from patients to the pharmacy should not be taken back as stock, but should be
destroyed.
Documentation
⦁ The pharmacy shall establish appropriate documented procedures and instructions related to all
storage and distribution of pharmaceutical products activities.
⦁ The title, nature and purpose of each document shall be clearly stated and shall comply with
national legislative requirements. The contents of documents shall be clear and unambiguous.
Documents shall be laid out in an orderly fashion and be easy to check.
⦁ All documents shall be completed, approved, signed (as required) and dated by an appropriate
authorized person(s) and shall not be changed without the necessary authorization.
⦁ Procedures shall be established and maintained for the editing, review, approval, use of and
control of changes to all documents relating to the distribution and storage activities. Procedures
must be in place for both internally generated documents and those from external sources.
⦁ The pharmacy shall keep records of all pharmaceutical products received. Records shall contain
at least the following information: date, name of the pharmaceutical product, quantity received
or supplied and name and address of the supplier.
⦁ All records must be readily retrievable, and be stored and retained using facilities that are
safeguarded against unauthorized modification, damage, deterioration and/or loss of
documentation.
⦁ Permanent records, written or electronic, shall exist for each stored product indicating
recommended storage conditions, any precautions to be observed and retest dates.
Pharmacopoeial requirements and current national regulations concerning labels and containers
shall be respected at all times.
⦁ The pharmacy shall ensure appropriate backup systems for electronic documents and records.
The server room shall also be appropriated maintained to prevent any data loss.
⦁ The holder of the marketing authorization, relevant official authorities and Drug Control
Department, should be informed immediately. A full detailed report of the case in hand, attached
with photos for the inner and outside packaging and the dosage form unit along with
representative samples should be submitted to be checked and analyzed by the Drug Control
Department.
References
1. Good trade and distribution practice (GTDP) of pharmaceutical starting materials. Geneva, World
Health Organization, 2002 (unpublished document QAS/01.014; available on request from
Essential Drugs and Medicines Policy, World Health Organization, 1211 Geneva 27, Switzerland).
2. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-fourth report.
Geneva, World Health Organization, 1996 (WHO Technical Report Series, No. 863).
3. Good manufacturing practices for pharmaceutical products. In: Quality assurance of
pharmaceuticals. A compendium of guidelines and related materials. Volume 2. Good
manufacturing practices and inspection. Geneva, World Health Organization, 1999; WHO Expert
Committee on Specifications for Pharmaceutical Preparations. Thirty-Fifth report. Geneva, World
Health Organization, 1999 (WHO Technical Report Series, No. 885); WHO Expert Committee on
Specifications for Pharmaceutical Preparations. Thirty-Sixth report. Geneva, World Health
Organization, 2002 (WHO Technical Report Series, No. 902)
4. The international pharmacopoeia, 3rd ed. Vol. 1: General methods of analysis; Vol. 2: Quality
specifications; Vol. 3: Quality specifications; Vol. 4: Tests, methods, and general requirements.
Quality specifications for pharmaceutical substances, excipients, and dosage forms; Volume 5:
Test and general requirements for dosage forms. Quality specifications for pharmaceutical
substances and tablets (in press). Geneva, World Health Organization, 1979–2002.
5. https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/u
cm073369
6. WHO good distribution practices for pharmaceutical products (WHO technical report series, No.
957, 2010)
7. United Arab Emirates Ministry of Health Drug Control Department, GOOD PHARMACEUTICAL
STORAGE & DISTRIBUTION PRACTICES (GS&DP), 2006
8. Quality assurance of pharmaceuticals. A compendium of guideline s and related materials.
Volume 1. Geneva, World Health Organization, 1997.
9. Quality assurance of pharmaceuticals. A compendium of guideline s and related materials.
Volume 2. Good manufacturing practices and inspection. Geneva, World Health Organization,
1999.
10. Good storage practice: Joint report of the Committee for Official Laboratories and Medicinal
Control Services and the Industrial Pharmacists Section of the International Pharmaceutical
Federation (FIP). Pharm. Ind., 1980, 42:1082– 1085.
11. Management of drug purchasing, storage and distribution. Manual for developing countries.
Geneva, World Health Organization, 1992.
Overview
Health care waste (HCW) is all waste that is generated in health care facilities. The management of
HCW poses a major environmental and public health challenge.
Exposure to HCW can cause several diseases all of which could cause death: leptospirosis, typhoid,
cholera, Human immunodeficiency virus (HIV), tuberculosis (TB), hepatitis A, B and C infections.
Types of Waste
⦁ Infectious waste: Waste contaminated with blood and other bodily fluids. Discarded diagnostic
samples, cultures, waste from autopsies, infected animals from laboratories, swabs, bandages
and disposable medical devices.
⦁ Pathological waste: Human tissues, organs or fluids, body parts and contaminated animal
carcasses.
⦁ Sharps waste: Syringes, needles, disposable scalpels and blades.
⦁ Chemical waste: Solvents and reagents used for laboratory preparations, disinfectants, and heavy
metals contained in medical devices (mercury in broken thermometers).
⦁ Pharmaceutical waste: Expired, unused and contaminated drugs and vaccines.
⦁ Cytotoxic waste: Highly hazardous substances that are, mutagenic, teratogenic or carcinogenic.
Cytotoxic drugs used in cancer treatment and their metabolites.
⦁ Radioactive waste: Radioactive diagnostic material or radio-therapeutic materials.
⦁ Non-hazardous or general waste: Waste that does not pose any particular biological, chemical,
radioactive or physical hazard.
Pharmaceutical Waste
⦁ Controlled Substances: Cytotoxic substances and residues, narcotics, psychotropic substances,
anti-infective drugs, antiseptics and disinfectants.
⦁ Chemical Wastes: Outdated, contaminated and discarded medicines.
⦁ Biomedical wastes: Laboratory cultures, specimens of microorganisms, live or attenuated
vaccines, toxins, dishes and devices used for the transfer of cultures.
⦁ Others:
- All unsealed syrups, creams, ointment or eye drops
- All damaged cold chain expired/unexpired pharmaceuticals: Insulin, polypeptide hormones,
gamma globulins and vaccines
- All bulk or loose tablets and capsules
- Any items used in cleaning up a spill
- Waste materials containing chemotherapy drug residues or excess drugs: Syringes, IV bags,
tubing, vials
- Open containers of drugs that cannot be used
- Containers that held acute hazardous waste drugs
Waste
Waste
Treatment &
Identification
Disposal
Internal Waste
Storage Segregation
Waste
Handling
Yellow
Sharps Puncture Proof Containers
“Marked SHARPS”
⦁ Data Stickers: Must be attached to the containers and bags of waste prior to their transportation
to stores within the health care facility. Stickers should have the following data:
- Waste generator name
- Site name
- Type of waste
- Weight and the quantity of waste
- Date and time of collection transportation date
- Time to disposal facility
⦁ Infectious: Waste which requires treatment to “render safe” in a suitably licensed and permitted
facility (usually alternative treatment plants). May also be disposed by incineration.
⦁ Anatomical: Waste which requires disposal by treatment to “render safe” in a suitably licensed
and permitted facility or by landfill at a suitably licensed and permitted site. May also be disposed
by incineration.
⦁ Sharps and pressurized containers: Waste which requires disposal by incineration in suitably
licensed and permitted facility.
⦁ Encapsulating:
- Pre-treatment involving filling containers with waste, adding an immobilizing material and
sealing the container e.g. bituminous sand, cement mortar
- Advantages: Prevents access to HCW by scavengers. Simple, low cost & safe
- Disadvantages: Bulky and heavy final waste product to be disposed of
- Condition: Sharps, chemical or pharmaceutical residue
Reference
1. Ali M, Wang W, Chaudhry N, Geng Y. Hospital waste management in developing countries: a
mini review. Waste Management & Research. 2017 Jun;35(6):581-92.
2. Jaseem M, Kumar P, John RM. An overview of waste management in pharmaceutical industry.
The Pharma Innovation. 2017 Mar 1;6(3, Part C):158.
3. World Health Organization, 2017. Safe management of wastes from health-care activities: a
summary.
4. Fundamentals of health-care waste management Guidance Manual (2017), United Nations
Environment Programme / SBC, World Health Organization.
5. Mathur P, Patan S, Shobhawat AS. Need of biomedical waste management system in hospitals-
An emerging issue-a review. Current World Environment. 2017 Jun 23;7(1).
6. Y. Chartier et al. (2014). Safe management of wastes from health-care activities. 2nd ed. Geneva
27, Switzerland: World Health Organization (WHO)
7. Karam R, Oueida F, Tissot-Guerraz F, Trepo D, Collombel C. Hospital waste management status
in Lebanon. Journal Scientifique Libanais. 2000 Jul 1;1(1):13.