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Magistrinis Mariaus 06.02 KAUNAS UNIVERSITY OF MEDICINE FACULTY OF PHARMACY DEPARTMENT OF BASIC AND CLINICAL PHARMACOLOGY Trends in the consumption of analgesic drugs in Lithuania in 2005 - 2007. MASTER WORK (Pharmacoepidemiology) Supervised by: Doc.dr. Edmundas Kaduševi čius Performed by: Marius Lasinskas Faculty of Pharmacy 5/3 gr. Kaunas, 2008 TABLE OF CONTENTS ABBREVIATIONS ............................................................................................................................. 3 1. INTRODUCTION........................................................................................................................... 4 2. REVIEW.......................................................................................................................................... 6 2.1. Pain types and chronic pain classification................................................................................ 6 2.2. Over-the-counter (OTC) pain relievers .................................................................................... 7 2.3. The safety of OTC medications................................................................................................ 7 2.4. Non-opioid analgesic pain relievers ......................................................................................... 8 2.5. Long-term pain management.................................................................................................... 9 2.6. Performed studies ................................................................................................................... 11 3. OBJECTIVE.................................................................................................................................. 16 4. AIMS ............................................................................................................................................. 16 5. METHODOLOGY ........................................................................................................................ 17 5.1. The purpose of the ATC/DDD system.................................................................................... 17 5.2. The ATC classification – structure and principles.................................................................. 17 5.3. The DDD – definition and principles ..................................................................................... 18 5.4. Drug utilization....................................................................................................................... 18 6. RESULTS ...................................................................................................................................... 20 6.1. Analysis of plain drugs consumption in DDD........................................................................ 20 6.2. Analysis of combined analgesic drugs in DDD...................................................................... 25 6.3. Analysis of pain relievers for injections in DDD ................................................................... 26 6.4. Analgesics consumption in various European countries ........................................................ 29 7. DISCUSSION................................................................................................................................ 31 7.1. Evaluation of analgesic drugs consumption in DDD ............................................................. 31 7.2. NSAIDs utilization, effectiveness and safety......................................................................... 32 7.3. Consumption and safety of paracetamol ............................................................................... 33 8. CONCLUSIONS ........................................................................................................................... 35 SUMMARY....................................................................................................................................... 36 SANTRAUKA .................................................................................................................................. 37 REFERENCES .................................................................................................................................. 38 ANNEX 1- 8...................................................................................................................................... 42 2 ABBREVIATIONS AGs Analgesics ATC Anatomical Therapeutic Chemical classification COX-2 Cyclooxygenase-2 DDD Defined daily dose ENSS Spanish National Health Survey FDA Food and drug administration GA Gastric bleeding GI Gastrointestinal system HF Heart failure LTY Liver toxicity NSAIDs Non-steroidal antiinflamatory drugs OA Osteoarthritis OTC Over-the-counter EU European Union WHO World Health Organization 3 1. INTRODUCTION In the current public health framework, the importance of medication as a determinant of citizens’ health emerges as a factor warranting special attention. [ 1, 2] Within the overall context of medicine, medication is regarded as an element having differential features for two specific reasons, these being its role in medical practice and, secondly, the value of knowing how it is used in such practice. [ 3] At the present time, consumption of drugs without medical prescription has risen to a significant level, and development that may, in turn, have serious consequences on the individual and collective health of the population. [ 4–6] This circumstance has been accentuated by the growing replacement of prescribed medicines by over-the-counter (OTC) remedies, which are not always correctly used. [ 7–11 ] However, one cannot ignore the fact that, while the term ‘self- medication’ has negative connotations, it now constitutes the most significant form of self-care in the population. Almost half of all medicines globally are used irrationally. This, say medicines experts at the World Health Organization (WHO), can have severe consequences: adverse drug reactions, drug resistance, protracted illness and even death. [12] Rational drug therapy means the use of right medicine in the right manner (dose, route and frequency of administration, duration of therapy etc.) in right patient at a right cost. Rational drug therapy also means using the drug when necessary. Hence, the drug chosen for a patient should be effective, safe and acceptable quality and cost. [13] The use of analgesics (pain relievers) and other medications is the most common method of chronic pain treatment. Pain medications can be helpful for some patients in chronic pain, but they are not universally effective. Short-term use of medications for pain is rarely worrisome, but prolonged use increases the possibility of adverse reactions including gastrointestinal distress, internal organ problems, balance troubles, and memory and concentration problems. It is important to remember, everyone responds in a different manner to the same dose of medication. Therefore, each person with chronic pain should be medically managed individually, and medication use should be determined by benefit, cost, potential side effects, and the person’s other medical problems. [14] Relevance and novelty of this work According to the available literature, the comprehensive pharmacoepidemiological analysis of analgesics consumption has not been performed in Lithuania yet. 4 In the mentioned analysis the drug consumption data was taken from the year 2005 – 2007, so the results are topical, confident and upto-date. The performed estimations are topical because: □ Every day millions of people use analgesics to relieve pain in the whole world. □ Consumption of OTC drugs has risen to a high level. □ Most, pain experienced by the general public is treated without consulting a health professional. [15] □ Such analysis should lead to implementation in different guidelines about the rational utilization of medicines. 5 2. REVIEW 2.1. Pain types and chronic pain classification Acute pain is distinguished as being of recent onset, transient, and usually from an identifiable cause. Chronic pain can be described as persistent or recurrent pain, lasting beyond the usual course of acute illness or injury or more than 3 to 6 months, and which adversely affects the individual’s well-being. A simpler definition for chronic pain is pain that continues when it should not. It is usually treated with medicine that you take at specific times every day (rather than as needed) so that you get pain relief throughout the day. Breakthrough or Flare-up pain can be described as transient pain beyond the normal pain baseline which is severe or excruciating. Breakthrough or flare-up pain consists of unpredictable pain flares that "break through" the medicine taken around-the-clock to treat persistent pain. Breakthrough or flare-up pain may be caused by changes in an underlying disease, including treatment, or involuntary or voluntary physical actions - such as coughing or getting up from a chair. Breakthrough or flare-up pain may also occur at the end of the scheduled pain medicine dose. Treatment for moderate-to-severe breakthrough pain is a strong, short-acting pain medicine, such as an opioid, that works quickly and lasts about as long as a breakthrough or flare-up pain episode. Some pain physicians feel that if you are taking pain medication for breakthrough or flare-up pain regularly, your regular long-acting pain medicine may not be effective. Alternative pain management strategies may be needed. Chronic pain is classified by pathophysiology (the functional changes
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