Category Archives: Number

Pharmaceutical Serialization, a Global Effort to Combat Counterfeit Medicines

Georgiana Andreea Pascu1, Gabriel Hancu2, Aura Rusu2

1. Regulatory Affairs Department, Gedeon Richter Romania
2. Department of Pharmaceutical Chemistry, Faculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, Romania

DOI: 10.2478/amma-2020-0028

Objective: Pharmaceutical serialization is a process in the pharmaceutical industry that offers a secure solution to track and authenticate drugs in the distribution chain. The unique recognition number for every drug unit helps to identify and combat counterfeit products. This paper aims to highlight the advantages of serialization implementation as an innovative tool to combat globally the counterfeiting drugs phenomenon.
Methods: Worldwide a considerable effort was focused on enhancing medicines identification. Analytical methods, development of the new lab equipment, digital solutions, and blockchain technology are the new directions for the future. Also, legislation needs to be correlated at the international level between the pharmaceutical industry, distribution, and pharmacies.
Results: A good collaboration between responsible entities should be implemented to protect public health and to promote patients’ access to safe medicines. A directive implemented on European Union focused on fake drugs, Global Monitoring and Surveillance System launched by the World Health Organization, or the international campaign “Fight the Fakes” are remarkable examples.
Conclusions: An efficient joint effort between the pharmaceutical industry and law enforcement is required. Counterfeit medicines are a worldwide threat to public health and demand a unitary pharmaceutical serialization system to be implemented as an ideal solution.

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Clinical Evolution of Patients with Schizophrenia Associated with Addictive Disorders

Andreea Salcudean1, Melinda Ferencz2, Daniela Sabau2, Madalina Gherman3

1. Department of Medical Ethics and Socio-Human Sciences, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, Targu Mures, Romania
2. Psychiatry Clinic 1, Mureș Clinical County Hospital, Targu Mures, Romania
3. Targu Mures Emergency County Hospital, Targu Mures, Romania

DOI: 10.2478/amma-2020-0033

Introduction: The prevalence of schizophrenia in the general population is about 0.3% -0.7% Pathological use of substances such as cocaine, alcohol, amphetamines and nicotine are common in schizophrenia with a lifetime prevalence of 80%. They tend to isolate themselves in an inner world, thus being prone to substance abuse. The most commonly used substances are: alcohol, nicotine, cocaine, amphetamines, hallucinogens and cannabis.
Method: We conducted a retrospective, descriptive-analytical study on a group of 139 patients with a positive diagnosis of schizophrenia from the Psychiatry Clinic I of the Mureș County Clinical Hospital hospitalized between 01.01.2018-31.12.2019. The clinical and paraclinical data used were processed from observation sheets in the clinic archive. These were introduced and analyzed in the Microsoft Excel 2016 program, and the statistical test used was Chi Square in the Graph-Pad statistical analysis program.
Results: Most patients with schizophrenia have a schizoid (41%) and paranoid (32%) personality. Other types are: organic 25% (unstable and impulsive) and obsessive anxiety 2%. Due to the evolution of diseases, patients end up consuming psychoactive substances, tobacco and alcohol. A percentage of 48% of patients were tobacco consumers, 37% were alcohol consumers and 15% consumed psychoactive substances. Tobacco use is not a statistically significant factor in the recurrence of the disease.
Conclusions: Alcohol, tobacco and psychoactive substances are an important risk factor in the unfavorable evolution of the disease, most hospitalized patients are in the age group 50-59 years.

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Complications Following Surgery for Low Rectal Cancer – Modified Intersphincteric Resections vs Non-Sphincter Saving Technique

Vlad Olimpiu Butiurca, Andrei Modiga, Ioan Teodor Bud, Paul Cristian Russu, Marian Botoncea, Calin Molnar, Simona Gurzu

George Emil Palade University of Medicine, Pharmacy, Sciences, and Technology, Targu Mures, Romania

DOI: 10.2478/amma-2020-0031

Introduction: In patients with low rectal cancer, a proper surgical technique is aimed to confer a better quality of life following surgery and a longer time of disease-free survival. Aim: In this study, we presented the results obtained by a single surgical centre in the treatment of low rectal cancer, using two types of surgery: intersphincteric resections (ISR) and abdominoperineal resections (APR).
Material and methods: The paper was focused on the rate of complications after surgery for low rectal cancer, which was retrospectively evaluated in 132 consecutive patients who underwent surgery over a period of 5 years. The statistical comparison was done between two groups: group 1 – that underwent ISR (n=60) and group 2 – patients evaluated after APR (n=72).
Results: The quality of life, evaluated at the regular follow-up, did not show significant difference between the two groups. Clavien-Dindo grade I and above complications were registered in 9 patients (15%) from group 1 respectively 23 patients (38.33%) from the group 2.
Conclusion: ISR is a good option for surgical removal of a low rectal cancer, with a lower rate of complications, compared with APR technique.

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Effect of Caffeine on Pain Management

Paul Grama1, Miruna Pepa Oltea2, Corina Adelina Zah1

1. Faculty of Medicine, “Iuliu Hațieganu” University of Medicine and Pharmacy, Cluj-Napoca, Romania
2. Transplant and Cardiovascular Disease Institute, Targu Mures, Romania

DOI: 10.2478/amma-2020-0030

Caffeine is a widely consumed substance, as its main intake reasons are its memory and concentration enhancing properties. Beside these well-known effects, there has been put forward a hypothesis that caffeine consumption along with antinociceptive medication can potentiate the analgesic effect of this class of drugs. Our aim was to point out the importance of this particular potentiator effect by selecting and analyzing all papers on this topic written in English from the Medline database, published until the present moment. We observed that caffeine can represent a significant aid for certain patients in matters of pain management, by both reducing the pain killer doses and by increasing life quality.

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Erratum

This is a correction of the article The Statistical Analysis of Pharmacokinetic Parameters in the Context of Bioequivalence Testing of Two Anthelmintic Formulas Based on Ivermectine and Triclabendazole in Sheep (Acta Medica Marisiensis 2019;65(2):60-65. DOI: 10.2478/amma-2019-0015), published in the June 2019 issue of Acta Medica Marisiensis (currently Acta Marisiensis – Seria Medica), which contains errors in the authors’ affiliation. The correct data are presented below:

The Statistical Analysis of Pharmacokinetic
Parameters in the Context of Bioequivalence Testing of Two Anthelmintic Formulas Based on Ivermectine and Triclabendazole in Sheep

Lenard Farczadi1,2,3, Laurian Vlase2*, Orsolya Melles1, Ramona Tolomeiu4, Octavia Tamas-Krumpe4, Andreea Buta4, Laurentiu Ognean4
1. Clinical and Analytical Research Center Vim Spectrum Ltd, Sighișoarei Street, no. 409, 547367, Corunca – Mureș, Romania
2. Department of Pharmaceutical Technology and Biopharmaceutics, Faculty of Pharmacy, “Iuliu Haţieganu” University of Medicine and Pharmacy, Emil Isac street, no. 13, 400023, Cluj-Napoca, Romania
3. Center for Advanced Medical and Pharmaceutical Research of the George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures, Romania
4. Department of Physiology, University of Agricultural Science and Veterinary Medicine, Mănăștur Street, no. 3-5, 400037, Cluj-Napoca, Romania

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The Efficacy of Rational Emotive Behavior Therapy Intervention in Generalized Anxiety Disorder

Alina Schenk1, Cosmin Octavian Popa2, Peter Olah2, Nicoleta Suciu2, Cristiana Cojocaru3

1. Save the Children Mures Branch, Romania
2. George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, Romania
3. Braun Dialysis Centre, Sighișoara, Mureș County, Romania

DOI: 10.2478/amma-2020-0027

Background: Generalized Anxiety Disorder is one of the anxiety disorders which presents excessive anxiety and worries as central elements that are difficult to control in many situations or activities. Rational Emotive Behavior Therapy is one of the most important orientations among psychological intervention in the psychotherapy field. This approach is based on a transdiagnostic perspective. Additionally, this therapy has a strong research foundation especially in the treatment of anxiety disorders and depression.
Objective: The present study aims to establish the efficacy of Rational Emotive Behaviour Therapy in medical students who are suffering from generalized anxiety disorder.
Method: The sample of this study consisted of N = 40 first-year medical students (33 women and 7 men) and the average age for the entire group was Mage= 19.22, SD= 1.04. Each student participated at eight therapy sessions. The level of anxiety and irrational beliefs were measured at pre-intervention and post-intervention using psychological questionnaires.
Results: Our findings indicate a statistically significant difference between the pre-intervention and post-intervention phase for the level of anxiety with a value of t = 20.31, df =78, P < 0.001, for irrational cognitions with t = 2.44, df =78, P < 0.05, for irrational beliefs with t = 3.45, df =77, P < 0.01, as well as low frustration tolerance with t = 2.57, df =77, P < 0.05 and awfulizing specifically.
Conclusion: The Rational Emotive Behavior Therapy intervention is an extremely efficient psychological treatment for improving emotional functioning in medical students.

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Factors Influencing the Choice of a Pharmacy in Romania: Comparation between Studies Performed in 2012 and 2020

Marius Călin Cherecheș1, Cristian Olimpiu Popa2

1. Faculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Sciences and Technology, Targu Mures, Romania
2. Faculty of European Studies, Babeș-Bolyai University Cluj Napoca, Romania

DOI: 10.2478/amma-2020-0029

The main factors perceived by patients as important in selecting a pharmacy were studied for many years. Selected studies mentioned primarily factors such as location, pharmacist competence and attitude, pharmacy services and premiums, and prices. We compared the results from our study in June 2012 with the results of the most recent study conducted in April 2020 focusing on the main factors influencing the patient’s option for a specific pharmacy. Respondents were asked an open question about what is the most important factor they consider when choosing a pharmacy and then answers were grouped into main categories. The urban population has been considered for both studies. The results tell us that the factors influencing the choice of a pharmacy remained unchanged over the time: i) prices, ii) availability of medicine, iii) professionalism of the pharmacist and iv) pharmacy proximity is the most mentioned by our respondents in both studies. However, the rank between these factors changed. Prices remain the top factor while the Availability of medicine (products) has been overcome by the Professionalism of the pharmacist (Attitude of the pharmacist) and Proximity. Using the logistic regression and Odds Ratio, we tried to identify socio-demographic segments significantly associated with these factors. Persons with low income are very likely to indicate Price as the most important factor in choosing a pharmacy in 2012 (OR = 2.088, p=0.018), while respondents aged 65 years and older are more likely not to indicate Price as the most important factor compared with other age groups, in both 2012 and 2020 studies (OR = 0.4, p=0.009, respective OR= 0.325, p=0.010). For this type of respondent, 65 years old and above, the attitude of the pharmacist is the most important factor influencing their choice of a pharmacy in 2020, while products availability has been the most frequent answer for this segment back in 2012. Results in Romania are similar to the ones collected from other countries as reported by other studies. However, particularities of the local market and regulations are influencing the ranking.

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Genitourinary Bacterial Infection: a Cause of Infertility in Men? A Cases Series and Short Review of Literature

Răzvan Lucian Coșeriu1, Camelia Vintilă1, Bianca Irina Kosovski2, Anca Delia Mare3, Cristina Nicoleta Ciurea3

1. Department of Immunology, Mures County Clinical Hospital – Infectious Diseases Laboratory, Targu Mures, Romania
2. Department of Physiopathology, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, Romania
3. Department of Microbiology, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, Romania

DOI: 10.2478/amma-2020-0024

Introduction: The role of bacterial infections on the onset and the development of male infertility is still highly controversial, as the clinical cases have different outcomes and the practitioners have no guidelines that will help them select the cases that could better benefit from antibiotic treatment.
Case presentation: Four case reports are presented in order to emphasize the possible clinical implications of genitourinary bacterial infections on male infertility. The first patient had two bacterial strains isolated from the semen culture, Escherichia coli, and then Enterococcus faecalis. The antibiotic treatment was not effective. The second patient had a semen culture positive with Enterococcus faecalis. The treatment was successful: the bacteria were eradicated and the patient was able to conceive a baby. Enterococcus faecalis was also identified in the third and the fourth case. These patients were able to conceive, despite the different clinical management strategies of the cases.
Conclusion: Bacterial prostatitis might play a role in male infertility, but the clinical cases are still highly unpredictable. Every case presents a different viewpoint and raises awareness of the complexity of the problem.

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Ovarian Endometriosis and Malignant Transformation in Clear Cell Carcinoma

Ioana Maria Maier1, Adrian Cornel Maier2

1. Doctoral school, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, Romania
2. Department of Urology, Faculty of Medicine, University “Dunarea de Jos” Galati, Romania

DOI: 10.2478/amma-2020-0023

Atypical endometriosis is considered to be precursors for malignancy. Coexistence of atypical endometriosis and ovarian neoplasm has been found in some studies. We describe the case of a 48-year old women diagnosed with clear cell carcinoma of ovary. The review of histological slide confirms the presence of benign endometriosis in both ovaries, the atypical endometriosis and clear cell carcinoma in the right ovary and the presence of uterine leiomyoma.

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